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 .
Status of the Claims
Claims 1, 3-8, and 10-22 are pending and under current examination. Claims 2 and 9 are cancelled.
Withdrawn Claim Objections and Rejections
All objections pertaining to claim 1 are withdrawn in view of the amendments to the claims filed 3/13/2026.
All rejections pertaining to claims 2 and 9 are moot because the claims are cancelled in the amendments to the claims filed 3/13/2026.
The rejections of claims 3, 7, 8, 10, and 13 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 3/13/2026.
All rejections under 35 U.S.C. 102 are withdrawn in view of the amendments to the claims filed 3/13/2026.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s amendments to the claims filed 3/13/2026 have necessitated the new grounds of rejection.
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 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation “an effective amount of HEPES and PDRN for skin improvement”. The term “effective amount of HEPES and PDRN for skin improvement” is a relative term which renders the claim indefinite. The terms “effective amount of HEPES and PDRN for skin improvement” 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. With no guidance provided as to what skin improvement effect is to be rendered by the effective amount, it is impossible to discern the metes and bounds of the claim.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 3/13/2026 have necessitated the new grounds of rejection.
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.
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 1, 3-8, and 10-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ornaghi (EP 2745849, publication date: 6/25/2014, of record), in view of Yacoo Science (available 4/29/2020, of record), Majmudar (U.S. Patent Application No. 2005/0123499, publication date: 6/9/2005, of record), INCI Decoder-Copper Tripeptide-1 (available 9/15/2020, of record) and INCI-Decoder-Acetyl Hexapeptide-8 (available 8/13/2017, of record), as evidenced by Bloomage Biotech (PDRN Polydeoxyribonucleotide, available 4/2021, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1, 3-8, 10-12, 15, and 20, Ornaghi teaches a composition comprising PDRN in the form of a salt and chitosan [0023]. The PDRN-salt solution is prepared by dissolving PDRN-Na in 50mM Tris at pH 7.5 [0044]. The composition can find application at the cosmetic level, for example for the treatment of scars, keloids, stretch marks, cellulite, wrinkles, and for recovery in general of the optimal characteristics of the epithelium [0031]. The composition increases the cell proliferation of human fibroblasts relative to a control composition [0042, 0053, and 0062].
Regarding claims 13 and 18, Ornaghi teaches a composition comprising PDRN in the form of a salt and chitosan [0023]. The PDRN-salt solution is prepared by dissolving PDRN-Na in 50mM Tris at pH 7.5 [0044]. The composition can find application at the cosmetic level, for example for the treatment of scars, keloids, stretch marks, cellulite, wrinkles, and for recovery in general of the optimal characteristics of the epithelium [0031]. Ornaghi also teaches that the composition may contain excipients and/or carriers suitable for the chosen route of administration such as preservatives, thickeners, antioxidants, emollients, moisturizers, and natural or artificial fragrances [0029].
Regarding claim 14 and 19, Ornaghi teaches a composition comprising PDRN in the form of a salt and chitosan [0023]. The PDRN-salt solution is prepared by dissolving PDRN-Na in 50mM Tris at pH 7.5 [0044]. The composition can find application at the cosmetic level, for example for the treatment of scars, keloids, stretch marks, cellulite, wrinkles, and for recovery in general of the optimal characteristics of the epithelium [0031].
Regarding claims 16, 17, 21, and 22, Ornaghi teaches a composition comprising PDRN in the form of a salt and chitosan [0023]. The PDRN-salt solution is prepared by dissolving PDRN-Na in 50mM Tris at pH 7.5 [0044]. The composition can find application at the cosmetic level, for example for the treatment of scars, keloids, stretch marks, cellulite, wrinkles, and for recovery in general of the optimal characteristics of the epithelium [0031].
