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 .
Status
Claims 1-30 are pending. Claims 2, 7-11, 13-19, 21, 22, 24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Therefore, Claims 1, 3-6, 12, 20, 23, and 26-30 are presented for examination on the merits.
Election/Restrictions
Applicant’s election without traverse of
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522
852
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(presented at p. 178 of specification) in the reply filed on 12/3/2025 is acknowledged.
Claims 2, 7-11, 14-19, 21, 22, 24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/3/2025.
Therefore, Claims 1, 3-6, 12, 20, 23, and 26-30 are presented for examination on the merits.
The elected compound species is free of the prior. Thus, the examination on the merits has been expanded to other species and it was found that the genus of compounds is free of the prior art.
Priority
This application is a continuation of U.S. Patent Application No. 18/590,713, filed February 28, 2024, which is a continuation of U.S. Patent Application No. 18/220,737, filed July 11, 2023, which is a continuation of International Patent Application No. PCT/US2022/027513, filed in the U.S. Receiving Office on May 3, 2022, which claims the benefit of U.S. Provisional Application No. 63/331,592, filed April 15, 2022, U.S. Provisional Application No. 63/293,447, filed December 23, 2021, U.S. Provisional Application No. 63/228,067, filed July 31, 2021, and U.S. Provisional Application No. 63/183,450, filed May 3, 2021. Applicant’s claim to priority is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed 4/14/2025 and 12/3/2025 have been considered by the Examiner. The submissions are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
Claim Rejections - 35 USC § 112 - Indefiniteness
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, 3-6, 12, 20, and 26-30 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.
Claim 1 recites the limitation "R22" (and its definition) at line 7 of p. 5 of the claims. There is insufficient antecedent basis for this limitation in the claim. It is not clear what part of the claimed product is intended to be limited by R22. A person of ordinary skill in the art (POSA) would not know the complete structure of the compound being claimed. Therefore, the POSA is not apprised of the metes and bounds of the claimed invention.
Regarding claim 1, the phrase "for example" (at line 14 of p. 5) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112 – Written description
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 nin 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, 3-6, 12, 20, and 26-30 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a divalent residue of a natural or unnatural amino acid”, “a divalent residue of a fatty acid”, and “a divalent residue of an unsaturated or saturated mono- or di-carboxylic acid” at pages 4 and 5 or the claims. There is insufficient written basis in the specification for derivatives of these claimed agents.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5,2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
Applicant has failed to provide any structural characteristics, chemical formula, name(s) or physical properties of a representative number of divalent residues of a natural or unnatural amino acid, divalent residues of a fatty acid, and divalent residues of an unsaturated or saturated mono- or di-carboxylic acid aside from a broad recitation that such are contemplated for use in the invention. As such, it is not apparent that Applicant was actually in possession of, and intended to use within the context of the present invention, any specific divalent residues of a natural or unnatural amino acid, divalent residues of a fatty acid, or divalent residues of an unsaturated or saturated mono- or di-carboxylic acid at the time the present invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622