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 .
Response to Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 6/22/2026 is acknowledged.
Applicant’s election without traverse of the polymer of claim 5 as the species in the reply filed on 6/22/2026 is also acknowledged.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
While the species search has not expanded beyond the elected species, the following rejection is made for purposes of compact prosecution as the 103 reference applies to the claims as noted below:
Claims 1, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldberg (WO 2016/191645 A1).
With regards to claims 1, 6, and 9, Goldberg teaches a polymer-based hydrogel implant (¶ 22) with a core and semi permeable membrane (¶¶ 112 and 113) where multiple polymers may be used (¶¶ 26 and 113). The core contains a biologically active molecule (¶ 102).
Examiner notes that hydrogels are by nature capable of absorbing water and transition from gel phase to liquid phase as the concentration of water increases.
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 1-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (WO 2016/191645 A1) in view of Li et al (US 7,397,348).
Goldberg is discussed and further teaches vectors as the actives (¶ 68), but not the specific vectors instantly claimed. Nor does Goldberg teach the use of ABA triblock copolymers.
With regards to claim 2, Li et al teaches implants using amphiphilic ABA triblock copolymer hydrogels (col 3 lines 41-42 and (col 2 lines 31-35).
With regards to claims 3 and 4, Li teaches the capping groups are poly(ethylene) oxide, an aliphatic group (col 3 lines 41-43)
It would have bene obvious to one of ordinary skill in the art to use known hydrogel polymers, such as disclosed by Li et al, in formulating the hydrogels of Goldberg.
Claims 1 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (WO 2016/191645 A1) in view of Genzyme Corp (TW 2016/25792A).
Goldberg is discussed above but does not teach the use of an AAV vector.
Genzyme Corp teaches treatment of the eye using rAAV vectors for treatment of retinal cells (pg s21 and 33).
It would have bene obvious to one of ordinary skill in the art to use known vectors, such as disclosed by Genzyme Corp, in formulating the hydrogel implants of Goldberg.
Claims 1, 6, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (WO 2016/191645 A1) in view of Carvalho et al (US 7,195,774B2).
Goldberg is discussed above but does not teach use of a backing layer.
With regards to claims 10-12 Carvalho et al teaches use of a backing layer facilitates unidirectional delivery of therapeutic agents to the retina and away from the vitreous and other ocular regions (col 16, lines 26-27). The backing layer may include polymers such as polyglycolic, polylactic, or silicone (col 15 lines 54-48).
It would have been obvious to include a backing layer to control delivery of the active.
Claims 1, 6, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (WO 2016/191645 A1) in view of Medicus (US 8,987,339).
Goldberg is discussed above but does not teach the implant is transparent.
Medicus teaches administration of polymer-based implants which come transparent upon exposure to an aqueous environment.
It would have been obvious to one of ordinary skill to formulate the implant to be transparent for benefit of the patient being treated.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and the double patenting rejections overcome.
Examiner notes the prior art does not teach the use of octadecane-poly(ethylene glycol)-octadecane as a hydrogel.
Double Patenting
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,329,730, in view of Li et al (US 7,397,348), Genzyme Corp (TW 2016/25792A), Carvalho et al (US 7,195,774B2), and Medicus (US 8,987,339). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘730 is directed to a method for treating the ear, but uses a thermoresponsive hydrogel with an active contained therein. It does not teach the various dependent limitations instantly claimed, but which are disclosed and discussed in the obviousness rejections above.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,491,263. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘263 is limited to just octadecane-poly(ethylene glycol)-octadecane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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