FINAL 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 Claims
Receipt is acknowledged of the claim amendments filed on 29 September 2025.
Claims 1-25, 27 and 33 are cancelled.
Claims 26 and 40 have been amended.
The species election of the molecular weight of the thiolated hyaluronic acid and species of molecular weight of the hyaluronic acid or salt is withdrawn after reconsideration. Claims 31-32 and 38-39 are no longer withdrawn from consideration.
Claims 28-29 and 46-51 remains withdrawn from consideration.
Claims 26, 30-32 and 34-45 are presented for examination herein to the extent that the sodium salt of hyaluronic acid as the hyaluronic acid or salts, a thiol content less than 500 µmol/g for the thiol content for the thiolated hyaluronic acid derivative, and a gel as the product type, e.g., applicant’s elected species in the reply filed on 12/22/2023.
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Rejections Withdrawn
The rejection of claims 26, 30, 34-37, 40-41 and 43-45 under 35 U.S.C. 103(a) as being unpatentable over BRETON (US 2010/0190742 A1, publication date: 29 July 2010) in view of HORNOF (WO 2008/077172 A2, publication date: 3 July 2008), is withdrawn in view of the claim amendments filed 29 September 2025.
The rejection of claim 42 under 35 U.S.C. 103(a) as being unpatentable over Breton in view of Hornof as applied to claims 26, 30, 34-37, 40-41 and 43-45 above, and further in view of TAKUSHI (WO 2007/099830 A1, publication date: 07 September 2007), is withdrawn in view of the claim amendments filed 29 September 2025.
New Grounds of Rejections
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 of this title, 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 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 26, 30-32, 34-36, 40 and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over RAYMA (“Let’s Talk About Hyaluronic Acid”, electronic article obtained from www.humblebeeandme.com on 06 January 2026, publication date of 14 May 2018, URL: https://www.humblebeeandme.com/lets-talk-about-hyaluronic-acid/) in view of HORNOF (WO 2008/077172 A2, publication date: 3 July 2008).
Rayma is primarily directed towards hyaluronic acid, formulations comprising hyaluronic acid, and the use of composition comprising hyaluronic acid (see entire copy of the electronic article).
Regarding claims 26, 36 and 40, Rayma discloses that hyaluronic acid has the ability to plump and hydrate skin, reducing the appearance of fine lines and leaving the skin looking healthy (page 1 of the copy). Rayma discloses that many professionally formulated hyaluronic acid products contain a variety of weight of HA (e.g., hyaluronic acid) to get the full spectrum of benefits including surface plumping of high molecular weight and the deeper hydration of low molecular weight (e.g., “at least one molecular weight”/ “two or more molecular weights of hyaluronic acids or salts at the same time”) (page 5 of the copy). Rayma discloses that sodium hyaluronate is more common, is more readily absorbed than hyaluronic acid and is less expensive than hyaluronic acid (page 6 of the copy). Rayma discloses 1% HA solution is relatively viscous and that a 1% HA solution can be used as a serum on its own (e.g., gel applied topically to care for skin) (page 9 of the copy). Rayma discloses a 1% hyaluronic acid solution made up of 98.5% distilled water, 0.5% of a preservative and 1% of a low molecular weight hyaluronic acid (age 11 of the copy). Rayma discloses that the solution has a shelf life of one to two years when properly preserved (page 34 of the copy, dated 19 June 2018). Rayma discloses that a solution without a preservative lasts 2 weeks in the fridge (page 38 of the copy, dated 06 October 2018).
Applicant is reminded that omission of an element and its function is obvious if the function of the element is not desired. Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient). See MPEP 2144.04(II). Therefore, it is prima facie obvious to omit a preservative if preservation of the composition up to a year or two is not desired.
Rayma does not specifically teach that the composition comprises a thiolated hyaluronic acid derivative, that the thiolated hyaluronic acid derivative has a thiol content of less than 500 µmol/g, and that the thiolated hyaluronic acid derivative has a concentration of less than 5 mg/ml. The deficiencies are made up for by the teachings of Hornof.