With regards to the “applying an effective amount of the placenta-mimic cosmetic” or “applying an effective amount of the cosmetic composition” limitations of the instant claims 16, 17, 21, and 22, the Ornaghi teaches a composition comprising PDRN that can find application at the cosmetic level for the recovery in general of the optimal characteristics of the epithelium [0031]. The Examiner therefore considers the method of applying the composition to a patient in need of treating wrinkles inherent to the disclosure of Ornaghi. Please refer to MPEP 2112 (III), which states:
“where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. ‘There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.’ In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic.”
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 3, 6-8, 10, and 14-15, and 20 Ornaghi does not teach the inclusion of HEPES, peptides, amino acids, or vitamins. However, this deficiency is cured by Yacoo Science, Majmudar, INCI Decoder-Copper Tripeptide-1, and INCI Decoder-Acetyl Hexapeptide-8.
Yacoo Science teaches that HEPES is zwitterionic buffer that can control a constant pH range for a long time. The pH value of HEPES is 6.8 to 8.2, which is suitable for pH adjustment under physiological conditions. It can be used as a common skin care additive (pg. 2). Majmudar teaches a cosmetic composition that may contain sodium DNA as a moisturizing agent [0062]. The composition may also contain vitamins and amino acids [0025] and can improve skin’s visual appearance by providing improvement in, for example, skin moisture, dryness, surface fine lines, wrinkles, firmness, and/or softness [0003]. The composition may also contain other beneficial agents such as moisturizing agents and anti-oxidants [0059]. INCI Decoder-Copper Tripeptide-1 teaches that copper tripeptide-1 has significant anti-inflammatory and antioxidant effect and can improve skin elasticity, clarity, firmness and reduce lines and wrinkles. It is used in several skin care products (pg. 2 Quick Facts and pg. 7 Products with Copper Tripeptide-1). INCI Decoder-Acetyl Hexapeptide-8 teaches that acetyl hexapeptide-8 is a humectant that increases the level of skin moisturization and decreases the depth and width of wrinkles “significantly” (pg. 2 Details). Bloomage Biotech teaches that the INCI name for PDRN is sodium DNA (pg. 2 Product Information).
Regarding claims 4, 11, 15, and 20, Ornaghi does not teach the inclusion of amino acids in a cosmetic composition comprising PDRN. However, this deficiency is cured by Majmudar.
Majmudar teaches that the composition may include arginine as a moisturizing agent [0062] and the marine extract AOSAINE ®, which contains lysine, histidine, proline, alanine, glycine, serine, threonine, tyrosine, isoleucine, leucine, and phenylalanine [0041].
Regarding claims 5, 12, 15, and 20, Ornaghi does not teach the inclusion of peptides, amino acids, or vitamins in a cosmetic composition comprising PDRN. However, this deficiency is cured by Majmudar.
Majmudar teaches that the composition may include the marine extract CHLORELLINE ®, which contains biotin and folic acid [0039]. The composition may also contain niacinamide [0068].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1 and 6-8, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (Tris and HEPES for buffering a solution at a pH of 7.5). See MPEP 2144.06 (II).
With regard to the “placenta-mimic” limitation of claim 1, the intended use of a 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. See MPEP 2111.02 (II).
The claims recite the limitation “placenta-mimic”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the composition embraced by Ornaghi reads on the instant claims. See MPEP 2112.01 (II).
With regard to the “amino acid” and “vitamin” limitations of the instant claims 1, 4, 5, 11, 12, 15, and 20, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the PDRN composition of Ornaghi and the cosmetic composition of Majmudar for improving wrinkles and the condition of the skin), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
With regard to the “peptide” limitation of the instant claims 1, 3, 10, 15, and 20, the idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional antioxidants and moisturizing agents used in cosmetic compositions. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Response to Arguments
Applicant's arguments filed 3/13/2026 have been fully considered but they are not persuasive.
