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 .
Formal Matters
Receipt of Applicant’s response dated 03/02/2026 is acknowledged.
Claims 1-6 and 20-25 are pending.
Claims 7-19 are canceled.
Claims 1-3 and 5-6 are amended.
Claims 20-25 are new.
Claims 1-6 and 20-25 are under consideration in the instant Office action to the extent of the elected species, i.e., the polymer or one of its physiologically acceptable salts is sodium hyaluronate, the crosslinking agent is 1,4-butanediol diglycidyl ether, and the at least one treatment that the reaction mixture undergoes is neutralization.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objections to the specification set forth in the Office action dated 11/03/2025 are hereby withdrawn in light of Applicant’s amendments to the specification.
Claim Objections
The objections to claims 1-3 and 6 set forth in the Office action dated 11/03/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
The rejections of claims 1-6 set forth in the Office action dated 11/03/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 6 set forth in the Office action dated 11/03/2025 are hereby withdrawn in light of Applicant’s amendments to the claim.
Claim Rejections - 35 USC § 103
The rejections of claims 1-3 and 5-6 over Öhrlund et al and of claim 4 over Öhrlund et al and further in view of Chen et al set forth in the Office action dated 11/03/2025 are hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below as necessitated by Applicant’s amendments to the claims.
NEW GROUNDS OF REJECTION
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24-25 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
(a) Claim 24 recites the limitation “the MoD is greater than or equal to 0.5%” and depends on claim 5 which recites “the…MoD…is less than or equal to 10%”. Claim 24 is rejected for failing to further limit the subject matter of claim 5 and for failing to include all of the limitations of claim 5 because there exist MoD values that satisfy the range required by claim 24 but not claim 5, e.g., a MoD value of 11% falls within the range required by claim 24 but outside of the range required by claim 5.
(b) Claim 25 recites the limitation “said incubating is performed at a temperature less than 9 °C” and depends on claim 1 which recites “incubating…at a temperature of more than 0 °C and less than 10 °C”. Claim 25 is rejected for failing to further limit the subject matter of claim 1 and for failing to include all of the limitations of claim 1 because there exist temperature values that satisfy the range required by claim 25 but not claim 1, e.g., a temperature of -1 °C falls within the range required by claim 25 but outside of the range required by claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 20-22, and 24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Barral (WO 2020/212615 A1, published 10/22/2020).
Barral teaches a process for crosslinking a polymer comprising the addition of 1,4-butanediol diglycidyl ether (BDDE) to sodium hyaluronate with crosslinking conditions of 48 h at 9 ° C, followed by neutralization of the final crosslinked gel (See entire document, e.g., Example 4, [000383]-[000386]). Barral teaches the MoD of the formulation resulting from said process being 4.7% (e.g., Table 6, [000389]). Barral teaches that this formulation exhibits significant and surprising advantages such as good deformation capacity, retained rigidity as well as optimized block compatibility and resistance to enzymatic degradation (e.g., [000392]).
This process taught by Barral anticipates the process of instant claims 1-6, 20-22, and 24.
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.
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 1-6 and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Barral (WO 2020/212615 A1, published 10/22/2020).
The process of Barral has been described supra. Because instant claims 1-6, 20-22, and 24 are anticipated by Barral, instant claims 1-6, 20-22, and 24 are also rendered obvious by Barral. Lack of novelty is the epitome of obviousness (In re May, 574 F.2d 1082, 197 USPQ at 607 (CCPA 1978) (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
With regards to instant claims 23 and 25, Barral teaches, in addition to the exemplified process described supra, a process for crosslinking a polymer comprising: providing a polymer, providing a crosslinking agent, carrying out one or more crosslinking steps in the presence of said polymer and said crosslinking agent, and obtaining a crosslinked polymer, wherein the one or more crosslinking steps may be carried out at constant temperature of less than or equal to 15°C, or less than or equal to 12 ° C, less than or equal to 10 ° C, or less than or equal to 9 ° C, wherein 1,4-butanediol diglycidyl ether (BDDE) is particularly preferred as the crosslinking agent, and wherein sodium hyaluronate is the particularly preferred polymer (See entire document, e.g., Abstract, [00064], [00068], [00075]-[00077], [000119], [000303]). Barral teaches the degree of modification of the crosslinked polymer being less than 5%, or less than 4%, or less than 3.5%, or less than 3% or less than 2.5% (e.g., [000332]-[000336]). Barral teaches neutralization of the final crosslinked gel (e.g., [000352], [000386], [000395]).
Barral teaches that its inventive process using a low crosslinking temperature for an elongated reaction time makes it possible to obtain crosslinked polymers having favorable features regarding the degree of modification value, elastic modulus value, the viscous modulus value, amount of polymer degradation, Tan D value, biocompatibility, and rheological properties in a simple, reliable, reproducible method requiring little human intervention and decreased energy consumption (e.g., [00030]). Barral teaches that the crosslinking step may have a duration of between 3 and 72 hours (e.g., [000121]), but also teaches that recent developments regarding using crosslinking temperatures lower than temperatures conventionally used include that disclosed in US 2010/0261893 wherein when the temperatures for carrying out the processes are less than 20° C the reaction times are always greater than 10 days and may be 28 days and disclosed in KR1018666678 is an example of implementation of a crosslinking process to less than 20°C with reaction times that are greater than 14 days (e.g., [00020], [00026]-[00027]).
The specific combination of features claimed is disclosed within the broad generic ranges taught by Barral but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious” (KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of the process taught by Barral and arrive at a process for crosslinking a polymer comprising: providing sodium hyaluronate as the polymer, providing BDDE as the crosslinking agent, carrying out a crosslinking step at a constant temperature of less than or equal to 15°C, or less than or equal to 12 ° C, less than or equal to 10 ° C, or less than or equal to 9 ° C in the presence of sodium hyaluronate and BDDE for a duration of between 3 and 72 hours or up to many days, e.g., 10 to 28 days, and neutralizing the final product, resulting in a crosslinked polymer with a degree of modification of less than 5%, or less than 4%, or less than 3.5%, or less than 3% or less than 2.5%.
One of ordinary skill in the art would have been motivated to extend the duration of the crosslinking step from 3 to 72 hours to up to many days, e.g., 10 to 28 days, in order to optimize at least one feature of the crosslinked polymer including the degree of modification value, elastic modulus value, the viscous modulus value, amount of polymer degradation, Tan D value, biocompatibility, and/or rheological properties and there would have been a reasonable expectation of success because Barral teach that the inventive process using a low crosslinking temperature over an elongated reaction time is a simple, reliable, reproducible method requiring little human intervention and decreased energy consumption that makes possible obtaining polymers having said features with favorable values.
Regarding the ranges required by the instant claims, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Thus, the process for crosslinking a polymer taught by Barral renders obvious the process of instant claims 1-6 and 20-25.
Response to Applicant’s Arguments
Applicant’s arguments filed on 03/02/2026 have been considered.
Applicant argues the rejections of claims 1-3 and 5-6 over Ohrlund et al and of claim 4 over Ohrlund et al and further in view of Chen et al set forth in the Office action dated 11/03/2025, which have been fully considered by the Examiner but are moot because said rejections have been withdrawn in favor of the new grounds of rejections set forth above, which do not rely on the teaching of Ohrlund et al nor of Chen et al.
Conclusion
No claims are allowable.
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 KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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