DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group I in the reply filed on 7/14/2026 is acknowledged. The traversal is on the ground(s) the International Preliminary Report on patentability for International Patent Application No. PCT/EP2022/068119 did not find lack of unity. This is not found persuasive because lack of unity has been established and each case is evaluated on its own merits. The claims lack unity for the reasons set forth in the restriction mailed 5/5/2026.The Examiner reminds Applicant that should the product claims subsequently be found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-11 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/14/2026.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statement filed 12/21/2023 is acknowledged.
OBJECTION
3. Claim 12 is objected to because of the following informalities: Claim 12 depends on a claim that is withdrawn. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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 1-9 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 1 recites “high molecular weight” PEGDE. The term “high” in is a relative term which renders the claim indefinite. The term “high” 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 “high” is a subjective term. The same issues applies to claims 2 and 3. Claim 3 further recites “low molecular weight” which is also a subjective term as to what constitutes being low. The dependent claims do not cure the deficiency of claim 1.
Claim 9 recites the term “preferably” which renders the claim indefinite because it is not clear if the lidocaine is a limitation of the claim or not.
Claim Rejections - 35 USC § 103
5. 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 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.
Claims 1-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. WO 2019/005848 and Zhang et al. “Controllable properties and Microstructure of Hydrogels Based on Crosslinked Poly(ethylene glycol) Diacrylates with Different Molecular Weights”as evidenced by Monticelli et al. “Chemical Characterization of Hydrogels Crosslinked with Polyethylene Glycol Soft Tissue Augmentation”.
Altman et al. WO 2019/005848 (hereinafter Altman et al.) disclose a
biocompatible tissue filler composition comprising a glycosaminoglycan, hyaluronic acid
and lidocaine (anesthetic). Hyaluronic acid is crosslinked with a polyfunctional epoxy
compound polyethylene glycol diglycidyl ether (PEGDE) having an average Mn of 500,
1000, 2000, 6000 (page 1, lines 28-31, page 3, lines 15-31 to page 4, line 13). The average molecular weight of PEGDE correlates and overlaps with the average number of repetitive units (n) as claimed. The molecular weight of the hyaluronic acid can be between 5kDa and 5MDa. The hyaluronic acid is included at about 10 mg/ml. Altman et al. disclose the degree of crosslinking of the cross-linked HA is between about 1 % and 100 %.
Altman et al. does not explicitly state high and low molecular weight PEDGE however, as evidenced by Monticelli et al. “Chemical Characterization of Hydrogels Crosslinked with Polyethylene Glycol Soft Tissue Augmentation” disclose that commercially available PEGDE shows an average molar mass of 500 g/mol and is a mixture of several where n ranges from 2 to 15. The effective crosslinker ratio is 1 when all of the PEG is crosslinked among two HA chains.
With regards to claim 12, it is noted that the patentability of a product does not depend on the process of manufacturing. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe.
Altman et al. does not disclose weight ratio of high molecular weight PEG-DE crosslinker to the second low molecular weight PEGDE crosslinker of 95:5 to 5:95.
Zhang et al. “Controllable properties and Microstructure of Hydrogels Based on Crosslinked Poly(ethylene glycol) Diacrylates with Different Molecular Weights” (hereinafter Zang et al.) teach that the mechanical properties and cell viability of PEGDA hydrogels can be tailored and that changing the ratio of the low and high molecular weight components in a polymer blend can control the mechanical properties of the matrix. A 20/80 blend of the high to low molecular weight PEGDA provided a balance of mechanical strength and cell viability.
Zhang et al. disclose that PEGDE with blends of high and low molecular weight with different ratios and among them, equilibrium water contents, hydrophilicity, and mesh size of the hydrogels increased while the elastic moduli decreased when increased the PEGDA MW or the content of higher MW PEGDA in the blends. These results show the properties of PEGDA hydrogel could be easily adjusted by varying PEGDA MW or the ratios of low- and high-MW macromers in the composites. Zang et al. teach that the EWC of hydrogel decreased with increasing content of lower MW PEGDA macromers in blend where the PEGDA 400/2000 ratio was 10/50. The microstructure and properties such as water-absorbent ability, wetting property, mechanical property and transparency of the hydrogel were investigated, and were found to be dependent on the molecular weight and the weight ratio of the macromers in the composite. The higher the molecular weight or/and the higher ratio of the bigger macromer the hydrogel has, the lower the crosslinking density it gets, and then the lower the elastic modulus, the higher equilibrium water content and hydrophilicity are presented.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the ratio of the high and low molecular weight PEGDE. One would have been motivated to do so because the higher the molecular weight or/and the higher ratio of the bigger macromer the hydrogel has, the lower the crosslinking density it gets and then the lower the elastic modulus.
CORRESPONENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
