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 without traverse of Group III, claims 7-18 and 19-20, in the reply filed on 8/10/2026 is acknowledged.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/10/2026.
Priority
Acknowledgment is made of Applicant's claim for foreign priority based on an application filed in India on 1/7/2023. It is noted, however, that applicant has not filed a certified copy of the IN 202221063505 application as required by 37 CFR 1.55.
It is noted that there is a Request to Retrieve Electronic Priority Application filed on 11/30/2023 by the Applicant and a Failure Status Report mailed on 6/7/2024 by the Office. As of 9/5/2026, a copy of the foreign priority document is not on record.
Information Disclosure Statement
The information disclosure statement filed 11/30/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
In particular, no copy of any foreign patent documents have been provided and no copies of the Non-Patent Literature Documents cite No. 1, 6, 7 have been provided by Applicants.
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 8-10 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 8 recites a structure which contains the variables “o” and “n”. These variables are not defined, and thus the scope of the structure is unclear. Therefore, claim 8 and all dependent claims are indefinite.
It is noted that any amendment to this structure must have support in the original specification.
Allowable Subject Matter
Claims 7 and 11-20 are allowed.
Claims 8-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 7 recites a process of preparing a solution of methacrylated poly-multi-carboxylic acid polyethylene glycol, preparing a solution of maleated gelatin, mixing the two solutions to form a polymer solution, preparing a hydrogel from the polymer solution, and molding the hydrogel to obtain a biodegradable 3D composite hydrogel scaffold.
The closest prior art references are the following: (1) Wang (CN 108102112) (citations are made to the attached translation); (2) Yang (US 2021/0346576); (3) Sehl (US 2003/0119985); (4) Fu et al., “In situ forming poly(ethylene glycol)-based hydrogels via thiol-maleimide Michael type-addition,” Journal of Biomedical Research Matrials Part A, Volume 98A, Issue 2, Aug 2011, Pages 201-211; and (5) Hutson et al., “Synthesis and Characterization of Tunable Poly(Ethylene Glycol): Gelatine Methacrylate Composite Hydrogels,:” Tissue Engineering Part A, Volume 17, Issue 13-14, Jul 2011.
Wang teaches a process of forming a solution of maleated gelatin (¶ 11). Wang fails to teach mixing with a methacrylated poly-multi-carboxylic acid polyethylene glycol or forming a hydrogel, followed by molding of said hydrogel.
Yang teaches a process for 3D printing of biomedical devices (abstract) which includes methacrylated poly(diol citrate) (abstract). Yang teaches reacting dodecanediol with citric acid followed by reaction with glycidyl methacrylate (¶83-84, Fig. 22). Yang teaches the product includes forming stents which can be molded (¶46). Yang teaches the diol can include polyethylene glycol (¶ 53-54).
Yang fails to teach a process which includes mixing a methacrylated-citrate-PEG with maleated gelatin. It would not have been obvious, based on Yang, to include a step of mixing a methacrylated-citrate-PEG with maleated gelatin.
Sehl teaches a process where compositions of pentaerythritol PEG tetra-succimidyl glutarate are blended with gelatin particles (¶ 228, Table 6).
Sehl fails to teach the PEG is methacrylated and Sehl fails to teach the gelatin is maleated. Additionally, Sehl fails to teach forming solutions of these components.
Fu teaches a process of mixing a functionalized PEG in solution with a gelatin in solution to form a hydrogel (pg. 203). However, Fu fails to teach methacrylated PEG and instead teaches thiol and maleimide-endcapped PEG. Additionally, Fu fails to teach the gelatin is maleated.
Hutson teaches a process of forming hydrogels (abstract) where methacrylated gelatin is mixed with PEGDMA and cured to form a hydrogel (pg. 1715).
Hutson fails to teach the gelatin is maleated. Hutson further fails to teach the PEG contains a poly-carboxylic acid as required by the instantly claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to K. B BOYLE whose telephone number is (571)270-7338. The examiner can normally be reached 8:30 am to 5pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at (571) 272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K. BOYLE/Primary Examiner, Art Unit 1766
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