Chapter 700 Examination of Applications ---SECTION---701 Statutory Authority for Examination 35 U.S.C. 131 Examination of application. The Commissioner shall cause an examination to be made of the application and the alleged new invention; and if on such examination it appears that the applicant is entitled to a patent under the law, the Commissioner shall issue a patent therefor. The main conditions precedent to the grant of a patent to an applicant are set forth in 35 U.S.C. 101, 102 and 103. 35 U.S.C. 101 Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Form Paragraph 7.04 copies 35 U.S.C. 101. 35 U.S.C. 100 Definitions. When used in this title unless the context otherwise indicates - (a) The term "invention" means invention or discovery. (b) The term " process" means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material. (c) The terms "United States" and "this country" mean the United States of America, its territories and possessions. (d) The word "patentee" includes not only the patentee to whom the patent was issued but also the successors in title to the patentee. ---SECTION---702 Requisites of the Application When a new application is assigned in the examining group, the examiner should review the contents of the application to determine if the application meets the requirements of 35 U.S.C. 111(a). Any matters affecting the filing date or abandonment of the application, such as lack of an oath or declaration, filing fee, or claims should be checked before the application is placed in the storage racks to await the first action. The examiner should be careful to see that the application meets all the requisites set forth in MPEP Chapter 600 both as to formal matters and as to the completeness and clarity of the disclosure. If all of the requisites are not met, applicant may be called upon for necessary amendments. Such amendments, however, must not include new matter. ---SECTION---702.01 Obviously Informal Cases When an application is reached for its first Office action and it is then discovered to be impractical to give a complete action on the merits because of an informal or insufficient disclosure, the following procedure may be followed: (A) A reasonable search should be made of the invention so far as it can be understood from the disclosure, objects of invention and claims and any apparently pertinent art cited. In the rare case in which the disclosure is so incomprehensible as to preclude a reasonable search the Office action should clearly inform applicant that no search was made; (B) Informalities noted by the Office of Initial Patent Examination (OIPE) and deficiencies in the drawing should be pointed out by means of attachments to the Office action (see MPEP Section 707.07(a)); (C) A requirement should be made that the specification be revised to conform to idiomatic English and United States practice; (D) The claims should be rejected as failing to define the invention in the manner required by 35 U.S.C. 112 if they are informal. A blanket rejection is usually sufficient. The examiner should attempt to point out the points of informality in the specification and claims. The burden is on the applicant to revise the application to render it in proper form for a complete examination. If a number of obviously informal claims are filed in an application, such claims should be treated as being a single claim for fee and examination purposes. It is obviously to applicant's advantage to file the application with an adequate disclosure and with claims which conform to the U.S. Patent and Trademark Office usages and requirements. This should be done whenever possible. If, however, due to the pressure of a Convention deadline or other reasons, this is not possible, applicants are urged to submit promptly, preferably within 3 months after filing, a preliminary amendment which corrects the obvious informalities. The informalities should be corrected to the extent that the disclosure is readily understood and the claims to be initially examined are in proper form, particularly as to dependency, and otherwise clearly define the invention. "New matter" must be excluded from these amendments since preliminary amendments do not enjoy original disclosure status. See MPEP Section 608.04(b). Whenever, upon examination, it is found that the terms or phrases or modes of characterization used to describe the invention are not sufficiently consonant with the art to which the invention pertains, or with which it is most nearly connected, to enable the examiner to make the examination specified in 37 CFR 1.104, the examiner should make a reasonable search of the invention so far as it can be understood from the disclosure. The action of the examiner may be limited to a citation of what appears to be the most pertinent prior art found and a request that applicant correlate the terminology of the specification with art-accepted terminology before further action is made. Use form paragraph 7.01 where the terminology is such that a proper search cannot be made. 7.01 Use of Terminology, Cannot Be Examined A preliminary examination of this application reveals that it includes terminology which is so different from that which is generally accepted in the art to which this invention pertains that a proper search of the prior art cannot be made. For example: [1] Applicant is required to provide a clarification of these matters or correlation with art-accepted terminology so that a proper comparison with the prior art can be made. Applicant should be careful not to introduce any new matter into the disclosure (i.e., matter which is not supported by the disclosure as originally filed). A shortened statutory period for reply to this action is set to expire ONE MONTH or THIRTY DAYS, whichever is longer, from the mailing date of this letter. Examiner Note: 1. Use this or paragraph 7.02 when a proper search cannot be made. However, see MPEP Section 702.01 which requires a reasonable search. 2. In bracket 1, fill in an appropriate indication of the terminology, properties, units of data, etc. that are the problem as well as the pages of the specification involved. 3. For the procedure to be followed when only the drawing is informal, see MPEP Section Section 608.02(a) and 608.02(b). Use form paragraph 7.02 where the application is so incomprehensible that a reasonable search cannot be made. 7.02 Disclosure Is Incomprehensible The disclosure is objected to under 37 CFR 1.71, as being so incomprehensible as to preclude a reasonable search of the prior art by the examiner. For example, the following items are not understood: [1] Applicant is required to submit an amendment which clarifies the disclosure so that the examiner may make a proper comparison of the invention with the prior art. Applicant should be careful not to introduce any new matter into the disclosure (i.e., matter which is not supported by the disclosure as originally filed). A shortened statutory period for reply to this action is set to expire ONE MONTH or THIRTY DAYS, whichever is longer, from the mailing date of this letter. Examiner Note: 1. Use this paragraph when a search cannot be made. 2. In bracket 1, indicate the page numbers and features which are not understood. 3. See form paragraphs 6.28 and 6.30 for improper idiomatic English. Use form paragraph 7.03 where the invention cannot be understood because of illegible handwritten pages. 7.03 Pages Are Illegible The examiner cannot understand the invention because certain portions of the disclosure are illegible. The illegible portion(s) consist of [1]. Applicant is required to submit an appropriate amendment rectifying this deficiency. In the alternative, a substitute specification under 37 CFR 1.125(b), may be filed. The substitute specification must be accompanied by: (1) a statement that the substitute specification contains no new matter; and (2) a marked-up copy showing the amendments to be made via the substitute specification relative to the specification at the time the substitute specification is filed. A shortened statutory period for reply to this action is set to expire ONE MONTH or THIRTY DAYS, whichever is longer, from the mailing date of this letter. Examiner Note: 1. In bracket 1, identify the portions of the specification which are illegible. 2. This form paragraph is to be used only when the invention cannot be understood because of the illegible material, see MPEP Section 702.01. 3. See Chapter 1700 for handwritten specifications filed by pro se applicants. 4. Use form paragraph 7.02 when the disclosure is incomprehensible. For the procedure to be followed when only the drawing is informal, see MPEP Section 608.02(a) and Section 608.02(b). ---SECTION---703 "General Information Concerning Patents" The pamphlet "General Information Concerning Patents" for use by applicants contemplating the filing or prosecution of their own applications, may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. The pamphlet is also available from the PTO Web page at: http://www.uspto.gov. ---SECTION---704 Search After reading the specification and claims, the examiner searches the prior art. The subject of searching is more fully treated in MPEP Chapter 900. See especially MPEP Section 904 through Section 904.02. The invention should be thoroughly understood before a search is undertaken. However, informal cases, or those which can only be imperfectly understood when they come up for action in their regular turn are also given a search, in order to avoid piecemeal prosecution. PREVIOUS EXAMINER'S SEARCH When an examiner is assigned to act on an application which has received one or more actions by some other examiner, full faith and credit should be given to the search and action of the previous examiner unless there is a clear error in the previous action or knowledge of other prior art. In general the second examiner should not take an entirely new approach to the case or attempt to reorient the point of view of the previous examiner, or make a new search in the mere hope of finding something. See MPEP Section 719.05. ---SECTION---705 Patentability Reports Where an application, properly assigned to one examining group, is found to contain one or more claims, per se, classifiable in one or more other groups, which claims are not divisible inter se or from the claims which govern classification of the application in the first group, the application may be referred to the other group or groups concerned for a report as to the patentability of certain designated claims. This report is known as a Patentability Report (P.R.) and is signed by the primary examiner in the reporting group. The report, if legibly written, need not be typed. Note that the Patentability Report practice is only to be used in extraordinary circumstances. See MPEP Section 705.01(e). ---SECTION---705.01 Instructions re Patentability Reports When an application comes up for any action and the primary examiners involved (i.e., from both the requesting and the requested group) agree that a Patentability Report is necessary, and if the Group Director of the requesting group approves, the application is forwarded to the proper group with a memorandum attached, for instance, "For Patentability Report from group -- as to claims --." ---SECTION---705.01(a) Nature of P.R., Its Use and Disposal The primary examiner in the group from which the Patentability Report is requested, if he or she approves the request, will direct the preparation of the Patentability Report. This Patentability Report is written or typed on a memorandum form and will include the citation of all pertinent references and a complete action on all claims involved. The field of search covered should be endorsed on the file wrapper by the examiner making the report. When an examiner to whom an application has been forwarded for a Patentability Report is of the opinion that final action is in order as to the referred claims, he or she should so state. The Patentability Report when signed by the primary examiner in the reporting group will be returned to the group to which the application is regularly assigned and placed in the file wrapper. The examiner preparing the Patentability Report will be entitled to receive an explanation of the disclosure from the examiner to whom the case is assigned to avoid duplication of work. If the primary examiner in a reporting group is of the opinion that a Patentability Report is not in order, he or she should so advise the primary examiner in the forwarding group. DISAGREEMENT AS TO CLASSIFICATION Conflict of opinion as to classification may be referred to a patent classifier for decision. If the primary examiner in the group having jurisdiction of the application agrees with the Patentability Report, he or she should incorporate the substance thereof in his or her action, which action will be complete as to all claims. The Patentability Report in such a case is not given a paper number but is allowed to remain in the file until the application is finally disposed of by allowance or abandonment, at which time it should be removed. DISAGREEMENT ON PATENTABILITY REPORT If the primary examiner does not agree with the Patentability Report or any portion thereof, he or she may consult with the primary examiner responsible for the report. If agreement as to the resulting action cannot be reached, the primary examiner having jurisdiction of the case need not rely on the Patentability Report but may make his or her own action on the referred claims, in which case the Patentability Report should be removed from the file. APPEAL TAKEN When an appeal is taken from the rejection of claims, all of which are examinable in the group preparing a Patentability Report, and the application is otherwise allowable, formal transfer of the application to said group should be made for the purpose of appeal only. The receiving group will take jurisdiction of the application and prepare the examiner's answer. At the time of allowance, the application may be sent to issue by said group with its classification determined by the controlling claims remaining in the case. ---SECTION---705.01(b) Sequence of Examination In the event that the supervisory patent examiners concerned in a P.R. case cannot agree as to the order of examination by their groups, the supervisory patent examiner having jurisdiction of the application will direct that a complete search be made of the art relevant to his or her claims prior to referring the application to another group for report. The group to which the application is referred will be advised of the results of this search. If the supervisory patent examiners are of the opinion that a different sequence of search is expedient, the order of search