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 .
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.
Response to Amendment
The amendment filed March 4, 2026 has been entered. Claims 84-89, 91-94, 96-100 have been amended, claims 1-83, 90, 95, and 101 have been cancelled, and claims 102-108 have been added. Applicant’s amendments to the claims have overcome objections to the claims, drawings and claims, and the 112(b), 112(d), and double patenting rejections over US 12,351,656 (cited in previous action) previously set forth in the Non-Final Office Action mailed October 15, 2025. Applicants cancellation of claims 90, 95, and 101 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed March 4, 2026 were fully considered but they were not persuasive. Maintained/modified rejections necessitated by Applicant’s amendment are addressed below.
Claims 84-89, 91-94, 96-100, and 102-108 are pending in this application.
Claim Interpretation
With respect to the claims, which are directed to a pharmaceutical composition and recites the phrase “dermal filler composition”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “dermal filler”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
The claims recite ”….wherein the in-vitro hyaluronidase degradation rate is slower than unmodified hyaluronic acid.”. Wherein the prior art teaches the derivative as claimed thereby anticipating the claim, this description is an inherent property of the compound. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)).
Modified/New Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 84-89, 91-94, 96-100, and 102-106 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gravett (WO 2019/046834, published March 7, 2019, international filing date September 1, 2018, IDS filed June 2, 2023).
Regarding claims 84-89, 91-94, 96-100, and 102-106: Gravett teaches a composition comprising a derivative of a polymeric polyhydric alcohol, e.g., hyaluronic acid (HA), wherein derivatives of a polymeric polyhydric alcohol may comprise the derivatives as disclosed above for polyhydric polymers (pg. 6, para. 0019). Gravett teaches that the polymers of the disclosure have hyaluronidase degradation rate that is the same as or less than that of hyaluronic acid that is not derivatized (pg. 62, para. 0188). For example, HA-(OCH2CH2SO2CH2CH2-X-R1-Y)n; (Y-R2-X-CH2CH2SO2CH2CH2O)m-HA-(OCH2CH 2S02CH2CH2-X-R1-Y)n; (CH 2=CH-SO2CH2CH2O )m-HA-(OCH2CH 2SO2CH2CH2-X-R1-Y)n; or (CH2=CH-SO2CH2CH2O)m-HA, where HA is hyaluronic acid or other polyhydric polymer, X is S or NH, R1 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, R2 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, and where applicable, wherein R1 and R2 are different from each other, Y is one or more of H, a carboxylic acid group or a salt or ester thereof, a hydroxyl group, a sulfonic acid group or a salt thereof, or an amine group; wherein n and m are each integers, and n ≥ 1 and m ≥ 1 A composition may further comprise an excipient (pgs. 6-7, para. 0019). Gravett teaches the reactions to produce the derivatives can involve different thiol containing compounds (pg. 24, para. 0083). Gravett teaches the preparation of a divinyl sulfone (DVS) modified HA wherein the hydroxyl substitution is about 25 % (i.e. DVS13, pg. 87-88, paras. 0272). Gravett teaches the production of a DVS modified HA with octanethiol, 2-mercaptobenzoic acid, or thiophenol (i.e. R1 is C8 aliphatic, benzene-COOH, benzene-OH, pg. 89, para. 0275, pg. 95, para. 0285, pg. 97, para. 0288). The substitution of the benzoic acid moiety was 10 % (pg. 95, para. 0285). Gravett teaches the HA can modified twice with 33% hydroxy substitution (i.e. R1 and R2 groups, pgs. 103, para. 0297-0298). Gravett teaches crosslinking of the modified HA derivatives (pg. 104, para. 0299, drawings, figure 2). Although Gravett does not explicitly teach an example wherein the R1 and R2 groups are different, wherein Gravett establishes the derivatives can contain the claimed R groups (i.e. aromatic, aliphatic), can be reacted twice, and states that the R1 and R2 are different to each other in other embodiments, a person of ordinary skill in the art can at once envisage the claimed arrangement based on the disclosure of Gravett (See MPEP 2131.02 (III)). Gravett teaches the derivatized polyhydric polymers and compositions can be used as dermal fillers (pg. 62, paras. 0188-0189). Gravett teaches the formulations can comprise saline (pg. 110, table 1). Gravett teaches In another aspect, the derivatized polyhydric polymers and compositions used as dermal fillers are in the form of particles of a crosslinked hydrogel (pgs. 62-63, para. 0189).
Claim Rejections - 35 USC § 103
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.
Claim(s) 84-89, 91-94, 96-100, and 102-108 are rejected under 35 U.S.C. 103 as being unpatentable over Gravett (WO 2019/046834, published March 7, 2019, international filing date September 1, 2018, IDS filed June 2, 2023) as applied to claims 84-89, 91-94, 96-100, and 102-106 above.
Regarding claims 84-89, 91-94, 96-100, and 102-106: As discussed above Gravett teaches the composition of claims 84-89, 91-94, 96-100, and 102-106 that can be used as dermal fillers. Even if assuming for the sake of argument, that Gravett does not specifically teach the claimed derivatives in a dermal filler composition, the claims would still have been rendered obvious over Gravett.
As discussed above, Gravett teaches the derivatized polyhydric polymers and compositions can be used as dermal fillers (pg. 62, paras. 0188-0189). Gravett teaches the formulations can comprise saline (pg. 110, table 1). Gravett teaches In another aspect, the derivatized polyhydric polymers and compositions used as dermal fillers are in the form of particles of a crosslinked hydrogel (pgs. 62-63, para. 0189).
Thus, it would have been prima facie obvious to utilize the compositions of Gravett as dermal fillers as Gravett explicitly states that this a known purpose for this class of compounds.
Regarding claims 107-108: As discussed above Gravett teaches/renders obvious the dermal fillers of claims 89 and 96.
