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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 8-13, 15-19, 21-23, and 29-30) in the reply filed on 04 February 2026 is acknowledged. The traversal is on the ground(s) that serious burden has not been shown to be required to examine all of the claims. This is not found persuasive because a showing of serious burden is not required for unity of invention practice.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24, 35, and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04 February 2026.
Applicant's election with traverse of species multi-arm poly(ethylene glycol)-maleimide polymer backbone and ethylene glycol bis(mercaptoacetate) first crosslinker in the reply filed on 04 February 2026 is acknowledged. The traversal is on the ground(s) that serious burden has not been shown to be required to examine all of the species. This is not found persuasive because a showing of serious burden is not required for unity of invention practice.
The requirement is still deemed proper and is therefore made FINAL.
Species other than those elected are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04 February 2026.
Claims 1, 8-13, 15-19, 21-23, and 29-30 are under current consideration.
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.
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.
Claim(s) 1, 8-13, 15-19, 21-23, and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ott et al. (WO 2020/247776 A1; published 10 December 2020).
Regarding claim 1, Ott et al. discloses hydrogel microparticles fabricated from polymer precursors such as polyethylene glycol maleimide or multi-arm varieties thereof (page 8 lines 26-33) wherein the polymer is crosslinked with crosslinking agents such as ethylene glycol bis-mercaptoacetate (claim 4). Although Ott et al. does not disclose a particular embodiment comprising all such elements, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Ott et al. as discussed above and to make the hydrogel microparticles of Ott et al. with multi-arm polyethylene glycol maleimide polymer and with ethylene glycol bis-mercaptoacetate crosslinking agent, with a reasonable expectation of success, which reads on the claimed hydrogel comprising the elected polymer backbone of multi-arm poly(ethylene glycol)-maleimide crosslinked with the elected first crosslinker of ethylene glycol bis(mercaptoacetate).
Regarding dependent claims 8-13 and 15-16, such claims merely further limit the polymer backbone and/or first crosslinker, and the teachings of Ott et al. read on such claims as discussed above regarding claim 1.
Regarding dependent claims 17-19, Ott et al. discloses that the polymer can be crosslinked with combinations of crosslinking agents including dithiothreitol (claim 4), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow such suggestions of Ott et al. as discussed above and to make the hydrogel microparticles of Ott et al. as discussed above further crosslinked with a second crosslinker of dithiothreitol (i.e., a hydrolytically stable crosslinker), with a reasonable expectation of success, which reads on the claimed polymer backbone further crosslinked with a second crosslinker which is hydrolytically stable comprising dithiothreitol.
Regarding dependent claim 21, Ott et al. discloses that the hydrogel microparticles a for delivery at a site of implantation (abstract), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow such suggestions of Ott et al. as discussed above and to make the hydrogel microparticles of Ott et al. as discussed above implantable, with a reasonable expectation of success, which reads on the claimed hydrogel being implantable.
Regarding dependent claim 22, Ott et al. discloses hydrogel microparticles (abstract), which reads on the claimed hydrogel being in the form of a microparticle.
Regarding dependent claim 23, Ott et al. discloses that the hydrogel microparticles comprise a therapeutically-effective amount of cells entrapped therein (abstract), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow such suggestions of Ott et al. as discussed above and to make the hydrogel microparticles of Ott et al. as discussed above with a therapeutically-effective amount of cells entrapped therein, with a reasonable expectation of success, which reads on the claimed hydrogel further comprising at least one cell.
Regarding dependent claims 29-30, Ott et al. discloses compositions containing the hydrogel microparticles which comprise a therapeutically-effective amount of cells entrapped therein (abstract), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow such suggestions of Ott et al. as discussed above and to make compositions containing the hydrogel microparticles of Ott et al. as discussed above with a therapeutically-effective amount of cells entrapped therein, with a reasonable expectation of success, which reads on the claimed therapeutic delivery composition comprising the hydrogel and one or more therapeutic agents such as cells.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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