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 1-20 are pending and under current examination.
Withdrawn Claim Objections and Rejections
All objections pertaining to claims 1 and 17 are withdrawn in view of the amendments to the claims filed 1/13/2026.
All rejections under 35 U.S.C. 112 (b) are withdrawn in view of the amendments to the claims filed 1/13/2026.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 1/13/2026 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 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okishima (U.S. Patent Application No. 2024/0065962, filing date: 1/28/2022) in view of Libal (Why Does Citric Acid Produce Electricity?, available 3/24/2022).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 8, Okishima teaches a cosmetic comprising a first agent containing at least one salt and hyaluronic acid and a second agent containing a chelating agent [0039-0043]. The cosmetic uses a hyaluronic acid compacted by neutralization of carboxyl groups of hyaluronic acid using a salt [0044]. Okishima teaches that hyaluronic acid generally has a negative charge due to the presence of carboxyl groups. Due to the electrostatic repulsion based on this negative charge, the molecule of hyaluronic acid is likely to be in the form of a spread filament [0045]. An electrolyte such as sodium chloride can be utilized to neutralize the negative charge of hyaluronic acid, thus the dominance of hydrogen bonds can be achieved to suppress spreading of the hyaluronic acid molecules so that compaction of even a hyaluronic acid molecule alone is possible [0046]. In cases where a cosmetic containing a compacted structure of hyaluronic acid is applied to the skin or body hair, carboxyl groups of the hyaluronic acid continue to be neutralized by the electrolyte such as sodium chloride, for example sodium ions. It is therefore thought that the carboxyl groups cannot sufficiently exert their ability to hold water [0047]. The salt may be salts of an organic acid such as citric acid and lactic acid [0059]. The pH of the aqueous medium may be 4.5 or more [0079]. The average particle diameter of the hyaluronic acid particles may be 100nm or less [0073]. After the hyaluronic acid penetrates into the skin or body hair, cations such as sodium ions that have been neutralizing the negative charge of carboxyl groups in the hyaluronic acid can be captured. By this, the hyaluronic acid can be swelled to allowed sufficient exertion of the moisture-retaining property of the hyaluronic acid itself [0111]. The instant specification defines the pH of the skin to be about 5 to 6 (pg. 7, second paragraph); the Examiner therefore considers the phrase “after the hyaluronic acid penetrates into the skin” to read on the “an environment of pH 5 to 6” limitation of the instant claim.
Furthermore, regarding claims 1 and 8, Okishima teaches that citric acid may be present as a chelating agent [0089]. With regards to the “acidic pH adjuster” and “to micronize the particles without depolymerization of the particles” limitations of instant claims 1 and 8, the prior art teaches the same organic acid as claimed and therefore, the pH adjuster and micronization properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claims 2 and 20, Okishima teaches a cosmetic comprising a first agent containing at least one salt and hyaluronic acid and a second agent containing a chelating agent [0039-0043].
Regarding claim 3, Okishima teaches that the chelating agent may be EDTA [0089].
Regarding claims 4, 15, and 18, Okishima teaches that the average molecular weight of the hyaluronic acid may be 500 or more or 1,500,000 or less [0067].
Regarding claims 5, 7, 16, and 19, Okishima teaches that as the ionic strength, and therefore the amount of salt, increases, the average particle diameter of the hyaluronic acid particles decreases. At an ionic strength of 0.03 or more, hyaluronic acid particles with a diameter of 100nm or less can be obtained (Table 6 and [0158]).
Regarding claim 6, Okishima teaches that the hyaluronic acid polymer is present at 0.005% by mass or more [0019] and is present at 0.4 and 0.5% by mass in some exemplary compositions [0166].
Regarding claims 9 and 10, Okishima teaches that the cosmetic composition may be applied to any part on the skin surface [0107].
Regarding claims 11 and 12, the claims recite the limitations “food composition” and “pharmaceutical composition”; 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 Okishima reads on the instant claims. See MPEP 2112.01 (II).
Regarding claim 13, Okishima teaches that the first agent can be prepared by adding hyaluronic acid to water or a buffer, dissolving the hyaluronic acid with stirring and mixing, and then adding a salt to the resulting solution [0100].
