Training Materials - Product & Process Claims

TRAINING MATERIALS FOR TREATMENT OF PRODUCT AND PROCESS CLAIMS IN LIGHT OF IN RE BROUWER AND IN RE OCHIAI AND 35 U.S.C. 103(b)

BACKGROUND INFORMATION

Prior to the decisions in In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed. Cir. 1995) and In re Brouwer, 77 F.3d 422, 37 USPQ2d 1663 (Fed. Cir. 1996) some examiners relied on In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985) and rejected process claims as having been obvious based on prior art which discloses the same general process using "similar" starting materials.

A notice was published in the Official Gazette on March 26, 1996 which establishes guidelines for treatment of product and process claims in light of In re Ochiai and In re Brouwer. (Copy attached) The notice established a new procedure to permit the rejoinder of process claims, which have been withdrawn from consideration as a result of a restriction requirement (a holding of lack of unity of invention for national stage applications filed under 35 U.S.C. 371), when the product is found allowable.

The procedures for rejoining withdrawn process claims when the product is found allowable are as follows:

Where product and process claims drawn to independent and distinct inventions (a group of inventions not linked as to form a single general inventive concept for national stage applications filed under 35 U.S.C. 371) are presented in the same application, a restriction requirement (a holding of lack of unity of invention) may be made. The examiner may thus, where appropriate, require applicant under 35 U.S.C. 121 to elect claims to either the product or process. Claims directed to the non-elected invention are withdrawn from further consideration under 37 CFR 1.142 (37 CFR 1.499 for national stage applications filed under 35 U.S.C. 371). If applicant elects claims directed to the product, and the product is subsequently found allowable, withdrawn process claims which depend from or otherwise include all the limitations of the allowable product will be rejoined. Examiners should review the restriction requirement (holding of lack of unity of invention) to determine whether it is still applicable. Where the restriction requirement (holding of lack of unity of invention) is no longer applicable, the requirement (holding of lack of unity of invention) should be withdrawn when the process claims are rejoined. Those process claims which do not depend from or otherwise include all the limitations of the allowable product will not be rejoined.

The rejoined process claims will be fully examined for patentability under 37 CFR 1.104 to 1.106. Thus, to be allowable, the rejoined process claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112.

Where the application as originally filed discloses the product and the process for making and/or using the product, and only claims directed to the product are presented for examination, when the product is found allowable, applicant may present claims directed to the process of making and/or using the patentable product by way of amendment pursuant to 37 CFR 1.115. In view of the rejoinder procedure provided for in the Notice and in order to expedite prosecution, applicants are encouraged to present such process claims, preferably as dependent claims, in the application at an early stage of prosecution. Process claims which depend from or otherwise include all the limitations of a patentable product claim will be entered as a matter of right if the amendment is presented prior to final rejection. Amendments submitted after final rejection are governed by 37 CFR 1.116. Amendments submitted after allowance are governed by 37 CFR 1.312. Process claims which do not depend from or otherwise include all the limitations of the patentable product will be withdrawn from consideration, via an election by original presentation (see MPEP 821.03).

Where applicant voluntarily presents claims to the product and process in separate applications (no restriction requirement/holding of lack of unity was made by the Office), and one of the applications issues as a patent, the remaining application may be rejected under the doctrine of obviousness-type double patenting, where appropriate (see MPEP 804 - 804.03), and applicant may overcome the rejection by the filing of a terminal disclaimer under 37 CFR 1.321(c). Similarly, if co-pending applications separately present product and process claims, provisional obviousness-type double patenting rejections should be made where appropriate. However, once a determination as to the patentability of the product has been reached, any process claim which contains limitations corresponding to the allowed/allowable product should not be rejected over prior art without consultation with a Patent Examining Group Director.

Where product and process claims are presented in a single application and that application qualifies under the transitional restriction practice pursuant to 37 CFR 1.129(b), applicant may either (1) elect the invention to be searched and examined and pay the fee set forth in 37 CFR 1.17(s) and have the additional inventions searched and examined under 37 CFR 1.129(b)(2), or (2) elect the invention to be searched and examined and not pay the additional fee (37 CFR 1.129(b)(3)). Where no additional fee is paid, if the elected invention is directed to the product and the claims directed to the product are subsequently found patentable, process claims which either depend from or include all the limitations of the allowable product will be rejoined in view of the Notice. If applicant chooses to pay the fees to have the additional inventions searched and examined pursuant to 37 CFR 1.129(b)(2), even if the product is found allowable, applicant would not be entitled to a refund of the fees paid under 37 CFR 1.129(b) by arguing that the process claims would have been rejoined pursuant to the Notice. 37 CFR 1.26 states that "[m]oney paid by actual mistake or in excess will be refunded, but a mere change of purpose after the payment of money...will not entitle a party to demand such a return...." At the time the fees were paid under 37 CFR 1.129(b) they were not paid by actual mistake nor paid in excess, therefore, applicant would not be entitled to a refund.

The following examples illustrate application of the legal principles discussed in the March 26, 1996 Notice.

EXAMPLES

The following illustrates analysis under 35 U.S.C. 103 of process claims for making or using a new and nonobvious product:

Example 1: DNA/Protein

Claim 1. DNA encoding human Protein Z which protein has the amino acid sequence of SEQ ID NO 3.

Claim 2. A method of making human Protein Z comprising expressing the DNA of claim 1 in a eukaryotic host cell.

The prior art does not contain the DNA encoding the human Protein Z, nor adequate other information, such as any part of the human Protein Z amino acid sequence or known structural similarity of the Protein Z molecules between different mammalian species to render claim 1 prima facie obvious. Indeed, human Protein Z is not known in the art. Claim 1 would be allowed over the prior art.

Prior to the decision in In re Ochiai and In re Brouwer, an examiner may well have taken the position that claim 2 was obvious, despite a finding that claim 1 was patentable, based on prior art which disclosed similar DNA being expressed as required by the claim and approaching the determination based on an analysis as was presented in In re Durden.

Inappropriate Rejection: Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Smith. Smith teaches the successful expression of functional murine Protein Z in chinese hamster ovary, which is a eukaryotic host cell. Smith does not teach human Protein Z which differs from the murine form. It would have been obvious to one of ordinary skill in the art at the time of the invention to express human Protein Z with a reasonable expectation of success due to the structural similarities between murine Protein Z and human Protein Z.

As illustrated, the rejection does NOT establish the obviousness of DNA encoding human Protein Z.

The court in Ochiai and Brouwer stated that the test for obviousness as established in Graham v. John Deere Co. must be followed. Once a determination is made that the DNA of claim 1 is patentable, any determination as to the patentability of claim 2 must speak to the specifics of the DNA of claim 1 and provide motivation for the use of the specific DNA in the process of claim 2. Therefore, the rejection illustrated above would be improper or inappropriate given this fact pattern.

It would be incorrect to examine a process claim while giving little or no weight to the product limitations in the process claim. The product limitations must be afforded full consideration as specific claim limitations.

This result is the same whether you characterize claim 2 as a method of making protein or as a method of using DNA. The court indicated in the Ochiai decision that such a distinction is not appropriate when conducting an analysis of obviousness under the test presented in Graham v. John Deere.

The following illustrates the procedures for rejoining withdrawn process claims when the product is found allowable:

Example 2: Microbe/Fermentation

Claim 1. A biologically pure culture of any species of the genus Aspergillus.

Claim 2. The culture of claim 1 wherein the species is Aspergillus nonsense sp. having ATCC #99978.

Claim 3. A method of producing Antibiotic ZU-1289 comprising culturing any species of the genus Aspergillus capable of producing Antibiotic ZU-1289 under suitable conditions.

Claim 4. A method of producing Antibiotic ZU-1289ME comprising culturing Aspergillus nonsense sp. having ATCC #99978 under suitable conditions.

Claim 5. Antibiotic ZU-1289 (generic structure).

Claim 6. Antibiotic ZU-1289ME (specific structure).

Claim 7. A method of treating a fungal infection by topically administering the Antibiotic ZU-1289 of claim 5.

