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
Status of claims
The amendment filed on 06/30/2026 is acknowledged. Claims 2-4, 9-11, and 23 have been canceled and claims 14-22 and 24 have been withdrawn. Claims 1, 5-8, 12, and 13 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 06//30/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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 remained for reasons of record and the following. The rejections are modified based on the amendments (newly underlined).
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, 5-8, 12, and 13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Roca Martinez et al. (WO 2016/128550 A1) in view of Njikang et al. (US 2016/0113855 A1).
Roca Martinez et al. teach
hyaluronic acid (HA) hydrogel for facial sculpturing and augmentation (the claimed hydrogel filler in the instant claims 1 and 12) by injection,
having a higher cohesivity (the claimed property of monophasic HA in the 8th wherein clause in the instant claim 1 according to the instant specification) and
high elasticity (the claimed property of biphasic HA in the 8th wherein clause in the instant claim 1 according to the instant specification) (abstract and paragraph 17) comprising
high molecular weight (MW) HA with a MW of about 3 MDa (paragraph 32) crosslinked (the 3rd wherein clause in the instant claim 1 and the 2nd wherein clause in the instant claim 12) with 1,4-butanediol diglycidyl ether (BDDE) (the instant claims 5 and 6) (paragraph 44)
with 4% degree of crosslinking based on the weight of crosslinking agent and HA monomer, i.e., 4% by weight of crosslinking agent relative to monomers in HA, (paragraph 18 and 37) and
an anesthetic agent lidocaine (the instant claims 7-8) (paragraph 14);
wherein the hydrogel having an elastic module of about 500-900 Pa (including 450 Pa according to ±10% deviation, paragraph 28) and a cohesivity of about 20 and 60-100 gmf (gram force, the “gf” in the unit of the claimed lift capability) (including 55 gmf according to ±5 gmf deviation) with an extrusion force of about 4-15 N using 27 G X 13 mm (1/2 inch, i.e., 27G1/2”) needle (injection) (paragraph 38, 42 and 44).
Lift capacity is a function of cohesivity and elastic module while lift capacity ≈ cohesivity x elastic module which is supported by examples 1 and 2 in the instant specification: 448 Pa x 36 gf = 16128 Pa*gf very close to the measured 16145 Pa*gf (0.1% difference) in example 1 and 707 Pa x 44 gf = 31108 Pa*gf very close to the measured 31391 Pa*gf (0.9% difference) in example 2.
Thus, the hydrogel taught by Roca Martinez et al. having an elastic module of about 500-900 Pa (including 450 Pa according to ±10% deviation, paragraph 28) and a cohesivity of about 20 and 60-100 gmf (gram force, the “gf” in the unit of the claimed lift capability and including 55 gmf according to ±5 gmf deviation) would necessarily have about 24,300 Pa*gf lift capacity (55 gmf x 450 Pa = 24,750 Pa*gf), whether expressly recognized by Roca Martinez et al. or not. Please refer to MPEP 2112.I and MPEP 2112 II:
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”
Or alternatively, the claimed range of lift capacity is 12,000-16,145 Pa*gf close enough to the range of lift capacity taught in the prior art of about 24,300 Pa*gf and therefor would have the same property of suitable as dermal filler. Also, HA hydrogel with lift capacity 10,000-50,000 Pa*gf is suitable according to the instant specification, thus, the criticality of the now claimed 12,000-16,145 Pa*gf over about 24,300 Pa*gf taught by Roca Martinez et al. is not established.