Regarding claim 17, Okishima teaches that the cosmetic composition may be applied to any part on the skin surface [0107]. When the cations are removed, the hyaluronic acid can be swelled to allow sufficient exertion of the moisture-retaining property of the hyaluronic acid itself, thereby enabling favorable moisturization of the skin or body hair [0111].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 8, and 13, Okishima does not teach the inclusion of an acidic pH adjuster to micronize the particles. However, this deficiency is cured by Libal (Why Does Citric Acid Produce Electricity?, available 3/24/2022).
Libal teaches that citric acid turns into an electrolyte when dissolved in fluid and that acids are electrolytes because they break into negatively charged anions and positively charged cations when placed in solution (pg. 2).
Regarding claims 5, 16, and 19, Okishima does not teach a ratio of hyaluronic acid to acidic pH adjuster.
Regarding claim 7, Okishima does not teach a weight percentage of acidic pH adjuster present in the composition.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 8, and 13, it would have been prima facie obvious to one of ordinary skill in the art to utilize an organic acid as the source of cations to micronize the hyaluronic of Okishima. One would have understood in view of Okishima that citric acid salts may be used as a source of electrolytes in solution and in view Libal that citric acid acts as an electrolyte in solution and breaks into negatively charged anions and positively charged cations. It would have been obvious to employ an organic acid such as citric acid as the source of cations to counteract the negative charge of hyaluronic acid. The artisan of ordinary skill would have had reasonable expectation of success because Okishima teaches that an electrolyte can be utilized to neutralize the negative charge of hyaluronic acid [0046] and that suitable organic acids to be used as salts include citric acid [0059]. See MPEP 2144.07.
Regarding claims 5, 16, and 19, the weight ratio of hyaluronic acid to acidic pH adjuster is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight ratio in order to best achieve the desired results as such would provide advantageous changes in particle size. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Okishima teaches that as the ionic strength of the composition increases, the particle size of the hyaluronic acid particles decreased [0158]. The Examiner considers it prima facie obvious to optimize the weight ratio of hyaluronic acid to acidic pH adjuster, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of acidic pH adjuster would have a direct effect on the diameter of the hyaluronic acid particles and therefore be an optimizable variable.
Regarding claim 7, the weight percentage of acidic pH adjuster is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight ratio in order to best achieve the desired results as such would provide advantageous changes in particle size. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Okishima teaches that as the ionic strength of the composition increases, the particle size of the hyaluronic acid particles decreased [0158]. The Examiner considers it prima facie obvious to optimize the weight percentage of acidic pH adjuster, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of acidic pH adjuster would have a direct effect on the diameter of the hyaluronic acid particles and therefore be an optimizable variable.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Okishima (U.S. Patent Application No. 2024/0065962, filing date: 1/28/2022) in view of Libal (Why Does Citric Acid Produce Electricity?, available 3/24/2022), as applied to claims 1-13 and 15-20 above, and further in view of Formula Botanica (The Formulator’s Guide to Antioxidants in Cosmetics, available 2/15/2022).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Okishima renders obvious the relevant limitations of claims 1 and 13 above. Okishima also teaches that the first and second agents of the cosmetic composition may contain various components within a range that does not affect the effect of the invention, such as antioxidants, preservatives, and antioxidant aids [0096]. The optional components may be added before or after the compaction of the hyaluronic acid [0103].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Okishima does not teach the inclusion of a metal chelating agent during micronization of the hyaluronic acid. However this deficiency is cured by Formula Botanica.
