TABLE OF CONTENTS

I.LEGAL JUSTIFICATION

A.CONSTITUTIONAL AUTHORITY

B.STATUTORY MANDATES

II. OVERVIEW OF EXAMINATION

A. PROCEDURAL

B. ASSUMPTIONS/ BURDEN ON THE EXAMINER

III. DETERMINING WHETHER THE ENABLEMENT REQUIREMENT IS MET

A. NECESSARY FACTORS TO EVALUATE

1. Scope/ Breadth of the Claims
2. Reasons For Lack Of Enablement: Undue Experimentation Needed To Make And Use The Invention

B. UTILITY AND OPERABILITY

1. Preferred Materials in Specification Need not be in the Claims
2. Inoperability/Inoperative Species within the Scope of the Claim

C. LACK OF ENABLEMENT IN VIEW OF AN OBVIOUSNESS REJECTION

D. THE INVENTION MAY BE ENABLED BUT NOT ADEQUATELY DESCRIBED

IV. COMMUNICATING FINDINGS TO THE APPLICANT

A. THE LEVEL OF DETAIL

B. THE FORM PARAGRAPHS

1. 35 U.S.C. 112,1st, Enablement 7.31.02
2. 35 U.S.C. 112, 1st, Scope Of Enablement 7.31.03
3. 35 U.S.C. 112, 1st, Essential Subject Matter Missing From Claims (Enablement) , 7.33.01 :
4. Multiple Use of Form Paragraphs
5. Practical Tips in Writing the Rejection

V. REBUTTAL TO THE REJECT5ION PROOF OF ENABLEMENT

EVIDENCE AND ATTORNEY ARGUMENT

A. USE OF POST FILING DATE EVIDENCE

B. EXPERT DECLARATIONS

C. USE OF FDA SUBMISSIONS

ENABLEMENT DECISION TREE

Example A: Hybridization Probes I

Example B: Hybridization Probes II

Example C: Chemical Reagents I

Example D: Chemical Reagents II

Example E: Peptides for Treating Obesity

Example F: Enablement and Prior Art Rejections

Example G: Gene Therapy

Example H: Endothelin Receptor Antagonists

Example I: Transgenic Animals

Example J: Selectin-Mediated Cellular Adhesion

Example K: HIV

Example L: Alzheimer's Disease

Example M: Polymers

Example N: DNA

Example O: Vaccines

REFERENCE LIST

TRAINING MATERIALS FOR EXAMINING PATENT APPLICATIONS WITH RESPECT TO 35 U.S.C. SECTION 112, FIRST PARAGRAPH-ENABLEMENT CHEMICAL/BIOTECHNICAL APPLICATIONS

I. LEGAL JUSTIFICATION

A. CONSTITUTIONAL AUTHORITY

Requiring an applicant to provide information about the invention in his patent application to enable any person skilled in the art to make and use the invention is just one aspect of the "quid pro quo" for obtaining the legal right to exclude others from making, using, selling, offering for sale, or importing the claimed invention. The right to exclude others is the personal property right of the patent owner and is not granted by the government without the public obtaining a public good, i.e., the promotion of the progress of science and the useful arts. The founding fathers of the United States of America recognized the public good that would flow from the promotion of science and the useful arts and specifically granted Congress the authority to establish a patent system.

Authority for Congress to establish the United States patent system is based in the United States Constitution which provides in pertinent part:

The Congress shall have Power . . . to promote the Progress of Science and Useful arts, by securing for a limited Time to Authors and Inventors the exclusive Right to their respective Writings and Discoveries . . . .

Article I, Section 8.

With this constitutional authority, Congress enacted Title 35 of the United States Code establishing the patent laws for the United States of America. Simply granting patents does not necessarily promote science and the useful arts. Rather, promotion of the progress of science and the useful arts is achieved by granting a patent in exchange for the public disclosure of the invention. Thus, Congress required more than a mere disclosure of the invention; Congress also required the inventor to teach the public how to make and use the invention as well. This requirement ensures that the invention will be available to the public once the patent term expires.

B. STATUTORY MANDATES

The requirement that the inventor adequately disclose his invention to obtain the right to exclude others from making, using, selling, offering for sale, or importing the claimed invention is mandated by 35 U.S.C. Section 112.

Section 112, first paragraph, provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. (Emphasis added.)

The emphasized terms are the three requirements from Section 112, first paragraph, that the patent specification must meet in order to be a valid patent. An "enabling" disclosure is only one of the three requirements for the specification.

In addition to being an "enabling" disclosure, the specification must also provide an adequate "written description" of the invention and must disclose the embodiment of the invention that the inventor believes to be the "best mode" of the invention. The written description and best mode requirements are separate and distinct from the enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991); and MPEP Section 2161.

A working definition for the written description and best mode requirements are provided below only to assist in distinguishing these additional specification requirements from the enablement requirement.

The "written description" requirement requires the inventor to clearly convey to those skilled in the art through the specification the information that the applicant has invented as the specific subject matter of the claims. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976). Although the applicant does not have to describe the subject matter claimed in the specification using exactly the same words used in the claims, the description must be sufficiently clear to allow one of ordinary skill to recognize that the applicant invented what is claimed. In re Lukach, 442 F.2d 967, 969, 169 USPQ 795, 796 (CCPA 1971); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989).

The "best mode" requirement mandates that the applicant disclose in the specification the "best mode" or the best way known to the inventor at the time of filing the application for carrying out the invention. Even though disclosing the best mode is a statutory requirement, it is unlikely that an examiner would ever have sufficient evidence to raise any doubt about whether the best mode has been disclosed.

II. OVERVIEW OF EXAMINATION

A. PROCEDURAL

Examination begins with a thorough review of the application in its entirety and with a preliminary determination of the scope of the claims. The examiner needs to determine what the claims recite and determine the meaning of each claim as a whole. The analysis should be systematic so that no claim is overlooked. The scope of dependent claims should be determined in addition to the scope of the independent claims. "A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers." 35 U.S.C. Section 112, fourth paragraph.

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 novel, non-obvious, 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 respond completely at the earliest opportunity. The examiner then reviews all the evidence, including arguments and evidence responsive to any rejection before issuing a Notice of Allowance or a final rejection.

These training materials provide the analytical framework and a discussion of relevant factors that the examiner should consider when determining whether there is sufficient evidence to support a determination that the specification does not enable one skilled in the art to make and use the claimed invention.

B. ASSUMPTIONS/ BURDEN ON THE EXAMINER

When rejecting a claim under the enablement requirement of section 112, the examiner bears the "initial burden of setting forth a reasonable explanation as to why [he/she] believes that the scope of protection provided by [the] claim is not adequately enabled by the description of the invention provided in the specification." In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). To object to a specification on the grounds that the disclosure is not enabling with respect to the scope of a claim sought to be patented, the examiner must provide evidence or technical reasoning substantiating those doubts. Id.; and MPEP Section 2164.04.

Without a reason to doubt the truth of the statements made in the patent application, the application must be considered enabling. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). The burden placed on the examiner is reflected in the MPEP Section 706.03.

Accordingly, the case law makes clear that properly reasoned and supported statements explaining any failure to comply with Section 112 are a requirement to support a rejection. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).

III. DETERMINING WHETHER THE ENABLEMENT REQUIREMENT IS MET

In making the determination of enablement, the examiner shall consider the original disclosure and all evidence in the record, weighing evidence that supports enablement against the evidence that the specification is not enabling.

In the mid-1800's the Supreme Court reasoned that a specification would be defective if it required one with skill to "experiment" in order practice the claimed invention. Wood v. Under Hill, 46 U.S. (4 How.) 1 (1847). The standard for determining whether the specification met the enablement requirement was recast in the later Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in art can make and use the invention without undue experimentation. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).

