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
Request for Continued Examination Under 37 CFR 1.1143
A request for continued examination (RCE) 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 mailed on October 2, 2026 has been entered.
Claims 1-16 and 18-20 are pending in the instant application. Claims 16 and 20 have been amended.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 20, 2026.
Accordingly, claims 16 and 18-20 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Arguments
Applicant's Amendment and Response filed October 2, 2026 has been considered. Communications, rejections and/or objections not reiterated from the previous Office Action mailed July 6, 2026 are hereby withdrawn. Any arguments addressing said rejections and/or objections are moot. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Petition to Accept Color Drawings
Applicant’s Petition to Accept Color Drawings filed May 11, 2026 is acknowledged. Approval of the Petition is PENDING.
Drawings
In the previous Office Action mailed July 6, 2026, the Drawings were objected to under 37 CFR 1.83(a) because they failed to show degeneration of filler samples as described in the Specification. This objection is withdrawn in view of Applicant’s Amendment to the Specification filed October 2, 2026 to further clarify turbidity in Figures 2(a) and 2(b).
Claim Rejections - 35 USC § 103
In the previous Office Action mailed July 6, 2026, claims 16 and 18-20 were rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10456347 in view of WO 2013/185934 A1. This rejection is withdrawn in view of Applicant’s Amendment to the claims and Applicant’s Remarks filed October 2, 2026.
Applicant's Amendment filed October 2, 2026 necessitated the new ground(s) of rejection presented:
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.
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 pre-AIA 35 U.S.C. 103(a) 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.
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.
Claims 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2407147 A2 to Mastelli et al. (hereinafter, “Mastelli”) (2012-01-08) (submitted and made of record on the Information Disclosure Statement filed May 4, 2023) in view of WO 2013/185934 A1 to Merz Pharma GmbH and Co KGaA (hereinafter, “Merz”) (submitted and made of record in the Office Action filed July 6, 2026).
The claims are drawn to a filler prepared by a method comprising: a) mixing a DNA fraction with a solvent to produce a solution; b) removing bacteria from the produced solution using a sterile filter; and c) mixing non-crosslinked hyaluronic acid (HA) and a pH modifier with the bacteria-removed solution, wherein the filler has a complex viscosity in a range of 0.3 Pa·s to 3 Pa·s at a temperature of 25°C when being measured with a rheometer. The claims are also drawn to a pre-filled syringe comprising said filler. NOTE: The Specification discloses that to increase the chemical and structural stability of HA and maintain its physicochemical properties in vivo for a long term, a method of stabilizing HA with the addition of a cross-linking agent is used. Particular cross-linking agents (e.g. 1,4-butanediol diglycidyl ether (BDDE) and divinyl sulfone (DVS) are disclosed ([0040]). The non-crosslinked HA used in Applicant’s invention is sodium hyaluronate (molecular weight: 700 kDa to 1,200 kDa). See Preparation of Example 2.
Mastelli is relevant and relied upon in its entirety. Mastelli discloses a composition comprising hyaluronic acid and polynucleotides (claim 1) for use in tissue repair or cosmetic (paragraph [0001]). In this example, the hyaluronic acid is not crosslinked. See below for further explanation:
More specifically, Mastelli teaches a composition comprising hyaluronic acid and polynucleotides that are preferably DNA ([001], [0015]). The hyaluronic acid is used as such or as a sodium salt, with a molecular weight of 500 to 3000 kDa ([0013]-[0014]). NOTE: This molecular weight falls within the size range of the non-crosslinked HA used in Applicant’s invention. Further, no crosslinking agent or crosslinking step is disclosed by Mastelli. The Examiner is therefore interpreting the hyaluronic acid of Mastelli as non-crosslinked.
In the Mastelli invention, phosphate buffer is used to control the pH of the formulation (paragraph [0022]). Mastelli teaches injectable formulations ([0022]) supplied in pre-filled syringes ([0047]), administered by subcutaneous instillation (claim 3), for bioregeneration of the skin, including skin folds ([0046]). The injectable formulations of Mastelli are used as an application of a cosmetic on the face, for example.
Mastelli further teaches that HA and DNA polynucleotides act synergistically; the polynucleotides increase fibroblasts and extracellular protein, while the HA acts in a hydrating function and facilitates cell migration in tissue ([0043]).
Mastelli does not teach the complex viscosity of the compositions of their invention, however, it should be understood that any underlying mechanism of action would naturally flow and be inherent to the presence of the HA in the DNA comprised injectable composition of Mastelli. See MPEP 2112 as it relates to inherency.
Furthermore, the instant specification serves as evidence of record establishing this inherency. Failure of those skilled in the art to contemporaneously recognize an inherent property (i.e. a biological mechanism of action) of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999). See also Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993).
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine that the HA/DNA injectable composition of Mastelli has a complex viscosity in a range of 0.3 Pa·s to 3 Pa·s at a temperature of 25°C when being measured with a rheometer as presently claimed. In the absence of evidence to the contrary, the burden is upon the Applicant to prove that the presently claimed non-crosslinked HA/DNA filler composition is any different from the non-crosslinked HA/DNA injectable composition taught and suggested by the prior art of Mastelli such that composition of the prior art cannot have the intended use/functionality, thereby establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd. Pat. App. & Int. 1989).
The Examiner has provided sound basis in fact and technical reasoning that reasonably supports the determination that the allegedly inherent characteristic necessarily flows from what has been specifically disclosed within the prior art and has shifted the burden to Applicant to provide evidence to the contrary.
Furthermore, Merz teaches an injectable non-crosslinked HA composition. Merz teaches the non-crosslinked HA improves flow through a syringe needle. Merz teaches that the composition of their invention is an injectable dermatological filler to increase the volume of skin tissue. Merz teach the injectable fillers comprising non-crosslinked HA have a complex viscosity (𝜂*) of 2,000 to 200,000 mPa·s (i.e. 2 to 200 Pa·s) at 0.7 Hz and 25° C.
Merz also teach a method of preparing a composition based on non-crosslinked hyaluronic acid comprising sterilization methods that eliminates, removes or kills all forms of microbial life. The sterilization method includes the use of a sterile filter.
Before the effective filing date of the claimed invention, an injectable filler composition having a synergistic effect comprising polynucleotides and hyaluronic acid for use in cosmetic applications was known in the art. It would have been obvious to a person of ordinary skill in the art to formulate Mastelli’s HA/DNA composition as a filler using Merz’s non-crosslinked HA composition so that the composition has a complex viscosity in the range of 0.3 Pa·s to 3 Pa·s as claimed in the present invention for the purpose of hydration and improving flow through a syringe needle during the cosmetic application process.
The skilled artisan would have been motivated and expected reasonable success because both references concern injectable HA compositions for the skin treatment and Mastelli teaches that DNA polynucleotides work together with HA in a synergistic manner. The complex viscosity of Merz’s injectable filler composition comprising non-crosslinked HA overlaps the claimed range of 0.3 Pa·s to 3 Pa·s, further establishing a prima facie case of obviousness. See MPEP 2144.05(I).
Therefore, the subject matter of claims 16 and 18-20 is obvious over Mastelli in view of Merz.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/
Primary Examiner, Art Unit 1635
