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 .
Acknowledgement of Papers Received: Amendment/Response dated 8/12/25.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Andino et al (WO 2015/196085 hereafter Andino) in view of Jarrett et al (US 2016/0166504 hereafter Jarrett).
Andino discloses a method for expanding a suprachoroidal space (SCS) of an eye comprising inserting a microneedle into the eye at an insertion site and infusing through the microneedle into the suprachoroidal space with a fluid with sufficient viscosity to expand the space to a thickness of at least 500 microns [abstract, 01048]. The viscosity of the fluid forms a gel with a viscosity of at least 1000 cP (1057, 1059]. The fluid comprises a polyethylene oxide [1137]. The method comprises multiple microneedles comprising multiple injection fluids [1137].
While the reference discloses a liquid formulation injected into the suprachoroidal space that can form a solid insert, the reference is silent to specific crosslinking or an additional insertion into the space. The presence of such components are well known in the art as seen in the Jarret patent.
Jarrett discloses an injectable liquid formulation comprising a pharmaceutical agent and a carrier where the components are covalently bound together and form a solid that precipitates its active agents into the eye over time [abstract. Fig. 1-2, 0023]. The hydrogel comprises materials such as carboxymethyl cellulose present at least 20% of the formulation (0014, 0017]. The hydrogel crosslinks after insertion [0022]. The molecular weight of the macromolecules used can be up to 1 million Daltons [0025, 0038-0040]. The forms hydrogel will degrade over time from 1 to 30 days [0063]. The pharmaceutical agents include VEGF [0089-0095]. The solidified hydrogel acts as an implant and prosthetic in the eye [0121]. It would have been obvious to combine these components into a releasable formulation as they solve the same problem of Andino.
Regarding the specific thickness of the suprachoroidal space as recited in claims 8, 9 and 18, the claims recite that the liquid is sufficient to expand the SCS of the eye, however there are no further limitations to the fluid other than viscosity and molecular weight. The fluids of the prior art combination meet these limitations as they are of the same viscosity and volume and are injected into the same space for the same purpose. The fluids are allowed to remain in place for the same amount of time for the same purpose and as such must complete the same tasks. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable means of expanding the SCS space for drug delivery. It would have been obvious to include the crosslinked hydrogel formulation of Jarrett into the method of Andino as it solves the same problem and the injected fluids are of similar use and viscosity. It would have been obvious to both inject a material into the suprachoroidal space as seen in Andino and inserting an additional implant into the same space to maintain the space as seen in Jarrett. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable means of drug delivery to the eye.
Response to Arguments
Applicant's arguments filed 8/12/25 have been fully considered but they are not persuasive. Applicant argues that the combination of the prior art does not render the claims obvious as the prior art does not disclose a method for expanding a suprachoroidal space by both infusing into a suprachoroidal space a liquid and further disposing a pharmaceutical agents or device into the space.
However, the combination of Andino and Jarrett discloses these limitations where Andino discloses that an fluid is infused through a microneedle into the suprachoroidal space of the eye [1048], while Jarrett discloses the implantation of a pharmaceutical agent into the same space [0121]. It would have been obvious to include the crosslinked hydrogel formulation of Jarrett into the method of Andino as it solves the same problem and the injected fluids are of similar use and viscosity. It would have been obvious to both inject a material into the suprachoroidal space as seen in Andino and inserting an additional implant into the same space to maintain the space as seen in Jarrett. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable means of drug delivery to the eye. For these reasons, the claims are rendered obvious.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618
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