Claim 8. A method of treating a fungal infection by topically administering the Antibiotic ZU-1289ME of claim 6.

Assume the examiner finds it necessary to restrict the inventions under 35 U.S.C. 121. The examiner groups the inventions in the following manner:

Invention 1: claims 1 and 2 are directed to a genus starting material and to a species, respectively;

Invention 2: claims 3 and 4 are directed to methods of making a product using the starting materials recited in claims 1 and 2 respectively;

Invention 3: claims 5 and 6 are directed to a genus end product and to a species, respectively; and

Invention 4: claims 7 and 8 are directed to methods of using the products recited in claims 5 and 6 respectively.

The examiner makes a four-way restriction requirement between the products of claims 1 and 2; the methods of claims 3 and 4; the products of claims 5 and 6; and the methods of claims 7 and 8 pursuant to 35 U.S.C. 121.

Applicant elects to prosecute the products of claims 1 and 2. Claims 3-8 are withdrawn from further consideration under 37 CFR 1.142(b).

What is the status of the withdrawn process claims 3 and 4 if the product of claim 2 is determined to be allowable if rewritten in independent form, but the product of claim 1 is rejected over prior art under 35 U.S.C. 102?

In accordance with the Notice, withdrawn process claims which either depend from or otherwise include all the limitations of an allowed product claim will be rejoined when the product claim is found allowable. Therefore, upon allowance of product claim 2, the examiner must determine if any of the withdrawn process claims can be rejoined. In the above example, claim 4 would be rejoined since it includes the specific product limitations of allowable claim 2. Claim 3 would not be rejoined due to the distinction in scope between claim 3 and allowable claim 2.

If we add the following facts to the above scenario, does the answer change?

In conducting the examination, the examiner determines claim 2 to be allowable not only because the specific Aspergillus strain is not obvious over the anticipatory reference that has been applied to claim 1 or any other prior art on the microbe, but also because the specific structure of Antibiotic ZU-1289ME is not known or suggested in the prior art.

In this fact scenario the examiner should indicate that claims 4, 6 and 8 are all rejoined with claim 2, in that the antibiotic product has been determined to be allowable as well as the microbial product. Broad claims 3, 5 and 7 need not be rejoined since they are neither commensurate in scope with the allowable microbe or the allowable antibiotic compound.

Had product claims 5 and 6 been initially elected and claim 6 found to be allowable with claim 5 being rejected over prior art, claims 4 and 8 would be rejoined, but in this scenario product claim 2 would not be rejoined. The patentability of the microbe cannot rest alone on its ability to produce a product not previously known in the art, such as Antibiotic ZU-1289ME. The microbe may well have existed for a long period of time in the prior art and have been used for another purpose entirely. This cannot be determined without an appropriate search of the relevant microbial art. Claim 7 would not be rejoined since claim 5 was determined to be unpatentable.

The following illustrates considerations regarding the time of presentation of process claims:

Example 3: A p-n Junction Device and Method of Preparation

Claim 1. A p-n junction device comprising:

a substrate composed of a semiconductor material;

a heavily doped n-type subcollector layer over said substrate;

a n-type collector layer over said subcollector layer;

a heavily doped p-type first base layer over said collector layer;

a p-type second base layer over said first base layer; and

a n-type emitter layer over said second base layer, whereby said second base layer serves as a diffusion barrier between said base and said emitter.

Claim 2. A method of forming heterojunction device comprising the steps of:

forming a heavily doped n-type subcollector layer over a semiconductor substrate;

forming an n-type collector layer over said subcollector layer;

forming a heavily doped p-type first base layer over said collector layer;

forming a p-type second base layer over said first base layer; and

forming an n-type emitter layer over said second base layer, whereby said

p-type second base layer serves as a diffusion barrier between said p-type first base layer and said n-type emitter layer.

Assume the subject matter of claim 2 has support in the original disclosure but claim 2 was not presented until after a first rejection in an amendment under 37 CFR 1.115.

If the examiner considered it necessary, a restriction between the product of claim 1 and process of claim 2 could be made based on the original presentation of the product if the product claim was unpatentable. If the amendment overcame the outstanding rejections and placed claim 1 in condition for allowance, the process of claim 2 would be entered and examined with the product and allowed since the claim meets the requirements of 35 U.S.C. 112.

Had a subsequent Office action been necessary on the process of claim 2 because claim 2 did not comply with the requirements of 35 U.S.C. 112, that subsequent action would have been made FINAL, as indicated in the Notice since the rejection under 35 U.S.C. 112 was necessitated by applicant's amendment.

Assume the subject matter of claim 2 has support in the original disclosure but claim 2 was not presented until after a final rejection in an amendment under 37 CFR 1.116.

If the amendment after final does not place the product of claim 1 in condition for allowance, a restriction between the product of claim 1 and process of claim 2 would be proper based on the original presentation of the product claim and the unpatentability of the product. The amendment to add claim 2 would not be entered.

If the amendment after final places the product claim 1 in condition for allowance, and since the process claim includes all the limitations of the allowable product claim, the process claim would be entered if the process claim were allowable.

If the process claim raises new issues that would require further consideration and likely rejection under 35 U.S.C. 112, first paragraph, the examiner could refuse to enter the process claim under the current practice regarding the handling of amendments after final rejection under 37 CFR 1.116. However, if the rejection under 35 U.S.C. 112 is under the second paragraph, such as a minor clarity of language problem, the examiner should enter the process claim and amend the claim with applicant's approval by examiner's amendment to avoid the potential rejection. In any case, the examiner should promptly notify applicant regarding the status of the process claim submitted in the amendment after final rejection.

The following illustrates the rejoinder procedures where not all rejoined claims are allowable:

Example 4: Multiple Methods

Claim 1. The monoclonal antibody produced by culturing hybridoma ECW322, ATCC # 77766.

Claim 2. In a method of purifying Protein X via immunoaffinity chromatography, the improvement comprising the use of the monoclonal antibody of claim 1.

Claim 3. A method of treating cancer comprising administering a cytotoxin conjugate of the antibody of claim 1.

The specification provides adequate guidance and description to enable one skilled in the art to practice the purification method of claim 2. However, the specification is insufficient as to enablement of the therapy method, particularly with regard to the scope, of claim 3.

Assume the examiner considered it necessary to restrict under 35 U.S.C. 121 between the inventions claimed in each of the claims. Claim 1 was elected and claims 2 and 3 were withdrawn from further consideration.

What is the status of the withdrawn process claims if the product of claim 1 is determined to be allowable?

In accordance with the Notice, withdrawn process claims which either depend from or otherwise include all the limitations of an allowed product claim will be rejoined when the product claim is found allowable. Therefore, upon allowance of the product claim, the examiner must determine if any of the withdrawn process claims can be rejoined. In the above example, claims 2 and 3 would be rejoined since claims 2 and 3 include all the limitations of the allowed product claim 1 and the restriction requirement originally made should be withdrawn by the examiner. Rejoined process claims 2 and 3 will then be fully examined for patentability in accordance with 37 CFR 1.104 - 1.106. In this particular example, a subsequent Office action is necessary to present the rejection of the process of claim 2 as being indefinite since claim 2 does not comply with the requirements of 35 U.S.C. 112, second paragraph in that claim 2 does not recite any active method steps (see Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)). Claim 3 would be rejected under 35 U.S.C. 112, first paragraph. As indicated in the Notice, that subsequent action would be made FINAL.

Assume the subject matter of claim 2 was not presented until after a final rejection in an amendment under 37 CFR 1.116.

If the amendment after final places the product claim 1 in condition for allowance, and if the process claim either depends from or includes all the limitations of the allowable product claim, the process claim could be rejoined. As noted above, claim 2 does not comply with the requirements of 35 U.S.C. 112, second paragraph. Claim 2 would be allowed if the phrase "the use of" is amended with applicant's approval by examiner's amendment to read "using."

Assume the subject matter of claim 3 was not presented until after a final rejection in an amendment under 37 CFR 1.116.

Had claim 3 been presented after a FINAL rejection, the examiner would take the position that the amendment would not be entered since claim 3 raises new issues that would require further consideration and rejection under 35 U.S.C. 112, first paragraph.

