001Notice 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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 21-44 in the reply filed on 1/13/2026 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 –
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-44 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kozlowski et al. (US 7,659,361 B2)
Kozlowski discloses maleimide-functional conjugates that, upon reaction with nucleophiles including thiols, form succinimide (thiosuccinimide) intermediates, and further disclose intentional ring opening of the succinimide/thiosuccinimide ring to form ring-opened succinamic (maleamic) acid structures (col. 3, ll. 15–45; col. 4, ll. 10–45; col. 5, ll. 1–25; col. 12, ll. 5–35; Figs. I, II, IV, V, VI, VII, IX, XI).
Kozlowski expressly teaches that ring opening produces positional isomers resulting from nucleophilic attachment at different ring carbon positions (C-2 vs. C-3), as depicted in Figures IV and V (col. 5, ll. 5–25; col. 6, ll. 1–20). Such ring opening therefore inherently results in a mixture of multiple ring-opened thiosuccinimide compounds.
Kozlowski further teaches chromatographic separation of the resulting conjugates and positional isomers (col. 8, ll. 10–40; col. 14, ll. 1–25).
Accordingly, Kozlowski discloses each and every element of the process recited in claim 21, including providing a mixture of ring-opened thiosuccinimide compounds and subjecting the mixture to chromatography to obtain individual products.
Claims 22–24 and 25–33 merely recite routine implementation details of chromatographic separation, which are inherent in the disclosed separation process.
Claims 34–39 recite polymer, linker, and conjugated moiety definitions that fall within the polymeric and PEG-based conjugates expressly taught by Kozlowski (col. 2, ll. 40–65; col. 7, ll. 1–35; col. 9, ll. 5–30).
Claims 40 and 44 expressly recite the ring-opening reaction of a thiosuccinimide group, which is explicitly taught by Kozlowski. Claims 41–43 recite isomeric compounds formed by the ring-opening reaction, which are expressly disclosed and inherently present in Kozlowski.
In the alternative, and only if Kozlowski is found not to expressly or inherently disclose every limitation, the claims would nevertheless have been obvious. Kozlowski teaches ring-opened thiosuccinimide conjugates, formation of isomeric mixtures, and chromatographic separation thereof. Any differences relating to the number of separation steps, order of fraction collection, or specific chromatographic conditions constitute routine optimization of known chromatographic techniques and would have been obvious to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAM M NGUYEN whose telephone number is (571)272-1452. The examiner can normally be reached Mon - Frid.
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/TAM M NGUYEN/Primary Examiner, Art Unit 1771