DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 19-21, 23, 25-26, 28-31, and 34-35 are withdrawn.
Claims 1-3, 5-6, 8-11, 13-15, and 17-18 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 12/23/2025 has been entered.
Claims 5-6, 13-15, and 17 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification and drawings, and the rejections under 35 U.S.C. 112(b).
Claim 5 is newly objected to due to the amendment.
The rejection of claims 1-3, 5-6, 8-11, 13-15, and 17-18 under 35 U.S.C. 103 has been modified to address the amendments and maintained.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues that the mass ratio in Leung is not 2:4, as the volumes during mixing are not specified, making it impossible to determine the mass ratio (Remarks, page 18). This argument is not persuasive, because Leung teaches a polymer concentration of 1% w/v to 10% w/v is preferable for the solution prior to injection (i.e., after mixing; Leung, page 4, paragraph 0025). Therefore, while Leung does not state the intended volume for a 2% concentration of HA-VS and a 4% concentration of HA-SH, the “% concentrations” taught by Leung refer to a “% w/v” for the solution prior to injection, and therefore a weight (i.e., mass) ratio of 2:4 can be determined for the solution.
Applicant argues that the ratio is necessary to achieve sustained release of macromolecules, and that neither Leung nor Daniloff discloses how to eliminate unwanted covalent bonds between proteins or peptides or polymers, and therefore those skilled in the art were unaware that the composition of claim 1 could eliminate these unwanted bonds and enable the sustained release of the macromolecules (Remarks, page 19). This argument is not persuasive, because a sustained release of macromolecules due to the elimination of covalent bonds is not claimed. Further, while Leung and Daniloff do not specifically mention a sustained release of macromolecules due to the elimination of covalent bonds, Leung and Daniloff teach the composition as stated in the rejection below and therefore would be expected to have the same properties. Leung teaches the solution can comprise modulators of IOP (Leung, page 5, paragraph 0036), such as peptides (Leung, page 5, paragraph 0037), and the injection of the solution results in elevated IOP over a prolonged period of time (Leung, page 5, paragraph 0042, example 4), suggesting a sustained release of the macromolecule.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1-3, 5-6, 8-11, 13-15, and 17-18 are considered to have an effective filing date of 01/16/2020.
New Claim Objections
Claim 5 is objected to because of the following informalities: “is at least one a polysaccharide” should read “is a polysaccharide”. Appropriate correction is required.
Modified/Maintained 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.
Claims 1-3, 5-6, 8-11, 13-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US 20150250815 A1; IDS reference, 01/03/2023) and Daniloff (US 20110033540 A1), and as evidenced by Wyatt Technology. The references were cited previously by the Examiner.
Regarding claim 1, Leung teaches a solution (i.e., composition) comprising HA-VS, a hyaluronic acid (i.e., a suitable first and/or second hydrogel forming polymer as listed in the instant claim 6) modified to contain vinylsulfone groups (i.e., a suitable “first modification” as listed in the instant claim 3 and “electrophilic” as defined by the instant specification, page 11, paragraph 0072), and HA-SH, thiolated (i.e., a suitable “second modification” as listed in the instant claim 3 and “nucleophilic” as defined by the instant specification, page 11, paragraph 0073) hyaluronic acid, in a 2:4 mass ratio (i.e., a ratio of less than 1 as claimed; Leung, page 5, paragraph 0042, example 4). Leung teaches the hydrogel is formed by reaction of the reactive groups of the modified polymers (Leung, page 3, paragraph 0025). Leung teaches the solution can further comprise a therapeutic agent (i.e., target agent; Leung, page 1, paragraph 0005), specifically modulators of IOP (Leung, page 5, paragraph 0036) and teaches the injection of the solution results in elevated IOP over a prolonged period of time (Leung, page 5, paragraph 0042, example 4), suggesting a sustained release of the target agent.
Daniloff teaches a hydrogel composition comprising modified hyaluronic acid (Daniloff, claim 1) wherein the polymeric composition is biodegradable (Daniloff, page 3, paragraph 0015) and states that hyaluronic acid is known in the art to be bioabsorbable (i.e., biodegradable; Daniloff, page 9, paragraph 0063).
