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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/01/2026 has been entered.
Formal Matters
Receipt of Applicant’s response dated 10/01/2026 is acknowledged.
Claims 1-3, 5-6, 20-22, and 24-25 are pending.
Claims 4, 7-19, and 23 are canceled.
Claim 1 is amended.
Claims 1-3, 5-6, 20-22, and 24-25 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.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 102
The rejection set forth in the Office action dated 06/01/2026 is hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 103
The rejection set forth in the Office action dated 06/01/2026 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
REJECTIONS MAINTAINED
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.
NEW GROUNDS OF OBJECTION/REJECTION
Claim Objections
Claim 1 is objected to because of the following:
The comma following “mixture” in line 3 of claim 1 should be deleted for grammatical correctness;
The comma following “functions” in line 4 of claim 1 should be deleted for grammatical correctness; and
The space in between “°C” and the comma in line 5 of claim 1 should be deleted for grammatical correctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-6, 20-22, and 24-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the polymer or one of its physiologically acceptable salts” in line 3. There is insufficient antecedent basis for this limitation in the claim because the claim does not earlier recite “a polymer or one of its physiologically acceptable salts”. Claims 2-3, 5-6, 20-22, and 24-25 are rejected for depending from claim 1. The Examiner suggests amending “the polymer or one of its physiologically acceptable salts” in line 3 to “a polymer or one of its physiologically acceptable salts” in order to overcome this rejection.
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 1-3, 5-6, 20-22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Barral (WO 2020/212615 A1, published 10/22/2020, cited in Notice of References Cited dated 06/01/2026) in view of Baek et al (Carbohydrate Polymers, 2018, 202, 545-553, published 09/11/2018, cited in IDS dated 10/01/2026).
Barral teaches 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 the crosslinking step has a duration of between 3 and 72 hours, 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], [000121], [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 by using a low crosslinking temperature for an elongated reaction time it is 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 does not teach the crosslinking step being carried out for a period of at least 7 days.
This deficiency is made up for in the teaching of Baek et al.
Baek et al teach the crosslinking of hyaluronic acid hydrogel with BDDE, wherein wide ranges of crosslinking temperature (from 3 °C to 37 °C) and time (up to 4 weeks) were explored for the effects on the physical properties of the hyaluronic acid hydrogel, i.e., the storage modulus and swelling ratio (See entire document, e.g., Abstract, Page 546 Col. 1 Last Par.). Baek et al identified the optimal crosslinking time for each temperature as follows: 18 h at 37 °C, 4 days at 20 °C, and 2 weeks at 10 °C, and that the crosslinking at 3 °C was too slow to be used efficiently however that the maximum storage modulus divided by the initial storage modulus value was not significantly different from that obtained from crosslinking at 10 °C for 4 weeks (e.g., Page 548 Col. 1 Last Par.-Col. 2 First Par.). Baek et al teach findings from their study include that crosslinking efficiency can be enhanced and crosslinking density can be improved by crosslinking at lower temperatures and supplying sufficient crosslinking time with the same amount of crosslinking agent (e.g., Page 549 Col. 1 First Par.).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Barral and Baek et al, to provide 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, 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 up to four weeks, 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 as is taught by Barral to up to four weeks in order to obtain a crosslinked polymer with optimized physical properties including the storage modulus and swelling ratio. There would have been a reasonable expectation of success because Baek et al teach that crosslinking efficiency can be enhanced and crosslinking density can be improved in a process of crosslinking hyaluronic acid with BDDE by crosslinking at lower temperatures and supplying sufficient crosslinking time with the same amount of crosslinking agent and Barral already teaches that by using a low crosslinking temperature for an elongated reaction time it is 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.
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 in view of Baek et al renders obvious the process of instant claims 1-3, 5-6, 20-22, and 24-25 to the extent of the elected species.
Response to Applicant’s Arguments
Applicant’s arguments filed 10/01/2026 have been considered.
Regarding the rejections under 35 USC 112(d) set forth in the Office action dated 06/01/2026, Applicant argues that these are improper rejections as the premise made by the Examiner reads each dependent limitation in isolation and omits the limitations incorporated by dependency instead of reading each added limitation cumulatively with the incorporated limitations. Applicant argues that neither dependent claim 24 nor 25 displaces or contradicts a parent limitation, but rather, each adds a compatible restriction that narrows the parent’s scope.
The above arguments have been fully considered by the Examiner but are not found persuasive because each of claims 24 and 25 broaden the ranges earlier recited in claims 5 and 1, respectively. In order to overcome the rejections, the Examiner suggests amending claim 24 to recite “The method of claim 5, wherein the MoD is greater than or equal to 0.5% and less than or equal to 10%” and suggests amending claim 25 to recite “The method of claim 1, wherein said incubating is performed at a temperature of more than 0 °C and less than 9 °C”.
Applicant’s arguments regarding the rejection under 35 USC 102 and the rejection under 35 USC 103 set forth in the Office action dated 06/01/2026 have been fully considered by the Examiner, however are considered moot as each of these rejections have been withdrawn, and as can be seen above, a new rejection under 35 USC 103 is set forth over Barral in view of Baek et al.
Conclusion
No claims are allowable.
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.
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 at (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.
/K.E.O./Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
