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 .
DETAILED ACTION
This Office Action is in response to Applicants’ Amendment and Remarks filed on 7/14/2026 in which claims 1, 2, 6, 8, 10, 11, 13 and 25 are amended and claim 28 is newly added. In addition, claims 8, 15-23 and 25-27 remain withdrawn as directed towards non-elected invention.
Claims 1-23 and 25-27 are pending in the instant application.
Claims 1-7, 9-14 and 28 are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/IB2021/000777, filed on 9/9/2021. The instant application claims foreign priority to FR 2009135, filed on 9/9/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 3/8/2023.
Withdrawn Rejections
Applicant’s amendment and response, filed on 7/14/2026, with respect to the rejection of claims 4 and 6 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant argued persuasively that the scope of claim 4 is clear. Applicant amended claim 6 to remove references to “Z1” and “Z2”. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 7/14/2026, wherein instant claim 28 is newly added. Therefore, rejections from the previous Office Action have been modified.
Modified Rejections
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7, 9-12, 14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee at al. (reference of record), in view of Jang et al. (US 2021/0290819A1, field 2019, reference of record).
Lee et al. discloses a process for preparing a hydrogel by combining 200 mg of hyaluronic acid of molecular weight ~2 MDa with 15 µL BDDE crosslinker and 15-45 µL GPTMS silanization agent, in an aqueous alkali solution, which was allowed to react for two days at 25°C. The hydrogel product isolated formed due to concomitant crosslinking of BDDE with HA and formation of siloxane linkages due to sol-gel chemistry of the silane groups. (Sec. 2.1, 2.2, 3.1; Figure 1) The reaction of Lee results in BDDE being present initially at 16.3 mol% per mol of HA repeat units and GPTMS being present initially at 13.6-40.8 mol% per mol of HA repeat units. Lee further discloses that the hydrogel product is effective as a drug delivery vehicle and is suitable for further investigation on modifying hydrogel properties for injection administration. (Abstract; Sec. 4)
Lee et al. does not teach that the crosslinker is present initially at 0.05-10 mol% per mol of HA repeat units.
Jang et al. discloses a crosslinked hyaluronic acid hydrogel, having low injection force, prepared by crosslinking HA with BDDE in aqueous alkali, where the BDDE was initially present at 1-10 mol% per mol of HA repeat units, prior to the crosslinking reaction. (¶0047) Jang also discloses that the method of preparing the hydrogel may further comprises treating the hydrogel with a buffer containing an anesthetic, such as lidocaine, such that the hydrogel acts as an anesthetic delivery vehicle. (¶0060)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel preparation method of Lee, by lowering the amount of crosslinker initially present to the range 1-10 mol%, thereby arriving at the instant invention. One would be motivated to modify Lee in this manner because Lee teaches that the hydrogels therein are suitable for further investigation as injectable hydrogels for drug delivery or other biomedical applications and Jang provides teaching that HA-BDDE hydrogels prepared with the BDDE crosslinker initially present at 1-10 mol% yield hydrogels with low injection force. Thus, modifying the method of Lee with the BDDE initial concentration range of Jang would serve to fulfill the suggestion of Lee for investigating the HA-GPTMS hydrogels crosslinked with BDDE, as suitable injectable hydrogels for drug delivery.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Lee/Jang, has been fully considered but is not persuasive.
Applicant argues that the working examples, particularly prototype 4, shows that when a low amount (2.2%) of initial BDDE crosslinker is used, combined with GPTMS at 12%, that the resulting hydrogel exhibits desired mechanical properties. In contrast, prototype 12 where BDDE is present at 2.1% and GPTMS is absent, the hydrogel does not exhibit desired mechanical properties. Applicant argues that this observation of desired mechanical properties is not recognized by Lee/Jang. Applicants’ argument is not persuasive because there is no data in the specification comparing a hydrogel prepared with BDDE at 0.05-10% with GPTMS and a gel prepared with BDDE at about 16% with GPTMS. Such a comparison would allow POSITA to determine if the instant gels are unexpectedly different from those of the closest prior art of Lee. The comparison of prototype 4 to prototype 12 is not a proper side-by-side comparison to the prior art because prototype 12 lacks GPTMS. It is well-settled that the evidence including a comparison with the closest prior art is one of elements to be considered as unexpected results (see for example, In re Merchant, 575 F.2d 865, 869, 197 USPQ 785, 788 (CCPA 1978), which is provided either in the specification or an affidavit or declaration submitted during prosecution on the issue.