should be correspondingly modified. ---SECTION---705.01(c) Counting and Recording P.R.'s The forwarding of the application for a Patentability Report is not to be treated as a transfer by the forwarding group. When the P.R. is completed and the application is ready for return to the forwarding group, it is not counted either as a receipt or action by transfer. Credit, however, is given for the time spent. The date status of the application in the reporting group will be determined on the basis of the dates in the group of original jurisdiction. To ensure orderly progress in the reported dates, a timely reminder should be furnished to the group making the P.R. ---SECTION---705.01(d) Duplicate Prints of Drawings In Patentability Report applications having drawings, the examiner to whom the case is assigned will furnish to the group to which the application is referred, prints of such sheets of the drawings as are applicable, for interference search purposes. That this has been done may be indicated by a pencil notation on the file wrapper. When an application that has had Patentability Report prosecution is passed for issue or becomes abandoned, NOTIFICATION of this fact will AT ONCE be given by the group having jurisdiction of the application to each group that submitted a Patentability Report. The examiner of each such reporting group will note the date of allowance or abandonment on the duplicate set of prints. At such time as these prints become of no value to the reporting group, they may be destroyed. ---SECTION---705.01(e) Limitation as to Use The above outlined Patentability Report practice is not obligatory and should be resorted to only where it will save total examiner time or result in improved quality of action due to specialized knowledge. A saving of total examiner time that is required to give a complete examination of an application is of primary importance. Patentability Report practice is based on the proposition that when plural, indivisible inventions are claimed, in some instances either less time is required for examination, or the results are of better quality, when specialists on each character of claimed invention treat the claims directed to their specialty. However, in many instances a single examiner can give a complete examination of as good quality on all claims, and in less total examiner time than would be consumed by the use of the Patentability Report practice. Where claims are directed to the same character of invention but differ in scope only, prosecution by Patentability Report is never proper. Exemplary situation where Patentability Reports are ordinarily not proper are as follows: (A) Where the claims are related as a manufacturing process and a product defined by the process of manufacture. The examiner having jurisdiction of the process can usually give a complete, adequate examination in less total examiner time than would be consumed by the use of a Patentability Report. (B) Where the claims are related as product and a process which involves merely the fact that a product having certain characteristics is made. The examiner having jurisdiction of the product can usually make a complete and adequate examination. (C) Where the claims are related as a combination distinguished solely by the characteristics of a subcombination and such subcombination, per se. The examiner having jurisdiction of the subcombination can usually make a complete and adequate examination. Where it can be shown that a Patentability Report will save total examiner time, one is permitted with the approval of the Group Director of the group to which the application is assigned. The "Approved" stamp should be impressed on the memorandum requesting the Patentability Report. ---SECTION---705.01(f) Interviews With Applicants In situations where an interview is held on an application in which a Patentability Report has been adopted, the reporting group may be called on for assistance at the interview when it concerns claims treated by them. See MPEP Section 713 to Section 713.10 regarding interviews in general. ---SECTION---706 Rejection of Claims After the application has been read and the claimed invention understood, a prior art search for the claimed invention is made. With the results of the prior art search, including any references provided by the applicant, the patent application should be reviewed and analyzed in conjunction with the state of the prior art to determine whether the claims define a useful, novel, nonobvious, and enabled invention that has been clearly described in the specification. The goal of examination is to clearly articulate any rejection early in the prosecution process so that the applicant has the opportunity to provide evidence of patentability and otherwise reply completely at the earliest opportunity. The examiner then reviews all the evidence, including arguments and evidence responsive to any rejection before issuing the next Office action. Although this part of the Manual explains the procedure in rejecting claims, the examiner should never overlook the importance of his or her role in allowing claims which properly define the invention. 37 CFR 1.104 Nature of examination. +++ (c) Rejection of claims. (1) If the invention is not considered patentable, or not considered patentable as claimed, the claims, or those considered unpatentable will be rejected. (2) In rejecting claims for want of novelty or for obviousness, the examiner must cite the best references at his or her command. When a reference is complex or shows or describes inventions other than that claimed by the applicant, the particular part relied on must be designated as nearly as practicable. The pertinence of each reference, if not apparent, must be clearly explained and each rejected claim specified. (3) In rejecting claims the examiner may rely upon admissions by the applicant, or the patent owner in a reexamination proceeding, as to any matter affecting patentability and, insofar as rejections in applications are concerned, may also rely upon facts within his or her knowledge pursuant to paragraph (d)(2) of this section. (4) Subject matter which is developed by another person which qualifies as prior art only under 35 U.S.C. 102(f) or (g) may be used as prior art under 35 U.S.C. 103 against a claimed invention unless the entire rights to the subject matter and the claimed invention were commonly owned by the same person or organization or subject to an obligation of assignment to the same person or organization at the time the claimed invention was made. (5) The claims in any original application naming an inventor will be rejected as being precluded by a waiver in a published statutory invention registration naming that inventor if the same subject matter is claimed in the application and the statutory invention registration. The claims in any reissue application naming an inventor will be rejected as being precluded by a waiver in a published statutory invention registration naming that inventor if the reissue application seeks to claim subject matter: (i) Which was not covered by claims issued in the patent prior to the date of publication of the statutory invention registration; and (ii) Which was the same subject matter waived in the statutory invention registration. +++ UNIFORM APPLICATION OF THE PATENTABILITY STANDARD The standards of patentability applied in the examination of claims must be the same throughout the Office. In every art, whether it be considered "complex," "newly developed," "crowded," or "competitive," all of the requirements for patentability (e.g., novelty, usefulness and unobviousness, as provided in 35 U.S.C. 101, 102, and 103) must be met before a claim is allowed. The mere fact that a claim recites in detail all of the features of an invention (i.e., is a "picture" claim) is never, in itself, justification for the allowance of such a claim. An application should not be allowed , unless and until issues pertinent to patentability have been raised and resolved in the course of examination and prosecution, since otherwise the resultant patent would not justify the statutory presumption of validity (35 U.S.C. 282), nor would it "strictly adhere" to the requirements laid down by Congress in the 1952 Act as interpreted by the Supreme Court. The standard to be applied in all cases is the "preponderance of the evidence" test. In other words, an examiner should reject a claim if, in view of the prior art and evidence of record, it is more likely than not that the claim is unpatentable. DEFECTS IN FORM OR OMISSION OF A LIMITATION; CLAIMS OTHERWISE ALLOWABLE When an application discloses patentable subject matter and it is apparent from the claims and the applicant's arguments that the claims are intended to be directed to such patentable subject matter, but the claims in their present form cannot be allowed because of defects in form or omission of a limitation, the examiner should not stop with a bare objection or rejection of the claims. The examiner's action should be constructive in nature and when possible should offer a definite suggestion for correction. PATENTABLE SUBJECT MATTER DISCLOSED BUT NOT CLAIMED If the examiner is satisfied after the search has been completed that patentable subject matter has been disclosed and the record indicates that the applicant intends to claim such subject matter, he or she may note in the Office action that certain aspects or features of the patentable invention have not been claimed and that if properly claimed such claims may be given favorable consideration. RECONSIDERATION OF CLAIMS AFTER REPLY BY APPLICANT 37 CFR 1.112 Reconsideration before final action. After reply by applicant or patent owner (Section 1.111) to a non-final action, the application or patent under reexamination will be reconsidered and again examined. The applicant or patent owner will be notified if claims are rejected, or objections or requirements made, in the same manner as after the first examination. Applicant or patent owner may reply to such Office action in the same manner provided in Section 1.111, with or without amendment, unless such Office action indicates that it is made final (Section 1.113). 37 CFR 1.112 provides for the reconsideration and continued examination of an application or a patent under reexamination after reply by the applicant or the patent owner. If claims are rejected, or objections or requirements made, applicant or patent owner will be notified in the same manner as after the first examination. Applicant or patent owner may reply to such Office action in the same manner provided in 37 CFR 1.111, with or without amendment, unless such Office action indicates that it is made final (37 CFR 1.113). REJECTIONS IN STATUTORY INVENTION REGISTRATIONS See MPEP Chapter 1100 for rejection of claims in an application for a Statutory Invention Registration. ---SECTION---706.01 Contrasted With Objections The refusal to grant claims because the subject matter as claimed is considered unpatentable is called a "rejection." The term "rejected" must be applied to such claims in the examiner's action. If the form of the claim (as distinguished from its substance) is improper, an "objection" is made. An example of a matter of form as to which objection is made is dependency of a claim on a rejected claim, if the dependent claim is otherwise allowable. See MPEP Section 608.01(n). The practical difference between a rejection and an objection is that a rejection, involving the merits of the claim, is subject to review by the Board of Patent Appeals and Interferences, while an objection, if persisted, may be reviewed only by way of petition to the Commissioner. Similarly, the Board will not hear or decide issues pertaining to objections and formal matters which are not properly before the Board. These formal matters should not be combined in appeals to the Board. ---SECTION---706.02 Rejection on Prior Art 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. A person shall be entitled to a patent unless - (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent, or (f) he did not himself invent the subject matter sought to be patented, or (g) before the applicant's invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it. In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other. 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter. (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if- (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1)- (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154 (3) For purposes of paragraph (1), the term `biotechnological process' means- (A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to- (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c) Subject matter developed by another person, which qualifies as prior art only under subsection (f) or (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. By far the most frequent ground of rejection is on the ground of unpatentability in view of the prior art, that is, that the claimed subject matter is either not novel under 35 U.S.C. 102, or else it is obvious under 35 U.S.C. 103. The language to be used in rejecting claims should be unequivocal. See MPEP Section 707.07(d). CHOICE OF PRIOR ART; BEST AVAILABLE Prior art rejections should ordinarily be confined strictly to the best available art. Exceptions may properly be made, for example, where: (A) the propriety of a 35 U.S.C. 102 or 103 rejection depends on a particular interpretation of a claim; (B) a claim is met only in terms by a reference which does not disclose the inventive concept involved; or (C) the most pertinent reference seems likely to be antedated by a 37 CFR 1.131 affidavit or declaration. Such rejections should be backed up by the best other art rejections available. Merely cumulative rejections, i.e., those which would clearly fall if the primary rejection were not sustained, should be avoided. See also MPEP Section 707.05. REEXAMINATION For scope of rejections in reexamination proceedings see MPEP Section 2258. DISTINCTION BETWEEN 35 U.S.C. 102 AND 103 The distinction between rejections based on 35 U.S.C. 102 and those based on 35 U.S.C. 103 should be kept in mind. Under the former, the claim is anticipated by the reference. No question of obviousness is present. In other words, for anticipation under 35 U.S.C. 102, the reference must teach every aspect of the claimed invention either explicitly or impliedly. Any feature not directly taught must be inherently present. Whereas, in a rejection based on 35 U.S.C. 103, the reference teachings must somehow be modified in order to meet the claims. The modification must be one which would have been obvious to one of ordinary skill in the art at the time the