There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:

1. the breadth of the claims,
2. the nature of the invention,
3. the state of the prior art,
4. the level of one of ordinary skill,
5. the level of predictability in the art,
6. the amount of direction provided by the inventor,
7. the existence of working examples, and
8. the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO's determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement).

In Wands, the court noted that the there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." Id. at 740, 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.

It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others. The examiner's analysis must consider all the evidence related to each of these factors, and any conclusion of non-enablement must be based on the evidence as a whole. Id. at 737 & 740, 8 USPQ2d at 1404 & 1407.

A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d at 1562, 27 USPQ2d at 1513.

The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. These factual considerations are discussed more fully below.

A. NECESSARY FACTORS TO EVALUATE

1. Scope/ Breadth of the Claims

Determining whether the enablement requirement has been met requires analyzing the claim to determine its scope.

All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled. Accordingly, the first analytical step requires that the examiner determine exactly what subject matter is encompassed by the claims. The examiner should determine what each claim recites and what the subject matter is when the claim is considered as a whole, not when its parts are analyzed individually. No claim should be overlooked. With respect to dependent claims, Section 112, fourth paragraph, of Title 35 should be followed. This paragraph states that "a claim in a dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers" and requires the dependent claim to further limit the subject matter claimed.

The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation'." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well-known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a "reasonable correlation" to the scope of the claims. E.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).

In this regard, MPEP Section 2164.08 provides, in pertinent part, as follows.

As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971)

The determination of the propriety of a rejection based upon the scope of a claim relative to the scope of the enablement involves two stages of inquiry. The first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is [sic, would have been] enabled to make and use the entire scope of the claimed invention without undue experimentation.

. . .

If a rejection is made based on the view that the enablement is not commensurate in scope with the claim, the examiner should identify the subject matter that is considered to be enabled. [Emphasis added.]

One does not look to the claims but to the specification to find out how to practice the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1558, 220 USPQ 303, 316-17 ( Fed. Cir. 1983); In re Johnson, 558 F.2d 1008, 1017, 194 USPQ 187, 195 (CCPA 1977). In In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976), the court stated:

to provide effective incentives, claims must adequately protect inventors. To demand that the first to disclose shall limit his claims to what he has found will work or to materials which meet the guidelines specified for "preferred" materials in a process such as the one herein involved would not serve the constitutional purpose of promoting progress in the useful arts.

When analyzing the enabled scope of a claim, the teachings of the specification must not be ignored because claims are to be given their broadest reasonable interpretation that is consistent with the specification. "That claims are interpreted in light of the specification does not mean that everything in the specification must be read into the claims." Raytheon Co. v. Roper Corp., 724 F.2d 951, 957, 220 USPQ 592, 597 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984).

Part of the examiner's job is to clarify the record so that the public will have notice as to the patentee's scope of protection when the patent issues. If a reasonable interpretation of the claim is broader than the description in the specification, it is necessary for the examiner to take the additional time and effort to make sure the full scope of the claim is enabled. Limitations and examples in the specification do not generally limit what is covered by the claims. Consequently, if the claim is to a method of transforming cells and the broadest reasonable interpretation of the claim includes transforming cells in vivo for gene therapy, the examiner must make a determination as to whether there is sufficient evidence to support a conclusion that such scope is not enabled. If applicants intended only in vitro use, such a limitation should appear in the claims.

The breadth of the claims was a factor considered in Amgen v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991). In the Amgen case, the patent claims were directed to a purified DNA sequence encoding polypeptides which are analogs of erythropoietin (EPO). The court stated that:

Amgen has not enabled preparation of DNA sequences sufficient to support its all-encompassing claims. . . . [D]espite extensive statements in the specification concerning all the analogs of the EPO gene that can be made, there is little enabling disclosure of particular analogs and how to make them. Details for preparing only a few EPO analog genes are disclosed. . . . This disclosure might well justify a generic claim encompassing these and similar analogs, but it represents inadequate support for Amgen's desire to claim all EPO gene analogs. There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them.

927 F.2d at 1213-14, 18 USPQ2d at 1027.

The court in Amgen focused on the fact that the claims were directed to DNA sequences that encoded amino acid sequences, wherein the amino acid sequences had substitutions but preserved a particular physiological activity. Thus, the amino acid sequences mentioned in the claims in Amgen were of differing scope. Additionally, the specification did not give those skilled in the art guidance as to which amino acids could be changed to either preserve or enhance the activity of the protein. Because a very small change in the amino acid sequence of a protein can result in a very large change in the structure-function activity of a protein and because the laws of protein folding are in such a primitive state, predicting protein structure (and hence, activity) while knowing only the sequence of the protein is akin to predicting the weather for a date in the distant future.

Similarly, in In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993), the court affirmed the Board's decision and stated that the evidence did not show that a skilled artisan would have been able to carry out the steps required to practice the full scope of claims which encompass "any and all live, non-pathogenic vaccines, and processes for making such vaccines, which elicit immunoprotective activity in any animal toward any RNA virus." 999 F.2d at 1562, 27 USPQ2d at 1513 (original emphasis).

In In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015 (Fed. Cir. 1993), the claims were directed to a method for producing mammalian peptides in plant cells by the integration of a DNA construct encoding mammalian peptide into plant cells. The court, in affirming the Board's decision, found that the specification did not support the broad scope of the claims because the specification contained only an example of producing gamma-interferon in a dicot species; and there was evidence that extensive experimentation would have been required for encoding mammalian peptide into a monocot plant at the time of filing. Thus, the application would not have enabled one of skill in the field of biotechnology to produce any type of mammalian peptide in any plant cell as broadly claimed.

2. Reasons For Lack Of Enablement: Undue Experimentation Needed To Make And Use The Invention

a. Points of Reference

Whether the specification would have been enabling as of the filing date involves many of the same considerations that are evaluated for determining whether or not the claimed invention would have been obvious as of the date it was invented. These considerations are: the nature of the invention, the state of the prior art, and the level of skill in the art. These considerations are reviewed here briefly in summary form to assist the explanation of the enablement analysis.

i. Nature of the Invention

The initial inquiry is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains. The nature of the invention becomes the backdrop to determine the state of the art and the level of skill possessed by one skilled in the art.

ii. State of the Art

The state of the prior art is what one skilled in the art a would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.

The state of the art for a given technology is not static in time. It is entirely possible that a disclosure filed on January 2, 1990, would not have been enabled; however, if the same disclosure had been filed on January 2, 1996, it might have enabled the claims. Therefore, the state of the prior art must be evaluated for each application based on its filing date.

(a) Relevant Art

Section 112 requires the specification to be enabling only to a person "skilled in the art to which it pertains, or with which it is most nearly connected." In general, the pertinent art should be defined in terms of the problem to be solved rather than in terms of the technology area, industry, trade, etc. for which the invention is used.

(b) Well-Known Information

The specification need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984).

iii. Level of Skill

The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.

b. Amount of Direction or Guidance Present: Sufficiency of Disclosure / Predictability/ Non-Predictability

The "amount of guidance or direction present" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2 833, 839, 166 USPQ 18, 24 (CCPA 1970). The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.

The "predictability or lack thereof" in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. In particular, the court in In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 368-70 (CCPA 1971), stated:

[i]n the field of chemistry generally, there may be times when the well-known unpredictability of chemical reactions will alone be enough to create a reasonable doubt as to the accuracy of a particular broad statement put forward as enabling support for a claim. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles. Most often, additional factors, such as the teachings in pertinent references, will be available to substantiate any doubts that the asserted scope of objective enablement is in fact commensurate with the scope of protection sought and to support any demands based thereon for proof. [Footnote omitted.]

