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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 08/18/2025; and IDS filed on 04/20/2022.
Claims 1-9, 12, 14-23 are pending in the instant application.
Claims 14-23 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-9, 12) in the reply filed on 08/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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) 1-9, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over TANG et al (Adaptable Fast Relaxing Boronate-Based Hydrogels for Probing Cell–Matrix Interactions. Adv. Sci. 2018, 5, 1800638 pg. 1-8) in view of SRIDHAR et al (WO 2017/210009).
Regarding claims 1-2, TANG teaches a method of cell encapsulation that can recapitulate many dynamic mechanical properties found in native tissues (see abstract) for applications in tissue engineering and regenerative medicine (see pg. 1, 1st col), which reads on stabilizing a therapeutic agent, such as cell therapy, comprising of: octa-arm PEG polymers (see pg. 2, 2nd col), which reads on multi-arm polyethylene glycol, boronate-based hydrogel for encapsulating cells (see abstract), such as human mesenchymal stem cells, by mixing in phosphate buffer (see pg. 3, 1st col) boronic acids and ciss-1,2-diols functionalized octa-arm PEGs (see pg. 2 at Fig. 1), wherein crosslinking is formed between the phenylboronic acids and cis-2-diols (see pg. 2, 1st col; and Figs. 1a and 1b) and are reversible bonds (see pg. 3, 1st col), which reads on Applicant’s dynamic polymeric hydrogel composition comprising a combination of: a phenylboronic acid (PBA) modified multi-arm polyethylene glycol (PEG) polymer backbone of formula (I) and a 1,2-diol modified multi-arm polyethylene glycol (PEG) polymer backbone of formula (II) and are reversibly covalently cross-linked through the phenylboronic acid derivative and the 1,2-diol groups.
Regarding claims 3-5, TANG teaches FPBA (see pg. 2, Fig. 1a), which has a fluoro on the phenylboronic acid ring.
Regarding claims 6-8, TANG teaches the cis-1,2 diols (see pg. 2, Fig. 1a).
Regarding claim 9, as discussed above, TANG teaches mixing the therapeutic agent with the solutions of 1,2-diol of formula (II) and PBA of formula (I), but does not explicitly teach putting the therapeutic agent with the solution of 1,2 diol of formula (II). However, it would have been obvious to one skilled in the art to mix the therapeutic agent either with the solution of 1,2-diol of formula (II) or solution of PBA of formula (I), because any of those two solutions would have been capable of carrying therapeutic agent before crosslinking the solutions into a hydrogel.
Regarding claim 12, as discussed above, TANG teaches encapsulating cells (see abstract), such as human mesenchymal stem cells, for tissue engineering and regenerative medicine (see pg. 1, 1st col), which reads on a therapeutic agent, such as cell therapy.
TANG further teaches viscoelasticity can substantially impact cellular response (see pg. 1, 2nd col), wherein the viscoelastic properties can be tuned by changing the small-molecule structure and properties (see pg. 7, 2nd col); form bonds near physiological pH by lowering the pKa of boronic acids (see pg. 2, 2nd col), wherein physiological pH is about 7.4 and would read on pKa of the phenylboronic acid group is about 7; varying concentration of different boronic acids (see pg. 3, 2nd col); other types of bonds can be added, such as end groups having azide-alkyne cycloaddition for permanent bonds (SPAAC; see pg. 4, 1st col; and Fig. 3).
TANG does NOT specifically teach the length of PEG polymer, such as having units of a, a’, b, b’, c, c’, d, and d’ from 10 to 250, as claimed by Applicant; or the amount of phenylboronic acid or 1,2-diol as claimed by Applicant, such as m1 and m2.
SRIDHAR teaches the prior art has known of making hydrogels (see [0005) for stabilizing bioactive therapeutics (see abstract) by using multi-arm PEG backbones, such as 4-arm and 8-arm backbones (see [0021]), which has repeating units of about 1-200 (see [0022] and especially at [0055]), wherein the structure of the 4-arm PEG at [0055] is shown below:
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, wherein the repeating units of a, b, c, and d can be 150 (see [0055]), which reads on Applicant’s a, a’, b, b’, c, c’, d, and d’. Additional disclosures include: the reactive end groups use click reactions (see [0020]), such as azide-alkyne cycloaddition (SPACC; see [0022]), which is one of the other reactive end groups taught in TANG for making hydrogel, as discussed above.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the 4-arm PEG as taught by SRIDHAR. The person of ordinary skill in the art would have been motivated to make those modifications, because the 4-arm and 8-arm PEG groups were well-known to be used to make hydrogels, and reasonably would have expected success, because both references dealt in the same field of endeavor, such as hydrogels.
The references do not specifically teach the numbers of repeating units, such as m1 and m2, as claimed by Applicant. The number of repeating units in a polymeric hydrogel composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal number of repeating units to add in order to best achieve the desired results, such as the size of the hydrogel. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of the numbers of repeating units in a polymeric composition would have been obvious at the time of Applicant's invention.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618