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 .
As directed by the amendment filed on 27 September 2024: specification has been amended to provide the priority claim.
Election/Restrictions
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 September 2026.
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Juan et al. (US 20070191863 A1).
Regarding Claim 14, De Juan discloses a system for facilitating the conduction of fluid from a posterior chamber to a suprachoroidal space of an eye ("shunt permits aqueous humor to flow out of the posterior chamber to release pressure in the posterior chamber" [0215]; FIG. 61), the system comprising,
an implant ("shunt 105" [0093]; FIG. 3A) comprising, an elongate member having a proximal segment and a distal segment ("elongate member having a proximal end 110, a distal end 120" [0093]),
wherein the elongate member is configured to maintain a bent configuration that substantially complies with anatomical curvatures of the posterior chamber and the suprachoroidal space, when deployed in the eye ("shunt 105 can have a radius of curvature that conforms to the radius of curvature of the suprachoroidal space" [0148]); and
a deployer tool ("delivery system 510" [0110]; FIG. 5) comprising, a guide tube ("advancing structure 530" [0111]; FIG. 5) for accessing the posterior chamber of the eye through an insertion site ([0145]), said guide tube comprising a distal tip that is configured to abut a ciliary sulcus or a portion of a ciliary body of the eye ([0111] & [0150-0151]; FIGs. 6E-6H); and
an access needle ("applier 525 has a sharpened distal tip" [0110]; FIG. 5) configured to be disposed within the guide tube and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye ([0120]; FIGs. 6E-6H);
wherein the deployer tool allows for movement of the implant in relation to the access needle in a distal direction along the delivery path ("advancing structure 530 and the applier 525 move relative to one another to remove the shunt 105" [0111]) such that a distal segment of the implant is disposed in the suprachoroidal space of the eye, and a proximal segment of the implant is disposed in the posterior chamber of the eye (see FIG. 61).
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.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Juan in view of Silvestrini et al. (US 20100137981 A1).
Regarding Claim 15, De Juan fails to specify the elongate member is configured to be straightened to facilitate loading of the implant on a distal end of the access needle. However, Silvestrini teaches devices and methods for treatment of eye disease comprising an implant ([0006]) wherein the elongate member is configured to be straightened ("implant is constrained in a first shape … " [0053]; FIG. 5A) to facilitate loading of the implant on a distal end of the access needle ("During delivery of the implant into the eye, the implant is constrained in an alternate shape" [0045]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of De Juan to incorporate the teachings of Silvestrini “to facilitate easy insertion into the eye” ([0040]).
Regarding Claim 16, De Juan discloses the implant and access needle are configured to be in a retracted position and disposed within the guide tube prior to deployment ([0153]; FIG. 6E).
Regarding Claim 17, De Juan discloses the insertion site is located on a cornea of the eye ("incision in the cornea of the eye" [0011]);
wherein the distal tip of the guide tube is configured to be inserted through the corneal insertion site into an anterior chamber of the eye, and to be inserted across a pupil of the eye, and to be moved along a posterior surface of an iris to abut the ciliary sulcus or a portion of the ciliary body of the eye ("applier can approach the location from across the anterior chamber such that the applier is advanced across the iris and/or the anterior chamber" [0144]).
Regarding Claim 18, De Juan discloses the deployer tool further comprises, an access needle holder configured to engage a proximal end of the access needle and configured to extend the access needle distally from the distal tip of the guide tube to allow a distal tip of the access needle to dissect tissue and create the delivery path ("applier control 540 that can be actuated to cause the applier 525 to extend in length in the distal direction" [0114]);
wherein the delivery path comprises a first section extending from the sulcus or a portion of the ciliary body to an inner surface of a sclera and a second section extending from the inner surface of the sclera to the suprachoroidal space; and wherein the first section and second section form a bent angle along the delivery path ("applier 525 is continuously advanced into the eye, via the trabecular meshwork and the ciliary body, until the distal tip is located at or near the suprachoroidal space" [0150]; FIG. 61).
Regarding Claim 19, De Juan discloses the deployer tool further comprises, an implant actuator ("implant advancing actuator 535" [0114]) configured to detachably engage the implant ("delivery component that removably couples to the elongate member" [0013]; "push the shunt 105 off of the applier" [0152]); and an implant actuator holder configured to engage the implant actuator and configured to move the implant actuator such that the implant actuator engages the implant and the implant is moved distally in relation to the access needle along the delivery path ("Once the applier 525 has been properly positioned, the shunt 105 is advanced off of the applier 525, such as by actuating the implant advancing actuator 535 to move the advancing structure 530 (FIG. 5) so as to push the shunt 105 off of the applier into proper placement in the eye" [0152]).
Regarding Claim 20, De Juan discloses the access needle holder is further configured to retract the access needle proximally such that the distal tip of the access needle is more proximal in relation to the distal tip of the implant actuator ("cause the applier 525 to … retract in the opposite direction (proximal direction)" [0114]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
