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 Objections
Claim 30 is objected to because of the following informalities: the list comprising dashes should be removed and a comma should be included between the third and fourth lines. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-29 and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 24, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 25-29 are rejected as dependents of claim 24.
Regarding claims 25 and 26, the limitation “a perpendicular portion” renders the claim indefinite as it is unclear whether this is the same or different than the “a perpendicular portion” in claim 24, from which claims 25 and 26 depend.
Claim 27 is rejected as a dependent of claim 26.
Regarding claim 32, the limitation “delivery shaft assembly of claim 1” renders the claim indefinite as claim 1 is cancelled and a claim cannot depend from a cancelled claim. Furthermore, it is unclear exactly which claim that claim 32 should depend from.
Allowable Subject Matter
Claims 16-23 and 31 are allowable; claims 24-29 and 32 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action; and claim 30 would be allowable if rewritten or amended to overcome the objection set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Vandiest et al. (US 2019/0038462), which discloses a delivery shaft assembly having a proximal end and a distal end for delivery of an ocular implant (see Figs. 3-7), wherein: the delivery shaft assembly comprises a delivery shaft 330 having a wall defining lumen configured for holding the ocular implant 200, and an adapter 360 at the proximal end of the delivery shaft configured for attachment to an inserter tool 320 for deployment of the implant (see par. 102); wherein the delivery shaft comprises a distal section 330a; wherein the delivery shaft is provided with an axially longitudinal observation fenestration at least partly disposed in the distal compliant section allowing visualization of the implant from an anterior side of the delivery shaft (see par. 94, 106, shaft is transparent); wherein the delivery shaft comprises a distal tip section having an atraumatic distal tip (see par. 152). Vandiest does not disclose the distal compliant section is repeatably bendable, compliant, and biased in a curve in a first plane; wherein the wall in the distal compliant section is provided with a plurality of flexibility slots that impart the bendability, wherein the wall in the distal tip section comprises a pair of cut outs that define a restricting flap and an extension body, wherein, the restricting flap and extension body co- operate to form a wedge-shaped distal tip, and the restricting flap is moveable around a living hinge between an open state and an occluding state and is biased in the occluding state. While additional prior art could be found disclosing the distal compliant section being repeatably bendable, compliant, and biased in a curve in a first plane and the provided with a plurality of flexibility slots that impart the bendability, such as disclosed by Hiorth (US 2022/0288356) and Eastwood et al. (US 2020/0015839), none of these prior art disclose the required restricting flap and extension body wherein the restricting flap is moveable around a living hinge between an open state and an occluding state and is biased in the occluding state.
Raschdorf et al. (CN 102395331) discloses a spring arm 606 that is biased toward another spring arm 606 such that when a rod is inserted the inward bias of the spring arm is pushed outward, thereby preventing the upper shaft 600 separated from the lower part shaft 614 (see par. 109-112, Fig. 83A-83B). However, due to the different configuration of the device of Raschdorf being in a device for tissue or valve repair and not for delivery of an ocular implant, with the arms, similar to flaps, being use to prevent parts of shafts from separating, which would not be beneficial to other prior art mentioned above or the claimed invention, one of ordinary skill would not be motivated to modify teachings described above to add a restricting flap and an extension body as disclosed by Raschdorf.
Vetter et al. (US 2016/0166240) discloses a medical device used for aspiration and soft tissue biopsy procedures that includes a distal tip with a pair of cut outs 466 that define a restricting flap/beak and the flap/beak movable around a living hinge (see par. 25), however, the beaks are biased in the open configuration (see par. 25) and not an occluding state. Due to the lack of biasing in the occluding state and the purpose of the beaks in biopsy procedures, one of ordinary skill in the art would not be motivated to modify the device disclosed by Vandiest, Hiorth, and Eastwood to include all the teachings of claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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