DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/07/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 and 12 and 2α,3α-dihydroxy-27-nor-5α-cholestan-6-one in the reply filed on 09/10/2025 is acknowledged. The traversal is on the ground(s) that amendments moot the prior art contribution. This is not found persuasive because there is still prior art anticipating the shared technical feature; see rejection under 35 U.S.C. 102.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-6 and 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/10/2025.
Applicant stated that claims 1, 7 and 12 read on the claims. Claim 2 also appears to read on the claims and is thus not withdrawn. Claim 5 recites “R” which renders it unclear whether it reads on the elected species and is therefore withdrawn.
Claim Objections
Claim 7 is objected to because of the following informalities:
The structure of general formula I in claim 1 is unclear and should be replaced with a clear structure.
Claim 7 recites at least “2α-hydroxy-24-nor-5α-cholan-6-on” which contains a typographical error and should instead recite “2α-hydroxy-24-nor-5α-cholan-6-one”. Additionally, several names utilize Latin and Greek characters interchangeably and should use Greek characters consistently in accordance with accepted naming conventions; i.e. the recitation “2α-hydroxy-26a,26b-dihomo-27-nor-5α-cholestan-6-one” should instead recite “2α-hydroxy-26α,26β-dihomo-27-nor-5α-cholestan-6-one”. There is an extraneous comma in the third line of page 5. Applicant should carefully review the claims for additional errors.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-2, 7 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit noted the importance of an application's disclosure and stated, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
In Ariad, the Federal Circuit articulates the factors to be considered when analyzing written description,
Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
A written description of a chemical genus “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe of a genus of compounds:
We held that a sufficient description of a genus instead requires the disclosure of
either a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
Claim 1 describes “isomers ". The term “isomer” is a commonly used term within chemistry. An isomer is a member of a group of compounds having identical molecular formulas but differing in the nature or bonding sequence of their atoms or arrangement of their atoms in space. The specification does not further define “isomers” and the term is therefore given its plain meaning.
Optical isomers retain the bonding sequence of atoms and differ only in the arrangement of these atoms in space, e.g., stereoisomers. Alternatively, structural isomers retain only the same molecular formula. To demonstrate, the elected species represents a molecular structure with a molecular formula of C26H44O3. An isomer of this compound includes every compound having the chemical formula, C26H44O3, even those which fall outside formula I. For example, the compound
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, plainly falls outside formula I but nonetheless represents an isomer formula I because of its shared chemical formula, C26H44O3.
Chemistry is generally considered to be unpredictable and/or have unpredictable factors. See, e.g.,In re Carleton, 599 F.2d 1021, 202 USPQ 165, 170 (CCPA 1979) ("Although there is a vast amount of knowledge about general relationships in the chemical arts, chemistry is still largely empirical, and there is often great difficulty in predicting precisely how a given compound will behave.”); In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved (emphasis added); In re Bowden, 183 F.2d 115, 86 USPQ 419, 423 (“chemical reactions frequently are unpredictable”). Even small changes in reaction conditions may not be trivial and may bring about unforeseeable changes in reactivity.
An "isomer" of formula I presents a genus having substantial variation amongst its compounds, including those sharing molecular formulas but falling outside the scope of formula I. The specification provides zero examples of isomers of formula I and focuses entirely on compounds falling within formula I. Zero examples of isomers of formula I demonstrates zero variation within the subgenus encompassed by an "isomer" of formula I. Considering the relatively high level of unpredictability found within organic chemistry, zero examples of an "isomer" of formula I does not adequately represent the genus of isomers of formula I. The disclosure, therefore, fails to reasonably convey to the skilled artisan that Applicant had possession of the claimed isomers of formula I.
In order to overcome this rejection, Applicant may remove the recitation of “isomer” from the claims. Note that the limitation “isomer” is construed to apply to dependent claims as well, i.e. claims 2, 7 and 12 also encompass isomers of the recited compounds.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 7 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 also recites
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; there is no R4 in general formula I, rendering said limitations unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem CID 139365936.
PubChem CID 139365936 is a structural isomer of the elected species because it has the same molecular formula as the elected species, C26H44O3. Therefore, claims 1-2 and 7 are anticipated. Solubility data is reported which suggests the compound in solution. Accordingly, claim 12 is also anticipated.
Conclusion
Claims 1-2, 7 and 12 are rejected.
Claims 3-6 and 8-11 are withdrawn.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623