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
Pursuant to the preliminary amendment dated 3/8/2023, claim 24 is cancelled, claims 1-23 and 25 are amended and claims 26 and 27 are newly added.
Claims 1-23 and 25-27 are pending in the instant application.
Applicants’ election with traverse for the invention of Group I drawn to a method of making a hydrogel, encompassing claims 1-14, in the reply filed on 2/6/2026 is acknowledged. Applicants’ election with traverse for the species of hyaluronic acid as the polysaccharide, BDDE and the crosslinker and GPTMS as the silanization agent, encompassing claims 1-7 and 9-14, in the reply filed on 9/6/2026 is acknowledged. The traversal is on the ground(s) that the restriction is improper because the art cited, Lee et al., to show lack of unity does not employ a crosslinking reagent within the claimed concentration range, thus Lee cannot be used to show that the groups of invention lack a special technical feature. This is not found persuasive because, the feature of a specific concentration range for a crosslinker is only found in Groups I and II. Since Groups III and IV do not recite a crosslinker concentration, this feature cannot be used to delineate a special technical feature. The unifying technical feature of Groups I thru IV is crosslinked hydrogel comprising a silane moiety and a crosslink different from said silane moiety, which is taught by Lee et al., hence this technical feature is not a special technical feature as it does not make a contribution over Lee et al. The requirement is still deemed proper and is therefore made FINAL.
Claims 15-23 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species.
Claims 1-7 and 9-14 will be examined on its 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.
Information Disclosure Statement
The information disclosure statements (IDS) dated 8/24/2023 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
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.
Claims 4 and 6 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation that Y is a polyvalent hydrocarbon group having a valence of “n”, where “n” equals the number of functional groups attached to the hydrocarbon chain provided n is at least 2. However, claim 4 then also recites that the hydrocarbon chain of Y can be optionally interrupted by one or more divalent groups, such as -O-. The optional addition of one or more divalent groups to the backbone of Y violates the limitation that the valency of Y must equal “n”, because whatever “n” is selected sets the valency condition for Y and the addition of more divalent groups to Y then alters the valency of Y which has already be set at the selected value. For instance, if “n” is selected as 3 then that means that there are three functional groups attached to Y and Y must have a valency of three, by claim definition. If one divalent group is added to the backbone of Y then the valency of Y is now 5, which violates the already defined valency of 3. Hence the metes and bounds of claim 4 are unclear in view of the optional replacement of methylene groups in the backbone of Y, by one or more divalent groups.
Claim 6 depends from claim 1 and recites the variables “Z1” and “Z2”. However, the variables “Z1” and “Z2” do not exist in claim 1, thus it is unclear what the variables “Z1” and “Z2” are modifying in claim 1. Note, that if it were under examination the same issue would exist for claim 8.
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 and 14 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, PTO-892).
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.
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, PTO-892), further in view of Sanchez et al. (Carb. Poly, 2019, PTO-892).
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.
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.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/DALE R MILLER/Primary Examiner, Art Unit 1693
Prosecution Insights