The predictability in the art is inversely related to the amount of guidance or direction needed for enablement. In other words, art areas that are predictable require less guidance or direction for enablement than art areas that are not predictable. In re Fisher, 427 F.2 833, 839, 166 USPQ 18, 24 (CCPA 1970).

i. How to Make

(a) One Method is Sufficient

As long as the specification discloses at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of Section 112 is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Failure to disclose other methods by which the claimed invention may be made does not render a claim invalid under Section 112. Spectra-Physics, Inc. v. Coherent, Inc. 827 F.2d 1524, 1533, 3 USPQ2d 1737, 1743 (Fed. Cir.), cert. denied, 484 U.S. 954 (1987).

Naturally, for unstable and transitory chemical intermediates, the "how to make" requirement does not require that the applicant teach how to make the claimed product in stable, permanent or isolatable form. In re Breslow, 616 F.2d 516, 521, 205 USPQ 221, 226 (CCPA 1980).

(b) Availability of Starting Materials and Apparatus

A key issue that can arise when determining whether the specification is enabling is whether the starting materials or apparatus necessary to make the invention are available. This is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening.

The CCPA in In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA 1971), made clear that if the practice of a method requires a particular apparatus, the application must provide a sufficient disclosure of the apparatus if the apparatus is not readily available. The same can be said if certain chemicals are required to make a compound or practice a chemical process. In re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981).

The problem with the availability of starting materials when the product or process requires the use of a particular strain of microorganisms is addressed in separate training materials relating to depositing a sample of a microorganism with an independent depository.

(c) Isolated DNA for Purified Protein (In re Deuel)

When claims are directed to any purified and isolated DNA sequence encoding a specifically named protein wherein the protein has a specifically identified sequence, a scope rejection is generally not appropriate.

In In re Deuel, 51 F.3d 1552, 1560, 34 USPQ2d 1210, 1216 (Fed. Cir. 1995), the court stated:

Because Deuel's patent application does not describe how to obtain any DNA except the disclosed cDNA molecules, claims 4 and 6 may be considered to be inadequately supported by the disclosure of the application. See generally Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1212-24, 18 USPQ2d 1016, 1026-28 (Fed. Cir.) (generic DNA sequence claims held invalid under 35 U.S.C. § 112, first paragraph), cert. denied, 502 U.S. 856 (1991); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (Section 112 "requires that the scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art"). As this issue is not before us, however, we will not address whether claims 4 and 6 satisfy the enablement requirement of § 112, first paragraph, but will leave to the PTO the question whether any further rejection is appropriate.

The court in Deuel left it to the PTO to decide whether a scope rejection would be appropriate. Responsive to the issue left open by the Federal Circuit in Deuel, the PTO has decided that scope rejections like those noted above should not be advanced for claims like those in Deuel.

The Deuel claims 4 and 6 were directed to any DNA that would encode a specific amino acid sequence. Claims 4 and 6 recited only one amino acid sequence each and each claim was directed to all nucleic acid sequences that encode the respective amino acid sequence. The various genetic codes are well-known. Thus, to list all cDNA of the sequences that encode a given amino acid sequence simply requires reverse translating the amino acid sequence to the nucleic acid sequence. Theoretically, one armed only with a pencil, paper, and the genetic code could list all of the cDNA that encode the two amino acid sequences mentioned in the claims. Admittedly, this could not be done in practice even by a fast computer because claim 4 embraces 2.09 x 1075 embodiments. However, any one of the embodiments could be readily determined. As to actually obtaining the cDNA, this could be done by simply writing down the sequence and ordering it from a company that custom synthesizes DNA.

ii. How to Use

If a statement of utility in the specification contains within it a connotation of how to use, and/or the art recognizes that standard modes of administration are known and contemplated, 35 U.S.C. Section 112, is satisfied. In re Johnson, 282 F.2d 370, 373, 127 USPQ 216, 219 (CCPA 1960); and In re Hitchings, 342 F.2d 80, 87, 144 USPQ 637, 643

(CCPA 1965); see also In re Brana, 51 F.2d 1560, 1566, 34 USPQ2d 1437, 1441 (Fed. Cir. 1993).

It is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation. If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use without undue experimentation, this would be sufficient to satisfy 35 U.S.C. Section 112. The applicant need not demonstrate that the invention is completely safe. See also 35 U.S.C. Section 103 , Utility Guidelines.

(a) Use Recited in the Claims

When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991)(claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).

In contrast, when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for non-enablement based on how to use. If multiple uses for claimed compounds or compositions are disclosed in the application, then an enablement rejection must include an explanation, sufficiently supported by the evidence, why the specification fails to enable each disclosed use. In other words, if any use is enabled when multiple uses are disclosed, the application is enabling for the claimed invention.

The following examples illustrate the application of these standards.

1. The claim: A composition for treating Alzheimer's disease comprising a compound having the formula X" (where X is specifically defined within the claim). Assuming it is clear from the specification and/or applicant's arguments that the claimed composition is limited to treating Alzheimer's disease, the enablement issue is whether one skilled in the art could have made or used the composition for treating Alzheimer's disease without undue experimentation, at the time the application was filed. The enablement analysis should be based on whether there is evidence that one skilled in the art could not have used the compound for treating Alzheimer's disease without undue experimentation. If the statement of use is only a statement of one intended use, then the claim should be treated as in example 2.
2. The claim: A composition comprising a compound having the formula X (where X is specifically defined within the claim). The enablement issue is whether one skill in the art could have made or used the composition for any disclosed or well-established use without undue experimentation, at the time the application was filed. The enablement analysis should be based on whether there is evidence that one skilled in the art could not have used the compound for any disclosed or well-established use undue experimentation.
3. The claim: A composition comprising a compound having the formula X in a pharmaceutically acceptable carrier (where X is specifically defined within the claim). The specification discloses both an in vitro and in vivo use for the composition.

The presence of the phrase "pharmaceutically acceptable" in combination with the disclosed in vivo use implies some pharmaceutical use. Therefore, the initial enablement analysis should be based on whether there is any evidence that one skilled in art could not use the compound for any disclosed or well-established pharmaceutical use, i.e., treatment of some disease or condition in vivo, without undue experimentation. Any subsequent enablement analysis should be based on the claim language, what is taught in the specification, as well as any rebuttal arguments.

All rebuttal arguments must be considered. The weight the evidence and each argument should be given will depend on the facts of the case. Assuming that the applicants rebuttal is persuasive, the 35 U.S.C. Section 112, first paragraph, rejection should be withdrawn. The persuasiveness of any evidence and arguments clearly depends on the specific language of the claim, the teachings in the specification and the evidence submitted in rebuttal to the rejection.

(b) Diagnosis Assays

Unless a specification specifically states something to the contrary, the term "diagnostic assay" is to be construed to mean any assay that can be used to help diagnose a condition, as opposed to an assay that can, in and of itself, diagnose a condition. A diagnosis is typically made by evaluating the results of several screening assays, each of which has some level of false results and, accordingly, each of the screening assays would be a "diagnostic assay". Therefore, to enable a diagnostic assay use, a disclosure merely needs to teach how to make and use the assay for screening purposes.

© Several Decisions Ruling that the Disclosure was Non-Enabling

The following summaries should not be relied upon to support a case of lack of enablement without carefully reading the case.