Leung and Daniloff are both considered to be analogous to the claimed invention, because all are in the same field of polymer compositions for ophthalmological hydrogels. 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 expected the hyaluronic acid hydrogel of Leung to be biodegradable, because Daniloff teaches the same hydrogel forming polymer to result in a composition that is biodegradable (Daniloff, page 3, paragraph 0015).
Regarding claim 2, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches a hyaluronic acid (i.e., a suitable first and/or second hydrogel forming polymer as listed in the instant claim 6) which is thiolated (i.e., the modification is a thiol; Leung, page 5, paragraph 0042, example 4).
Regarding claim 3, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches HA-VS, a hyaluronic acid (i.e., a suitable first and/or second hydrogel forming polymer as listed in the instant claim 6) modified to contain vinylsulfone groups (i.e., a “first modification”), and HA-SH, thiolated (i.e., a “second modification”; Leung, page 5, paragraph 0042, example 4).
Regarding claim 5, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches a modified hyaluronic acid as both the first and second polymer (Leung, page 5, paragraph 0042, example 4). As evidenced by Wyatt Technology, hyaluronic acid is a polysaccharide (Wyatt Technology, page 1).
Regarding claim 6, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches a modified hyaluronic acid as both the first and second polymer (Leung, page 5, paragraph 0042, example 4).
Regarding claim 8, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the hydrogel composition may be susceptible to enzymatic or hydrolytic degradation processes (Leung, page 11, paragraph 0077), suggesting the hydrogel is able to be hydrolyzed without the involvement of enzymes.
Regarding claim 9, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the polymeric composition is biodegradable (Daniloff, page 3, paragraph 0015) and specifies the polymers may contain an ester linkage (i.e., a hydrolysable functional group as listed in claim 11; Leung, page 9, paragraph 0059).
Regarding claim 10, Leung and Daniloff together teach all the elements of the current invention as applied to claim 9. Leung teaches the polymers may contain an ester linkage (i.e., a hydrolysable functional group as listed in claim 11; Leung, page 9, paragraph 0059).
Regarding claim 11, Leung and Daniloff together teach all the elements of the current invention as applied to claim 10. Leung teaches the polymers may contain an ester linkage (Leung, page 9, paragraph 0059).
Regarding claim 13, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the composition comprises HA-VS (i.e., a first hydrogel forming polymer) and HA-SH (i.e., a second hydrogel forming polymer) with a degree of modification of 20% each (Leung, page 5, paragraph 0042, example 4).
Regarding claim 14, Leung and Daniloff together teach all the elements of the current invention as applied to claim 13. Leung teaches the composition comprises HA-VS (i.e., a first hydrogel forming polymer) and HA-SH (i.e., a second hydrogel forming polymer) with a degree of modification of 20% each (Leung, page 5, paragraph 0042, example 4), resulting in a ratio of 1:1 between the first and second degrees of modification.
Regarding claim 15, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the composition comprises HA-VS (i.e., a hyaluronic acid modified with vinylsulfone groups) and HA-SH (i.e., a hyaluronic acid modified with thiol groups; Leung, page 5, paragraph 0042, example 4).
Regarding claim 17, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the composition as stated above to be a liquid (Leung, page 5, paragraph 0042, example 4). Daniloff, however, teaches formulations which can be liquids or powders (Daniloff, page 14, paragraph 0096). It would have been prima facie obvious to one of ordinary skill in the art to have modified the composition of Leung to utilize the reasonable alternative of a powder as taught by Daniloff, because Daniloff teaches improved release rates from polymer matrices formulated as powder admixes (Daniloff, page 42, paragraph 0253).
Regarding claim 18, Leung and Daniloff together teach all the elements of the current invention as applied to claim 1. Leung teaches the composition comprises HA-VS (i.e., a first hydrogel forming polymer) and HA-SH (i.e., a second hydrogel forming polymer) in a total of 6% in PBS (i.e., a liquid; Leung, page 5, paragraph 0042, example 4), which lies within the claimed range.
Conclusion
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 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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613