Or alternatively, although Roca Martinez et al. are silent about the lift capacity, lift capacity is a function of cohesivity and elastic module, with the crosslinked HA hydrogel having the same molecular weight, the same degree of crosslinking (calculated below) by the same crosslinker, elastic module of about 500-900 Pa taught by Roca Martinez et al. includes the elastic module of 448 Pa and 707 Pa in examples 1 and 2 in the instant specification, cohesivity of about 60-100 gmf (including 55 gmf according to ±5 gmf deviation) taught by Roca Martinez et al. is slightly higher than 36 and 44 gf in examples 1 and 2 in the instant specification, it is reasonable to assume the lift capacity of the crosslinked HA hydrogel being close to 16128 Pa*gf and 31108 Pa*gf in examples 1 and 2. Furthermore, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Given the HA containing disaccharide glycosaminoglycan monomer which contains glucuronic acid, MW 194.14 g/mol, and N-acetylglucosamine, 221.21 g/mol with glucuronic acid being the crosslinking portion (disaccharide glycosaminoglycan monomer MW of 379.35 g/mol as glucuronic acid + N-acetylglucosamine – 2 H2O: 194.14+221.21-36.03 = 379.32 g/mol and glucuronic acid portion in the HA being glucuronic acid – H2O = 176.125 g/mol) and BDDE MW of 202.25 g/mol:
the mol% crosslinker / HA is calculated to be 3.47 mol% (the claimed degree of cross-linking modification in 4th and 6th wherein clauses in the instant claims 1, 3rd and 5th wherein clauses in the instant claim 12, and claim 13) based on 4% by weight of degree of crosslinking using 1 g of HA as calculation base:
100% of 1 g HA glucuronic acid monomer → 5.68 mmol of HA glucuronic acid monomer (1 g / 176.125 g/mol = 5.68 mmol);
BDDE being 4% of 1 g HA → 0.197 mmol of BDDE ((1 g * 4%) / 202.25 g/mol = 0.197 mmol);
degree of cross-linking modification → 3.47% (0.197/5.68 = 0.0347) (the 4th and 6th wherein clauses in the instant claim 1); and
crosslinking ratio of example 1 is calculated to be 0.30 (the crosslinking ratio the 5th and 7th wherein clauses in the instant claim 1 and 4th and 6th wherein clauses in the instant claim 12):
1 g of HA → 2.64 mmol of disaccharide glycosaminoglycan monomer of HA = 2.64 mmol of glucuronic acid monomer (1 g / 379.32 g/mol =2.64 mmol);
g of BDDE → 0.494 mmol of BDDE;
6.5% crosslinking → 0.149 mmol BDDE in crosslinked HA (2.64 mmol * 176.125 g/mol * 6.5% / 202.25 g/mol = 0.149 mmol); and
crosslinking ratio = 0.149 mmol / 0.494 mmol = 0.30.
Although Roca Martinez et al. do not specify, in example 1, the same crosslinking ratio (0.3 vs the claimed 0.1-0.2 in the 5th and 7th wherein clauses in the instant claim 1 and the 4th and 6th wherein clause in the instant claim 12); i.e., the ratio of reacted crosslinker to total crosslinker initially introduced into the crosslinking reaction, the ratio of reacted crosslinker to total crosslinker initially introduced into the crosslinking reaction is a product-by-process limitation. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the 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. Crosslinked HA hydrogel taught by Roca Martinez et al. and crosslinked HA hydrogel recited in the instant claims both the same degree of crosslinking and crosslinked by the same crosslinker, thus the product taught by Roca Martinez et al. would necessarily be the same as the product recited in the instant claims. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed crosslinked HA hydrogel resulted from the said process is different from that of crosslinked HA hydrogel d taught by Roca Martinez et al. See MPEP 2113.
Roca Martinez et al. do not specify the same injection force measured using the same 29G1/2”, i.e., gram force (about 4-15 N measured with 27G1/2” needle vs claimed 19-25 N measured using 29G1/2” needle 1st wherein clause in the instant claim 1).
The claimed 29G ½” of needle for testing the claimed injection force (same as injection force and extrusion force) is different from 27G 13 mm (27G1/2”) needle taught by Roca Martinez et al. The gram force of a gel is affected by the gauge of needle used to measure the gram force, i.e., the higher gauge number (smaller needle opening) the high gram force. The injection force of the same gel tested by 27G 13 mm needle taught by Roca Martinez et al. would be lower than the injection force of the same gel tested by 29G ½” needle disclosed in the instant specification. Thus, the injection force of the gel tested by 27G 13 mm needle taught by Roca Martinez et al. would be > about 4-15 N when tested by 29G ½” needle which includes the claimed 19-25 N and thus being obvious. Furthermore, HA hydrogel with injection force 10-30 N is suitable according to the instant specification, thus, the criticality of the now claimed 19-25 N over > about 4-15 N taught by Roca Martinez et al. is not established. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad number of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ indented material differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Roca Martinez et al. do not specify the particle size of the crosslinked HA hydrogel in the 2nd wherein clause in the instant claim 1 and 1st wherein clause in the instant claim 12.
