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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 155-157, 160, 161, 163-165, 167, 168, 170, 173-175, and 177-179) in the reply filed on 12/8/25 is acknowledged. Claims 180-182 are withdrawn from consideration.
In light of Applicant’s remarks regarding the election of species requirement, that requirement is withdrawn.
Claim Rejections - 35 USC § 102
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) 155-157, 160, 161, 163-165, 170, 173, 177, and 178 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kangastupa (US 20170266045).
Regarding claim 155, Kangastupa discloses an apparatus (see general apparatus illustrated in fig. 1), comprising: (a) a shaft 12 having: (i) a proximal end (end of 12 toward the top of fig. 1), (ii) a distal end (end of 12 toward the bottom of fig. 1), and (iii) a fluid pathway 16; and (b) a head at the distal end of the shaft (portion of 14 and 13 to which 12 is connected, see fig. 1), the head including: (i) a distal face (distal face of the portion of 14 and 13 to which 12 is connected), the distal face being configured to engage an exterior surface of a patient's eye at an anterior region of the patient's eye (par. 0051), the distal face having a concave curvature contoured to complement a curvature of the patient's eye (see fig. 1; par. 0051), and (ii) a needle (see fig. 1; par. 0049, 0057-0059), the needle being configured to extend distally from the distal face (see fig. 1; par. 0049, 0057-0059), the needle having a length sufficient to enter the patient's eye at a first anterior location and extend through a sclera layer of the patient's eye and thereby position at least a portion of a distal tip of the needle in a suprachoroidal space of the patient's eye at [[an]] a second anterior location [[of]] in the patient's eye while the distal face is seated against the patient's eye, the second anterior location being posterior to the first anterior location (fully capable of achieving the positioning claimed; see par. 0088, 0095, 0098-0100), the needle being in fluid communication with the fluid pathway such that the needle is operable to deliver fluid from the fluid pathway into the suprachoroidal space of the patient's eye (see fig. 1 and at least par. 0059).
Regarding claim 156, Kangastupa discloses the head further including an indexing feature (the rest of 14 in fig. 1), the indexing feature being configured to complement a landmark of the patient's eye to thereby position the needle at a predetermined location in relation to the landmark of the patient's eye (see fig. 1; par. 0050).
Regarding claim 157, Kangastupa disclose the distal face having an edge (edge of 13), the edge defining the indexing feature (indexing feature is defined within the bounds of 13, see fig. 1), the indexing feature having a curvature configured to complement a curvature of the limbus of the patient's eye (see fig. 1, ring/circular shape).
Regarding claim 160, Kangastupa discloses the needle being longitudinally fixed relative to the distal face (via at least stopper 40; see par. 0059).
Regarding claim 161, Kangastupa discloses the distal face having a three-dimensional concave curvature (exists in three dimensions, see fig. 1; additionally curves both circumferentially and radially, see fig. 1).
Regarding claim 163, Kangastupa discloses the shaft defining a longitudinal axis, the needle extending along an exit axis that is parallel with the longitudinal axis of the shaft (see fig. 1).
Regarding claim 164, Kangastupa discloses the needle having a straight configuration (see fig. 1).
Regarding claim 165, Kangastupa discloses the needle having a beveled distal tip (par. 0059, 0107), the beveled distal tip defining a bevel angle (par. 0059, 0107), the bevel angle being configured to be parallel with boundaries of layers of the patient's eye as the needle is inserted into the patient's eye (fully capable of achieving the position claimed; see par. 0088, 0095, 0098-0100).
Regarding claim 170, Kangastupa discloses the shaft further including a laterally facing guidance feature (59 in fig. 5D), the laterally facing guidance feature being configured to complement a landmark of the patient's eye to thereby position the needle at a predetermined orientation in relation to the patient's eye (see positioning of 59 in fig. 5D), the laterally facing guidance feature including a concave face (face of 59 toward the eye in fig. 5D) configured to complement the curvature of the landmark of the patient's eye (see fig. 5D).
Regarding claim 173, Kangsatupa discloses the shaft further including a marking assembly (distal end/face of 12), the marking assembly being configured to mark a needle entry point in relation to a landmark of the patient's eye (distal end of 12 is fully capable of being utilized for marking as claimed).
Regarding claim 177, Kangastupa discloses the marking assembly being configured to mark a needle entry point in relation to a limbus of the patient's eye (see fig. 1; fully capable of performing the claimed function).
Regarding claim 178, Kangastupa discloses an apparatus (see general apparatus illustrated in fig. 1), comprising: (a) a shaft 12 having: (i) a proximal end (end of 12 toward the top of fig. 1), (ii) a distal end (end of 12 toward the bottom of fig. 1), and (iii) a fluid pathway 16; and (b) a head at the distal end of the shaft (portion of 14 and 13 to which 12 is connected, see fig. 1), the head including: (i) a distal face (distal face of the portion of 14 and 13 to which 12 is connected), the distal face being configured to engage an exterior surface of a patient's eye (par. 0051), and (ii) a needle (see fig. 1; par. 0049, 0057-0059) extending distally from the distal face (see fig. 1; par. 0049, 0057-0059), the needle having a length sufficient to enter a the patient's eye at a first anterior location and extend through a sclera layer of the patient's eye and position a distal tip of the needle in a suprachoroidal space of the patient's eye at a second anterior location in the patient's eye while the distal face is seated against the patient's eye, the second anterior location being posterior to the first anterior location (fully capable of achieving the positioning claimed; see par. 0088, 0095, 0098-0100), the needle being in fluid communication with the fluid pathway such that the needle is operable to deliver fluid from the fluid pathway into the suprachoroidal space of the patient's eye (see fig. 1 and at least par. 0059).
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.
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) 167 and 168 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kangastupa in view of Dewoolfson et al. (US 20130144260).
Regarding claims 167 and 168, Kangastupa discloses the apparatus as claimed, except for specifically disclosing the fluid pathway comprising a flexible conduit, with a syringe coupled with the flexible conduit, the syringe being spaced apart from the shaft via the flexible conduit. However, Dewoolfson et al. teaches utilizing a flexible conduit 8 with a coupled syringe 7 which is spaced away from the equivalent shaft by the flexible conduit (see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid pathway of Kangastupa to utilize a flexible conduit and syringe arrangement as claimed, as taught by Dewoolfson et al., since such a modification is the result of a simple substitution of one known injector arrangement for another to achieve the predictable result of delivering fluid (see par. 0061 of Dewoolfson et al.).
Claim(s) 173-175, 177, and 179, claims 173 and 177 in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kangastupa in view of Andino et al. (US 20180042767).
Regarding claims 173, 175, and 177, claims 173 and 177 in the alternative, Kangsatupa fails to specifically disclose the shaft further including a marking assembly, the marking assembly being configured to mark a needle entry point in relation to a landmark/limbus of the patient's eye, where the marking assembly includes two prongs fixedly spaced apart from each other by a predetermined distance. However, Andino et al. teaches providing a marking assembly on a shaft, in the form of two prongs (element 3270, fig. 12; par. 0102). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of Kangastupa to include a marking assembly as taught by Andino et al. for the purpose of providing sufficient structure to measure and/or mark the surface of the eye (Andino et al., par. 0102).
Regarding claims 174 and 179, Kangastupa, modified by Andino et al., while teaching a modular marking assembly that can be removed and arranged relative to the device as a whole (see fig. 12, par. 0102 of Andino et al.), fails to explicitly teach the marking assembly at the proximal end of the shaft. However, such a modification is the result of rearrangement of parts which is held to be an obvious matter of design choice (MPEP 2144.04(VI)(C)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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