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 .
Continued examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
Status of the Application
Claims 86, 91, 94, 108-110, 117-130, 132, 134-142, 143-145 are pending, of which claims 91, 94, and 141, 144-145 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 86, 108-110, 117-130, 132, 134-140, 142 and 143 are under current examination.
Objection
Claim 86, is objected as the claim at several instances recites abbreviations. For example, claim 86 recites CA-170, EICAR, EB1089 etc. This is the first time these abbreviations appear in the claims and must be defined.
Appropriate correction required.
Claim Rejections - 35 USC § 112(a) -Written Description
The following is a quotation of the first paragraph of 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 86, 108-110, 117-130, 132, 134-140, 142 and 143 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a polymer having repeating units:
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722
929
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837
1008
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846
992
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773
1022
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837
1004
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239
881
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763
1022
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376
936
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795
990
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Thus, claim 86 is drawn to millions of polymers of varied structure.
Said genus of polymers is not adequately defined in the instant specification. The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species in examples that encompass the genus. (MPEP § 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described."). If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The applicants have broadly claimed a polymer having any structure as long as the polymer has a repeating unit, which again comprise (having any structure) any structure as long as the structure has moiety of formula:
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148
457
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.Further, formula:
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457
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itself may comprise millions of structures. It is unquestionable that claims 86, 108-110, 117-130, 132, 134-140, 142 and 143 are broad and generic, with respect to all possible polymers encompassed by claim 86. There is a very large number of structural variations encompassed by the polymer. The claims lack in written description because the specification lacks sufficient variety of species to reflect this variance in the genus.
The specification provides guidance to a very limited number of polymers, 4 polymers. For example, the instant claims do not include a structure of polymer, other than definition of reactants and polymer that may comprise any unit any structure, substituted, unsubstituted etc., as long as the polymer comprises repeating unit:
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. The instant specification provides synthesis of only 4 polymers with only two type of M, Bortezomib, and Ixazomib only one type of linker (L1 as in claims 121-124; L1a as in claims 125-127; and L as in claims 134-135) Vs millions of polymers encompassed by the instant claims. "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention.").
Having analyzed the claims with regard to the written description guidelines, the specification does not provide sufficient descriptive support for the myriad of polymers embraced by the claims. There are millions of combinations of elements X, L1, L1a, L, R1, M with any substitution, structure, linkage in the reactants itself as well as broadly defined any polymer of any structure with only one constraint of having a repeating unit of formula:
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, which again may comprise any structure, embraced by the instant claims. Considering the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of claims 86, 108-110, 117-130, 132, 134-140, 142 and 143.
Response to Applicant’s remarks
Applicant’s remarks, IDS and amendment, filed on 05/05/2026, have been fully considered but not found persuasive.
Applicant argued that claims are amended and complies with 112a, written description requirement and therefore claims should be allowed.
This is not found persuasive as the amended instant claims doesn’t complies with 112a, written description requirement. Please see rejection as set forth above.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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