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
This Office Action is a response to Applicant’s Amendment and Remarks filed May 11, 2026.
Claim 17 has been canceled. Claims 16, 19 and 20 have been amended.
Claims 1-16 and 18-20 are pending in the present application.
This application contains claims 1-15 drawn to an invention nonelected without traverse in the reply filed January 20, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
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.
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed June 22, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
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 February 12, 2026, the Drawings were objected to under 37 CFR 1.83(a) because they fail to show degeneration of filler samples as described in the Specification. This objection is maintained for the reasons of record set forth in the previous Office Action mailed February 12, 2026.
Response to Arguments
In response to this objection, Applicants submitted Corrected Drawing Sheets and a Petition to Accept Color Drawings in their response filed May 11, 2026. The Examiner is not clear how the Corrected Drawing Sheets actually show degeneration of filler samples as described in the Specification. Also, a Petition to Accept Color Drawings was filed, however, the instant Specification does not appear to reference any colors in the Figures.
The present Specification discloses:
Specifically, whether the filler of Example 2 and the filler samples of Comparative Examples 4 to 6 were degenerated or not was examined through comparison immediately after the respective preparations and leaving each of the filler samples at a temperature of 35° C. for 2 weeks. The results thereof are shown in FIG. 2. As confirmed in FIG. 2 (b), the filler sample of Comparative Example 4 degenerated when two weeks elapsed. In addition, the filler samples of Example 2 and Comparative Examples 5 and 6 did not degenerate.
The Examiner maintains that the structural detail in Figure 2 is essential for a proper understanding of the disclosed invention. See MPEP § 608.02(d). For example, what is the measurement of degeneration? Is it a particular color monitored? Or some visual measure like clarity or density? Correction is required.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed February 12, 2026, claim 17 was 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 pre-AIA the applicant regards as the invention. This rejection is moot in view of Applicant’s Amendment filed May 11, 2026 to cancel claim 17.
Claim Rejections - 35 USC § 102
In the previous Office Action mailed February 12, 2026, claims 16, 18 and 19 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 20190102967 A (NUTRAPHARM TECH COL TD (hereinafter, “NUTRAPHARM”) (2019-09-04), This rejection is withdrawn in view of Applicant’s Amendment to the claims filed May 11, 2026. It should be noted that NUTRAPHARM does not teach, 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. See last column of Figure 3 of NUTRAPHARM below:
PNG
media_image1.png
254
708
media_image1.png
Greyscale
Claim Rejections - 35 USC § 103
In the previous Office Action mailed February 12, 2026, claim 20 was rejected under 35 U.S.C. 103 as being unpatentable over KR 20190102967 A. This rejection is withdrawn in view of Applicant’s Amendment to claim 20 filed May 11, 2026. It should be noted that NUTRAPHARM does not teach, 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. See last column of Figure 3 of NUTRAPHARM supra.
******
In the previous Office Action mailed February 12, 2026, claims 16 and 18-20 were rejected under 35 U.S.C. 103 as being unpatentable over EP 2407147 A2 (Mastelli et al. (hereinafter, “Mastelli”) in view of KR 20190102967 A (NUTRAPHARM TECH COL TD (NUTRAPHARM TECH COL TD (hereinafter, “NUTRAPHARM”). This rejection is withdrawn in view of Applicant’s Amendment to the claims filed May 11, 2026. It should be noted that Mastelli does not teach, 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. In fact, Mastelli does not reference complex viscosity at all in their Disclosure.
Applicant's Amendment filed May 11, 2026 necessitated the new ground(s) of rejection presented:
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.
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 U.S. Patent No. 10456347 (submitted and made of record on the Information Disclosure Statement filed August 30, 2024) in view of WO 2013/185934 A1 to Merz Pharma GmbH and Co KGaA (hereinafter, “Merz”).
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 hyaluronic acid 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 filled comprising said filler.
U.S. Patent No. 10456347 is relied upon in its entirety and teach a filler prepared by a method comprising: a) mixing a DNA fraction with a solvent to produce a solution, and (b) mixing hyaluronic acid and a pH modifier, 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.
For example, see Example 2 of U.S. Patent No. 10456347, wherein hyaluronic acid (molecular weight: about 2 million to 3 million Da) was mixed with NaOH solution of 0.25N, to 10 wt %, and 1,4-butanediol diglycidyl ether was added with amount of degree of crosslinking of 5%, and crosslinked in the constant temperature water bath. The hyaluronic acid-based PDRN complex gel containing 1.875 mg/ml of PRDN was prepared by adding PDRN fractions (12.5 mg/mL) dissolved in physiological saline solution of 15 wt % to the crosslinked gel. Further, the gel was prepared by adding 20 mg/mL of HA (molecular weight: 0.8 million to 1 million Da) to the gel prepared with the method of Example 2, to 15 wt %. See Example 5. NOTE: Example 5 has a complex viscosity 0.9 Pa·s at a temperature of 25°C when being measured with a rheometer. See Table 1 below and Analysis Conditions of the Rotational Rheometer:
PNG
media_image2.png
388
576
media_image2.png
Greyscale
U.S. Patent No. 10456347 also teach a prefilled syringe of the filler composition/solution according to their invention.
U.S. Patent No. 10456347 further teach the filler composition/solution of their invention is used in a method for repair or biological tissue or filling wrinkles.
U.S. Patent No. 10456347 does not necessarily teach removing bacteria from the filler composition/solution of their invention using a sterile filter.
Merz teach a method of preparing a composition based on 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, a filler prepared by a method comprising: a) mixing a DNA fraction with a solvent to produce a solution, and (b) mixing hyaluronic acid and a pH modifier, 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 was known and taught in the prior art of U.S. Patent No. 10456347.
It would have been obvious and one of skill in the art would have been motivated to modify the teachings of U.S. Patent No. 10456347 to include removing bacteria from the filler composition/solution using the sterilization process of Merz for the purpose of using the filler composition/solution for tissue repair in the skin.
Therefore, the subject matter of claims 16 and 18-20 is obvious over U.S. Patent No. 10456347 in view of Merz.
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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO's Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO's Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO's PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/TERRA C GIBBS/
Primary Examiner, Art Unit 1635
Prosecution Insights