Formula Botanica teaches that metal chelating agents are secondary antioxidants for inclusion in cosmetic formulations (pg. 9, Secondary Antioxidants).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
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 used in cosmetic formulations. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Conclusion
Applicant’s arguments with respect to the rejection of claims 1, 4, 6-13, 15, and 18 under 35 U.S.C. 103 over Komedo in view of Lubart have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
Applicant’s amendments to the claims filed 1/13/2026 have necessitated the new grounds of rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 and 24-44 of copending Application No. 19/110,483.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘483 application embrace a skin external application composition comprising a high molecular weight hyaluronic acid or salt particles thereof and an acidic pH adjuster. The hyaluronic acid or salt particles thereof have an average particle diameter of 100nm or less. The pH adjuster is an organic or inorganic acid and the pH of the composition is 3.0 or more but less than 5.0. The application may also contain a metal ion sequestering agent such as an alkaline salt of EDTA or a phosphate-based compound. The average molecular weight of the hyaluronic acid is 5 to 10,000 kDa and the weight ratio of the hyaluronic acid to acidic pH adjuster is 1:0.01 to 10. The hyaluronic acid is present at 0.1 to 10 wt. % based on a total weight of the composition and the acidic pH adjuster is present at 0.01 to 50 wt. % based on a total weight of the composition. The organic acid is one or more species selected from the group consisting of citric acid, phosphoric acid, fumaric acid, ascorbic acid, ferulic acid, succinic acid, lactic acid, hyaluronic acid, malic acid, butyric acid, formic acid, acetic acid, salicylic acid, glycolic acid, tartaric acid, and gluconolactone, and wherein the inorganic acid is one or more species selected from the group consisting of carbonic acid, hydrochloric acid, nitric acid, and sulfuric acid. The composition may be cosmetic or pharmaceutical composition. The claims of the ‘483 application also embrace a method for moisturizing skin comprising administering an effective amount of the composition to the skin of a subject in need thereof. The instant claims recite the limitation “food composition”; 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 the claims reads on the instant claims of the ‘483 application. See MPEP 2112.01 (II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 and 24-44 of copending Application No. 19/110,483, as applied to claims 1-12 and 17-20 above, and further in view of Okishima (U.S. Patent Application No. 2024/0065962, filing date: 1/28/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘483 application embrace the relevant limitations as described above. The claims of the ‘483 application do not embrace a method of preparing the composition of the instant claim 1. However, this deficiency is cured by Okishima. Okishima teaches a cosmetic comprising a first agent containing at least one salt and hyaluronic acid and a second agent containing a chelating agent [0039-0043]. The cosmetic uses a hyaluronic acid compacted by neutralization of carboxyl groups of hyaluronic acid using a salt [0044]. Okishima teaches that hyaluronic acid generally has a negative charge due to the presence of carboxyl groups. Due to the electrostatic repulsion based on this negative charge, the molecule of hyaluronic acid is likely to be in the form of a spread filament [0045]. An electrolyte such as sodium chloride can be utilized to neutralize the negative charge of hyaluronic acid, thus the dominance of hydrogen bonds can be achieved to suppress spreading of the hyaluronic acid molecules so that compaction of even a hyaluronic acid molecule alone is possible [0046]. In cases where a cosmetic containing a compacted structure of hyaluronic acid is applied to the skin or body hair, carboxyl groups of the hyaluronic acid continue to be neutralized by the electrolyte such as sodium chloride, for example sodium ions. It is therefore thought that the carboxyl groups cannot sufficiently exert their ability to hold water [0047]. The salt may be salts of an organic acid such as citric acid and lactic acid [0059]. The pH of the aqueous medium may be 4.5 or more [0079]. The average particle diameter of the hyaluronic acid particles may be 100nm or less [0073]. After the hyaluronic acid penetrates into the skin or body hair, cations such as sodium ions that have been neutralizing the negative charge of carboxyl groups in the hyaluronic acid can be captured. By this, the hyaluronic acid can be swelled to allowed sufficient exertion of the moisture-retaining property of the hyaluronic acid itself [0111]. The instant specification defines the pH of the skin to be about 5 to 6 (pg. 7, second paragraph); the Examiner therefore considers the phrase “after the hyaluronic acid penetrates into the skin” to read on the “an environment of pH 5 to 6” limitation of the instant claim. The first agent can be prepared by adding hyaluronic acid to water or a buffer, dissolving the hyaluronic acid with stirring and mixing, and then adding a salt to the resulting solution [0100]. The first and second agents of the cosmetic composition may contain various components within a range that does not affect the effect of the invention, such as antioxidants, preservatives, and antioxidant aids [0096]. The optional components may be added before or after the compaction of the hyaluronic acid [0103].
It would have been prima facie obvious to one of ordinary skill in the art of filing to prepare the composition embraced by the claims of the ‘483 application by the preparation method of Okishima. One would have understood in view of Okishima that hyaluronic acid may be compacted by the addition of an electrolyte in aqueous solution in the preparation of a nearly identical cosmetic composition. It would have been obvious that the composition embraced by the claims of the ‘483 application may also be prepared by such a method. One of ordinary skill in the art of filing would have been motivated to prepare the composition embraced by the claims of the ‘483 application by the preparation method of Okishima in order to compact large molecular weight hyaluronic acid particles without changing the molecular weight of the composition. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Okishima teaches that a nearly identical composition may be prepared by such a method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ request for the double patenting rejection of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
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.
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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.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614