Gravett does not explicitly demonstrate a derivative wherein the cross-linking agent is 1,4-butanediol diglycidyl ether.
However, Gravett teaches 1,4-butanediol diglycidyl ether (BDDE) is a suitable alternative for divinyl sulfone as a crosslinking agent.
Taken together it would have been prima facie obvious to modify the composition such that divinyl sulfone is replaced with BDDE as taught by Gravett. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as Gravett teaches BDDE as a suitable alternative crosslinking agent, and it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)).
Modified/New 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 84-89, 91-94, 96-100, and 102-108 rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 11,440,976 (cited in previous action) in view of Gravett (WO 2019/046834, published March 7, 2019, international filing date September 1, 2018, IDS filed June 2, 2023). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 84-89, 91-94, 96-100, and 102-106: Patented claim 1 teaches the following derivatives:
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. Patent claims 6-8 teach wherein in the process of preparing the polymers, 0.25-50% of the hydroxyl groups are modified. Thus, the claimed derivatives necessarily possess this feature. Patented claim 12 teaches wherein the polymer is crosslinked. Patented claim 12 teaches compositions comprising the hyaluronic acid polymer derivative and a pharmaceutically acceptable excipient. Thus, the hyaluronic derivatives instantly claimed are anticipated by the patent. Although the patented claims do not teach wherein the in-vitro hyaluronidase degradation rate is slower than unmodified hyaluronic acid, wherein the prior art teaches the derivative as claimed thereby anticipating the claim, this description is an inherent property of the derivative, absent evidence to the contrary. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)).
The patented claims do not teach wherein the composition is a dermal filler. They do not teach the formulations can comprise saline. They do not teach wherein the composition is in the form of particles.
However, Gravett teaches a composition comprising a derivative of a polymeric polyhydric alcohol, e.g., hyaluronic acid (HA), wherein derivatives of a polymeric polyhydric alcohol may comprise the derivatives as disclosed above for polyhydric polymers (pg. 6, para. 0019). Gravett teaches that the polymers of the disclosure have hyaluronidase degradation rate that is the same as or less than that of hyaluronic acid that is not derivatized (pg. 62, para. 0188). For example, HA-(OCH2CH2SO2CH2CH2-X-R1-Y)n; (Y-R2-X-CH2CH2SO2CH2CH2O)m-HA-(OCH2CH 2S02CH2CH2-X-R1-Y)n; (CH 2=CH-SO2CH2CH2O )m-HA-(OCH2CH 2SO2CH2CH2-X-R1-Y)n; or (CH2=CH-SO2CH2CH2O)m-HA, where HA is hyaluronic acid or other polyhydric polymer, X is S or NH, R1 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, R2 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, and where applicable, wherein R1 and R2 are different from each other, Y is one or more of H, a carboxylic acid group or a salt or ester thereof, a hydroxyl group, a sulfonic acid group or a salt thereof, or an amine group; wherein n and m are each integers, and n ≥ 1 and m ≥ 1 A composition may further comprise an excipient (pgs. 6-7, para. 0019). Gravett teaches the reactions to produce the derivatives can involve different thiol containing compounds (pg. 24, para. 0083). Gravett teaches the preparation of a divinyl sulfone (DVS) modified HA wherein the hydroxyl substitution is about 25 % (i.e. DVS13, pg. 87-88, paras. 0272). Gravett teaches the production of a DVS modified HA with octanethiol, 2-mercaptobenzoic acid, or thiophenol (i.e. R1 is C8 aliphatic, benzene-COOH, benzene-OH, pg. 89, para. 0275, pg. 95, para. 0285, pg. 97, para. 0288). The substitution of the benzoic acid moiety was 10 % (pg. 95, para. 0285). Gravett teaches the HA can modified twice with 33% hydroxy substitution (i.e. R1 and R2 groups, pgs. 103, para. 0297-0298). Gravett teaches the derivatized polyhydric polymers and compositions can be used as dermal fillers (pg. 62, paras. 0188-0189). Gravett teaches the formulations can comprise saline (pg. 110, table 1). Gravett teaches In another aspect, the derivatized polyhydric polymers and compositions used as dermal fillers are in the form of particles of a crosslinked hydrogel (pgs. 62-63, para. 0189).
Taken together, it would have been prima facie obvious to apply the composition of the patented claims as a dermal filler and formulate with saline in the form of particles as taught by Gravett. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compositions comprising these types of hyaluronic acid derivatives are known in the art to be suitable for this purpose.
Regarding claims 107-108: As discussed above the prior art and Gravett teaches/renders obvious the dermal fillers of claims 89 and 96.
The patented claims do not teach wherein the cross-linking agent is 1,4-butanediol diglycidyl ether.
However, Gravett teaches 1,4-butanediol diglycidyl ether (BDDE) is a suitable alternative for divinyl sulfone as a crosslinking agent.
Taken together it would have been prima facie obvious to modify the composition such that derivative crosslinked with BDDE as taught by Gravett. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as Gravett teaches BDDE as a suitable alternative crosslinking agent, and it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)).
Response to Arguments
Applicant’s arguments filed March 4, 2026 with respect to the claims have been fully considered but they are not persuasive.
On page 14 of Applicant’s response, Applicant argues the amended claims now recite the hyaluronic acid derivatives in a dermal filler composition when compared to current crosslinked unmodified hyaluronic acid based dermal fillers, which is not disclosed by Gravett (pg. 14, para. 2).
However, see modified 102 rejections above wherein Gravett teaches the compositions are useful as dermal fillers.
On page 14 of Applicant’s response, Applicant argues the amended claims overcome the double patenting rejections and should be withdrawn (last para.).
However, see modified/new double patenting rejections above which account for the newly amended claims.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 102 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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