invention was made. See MPEP Section 2131 - Section 2146 for guidance on patentability determinations under 35 U.S.C. 102 and 103. DETERMINING THE EFFECTIVE FILING DATE OF THE APPLICATION The effective filing date of a U.S. application may be determined as follows: (A) If the application is a continuation or divisional of one or more earlier U.S. applications and if the requirements of 35 U.S.C. 120 have been satisfied, the effective filing date is the same as the earliest filing date in the line of continuation or divisional applications. (B) If the application is a continuation-in-part of an earlier U.S. application, any claims in the new application not supported by the specification and claims of the parent application have an effective filing date equal to the filing date of the new application. Any claims which are fully supported under 35 U.S.C. 112 by the earlier parent application have the effective filing date of that earlier parent application. (C) If the application claims foreign priority under 35 U.S.C. 119(a)-(d), the effective filing date is the filing date of the U.S. application, unless situation 1 or 2 as set forth above applies. The filing date of the foreign priority document is not the effective filing date, although the filing date of the foreign priority document may be used to overcome certain references. See MPEP Section 706.02(b) and Section 2136.05. (D) If the application is entitled to priority under 35 U.S.C. 119(e) from a provisional application, the effective filing date is the filing date of the provisional application. See MPEP Section 1893.03(b) for determining the effective filing date of an application filed under 35 U.S.C. 371. See MPEP Section 201.11(a) and Section 1895 for determining the effective filing date of a continuation, divisional, or continuation-in-part of a PCT application designating the U.S. See also MPEP Section 1895.01 and Section 1896 which discuss differences between applications filed under 35 U.S.C. 111(a) and 35 U.S.C. 371. ---SECTION---706.02(a) Rejections Under 35 U.S.C. 102(a), (b), or (e); Printed Publication or Patent Once the examiner conducts a search and finds a printed publication or patent which discloses the claimed invention, the examiner should determine whether the rejection should be made under 35 U.S.C. 102(a), (b), or (e). In order to determine which section of 35 U.S.C. 102 applies, the effective filing date of the application must be determined and compared with the date of the reference. See MPEP Section 706.02 regarding determination of effective filing date of the application. DETERMINING THE REFERENCE ISSUE OR PUBLICATION DATE The examiner must also determine the issue or publication date of the reference so that a proper comparison between the application and reference dates can be made. Where the last day of the year dated from the date of publication falls on a Saturday, Sunday or Federal holiday, the publication is not a statutory bar under 35 U.S.C. 102(b) if the application was filed on the next succeeding business day. Ex parte Olah, 131 USPQ 41 (Bd. App. 1960) (The Board in Olah held that 35 U.S.C. 21(b) is applicable to the filing of an original application for patent and that applicant's own activity will not bar a patent if the 1-year grace period expires on a Saturday, Sunday, or Federal holiday and the application's U.S. filing date is the next succeeding business day.) Despite changes to 37 CFR 1.6(a)(2) and 1.10 which permit the PTO to accord a filing date to an application as of the date of deposit as "Express Mail" with the U.S. Postal Service in accordance with 37 CFR 1.10 (e.g., a Saturday filing date), the rule changes do not affect applicant's concurrent right to defer the filing of an application until the next business day when the last day for "taking any action" falls on a Saturday, Sunday, or Federal holiday (e.g., the last day of the 1-year grace period falls on a Saturday). It should also be noted that a magazine is effective as a printed publication under 35 U.S.C. 102(b) as of the date it reached the addressee and not the date it was placed in the mail. Protein Foundation Inc. v. Brenner, 260 F. Supp. 519, 151 USPQ 561 (D.D.C. 1966). See MPEP Section 707.05(f). For foreign patents see MPEP Section 901.05. See MPEP Section 2124, Section 2126, and Section 2128 - Section 2128.02 for case law relevant to reference date determination. DETERMINING WHETHER TO APPLY 35 U.S.C. 102(a), (b), or (e) First, the examiner should consider whether the reference qualifies as prior art under 35 U.S.C. 102(b) because this section results in a statutory bar to obtaining a patent. If the publication or issue date of the reference is more than 1 year prior to the effective filing date of the application (MPEP Section 706.02), the reference qualifies as prior art under 35 U.S.C. 102(b). If the publication or issue date of the reference is too recent for 35 U.S.C. 102(b) to apply, then the examiner should consider 35 U.S.C. 102(e). For 35 U.S.C. 102(e) to apply: (A) The reference must be a U.S. Patent with a filing date earlier than the effective filing date of the application. Note that, for purposes of 35 U.S.C. 102(e), the filing date of the reference patent which has issued on an application entitled to priority from a provisional application under 35 U.S.C. 119(e) is the filing date of the provisional application, except for a patent granted on an international application (PCT) in which applicant has fulfilled the requirements of paragraphs (1), (2) and (4) of 35 U.S.C. 371. The filing date of a patent granted on such a 35 U.S.C. 371 application is the date on which paragraphs (1), (2) and (4) of 35 U.S.C. 371 have been fulfilled; and (B) The inventive entity of the application must be different than that of the reference. Note that, where there are joint inventors, only one inventor need be different for the inventive entities to be different and a rejection under 35 U.S.C. 102(e) is applicable even if there are some common inventors. If 35 U.S.C. 102(e) does not apply, then the examiner should consider 35 U.S.C. 102(a). For 35 U.S.C. 102(a) to apply, the reference must have a publication date earlier in time than the effective filing date of the application, and must not be applicant's own work. ---SECTION---706.02(b) Overcoming a 35 U.S.C. 102 Rejection Based on a Printed Publication or Patent A rejection based on 35 U.S.C. 102(b) can be overcome by: (A) Persuasively arguing that the claims are patentably distinguishable from the prior art; or (B) Amending the claims to patentably distinguish over the prior art. A rejection based on 35 U.S.C. 102(e) can be overcome by: (A) Persuasively arguing that the claims are patentably distinguishable from the prior art; (B) Amending the claims to patentably distinguish over the prior art; (C) Filing an affidavit or declaration under 37 CFR 1.132 showing that the reference invention is not by "another." See MPEP Section 715.01(a), Section 715.01(c), and Section 716.10; (D) Filing an affidavit or declaration under 37 CFR 1.131 showing prior invention, if the reference is not a U.S. patent (or application in the case of a provisional rejection) claiming the same patentable invention as defined in 37 CFR 1.601(n). See MPEP Section 715 for more information on 37 CFR 1.131 affidavits. When the claims of the reference and the application are directed to the same invention or are obvious variants, an affidavit or declaration under 37 CFR 1.131 is not an acceptable method of overcoming the rejection. Under these circumstances, the examiner must determine whether a double patenting rejection or interference is appropriate. If there is a common assignee or inventor between the application and patent, a double patenting rejection must be made. See MPEP Section 804. If there is no common assignee or inventor and the rejection under 35 U.S.C. 102(e) is the only possible rejection, the examiner must determine whether an interference should be declared. See MPEP Chapter 2300 for more information regarding interferences; (E) Perfecting a claim to priority under 35 U.S.C. 119(a)-(d). The foreign priority filing date must antedate the reference and be perfected. The filing date of the priority document is not perfected unless applicant has filed a certified priority document in the application (and an English language translation, if the document is not in English) (see 37 CFR 1.55) and the examiner has established that the priority document satisfies the enablement and description requirements of 35 U.S.C. 112, first paragraph; or (F) Perfecting priority under 35 U.S.C. 119(e) by amending the specification of the application to contain a specific reference to a provisional application in accordance with 37 CFR 1.78(a)(4). A rejection based on 35 U.S.C. 102(a) can be overcome by: (A) Persuasively arguing that the claims are patentably distinguishable from the prior art; (B) Amending the claims to patentably distinguish over the prior art; (C) Filing an affidavit or declaration under 37 CFR 1.131. See MPEP Section 715 for information on the requirements of 37 CFR 1.131 affidavits. (D) Filing an affidavit or declaration under 37 CFR 1.132 showing that the reference invention is not by "another." See MPEP Section 715.01(a), Section 715.01(c), and Section 716.10; (E) Perfecting a claim to priority under 35 U.S.C. 119(a)-(d) as explained in reference to 35 U.S.C. 102(e) above; (F) Perfecting priority under 35 U.S.C. 119(e) by amending the specification of the application to contain a specific reference to a provisional application in accordance with 37 CFR 1.78(a)(4). ---SECTION---706.02(c) Rejections Under 35 U.S.C. 102(a) or (b); Knowledge by Others or Public Use or Sale An applicant may make an admission, or submit evidence of sale of the invention or knowledge of the invention by others, or the examiner may have personal knowledge that the invention was sold by applicant or known by others in this country. The language "in this country" means in the United States only and does not include other WTO or NAFTA member countries. In these cases the examiner must determine if 35 U.S.C. 102(a) or 102(b) applies. See MPEP Section 2133.03 for a discussion of case law treating the "public use" and "on sale" statutory bars. If the activity is by an entity other than the inventors or assignee, such as sale by another, manufacture by another or disclosure of the invention by applicant to another then both 35 U.S.C. 102(a) and (b) may be applicable. If the evidence only points to knowledge within the year prior to the effective filing date then 35 U.S.C. 102(a) applies. However, no rejection under 35 U.S.C. 102(a) should be made if there is evidence that applicant made the invention and only disclosed it to others within the year prior to the effective filing date. 35 U.S.C. 102(b) is applicable if the activity occurred more than 1 year prior to the effective filing date of the application. See MPEP Section 2133.03 for a discussion of "on sale" and "public use" bars under 35 U.S.C. 102(b). Note that as an aid to resolving public use or on sale issues, as well as to other related matters of 35 U.S.C. 102(b) activity, an applicant may be required to answer specific questions posed by the examiner and to explain or supplement any evidence of record. See 35 U.S.C. 132, 37 CFR 1.104(a)(2). Information sought should be restricted to that which is reasonably necessary for the examiner to render a decision on patentability. A 1- or 2-month time period should be set by the examiner for any reply to the requirement, unless the requirement is part of an Office action having a shortened statutory period, in which case the period for reply to the Office action will also apply to the requirement. If applicant fails to reply in a timely fashion to a requirement for information, the application will be regarded as abandoned. 35 U.S.C. 133. See MPEP Section 2133.03. If there is not enough information on which to base a public use or on sale rejection, the examiner should make a requirement for more information. Form paragraph 7.104 can be used. 7.104 Requirement for Information, Public Use or Sale An issue of public use or on sale activity has been raised in this application. In order for the examiner to properly consider patentability of the claimed invention under 35 U.S.C. 102(b), additional information regarding this issue is required as follows: [1] Applicant is reminded that failure to fully reply to this requirement for information will result in a holding of abandonment. Examiner Note: 1. Information sought should be restricted to that which is reasonably necessary for the examiner to render a decision on patentability. See MPEP Section 2133.03. 2. A one or two month time period should be set by the examiner for reply to the requirement unless it is part of an Office action having an SSP, in which case the period for reply will apply also to the requirement. 