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 .
Applicants’ arguments, filed 12/26/2025, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.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 – New by Amendment
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. 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 § 112 – New by Amendment
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.
Claims 15-19 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. Claims 15-19 do not recite any additional limitations and the tissue filler of claim 1 would have been expected to be capable of all the applications recited in claims 15-19. 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.
Claim Rejections - 35 USC § 103--Previous
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, 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 disclose 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.
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 Belotero Hydro is a ready to use dermal filler comprising 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 tricarboxylic acid and a phosphate buffer (i.e., phosphate-citrate buffer). Wherein the crosslinked phase comprises hyaluronic acid crosslinked with butandiol diglycidyl ether. Wherein non-crosslinked phase comprises hyaluronic acid and a tricarboxylic acid (citric acid) within the instantly claimed amounts. 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. claims 15-19.
Response to Arguments
1) On page 9 of their remarks, Applicant argues that premixed hyaluronic acid products are not designed to be combined with carboxymethylcellulose and that differences in ionic strength, excipient composition and rheologic behavior would result in instability or non-optimal viscosity profile.
This argument is not persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, a skilled artisan would have nevertheless had an expectation of success in combining the composition of Belotero with dermal filler of Oytun.
First, Oytun specifically desires non-crosslinked hyaluronic acid and lidocaine to facilitate extrusion for an injectable product and Belotero discloses an injectable product comprising non-crosslinked hyaluronic acid and lidocaine. Second, both Oytun and Belotero desire a pH of 7 (see Oytun at p. 21, line 6; see Belotero Hydro at Composition). Third, Oytun teaches the use of buffers (see, for example, Oytun at page 21, line 1) and discloses adding the non-crosslinked hyaluronic and lidocaine phase to the already crosslinked phase (see, for example, p. 20, line 27-p. 21, line 9).
Oytun also discloses the ratio of CMC in the crosslinked phase significantly impacts the complex viscosity [p. 17, lines 6-8]. Therefore, a skilled artisan would not have expected the addition of a composition comprising non-crosslinked hyaluronic acid, lidocaine and phosphate-citrate buffer to impact the complex viscosity of Oytun because one would not expect it to affect the crosslinking or ratio of CMC in the crosslinked phase. Rather, one would have expected the addition of a composition comprising non-crosslinked hyaluronic acid, lidocaine and phosphate-citrate buffer to adjust the extrusion force and facilitate extrusion [p. 21, line 5], which is important with respect to tissue damage [p. 17, lines 19-25].
2) On page 9 of their remarks, Applicant argues that a finished commercial hyaluronic acid formulation would prevent a skilled person from controlling critical parameters such as hyaluronic acid concentration, molecular weight, buffer composition and rheological properties. Applicant asserts these parameters are essential in Oytun for achieving the desired synergistic behavior between hyaluronic acid and carboxymethylcellulose.
This argument is not persuasive. Oytun does not appear to identify molecular weight of the non-crosslinked hyaluronic acid and buffer composition to be essential. Additionally, Oytun discloses the desired behavior of the tissue filler is the result of crosslinking hyaluronic acid and carboxymethylcellulose. Specifically, Oytun discloses the crosslinked hyaluronic acid carboxymethylcellulose tissue fillers achieve the rheological properties of highly crosslinked hyaluronic acid tissue fillers without the concomitant biocompatibility issue (see, for example, p. 7, lines 17-20). Oytun does not, however, disclose that the desired behavior is the result of interactions between crosslinked phase and the non-crosslinked phase. Rather, Oytun disclose the non-crosslinked phase is added after crosslinking to facilitate extrusion [p. 21, line 5], which is important with respect to tissue damage [p. 17, lines 19-25]. Therefore, a skilled artisan would have understood that the concentration of hyaluronic acid is only critical in the production of the crosslinked phase and that the amount of non-crosslinked hyaluronic acid added may be adjusted to facilitate extrusion.
3) On page 9 of their remarks, Applicant argues that a skilled artisan would not have used a product such a Belotero Hydro in the formulations disclosed by Oytun because it would undermine control of sterility, excipient identity, and manufacturing consistency.
This argument is not persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the present case, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the composition of Belotero Hydro as the non-crosslinked phase of Oytun for the reasons discussed above and not necessarily the product Belotero Hydro.
Conclusion
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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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612