The examiner would deny entry of the amendment and provide the reasons for nonentry in an Advisory Action, as indicated in the Notice.

The following illustrates the rejoinder procedures where product and process claims are presented in separate applications:

Example 5:

Application A (claims drawn to the product)

Claim 1. A programmable logic array comprising:

a plurality of input lines; a plurality of output lines;

a plurality of logic gate means arranged in rows and columns; and field programmable means for selectively interconnecting at least one of said plurality of input lines to the logic gate means.

Claim 2. The programmable logic array of claim 1 wherein the field programmable means is an antifuse and a diode connected in series.

Claim 3. The programmable logic array of claim 2 wherein the antifuse is formed over a diffusion area in a well area and said diode is formed from said diffusion area and said well area.

Application B (claims drawn to the process)

Claim 1. A method of manufacturing a programmable logic array comprising the steps of:

forming a plurality of input lines;

forming a plurality of output lines;

providing a plurality of logic gates; and

forming a antifuse over a diffusion area in a well area and a diode from said diffusion area and said well area to interconnect at least one of the plurality of input lines to the logic gates.

Claim 2. A method of manufacturing as recited in claim 1 further comprising the step of: (specific method step)

Claim 3. A method of manufacturing as recited in claim 2 further comprising the steps of: (more specific method steps)

If the examiner of Application A finds the product claims to be allowable, would a rejoinder be made with the process claims of Application B?

Since the product and process claims were not presented in the same application, the question of rejoinder is not an issue. That is, rejoinder of claims only applies when a restriction has been made between product and process claims in a single application. However, applicant may wish to merge the applications into a C-I-P or abandon Application B and add Application B's claims to Application A if Application A's product claims are allowed and Application A's specification will support Application B's claims.

If applicant were to submit the process claims of Application B in an amendment in Application A after the allowance of the product claims, would the amendment be entered?

The Notice does not affect the amendment after allowance practice under 37 CFR 1.312. Therefore, the process claims could be entered after the allowance of the product claims as long as the claims meet the requirements of 35 U.S.C. 112 and also if claims 2 and 3 in Application B have support in Application A's specification.

The product claims of Application A are allowed. Prior to a first action on the merits of the process claims, applicant submits a letter informing the examiner of Application B that product claims of commensurate scope have been allowed and, as such, requests that the method claims be allowed. Can the process claims of Application B be allowed based on the product claims of Application A?

The process claims must be fully examined for patentability in accordance with 37 CFR 1.104 - 1.106. The examiner must determine whether the requirements of 35 U.S.C. 101, 102, 103 and 112 have been met. Furthermore, the examiner must determine whether an obviousness-type double patenting rejection over Application A would be appropriate assuming that the separate applications were not filed as a result of a restriction requirement.

Is examiner required to make a prior art search in Application B before allowing the process claim?

The examiner should perform a separate prior art search for the claimed process before allowing the process claim. However, if the process claim includes all the limitations of the allowable product, it is unlikely that a rejection over prior art could be made if the prior art were properly cross-referenced in the classified search files or would appear as a search result as part of an on-line search query when searching the product in APS or a commercial data base.

The following illustrates obviousness type double patenting considerations:

Example 6: Apparatus/Multiple Methods, Some of Different Scope

Claim 1. An optical module comprising:

an optical device;

a first fiber optic cable coupled to one end of the optical device;

a second fiber optic cable coupled to the other end of said optical device;

an enclosure body of epoxy resin to enclose said optical device; and

a urethane resin interposed between said enclosure body and said optical device.

Claim 2. A method of manufacturing an optical module having an optical device with a first fiber optical cable coupled to one end and a second fiber optical cable coupled to the other end comprising the steps of:

placing the optical device in a mold;

forming an enclosure body to enclose said optical device;

injecting the space between the enclosure body and said optical device with a resin.

Claim 3. A method as recited in claim 2 wherein the resin used in the step of injecting is a urethane resin.

Claim 4. A method as recited in claim 2 wherein the resin used in the step of injecting is a silicone resin.

For this example, assume that urethane resin and silicone resin are not art recognized equivalents and that they are patentably distinct.

Assume the examiner found it necessary to restrict under 35 U.S.C. 121 between the apparatus of claim 1 and the method of making of claims 2-4. The examiner further indicates that if applicant elects the invention directed to the method of making then, applicant must further elect between the species recited in claims 3 and 4. Note that method of manufacturing in claim 2 is broader in scope than the apparatus of claim 1.

Applicant elects the apparatus and the method claims are withdrawn from further consideration.

Assume that claim 1 is allowed because the resin is a "urethane" resin as opposed to any resin. At the time the product is found to be allowable, the method claims which either depend from or include all the limitations of the allowable product will be rejoined with the allowable product. Examiners should review the restriction requirement and determine whether it is still applicable. In the above example, only claim 3 is of equal scope with the allowed product. Claim 3 is rejoined and amended to include all the limitations of claim 2, and claims 1 and 3 are allowed. The restriction requirement is still applicable. In view of the differences in scope between the allowed apparatus of claim 1 and the method recited in claims 2 and 4, claims 2 and 4 are not rejoined. A DIVISIONAL application is filed prior to the issuance of claims 1 and 3 setting forth claims 2 and 4.

Under these circumstances would the examiner make an obviousness type double patenting rejection?

The examiner could reject the broader process claim 2 in the divisional application under the doctrine of obviousness type double patenting based on the narrower process allowed in the parent application (claim 3). Note that claim 2 could not be rejected over allowed claim 1 in the parent application because the restriction requirement is still applicable (see 35 U.S.C. 121). Claim 4 should not be rejected as obvious over allowed claim 3 of the parent application since silicone resin is a patentably distinct resin from urethane resin, i.e., they are not art recognized interchangeable equivalents and there would have been no motivation to substitute one resin for the other.

PETITIONS UNDER 35 U.S.C. 103(b)

Public Law 104-41 was enacted as a legislative response to the undesirable circumstance in which a patented starting material (most notably DNA) could be used to produce an unpatentable product (such as a protein) outside of the United States and the importation of that product into the United States would not be considered as an act of infringement of the patented starting material. This result would be altered and an act of infringement would occur if the patent also contained a claim encompassing a method of producing the imported product. In at least some instances such a process claim would not have been patented along with the patentable starting material because it would have been found to be obvious despite the patentability of the starting material. Thus, 35 U.S.C. 103(b) provides a statutory exception to the holding of obviousness under 35 U.S.C. 103(a) for biotechnological inventions, which are defined in the statute, at applicant's election if certain requirements are met. See the March 26, 1996 Notice regarding the details of an election under 35 U.S.C. 103(b).

Public Law 104-4- Nov. 1, 1995 109 STAT. 351

Public Law 104-41 104th Congress

AN ACT
To amend title 35, United States Code, with respect to patents on biotechnological processes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. BIOTECHNOLOGICAL PROCESS PATENTS; CONDITIONS FOR PATENTABILITY; NONOBVIOUS SUBJECT MATTER.

Section 103 of title 35, United States Code, is amended---

(1) by designating the first paragraph as sub-section (a);

(2) by designating the second paragraph as subsection (c); and

(3) by inserting after the first paragraph the following

"(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 com-position 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).".

SEC. 2. PRESUMPTION OF VALIDITY; DEFENSES.

Section 282 of title 35, United States Code, is amended by inserting after the second sentence of the first paragraph the following: "Notwithstanding the preceding sentence, if a claim to a composition of matter is held in valid and that claim was the basis of a determination of nonobviousness under section 103(b)(1), the process shall no longer be considered nonobvious solely on the basis of section 103 (b)(1).'".

SEC. 3. EFFECTIVE DATE.

The amendments made by section 1 shall apply to any application for patent filed on or after the date of enactment of this Act and to any application for patent pending on such date of enactment, including (in either case) an application for the reissuance of a patent.