On page 9, Applicant argues that the prior art does not disclose each and every claim feature, nor does it teach or suggest the claimed invention. This is not found persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
On page 9, Applicant argues that based on the data in the specification as filed, the claimed invention demonstrates synergistic results. This is not found persuasive. With regard to the Soller et. al. reference recited on page 3; the Applicant has not attached a copy of the article or cited the reference in an IDS therefore the reference has not been formally considered on the record by the examiner. However, in the interest of compact prosecution, the examiner points out that Soller et. al. are merely relied upon for a description of the well-known Colby method to test for synergy among different bioactive agents. The teachings of Soller relate to the Colby formula, a common formula for calculating expected value, and have thus been considered with regard to calculating the expected values as described in the arguments and declaration.
Please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: The evidence of unexpected results is unexpected and unobvious over the prior art.
Differences are of both practical and statistical significance: The evidence of unexpected results is of practical and statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The evidence of unexpected results amounts to a synergistic improvement in melanin synthesis inhibition, elasticity, hyaluronic acid biosynthesis, and NO production inhibition when PDRN is combined with HEPES and the amino acids and vitamins as described in the examples of the instant specification at a single concentration of each component. The instant claims, however, embrace one or more of the claimed peptides, vitamins, and amino acids at any concentration. In order to be in commensurate scope with the claims, the evidence of unexpected results must demonstrate a synergistic effect when PDRN is combined with HEPES and any peptides, any vitamin, and any molecule falling within the scope of the term “amino acids”, as claimed, at every concentration. The evidence of unexpected results is limited to a synergistic effect of PDRN, HEPES, undisclosed specific peptide(s), undisclosed specific amino acid(s), undisclosed specific vitamin(s) at a single concentration used in the experiments that generated the data. The Examiner also notes that the instant claim 1 is much broader in scope than the example compositions described in the declaration/specification and embraces any peptide, any amino acid (i.e. any compound possessing an amino group and an acid group), and any vitamin. The Applicant has not clearly demonstrated which peptides, vitamins, and amino acids are responsible for the improved performance of the composition and the evidence of record does not support that the unexpected results would construe across the full scope of the claims. Therefore, the evidence of unexpected results is not in commensurate scope with the claims.
Additionally, no side-by-side comparison to the closest prior art, a composition comprising PDRN and TRIS such as that taught by Ornaghi, is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
Response to Declaration
The declaration under 37 CFR 1.132 filed 3/13/2026 is insufficient to overcome the rejections of record based upon Or as set forth in the last Office action because:
On page 5, Applicant argues that the compositions according to the claimed invention show synergy over the individual components. This is not found persuasive. As described in the response to arguments above, while the evidence of unexpected results is unexpected and is of practical and statistical significance, the evidence is not in commensurate scope with the claims because the data only demonstrate synergy for PDRN and HEPES when combined with each and every peptide, amino acid, and vitamin claimed at a single concentration. The Examiner also notes that the instant claim 1 is very broad and embraces any peptide, any amino acid, and any vitamin. The Applicant has not clearly demonstrated which peptides, vitamins, and amino acids are responsible for the improved performance of the composition. Furthermore, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
On page 6, Applicant argues that the surprising and unexpected results are expected over the ranges set forth in the claims, even with when varying the peptide(s), amino acid(s) and vitamin(s) and amounts thereof. This is not found persuasive. As described in the response to arguments above, the evidence of unexpected results provides no evidence that the synergy may be observed when a single species or when any other combination of peptides, amino acids, and vitamins is used in combination with PDRN and HEPES. The data are not commensurate in scope with the claims as discussed in detail above and therefore, the Applicant’s argument is not persuasive and the rejection is maintained.
With regard to the Soller et. al. reference recited on page 3; the Applicant has not attached a copy of the article and therefore the teachings of Soller have not been considered. The references are not properly submitted on the record with an appropriate affidavit or declaration. However, in the interest of compact prosecution, the teachings of Soller et. al. have been considered along with the evidence of unexpected results present in the as-filed specification and declaration. The teachings of Soller relate to the Colby formula, a common formula for calculating expected value, and have thus been considered with regard to calculating the expected values as described in the arguments and declaration.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
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 ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
Prosecution Insights