Applicant further argues that the teaching in Lee for investigation into injectable hydrogels, does not provide a sufficient suggestion to look to Jang for a means of modifying Lee by reducing the amount of BDDE. Applicant argues that Lee is primality directed towards more solid-like gels and one would not have a reasonable expectation of success in modifying Lee by reducing the crosslinker content, in order to achieve an injectable hydrogel. Applicants’ argument is not persuasive because Applicant underplays the teaching of Lee as, “Such a generalized statement does not provide a specific technical teaching as to how Lee's process should be modified to obtain an injectable hydrogel, much less a teaching to reduce the BDDE concentration to the claimed range while retaining GPTMS”. Lee does not only provide a generalized suggestion to investigate injectable hydrogels. Lee states that, “The system is now ready for coupling with dissimilar materials via sol–gel condensation and is thus expected to serve as a great building block for biomedical applications. Our findings will provide insight into the hydrogel structure–property relationships, which will be beneficial for tailoring of the biomechanical properties for specific applications.” Lee further teaches that silanization agents such as GPTMS can be employed as reversible bonding agents utilized for an injectable hydrogel framework. (Sec 1) Taken as a whole, the disclosure of Lee provides proof-of-concept that HA hydrogels crosslinked with BDDE and functionalized with GPTMS are a beneficial material for biomedical applications, which are suitable for modification and tailoring to various applications, specifically injectable hydrogels. Moreover, it is well established in the art of HA hydrogels that altering the amount of crosslinker, of which BDDE is a flagship member, has direct correlation with degree of crosslinking, and hydrogel mechanical and rheological properties, including injectablilty. The teaching of Jang is representative of this well-known means for modifying HA hydrogel injectability and provides specific guidance on adjusting the amount of BDDE in the range 1-10 mol%. Based on the disclosure of Lee as-a-whole and the mature status of the HAA hydrogel art with respect to adjusting hydrogel properties by modifying crosslinker amount, as represented by Lee, the claims are obvious over the collective prior art.
The rejection is still deemed proper and is maintained.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lee at al. (reference of record), in view of Jang et al. (US 2021/0290819A1, field 2019, reference of record), further in view of Sanchez et al. (Carb. Poly, 2019, reference of record).
The disclosure of Lee/Jang is referenced as discussed above. Lee/Jang does not teach the addition of an additional silane, having the instant formula Chem III, after crosslinking and silanization.
Sanchez et al. discloses a process for preparing crosslinked HA silanized with APTES (3-aminopropyltriethoxysilane) by addition of TEOS (tetraethylorthosilicate) and/or PDMS (polydimethylsiloxane), such that the HA bound APTES forms crosslinks via sol-gel chemistry with the added TEOS. (p. 4, Col. 1; Figure 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Lee/Jang could be modified to prepare a hydrogel where during the sol-gel reaction, a reagent such as TEOS is added to modify the formation of siloxane linkages, thereby modifying the properties of the final hydrogel. One would be motivated to modify Lee/Jang in this manner because Sanchez discloses that the properties of hydrogels formed from silanized HA can be modified by the addition of TEOS and or PDMS, to change the nature of the siloxane crosslinks.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 of the instant application is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of copending application 18/857049. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method of ‘049 anticipates the instant method.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicants’ response with respect to the provisional double patenting rejections has been fully considered.
Applicant responds to the provisional double patenting rejections requesting that the rejections be held in abeyance should patentability hinge on the double patenting rejections alone. Applicants’ request is improper because filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary to overcome a provisional obvious type double patenting rejection. Obvious type double patenting rejections may not be held in abeyance because they are not related to objections or requirements “as to form”. (MPEP § 804) The rejection is still deemed proper and maintained.
Conclusion
No claims are allowed.
Applicants’ amendment necessitated the new and/or modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
