DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 December 2025 has been entered.
This Office Action is in response to Applicant’s Amendment and Remarks filed on 04 December 2025 in which claim 9 was canceled, claims 5 and 11 were amended to change the scope and breadth of the claims. Claim(s) 5-8, 10-14 and 16-20 are pending in the current application and are examined on the merits herein.
The Declaration of Dr. Maria De Benedictis, submitted by Applicant on 04 December 2025 under 37 CFR §1.132 is acknowledged and will be further discussed below.
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 .
Withdrawn Rejections & Allowable Subject Matter
Applicant’s amendment, remarks and Declaration, filed 04 December 2025, with respect to the rejections of claims 5-14 and 16-20 under 35 U.S.C. § 103 as being unpatentable over Horibe et al. and Chen et al., and further in view of Njikang et al. and Bon Betemps et al., has been fully considered and is persuasive because the claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification.
Applicant has shown in the Declaration, the claimed PPE-crosslinked hydrogels show a statistically significant improvement in degradation rate compared to hydrogels crosslinked the prior art crosslinkers GDE, BDDE and PEGDE.
Applicant has shown that while the absolute degradation rate of the crosslinked polysaccharides decrease as storage modulus G’ increases, the claimed crosslinked polysaccharides exhibit a statistically lower degradation rate than the comparative products at each G’ value. This shows PPE exert a protective effect against both enzymatic and oxidative degradation.
Applicant has shown the same unexpected properties for polysaccharides including hyaluronic acid, starch and sodium carboxymethyl cellulose. Applicant has also shown preparing the crosslinked polysaccharide using crosslinkers having different MW and EEW and by using different concentrations of crosslinker. Thus, the present claims are commensurate in scope with the unexpected results.
The rejection is hereby withdrawn.
Objections
Claims 17 and 18 are objected to because of the following informalities: Appropriate correction is required.
The recitation “wherein the one or more of the crosslinked polysaccharides are a therapeutically effective amount” in claim 17 appears to be a typographical error. It appears Applicant meant to recite the polysaccharide is present in a therapeutically effective amount.
Claim 18 has a similar typographical error.
Claim Rejections - 35 USC § 112(b)
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.
Claim 20 is 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 20 depends from canceled claim 9. Thus, the metes and bounds of claim 20 is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 depends from claim 5, and claim 5 has been amended to require the composition to be in the form of a hydrogel. Therefore, it is understood that claim 5 is already directed towards a composition comprising one or more crosslinked polysaccharides and water, which can be interpreted as an excipient or carrier. Thus, it is not clear if the “one or more excipients or carriers”.
The claim could be amended to recite “the hydrogel composition further comprising…”. Alternatively, Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5-8, 10-14 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,329,856 (previously referred to as US 18/575,483). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘856 Patent is directed to crosslinking a hyaluronic acid (polysaccharide) with a hyperbranched polyglycerol polyglycidyl ether of formula (I) or formula (II), which are structurally almost identical and only differ in the range of integers of c and d. The present claim requires c and d are 1 to 70, while the reference application allows for c and d to range from 0 to 70.
The crosslinking percentage of the crosslinked HA of the reference application significantly overlaps with the ranges recited in the present claims. The MW and EEW of the crosslinker of the reference application is the same or similar to the ranges presently claimed.
The claims of the present application are prima facie obvious over the claims of the ‘856 Patent.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699