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 reply to Applicant’s Election (Response to Restriction Requirement) filed January 20, 2026.
Claims 1-20 are pending in the instant application.
Election/Restrictions
Applicant’s election (without traverse) of Group II (claims 16-20) in the reply filed on January 20, 2026 is acknowledged.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 16-20 have been examined on the merits as detailed below:
Priority
Acknowledgment is made of applicant's claim for foreign priority based on KR 10-2021-0092042 filed 07/14/2021. The certified copy has been placed in the file.
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed May 28, 2025 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.
Applicant’s IDS filed January 21, 2025 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.
Applicant’s IDS filed August 30, 2024 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.
Applicant’s IDS filed May 4, 2023 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.
Drawings
The Drawings filed on May 4, 2023 are acknowledged. The Drawings are objected to under 37 CFR 1.83(a) because they fail to show degeneration of filler samples as described in the Specification. See Figure 2. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 16 recites, “pH modifier”. The present Specification defines: “pH modifier” means a material used for regulating or stabilizing pH. The Examiner will interpret the term, “pH modifier” as recited in the claims to mean a pH modifier used for regulating or stabilizing pH.
Claim 19 contains a typographical error since it refers to "the method of claim 16". Claim 16 is a product claim. The Examiner will interpret the preamble of claim 19 to instead mean, “the filler of claim 16”.
Claim Rejections - 35 USC § 112
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.
Claim 17 is 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.
Claim 17 is rejected under 35 U.S.C. 112, second paragraph, as being incomplete for omitting essential steps, such omission not including parameters that strongly affects obtained measurements. See MPEP § 2172.01. In claim 17, "wherein the filler has a complex viscosity in a range of 0.3 Pa·s to 3 Pa·s when being measured with a rheometer" is incomplete since the Specification makes clear that the Pascal measurement (Pa·s) is only achieved at a temperature of 25°C. The present Specification provides no example of when the measurement result is achieved without the temperature parameter.
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 § 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 16, 18 and 19 are 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) (submitted and made of record on the Information Disclosure Statement filed May 4, 2023) (Google Translation attached).
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.
NUTRAPHARM discloses a dermal filler composition. The filler comprises dissolving DNA polynucleotides or polydeoxyribonucleotides in sterile distilled water followed by filtering the resulting solution through a 0.2μm pore filter. See Preparation of Skin Filler Compositions. This composition is further dried and mixed with phosphate-buffered saline and hyaluronic acid. See Preparation of Skin Filler Compositions. NOTE: Phosphate buffer saline is used to control the pH of the formulation.
The dermal filler composition of NUTRAPHARM is used for tissue repair and for wrinkle improvement. See claims and Experimental Example 2.
Therefore, claims 16, 18 and 19 are anticipated by NUTRAPHARM.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over KR 20190102967 A (NUTRAPHARM TECH COL TD (2019-09-04) (submitted and made of record on the Information Disclosure Statement filed May 4, 2023) (Google Translation attached).
The claims are as described above.
NUTRAPHARM is relied upon as described above.
NUTRAPHARM teach the dermal filler samples of their invention are injected into skin tissue. This is interpreted by the Examiner to include, embrace and encompass a pre-filled syringe.
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; 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 was known and taught in the prior art of NUTRAPHARM.
It would have been obvious and one of skill in the art would have been motivated to have the dermal filler sample of NUTRAPHARM comprised within a pre-filled syringe for the purpose of injecting skin tissue for a wrinkle improvement effect of skin.
Therefore, the subject matter of claim 20 is obvious over NUTRAPHARM.
******
Claims 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2407147 A2 (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 KR 20190102967 A (NUTRAPHARM TECH COL TD (2019-09-04) (submitted and made of record on the Information Disclosure Statement filed May 4, 2023) (Google Translation attached).
The claims are as described above.
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. Phosphate buffer is used to control the pH of the formulation (paragraph [0022]).
Mastelli teach suitable pharmaceutical forms for the compositions of their invention include pre-filled and disposable syringes.
Mastelli do not teach sterile filtering of the composition comprising hyaluronic acid and polynucleotides.
NUTRAPHARM is relied upon as discussed above. NUTRAPHARM particularly teach preparation of the dermal filler sample comprises dissolving DNA polynucleotides or polydeoxyribonucleotides in sterile distilled water followed by filtering the resulting sample through a 0.2μm pore filter.
The composition comprising hyaluronic acid and a mixture of polynucleotides of Mastelli is used for cosmetic treatment. While it is noted that the claims 18 and 19 recite, “wherein the filler is used for tissue repair” and “wherein the filler is used for reducing mild wrinkles or for facial contouring”, such is nothing more than an intended use. Applicant is reminded that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the dermal 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 taught and suggested by the combination of Mastelli in view of NUTRAPHARM meets the functionality reported in the present application, absent some evidence to the contrary.
Before the effective filing date of the claimed invention, a filler prepared by a method comprising: mixing a DNA fraction with a solvent to produce a solution and mixing hyaluronic acid and a pH modifier was known and taught in the prior art of Mastelli.
A person of ordinary skill in the art would have been motivated to modify the filler prepared by a method comprising: mixing a DNA fraction with a solvent to produce a solution and mixing hyaluronic acid and a pH modifier of Mastelli to include sterile filtration for the purpose of removing impurities and contaminants, such as bacteria from the filler for injectable use.
Therefore, the subject matter of claims 16 and 18-20 is obvious over Mastelli in view of NUTRAPHARM, absent some evidence to the contrary.
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.
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