3. If sufficient evidence already exists to establish a prima facie case of public use or on sale, use form paragraph 7.16 to make a rejection under 35 U.S.C. 102(b). See MPEP Section 2133.03. ---SECTION---706.02(d) Rejections Under 35 U.S.C. 102(c) Under 35 U.S.C. 102(c), abandonment of the "invention" (as distinguished from abandonment of an application) results in loss of right to a patent. See MPEP Section 2134 for case law which sets forth the criteria for abandonment under 35 U.S.C. 102(c). ---SECTION---706.02(e) Rejections Under 35 U.S.C. 102(d) 35 U.S.C. 102(d) establishes four conditions which, if all are present, establish a statutory bar against the granting of a patent in this country: (A) The foreign application must be filed more than 12 months before the effective filing date of the United States application. See MPEP Section 706.02 regarding determination of the effective filing date of the application. (B) The foreign and United States applications must be filed by the same applicant, his or her legal representatives or assigns. (C) The foreign application must have actually issued as a patent or inventor's certificate (e.g., granted by sealing of the papers in Great Britain) before the filing in the United States. It need not be published but the patent rights granted must be enforceable. (D) The same invention must be involved. If such a foreign patent or inventor's certificate is discovered by the examiner, the rejection is made under 35 U.S.C. 102(d) on the ground of statutory bar. See MPEP Section 2135.01 for case law which further clarifies each of the four requirements of 35 U.S.C. 102(d). SEARCHING FOR 35 U.S.C. 102(d) PRIOR ART The examiner should only undertake a search for an issued foreign patent for use as 35 U.S.C. 102(d) prior art if there is a reasonable possibility that a foreign patent covering the same subject matter as the U.S. application has been granted to the same inventive entity before the U.S. effective filing date, i.e., the time period between foreign and U.S. filings is greater than the usual time it takes for a patent to issue in the foreign country. Normally, the probability of the inventor's foreign patent issuing before the U.S. filing date is so slight as to make such a search unproductive. However, it should be kept in mind that the average pendency varies greatly between foreign countries. In Belgium, for instance, a patent may be granted in just a month after its filing, while in Japan the patent may not issue for a decade. The search for a granted patent can be accomplished on an electronic database either by the examiner or by the staff of the Scientific and Technical Information Center. See MPEP Section 901.06(a), paragraph IV.B., for more information on online searching. The document must be a patent or inventor's certificate and not merely a published or laid open application. ---SECTION---706.02(f) Provisional Rejections Under 35 U.S.C. 102(e); Reference Is a Copending U.S. Patent Application If a copending U.S. patent application discloses subject matter which would anticipate the claims in another pending U.S. application which has a different inventive entity, the examiner should determine whether a provisional 35 U.S.C. 102(e) rejection can be made. I. COPENDING U.S. APPLICATIONS HAVING AT LEAST ONE COMMON INVENTOR OR ARE COMMONLY ASSIGNED If (1) at least one common inventor exists between the applications or the applications are commonly assigned and (2) the effective filing dates are different, then a provisional rejection of the later filed application should be made. The provisional rejection is appropriate because if the earlier filed application becomes a patent it would constitute actual prior art under 35 U.S.C. 102. Since neither application is published at the time of the provisional rejection, the rejection must be made under 35 U.S.C. 102(e). A provisional rejection under 35 U.S.C. 102(e) can be overcome in the same manner that a 35 U.S.C. 102(e) rejection can be overcome. See MPEP Section 706.02(b). The provisional rejection can also be overcome by abandoning the applications and filing a new application containing the subject matter of both. Form paragraph 7.15.01 should be used when making a provisional rejection under 35 U.S.C. 102(e). 7.15.01 Provisional Rejection, 35 U.S.C. 102(e) - Common Assignee or At Least One Common Inventor Claim [1] provisionally rejected under 35 U.S.C. 102(e) as being anticipated by copending Application No. [2] which has a common [3] with the instant application. Based upon the earlier effective U.S. filing date of the copending application, it would constitute prior art under 35 U.S.C. 102(e), if patented. This provisional rejection under 35 U.S.C. 102(e) is based upon a presumption of future patenting of the copending application. [4]. This provisional rejection under 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the copending application was derived from the inventor of this application and is thus not the invention "by another," or by an appropriate showing under 37 CFR 1.131. This rejection may not be overcome by the filing of a terminal disclaimer. See In re Bartfeld, 925 F.2d 1450, 17 USPQ2d 1885 (Fed. Cir. 1991). Examiner Note: 1. This paragraph is used to provisionally reject over a copending application with an earlier filing date that discloses the claimed invention. The copending application must have either a common assignee or at least one common inventor. 2. If the claims are obvious over the invention disclosed in the other copending application, use paragraph 7.21.01. 3. In bracket 3, insert either --assignee-- or --inventor--. 4. In bracket 4, an appropriate explanation may be provided in support of the examiner's position on anticipation, if necessary. 5. If the claims of the copending application conflict with the claims of the instant application, a provisional double patenting rejection should also be given using paragraphs 8.30 and 8.32. 6. If evidence is additionally of record to show that either invention is prior art unto the other under 35 U.S.C. 102(f) or (g), a rejection using paragraphs 7.13 and/or 7.14 should also be made. II. COPENDING APPLICATIONS HAVING NO COMMON INVENTOR OR ASSIGNEE If there is no common assignee or common inventor, the confidential status of applications under 35 U.S.C. 122 must be maintained and no rejection can be made relying on the earlier filed application as prior art under 35 U.S.C. 102(e). If the filing dates of the applications are within 6 months of each other (3 months for simple subject matter) then interference may be proper. See MPEP Chapter 2300. Otherwise, the application with the earliest effective U.S. filing date must be allowed to issue. After the allowed application is published, it can be used as a reference in a rejection under 35 U.S.C. 102(e) in the still pending application. ---SECTION---706.02(g) Rejections Under 35 U.S.C. 102(f) 35 U.S.C. 102(f) bars the issuance of a patent where an applicant did not invent the subject matter being claimed and sought to be patented. See also, 35 U.S.C. 101, which requires that whoever invents or discovers is the party who may obtain a patent for the particular invention or discovery. The examiner must presume the applicants are the proper inventors unless there is proof that another made the invention and that applicant derived the invention from the true inventor. See MPEP Section 2137 - Section 2137.02 for more information on the substantive requirements of rejections under 35 U.S.C. 102(f). ---SECTION---706.02(h) Rejections Under 35 U.S.C. 102(g) 35 U.S.C. 102(g) bars the issuance of a patent where another made the invention in the United States before applicant and had not abandoned, suppressed, or concealed it. This section of 35 U.S.C. 102 forms a basis for interference practice. See MPEP Chapter 2300 for more information on interference procedure. See MPEP Section 2138 - Section 2138.07 for more information on the requirements of 35 U.S.C. 102(g). ---SECTION---706.02(i) Form Paragraphs for Use in Rejections Under 35 U.S.C. 102 The following form paragraphs should be used in making the appropriate rejections. Note that the particular part of the refence relied upon to support the rejection should be identified. 7.07 Statement of Statutory Basis, 35 U.S.C. 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless -- Examiner Note: 1. The statute is no longer being re-cited in all Office actions. It is only required in first actions on the merits and final rejections. Where the statute is not being cited in an action on the merits, use paragraph 7.103. 2. Paragraphs 7.07 to 7.14 are to be used ONLY ONCE in a given Office action. 7.08 102(a), Activity by Another Before Invention by Applicant (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent. Examiner Note: This paragraph must be preceded by paragraph 7.07. 7.09 102(b), Activity More Than One Year Prior to Filing (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by paragraph 7.08. 7.10 102(c), Invention Abandoned (c) he has abandoned the invention. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by one or more of paragraphs 7.08 and 7.09. 7.11 102(d), Foreign Patenting (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by one or more of paragraphs 7.08 to 7.10. 7.12 102(e), Patent to Another with Earlier Filing Date (e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by one or more of paragraphs 7.07 to 7.11. 7.13 102(f), Applicant Not the Inventor (f) he did not himself invent the subject matter sought to be patented. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by one or more of paragraphs 7.08 to 7.12. 7.14 102(g), Priority of Invention (g) before the applicant's invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it. In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other. Examiner Note: This paragraph must be preceded by paragraph 7.07, and may be preceded by one or more of paragraphs 7.08 to 7.13. 7.15 Rejection, 35 U.S.C. 102(a), (b) Patent or Publication, and (g) Claim [1] rejected under 35 U.S.C. 102([2]) as being [3] by [4]. Examiner Note: 1. In bracket 2, insert the appropriate paragraph letter or letters of 35 U.S.C 102 in parentheses. If paragraph (e) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.02. 2. In bracket 3, insert either --clearly anticipated-- or --anticipated-- with an explanation at the end of the paragraph. 3. In bracket 4, insert the prior art relied upon. 4. This rejection must be preceded either by paragraph 7.07 and paragraphs 7.08, 7.09, and 7.14 as appropriate, or by paragraph 7.103. 5. If 35 U.S.C. 102(e) is also being applied, this paragraph must be followed by either form paragraph 7.15.02 or 7.15.03. 7.15.01 Provisional Rejection, 35 U.S.C. 102(e) - Common Assignee or At Least One Common Inventor Claim [1] provisionally rejected under 35 U.S.C. 102(e) as being anticipated by copending Application No. [2] which has a common [3] with the instant application. Based upon the earlier effective U.S. filing date of the copending application, it would constitute prior art under 35 U.S.C. 102(e), if patented. This provisional rejection under 35 U.S.C. 102(e) is based upon a presumption of future patenting of the copending application. [4]. This provisional rejection under 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the copending application was derived from the inventor of this application and is thus not the invention "by another," or by an appropriate showing under 37 CFR 1.131. This rejection may not be overcome by the filing of a terminal disclaimer. See In re Bartfeld, 925 F.2d 1450, 17 USPQ2d 1885 (Fed. Cir. 1991). Examiner Note: 1. This paragraph is used to provisionally reject over a copending application with an earlier filing date that discloses the claimed invention. The copending application must have either a common assignee or at least one common inventor. 2. If the claims are obvious over the invention disclosed in the other copending application, use paragraph 7.21.01. 3. In bracket 3, insert either --assignee-- or --inventor--. 4. In bracket 4, an appropriate explanation may be provided in support of the examiner's position on anticipation, if necessary. 5. If the claims of the copending application conflict with the claims of the instant application, a provisional double patenting rejection should also be given using paragraphs 8.30 and 8.32. 6. If evidence is additionally of record to show that either invention is prior art unto the other under 35 U.S.C. 102(f) or (g), a rejection using paragraphs 7.13 and/or 7.14 should also be made. 7.15.02 Rejection, 35 U.S.C. 102(e), Common Assignee or Inventor(s) Claim [1] rejected under 35 U.S.C. 102(e) as being anticipated by [2]. The applied reference has a common [3] with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under 35 U.S.C. 102(e). This rejection under 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not the invention "by another," or by an appropriate showing under 37 CFR 1.131. Examiner Note: 1. This paragraph is used to reject over a patent with an earlier filing date that discloses but does not claim the same invention. The patent must have either a common assignee or a common inventor. 2. In bracket 3, insert either --assignee-- or --inventor--. 7.15.03 Rejection, 35 U.S.C. 102(e), No Common Assignee or Inventor(s) Claim [1] rejected under 35 U.S.C. 102(e) as being [2] by [3]. Examiner Note: 1. This paragraph is used to reject over a patent with an earlier filing date that discloses but does not claim the same invention. The patent must have neither a common assignee nor a common inventor. 2. In bracket 2, insert either --clearly anticipated-- or --anticipated-- with an explanation at the end of the paragraph. 3. In bracket 3, insert the prior art relied upon. 7.16 Rejection, 35 U.S.C. 102(b), Public Use or on Sale Claim [1] rejected under 35 U.S.C. 102(b) based upon a public use or sale of the invention. [2] Examiner Note: 1. This paragraph must be preceded either by paragraphs 7.07 and 7.09 or by paragraph 7.103. 2. A full explanation of the evidence establishing a public use or sale must be provided in bracket 2. 7.17 Rejection, 35 U.S.C. 102(c), Abandonment of Invention Claim [1] rejected under 35 U.S.C. 102(c) because the invention has been abandoned. [2] Examiner Note: 1. This paragraph must be preceded either by paragraph 7.07 and 7.10 or by paragraph 7.103. 2. In bracket 2, insert a full explanation of the evidence establishing abandonment of the invention. See MPEP Section 2134. 7.18 Rejection, 35 U.S.C. 102(d), Foreign Patenting Claim [1] rejected under 35 U.S.C. 102(d) as being barred by applicant's [2]. [3] Examiner Note: 1. This paragraph must be preceded either by paragraphs 7.07 and 7.11 or by paragraph 7.103. 2. In bracket 3, insert an explanation of this rejection which must include appropriate dates and how they make the foreign patent available under 35 U.S.C. 102(d). 3. Refer to MPEP Section 2135 for applicable 35 U.S.C. 102(d) prior art. 7.19 Rejection, 35 U.S.C. 102(f), Applicant Not the Inventor Claim [1] rejected under 35 U.S.C. 102(f) because the applicant did not invent the claimed subject matter. [2] Examiner Note: 1. This paragraph must be preceded either by paragraphs 7.07 and 7.13 or by paragraph 7.103. 2. In bracket 2, insert an explanation of the supporting evidence establishing that applicant was not the inventor. See MPEP Section 2137. ---SECTION---706.02(j) Contents of a 35 U.S.C. 103 Rejection 35 U.S.C. 103 authorizes a rejection where, to meet the claim, it is necessary to modify a single reference or to combine it with one or more other references. After indicating that the rejection is under 35 U.S.C. 103, the examiner should set forth in the Office action: (A) the relevant teachings of the prior art relied upon, preferably with reference to the relevant column or page number(s) and line number(s) where appropriate, (B) the difference or differences in the claim over the applied reference(s), (C) the proposed modification of the applied reference(s) necessary to arrive at the claimed subject matter, and (D) an explanation why one of ordinary skill in the art at the time the invention was made would have been motivated to make the proposed modification. To establish a prima facie case of obviousness, three basic criteria must be met. First, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings. Second, there must be a reasonable expectation of success. Finally, the prior art reference (or references when combined) must teach or suggest all the claim limitations. The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art and not based on applicant's disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991). See MPEP Section 2143 - Section 2143.03 for decisions pertinent to each of these criteria. The initial burden is on the examiner to provide some suggestion of the desirability of doing what the inventor has done. "To support the conclusion that the claimed invention is directed to obvious subject matter, either the references must expressly or impliedly suggest the claimed invention or the examiner must present a convincing line of reasoning as to why the artisan would have found the claimed invention to have been obvious in light of the teachings of the references." Ex parte Clapp, 227 USPQ 972, 973 (Bd. Pat. App. & Inter. 