1. In In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993), the 1983 application disclosed a vaccine against the RNA tumor virus known as Prague Avian Sarcoma Virus, a member of the Rous Associated Virus family. Using functional language, Wright claimed a vaccine "comprising an immunologically effective amount" of a viral expression product. Id. at 1559, 27 USPQ2d at 1511. Rejected claims covered all RNA viruses as well as to avian RNA viruses. The Examiner provided a teaching that in 1988, a vaccine for another retrovirus (i.e., AIDS) remained an intractable problem. This evidence, along with evidence that the RNA viruses were a diverse and complicated genus, convinced the Federal Circuit that the invention was not enabled for either all retroviruses or even for avian retroviruses.
2. In In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993), a 1985 application functionally claimed a method of producing protein in plant cells by expressing a foreign gene. The court stated: "[n]aturally, the specification must teach those of skill in the art 'how to make and use the invention as broadly as it is claimed.'" Id. at 1050, 29 USPQ2d at 2013. Although protein expression in dicotyledonous plant cells was enabled, the claims covered any plant cell. The examiner provided evidence that even as late as 1987, use of the claimed method in monocot plant cells was not enabled. Id. at 1051, 29 USPQ2d at 2014.
3. In In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the court found that several claims were not supported by an enabling disclosure "[t]aking into account the relatively incomplete understanding of the biology of cyanobacteria as of appellant's filing date, as well as the limited disclosure by appellants of the particular cyanbacterial genera operative in the claimed invention. . . ." The claims at issue were not limited to any particular genus or species of cyanbacteria and the specification mentioned nine genera and the working examples employed one species of cyanobacteria.
4. In In re Colianni, 561 F.2d 220, 222-23,195 USPQ 150, 152 (CCPA 1977), where the court affirmed a rejection under Section 112, first paragraph, because the specification directed to a method of mending a fractured bone by applying "sufficient" ultrasonic energy to the bone did not define a "sufficient" dosage or teach one of ordinary skill how to select the appropriate intensity, frequency, or duration of the ultrasonic energy.

(d) Several Decisions Ruling that the Disclosure was Enabling

The following summaries should not be relied upon to support a case of lack of enablement without carefully reading the case.

1. In PPG Ind. v. Guardian Ind., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996), the court ruled that even though there was a software error in calculating the ultraviolet transmittance data for examples in the specification making it appear that the production of a cerium oxide-free glass that satisfied the transmittance limitation would be difficult, the specification indicated that such glass could be made. The specification was found to indicate how to minimize the cerium content while maintaining low ultraviolet transmittance.
2. In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), the court reversed the rejection for lack of enablement under Section 112, first paragraph, concluding that undue experimentation would not be required to practice the invention. The nature of monoclonal antibody technology is such that experiments first involve the entire attempt to make a monoclonal hybridomas to determine which ones secrete antibody with the desired characteristics. The court found that the specification provided considerable direction and guidance on how to practice the claimed invention and presented working examples, that all of the methods needed to practice the invention were well known, and that there was a high level of skill in the art at the time the application was filed. Furthermore, the applicant carried out the entire procedure for making a monoclonal antibody against HBsAg three times and each time was successful in producing at least one antibody which fell within the scope of the claims.
3. In In re Bundy, 642 F.2d 430, 434, 209 USPQ 48, 51-52 (CCPA 1981), the court ruled that the claimed analogs of naturally occurring prostaglandins had certain pharmacological properties even though the specification lacked any examples of specific dosages, but did state that the novel compound possessed activity similar to E-type prostaglandins.

c. Presence or Absence of Working Examples (Make or Use)

The presence of a working examples demonstrates the making or using of the invention. However, working examples are not required by the statute, rules, or the case law.

i. None or One Working Example

The lack of working examples is one consideration in the overall analysis of lack of enablement. In re Colianni, 561 F.2d at 224, 195 USPQ at 153. The MPEP, Section 2164.02, states: "[t]he specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation."

When considering the factors relating to a determination of non-enablement, if all the other factors point toward enablement, then the absence of working examples will not by itself render the invention non-enabled. In other words, lack of working examples or lack or evidence that the claimed invention works as described should never be the sole reason for rejecting the claimed invention on the grounds of lack of enablement. A single working example in the specification for a claimed invention is enough to preclude a rejection which states that nothing is enabled since at least that embodiment would be enabled. However, a rejection stating that enablement is limited to a particular scope may be appropriate.

The presence of only one working example should never be the sole reason for making a scope rejection, even though it is a factor to be considered along with all the other factors. To make a valid rejection, one must evaluate all the facts and evidence and state why one would not expect to be able to extrapolate that one example across the entire scope of the claims.

ii. Correlation: In Vitro/In Vivo

The issue of "correlation" is related to the issue of the presence or absence of working examples. "Correlation" for purposes of this portion of the training materials refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples." In this regard, the issue of "correlation" is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995)(reversing the PTO decision based on finding that in vitro data did not support in vivo applications).

Since the initial burden is on the examiner to give reasons for the lack of enablement, when possible to supported by evidence, the examiner must also give reasons for a conclusion of lack of correlation for an in vitro or in vivo animal model example. A rigorous or an invariable exact correlation is not required, as stated in Cross v. Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747 (Fed. Cir. 1985):

based upon the relevant evidence as a whole, there is a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence. (Citations omitted.)

iii. Working Examples and a Claimed Genus

For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art-in view of level of skill, state of the art and the information in the specification-would expect the claimed genus could be used in that manner without undue experimentation. Proof of enablement will be required for other members of the claimed genus only where adequate reasons are advanced by the examiner to establish that a person skilled in the art could not use the genus as a whole without undue experimentation.

d. Quantity of Experimentation

The quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether "undue experimentation" is required to make and use the invention. "[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance." In re Colianni, 561 F.2d at 224,195 USPQ at 153. "'The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.' In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (citing In re Angstadt, 537 F.2d 489, 502-04, 190 USPQ 214, 218 (CCPA 1976)). Time and expense are merely factors in this consideration and are not the controlling factors. United States v. Telectonics Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989).

In the chemical arts, the guidance and ease in carrying out an assay to achieve the claimed objectives may be an issue to be considered in determining the quantity of experimentation needed. For example, if a very difficult and time consuming assay is needed to identify a compound within the scope of a claim, then this great quantity of experimentation should be considered in the overall analysis. Time and difficulty of experiments are not determinative if they are merely routine. Quantity of examples is only one factor that must be considered before reaching the final conclusion that undue experimentation would be required. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.

i. Example of Reasonable Experimentation

In United States v. Telectonics Inc., 857 F.2d 778, 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989), the court reversed the findings of the district court for lack of clear and convincing proof that undue experimentation was needed. The court ruled that since one embodiment (stainless steel electrodes) and the method to determine dose/response was set forth in the specification, the specification was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue experimentation.

ii. Example of Unreasonable Experimentation

In In re Ghiron, 442 F.2d at 991-92, 169 USPQ at 727-28, functional "block diagrams" were insufficient to enable a person skilled in the art to practice the claimed invention with only a reasonable degree of experimentation because the claimed invention required a "modification to prior art overlap computers," and because "many of the components which appellants illustrate as rectangles in their drawing necessarily are themselves complex assemblages . . . . It is common knowledge that many months or years elapse from the announcement of a new computer by a manufacturer before the first prototype is available. This does not bespeak of a routine operation but of extensive experimentation and development work . . . ."

e. Supplementing a Disclosure

The specification may be enabling even though amendments may be needed. Such amendments often occur when the applicant incorporates information by reference into the specification or uses a trade name or trademark to provide descriptive information.

i. Incorporating by Reference

The Commissioner has considerable discretion to permit the applicant to incorporate information by reference into the specification. The information incorporated by reference at the time of filing is as much a part of the application as filed as if the text were repeated therein. Editing the application by inserting verbatim that which was previously only incorporated by reference does not raise new matter issues. In re Hawkins, 486 F.2d 569, 574, 179 USPQ 157, 161 (CCPA 1973); and MPEP Sections 608.01(p) and 2163.07(b).

ii. Use of Trademarks: Potential4Future Non-enablement

When the applicant refers to materials, products or processes, etc. by their respective trade name or trademark in the specification, the examiner should require that a generic description be inserted in place of, or in addition to, a trade name or trademark. This is necessary since the owner of the product to which the trade name or trademark refers can change the product over time. Such future decisions are often outside the control of the applicant. If such a change occurred, the trade name or trademark could come to represent different things at different points in time with no way learning what the differences were. Whether the use of a trade name or trademark provides sufficient description and disclosure of the claimed invention must be decided on a case-by-case basis. Where the identification material or apparatus referred to by its trademark or trade name is introduced by amendment, the information must be restricted to the characteristics of the product known at the time the application was filed to avoid any question of new matter. In re Metcalfe, 410 F.2d 1378, 1382, 161 USPQ 789, 792 (CCPA 1969); and MPEP Section 608.01(v).