Hornof is primarily directed towards thiol-group-containing polymer for preparing an implant for tissue augmentation (abstract).
Regarding claims 26 and 34-35, Hornof teaches that hyaluronic acid exhibits itself a minor anti-inflammatory effect and is a weak scavenger of hydroxyl groups (page 2, last paragraph). Hornof teaches that improvement of the hydroxy scavenger and anti-oxidative properties of hyaluronic acid is achieved by thiolation (page 4, second paragraph). Hornof teaches that the thiol-group portion of the polymer preferably is more than 20 µmol/g of polymer (page 6, third paragraph). The range of more than 20 µmol/g overlaps the range of “less than 500 µmol/g”, recited in claim 26. Thus, the range of “less than 500 µmol/g” is rendered prima facie obvious. See MPEP 2144.05 (quoted supra). Hornof teaches that thiol-group-containing polymer is present at a concentration of from 0.01-10% m/v (e.g., 5 mg/ml = .5%) (page 8, last paragraph). The range of from 0.01-10% m/v overlaps the range of “less than 5 mg/ml” (e.g., less than .5%), “less than 2 mg/ml” (e.g., less than .2%) and “less than 1 mg/ml” (e.g., less than .1%), recited in claims 26, 34 and 35, respectively. Thus, the ranges “less than 5 mg/ml”, “less than 2 mg/ml” and “less than 1 mg/ml” are rendered prima facie obvious. See MPEP 2144.05 (quoted supra). Hornof teaches including both thiol-group containing polymers and also unmodified polymers, at variable mixing ratio relative to each other (page 11, third paragraph). Hornof teaches that the thiol-group-containing polymer is used for including reducing the aging of skin (page 12, sixth paragraph).
Regarding claims 30-32, Hornof teaches that the thiol-group-containing polymer has a molecular mass of at least 10,000 g/mol (e.g., at least 10 KDa) (page 4, fourth paragraph). The molecular mass of the thiol-group-containing polymer Hornof teaches that the molecular mass of the thiol-group-containing polymer (e.g., thiol-group-containing hyaluronic acid) effects how long the thiol-group-containing polymer remain directly at the active site or in the immediate vicinity of the active site (page 4, last paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for application to the skin reduce signs of aging that comprises hyaluronic acid including sodium salt of hyaluronic acid and thiolated hyaluronic acid; wherein the sodium salt of hyaluronic acid includes a variety of sodium salt of hyaluronic acid of different molecular weights; wherein the thiol-group portion of the thiolated hyaluronic acid is more than 20 µmol/g; wherein the amount of the thiolated hyaluronic acid is at least 0.01% m/v (e.g., 5 mg/ml = .5%); and wherein the molecular mass of the thiolated hyaluronic acid is at least 10,000 g/mol (e.g., at least 10 KDa). The person of ordinary skill in the art would have been motivated to make those modifications to obtain a composition with improvement of the hydroxy scavenger and anti-oxidative properties by replacing a portion of the 1% hyaluronic acid including sodium hyaluronate of the composition of Rayma with a thiol-group-containing hyaluronic acid, which Hornof teaches as having better anti-oxidative properties than hyaluronic acid. The person of ordinary skill in the art would have reasonably expected success because Rayma discloses that hyaluronic acid has the ability to plump and hydrate skin, reducing the appearance of fine lines and leaving the skin looking healthy (page 1 of the copy). Rayma discloses that many professionally formulated hyaluronic acid products contain a variety of weight of HA (e.g., hyaluronic acid) to get the full spectrum of benefits including surface plumping of high molecular weight and the deeper hydration of low molecular weight (e.g., “at least one molecular weight”/ “two or more molecular weights of hyaluronic acids or salts at the same time”) (page 5 of the copy). Rayma discloses that sodium hyaluronate is more common, is more readily absorbed than hyaluronic acid and is less expensive than hyaluronic acid (page 6 of the copy). Rayma discloses 1% HA solution is relatively viscous and that a 1% HA solution can be used as a serum on its own (e.g., gel applied topically to care for skin) (page 9 of the copy). Rayma discloses a 1% hyaluronic acid solution made up of 98.5% distilled water, 0.5% of a preservative and 1% of a low molecular weight hyaluronic acid (age 11 of the copy). Rayma discloses that a solution without a preservative lasts 2 weeks in the fridge (page 38 of the copy, dated 06 October 2018). Hornof teaches that hyaluronic acid exhibits itself a minor anti-inflammatory effect and is a weak scavenger of hydroxyl groups (page 2, last paragraph). Hornof teaches that improvement of the hydroxy scavenger and anti-oxidative properties of hyaluronic acid is achieved by thiolation (page 4, second paragraph). Hornof teaches that the thiol-group portion of the polymer preferably is more than 20 µmol/g of polymer (page 6, third paragraph). Hornof teaches that thiol-group-containing polymer is present at a concentration of from 0.01-10% m/v (e.g., 5 mg/ml = .5%) (page 8, last paragraph). Hornof teaches including both thiol-group containing polymers and also unmodified polymers, at variable mixing ratio relative to each other (page 11, third paragraph). Hornof teaches that the thiol-group-containing polymer is used for including reducing the aging of skin (page 12, sixth paragraph).