1985). See MPEP Section 2144 - Section 2144.09 for examples of reasoning supporting obviousness rejections. Where a reference is relied on to support a rejection, whether or not in a minor capacity, that reference should be positively included in the statement of the rejection. See In re Hoch, 428 F.2d 1341, 1342 n.3 166 USPQ 406, 407 n. 3 (CCPA 1970). It is important for an examiner to properly communicate the basis for a rejection so that the issues can be identified early and the applicant can be given fair opportunity to reply. Furthermore, if an initially rejected application issues as a patent, the rationale behind an earlier rejection may be important in interpreting the scope of the patent claims. Since issued patents are presumed valid (35 U.S.C. 282) and constitute a property right (35 U.S.C. 261), the written record must be clear as to the basis for the grant. Since patent examiners cannot normally be compelled to testify in legal proceedings regarding their mental processes (see MPEP Section 1701.01), it is important that the written record clearly explain the rationale for decisions made during prosecution of the application. See MPEP Section 2141 - Section 2144.09 generally for guidance on patentability determinations under 35 U.S.C. 103, including a discussion of the requirements of Graham v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966). See MPEP Section 2145 for consideration of applicant's rebuttal arguments. See MPEP Section 706.02(l) for a discussion of 35 U.S.C. 103(c). ---SECTION---706.02(k) Provisional Rejection (Obviousness) Under 35 U.S.C. 102(e)/103 Where two applications of different inventive entities are copending and the filing dates differ, a provisional rejection under 35 U.S.C. 102(e)/103 should be made in the later filed application if the applications have a common assignee or a common inventor. Otherwise the confidential status of applications under 35 U.S.C. 122 must be maintained. Such a rejection alerts the applicant that he or she can expect an actual rejection on the same ground if one of the applications issues and also lets applicant know that action must be taken to avoid the rejection. This gives applicant the opportunity to analyze the propriety of the rejection and possibly avoid the loss of rights to desired subject matter. Provisional rejections of the obviousness type under 35 U.S.C. 102(e)/103 are rejections applied to copending applications having different effective filing dates wherein each application has a common assignee or a common inventor. The earlier filed application, if patented, would constitute prior art under 35 U.S.C. 102(e). The rejection can be overcome by: (A) Arguing patentability over the earlier filed application; (B) Combining the subject matter of the copending applications into a single application claiming benefit under 35 U.S.C. 120 of the prior applications and abandoning the copending applications (Note that a claim in a subsequently filed application that relies on a combination of prior applications may not be entitled to the benefit of an earlier filing date under 35 U.S.C. 120 since 35 U.S.C. 120 requires that the earlier filed application contain a disclosure which complies with 35 U.S.C. 112, first paragraph for each claim in the subsequently filed application. Studiengesellschaft Kohle m.b.H. v. Shell Oil Co., 112 F.3d 1561, 42 USPQ2d 1674 (Fed. Cir. 1997).); (C) Filing an affidavit or declaration under 37 CFR 1.132 showing that any unclaimed invention disclosed in the copending application was derived from the inventor of the other application and is thus not invention "by another" (see MPEP Section 715.01(a), Section 715.01(c), and Section 716.10); or (D) Filing an affidavit or declaration under 37 CFR 1.131 showing a date of invention prior to the effective U.S. filing date of the copending application. See MPEP Section 715. Where the applications are claiming the same patentable invention, a terminal disclaimer and an affidavit or declaration under 37 CFR 1.130 may be used to overcome a rejection under 35 U.S.C. 103 in a common ownership situation if the earlier filed application has matured into a patent. See MPEP Section 718. If a provisional rejection is made and the copending applications are combined into a single application and the resulting single application is subject to a restriction requirement, the divisional application would not be subject to a provisional or actual rejection under 35 U.S.C. 102(e)/103 since the provisions of 35 U.S.C. 121 preclude the use of a patent issuing therefrom as a reference against the other application. Additionally, the resulting continuation-in-part is entitled to 35 U.S.C. 120 benefit of each of the prior applications. This is illustrated in Example 2, below. The following examples are instructive as to the application of 35 U.S.C. 102(e)/103: Example 1. Assumption: Employees A and B work for C, each with knowledge of the other's work, and with obligation to assign inventions to C while employed. SITUATIONS RESULTS 1. A invents X and later files application. This is permissible. 2. B modifies X to XY. B files application before A's filing No 35 U.S.C. 102(f)/103 or 102(g)/103 rejection; provisional 35 U.S.C. 102(e)/103 rejection applies. Provisional double patenting rejection made. 3. B's patent issues. A's claims rejected under 35 U.S.C. 102(e)/103 and double patenting. 4. A files 37 CFR 1.130 affidavit to disqualify B's patent as prior art where the same patentable invention is being claimed. Terminal disclaimer filed under 37 CFR 1.321(c). Rejection under 35 U.S.C. 102(e)/103 may be overcome and double patenting rejection may be overcome if inventions X and XY are commonly owned and all requirements of 37 CFR 1.130 and 1.321 are met. In situation (2.) above, the result is a provisional rejection by the examiner under 35 U.S.C. 102(e)/103. The rejection is provisional since the subject matter and the prior art are pending applications. Example 2. Assumption: Employees A and B work for C, each with knowledge of the other's work, and with obligation to assign inventions to C while employed. SITUATIONS RESULTS 1. A invents X and files application. This is permissible. 2. B modifies X to XY after A's application is filed. B files application establishing that A and B were both under obligation to assign inventions to C at the time the inventions were made. Provisional 35 U.S.C. 102(e)/103 rejection made; provisional double patenting rejection made; no 35 U.S.C. 102(f)/103 or 102(g)/103 rejection made. 3. A and B file continuing application claiming priority to their earlier applications and abandon the earlier applications. Assume it is proper that restriction be required between X and XY. 4. X is elected and patent issues on X with divisional application being timely filed on XY. No rejection of divisional application under 35 U.S.C. 102(e)/103 in view of 35 U.S.C. 121. EXAMINATION OF APPLICATIONS OF DIFFERENT INVENTIVE ENTITIES WHERE COMMON OWNERSHIP IS ESTABLISHED The disclosure of an earlier filed patent application which issues as a patent continues to be prior art under 35 U.S.C. 102(e) against a later invented and filed application of another inventor even though the patent and the later invention were owned by, or subject to, an obligation of assignment to the same person at the time the later invention was made. See MPEP Section 706.02(l) for examination of applications of different inventive entities where common ownership has not been established. Once the examiner checks the applications and it is established from the record that common ownership existed at the time the later invention was made, he or she should: (A) examine the applications as to all grounds except 35 U.S.C. 102(f) and (g) as they apply through 35 U.S.C. 103, (B) examine the applications for double patenting, including double patenting of the obviousness type, and make a provisional double patenting rejection, if appropriate (See In re Mott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976)), (C) examine the later filed application under 35 U.S.C. 102(e) as it applies through 35 U.S.C. 103 and make a provisional rejection under 35 U.S.C. 102(e)/ 35 U.S.C. 103 in the later filed application, if appropriate, and (D) permit the applicant of the later filed application to file an affidavit or declaration under 37 CFR 1.131, or a terminal disclaimer and an affidavit or declaration under 37 CFR 1.130 if the same patentable invention is being claimed (see MPEP Section 715.05 and Section 718), or an affidavit or declaration under 37 CFR 1.132 showing the invention is not "by another," to overcome the provisional or actual 35 U.S.C. 102(e)/ 35 U.S.C. 103 rejection, if appropriate, and a terminal disclaimer to overcome the provisional or actual rejection on double patenting of the obviousness type. An affidavit or declaration under 37 CFR 1.130 cannot be used to overcome a provisional 35 U.S.C. 102(e)/103 rejection. See MPEP Section 718. The practice of rejecting claims on the ground of double patenting in commonly owned applications of different inventive entities is in accordance with existing case law and prevents an organization from obtaining two or more patents with different expiration dates covering nearly identical subject matter. See MPEP Section 804 for guidance on double patenting issues. In accordance with established patent law doctrines, double patenting rejections can be overcome in certain circumstances by disclaiming, pursuant to the existing provisions of 37 CFR 1.321, the terminal portion of the term of the later patent and including in the disclaimer a provision that the patent shall be enforceable only for and during the period the patent is commonly owned with the application or patent which formed the basis for the rejection, thereby eliminating the problem of extending patent life. The following example is illustrative: ASSUMPTION: Employees A and B work for C, each with knowledge of the other's work, and with obligation to assign inventions to C while employed: SITUATIONS RESULTS 1. A invents X and files application with assignment to C recorded in PTO showing C's ownership at the time the invention X was made. This is permissible. 2. A and B modify X to XY and file application with assignment recorded in PTO showing C's ownership at the time the invention XY was made. Provisional double patenting rejections of the obviousness type may be made. Provisional rejection under 35 U.S.C. 102(e)/103 may be made in later filed application. 3. A and B file terminal disclaimers to overcome provisional double patenting and insufficient 37 CFR 1.131 affidavit to overcome provisional 35 U.S.C. 102(e)/103 rejection. Examiner finds 37 CFR 1.131 affidavit insufficient; accepts terminal disclaimers. 4. A and B file continuing application disclosing and claiming both X and XY and claiming 35 U.S.C. 120 benefit of both prior applications; both prior applications are then abandoned. This is permissible. EXAMINATION OF CONTINUING APPLICATION COMMONLY OWNED WITH ABANDONED PARENT APPLICATION TO WHICH BENEFIT IS CLAIMED UNDER 35 U.S.C. 120 An application claiming the benefit of a prior filed copending national or international application under 35 U.S.C. 120 must name as an inventor at least one inventor named in the prior filed application. The prior filed application must also disclose the named inventor's invention claimed in at least one claim of the later filed application in the manner provided by the first paragraph of 35 U.S.C. 112. This practice contrasts with the practice in effect prior to November 8, 1984 (the date of enactment of Public Law 98-622) where the inventorship entity in each of the applications was required to be the same for benefit under 35 U.S.C. 120. So long as the applications have at least one inventor in common and the other requirements are met, the Office will permit a claim for 35 U.S.C. 120 benefit without any additional submissions or notifications from applicants regarding inventorship differences. In addition to the normal examination conducted by the examiner, he or she must examine the earlier filed application to determine if the earlier and later applications have at least one inventor in common and that the other 35 U.S.C. 120 requirements are met. The claim for 35 U.S.C. 120 benefit will be permitted without examination of the earlier application for disclosure and support of at least one claim of the later filed application under 35 U.S.C. 112, first paragraph unless it becomes necessary to do so, for example, because of an intervening reference. EXAMINATION OF COMMONLY OWNED PENDING APPLICATIONS HAVING DIFFERENT INVENTIVE ENTITIES CLAIMING BENEFIT UNDER 35 U.S.C. 120 See MPEP Section 706.02(l) for examination of applications of different inventive entities where common ownership is not established. Commonly owned applications of different inventive entities may be rejected on the ground of double patenting. Despite the fact that a later filed application claims 35 U.S.C. 120 benefit to an earlier application, a double patenting rejection may also be appropriate so long as at least one inventor is common to each application. The rejection based on a pending application would be a provisional rejection since no patent has issued. If the applications are commonly owned, a rejection of the applications on the ground of double patenting can be overcome by an appropriate terminal disclaimer as long as the identical invention is not being claimed. See In re Robeson, 331 F.2d 610, 141 USPQ 485 (CCPA 1964) and In re Kaye, 332 F.2d 816, 141 USPQ 829 (CCPA 1964). The following example is illustrative: ASSUMPTION: Employees A and B work for C, each with knowledge of the other's work, and with obligation to assign inventions to C while employed. SITUATIONS RESULTS 1. A invents X, A and B together invent XY. This is permissible. 2. A later files application on X with assignment to C. This is permissible. 