OFFICIAL GAZETTE NOTICE

Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b)

The purpose of this Notice is to provide guidance to Patent and Trademark Office personnel and to the public on the proper consideration of certain claims in light of In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed. Cir. 1995) and In re Brouwer, 71 F.3d 1565, 37 USPQ2d 1663 (Fed. Cir. 1996) and the passage of 35 U.S.C. § 103(b), which became effective November 1, 1995.

Ochiai, Brouwer and § 103(b) relate to how process claims directed to making or using nonobvious products are to be treated.

The Court in Ochiai and Brouwer addressed the issue of whether an otherwise conventional process could be patented if it were limited to making or using a nonobvious product. In both cases, the Federal Circuit held that the use of per se rules is improper in applying the test for obviousness under the 35 U.S.C. § 103. Rather, § 103 requires a highly fact-dependent analysis involving taking the claimed subject matter as a whole and comparing it to the prior art. To support a rejection under § 103, the collective teachings of the prior art must have suggested to one of ordinary skill in the art that, at the time the invention was made, applicant's claimed invention would have been obvious. In applying this test to the claims on appeal, the Court held that there simply was no suggestion or motivation in the prior art to make or use the nonobvious products to which the claims were limited and consequently overturned the rejections based upon § 103.

Interpreting a claimed invention as a whole requires consideration of all claim limitations. Thus, language in a process claim which recites making or using a nonobvious product must be treated as a material limitation, and a motivation to make or use the nonobvious product must be present in the prior art for a § 103 rejection to be sustained.

In light of Ochiai and Brouwer, Office personnel will consider all claim limitations when analyzing process claims which make or use nonobvious products under § 103. Office personnel will focus on treating claims as a whole and follow the analysis set forth in Graham v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966).

Accordingly, to facilitate examination under § 103, where product and process claims are presented in the same application, applicant may be called upon under 35 U.S.C. § 121 to elect claims to either the product or process. The claims to the non-elected invention will be withdrawn from further consideration. However, in the case of an elected product claim, rejoinder will be permitted when a product claim is found allowable and the withdrawn process claim depends from or otherwise includes all the limitations of an allowed product claim. Withdrawn process claims not commensurate in scope with an allowed product claim will not be rejoined. In the event of rejoinder, the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104 - 1.106. If the application containing the rejoined claims is not in condition for allowance, the subsequent Office action may be made final, or, if the application was already under final rejection, the next Office action may be an advisory action.

35 U.S.C. § 103(b) is applicable to biotechnological processes only. Section 103(b) precludes a rejection of process claims which involve the use or making of certain nonobvious biotechnological compositions of matter under § 103(a). Section 103(b) requires that:

1.the biotechnological process and composition of matter be contained in either the same application or in separate applications having the same effective filing date;

2.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;

3.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;

4.the biotechnological process falls within the definition set forth in § 103(b); and

5.a timely election be made to proceed under the provisions of § 103(b).

In view of the Federal Circuit's decisions in Ochiai and Brouwer, an applicant's need to rely upon § 103(b) should be rare. Consequently, the Patent and Trademark Office will treat § 103(b) elections on a case-by-case basis by way of petition under 37 CFR 1.182. That petition must establish that all the requirements set forth in § 103(b) have been satisfied. An election will normally be considered timely if it is made no later than the earlier of either (1) the payment of the issue fee, or (2) 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 § 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 the date of this Notice, the timeliness requirement for an election under § 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 § 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 § 103(b) treatment.

Any questions, comments or suggestions regarding petitions under 37 CFR 1.182 filed pursuant to this Notice should be directed to the Special Program Law Office, attention: Hiram Bernstein, Senior Legal Advisor. All other questions, comments or suggestions regarding this Notice should be directed to the Solicitor's Office, attention: Craig Kaufman, Associate Solicitor.

{Signature}Bruce A. Lehman

Date: FEB 28 1996

Assistant Secretary of Commerce and Commissioner of Patents and Trademarks

* Note: This Notice was published at 1184 OG 86 on March 26, 1996.

U.S. Court of Appeals Federal Circuit In re Brouwer

No. 92-1225

Decided December 13, 1995

Precedential Opinion Issued February 8, 1996

PATENTS

1. Patentability/Validity -- Obviousness --

Relevant prior art -- Particular inventions

(§ 115.0903.03)

Application claims for process of reacting crosslinked resin with ester of alkenesulfonic acid to make sulfoalkylated resin catalyst are not prima facie obvious over references cited by examiner, which teach generic reaction of compound containing active methlyene group with ester of sulfonic acid, since mere fact that device or process utilizes known scientific principle does not alone make that device or process obvious, and since mere possibility that ester or active methylene group-containing compound disclosed in reference could be modified or replaced in manner that would lead to specific sulfoalkylated resin recited in claims does not render claimed process obvious absent suggestion in prior art that such modification or replacement is desirable.

2. Patentability/Validity -- Obviousness --

In general (§ 115.0901)

Patent construction -- Claims -- Process

(§ 125.1309)

Examiner erred by resting prima facie case of obviousness for claimed process on purportedly controlling nature of precedent, rather than on particularized findings regarding set of one or more references that would make claimed process obvious, since suitable method claims, if properly presented and argued, should be examined in light of all relevant factors, free from any presumed controlling effect of precedent.

Appeal from the U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences.

Patent application of Dirk M. Brouwer and Elizabeth M. Van De Vondervoort, serial no. 07/098,154, filed September 18, 1987, which is division of serial no. 831,398, filed February 20, 1986, now patent no. 4,728,695. From reconsideration decision upholding examiner's rejection of claims 8-27 in application, applicants appeal. Reversed.

M.P. Haddican and Dean F. Vance, Houston, Texas, for appellant.

Fred E. McKelvey, solicitor (at the time briefs were filed), Richard E. Schafer, Teddy S. Gron, associated solicitors, Joseph G. Piccolo, assistant solicitor, Harris A. Pitlick, John W. Dewhirst, and Lee E. Barrett, PTO, for appellee.

Before Archer, chief judge,* Michel, circuit judge, and Carrigan, district judge.**

Per curiam .

* Judge Archer assumed the position of Chief Judge on March 18, 1994.

** Honorable James R. Carrigan, United States District Court for the District of Colorado, sitting by designation. Judge Carrigan retired from the federal judiciary effective August 19, 1995, and thus took no part in the disposition of this appeal.

This appeal is from the December 9, 1991, reconsideration decision of the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board), Appeal No. 90-1349. That decision adhered to the Board's March 18, 1991, decision affirming the examiner's rejection of claims 8 through 27 of Brouwer and Van De Vondervoort's (collectively Brouwer) application serial no. 98,154, a division of application serial no. 831,398, filed February 20, 1986, now U.S. Patent No. 4,728,695 (crosslinked resins containing thermally stable sulfonic acid groups). The real party in interest is Shell Oil Company, the assignee of any patent issuing from the application.

The rejection of the above claims was predicated solely on obviousness, per 35 U.S.C. Section 103, in view of the combined teaching of two references. 1 Because, under the legally correct method for determining obviousness, the claimed process is not obvious in view of the cited prior art references, we reverse.

1 The references are as follows: Distler, The Chemistry of Vinylsulfonic Acid [1], 4 Angew. Chem. Int'l Ed. 300 (1965); and Morrison & Boyd, Organic Chemistry 1179-1181 (4th ed. 1983).

DISCUSSION

The Invention

Brouwer's application is directed to a process for preparing sulfoalkylated polystyrene-divinylbenzene resins. Claim 8, the principal claim on appeal, 2 is as follows:

2 Because Brouwer did not argue the separate patentability of claims 8 through 27 before the Board, all the claims stand (or fall) together. In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1900 (Fed. Cir. 1990) (in banc), cert. denied, 500 U.S. 904 (1991); In re Kroekel, 803 F.2d 705, 709, 231 USPQ 640, 642-43 (Fed. Cir. 1986).