Regarding the concentration of the hyaluronic acid or salt of less than 10 mg/ml (e.g., claim 43), less than 8 mg/ml (e.g., claim 44) and less than 4 mg/ml (e.g., claim 45), Rayma discloses 1% HA serum (page 9 of the copy). Hornof teaches that hyaluronic acid exhibits itself a minor anti-inflammatory effect and is a weak scavenger of hydroxyl groups (page 2, last paragraph). Hornof teaches that improvement of the hydroxy scavenger and anti-oxidative properties of hyaluronic acid is achieved by thiolation (page 4, second paragraph). Hornof teaches that thiol-group-containing polymer is present at a concentration of preferably from 0.01-10% m/v (e.g., 5 mg/ml = .5%) (page 8, last paragraph). Hornof teaches including both thiol-group containing polymers (e.g., thiol-group containing hyaluronic acid) and also unmodified polymers (e.g., hyaluronic acid), at variable mixing ratio relative to each other (page 11, third paragraph). Hornof teaches that the thiol-group-containing polymer is used for including reducing the aging of skin (page 12, sixth paragraph). The amount of hyaluronic acid and thiol-group-containing hyaluronic acid is an art-recognized result-effective variable, e.g., reducing aging skin, reduce inflammatory effect and improve anti-oxidative properties, which 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 reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio amount of hyaluronic acid to thiol-group-containing hyaluronic acid (e.g., at least 0.01% m/v of thiol-group-containing hyaluronic acid and up to less than 1% (e.g., amount of hyaluronic acid in Rayma solution)) that adds up to 1% (e.g., 10mg/ml) to add to the solution in order to obtain a serum with desired reducing of skin aging, reduced inflammatory effect and improved anti-oxidative properties. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 37-39 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Rayma in view of Hornof as applied to claims 26, 30, 34-37, 40-41 and 43-45 above, and further in view of PAULINA (“What Is Hyaluronic Acid And How To Use It — Quick Crash Course”, electronic article from medium.com, obtained on 06 January 2026, URL: https://medium.com/@fromnature.ca/what-is-hyaluronic-acid-and-how-to-use-it-quick-crash-course-80f14cff6410, publication date of 12 January 2017).
Regarding claims 37-39 and 41-42, the composition of claims 26 and 40 are described above in section 8.
Rayma and Horn of do not specifically teach that the hyaluronic acid or salt thereof has a molecular weight of between 1 KDa and 10,000 KDa (e.g., claim 37). Rayma and Horn of do not specifically teach that the hyaluronic acid or salt thereof has a molecular weight of between 1.6 KDa and 3,000 KDa (e.g., claim 38). Rayma and Horn of do not specifically teach that the hyaluronic acid or salt thereof has a molecular weight of between 2.4 KDa and 2,800 KDa. Rayma and Horn of do not specifically teach that at least one of the hyaluronic acid or salt thereof has a molecular weight of between 1.6 KDa and 500 KDa and at least one of hyaluronic acids or salts thereof has a molecular weight of between 800 KDa and 3,000 KDa. Rayma and Horn of do not specifically teach that at least one of the hyaluronic acid or salt thereof has a molecular weight of between 2.4 KDa and 8 KDa and at least one of hyaluronic acids or salts thereof has a molecular weight of between 1,000 KDa and 2,800 KDa. The deficiencies are made up for by the teachings of Paulina.
