52652DETAILED 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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2026 has been entered.
Applicants’ arguments, filed 06/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 15-19 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.
The term “formulated” in claims 15-19 is a relative term which renders the claim indefinite. The term “formulated” 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. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. Specifically, the term configured suggests modification of the hyaluronic acid composition recited in claim 1, but neither the instant claims nor the specification disclose how the hyaluronic acid composition recited in claim 1 is modified. Thus, it is not clear how far from the hyaluronic tissue filler composition one can deviate and still meet the requirement of the claim. For the purposes of examination “formulated for use” will be interpreted as “capable of being used”.
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 (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.
Claims 1-5, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Oytun et al. (WO 2020/242420 A1, publication date 12/03/2020) and Belotero (Belotero, 04/10/2014 [retrieved 10/01/2025], https://www.merz.com/blog/news/belotero/), as evidenced by Belotero Hydro (Instructions for Use Belotero Hydro, 10/01/2025).
Oytun relates to hybrid hydrogel dermal fillers [title]. Specifically, Oytun discloses a filler comprising carboxymethyl cellulose and hyaluronic acid crosslinked with 1,4-butanediol diglycidyl ether (BDDE) [p. 20, lines 11-24]. Additionally, Oytun discloses adding “non-crosslinked hyaluronic acid to facilitate extrusion and lidocaine HCL to provide an anesthetic effect,” and adjusting the pH of the mixture to 7 [p. 21, lines 4-7].
Oytun does not disclose citric acid.
Belotero discloses that Belotero Hydro, which comprises non-crosslinked hyaluronic acid, is an effective dermal filler for targeted hydration and restoring radiance and elasticity [p. 1, first bullet point]. Such dermal fillers also comprise lidocaine for comfort [p. 1, second para.].
Belotero Hydro comprises a phosphate-citrate buffer (i.e., citric acid), as evidenced by Belotero Hydro on page 1 at the Composition section.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply used the non-crosslinked hyaluronic acid, lidocaine and pH adjuster of Belotero Hydro as dermal filler in Oytun, based on its suitability for its intended use as non-crosslinked hyaluronic acid dermal filler. One would have been motivated to incorporate the desirable effects of hydration and elasticity provided by Belotero Hydro. One would have had an expectation of success because the composition of Belotero Hydro is suitable for use as a dermal filler and comprises all the elements Oytun requires for the non-crosslinked phase (i.e., non-crosslinked hyaluronic acid, lidocaine and a pH adjuster). The skilled artisan would have used the Belotero Hydro dermal filler of Belotero to provide anesthetic effect and adjust pH with a reasonable expectation of success.
Belotero is silent concerning the concentration of tricarboxylic acid, i.e. citrate. However, it has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the composition taught by Oytun and Belotero to achieve the pH of 7, as desired by Oytun.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a tissue filler comprising a crosslinked phase and a non-crosslinked phase. Wherein the non-crosslinked phase comprises non-crosslinked hyaluronic acid, a phosphate buffer and a tricarboxylic acid (i.e., phosphate-citrate buffer) within the instantly claimed amounts, i.e., rheology affecting amount (instant claims 1, 4 and 5). Wherein the crosslinked phase comprises hyaluronic acid crosslinked with butanediol diglycidyl ether (instant claim 2). Wherein the non-crosslinked phase comprises hyaluronic acid and citric acid (i.e., phosphate-citrate buffer; instant claim 3). Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same intended use, i.e. instant claims 15-19.
Response to Arguments
1) On page 5 of their Remarks, Applicant argues the term “formulated” in claims 15-19 does not render the claims indefinite because “[t]he components of compositions for such uses [as recited in claims 15-19] are well known. When a composition is formulated for such a composition these components are present.”
The Examiner respectfully disagrees. The term formulated implies specific modifications to the compositions, i.e., the specific components for compositions of “such uses”. However, neither the claims nor the specification defines these modifications. Nor do the claims and specification define the specific components “for such uses” that are present in compositions when formulated “for such uses”. Accordingly, skilled artisan cannot apricate the metes and bounds of what is claimed.
2) On pages 6 and 7 of their Remarks, Applicant argues the instantly claimed “rheology-affecting amount” of a tricarboxylic acid “is considerably lower than the amount required for the buffering role played by citric acid” (see page 6 of Remarks) in the prior art. Specifically, Applicant argues that “[n]o indication is given of the amount of citrate present in the buffer but conventionally, it is present in amounts of 10--30%. This is considerably greater than the amounts required for rheological control, for which the present specification gives an example of 0.5% and in practice a range of 0.5- 2.0%, is normally used” (see page 7 of Remarks).
This argument is not persuasive. The instant claims define a rheology affecting amount of a non-toxic tricarboxylic acid as being “at least 0.5% tricarboxylic acid by weight” (see instant claim 4). Therefore, any amount of tricarboxylic acid above 0.5% w/w may be considered “rheology affecting”. Accordingly, the prior art may be considered to have a “rheology affecting” amount of citric acid even if the lower end of the claimed range “is considerably lower than the amount required for the buffering role played by citric acid” in the prior art.
Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., 0.5-2% w/w tricarboxylic acid) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, the assertion that a rheologic affective amount of a tricarboxylic acid is from 0.5 to 2% w/w does that range appear to be supported by the instant specification.
3) On page 7 of their Remarks, Applicant argues that “the hybrid hydrogel of Oytun is not a simple crosslinked hyaluronic acid as specified in the present claims.”
This argument is not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “simple crosslinked hyaluronic acid”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the present case, the claims recite “a hyaluronic acid gel that comprises a crosslinked phase …” at claim 1 and “wherein the crosslinked phase comprises hyaluronic acid crosslinked by butanediol diglycidyl ether” at claim 2. Importantly, both claims recite open claim language and so additional components, such as carboxymethylcellulose of Oytun, cannot be excluded from the claimed composition. Additionally, the Examiner will respectfully note that independent claim does not define the makeup of the crosslinked phase. Therefore, the crosslinked phase of Oytun reads on the crosslinked phase of the instant claims.
4) On page 7 of their Remarks, Applicant argues a skilled artisan “the amount of citrate used would have been to optimize its buffering properties” and that “[t]here is no motivation to try to optimize the concentration to improve its rheological properties.”
This argument is not persuasive. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the present case, a skilled artisan would have been motivated to optimize the amount of citrate in composition to reach the optimal pH discussed in Oytun (see Oytun at page 21, lines 4-7). Thus, even though it is for a different reason than the instant inventors, a skilled artisan would have nevertheless been motivated to optimize the amount of citric acid in composition. Furthermore, given the open-ended range of rheology affecting amount as defined by instant claim 4 (i.e., at least 0.5% w/w), any amount greater than or equal to 0.5% w/w tricarboxylic acid reads on the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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