8. A process for the preparation of a catalyst comprising an aryl group having a functional substituent group of general formula

 (COOM)b | -(CH2)a-C-[C(H) (R1)-CH2-SO3M]d (I), | He 

wherein a is O or 1, b is 1 or 2, d is 1 or 2, e is 01 or 1, b+d+e=3, R1 represents H or a C1 to C4 alkyl group and M is a proton or another cation; which process comprises the steps of

a) reacting (1) a crosslinked resin comprising at least one substituted aryl group having a functional substituent group of general formula

 Rb2 | -(CH2)a-C-H (II), | He 

wherein a, b, and e have the same meaning as in general formula (I), b+e=2, R2 is a -CN orcarboxyester group and if b is 2, each R2 represents a -CN or a carboxyester group, and (2) an ester of an alkenesulfonic acid of general formula

 C(H) (R1 ) = C(H)-SO3R3 (III), 

wherein R1 has the same meaning as in general formula (I), and R3 is a hydrocarbyl group, under conditions suitable for the formation of an addition product of general formula

 Rb2 | -(CH2)a-C-[C(H) (R1)-CH2-SO3R3]d (IV), | He 

wherein a, b, d, e and R1 have the same meaning as in general formula (I), b+d+e=3, R2 has the same meaning as in general formula (II) and R3 has the same meaning as in general formula (III), and then

(b) hydrolyzing the addition product of general formula (IV) to produce a compound having a functional group of general formula (I).

Brouwer's U.S. Patent No. 4,728,695 covers the sulfoalkylated resins resulting from the process recited in claim 8. In other words, viewed as of the time the claimed process was invented, claim 8 recites a process of reacting a crosslinked resin with an ester of an alkenesulfonic acid to make a new, nonobvious sulfoalkylated resin catalyst. The '695 patent, like the application at bar, claims priority to the February 1986 parent application.

The Rejection

The examiner rejected claims 8 through 27 in light of the combined teaching of the two references noted above. As Brouwer acknowledges, Distler teaches so-called "Michael addition" reactions 3 in which a vinylsulfonate is reacted with an active methylene group-containing compound. Distler, however, neither discloses nor suggests making a catalyst by reacting an ester of an alkenesulfonic acid with a crosslinked resin; instead, Distler discloses simple, well-defined compounds the derivatives of which would not be expected to exhibit the catalytic activity and thermal stability of the sulfoalkylated resin made according to the process of claim 8. Specifically, the crosslinked resin recited in claim 8, unlike the Distler compound having an active methylene group, has an aryl-pendant -CN or carboxyester functional group. Morrison & Boyd's Organic Chemistry broadly discloses Michael addition reactions with two simple hydrocarbons; like Distler, it neither discloses nor suggests reacting an ester of an alkenesulfonic acid with a crosslinked resin. The examiner explained his initial rejections thusly:

Process of preparing polymer by using a unsaturated compound with active methylene substrate is well known as shown by Distler or Organic Chem. Applicants' methylene unit (III) possess [es] the characteristics required to carry out reactions of the Michael-type reactions. In re Durden, 226 USPQ 359.

3 Michael addition, named after chemist Arthur Michael (1854-1942), is a standard technique in organic chemistry for reacting a material having an alpha,beta-unsaturated carbonyl group with a material having an active methylene group.

Importantly, the examiner discussed no references containing any suggestion or motivation either (a) to use a resin-substituted methylene reactant in the generic addition reaction taught by the cited references, or (b) to obtain the specific sulfoalkylated resin catalyst made according to the process of claim 8. The examiner offered this same explanation, virtually verbatim, in both his final rejection and his answer to Brouwer's appeal to the Board.

On appeal, the Board affirmed the examiner's rejection. According to the Board,

The basic difference between the claimed Michael addition reaction and reaction "(n)" disclosed on page 304 of Distler is that the latter's methylene reactant is not attached to a resin as called for by the claims. Thus, the examiner considers that although Distler does not disclose the claimed methylene reactant attached to a resin, one skilled in the art would have expected that reacting the same with vinylsulfonic acid would result in the claimed Michael adduct. . . . [O]ne desiring to make a sulfoalkylated resin would have found it obvious to do so via a Michael addition reaction such as reaction "(n)" of Distler by selecting a resin substituted methylene reactant.

In other words, the Board concluded that one desiring to make the nonobvious resin resulting from the process recited in claim 8 would know, on the basis of Distler, how to make it. The Board adhered to its decision on reconsideration.

Brouwer appeals, contending that both the examiner and the Board failed to apply the proper test for obviousness established by Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), and its progeny. According to Brouwer, both the examiner and the Board, persuaded that our decision in In re Durden , 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985), controlled the outcome of the instant case, failed to weigh the specific differences between the claimed invention -- with all its limitations -- and the prior art references, the so-called "second Graham factor." See Graham , 383 U.S. at 17 ("Under Section 103 . . . differences between the prior art and the claims at issue are to be ascertained [.]"). Specifically, Brouwer contends that the Board erred by treating its disclosure -- namely, the sulfoalkylated resin made according to the process recited in claim 8 -- as prior art, leading it to affirm the examiner's rejection despite the lack of citation to any reference containing a suggesting or motivation either (a) to use a resinsubstituted methylene reactant in a generic Michael addition reaction, or (b) to obtain the specific sulfoalkylated resin catalyst made according to the process recited in claim 8. We agree.

The Analysis

The test of obviousness vel non is statutory. It requires that one compare the claim's "subject matter as a whole" with the prior art "to which said subject matter pertains." 35 U.S.C. Section 103. The inquiry is thus highly fact-specific by design. This is so "whether the invention be a process for making or a process of using, or some other process." In re Kuehl , 475 F.2d 658, 665, 177 USPQ 250, 255 (CCPA 1973). When the references cited by the examiner fail to establish a prima facie case of obviousness, the rejection is improper and will be overturned. In re Fine , 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1986 (Fed. Cir. 1988).

[ 1 ] Applying this statutory test to the art of record, we conclude that Brouwer's process invention is not prima facie obvious. Although the prior art references the examiner cited teach a generic chemical reaction of a compound containing an active methylene group with an ester of vinylsulfonic acid, we have made clear that " [t]he mere fact that a device or process utilizes a known scientific principle does not alone make that device or process obvious." Uniroyal, Inc. v. Rudkin-Wiley Corp ., 837 F.2d 1044, 1053, 5 USPQ2d 1434, 1440 (Fed. Cir. 1988). See also Lindemann Maschinenfabrik GmbH v. American Hoist & Derrick Co ., 730 F.2d 1452, 1462, 221 USPQ 481, 489 (Fed. Cir. 1984) (same). Moreover, the mere possibility that one of the esters or the active methlylene group-containing compounds disclosed in Distler could be modified or replaced such that its use would lead to the specific sulfoalkylated resin recited in claim 8 does not make the process recited in claim 8 obvious "unless the prior art suggested the desirability of [such] a modification" or replacement. In re Gordon , 733 F.2d 900, 902, 221 USPQ 1125, 1127 (Fed. Cir. 1984). Without first knowing Brouwer's claimed process steps or the composition resulting from those steps, there is simply no suggestion in the references cited by the examiner to practice the claimed process. It is therefore not prima facie obvious.

[ 2 ] The examiner erred by resting his prima facie case of obviousness on the purportedly controlling nature of our decision in Durden rather than on particularized findings, required by Graham , 383 U.S. at 17, regarding a set of one or more references that would make the claimed process obvious, an error the Board failed to correct. As we clearly indicated in In re Dillon, a recent in banc decision, "[w]hen any applicant properly presents and argues suitable method claims, they should be examined in light of all . . . relevant factors, free from any presumed controlling effect of Durden " or any other precedent. 919 F.2d 688, 695, 16 USPQ2d 1897, 1903 (Fed. Cir. 1990) (in banc), cert. denied , 500 U.S. 904 (1991). See also In re Ochiai , 72 F3d 1565, 1570, 37 USPQ2d 1127, 1132 (Fed. Cir. 1995) ("[T]here are not ' Durden obviousness rejections' or ' Albertson obviousness rejections,' but rather only section 103 obviousness rejections."). Having compared Brouwer's claims to the prior art of record, we reverse the rejection of claims 8 through 27 as an incorrect conclusion reached by incorrect methodology.

