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 .
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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/10/2026 has been entered.
Status of claims
The amendment filed on 03/16/2026 is acknowledged. Claims 4, 5, 10, 13, 14, and 16-20 have been canceled and new claim 21 has been added. Claims 1-3, 6-9, 11, 12, 15, and 21 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 03/16/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are maintained for reasons of record and the following.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(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.
Claims 1-3, 6-9, 11, 12, and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gousse et al. (US 2017/0273886 A1).
Gousse et al. teach hydrogel compositions as injectable dermal fillers or topical cream, etc., (cosmetic in the instant claim 7 and the claimed creams in the instant claim 9) of hydrogel particles with particle size about 50-75 µm according to paragraph 81 of WO 2016/051219 (the instant application is the national stage of PCT//IB2014/001959, WO 2016/051219, with “µm” being miss-printed as “pm” in US 2017/0273886 A1) (particle size in the instant claims 1 and 8)
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(abstract and paragraph 81 and 109) in form of hyaluronic acid (HA), as a glycosaminoglycan polymer, hydrogel with a molecular weight (MW) of about 5,000-20,000,000 Da (the claims ≥10,000,000 Da in the instant claim 1 and the claimed ≤5,000 Da in the instant claims 1 and 8) (paragraph 29 and 32) comprising
a combination of crosslinked HA, crosslinked with butanediol diglycidyl ether (epoxide-based, instant claims 2, 3, 11, and 12) (paragraph 33-34), and uncrosslinked HA with crosslinked HA being about 25% based on the total weight of glycosaminoglycan polymers (paragraph 36), i.e., uncrosslinked HA being 75% based on the total weight of glycosaminoglycan polymers (paragraph 47-49);
antioxidants (including vitamin C, etc., the instant claims 6 and 15), and
a carrier phase such as water, etc., (medium in the instant claims 1 and 8);
wherein the crosslinked HA, being about 5 mg/g of total composition (0.5% by weight), includes crosslinked high MW HA with MW of ≥ about 1,000,000 Da (paragraph 37-38) and the uncrosslinked HA, being about 5 mg/g of total composition (0.5% by weight), includes uncrosslinked low MW HA with mean MW of about 100,000 Da (paragraph 41-43), i.e., total HA 1% by weight;
wherein the hydrogel having Tan δ 0.5, 1.5, etc., (paragraph 75);
wherein the term “about” means a range of ±10% deviation of the value (paragraph 149).
The 5,000-20,000,000 Da MW of glycosaminoglycan polymer is calculated to encompass 4,500-22,000,000 Da.
The weight ratio between crosslinked HA and uncrosslinked HA is calculated to be 1:3 (75/25=3).
With regard to the claimed crosslinked HMW HA and uncrosslinked LMW HA being mixed together and freeze-fried, the instant claim is directed to a composition in form of gel comprising a freeze-fried HA, i.e., the mixing crosslinked HMW HA and uncrosslinked LMW HA being mixed together and freeze-drying limitation is a product-by-process limitation of an intermediate product for forming a gel. Although the method of making HA mixture in the composition taught by Gousse et al. is different from the method of making HA mixture, an intermediate product for forming the gel recited in the instant claim; the limitation is a product-by-process limitation of an intermediate product for forming a gel. The determination of patentability of a product-by-process limitation of an intermediate product is based on the gel itself, not the method of production of the intermediate product. If the product comprising the intermediate from product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.
Although Gousse et al. do not teach an embodiment comprising a crosslinked HMW HA and uncrosslinked LMW HA; based on Gousse et al.’s teachings of hydrogel comprising both crosslinked HA and uncrosslinked HA while crosslinked HA includes HMW HA and uncrosslinked HA includes LMW HA, a person of ordinary skill in the art before the effective filing date of the claimed invention can readily envisage a combination of crosslinked HMW HA and uncrosslinked LMW HA.
Gousse et al. do not teach the same MW of the LMWHA (4,500 Da vs the claimed ≤3,000 Da)).
This deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of MW of the LMWHA is ≤3,000 Da and the range of MW of the LMWHA taught in the prior art is 4,500 Da and therefor, very close to the claimed range. Furthermore, a LMW HA of ≤ 5000 Da is disclosed in the instant specification (paragraph 30-32 in PGPUB) as being suitable and thus the criticality of the now claimed ≤ 3000 Da over 4,500 Da taught by Gousse et al. is not established. Please refer to MPEP 2144.05.I and III:
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.
Response to Applicants’ arguments:
Applicants argue that Gousse et al. teach the hydrogel compositions comprising antioxidant to resist oxidative stress (paragraph 10, 14,1 6) and thus acts as a preservative.
However, this argument is not deemed persuasive. Antioxidant and preservative are not defined as having the same function either Gousse et al. or the instant specification (listed as two separate ingredients in the paragraph bridges page 11 and 12) while
an antioxidant is substance that protects cells from the damage caused by free radicals (unstable molecules made by the process of oxidation during normal metabolism) (https://www.cancer.gov/publications/dictionaries/cancer-terms/def/antioxidant) which is consistent with Gousse et al.’s teaching of the function of antioxidant; and
a preservative is to protect the product against microbial proliferation (Preservatives: https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/preservative).
New ground of rejection
Upon reconsideration the following new ground of rejections are applied.