3. A and B later file application on XY with assignment to C. Examiner may make provisional rejection of A and B's application on grounds of double patenting and 35 U.S.C. 102(e)/103 in view of A's application. 4. A and B file 37 CFR 1.130 affidavit to disqualify A's application as prior art where same patentable invention claimed, and terminal disclaimers in both applications. An affidavit under 37 CFR 1.130 cannot be used to overcome a provisional rejection. ---SECTION---706.02(l) Rejections Under 35 U.S.C. 102(f)/103 and 35 U.S.C. 102(g)/103; 35 U.S.C. 103(c) 37 CFR 1.104 Nature of examination. +++ (c) Rejection of claims. +++ (4) Subject matter which is developed by another person which qualifies as prior art only under 35 U.S.C. 102(f) or (g) may be used as prior art under 35 U.S.C. 103 against a claimed invention unless the entire rights to the subject matter and the claimed invention were commonly owned by the same person or organization or subject to an obligation of assignment to the same person or organization at the time the claimed invention was made. +++ 37 CFR 1.104(c)(4) basically reiterates the requirements of 35 U.S.C. 103(c) which provides that subject matter developed by another which qualifies as "prior art" only under subsections 35 U.S.C. 102(f) or 35 U.S.C. 102(g) is not to be considered when determining whether an invention sought to be patented is obvious under 35 U.S.C. 103, provided the subject matter and the claimed invention were commonly owned at the time the invention was made. Note that if the prior art is published and the inventive entity is not identical then 35 U.S.C. 102(e)/103 will apply and the prior art will not be disqualified under 35 U.S.C. 103(c). The subject matter that is disqualified as prior art under 35 U.S.C. 103 is strictly limited to subject matter that A) qualifies as prior art only under 35 U.S.C. 102(f) or 35 U.S.C. 102(g), and B) was commonly owned with the claimed invention at the time the invention was made. If the subject matter that qualifies as prior art only under 35 U.S.C. 102(f) or 35 U.S.C. 102(g) was not commonly owned at the time of the invention, the subject matter is not disqualified as prior art under 35 U.S.C. 103. See OddzOn Products, Inc. v. Just Toys, Inc., 122 F.3d 1396, 1403-04, 43 USPQ2d 1641, 1646 (Fed. Cir. 1997) ("We therefore hold that subject matter derived from another not only is itself unpatentable to the party who derived it under Section 102(f), but, when combined with other prior art, may make a resulting obvious invention unpatentable to that party under a combination of Section Section 102(f) and 103.") If the subject matter qualifies as prior art under any other subsection (e.g., subsection 35 U.S.C. 102(a), 35 U.S.C. 102(b), or 35 U.S.C. 102(e)) it will not be disqualified as prior art under 35 U.S.C. 103(c). It is important to recognize that 35 U.S.C. 103(c) applies only to consideration of prior art for purposes of obviousness under 35 U.S.C. 103. It does not apply to or affect subject matter which qualifies as prior art under 35 U.S.C. 102. A patent applicant urging that subject matter is disqualified has the burden of establishing that it was commonly owned at the time the claimed invention was made. Absent proper evidence of common ownership at the time the later invention was made, the appropriate rejection under 35 U.S.C. 102(f) or 35 U.S.C. 102(g) as it applies through 35 U.S.C. 103 should be made. Information learned from or transmitted to persons outside the organization is not disqualified as prior art. The term "subject matter" will be construed broadly, in the same manner the term is construed in the remainder of 35 U.S.C. 103. The term "another" as used in 35 U.S.C. 103 means any inventive entity other than the inventor and would include the inventor and any other persons. The term "developed" is to be read broadly and is not limited by the manner in which the development occurred. The term "commonly owned" means wholly owned by the same person, persons, or organization at the time the invention was made. Inventors of subject matter not commonly owned at the time of the invention, but currently commonly owned, may file as joint inventors in a single application. However, the claims in such an application are not protected from a 35 U.S.C. 102(f)/103 or 35 U.S.C. 102(g)/103 rejection. Applicants in such cases have an obligation pursuant to 37 CFR 1.56 to point out the inventor and invention dates of each claim and the lack of common ownership at the time the later invention was made to enable the examiner to consider the applicability of a 35 U.S.C. 102(f)/103 or 35 U.S.C. 102(g)/103 rejection. The examiner will assume, unless there is evidence to the contrary, that applicants are complying with their duty of disclosure. Foreign applicants will sometimes combine the subject matter of two or more related applications with different inventors into a single U.S. application naming joint inventors. The examiner will make the assumption, absent contrary evidence, that the applicants are complying with their duty of disclosure if no information is provided relative to invention dates and common ownership at the time the later invention was made. Such a claim for 35 U.S.C. 119(a)-(d) benefit based upon the foreign filed applications is appropriate and 35 U.S.C. 119(a)-(d) benefit can be accorded based upon each of the foreign filed applications. I. DEFINITION OF COMMON OWNERSHIP In order to be disqualified as prior art under 35 U.S.C. 103(c), the subject matter which would otherwise be prior art to the claimed invention and the claimed invention must be commonly owned at the time the claimed invention was made. The term "commonly owned" is intended to mean that the subject matter which would otherwise be prior art to the claimed invention and the claimed invention are entirely or wholly owned by the same person, persons, or organization at the time the claimed invention was made. If the person, persons, or organization owned less than 100 percent of the subject matter which would otherwise be prior art to the claimed invention, or less than 100 percent of the claimed invention, then common ownership would not exist. Common ownership requires that the person, persons, or organization own 100 percent of the subject matter and 100 percent of the claimed invention. As long as principal ownership rights to either the subject matter or the claimed invention reside in different persons or organizations common ownership does not exist. A license of the claimed invention to another by the owner where basic ownership rights are retained would not defeat ownership. The requirement for common ownership at the time the claimed invention was made is intended to preclude obtaining ownership of subject matter after the claimed invention was made in order to disqualify that subject matter as prior art against the claimed invention. The question of whether common ownership exists at the time the claimed invention was made is to be determined on the facts of the particular case in question. Actual ownership of the subject matter and the claimed invention by the same individual or organization or a legal obligation to assign both the subject matter and the claimed invention to the same individual or organization must be in existence at the time the claimed invention was made in order for the subject matter to be disqualified as prior art. A moral or unenforceable obligation would not evidence common ownership. Under 35 U.S.C. 103(c), an applicant's admission that subject matter was developed prior to applicant's invention would not make the subject matter prior art to applicant if the subject matter qualifies as prior art only under sections 35 U.S.C. 102(f) or 35 U.S.C. 102(g), and if the subject matter and the claimed invention were commonly owned at the time the invention was made. See In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982), for a decision involving an applicants' admission which was used as prior art against their application. If the subject matter and invention were not commonly owned, an admission that the subject matter is prior art would be usable under 35 U.S.C. 103. The burden of establishing that subject matter is disqualified as prior art under 35 U.S.C. 103(c) is intended to be placed and reside upon the person or persons urging that the subject matter is disqualified. For example, a patent applicant urging that subject matter is disqualified as prior art under 35 U.S.C. 103(c), would have the burden of establishing that it was commonly owned at the time the claimed invention was made. The patentee in litigation would likewise properly bear the same burden placed upon the applicant before the Patent and Trademark Office. To place the burden upon the patent examiner or the defendant in litigation would not be appropriate since evidence as to common ownership at the time the claimed invention was made might not be available to the patent examiner or the defendant in litigation, but such evidence, if it exists, should be readily available to the patent applicant or the patentee. In view of 35 U.S.C. 103(c), the Commissioner has reinstituted in appropriate circumstances the practice of rejecting claims in commonly owned applications of different inventive entities on the grounds of double patenting. Such rejections can be overcome in appropriate circumstances by the filing of terminal disclaimers. This practice has been judicially authorized. See In re Bowers, 359 F.2d 886, 149 USPQ 57 (CCPA 1966). The use of double patenting rejections which then could be overcome by terminal disclaimers preclude patent protection from being improperly extended while still permitting inventors and their assignees to obtain the legitimate benefits from their contributions. See also MPEP Section 804. The following examples are provided for illustration only: Example 1 Parent Company owns 100% of Subsidiaries A and B - inventions of A and B are commonly owned. Example 2 Parent Company owns 100% of Subsidiary A and 90% of Subsidiary B - inventions of A and B not commonly owned. Example 3 If same person owns subject matter and invention at time invention was made, license to another may be made without the subject matter becoming prior art. Example 4 Different Government inventors retaining certain rights (e.g. foreign filing rights) in separate inventions owned by Government precludes common ownership of inventions. Example 5 Company A and Company B form joint venture Company C. Employees of A while working for C with an obligation to assign inventions to C, invent invention #1, employees of B while working for C with an obligation to assign inventions to C, invent invention #2, with knowledge of #1. Question: Are #1 and #2 commonly owned at the time the later invention was made so as to preclude a rejection under 35 U.S.C. 102(f) or (g) in view of 35 U.S.C. 103? Answer: Yes-An official of company C can sign an affidavit that C owned both inventions. The examiner must examine the application as to all grounds except 35 U.S.C. 102(f) and (g) as they apply through 35 U.S.C. 103 only if the application file(s) establishes common ownership at the time the later invention was made. Thus, it is necessary to look to the time at which common ownership exists. If common ownership does not exist at the time the later invention was made, the earlier invention is not disqualified as potential prior art under 35 U.S.C. 102(f) and (g) as they apply through 35 U.S.C. 103. An invention is "made" when conception is complete as defined in Mergenthaler v. Scudder, 11 App. D.C. 264, 81 O.G. 1417, 1897 C.D. 724 (D.C. Cir. 1897); In re Tansel, 253 F.2d 241, 117 USPQ 188 (CCPA 1958). Common ownership at the time the invention was made for purposes of obviating a 35 U.S.C. 102(f)/ 35 U.S.C. 103 or 35 U.S.C. 102(g)/ 35 U.S.C. 103 rejection may be established irrespective of whether the invention was made in the United States or abroad. The provisions of 35 U.S.C. 104, however, will continue to apply to other proceedings in the Patent and Trademark Office, e.g. in an interference proceeding, with regard to establishing a date of invention by knowledge or use thereof, or other activity with respect thereto, in a foreign country. The foreign filing date will continue to be used for interference purposes under 35 U.S.C. 119(a)-(d) and 35 U.S.C. 365. II. EVIDENCE REQUIRED TO ESTABLISH COMMON OWNERSHIP It is important to recognize just what constitutes sufficient evidence to establish common ownership at the time the invention was made. The common ownership must be shown to exist at the time the later invention was made. A statement of present common ownership is not sufficient. In re Onda, 229 USPQ 235 (Comm'r Pat. 1985). A. Nature of the Showing 37 CFR 1.104 Nature of examination. (a) Examiner's action. +++ (5) Copending applications will be considered by the examiner to be owned by, or subject to an obligation of assignment to, the same person if: (i) The application files refer to assignments recorded in the Patent and Trademark Office in accordance with Part 3 of this chapter which convey the entire rights in the applications to the same person or organization; or (ii) Copies of unrecorded assignments which convey the entire rights in the applications to the same person or organization are filed in each of the applications; or (iii) An affidavit or declaration by the common owner is filed which states that there is common ownership and states facts which explain why the affiant or declarant believes there is common ownership, which affidavit or declaration may be signed by an official of the corporation or organization empowered to act on behalf of the corporation or organization when the common owner is a corporation or other organization; or (iv) Other evidence is submitted which establishes common ownership of the applications. +++ 37 CFR 1.104(a)(5) specifies the nature of the showing necessary before the examiner would consider copending applications to be owned by, or subject to an obligation of assignment to, the same person for purposes of 35 U.S.C. 102(f)/103, 35 U.S.C. 102(g)/103 and 37 CFR 1.104(c)(4). If common ownership does not exist at the time the later invention was made, the earlier invention is not disqualified as potential prior art under 35 U.S.C. 102(f) and (g) as they apply through 35 U.S.C. 103. The rule permits the necessary showing to be made in different alternative ways. The necessary showing will be considered by the examiner to be present if the application files refer to assignments which are recorded in the Patent and Trademark Office in accordance with 37 CFR Part 3 as long as the assignments conveyed the