REVERSED

U.S. Court of Appeals Federal Circuit In re Ochiai

No. 92-1446

Decided December 11, 1995

PATENTS

1. Patentability/Validity -- Obviousness --

Relevant prior art -- Particular inventions

(§ 115.0903.03)

Patent construction -- Claims -- Process

(§ 125.1309)

Application claim for process of making particular cephem compound having antibiotic properties, using particular type of organic acid first disclosed in parent application, is not prima facie obvious over prior art of record, since obviousness inquiry of 35 USC 103 requires comparison of claim's "subject matter as a whole" with prior art "to which said subject matter pertains," since process invention recited in claim specifically requires use of new, unobvious acid as one of starting materials, and since it would not have been obvious to those of ordinary skill in art to choose particular acid required by claim, which was unknown but for its disclosure in application, as acylating agent for known amine; characterization of specifically claimed acid as "similar" to or "slightly different" from those used in prior art cannot establish obviousness of use of starting material that is new and nonobvious, both in general and in claimed process.

2. Patentability/Validity -- Obviousness --

In general (§ 115.0901)

Patent construction -- Claims -- Process

(§ 125.1309)

There is no per se rule that process claim is obvious if prior art references disclose same general process using "similar" starting materials; application of such rule is improper, since it sidesteps particularized obviousness inquiry required by 35 USC 103 and necessarily produces erroneous results.

3. Patentability/Validity -- Obviousness --

In general (§ 115.0901)

No per se rules of obviousness have been established by precedent, and reliance on any such rules that eliminate need for fact- specific analysis of claims and prior art is legally incorrect and must cease, since use of per se rules in obviousness determination is inconsistent with 35 USC 103, which entitles applicant to issuance of otherwise proper patent unless Patent and Trademark Office establishes that invention, as claimed in application, is obvious over cited prior art, based on specific comparison of that prior art with claim limitations.

Appeal from the U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences; 24 USPQ2d 1265.

Patent application of Michihiko Ochiai, Taiiti Okada, Osami Aki, Akira Morimoto, Kenji Kawakita, and Yoshihiro Matsushita, serial no. 07/462,492, filed January 8, 1990. from decision upholding examiner's rejection of claims 6 through 10, applicants appeal. Reversed.

Harold C. Wegner, Herbert I. Cantor, and Douglas P. Mueller, of Wegner, Cantor, Mueller & Player, Washington, D.C.; Don J. Pelto, of Foley & Lardner, Washington, for appellant.

Fred E. McKelvey, solicitor, U.S. Patent and Trademark Office, Nancy J. Linck, solicitor, Lee E. Barrett, John W. Dewhirst, and Richard E. Schafer, associate solicitors, and Albin F. Drost, deputy solicitor, for PTO.

Before Archer, chief judge,* Michel, circuit judge, and Carrigan, district judge.**

Per curiam.

* Judge Archer assumed the position of Chief Judge on March 18, 1994.

** Honorable James R. Carrigan, United States District Court for the District of Colorado, sitting by designation. Judge Carrigan retired from the federal judiciary effective August 19, 1995, and thus took no part in the disposition of this appeal.

This appeal is from the July 8, 1992, decision of the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board) affirming the examiner's rejection of claims 6 through 10 of Michihiko Ochiai et al.'s (collectively "Ochiai") application serial no. 07/462,492, claiming priority from parent application serial no. 642,356, filed December 19, 1975, now U.S. Patent No. 4,098,888 (methods for the manufacture of cephems). Ex parte Ochiai , 24 USPQ2d 1265 (Bd. Pat. App. & Int. 1992). The real party in interest is Takeda Chemical Industries, Ltd., the assignee of any patent issuing from the application.

The rejection of the above claims was predicated on an asserted view of the law of obviousness, per 35 U.S.C. Section 103, in view of the combined teaching of six references. 1 Because, under the legally correct method for determining obviousness, the claimed process is not obvious in view of the cited prior art references, we reverse.

1 The references are as follows: U.S. Patent No. 3,167,549 to Hoover; U.S. Patent No. 3,338,897 to Takano et al.; U.S. Patent No. 3,360,515 to Takano et al.; U.S. Patent No. 4,024,133 to Cook et al.; U.S. Patent No. 4,024,134 to Gregson et al.; and Flynn, Cephalosporin and Penicillins 83-91 (1972). Ochiai, 24 USPQ2d at 1266.

The Invention

Ochiai's application is directed to a process for using an acyl side chain from a particular type of organic acid having a 2-aminothiazolyl group, and a particular type of amine to make a particular cephem compound having antibiotic properties.

Claim 6, the principal claim on appeal, 2 is as follows:

2 Because Ochiai did not argue the separate patentability of claims 6 through 10 before the Board, all the claims stand (or fall) together. In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1900 (Fed. Cir. 1990) (in banc), cert. denied, 500 U.S. 904 (1991); In re Kroekel, 803 F.2d 705, 709, 231 USPQ 640, 642-43 (Fed. Cir. 1986).

6. A process for preparing a cephem compound of the formula:

 H2N S R4 R3 \ / \ / | S || || | / \ N_______ ____ CCONH_______ _____ | || | | | NR5 | ___ N | // \ // \ O | CH2R4 COOH 

wherein R3 is hydrogen or methoxy, R4 is hydrogen or a residue of a nucleophilic compound, R5 is hydroxyl or a protected hydroxyl, and R5 is hydrogen or a halogen, or a pharmaceutically acceptable salt or ester thereof, which comprises introducing an acyl group of the formula:

 H2N S R8 \ / \ / || || N ___ ___ C ___ CO __ || NR5 

wherein R5 and R8 are as defined above into the amino group of the molecule of the formula:

 R3 | S | H2N _____|_____/ \ | | | | ___N | // \ // \ O | CH2R4 COOH 

wherein R3 and R4 are as defined above or a salt or ester thereof.

Id . at 1266.

Ochiai's U.S. Patent No. 4,298,606 covers the cephem compound resulting from the process of claim 6, and Ochiai's U.S. Patent No. 4,203,899 covers the organic acid used in the process of claim 6. Id . at 1267. In other words, viewed as of the time the claimed process was invented, claim 6 recites a process of using a new, nonobvious acid to make a new, nonobvious cephem. The '606 and '899 patents, like the application at bar, claim priority from the December 1975 parent application.

The Rejection

The examiner rejected claims 6 through 10 as obvious in light of the combined teaching of the six references noted above. All six references, as Ochiai acknowledges, teach the use of a type of acid to make a type of cephem by a standard acylation reaction with the very same amine recited in claim 6. The examiner explained the rejections thusly in his answer to Ochiai's appeal to the Board:

It must again be stressed that the citation of six references is to demonstrate convincingly that a standard, conventional process of preparing cephalosporin compounds is being claimed. The only difference between what is being claimed and the prior art is the selection of a slightly different acylation agent [ i.e., acid] to result in a slightly different final product. The closest prior art of the six references is represented by the Cook et al. 4,024,133 and, Gregson et al. patent 4,024,134. These two references use [sic, are] quite similar in their disclosure, Cook being the most [sic, more] relevant. Both of these references generically disclose the "2-amino-thiazolyl" group which appellants seek to introduce. . . .

. . .

The examiner recognizes that the specific "2 amino thiazolyl" moiety has not been specifically named in [the] Cook et al [.] patent. However, Cook et al. when viewed from the standpoint of one skilled in the art would recognize the use of "2-aminothiazolyl" if the final products sought were to contain this moiety. This merely states the obvious. . . .
. . .

The facts presented here are identical to those that occurred in the Durden decision (In re Durden 226 USPQ 359 ). The acylating agent herein being used has been patented by appellants, see Ochia et al. 4,203,899. The final products have also been patented by appellants which appellants acknowledge, brief page 5 footnote 4.

The only difference between the facts in Durden those Durden [sic] and the instant situation is that appellants have not admitted on the record that the process is obvious. Appellants seek to distinguish the Durden decision based on this difference. However, the Durden decision is believed to be controlling because of the reasoning used therein and not an admission or lack of admission of the obviousness of the process. The references discussed above abundantly demonstrate the routineness of the claimed process. Thus, the Court rejected the argument that a conventional manipulation or reaction was unobvious "not-withstanding the specific starting material or resulting product or both, is not to be found in the prior art".