B. UTILITY AND OPERABILITY

1. Preferred Materials in Specification Need not be in the Claims

Limiting an applicant to the preferred materials in the absence of limiting prior art would not serve the constitutional purpose of promoting the progress in the useful arts. Therefore, an enablement rejection based on the grounds that a disclosed critical limitation is missing from a claim should be made only when the language of the specification makes it clear that the limitation is critical for the invention to function as intended. Broad language in the disclosure, including the abstract, omitting an allegedly critical feature, tends to rebut the argument of criticality.

2. Inoperability/Inoperative Species within the Scope of the Claim

The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. duPont de Nemous & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984)(prophetic examples do not make the disclosure non-enabling). Although, typically, inoperative embodiments are excluded by language in a claim the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable. A disclosure of a large number of operable embodiments and the identification of a single inoperative embodiment did not render a claim broader than the enabled scope because undue experimentation was not involved in determining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-03, 190 USPQ 214, 218 (CCPA 1976); and MPEP Section 2164.08(b). However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemous & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); see also MPEP Section 2164.08(b).

C. LACK OF ENABLEMENT IN VIEW OF AN OBVIOUSNESS REJECTION

Many times an Office action will contain both a 35 U.S.C. Section 112, first paragraph, enablement rejection and a prior art rejection under 35 U.S.C. Section 102 and/or 103 against the same claim. In such cases, the examiner has determined that the claimed invention is not enabled and yet is anticipated or prima facie obvious in view of prior art. The presence of both rejections in an Office action against the same claim appears contradictory. However, it is not necessarily a contradiction or an improper Office action. The following examples illustrate scenarios where both can coexist.

1. A claim recites a genus but the specification is enabling only for species X. A reference found by the examiner provides evidence that the specification is enabling for species X only and discloses species X. In this case, a scope rejection stating that the claims should be limited to species X is appropriate as is a 102 rejection.
2. A claim recites a genus. The specification discloses only one use for the genus and demonstrates only species X for that use. The examiner finds a first reference that supports the position that it would require undue experimentation to use members of that genus other than species X for the only disclosed purpose. The examiner also finds a second reference that suggests another member, species Y, of the genus for a different purpose. In this case, a scope rejection stating that the claim should be limited to species X is appropriate as is a Section 103 rejection stating that species Y would have been obvious. These rejections are not contradictory.
3. A claim recites a method of treating HIV infection in a human by administering X to the human. The specification discloses an in vitro assay which demonstrates that X will inhibit HIV replication. The examiner finds five references to support the position that treating HIV is unpredictable and that in vitro models do not reasonably correlate to in vivo treatment. The examiner also finds a sixth reference that demonstrates that X will inhibit HIV replication in vitro and suggests treating HIV infection in a human byadministering X to the human. In this case, a lack of enablement rejection would be appropriate using the five references as support. A Section 103 rejection using the sixth reference would also be appropriate. Admittedly, the rejections are contradictory. Nevertheless, in view of the contradictory nature of the suggestions in the state of the art, the contradictory rejections are appropriate since one position is likely to be correct. This type of treatment should be limited to those art areas in which the teachings and suggestions in the art are in conflict with one another.

D. THE INVENTION MAY BE ENABLED BUT NOT ADEQUATELY DESCRIBED

The enablement requirement of 35 U.S.C. Section 112, first paragraph, is separate and distinct from the description requirement. Vas Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991)("the purpose of the 'written description' requirement is broader than to merely explain how to 'make and use'"); and MPEP Section 2161. Therefore, the fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled. In other words, the statement of a new limitation in and of itself may enable one skilled in the art to make and use the claim containing that limitation even though that limitation may not be described in the original disclosure. Consequently, such limitations must be analyzed for both enablement and description using their separate and distinct criteria.

Furthermore, when the subject matter is not in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claim containing the limitation. When claimed subject matter is only presented in the claims and not in the specification portion of the application, the specification should be objected to for lacking the requisite support for the claimed subject matter using Form Paragraph 7.44. See MPEP Section 2163.06. This is a technical rejection only and enablement issues should be treated separately.

Form Paragraph 7.44 provides:

CLAIMED SUBJECT MATTER NOT IN SPECIFICATION

The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFI 1.75(d)(1) and MPEP 608.01(1). Correction of the following is required: [1].

IV. COMMUNICATING FINDINGS TO THE APPLICANT

A.THE LEVEL OF DETAIL

While the analysis and conclusion are based on all the above factors and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection. The language should focus on those factors, reasons, and evidence that lead the examiner to conclude that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims. This can easily be done by making specific findings of fact, supported by the evidence, and then drawing conclusions based on these findings of fact. For example, doubt may arise about enablement because information is missing about one or more essential parts or relationships between parts which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why one skilled in the art could not supply the information without undue experimentation. MPEP § 2164.06. References should be supplied if possible to support a prima facie case of lack of enablement, but are not always required. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). However, specific technical reasons are always required.

In accordance with the principles of compact prosecution, if an enablement rejection is appropriate, the first Office action on the merits should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal. Providing the best case in the first Office action will also allow the second Office action to be made final should applicant fail to provide appropriate convincing arguments and/or evidence. Citing new references and/or expanding arguments in a second Office action could prevent that Office action from being made final. The principles of compact prosecution also dictate that if an enablement rejection is appropriate and the examiner recognizes limitations that would render the claims enabled, the examiner should note such limitations to applicant as early in the prosecution as possible.

In other words, the examiner should always look for enabled, allowable subject matter and communicate to applicant what that subject matter is at the earliest point possible in the prosecution of the application.

B. THE FORM PARAGRAPHS

The relevant form paragraphs that should be used when making a rejection for lack of enablement are paragraphs 7.31.02, 7.31.03, or 7.33.01. See MPEP § 706.03©. Regardless of which Form paragraph is used, the examiner must always clearly articulate the reasons for his or her belief that an enablement issue exists and cite to the evidence that supports his or her belief.

1 35 U.S.C. 112,1st, Enablement 7.31.02

Form paragraph 7.31.02 is to be used when it is the examiner's position that nothing within the scope of the claims is enabled. In such a rejection, the examiner should explain all the reasons why nothing within the scope of the claims is enabled. To make sure all relevant issues are raised, this should include any issues regarding the breadth of the claims relative to the guidance in the disclosure. Form paragraph 7.31.02 is as follows:

Claim [1] rejected under 35 U.S.C. 112, first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to [2] the invention. [3].

