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 .
Claims 42, 44-48, 52 and 56-61 have been amended. Claims 42-61 are pending and under consideration.
The rejection of claims 42-61 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The rejection of claims 42, 43, 47-53, and 56-60 under 35 U.S.C. 103 as being unpatentable over Kim et al (Bioconjugate Chemistry, 2011, Vol. 22, pp. 1031-1038, reference of the IDS filed 5/25/2023) in view of He et al (Journal of Controlled Release, 2008, Vol. 127, pp. 189-207, reference of the IDS filed 5/25/2023), Bolu et al (Molecules, 2018, Vol. 23, 26 pages), Rosenthal et al (Bioconjugate Chemistry, 2005, Vol. 16, pp. 200-207), O’Shea et al (WO2016/037180) and Kim et al (US2013/0330826); and
the rejection of claims 42-53, and 56-60 under 35 U.S.C. 103 as being unpatentable over Kim et al (2011), He et al, Bolu et al, Rosenthal et al, O’Shea et and Kim et al (‘826) as applied to claims 42, 43, 47-53, and 56-60 above, and further in view of Harui et al (Cancer Immunology, Immunotherapy, ePub 4/24/2020, Vol. 69, pp. 1737-1749) and Baxi et al (BMJ, 2018, Vol. 360, k793, 13 pages)
is withdrawn in light of applicants’ argument that the proposed modifications of the hydrogel of Kim would render the hydrogel unable to release NO which is in conflict with the MPEP which instructs that if a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there may be no suggestion or motivation to make the proposed modification.
New Grounds of Rejection
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 42-57 and 61 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.
(A)It is unclear if the one or more thiol groups in claim 42 are part of the polymer having at least 3 primary amino groups or if the one or more thiol groups of the amphiphilic polymer.
(B)Figure 1 of the specification teaches that the amphiphilic polymer is activated with nitrophenyl chloroformate and reacted with the polymer containing at least 3 primary amine groups in the presence of p-nitrophenyl chloroformate. The resulting adduct is then exposed to propylene sulfide to introduce CH2-CH(SH)-CH3 groups at the primary amino groups. It appears that the one or more thiol groups replace the “at least three primary amine groups” in the polymer having at least three primary amine groups which is consistent with claims 59 and 60.
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It is unclear if applicant intends that the at least three primary amine groups are in excess of the one or more thiol groups.
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 42-61 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.
This is a new matter rejection. Applicant has canceled all references to “thiolated thermoresponsive polymer” in favor of “thiolated polymer” in claims 42 and 56-58 or “intermediate polymer” in claims 59 and 60. The specification only refers to the thiolated polymer as “thermoresponsive”. The specification provides no description of alternative thiolated polymers that are not thiolated thermoresponsive polymers. One of skill in the art would reasonably conclude that applicant was not in possession of a genus of thiolated polymers that were not thiolated thermoresponsive polymers at the time of filing.
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 –
(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 42, 43, 53-55, 57 and 58 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bierman (U.S. 2021/0283312, priority to 62/988,879).
Bierman discloses a cross-linked hydrogel made up of 4-arm PEG maleimide, and 4-arm PEG thiol (paragraph [0043], Figure 3 of ‘312 and Figure 1 of ‘879), wherein an RGD peptide was included within the hydrogel matrix, which meets the limitations of claim 42 as far as can be construed due to the instant language of an amphiphilic polymer having one or more thiol groups which is 4-arm PEG thiol, crosslinked to an “electrophilic “ polymer , wherein the “electrophilic ”polymer is 4-arm-PEG maleimide, having a core, “C”, wherein “c” is four. Figure 3 of Bierman also meets the limitation of claim 58 for the crosslinking between an electrophilic polymer and a thiolated polymer, wherein maleimide is the electrophile, “Q” in claim 58, “C” is a core, “c” is the integer 4 and the encircled polymer is hydrophilic; claim 53 for PEG as the hydrophilic polymer; claim 54 for “C”:
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;
claim 55 for Q1 of
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wherein A is NH, and “a” is 1.
The RDG peptide meets the limitation of claim 43 requiring a therapeutic agent. Biermann discloses that the crosslinked hydrogel comprises 0.5% (w/v) HA and a 1:1.2 ratio of total thiol to maleimide, which meets the limitation of claim 57.
All claims are rejected. All other rejections and/or objections as set forth in the previous Office action are withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643