entire rights in the applications to the same person or organization. A second alternative which can be used, if assignments have not been recorded, permits the examiner to consider copies of unrecorded assignments filed in each of the applications by the applicants as long as the unrecorded assignments convey the entire rights in the applications to the same person or organization. The submission of copies of assignment agreements that were filed in the Office and that were executed at the time the application was filed would not be sufficient to disqualify the earlier invention as potential prior art against the later invention unless the assignment document itself contained language which indicate the relevant dates involved and established that the inventions were commonly owned at the time the later invention was made. Absent specific language in the assignment document which would establish that the inventions claimed in the applications were commonly owned at the time the later invention was made, the attorney/applicants would have to supply additional evidence or showings establishing common ownership at the time the later invention was made. This additional evidence or showing might take the form of an affidavit or declaration by the common owner which refers to the assignment and further avers that the inventors of the subject matter of the applications were all under an obligation to assign the inventions to the common owner at the time the later invention was made, e.g., by virtue of employment agreements. The affidavit or declaration might also include copies of the employment agreements although the submission of the copies of the employment agreements would not be essential as long as unqualified averments are made that the inventions were commonly owned at the time the later invention was made. A third alternative permits an affidavit or declaration to be filed by the common owner stating that there is common ownership and stating facts which explain why the affiant or declarant believes there is common ownership. Under this alternative, sufficient facts will have to be presented in order to enable the examiner to conclude that a prima facie case of common ownership exists. It is expected that the most common form of submission to establish common ownership at the time the later invention was made will be verified statements, i.e., oaths or declarations from the common owner. It should be emphasized that such oaths or declarations must be executed by the common owner or someone empowered to act on behalf of the common owner. The fourth alternative permits other evidence to be used which would establish common ownership of the applications, e.g., a court decision determining the owner. B. Showing by Affidavit or Declaration; Who May Sign on Behalf of an Organization The terms "person" and "organization" in the rule would include circumstances where the ownership resided in more than one person and/or organization as long as the applications are owned jointly by the same owners. 37 CFR 1.104(a)(5)(iii) also provides that where the common owner is a corporation or other organization an affidavit or declaration averring common ownership may be signed by an official of the corporation or organization who is empowered to act on behalf of the corporation or organization. The requirements of 37 CFR 3.73(b) do not apply. A mere power of attorney to prosecute a patent application will not make an individual an official of the corporation or organization or empower the individual to act on behalf of the corporation or organization for purposes of averring common ownership. However, such an affidavit could be made by a patent attorney, patent agent, or other individual if the attorney, agent, or other individual has been appointed in writing by the corporation or organization as an official of the corporation or organization specifically empowered to make affidavits or declarations on its behalf averring to common ownership. In circumstances where such a written appointment has been given to a patent attorney, patent agent, or other individual, that person could then make affidavits or declarations averring to common ownership as long as the affidavit or declaration referred to an attached copy of the written appointment and averred that the authority is still in effect. Under this practice the original signed copy of the written appointment would be retained by the affiant or declarant unless the Patent and Trademark Office specifically required it to be filed. Unless some question arose as to the authority of the individual to make the averment as to common ownership, the Patent and Trademark Office would ordinarily not need to require the original signed copy of the written appointment. While this practice should simplify the establishing of common ownership by necessitating only one original signed written appointment, corporations and other organizations must exercise care that the written appointment is only given to those persons who are in a position to know that common ownership does in fact exist and can therefore properly make affirmative representations to that effect to the Patent and Trademark Office. III. EXAMINATION OF APPLICATIONS OF DIFFERENT INVENTIVE ENTITIES WHERE COMMON OWNERSHIP IS NOT ESTABLISHED See MPEP Section 706.02(k) for examination of applications of different inventive entities where common ownership is established. Where the applications do not establish common ownership, the examiner will: (A) assume that the applications are not commonly owned; (B) examine the applications on all grounds other than any conflict between the applications; (C) consider the applicability of 35 U.S.C. 102(f)/103 or 35 U.S.C. 102(g)/103 if one application refers to the other or if one inventor is common to both applications. If there is no cross-reference or common inventor between the applications it would be inappropriate for the examiner to refer to one application in the other in view of 35 U.S.C. 122; (D) consider interference if appropriate; and (E) suspend the later filed application if it is otherwise allowable until the earlier filed application is abandoned or issues as a patent and then reject the later filed application under 35 U.S.C. 102(e)/103, if appropriate. ---SECTION---706.02(m) Form Paragraphs for Use in Rejections Under 35 U.S.C. 103 The following form paragraphs should be used in making the appropriate rejections under 35 U.S.C. 103. 7.20 Statement of Statutory Basis, 35 U.S.C. 103(a) The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. Examiner Note: 1. The statute is not to be cited in all Office actions. It is only required in first actions on the merits employing 35 U.S.C. 103(a) and final rejections. Where the statute is being applied, but is not cited in an action on the merits, use paragraph 7.103. 2. This paragraph should only be used ONCE in a given Office action. 3. This paragraph must precede paragraphs 7.20.01 - 7.22 when this paragraph is used to cite the statute in first actions and final rejections. 7.20.01 103(a) Rejection Using Art Disqualified Under 102 (f) or (g) Applicant has provided evidence in this file showing that the invention was owned by, or subject to an obligation of assignment to, the same entity as [1] at the time this invention was made. Accordingly, [2] is disqualified as prior art through 35 U.S.C. 102(f) or (g) in any rejection under 35 U.S.C. 103(a) in this application. However, this applied art additionally qualifies as prior art under subsection [3] of 35 U.S.C. 102 and accordingly is not disqualified as prior art under 35 U.S.C. 103(a). Applicant may overcome the applied art either by a showing under 37 CFR 1.132 that the invention disclosed therein was derived from the invention of this application, and is therefore, not the invention "by another," or by antedating the applied art under 37 CFR 1.131. Examiner Note: 1. This paragraph must be included following paragraph 7.20 in all actions containing rejections under 35 U.S.C. 103(a) using art that is disqualified under 103(c) using 102(f) or (g), but which qualifies under another section of 35 U.S.C. 102. 2. In brackets 1 and 2, identify the commonly owned applied art (patent or co-pending application). 3. In bracket 3, insert --(a)-- or --(e)-- as appropriate. 7.20.02 Joint Inventors, Common Ownership Presumed This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a). Examiner Note: This paragraph must be used in all applications with joint inventors (unless the claims are clearly restricted to only one claimed invention, e.g., only a single claim is presented in the application). 7.21 Rejection, 35 U.S.C. 103(a) Claim [1] rejected under 35 U.S.C. 103(a) as being unpatentable over [2]. Examiner Note: 1. This paragraph must be preceded by either form paragraph 7.20 or form paragraph 7.103. 2. An explanation of the rejection applying the Graham v. Deere test must follow this form paragraph. 3. If this rejection relies upon art that is disqualified under 35 U.S.C. 102(f) or (g) based upon the common ownership of the invention, paragraph 7.20.01 must follow this paragraph. 4. If this rejection is a provisional 35 U.S.C. 103(a) rejection based upon a copending application that would comprise prior art under 35 U.S.C. 102(e) if patented, use paragraph 7.21.01 instead of this paragraph. 7.21.01 Provisional Rejection, 35 U.S.C. 103(a), Common Assignee or at Least One Common Inventor Claim [1] provisionally rejected under 35 U.S.C. 103(a) as being obvious over copending Application No. [2] which has a common [3] with the instant application. Based upon the earlier effective U.S. filing date of the copending application, it would constitute prior art under 35 U.S.C. 102(e) if patented. This provisional rejection under 35 U.S.C. 103(a) is based upon a presumption of future patenting of the conflicting application. [4] This provisional rejection might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the copending application was derived from the inventor of this application and is thus not the invention "by another," or by a showing of a date of invention for the instant application prior to the effective U.S. filing date of the copending application under 37 CFR 1.131. Examiner Note: 1. This paragraph is used to provisionally reject claims not patentably distinct from the disclosure in a copending application having an earlier U.S. filing date and also having either a common assignee or at least one common inventor. 2. If the claimed invention is fully disclosed in the copending application, use paragraph 7.15.01. 3. In bracket 3, insert either --assignee-- or --inventor--. 4. In bracket 4, insert explanation of obviousness. 5. If the claimed invention is also claimed in the copending application, a provisional obviousness double patenting rejection should additionally be made using paragraph 8.33 and 8.37. 6. If evidence indicates that the copending application is also prior art under 35 U.S.C. 102(f) or (g) and the copending application has not been disqualified as prior art in a 35 U.S.C. 103(a) rejection based upon common ownership, a rejection should additionally be made under 35 U.S.C. 103(a) using paragraph 7.21 (e.g., applicant has named the prior inventor in response to a requirement made using paragraph 8.28). 7.21.02 Rejection, 35 U.S.C. 103(a), Common Assignee or at Least One Common Inventor Claim [1] rejected under 35 U.S.C. 103(a) as being obvious over [2]. The applied reference has a common [3] with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under 35 U.S.C. 102(e). This rejection under 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention "by another"; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the effective U.S. filing date of the reference under 37 CFR 1.131; or (3) an oath or declaration under 37 CFR 1.130 stating that the application and reference are currently owned by the same party and that the inventor named in the application is the prior inventor under 35 U.S.C. 104, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). [4] Examiner Note: 1. This paragraph is used to reject over a patent with an earlier filing date that discloses the claimed invention. The patent must have either a common assignee or at least one common inventor. 2. In bracket 3, insert either --assignee-- or --inventor--. 3. In bracket 4, insert explanation of obviousness. 7.22 Rejection, 35 U.S.C. 103(a), Further in View Of Claim [1] rejected under 35 U.S.C. 103(a) as being unpatentable over [2] as applied to claim [3] above, and further in view of [4]. Examiner Note: 1. This paragraph must be preceded by paragraph 7.21. 2. An explanation of the rejection applying the Graham v. Deere test must follow this form paragraph. 7.23 Graham v. Deere, Test for Obviousness The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Examiner Note: This paragraph may be used, if appropriate, in response to an argument of the use of Graham v. Deere. 7.27 Rejection, 35 U.S.C. 102 or 103(a) Claim [1] rejected under 35 U.S.C. 102([2]) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over [3]. Examiner Note: 1. This paragraph is NOT intended to be commonly used as a substitute for a rejection under 35 U.S.C. 102. In other words, a single rejection under either 35 U.S.C. 102 or 35 U.S.C. 103(a) should be made whenever possible using appropriate form paragraphs 7.15 to 7.19, 7.21 and 7.22. Examples of circumstances where this paragraph may be used are as follows: a. When the interpretation of the claim(s) is or may be in dispute, i.e., given one interpretation, a rejection under 35 U.S.C. 102 is appro priate and given another interpretation, a rejection under 35 U.S.C. 103(a) is appropriate. See MPEP Section Section 2111- 2116.01 for guidelines on claim interpretation. b. When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP Section Section 2112- 2112.02. c. When the reference teaches a small genus which places a claimed species in the possession of the public as in In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), and the species would have been obvious even if the genus were not sufficiently small to justify a rejection under 35 U.S.C. 102. See MPEP Section Section 2131.02 and 2144.08 for more information on anticipation and obviousness of species by a disclosure of a genus. d. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP Section 2113. e. When the reference teaches all claim limitations except a means plus function limitation and the examiner is not certain wheth er the element disclosed in the reference is an equivalent to the claimed element and therefore anticipatory, or whether the prior art element is an obvious variant of the claimed element. See MPEP Section Section 2183- 2184. f. When the ranges disclosed in the reference and claimed by applicant overlap in scope but the reference does not contain a specific example within the claimed range. See the concurring opinion in Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). See MPEP Section 2131.03. 