Examiner Note:

1. If the problem is one of scope, form paragraph 7.31.03 should be used.
2. In bracket 2, fill in only the appropriate portion of the statute, i.e., one of the following "make," "use," or "make and use".
3. In bracket 3, identify the claimed subject matter for which the specification is not enabling along with an explanation as to why the specification is not enabling. The explanation should include any questions posed by the examiner which were not satisfactorily resolved and consequently raise doubt as to enablement.
4. Where an essential component or step of the invention is not recited in the claims, use form paragraph 7.33.01.

2. 35 U.S.C. 112, 1st, Scope Of Enablement 7.31.03

Form paragraph 7.31.03 is to be used when it is the examiner's position that something within the scope of the claims is enabled but the claims are not limited to that scope. Form paragraph 7.31.03 states:

Claim [1] rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for [2], does not reasonably provide enablement for [3]. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to [4] the invention commensurate in scope with these claims. [5].

Examiner Note:

1. This paragraph is to be used when the scope of the claims is not commensurate with the scope of the enabling disclosure.
2. In bracket 2, identify the claimed subject matter for which the specification is enabling. This may be by reference to specific portions of the specification.
3. In bracket 3, identify aspect(s) of the claims(s) for which the specification is not enabling.
4. In bracket 4, fill in only the appropriate portion of the statute, i.e., one of the following: "make," "use," or "make and use".
5. In bracket 5, identify the problem along with an explanation as to why the specification is not enabling. The explanation should include any questions posed by the examiner which were not satisfactorily resolved and consequently raise doubt as to enablement.

3. 35 U.S.C. 112, 1st, Essential Subject Matter Missing From Claims (Enablement) , 7.33.01 :

Form paragraph 7.33.01 is to be used when it is the examiner's position that a feature that is critical or essential to the practice of the claimed invention is missing from the claim.

Form paragraph 7.33.01 states:

Claim [1] rejected under 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. [2] critical or essential to the practice of the invention, but not included in the claim(s) is not enabled by the disclosure. In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). [3].

Examiner Note:

1. In bracket 2, recite the subject matter omitted from the claims.
2. In bracket 3, give the rationale for considering the omitted subject matter critical or essential.
3. The examiner shall cite the statement, argument, date, drawing, or other evidence which demonstrates that a particular feature was considered essential by the applicant, is not reflected in the claims which are rejected.

4. Multiple Use of Form Paragraphs

A claim should not be rejected using form paragraph 7.31.02 and also rejected using either form paragraph 7.31.03 or form paragraph 7.33.01 within the same Office action since this would present conflicting and confusing positions. Form paragraph 7.31.02 states that nothing is enabled in that claim and each of the other two form paragraphs state that something within the scope of the claim is enabled. If the examiner concludes that nothing is enabled for one reason and that the breadth of the claims is also not commensurate in scope with the guidance in the specification, then all these issues should be raised with respect to that claim using form paragraph 7.31.02. Sometimes the scope of a claim may not be enabled because a critical or essential feature is missing in addition to other reasons. In such cases, all the scope issues may be raised under form paragraph 7.31.03 or form paragraph 7.33.01, or the issues may be raised separately by using both form paragraph 7.31.03 and form paragraph 7.33.01.

5. Practical Tips in Writing the Rejection

V. REBUTTAL TO THE REJECTION PROOF OF ENABLEMENT:

EVIDENCE AND ATTORNEY ARGUMENT

Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. The evidence provided by applicant need not be conclusive but merely convincing to one skilled in the art. A declaration or affidavit is, itself, evidence that must be considered.

To overcome a prima facie case of lack of enablement, applicant must demonstrate by argument and/or evidence that the disclosure, as filed, would have enabled the claimed invention for one skilled in the art at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope, i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must bear a reasonable correlation.

The examiner must then weigh all the evidence before him or her, including the specification and any new evidence supplied by applicant with the evidence and/or sound scientific reasoning previously presented in the rejection and decide whether the claimed invention is enabled. The examiner should never make the determination based on personal opinion. The determination should always be based on the weight of all the evidence.

A. USE OF POST FILING DATE EVIDENCE

In general, if an applicant seeks to use a patent to prove the state of the art for the purpose of the enablement requirement, the patent must have an issue date earlier than the effective filing date of the application. In re Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976). Similarly, in general, the examiner should not use post-filing date references to demonstrate that the patent is non-enabling. Exceptions to these rules could occur if a later-dated reference provides evidence of what one skilled in the art would have known on or before the effective filing date of the patent application. That is, if individuals of skill in the art state that a particular invention is not possible years after the filing date, that would be evidence that the disclosed invention was not possible at the time of filing and should be considered.

B. EXPERT DECLARATIONS

Declarations and affidavits are evidence. The weight to give them will depend upon the amount of factual evidence they contain to support the conclusion of enablement. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991)("expert's opinion on the ultimate legal conclusion must be supported by something more than a conclusory statement"); cf. In re Alton, 76 F.3d 1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996)(declarations relating to the written description requirement should have been considered).

C. USE OF FDA SUBMISSIONS

An applicant may argue that the FDA has approved clinical trials and, therefore, the claims should be considered enabled by the specification. FDA approval is an important consideration. However, considerations made by the FDA for approving clinical trial are different from those made by the PTO in determining whether a claim is enabled. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) ("[t]esting for full safety and effectiveness of a prosthetic device is more properly left to the [FDA].")

Applicant should be encouraged to provide any evidence to demonstrate that the disclosure enables the claimed invention, including evidence actually submitted to the FDA to obtain approval for clinical trials. Once that evidence is submitted, it must be weighed with all other evidence according to the standards set forth above so as to reach a determination as to whether the disclosure enables the claimed invention.

ENABLEMENT DECISION TREE

Example A: Hybridization Probes I

Specification: The specification discloses that bacteria A is known to cause a specific disease and, therefore, detection of bacteria A in a sample is desirable. The specification even discloses that methods are known which detect bacteria A in a sample via culturing techniques. According to the specification, such detection methods are difficult to perform and therefore detection methods using nucleic acid probes are preferred.

The specification discloses that one object of the invention is to provide nucleic acids complementary to unique nucleic acid sequences within the RNA or DNA of bacteria A and which can be used to detect bacteria A. Another object of the invention is to provide a method of detecting bacteria A in a sample by contacting the sample with a probe which preferentially hybridizes to RNA or DNA of bacteria A but not to non-bacteria A organisms.

The term "probe" is described in the specification as a nucleic acid between 10 and 300 base pairs in length which contain specific nucleotide sequences that specifically and preferentially hybridize under predetermined conditions to nucleic acid sequences of bacteria A. The probes optionally contain a detectable moiety.

The following three specific probes were disclosed:

Bacteria A probe 1 (35mer) (SEQ ID NO:1)

5'-CATTAGAGTC GTACGTGCTA GACTGATTAA CCGGT-3'

Bacteria A probe 2 (33mer) (SEQ ID NO:2)

5'-CAATCCAGTA AGTTTTACCC GGCCAAATAA AGG-3'

Bacteria A probe 3 (30mer) (SEQ ID NO:3)

5'-AAATAGCCAG ATCATTGCCC CGGACCCTTG-3'

An example appears in the specification which demonstrates how to carry out the detection and which shows that the three probes are specific for bacteria A and fail to hybridize to 50 other types of bacteria.

Claims:

1. An isolated nucleic acid consisting of 10 to 300 nucleotides which hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A organisms, wherein said nucleic acid is or is complementary to a nucleotide sequence comprising at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3.
2. A probe comprising a nucleic acid of claim 1 and a detectable moiety.
3. A method of detecting the presence of bacteria A in a sample suspected of containing bacteria A comprising
• a) contacting the sample with an isolated nucleic acid of claim 1,
• b) imposing hybridization conditions on the sample and said isolated nucleic acid to allow the formation of a hybridization product between said nucleic acid and RNA or DNA from bacteria A, if present in the sample, but not from RNA or DNA from non-bacteria A bacteria; and
• c) detecting any hybridization product as an indication of the presence of bacteria A in the sample.