(Emphasis in original). Importantly, the examiner conceded the total absence from the prior art of both the acid used and the cephem made in the process recited in claim 6. In addition, the examiner discussed no references containing any suggestion or motivation either (a) to reject known acids and select instead the particular one used in claim 6, or (b) to obtain the particular cephem made according to the process of claim 6.

On appeal, the Board affirmed the examiner's rejection. After reviewing the examiner's reliance on In re Durden , 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985), and the "standard" nature of the acylation reaction disclosed in the rejected claims, the Board acknowledged Ochiai's contention that the fact that "neither the final product nor the method of introducing the particular [acid] component were known, obvious or even remotely suggested in the prior art . . . should be dispositive of the obviousness of the invention" recited in claim 6. Ochiai , 24 USPQ2d at 1267. The Board did not, however, find Ochiai's contention persuasive. According to the Board,

[w]e are not here concerned with the patentability of the starting materials, the final compounds or other processes of making the [cephem] compounds. We are concerned only with the claimed process and the patentability thereof. Cases such as In re Larsen , 292 F.2d 531, 130 USPQ 209 (CCPA 1961); In re Albertson , 332 F.2d 379, 141 USPQ 730 (CCPA 1964) and, particularly, In re Durden , supra , all of which were directed to processes of making chemical compounds, are controlling herein. . . . In each case, a material A, either known or novel, was subjected to a standard process of reacting with a standard reactant, B, in order to produce the result expected from the reaction of A with B. Indeed in Albertson as in the instant case, the only manipulative step of the process is that which is embodied in the word "reacting."

Id . The Board also rejected Ochiai's assertion that cases such as In re Pleuddemann , 910 F.2d 823, 15 USPQ2d 1738 (Fed. Cir. 1990), In re Mancy , 499 F.2d 1289, 182 USPQ 303 (CCPA 1974), and In re Kuehl , 475 F.2d 658, 177 USPQ 250 (CCPA 1973), are in tension with Durden and Albertson and counsel allowance of the rejected claims. Distinguishing Pleuddemann , Mancy , and Kuehl as "method of using" rather than "method of making" cases, the Board summarized its decision as follows:

In the case before us, appellants have admitted the claims are directed to a process of making a desired AB product. The process steps, "introducing" A into AB or "reacting" A with B are standard processes used by practitioners in the prior art for reacting similar A moieties with the same B moiety. We are in agreement with the examiner that there is nothing unobvious in the particular process chosen and claimed by the appellants.

Ochiai , 24 USPQ2d at 1270 (emphasis in original).

Ochiai appeals, contending that both the examiner and the Board failed to apply the proper test for obviousness established by Graham v. John Deere Co ., 383 U.S. 1, 148 USPQ 459 (1966), and its progeny. Specifically, according to Ochiai, both the examiner and the Board, on the assumption that our decision in Durden controlled the outcome of the instant case, failed to weigh the specific differences between the claimed invention -- with all its limitations -- and the prior art references, the so-called "second Graham factor." See id . at 17 ("Under Section 103 . . . differences between the prior art and the claims at issue are to be ascertained [.]"). In addition, Ochiai contends that the decisions in Mancy and Kuehl , which, like all Court of Customs and Patent Appeals decisions, were in banc, limit the decision in Albertson to its facts.

The Solicitor, while defending the correctness of the Board's conclusion and, unlike the Board itself, doing so in the familiar terms of Graham , also asserts that a supposed irreconcilable conflict in our cases -- between Albertson and Durden , on the one hand, and Pleuddemann , on the other -- "makes it very difficult for patent attorneys to give cogent advice to clients or for patent examiners to render consistent decisions on the patentability (under Section 103) of processes involving the use of new and unobvious starting materials." Unlike Ochiai, however, the Solicitor asks us to take the opportunity to reaffirm the vitality of Albertson and Durden in the course of deciding this appeal.

The Issue

The issue before this court is whether the Board erred in upholding the examiner's rejection of claim 6 as obvious under 35 U.S.C. Section 103 in view of Larsen , Albertson , and Durden as interpreted by the PTO when neither the particular acid used nor the particular cephem produced is either taught or suggested by the art that predates the parent application.

The Analysis

The test of obviousness vel non is statutory. It requires that one compare the claim's "subject matter as a whole" with the prior art "to which said subject matter pertains." 35 U.S.C. Section 103. The inquiry is thus highly fact-specific by design. This is so "whether the invention be a process for making or a process of using, or some other process." Kuehl , 475 F.2d at 665, 177 USPQ at 255. When the references cited by the examiner fail to establish a prima facie case of obviousness, the rejection is improper and will be overturned. In re Fine , 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).

[1] Applying this statutory test to the art of record, we conclude that Ochiai's process invention as claimed is not prima facie obvious. The process invention Ochiai recites in claim 6 specifically requires use of none other than its new, nonobvious acid as one of the starting materials. One having no knowledge of this acid could hardly find it obvious to make any cephem using this acid as an acylating agent, much less the particular cephem recited in claim 6. In other words, it would not have been obvious to those of ordinary skill in the art to choose the particular acid of claim 6 as an acylating agent for the known amine for the simple reason that the particular acid was unknown but for Ochiai's disclosure in the '492 application. As one of our predecessor courts had occasion to observe, in a case involving a highly analogous set of facts, "one cannot choose from the unknown." Mancy , 499 F.2d at 1293, 182 USPQ at 306. 3

3 In Mancy, the applicant claimed a process for using a newly discovered strain of the microorganism Streptomyces to produce a known antibiotic by means of conventional aerobic cultivation. 499 F.2d at 1290, 182 USPQ at 304. The examiner rejected the claim, and the Board affirmed the rejection. The court reversed, having concluding that [w]ithout Streptomyces bifurcus, strain DS 23,219, knowledge of which is supplied [only] by appellants' application and availability of which is supplied by appellants' deposit of the microorganism with the Department of Agriculture, one skilled in the art would not find it obvious to produce daunorubicin by aerobically cultivating Streptomyces bifurcus.

Id. at 1292, 182 USPQ at 305.

In addition, although the prior art references the examiner discussed do indeed teach the use of various acids to make various cephems, they do not define a class of acids the knowledge of which would render obvious the use of Ochiai's specifically claimed acid. 4 The Board noted that Ochiai's specifically claimed acid is "similar" to the acids used in the prior art. Likewise, the examiner asserted that the claimed acid was " slightly different" from those taught in the cited references. Neither characterization, however, can establish the obviousness of the use of a starting material that is new and nonobvious, both in general and in the claimed process. The mere chemical possibility that one of those prior art acids could be modified such that its use would lead to the particular cephem recited in claim 6 does not make the process recited in claim 6 obvious "unless the prior art suggested the desirability of [such a] modification." In re Gordon , 733 F.2d 900, 902, 221 USPQ 1125, 1127 (Fed. Cir. 1984). As we noted above, the examiner discussed no references containing any suggestion or motivation either (a) to modify known acids to obtain the particular one recited in claim 6, or (b) to obtain the particular new and nonobvious cephem produced by the process of claim 6. In short, the prior art contains nothing at all to support the conclusion that the particular process recited in claim 6 is obvious.

4 The prior art teaches the use of thienyl, pyridyl, and isothiazolyl compounds, whereas claim 6 recites the use of 2-aminothiazolyl.

Second, the examiner incorrectly drew from Durden , a case turning on specific facts, a general obviousness rule: namely, that a process claim is obvious if the prior art references disclose the same general process using "similar" starting materials. 5 No such per se rule exists. Mere citation of Durden , Albertson , or any other case as a basis for rejecting process claims that differ from the prior art by their use of different starting materials is improper, as it sidesteps the fact-intensive inquiry mandated by section 103. In other words, there are not " Durden obviousness rejections" or " Albertson obviousness rejections," but rather only section 103 obviousness rejections.