Claims 1-3, 6-9, 11, 12, 15, and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Simon Ludovic et al. (WO 2019/053483 A1) as evidenced by Gousse et al. (US 2017/0273886 A1) in view of Lim et al. (WO 2008/100044 A1).
Simon Ludovic et al. teach a sterile and topical cosmetic composition in gel form (the instant claims 1, 7, and 8) (claim 10) or cream (the instant claim 9) (page 26, line 13) comprising, in a physiologically acceptable medium (claims 1 and 9),
about 0.1-0.6% by weight, relative to the composition, of crosslinked HA (page 11, line 3-7 and claims 1 and 9); and
0.5-5% by weight relative to t the composition of un-crosslinked HA (page 16, line 6-18 and claims 1 and 9);
vitamin C (water-soluble, the instant claims 6 and 15) (page 14, line 27);
wherein the crosslinked HA is crosslinked by 1,4-butanediol diglycidyl ether (BDDE) (the instant claims 2, 3, 11, and 12) (page 9, line 28-31) and the MW of crosslinked HA is about 50,000-10,000,000 Da (the instant claim 1) (page 9, line 6-9) and the MW of un-crosslinked HA is about 1,000-5,000,000 Da (the instant claim 1) (page 16, line 11-14);
the composition is devoid of preservative (the instant claim 1) (claim 11).
Antioxidant is not a must have component (the instant claim 21) (page 14, line 14-17).
The weight ratio between the crosslinked HA and un-crosslinked HA is calculated to be 1:5 based on 0.1% crosslinked HA and 0.5% un-crosslinked HA discussed above. The weight percentage of the mixture of the crosslinked HA and un-crosslinked HA is calculated to be about 0.6-5.6% (0.1+0.5=0.6 and 0.6+5=5.6%).
With regard to the claimed crosslinked HMW HA and uncrosslinked LMW HA being mixed together and freeze-fried in the instant claims 1 and 8, the instant claims are directed to a composition in form of gel/cream comprising a freeze-fried HA, i.e., the mixing crosslinked HMW HA and uncrosslinked LMW HA being mixed together and freeze-drying limitation is a product-by-process limitation of an intermediate product for forming a gel. Although the method of making HA mixture in the composition taught by Simon Ludovic et al. is different from the method of making HA mixture, an intermediate product for forming the gel recited in the instant claim; the limitation is a product-by-process limitation of an intermediate product for forming a gel. The determination of patentability of a product-by-process limitation of an intermediate product is based on the gel itself, not the method of production of the intermediate product. If the product comprising the intermediate from product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.
According to Gousse et al. discussed above a hydrogel comprising 1% by weight of 0.5% by weight of crosslinked HA with MW of ≥ about 1,000,000 Da and the 0.5% by weight of uncrosslinked HA with mean MW of about 100,000 Da having Tan δ 0.5, 1.5, etc. (the instant claims 1 and 8).
Simon Ludovic et al. do not specify the same MW of crosslinked HA (about 50,000-10,000,000 Da vs ≥ 10,000,000 Da in the instant claim 1); the same MW of un-crosslinked HA (about 1,000-5,000,000 Da vs ≤ 3,000 Da in the instant claims 1 and 8), the same weight percentage of the mixture of crosslinked HA and un-crosslinked HA relative to the composition (about 0.6-5.6% vs the claimed 0.5-1.6% in the instant claims 1 and 8).
This deficiency is cured by a prima facie case of obviousness typically exists when the range of a claimed composition lies inside/overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of the MW of crosslinked HA is ≥ 10,000,000 Da and the range of the MW of crosslinked HA taught in the prior art is about 50,000-10,000,000 Da and therefor, overlaps with the claimed range. Since the particle size of HA is proportional to the MW and the MW of crosslinked HA taught in the prior art overlaps with the claimed range, the particle size of HA would overlap with the claimed range of the particle size of HA.
The claimed range of MW of un-crosslinked HA is ≤ 3,000 Da and the range of MW of un-crosslinked HA taught in the prior art is about 1,000-5,000,000 Da and therefor, includes the claimed range.
The claimed range of mixture of crosslinked HA and un-crosslinked HA is 0.5-1.6% by weight and the range of mixture of crosslinked HA and un-crosslinked HA taught in the prior art is about 0.6-5.6% by weight and therefor, overlaps with the claimed range.
Simon Ludovic et al. are silent about the particle size in the instant claims 1 and 8.
This deficiency is cured by Lim et al. who teach crosslinked HA with MW of 300K-10M Da having particle size of from a few to a few tens µm (page 4 and 9).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Simon Ludovic et al. and Lim et al. to specify the crosslinked HA taught by Pierre having a particle size of a few to a few tens µm, i.e., >0 μm and <100 μm. Crosslinked HMW HA having a particle size of >0 μm and <100 μm was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Simon Ludovic et al. do not specify the same weight ratio between the crosslinked HA and un-crosslinked HA (1:5 vs the claimed 1:3-1 in the instant claims 1 and 8).
A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Furthermore, a crosslinked HA and un-crosslinked HA weight ratio of 1:5 to 3:1 (→ 1:0.33-5) is disclosed as being suitable in the instant specification page 3, line 7-10 and previously claimed (dated 07/21/2020), thus, the criticality of now claimed 1:3-1over 1:5 is not established.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 03/16/2026, have been fully considered but they are moot in view of new ground of rejections.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
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