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 .
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.
Claims 1, 2, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andino et al. US Patent Application Publication 2018/0333297.
As to claim 1, Andino teaches a method 200, comprising:
inserting a distal end portion of a hollow conduit (Fig. 5, para. 0136) of a medical injector into an eye of a patient - where Andino teaches inserting a distal tip of a needle of a medical injector a first distance into a target tissue until the distal end portion reaches a reference location (para. 0171);
confirming positioning of the distal end portion of the hollow conduit in the reference location – where Andino teaches releasing the actuation rod of the injection assembly, and the force will be insufficient, thus the actuation rod may not move (para. 0172); additionally, if the puncturing member is in a layer other than the target layer, the biasing members 2146 will not overcome the backpressure of the other layer and the actuator 2320 will not displace proximally, which can inform the user that the puncturing member is not within the target layer (para. 0170);
after the confirming, extending the distal end portion of the hollow conduit distally and from the reference location such that the distal end portion enters an injection region of the eye – where Andino teaches the distal tip of the needle included in the medical injector can be inserted a second distance greater than the first distance into the target tissue (para. 0173);
and with the distal end portion of the hollow conduit disposed within the injection region of the eye, conveying a medicament into the injection region via the hollow conduit – where Andino teaches the distal end portion of the actuation rod moves through the injection distance within the medicament container delivering a portion of the medicament to the target tissue (para. 0173-0174).
As to claim 2, Andino teaches inserting the distal end portion into a reference location that is a suprachoroidal space (SCS) of the eye. Where Andino teaches the methods may be designed for drug delivery specifically to the sclera (para. 0332, 0344). Andino further teaches in the second configuration, the distal tip of the puncture member 32240 is inserted deeper into the ocular tissue until at least a portion of the distal tip is disposed within the suprachoroidal space SCS which can be the target region for delivering a medicament (para. 0032).
As to claim 6, Andino teaches the confirming disposal of the distal end portion of the hollow conduit in the reference location includes measuring a pressure within the reference location, the pressure meeting a predetermined threshold pressure – where Andino teaches sensing pressure of the tissue layer based on the backpressure (para. 0170).
As to claim 7,the confirming disposal of the distal end portion of the hollow conduit in the reference location includes measuring a light emissivity gradient between a sclera of the eye and a retinal pigment epithelium of the eye – where Andino teaches in some embodiments a medical injector can include a puncture member included to sense light to determine the depth of the insertion of the puncture member (para. 0331).
Claim Rejections - 35 USC § 103
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 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 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Andino et al. US Patent Application Publication 2018/0333297 in view of Brennan et al. US Patent Application Publication 2015/0148615.
As to claim 22, Andino teaches the present invention substantially as claimed. Andino does not teach the method includes inserting a trocar into the eye, the trocar coupled to an outer sleeve. Brennan teaches ophthalmic surgical systems, methods, and devices (Abstract). Brennan teaches a surgical devices including a handpiece held by the surgeon, where the distal tip of the handpiece can be inserted into the eye and can be, for example a hypodermic needle, tube, cannula, or trocar (Brennan para. 0134). It would have been obvious to include a trocar in the method of Andino since both references are from the same field of endeavor and are both concerned with ophthalmic insertion.
As to claim 24, Andino/Brennan teach . (Original) The method of claim 22, further comprising: removing the trocar while leaving the outer sleeve inserted in the eye – where Brennan teaches a valved cannula and/or valved trocar can be used to reduce leakage of infused fluid from the anterior chamber (Brennan para. 0146). It is old and well known in the art that the cannula (sleeve) is left behind to provide access.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prausnitz et al. WO 2007/131050 is cited to show a drug delivery method to ocular tissue in IDS filed 09/13/2023.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781