State of the Prior Art: A search was carried out to compare the multitude of 10 nucleotide probes encompassed by the claims with sequences in the EMBL database with the following results:

10,541 database hits for the 10mers of probe 1;

15,378 database hits for the 10mers of probe 2;

5,691 database hits for the 10mers of probe 3.

Some of the hits for each probe were in the RNA or DNA of bacteria other than bacteria A, such as Salmonella, Candida, and Streptococcus.

Wallace et al, Methods Enzymol. 152:432-443 (1987).

Sambrook et al, Molecular Cloning, A Laboratory Manual, Second Edition, 1989, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY, p. 11.47.

Wallace et al and Sambrook et al teach the empirical nature of determining the specificity of hybridization probes and the unpredictability of the effect of mismatches within an oligonucleotide probe.

The 50 different bacteria tested within the example in the specification are representative of bacteria in general.

Analysis:

There is a demonstration in the specification that the three specifically disclosed probes can be used to detect bacteria A. Furthermore, the sequences of those probes are disclosed so that one skilled in the art could clearly make them. Therefore, the specification does teach how to make and use three embodiments encompassed by the claims. Accordingly, an objection/rejection using form paragraph 7.31.02 would be inappropriate. The issue then is whether the enabled embodiments are representative of the scope of the claims.

Before this can be determined, the scope of at least claim 1 must be determined. Claim 1 recites three limitations on the nucleic acid, two structural and one functional. The two structural limitations are 1) that the nucleic acid consists of 10 to 300 nucleotides and 2) that the nucleic acid is or is complementary to a nucleotide sequence comprising at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3. Since the nucleotide sequence mentioned merely comprises at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3, it encompasses any random sequence of any length as long as it has a stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3. Furthermore, since there is no limitation that the claimed nucleic acid be complementary to the nucleotide sequence at the stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3, the structural limitations encompass any nucleic acid consisting of 10 to 300 nucleotides. The functional limitation is that the nucleic acid must be such that is hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A bacteria. Thus, claim 1 encompasses any nucleic acid that is 10 to 300 nucleotides in length and hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A bacteria.

Clearly if a nucleic acid hybridizes preferentially to RNA or DNA or bacteria and not to non-bacteria A bacteria, one skilled in the art would know how to use that nucleic acid based on the teachings in the specification. Thus, the specification teaches how to use all the nucleic acids encompassed by the claims. However, does the specification teach how to identify or make all nucleic acids that have both the structural limitation and the functional limitation? The answer in this case would be no since there is evidence sufficient to rebut the presumption that the full scope of claim 1 would be enabled without undue experimentation. Specifically, the state of the prior art as exemplified by Wallace et al and Sambrook et al is such that determining the specificity of hybridization probes is empirical by nature and the effect of mismatches within an oligonucleotide probe is unpredictable. The database search results suggest that there are probes that would meet the structural limitations of the claims but not the functional limitation. The only specific guidance or working example given in the specification is for the three specific sequences of SEQ ID NOS 1-3 but there is no suggestion as to what the target sites in bacteria A are or what modifications can be made while retaining the functional limitation. The structural limitations of the claims clearly cover any nucleic acid that is 10 to 300 nucleotides in length (on the order of 4300 possible nucleic acids). Because of these considerations, one skilled in the art would have to make and test all nucleic acids that meet the structural limitations to determine which also meet the functional limitation. This amount of experimentation would be impossible in many lifetimes. Therefore, based on the empirical and unpredictable nature of the invention and state of the prior art, the limited guidance and working examples in the specification, and the extensive quantity of experimentation needed to identify the nucleic acids encompassed by the claims, it would be reasonable to conclude that it would require an undue amount of experimentation to identify the nucleic acids encompassed by the claims. In this case a scope rejection using form paragraph 7.31.03 would be appropriate.

The only issue remaining is the decision as to the scope that is enabled by the specification. Clearly the three probes used in the example are enabled. Is this all that is enabled? The answering of this question can be approached by considering claims having narrower scope, but still having written descriptive support, and determining whether the specification enables such a claim. Doing this, a claim of the following scope would be enabled on the facts presented here:

An isolated nucleic acid consisting of 10 to 35 nucleotides which hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A organisms, wherein said nucleic acid is or is complementary to a nucleotide sequence consisting of at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3.

Note, the upper limit of 35 nucleotides has clear descriptive support based on the fact that one of the specific probes of the example has 35 nucleotides. Nothing larger than 35, other than 300, has specific descriptive support and an upper limit of 300 would not be enabled for the reasons set forth above. The structural limitations of this claim would include approximately 800 different nucleic acids, some of which would not be expected to work in view of the state of the prior art. However, in view of the limited number of possibilities and the expectation that there are at least some, other than the specifically disclosed three, that would also meet the functional limitation, it would be reasonable to conclude that it would not require an undue amount of experimentation to identify the nucleic acids encompassed by the claim.

Rejection:

Claims 1-3 are rejected under 35 U.S.C. § 112, first paragraph, because the specification, while being enabling for an isolated nucleic acid consisting of 10 to 35 nucleotides which hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A organisms, wherein said nucleic acid is or is complementary to a nucleotide sequence consisting of at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3, does not reasonably provide enablement for any other embodiment encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to identify or make the invention commensurate in scope with these claims.

The specification discloses and the claims recite probes that hybridize preferentially to RNA or DNA of bacteria A but not to non-bacteria A organisms as well as methods of using the probes to detect bacteria A. However, the state of the prior art as exemplified by Wallace et al and Sambrook et al is such that determining the specificity of hybridization probes is empirical by nature and the effect of mismatches within an oligonucleotide probe is unpredictable. Furthermore, a database search was done for 10mers of the three specifically disclosed probes, the results of which are attached, which suggest that some of the probes encompassed by the structural limitations of the claims would not meet the functional limitation thereof. The only working example given in the specification is limited to the three specific sequences of SEQ ID NOS 1-3 and there is no suggestion as to what the target sites in bacteria A are or what modifications can be made while retaining the functional limitation. In addition, claim 1 recites three limitations on the nucleic acid, two structural and one functional. The two structural limitation are 1) that the nucleic acid consists of 10 to 300 nucleotides and 2) that the nucleic acid is or is complementary to a nucleotide sequence comprising at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3. Since the nucleotide sequence mentioned merely comprises at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3, it encompasses any random sequence of any length as long as it has a stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3. Furthermore, since there is no limitation that the claimed nucleic acid be complementary to the nucleotide sequence at the stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3, the structural limitations encompass any nucleic acid consisting of 10 to 300 nucleotides. Thus, claim 1 encompasses any nucleic acid that is 10 to 300 nucleotides in length and hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A bacteria. Since the structural limitations of the claim clearly covers any nucleic acid that is 10 to 300 nucleotides in length (on the order of 4300 possible nucleic acids) and in view of the empirical and unpredictable nature of the art and lack of guidance with respect to appropriate modifications, one skilled in the art would have to make and test all nucleic acids that meet the structural limitations to determine which also meet the functional limitation. This amount of experimentation would be impossible in many lifetimes. Therefore, based on the empirical and unpredictable nature of the invention and state of the prior art, the limited guidance and working examples in the specification, and the extensive quantity of experimentation needed to identify the nucleic acids encompassed by the claims, it would require an undue amount of experimentation to identify or make the nucleic acids encompassed by the claims.