This deficiency is cured by Njikang et al. who teach highly injectable, long-lasting hyaluronic acid-based hydrogel dermal filler compositions comprising crosslinked hyaluronan polymers of high MW of about 2,500,000-3,000,000 Da and hydrogel being milled to a particle size of about 10-1000 µm (abstract and paragraph 58 and 77).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Roca Martinez et al. and Njikang et al. to specify the particle size of crosslinked HA hydrogel in the composition taught by Roca Martinez et al. having a particle size of about 10-1000 µm. Hyaluronic acid-based hydrogel comprising crosslinked hyaluronan polymers of about 2,500,000-3,000,000 Da MW having a particle size of about 10-1000 µm being suitable highly injectable, long-lasting dermal filler was well known to a person of ordinary skill in the art before the effective filing date of the claimed 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.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Applicants argue that the instant specification does not define lift capacity as an absolute physical equation of cohesivity and elastic module.
However, this argument is not deemed persuasive. The instant specification discloses: lift capability …… can be represented as the product of storage elastic modulus and resistance during compression (page 9, line 9-11)
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elasticity is represented by storage modulus (page 8, line 19-20)
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, and cohesivity …… is measured as resistance when compressed at a certain rate after loading on a rheometer, and its unit is gf (gram force) (page 9, line 7-8)
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. The mathematical meaning of “product” of two values is multiplication of the two values; thus, the instant specification discloses: lift capability = storage elastic modulus (elasticity) x resistance during compression (cohesivity).
Applicants argue that both Roca Martinez et al. and Njikang et al. fail to recognize the importance of a combination of high lift capacity and low injection force.
However, this argument is not deemed persuasive. As stated in the rejection and response above, lift capacity and injection force of the hydrogel filler for injection taught by Roca Martinez et al. are obvious to the claimed lift capacity and injection force of the claimed hydrogel filler for injection. Please refer to MPEP 2145:
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
Applicants argue that both Roca Martinez et al. and Njikang et al. fail to teach the combination of 300-400 µm average particle size, the ≥2.5 M Da molecular weight, and HA hydrogel with 3-5% crosslinking modification.
However, this argument is not deemed persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants argue that the combination of 300-400 µm average particle size, the ≥2.5 M Da molecular weight, and HA hydrogel with 3-5% crosslinking modification results in simultaneous high lift capacity and low injection force and a person of ordinary skill in the art would not have been motivated to arrive at the claimed invention based on the teachings of Roca Martinez et al. and Njikang et al.
However, this argument is not deemed persuasive. As stated in the rejection and response above, lift capacity and injection force of the hydrogel filler for injection taught by Roca Martinez et al. are obvious to the claimed lift capacity and injection force of the claimed hydrogel filler for injection. Please refer to MPEP 2145 discussed above.
Claims 1, 5-8, 12, and 13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gousse et al. (US 2017/0273886 A1).
Gousse et al. teach injectable dermal filler composition comprising
crosslinked hyaluronic acid-based polymer (abstract) including hyaluronic acid with MW of 25,000,000 Da crosslinked with BDDE (the 3rd wherein clause in the instant claim 1 and the 2nd wherein clause in the instant claim 12 and the instant claims 5-6) (paragraph 32, 34, and 38)
with 4% by weight of degree of crosslinking (paragraph 36 and 40) → 3.47 mol% crosslinker / HA (the claimed degree of cross-linking modification in 4th and 6th wherein clauses in the instant claim 1, 3rd and 5th wherein clauses in the instant claim 12, and claim 13) and
having particle size of about 200-300 µm (the 2nd wherein clause in the instant claim 1) (paragraph 81),
elastic modulus about 200 Pa (the claimed 8th wherein clause of property of biphasic HA in the instant claim 1 according to the instant specification) (paragraph 73),
extrusion force of ≤20 N using either 27G or smaller and 30G needle → it is reasonable to assume the extrusion force using 29G needle, between 27G and 30G, would have the same extrusion force of ≤20 N (the instant claim 1) (paragraph 83 and 84), and
cohesivity of 60 gmf (the claimed 7th wherein clause of property of monophasic HA in the instant claim 1 according to the instant specification) (paragraph 85 and 85) and
further including lidocaine (the instant claims 7-8) (paragraph 50).
Lift capacity is a function of cohesivity and elastic module while lift capacity ≈ cohesivity x elastic module which is supported by examples 1 and 2 in the instant specification: 448 Pa x 36 gf = 16128 Pa*gf very close to the measured 16145 Pa*gf (0.1% difference) in example 1 and 707 Pa x 44 gf = 31108 Pa*gf very close to the measured 31391 Pa*gf (0.9% difference) in example 2.
