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 and 16-20) in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground(s) that search and examination of the subject matter of Group I would necessarily include consideration of the scope of at least Groups II-IV. This is not found persuasive because inventions I-VIII would require separate fields of search including different search queries. Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other inventions (e.g., employing different search queries), a different field of search is shown. See MPEP 808.02. This is sufficient to establish a serious search and/or examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 11/24/2025.
Response to Amendment
The amendment filed on 11/24/2025 has been entered. Claim(s) 1-7 is/are currently amended. Claim(s) 16-20 are new. Claim(s) 1-20 is/are pending with claim(s) 9-15 withdrawn from consideration. Claim(s) 1-8 and 16-20 is/are under examination in this office action.
Claim Rejections - 35 USC § 112
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 7 and 8 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.
Claim 7 recites “a macromer content in the composition is 1 to 30% by weight based on all macromers”. The composition contains only two macromers. Therefore, the total content of the two macromers should be 100%. If one macromer content is 1-30 wt%, the other macromer content should be 70-99 wt%. However, the specification seems to indicate equal amounts of the two macromers (see [P49L8-9 sepc.]). The real content of the two macromers cannot be determined from the claim.
The term “physiological conditions” in claim 8 is a relative term which renders the claim indefinite. The term “physiological conditions” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term does not have an accepted meaning in the art. The claims and specification do not even specify which species the conditions relate to.
As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06(II). Since the meanings and scopes of claims 7 and 8 are not clear, it is not proper to reject claims 7 and 8 on the basis of prior art.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (“Bone Marrow Mesenchymal Stem Cells Encapsulated in a Hydrogel System via Bioorthogonal Chemistry for Liver Regeneration”, ACS Appl. Bio Mater. 2019, 2, 2444−2452) in view of Liang et al (“A biocompatible condensation reaction for controlled assembly of nanostructures in living cells”, Nature chemistry, vol 2, January 54, 2010).
Regarding claim 1, Zhang teaches a process for producing a hydrogel comprising producing a composition comprising PEG-CBT and PEG-Cys in the presence of dithiothreitol (DTT), and reacting PEG-CBT and PEG-Cys via the functional groups to form a hydrogel [P2445 under “Preparation of GEG hydrogels” and P2446 Scheme 1].
PEG-CBT and PEG-Cys read on the claimed a1) macromer comprising at least two 1,2- or 1,3-aminothiol groups as functional groups and a2) macromer comprising at least two aromatic or heteroaromatic groups as functional groups, each of which are substituted by at least one cyano group, as evidenced by the applicant [Fig. 1a and P24L3-13, spec.].
DTT is a reducing agent containing a thiol group. Zhang does not teach the claimed a3) a reducing agent without thiol groups.
In the same field of endeavor, Liang teaches a process of forming hydrogels through condensation reaction between 2-cyanobenzothiazole (CBT) and cysteine (Cys) in the presence of reducing agents such as tris(2-carboxyethyl)phosphine (TCEP) [paragraph spanning p. 56-57; p. 57, col. 2, 2nd and 3rd full paragraph].
It is prima facie obvious to substitute equivalents for the same purpose where the equivalence is recognized by the prior art. See MPEP 2144.06. Since Zhang and Liang recognized DTT and TCEP are equivalent for the same purpose as a reducing agent for CBT and Cys condensation, it would have been obvious for one of ordinary skilled in the art at the time of filing to substitute DTT with TCEP in Zhang’s method.
TCEP reads on the claimed a3) a reducing agent without thiol groups, as evidenced by the applicant [P7L19-20, spec.].
Regarding claim 2, Zhang teaches molecular weight cut-off (MWCO) of 3500 (3.5KDa) for the PEG-CBT and PEG-Cys [P2445 under “Synthesis of CBT- and Cys-Modified 4-Arm PEG”], meeting the claimed less than 500 KDa.
Regarding claim 3, Zhang teaches that the PEG-CBT and PEG-Cys each has 4 functional groups [P2446 Scheme 1].
Regarding claim 4, the PEG-CBT and PEG-Cys are based on PEG.
Regarding claims 5-6, PEG-CBT meets the claimed formula (1), wherein Ar is benzothiazole.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Liang as applied to claim 1 above, further in view of Oldinski et al (US 20190314555 A1).
Regarding claims 16-19, Zhang in view of Liang teaches the process in claim 1. Zhang teaches that the macromer is based on PEG, but does not teach macromers based on poly(meth)acrylamides, poly(meth)acrylic acid, polyHPMA, polyHEMA, a block copolymer of ethylene oxide (PEG) and propylene oxide (PPG), agarose, chitin, chitosan, chondroitin, mannan, inulin, dextran, cellulose, polylysine, polyethyleneimine (PEI), collagens, VPM, albumin or fibrin.
Oldinski teaches hydrogels based on poly(acrylamide), PEG, poly(acrylamide), PEG-b-PPG-b-PEG copolymers, chitosan, agarose, collagen, etc. [0005]. Oldinski is in the same field of endeavor as Zhang for biomedical applications (e.g., tissue engineering) (Oldinski [0003], Zhang [abstract]).
It is prima facie obvious to substitute equivalents for the same purpose where the equivalence is recognized by the prior art. See MPEP 2144.06. Since Oldinski recognized PEG and poly(acrylamide), PEG-b-PPG-b-PEG copolymers, chitosan, agarose, collagen are equivalent for the same purpose of making the hydrogel, it would have been obvious for one of ordinary skilled in the art at the time of filing to substitute PEG with poly(acrylamide), PEG-b-PPG-b-PEG copolymers, chitosan, agarose, collagen in Zhang’s method.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Liang as applied to claim 1 above, further in view of Yang et al (“Bioactivation of 2‑(Alkylthio)-1,3,4-Thiadiazoles and 2‑(Alkylthio)-1, 3-Benzothiazoles”, Chem. Res. Toxicol. 2012, 25, 2770−2779).
Regarding claim 20, Zhang in view of Liang teaches the process in claim 1. Zhang teaches that the Ar is benzothiazole as stated above, but does not teach that the Ar is 1,2,3-thiadiazole, 1,2,4-thiadiazole, 1,2,5-thiadiazole or 1,3,4-thiadiazole.
Yang teaches modification of cysteine residues with compounds including both benzothiazole rings (similar to Zhang) and 1,3,4-thiadiazole rings [P2776, Fig. 8]. Benzothiazoles and thiadiazoles are both described as having diverse biological utilities leading to improved biological properties [P2770, Introduction].
It is prima facie obvious to substitute equivalents for the same purpose where the equivalence is recognized by the prior art. See MPEP 2144.06. Since Yang recognized benzothiazole and 1,3,4-thiadiazole are equivalent in reacting with cysteine, it would have been obvious for one of ordinary skilled in the art at the time of filing to substitute benzothiazole in Zhang’s PEG-CBT with 1,3,4-thiadiazole.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762