2. If the interpretation of the claim(s) renders the claim(s) indefinite, a rejection under 35 U.S.C. 112, 2nd paragraph, may be appropriate. 3. In bracket 2, insert the appropriate paragraph letter(s) in parenthesis. 4. A full explanation should follow this form paragraph. 5. This paragraph must be preceded by 7.07, one or more of paragraphs 7.08 to 7.14 as appropriate, and paragraph 7.20 or paragraph 7.103. ---SECTION---706.02(n) Biotechnology Process Applications; 35 U.S.C. 103(b) 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter. +++ (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if- (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1)- (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term "biotechnological process" means- (A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to- (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). +++ 35 U.S.C. 103(b) is applicable to biotechnological processes only. 35 U.S.C. 103(b) precludes a rejection of process claims which involve the use or making of certain nonobvious biotechnological compositions of matter under 35 U.S.C. 103(a). 35 U.S.C. 103(b) requires that: (A) the biotechnological process and composition of matter be contained in either the same application or in separate applications having the same effective filing date; (B) both the biotechnological process and composition of matter be owned or subject to an assignment to the same person at the time the process was invented; (C) a patent issued on the process also contain the claims to the composition of matter used in or made by the process, or, if the process and composition of matter are in different patents, the patents expire on the same date; (D) the biotechnological process falls within the definition set forth in 35 U.S.C. 103(b); and (E) a timely election be made to proceed under the provisions of 35 U.S.C. 103(b). An election to proceed under 35 U.S.C. 103(b) shall be made by way of petition under 37 CFR 1.182. The petition must establish that all the requirements set forth in 35 U.S.C. 103(b) have been satisfied. An election will normally be considered timely if it is made no later than the earlier of either the payment of the issue fee or the filing of an appeal brief in an application which contains a composition of matter claim which has not been rejected under 35 U.S.C. 102 or 103. In an application where at least one composition of matter claim has not been rejected under 35 U.S.C. 102 or 103, a 35 U.S.C. 103(b) election may be made by submitting the petition and an amendment requesting entry of process claims which correspond to the composition of matter claim. For applications pending on or after November 1, 1995, in which the issue fee has been paid prior to March 26, 1996, the timeliness requirement for an election under 35 U.S.C. 103(b) will be considered satisfied if the conditions of 37 CFR 1.312(b) are met. However, if a patent is granted on an application entitled to the benefit of 35 U.S.C. 103(b) without an election having been made as a result of error without deceptive intent, patentees may file a reissue application to permit consideration of process claims which qualify for 35 U.S.C. 103(b) treatment. See MPEP Section 2116.01 for a discussion of the Federal Circuit's decisions in In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995) and In re Brouwer, 77 F.3d 422, 37 USPQ2d 1663 (Fed. Cir. 1996) which address the general issue of whether an otherwise conventional process could be patented if it were limited to making or using a nonobvious product. In view of the Federal Circuit's decisions in Ochiai and Brouwer, an applicant's need to rely upon 35 U.S.C. 103(b) should be rare. See also 1184 O G 86 (Comm'r Pat. 1996). See 35 U.S.C. 282 for the effect of a determination of nonobviousness under 35 U.S.C. 103(b)(1) on the presumption of validity. ---SECTION---706.03 Rejections Not Based on Prior Art The primary object of the examination of an application is to determine whether or not the claims are patentable over the prior art. This consideration should not be relegated to a secondary position while undue emphasis is given to nonprior art or "technical" rejections. Effort in examining should be concentrated on truly essential matters, minimizing or eliminating effort on technical rejections which are not really critical. Where a major technical rejection is proper (e.g., lack of proper disclosure, undue breadth, utility, etc.) such rejection should be stated with a full development of the reasons rather than by a mere conclusion coupled with some stereotyped expression. Rejections based on nonstatutory subject matter are explained in MPEP Section 706.03(a), Section 2105, Section 2106 - Section 2106.02, and Section 2107 - Section 2107.02. Rejections based on subject matter barred by the Atomic Energy Act are explained in MPEP Section 706.03(b). Rejections based on duplicate claims are addressed in MPEP Section 706.03(k), and double patenting rejections are addressed in MPEP Section 804. See MPEP Section 706.03(o) for rejections based on new matter. Foreign filing without a license is discussed in MPEP Section 706.03(s). Disclaimer, after interference or public use proceeding, res judicata, and reissue are explained in MPEP Section 706.03(u) to Section 706.03(x). Rejections based on 35 U.S.C. 112 are discussed in MPEP Section 2161 - Section 2174. IF THE LANGUAGE IN THE FORM PARAGRAPHS IS INCORPORATED IN THE LETTER TO STATE THE REJECTION, THERE WILL BE LESS CHANCE OF A MISUNDERSTANDING AS TO THE GROUNDS OF REJECTION. ---SECTION---706.03(a) Rejections under 35 U.S.C. 101 Patents are not granted for all new and useful inventions and discoveries. The subject matter of the invention or discovery must come within the boundaries set forth by 35 U.S.C. 101, which permits patents to be granted only for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." The term "process" as defined in 35 U.S.C. 100, means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material. See MPEP Section 2105 for patentability of microorganisms and MPEP Section 2106 - Section 2106.02 for patentability of mathematical algorithms or computer programs. LACK OF UTILITY A rejection on the ground of lack of utility includes the more specific grounds of inoperativeness, involving perpetual motion, frivolous, fraudulent, and against public policy. The statutory basis for this rejection is 35 U.S.C. 101. See MPEP Section 706.03(a)(1) for guidelines governing rejections for lack of utility. See MPEP Section 2107 - Section 2107.02 for legal precedent governing the utility requirement. Decisions have determined the limits of the statutory classes. Examples of subject matter not patentable under the Statute follow: PRINTED MATTER For example, a mere arrangement of printed matter, though seemingly a "manufacture," is rejected as not being within the statutory classes. See In re Miller, 418 F.2d 1392, 164 USPQ 46 (CCPA 1969); Ex parte Gwinn, 112 USPQ 439 (Bd. App. 1955); and In re Jones, 373 F.2d 1007, 153 USPQ 77 (CCPA 1967). NATURALLY OCCURRING ARTICLE Similarly, a thing occurring in nature, which is substantially unaltered, is not a "manufacture." A shrimp with the head and digestive tract removed is an example. Ex parte Grayson, 51 USPQ 413 (Bd. App. 1941). SCIENTIFIC PRINCIPLE A scientific principle, divorced from any tangible structure, can be rejected as not within the statutory classes. O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1854). This subject matter is further limited by the Atomic Energy Act explained in MPEP Section 706.03(b). Use Form Paragraphs 7.04 through 7.05.03 to reject under 35 U.S.C. 101. 7.04 Statement of Statutory Basis, 35 U.S.C. 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Examiner Note: This paragraph must precede the first use of 35 U.S.C. 101 in all first actions on the merits and final rejections. 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Non-Statutory, Inoperative) Claim [1] rejected under 35 U.S.C. 101 because Examiner Note: 1. This form paragraph must be followed by any one of paragraphs 7.05.01- 7.05.03 or another appropriate reason. 2. Explain the rejection following the recitation of the statute and the use of form paragraphs 7.05.01-7.05.03 or other reason. 3. See MPEP Section Section 706.03(a) and 2105- 2107.02 for other situations. 4. This paragraph must be preceded by paragraph 7.04 in first actions and final rejections. 7.05.01 Rejection, 35 U.S.C. 101, Non-Statutory the claimed invention is directed to non-statutory subject matter. [1] Examiner Note: In bracket 1, insert identification of non-statutory subject matter. 7.05.02 Rejection, 35 U.S.C. 101, Utility Lacking the claimed invention lacks patentable utility. [1] Examiner Note: In bracket 1, provide explanation of lack of utility, such as, for example, that which is frivolous, fraudulent, against public policy, or lacks proper chemical specificity, etc. See MPEP Section Section 706.03(a) and 2105- 2107.02. 7.05.03 Rejection, 35 U.S.C. 101, Inoperative the disclosed invention is inoperative and therefore lacks utility. [1] Examiner Note: In bracket 1, explain why invention is inoperative. 7.05.04 Utility Rejections Under 35 U.S.C. 101 and 35 U.S.C. 112, First Paragraph Claim [1] rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a [2] asserted utility or a well established utility. [3] Claim [4] also rejected under 35 U.S.C. 112, first paragraph. Specifically, since the claimed invention is not supported by either a [5] asserted utility or a well established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. Examiner Note: Format A: (a) Insert the same claim numbers in brackets 1 and 4. (b) Insert --specific-- in inserts 2 and 5. (c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a specific asserted utility or a well established utility. Include within the insert the following statement: --Note, because the claimed invention is not supported by a specific asserted utility for the reasons set forth above, credibility cannot be assessed.--. (d) Format A is to be used when there is no asserted utility and when there is an asserted utility but that utility is not specific. Format B: (a) Insert the same claim numbers in brackets 1 and 4. (b) Insert --credible-- in inserts 2 and 5. (c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a credible asserted utility or a well established utility. For claims that have multiple utilities, some of which are not specific, some of which are not credible, but none of which are specific and credible: (a) Insert the same claim numbers in brackets 1 and 4. (b) Insert --specific asserted utility, a credible-- in inserts 2 and 5. (c) In bracket 3, insert the explanation as to why the claimed invention is not supported by either a specific asserted utility, a credible asserted utility or a well established utility. Each utility should be addressed. Include within the insert the following statement for those utilities which are not specific: --Note, because such a utility for the claimed invention is not specific for the reasons set forth above, credibility cannot be assessed for that utility.--. 1. In each case, a separate rejection under 35 U.S.C. 112, first paragraph, enablement should be made using the factors set forth in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) and an undue experimentation analysis. See MPEP Section Section 2164- 2164.08(c). 2. A utility that is inoperative should be treated as being not credible since a utility that is inoperative cannot be credible. ---SECTION---706.03(a)(1) Guidelines For Examination of Applications for Compliance With the Utility Requirement of 35 U.S.C. 101 and 35 U.S.C. 112 The following guidelines establish the policies and procedures to be followed by Office personnel when examining applications for compliance with the utility requirements of 35 U.S.C. 101 and 35 U.S.C. 112. The guidelines also address issues that may arise during examination of applications claiming protection for inventions in the field of biotechnology and human therapy. See MPEP Section 2107- Section 2107.02 for a discussion of the legal precedent governing utility rejections. GUIDELINES Office personnel must adhere to the following procedures when reviewing applications for compliance with the useful invention (utility) requirement of 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph: (A) Determine what the applicant has invented and is seeking to patent: (1) Ensure that the claims define statutory subject matter (e.g., a process, a machine, a manufacture, or a composition of matter); and (2) Review the complete specification, including the detailed description of the invention, any specific embodiments that have been disclosed, the claims, and any specific utilities that have been asserted for the invention. (B) Review the specification and claims to determine if the applicant has asserted any credible utility for the claimed invention. (1) If the applicant has asserted that the claimed invention is useful for any particular purpose (i.e., a "specific utility") and that assertion would be considered credible by a person of ordinary skill in the art, do not impose a rejection based on lack of utility. Credibility is to be assessed from the perspective of one of ordinary skill in the art in view of any evidence of record (e.g., data, statements, opinions, references, etc.) that is relevant to the applicant's assertions. An applicant must provide only one credible assertion of specific utility for any claimed invention to satisfy the utility requirement. (2) If the invention has a well-established utility, regardless of any assertion made by the applicant, do not impose a rejection based on lack of utility. An invention has a well-established utility if a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties of a product or obvious application of a process). (3) If the applicant has not asserted any specific utility for the claimed invention and it does not have a well-established utility, impose a rejection under 35 U.S.C. 101, emphasizing that the applicant has not disclosed a specific utility for the invention. Also impose a separate rejection under 35 U.S.C. 112, first paragraph, on the basis that the applicant has not shown how to use the invention due to lack of disclosure of a specific utility. The 35 U.S.C. 101 and 112 rejections should shift the burden to the applicant to: (i) explicitly identify a specific utility for