Thus, the hydrogel taught by Gousse et al. having an elastic module of about 200 Pa and a cohesivity of 60 gmf (gram force, the “gf” in the unit of the claimed lift capability) would necessarily have about 12,000 Pa*gf lift capacity (200 Pa x 60 gmf = 12,000 Pa*gmf), whether expressly recognized by Gousse et al. or not. Please refer to MPEP 2112.I and MPEP 2112 II:
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”
Or alternatively, the claimed range of lift capacity is 12,000-16,145 Pa*gf and the range of lift capacity taught in the prior art is about 12,000 Pa*gf and therefor overlaps with the claimed range and having the same property of suitable as dermal filler.
Or alternatively, although Gousse et al. are silent about lift capacity, lift capacity is a function of elastic module, with the crosslinked HA hydrogel having the same molecular weight, the same degree of crosslinking (calculated below) by the same crosslinker, elastic module of about 200 Pa taught by Gousse et al. is lower than the elastic module of 448 Pa and 707 Pa in examples 1 and 2 in the instant specification, cohesivity of 60 gmf taught by Gousse et al. is slightly higher than 36 and 44 gf in examples 1 and 2 in the instant specification, it is reasonable to assume the lift capacity of the crosslinked HA hydrogel being lower than 16128 Pa*gf and 31108 Pa*gf in examples 1 and 2. Furthermore, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Although Gousse et al. are silent about the crosslinking ratio in the 5th and 7th wherein clauses in the instant claim 1 and the 4th and 6th wherein clauses in the instant claim 12, i.e., ratio of reacted crosslinker to total crosslinker initially introduced into the crosslinking reaction, the ratio of reacted crosslinker to total crosslinker initially introduced into the crosslinking reaction is a product-by-process limitation. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the 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. Crosslinked HA hydrogel taught by Gousse et al. and crosslinked HA hydrogel recited in the instant claims both the same degree of crosslinking and crosslinked by the same crosslinker, thus the product taught by Gousse et al. would necessarily be the same as the product recited in the instant claims. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed crosslinked HA hydrogel resulted from the said process is different from that of crosslinked HA hydrogel d taught by Gousse et al. See MPEP 2113.
Gousse et al. do not specify the same extrusion force, the same particle size of the crosslinked HA hydrogel in the 2nd wherein clause in the instant claim 1.
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of extrusion force is 19-25 N and the range of extrusion force taught in the prior art is ≤20 N and therefor, overlaps with the claimed range.
The claimed range of particle size of the crosslinked HA hydrogel is 300-400 µm and the range of particle size of the crosslinked HA hydrogel taught in the prior art is about 200-300 µm and therefor, overlaps with the claimed range.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Applicant’s arguments regarding lift capacity is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
Applicants argue that Gousse et al. fail to recognize the importance of a combination of high lift capacity and low injection force.
However, this argument is not deemed persuasive. As stated in the rejection and response above, lift capacity and injection force of the hydrogel filler for injection taught by Gousse et al. are obvious to the claimed lift capacity and injection force of the claimed hydrogel filler for injection. Please refer to MPEP 2145 discussed above.
Applicants argue that Gousse et al. fail to teach the combination of 300-400 µm average particle size, the ≥2.5 M Da molecular weight, and HA hydrogel with 3-5% crosslinking modification.
However, this argument is not deemed persuasive. As stated in the rejection above and in the previous office action, Gousse et al. teach HA hydrogel particle size of about 200-300 µm (obvious to the claimed 300-400 µm), 25,000,00 Da MW, and 3.47 mol% crosslinking modification.
Applicants argue that the combination of 300-400 µm average particle size, the ≥2.5 M Da molecular weight, and HA hydrogel with 3-5% crosslinking modification results in simultaneous high lift capacity and low injection force and a person of ordinary skill in the art would not have been motivated to arrive at the claimed invention based on the teachings of Gousse et al.
However, this argument is not deemed persuasive. As stated in the rejection and response above, lift capacity and injection force of the hydrogel filler for injection taught by Gousse et al. are obvious to the claimed lift capacity and injection force of the claimed hydrogel filler for injection. Please refer to MPEP 2145 discussed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 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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/HONG YU/
Primary Examiner, Art Unit 1614
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