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Claims 19-21, 23, 25-26, 28-31, and 34-35 are withdrawn.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, 8-11, 13-15, and 17-18 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/18/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding Leung with respect to sustained release and concentration (Remarks, pages 7-8) were addressed in the Advisory Action mailed 07/08/2026.
Applicant argues that Example 4 of Leung does not disclose a composition comprising a protein or peptide, and that a generic disclosure of possible IOP modulators in Leung is not a disclosure or suggestion of the specific amended composition (Remarks, page 7). This argument is not persuasive, because Leung teaches hydrogels for inducing elevation of intraocular pressure (Leung, abstract), and therefore, it would be obvious to one of ordinary skill in the art that an IOP modulator would be included as suggested by Leung (Leung, page 5, paragraph 0036). Example 4 cited as an example of a hydrogel composition comprising the hydrogel forming polymers as claimed. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP § 2123(II).
Applicant argues that a mass ratio of below 0.65 addresses a chemical problem by reducing undesired covalent binding, and states that Leung does not provide a release profile for a protein or peptide from the hydrogel of Example 4 or teach that such a mass ratio is used to avoid undesired covalent binding (Remarks, page 8). Applicant further states that the claimed ratio of vinylsulfone-modified polymer to thiol-modified polymer produces a non-obvious technical effect of proteins remaining free rather than being trapped in chemical conjugation, citing Example 8 (Remarks, pages 9-10). This argument is not persuasive, because Leung teaches the claimed mass ratio of a vinylsulfone-modified polymer to a thiol-modified polymer as stated in the rejection below, and therefore the same results attributed to the mass ratio would be expected, absent evidence to the contrary. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See MPEP 716.02(b). In the instant case, the evidence provided by the Applicant demonstrates that a VS/SH ratio of higher than 0.67 results in trapped proteins, and that decreasing the ratio to 0.67 is effective to inhibit undesired binding (instant specification, page 49, paragraph 00233). Therefore, it would be reasonable to expect the ratio of Leung, which is less than 0.65 as claimed, would result in the same technical effect.
Applicant argues that Example 4 of Leung fails to meet the newly recited molecular weight limitation (Remarks, pages 8-9). This argument is not persuasive, because as above, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP § 2123(II). Further, Leung teaches the molecular weight of hydrogel precursors can be in a range of from 5 kDa to 200 kDa (Leung, page 4, paragraph 0025), which lies within the claimed range.
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, 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). 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 first hydrogel forming polymer from the claimed list) modified to contain vinylsulfone groups (i.e., the first modification as claimed), and HA-SH, a thiolated (i.e., the second modification as claimed) hyaluronic acid (i.e., a second hydrogel forming polymer from the claimed list). Leung teaches a 2% concentration of HA-VS and a 4% concentration of HA-SH (Leung, page 5, paragraph 0042, example 4), and teaches a polymer concentration of 1% w/v to 10% w/v is preferable for the solution prior to injection (Leung, page 4, paragraph 0025). Therefore, it would be reasonable to expect the 2% and 4% concentrations cited by the example of Leung to refer to the % w/v in the solution prior to injection (i.e., a 2:4 or 0.33 mass ratio). Leung teaches the molecular weight of hydrogel precursors can be in a range of from 5 kDa to 200 kDa (Leung, page 4, paragraph 0025), which lies within the claimed range. 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. Leung further teaches the modulator is identified from screening of a library which is well known to those of skill in the art, and such as a library comprising polypeptides or antibodies (i.e., proteins; Leung, page 5, paragraphs 0036-0037).
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 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. As above, Leung and Daniloff both teach hyaluronic acid hydrogels, and Daniloff teaches the polymeric composition is biodegradable (Daniloff, page 3, paragraph 0015). Leung further specifies the polymers may contain an ester linkage (i.e., a hydrolysable functional group as listed in claim 11; Leung, page 9, paragraph 0059). 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 hydrolysable linker 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 10, Leung and Daniloff together teach all the elements of the current invention as applied to claim 9. As above, 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. As above, 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
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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