5 This is most apparent from the examiner's baffling assertions that "a standard, conventional process . . . is being claimed" and that " [t]he references . . . abundantly demonstrate the routineness of the claimed process." Because the claimed process includes as a limitation the use of an acid unknown in the prior art, the prior art can only demonstrate the routineness of a process similar to the claimed one. Similarity is, of course, not necessarily obviousness.

[2] In light of the above, the examiner's errors are evident. First, the examiner concluded that one of ordinary skill in the art would "recognize the use of '2-aminothiazolyl' if the final products sought were to contain this moiety." The prior art, however, contains nothing at all to suggest that one seek this concededly nonobvious final product. The examiner erred by indulging in an essentially hindsight comparison of the functioning of the new acid in claim 6 as a precursor to the claimed cephem with that of other acids in the prior art processes that produced other cephems. Such a comparison uses Ochiai's specification as though it were prior art in order to make the claim to a method that uses the nonobvious acid to make the nonobvious cephem appear to be obvious.

The Board essentially repeated the examiner's error of sidestepping the particularized inquiry required by section 103 by grounding the rejection on the supposedly "controlling" effect of " [c]ases such as In re Larsen , In re Albertson , and, particularly, In re Durden , all of which were directed to processes of making chemical compounds." Ochiai , 24 USPQ2d at 1267 (citations omitted). After categorizing the process recited in claim 6 as a "process of making" rather than as a "process for using," the Board reached its conclusion according to the following syllogism: (a)"process of making" claims have led to rejections, as in Larsen , Albertson , and Durden, whereas "process for using" claims have led to allowances, as in Kuehl , Mancy , and Pleuddemann ; (b) Ochiai's claim is directed to a "process of making"; (c) therefore, the rejection should be affirmed. Id . at 1268-70. This method of analysis is founded on legal error because it substitutes supposed per se rules for the particularized inquiry required by section 103. It necessarily produces erroneous results. Moreover, the Board indulged a non sequitur when it grounded its conclusion of obviousness on the assertion that the starting materials recited in claim 6 are "similar" to those of the prior art. The recited acid is nonobvious, having itself been patented based on the parent application. Nor did the Board justify its characterization of "similar [ity]" in any other manner. Similarity is, as we noted above, not necessarily obviousness.

The Alleged Conflict in Our Case Law

Both the Solicitor and Ochiai devote substantial portions of their briefs to purported demonstrations that our precedents on the obviousness vel non of chemical processes are, if not in conflict, at least in severe tension with one another and thus create unnecessary confusion. Both parties identify the same two sets of three cases as presenting the conflict: Larsen , Albertson , and Durden , upholding rejections on appeal, are said to be inconsistent with Kuehl , Mancy , and Pleuddemann , reversing rejections on appeal. While we agree that some generalized commentary found within several of these decisions may present minor tensions, both Ochiai and the Solicitor draw far too bleak a picture of the state of our case law. Other language in these cases, like their actual holdings, obviates any real inconsistency.

In Albertson , the court "reiterate [d] that all of the evidence must be considered on the 'subject matter as a whole,' from the viewpoint of one skilled in the art, in the determination of obviousness, and not simply the patentability of one of the starting reactants in a process." Albertson , 332 F.2d at 382, 141 USPQ at 732. Thus, the Board in this case looked to the general result in Albertson while ignoring the Albertson court's explicit methodology. Every subsequent case that the parties discuss has been grounded on the same analytic principle: namely, that section 103 requires a fact-intensive comparison of the claimed process with the prior art rather than the mechanical application of one or another per se rule. See Pleuddemann , 910 F.2d at 827, 15 USPQ2d at 1741 ("We repeat that the controlling law is in Section 103 of the statute, which must be applied to the facts of this case."); Durden , 763 F.2d at 1411, 226 USPQ at 362 ("Our function is to apply, in each case, Section 103 as written to the facts of disputed issues, not to generalize or make rules for other cases which are unforeseeable."); Mancy , 499 F.2d at 1292, 182 USPQ at 305 ("[T]he statutory standard of Section 103 for determining obviousness of an invention is whether in view of the prior art the invention as a whole would have been obvious at the time it was made."); Kuehl , 475 F.2d at 665, 177 USPQ at 255 ("The test of unobviousness is a statutory test and requires comparison of the invention with the prior art in each case. . . ."). As a consequence, these cases do not -- indeed, cannot -- present or create conflicting legal rules. They present, instead, applications of a unitary legal regime to different claims and fields of art to yield particularized results. It is thus surprising that the Board relies on Durden for a general rule when the Durden court expressly cautioned the bar "not to generalize or make rules for other cases."

Because the regime of section 103, much like the Fourth Amendment proscriptions against "unreasonable" searches and warrants issued upon less than "probable cause," mandates that legal outcomes turn on the close analysis of facts, reasonable persons may well disagree about the outcome of a given obviousness determination. These disagreements over the application of a legal rule can, however, be transformed into perceived "irreconcilable conflicts" between legal rules only when, as occurred here, examiners, members of the Board, and patent lawyers purport to find competing per se rules in our precedents and argue for rejection or allowance of a particular claim accordingly. We acknowledge that some generalized commentary found in these cases reviewing rejections of claims directed to chemical processes may, if viewed in isolation, have inadvertently provided encouragement to those who desire per se rules in this area. For example, one case includes an extensive discussion of the conceptual link between the obviousness vel non of a chemical composition and the obviousness vel non of a process for making the composition. 6 Such discussion, while entirely accurate, may have contributed to the erroneous view that one may determine the obviousness of a chemical process merely by determining whether it is a process for making a composition. As the cases noted above make clear, however, this is not and has never been the law of section 103. Indeed, Durden , the very case relied on by the examiner and the Board for a purported per se rule, clearly states that there are no such per se rules.

6 See Pleuddemann, 910 F.2d at 827, 15 USPQ2d at 1741 ("'From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.' In re Papesch, 50 CCPA 1084, 315 F.2d 381, 391, 137 USPQ 43, 51 (1963). It is the properties of appellant's compounds as bonding/priming agents for certain polymers and fillers or support surfaces that give them their utility. As stated above, the compounds and their use are but different aspects of, or ways of looking at, the same invention and consequently that invention is capable of being claimed both as new compounds or as a new method or process of bonding/priming. On the other hand, a process or method of making the compounds is a quite different thing; they may have been made by a process which was new or old, obvious or nonobvious. In this respect, therefore, there is a real difference between a process of making and a process of using and the cases dealing with one involve different problems from the cases dealing with the other.").

[3] The use of per se rules, while undoubtedly less laborious than a searching comparison of the claimed invention -- including all its limitations -- with the teachings of the prior art, flouts section 103 and the fundamental case law applying it. Per se rules that eliminate the need for fact-specific analysis of claims and prior art may be administratively convenient for PTO examiners and the Board. Indeed, they have been sanctioned by the Board as well. But reliance on per se rules of obviousness is legally incorrect and must cease. Any such administrative convenience is simply inconsistent with section 103, which, according to Graham and its progeny, entitles an applicant to issuance of an otherwise proper patent unless the PTO establishes that the invention as claimed in the application is obvious over cited prior art, based on the specific comparison of that prior art with claim limitations. We once again hold today that our precedents do not establish any per se rules of obviousness, just as those precedents themselves expressly declined to create such rules. Any conflicts as may be perceived to exist derive from an impermissible effort to extract per se rules from decisions that disavow precisely such extraction.

In sum, as we clearly indicated in In re Dillon , a recent in banc decision, "[w]hen any applicant properly presents and argues suitable method claims, they should be examined in light of all . . . relevant factors, free from any presumed controlling effect of Durden " or any other precedent. 919 F.2d 688, 695, 16 USPQ2d 1897, 1903 (Fed. Cir. 1990) (in banc), cert. denied , 500 U.S. 904 (1991). Having compared Ochiai's claims, limited as they are to the use of a particular nonobvious starting material for making a particular nonobvious end product, to the prior art of record, we reverse the rejection of claims 6 through 10 as an incorrect conclusion reached by incorrect methodology.

Reversed.