If claim 1 was limited as follows, this rejection would be overcome:

1. An isolated nucleic acid consisting of 10 to 35 nucleotides which hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A organisms, wherein said nucleic acid is or is complementary to a nucleotide sequence consisting of at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3.

Example B: Hybridization Probes II

Specification: THE ONLY DIFFERENCE BETWEEN THE FACTS IN EXAMPLE A AND THOSE OF EXAMPLE B IS THE LANGUAGE OF CLAIM 1. Specifically, the specification discloses that bacteria A is known to cause a specific disease and, therefore, detection of bacteria A in a sample is desirable. The specification even discloses that methods are known which detect bacteria A in a sample via culturing techniques. According to the specification, such detection methods are difficult to perform and therefore detection methods using nucleic acid probes are preferred.

The specification discloses that one object of the invention is to provide nucleic acids complementary to unique nucleic acid sequences within the RNA or DNA of bacteria A and which can be used to detect bacteria A. Another object of the invention is to provide a method of detecting bacteria A in a sample by contacting the sample with a probe which preferentially hybridizes to RNA or DNA of bacteria A but not to non-bacteria A organisms.

The term "probe" is described in the specification as a nucleic acid between 10 and 300 base pairs in length which contain specific nucleotide sequences that specifically and preferentially hybridize under predetermined conditions to nucleic acid sequences of bacteria A. The probes optionally contain a detectable moiety.

The following three specific probes were disclosed:

Bacteria A probe 1 (35mer) (SEQ ID NO:1)

5'-CATTAGAGTC GTACGTGCTA GACTGATTAA CCGGT-3'

Bacteria A probe 2 (33mer) (SEQ ID NO:2)

5'-CAATCCAGTA AGTTTTACCC GGCCAAATAA AGG-3'

Bacteria A probe 3 (30mer) (SEQ ID NO:3)

5'-AAATAGCCAG ATCATTGCCC CGGACCCTTG-3'

An example appears in the specification which demonstrates how to carry out the detection and which shows that the three probes are specific for bacteria A and fail to hybridize to 50 other types of bacteria.

Claims:

1. An isolated nucleic acid consisting of 10 to 300 nucleotides wherein said nucleic acid is or is complementary to a nucleotide sequence comprising any ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3.
2. A probe comprising a nucleic acid of claim 1 and a detectable moiety.
3. A method of detecting the presence of bacteria A in a sample suspected of containing bacteria A comprising

a) contacting the sample with an isolated nucleic acid of claim 1,

b) imposing hybridization conditions on the sample and said isolated nucleic acid to allow the formation of a hybridization product between said nucleic acid and RNA or DNA from bacteria A, if present in the sample, but not from RNA or DNA from non-bacteria A bacteria; and

c) detecting any hybridization product as an indication of the presence of bacteria A in the sample.

State of the Prior Art: Same as in Example A. Specifically, a search was carried out to compare the multitude of 10 nucleotide probes encompassed by the claims with sequences in the EMBL database with the following results:

10,541 database hits for the 10mers of probe 1;

15,378 database hits for the 10mers of probe 2;

5,691 database hits for the 10mers of probe 3.

Some of the hits for each probe were in the RNA or DNA of bacteria other than bacteria A, such as Salmonella, Candida, and Streptococcus.

Wallace et al, Methods Enzymol. 152:432-443 (1987).

Sambrook et al, Molecular Cloning, A Laboratory Manual, Second Edition, 1989, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY, p. 11.47.

Wallace et al and Sambrook et al teach the empirical nature of determining the specificity of hybridization probes and the unpredictability of the effect of mismatches within an oligonucleotide probe.

The 50 different bacteria tested within the example in the specification are representative of bacteria in general.

Analysis:

There is a demonstration in the specification that the three specifically disclosed probes can be used to detect bacteria A. Furthermore, the sequences of those probes are disclosed so that one skilled in the art could clearly make them. Therefore, the specification does teach how to make and use three embodiments encompassed by the claims. Accordingly, an objection/rejection using form paragraph 7.31.02 would be inappropriate. The issue is whether the enabled embodiments are representative of the scope of the claims.

Before this can be determined, the scope of at least claim 1 must be determined. Claim 1 recites two structural limitations for the nucleic acid which are 1) that the nucleic acid consist of 10 to 300 nucleotides and 2) that the nucleic acid is or is complementary to a nucleotide sequence comprising at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3. Since the nucleotide sequence mentioned merely comprises at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3, it encompasses any random sequence of any length as long as it has a stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3. Furthermore, since there is no limitation that the claimed nucleic acid be complementary to the nucleotide sequence at the stretch of at least ten consecutive nucleotides that is the same as in SEQ ID NOS 1-3, claim 1 encompasses any nucleic acid that is 10 to 300 nucleotides in length.

Since all nucleic acids within the scope of claim 1 could be clearly identified and since nucleic acids can readily be synthesized by those skilled in the art, one skilled in the art would know how to identify and make all the nucleic acids encompassed by claim 1. However, does the specification teach how to use all nucleic acids encompassed by claim 1? The answer in this case would be no. The only disclosed use for the nucleic acids is in a method of detecting the presence of bacteria A in a sample by preferentially hybridizing to RNA or DNA of bacteria A but not to non-bacteria A organisms, as in claim 3. The state of the prior art as exemplified by Wallace et al and Sambrook et al is such that determining the specificity of hybridization probes is empirical by nature and the effect of mismatches within an oligonucleotide probe is unpredictable. The database search results suggest that there are probes that would meet the limitations of the claims but would not function to detect bacteria A by preferentially hybridizing to RNA or DNA of bacteria A but not to non-bacteria A organisms. The only specific guidance or working example given in the specification is for the three specific sequences of SEQ ID NOS 1-3 but there is no suggestion as to what the target sites in bacteria A are or what modifications can be made while retaining the ability to preferentially hybridize to RNA or DNA of bacteria A. Therefore, based on these considerations, it would be reasonable to conclude that it would require an undue amount of experimentation to determine how to use all the nucleic acids encompassed by the claims for detecting bacteria A in a sample. In this case a scope rejection using form paragraph 7.31.03 would be appropriate.

The only issue remaining is the decision as to the scope that is enabled by the specification. Clearly the three probes used in the example are enabled. Is this all that is enabled? The answering of this question can be approached by considering claims having narrower scope, but still having written descriptive support, and determining whether the specification enables such a claim. Doing this, a claim of the following scope would be enabled on the facts presented here:

An isolated nucleic acid consisting of 10 to 35 nucleotides which hybridizes preferentially to RNA or DNA of bacteria A and not to non-bacteria A organisms, wherein said nucleic acid is or is complementary to a nucleotide sequence consisting of at least ten consecutive nucleotides from a nucleotide sequence selected from the group consisting of SEQ ID NOS 1, 2, and 3.

Note, the insertion of the functional limitation, i.e., that the nucleic acid must hybridize preferentially to RNA or DNA or bacteria A and not to non-bacteria A organisms, by itself would be such that the disclosure would enable the use of those nucleic acids encompassed by the claim. However, there would still be enablement problems, as seen in Example A, requiring further structural limitations. The upper limit of 35 nucleotides has clear descriptive support based on the fact that one of the specific probes of the example has 35 nucleotides. Nothing larger than 35, other than 300, has specific descriptive support and an upper limit of 300 would not be enabled for the reasons set forth above and in Example A. The structural limitations of this claim would include approximately 800 different nucleic acids, some of which would not be expected to work in view of the state of the prior art. However, in view of the limited number of possibilities and the expectation that there are at least some, other than the specifically disclosed three, that would also meet the functional limitation, it would be