Paulina is primarily directed towards hyaluronic acid and the use thereof for the skin (see the entire copy of Paulina).
Regarding claims 37-39 and 41-42, Paulina teaches that high molecular weight hyaluronic acid of 1-1.08 Mda (e.g., 1,000 KDa – 1080 KDa) creates a barrier on the skin surface which locks the moisture and prevents water escape (page 5 of the copy of Paulina). Paulina teaches that low molecular weight hyaluronic acid of 0.1 to 0.4 Mda (e.g., 100 KDa to 400 KDa) moisturizes and enhances penetration of active ingredients (page 5 of the copy of Paulina). Paulina teaches that super low molecular weight of 10 kDa and less penetrates and moisturizes deep layers of the skin (page 6 of the copy of Paulina).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for application to the skin reduce signs of aging that comprises hyaluronic acid including sodium salt of hyaluronic acid and thiolated hyaluronic acid; wherein the sodium salt of hyaluronic acid includes a variety of sodium salt of hyaluronic acid of different molecular weights; wherein the thiol-group portion of the thiolated hyaluronic acid is more than 20 µmol/g; wherein the amount of the thiolated hyaluronic acid is at least 0.01% m/v (e.g., 5 mg/ml = .5%); wherein the molecular mass of the thiolated hyaluronic acid is at least 10,000 g/mol (e.g., at least 10 KDa); and wherein the variety of molecular weight sodium salt of hyaluronic acid is selected from a group that includes 1-1.08 Mda (e.g., 1,000 KDa – 1080 KDa), 0.1 to 0.4 Mda (e.g., 100 KDa to 400 KDa) and 10 kDa and less. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a composition with a full spectrum of benefits by including sodium hyaluronate of different molecular weights including a molecular weight of 1-1.08 Mda (e.g., 1,000 KDa – 1080 KDa) which creates a barrier on the skin surface which locks the moisture and prevents water escape, a molecular weight of 0.1 to 0.4 Mda (e.g., 100 KDa to 400 KDa) that moisturizes and enhances penetration of active ingredients and molecular weight of 10 kDa and less which penetrates and moisturizes deep layers of the skin. The person of ordinary skill in the art would have reasonably expected success because Rayma discloses that many professionally formulated hyaluronic acid products contain a variety of weight of HA (e.g., hyaluronic acid) to get the full spectrum of benefits including surface plumping of high molecular weight and the deeper hydration of low molecular weight (e.g., “at least one molecular weight”/ “two or more molecular weights of hyaluronic acids or salts at the same time”) (page 5 of the copy). Paulina teaches that high molecular weight hyaluronic acid of 1-1.08 Mda (e.g., 1,000 KDa – 1080 KDa) creates a barrier on the skin surface which locks the moisture and prevents water escape (page 5 of the copy of Paulina). Paulina teaches that low molecular weight hyaluronic acid of 0.1 to 0.4 Mda (e.g., 100 KDa to 400 KDa) moisturizes and enhances penetration of active ingredients (page 5 of the copy of Paulina). Paulina teaches that super low molecular weight of 10 kDa and less penetrates and moisturizes deep layers of the skin (page 6 of the copy of Paulina).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant’s arguments will be addressed as they pertain to the new grounds of rejection above.
Applicant’s arguments with respect to claim(s) 26, 30-32 and 34-45 have been considered but are moot because the new ground of rejection above that was necessitated by the claim amendments filed 29 September 2025.
Thus, for the reasons of record and for the reasons presented above claims 26, 30-32 and 34-45 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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, David Blanchard can be reached on (571) 272-0827. 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.
/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600