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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 7/23/26. The claims 1-18 are pending. The claims 1, 4, 7-9, 11, 14, and 15 are amended. Claim 18 is new.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 5 and 15 under 35 U.S.C. 112(b) have been considered and the amendments have overcome the rejection.
Applicant’s amendments have overcome the previous claim objections.
Applicant’s arguments, filed 7/23/26 with respect to the rejections of claims 1-17 under 35 U.S.C. 103 as being unpatentable over Vandiest (US2019/0038462) in view of Hiorth (US2022/0288356) have been fully considered but are not persuasive. Applicant argues, the references do not teach or suggest where “the delivery shaft is provided with an axially longitudinal observation fenestration allowing visualization of the ocular implant from an anterior side of the delivery shaft”. Examiner respectfully disagrees, claim 1 requires “an axially longitudinal observation fenestration allowing visualization of the ocular implant from an anterior side of the delivery shaft”. Applicant argues that Vandiest’s fenestration is a transparent material and therefore does not meet the claimed structure. Examiner makes notice, the term “fenestration” is not construed to require ans aperture. Under broadest reasonable interpretation, a “fenestration” includes a window, a region of a wall through which a structure behind it may be viewed. Where Vandiest’s hollow shaft 330 is formed of substantially transparent material extending along its longitudinal axis, through which the implant held in the lumen is visualized from outside the shaft ([0094], [0106]). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues, Vandiest’s transparent shaft is combined with an internal embedded light source and is fundamentally different to the claimed invention. However, Vandiest does not require a light source as Applicant claims. Where, Vandiest describes the LED or optical waveguide as an optional feature that the shaft may be coupled to ([0095]). It is an optional feature, and Vandiest’s transparent shaft permits visualization of the implant independently of it ([0032]).
Applicant argues, Hiorth introducer lumen does not teach a fenestration. Hiorth was not relied upon to teach the observation fenestration. It was relied upon to teach the distal compliant section. Applicant further argues, the proposed substitution of the laser cut nitinol tube of Hiorth for the hollow shaft of Vandiest is physically impossible; since Hiorth’s bending cuts cannot mechanically form or coexist with “an axially longitudinal observation fenestration”. Examiner makes notice, the claim does not require the observation fenestration and the distal compliant section to be on the same section of the shaft or overlap. Hiorth teaches a flexible tube by laser cutting, and the removal of material creating flexibility in the distal portion 10 ([0033]). The observation fenestration is a separate axially extending viewing region of the shaft wall, the modified invention has the features as two distinct structures in the same tube wall, consistent with claim 1.
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 of this title, 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.
Claims 1-3 and 6-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vandiest (US2019/0038462) in view of Hiorth (US2022/0288356).
Regarding claim 1, Vandiest discloses a delivery shaft assembly having a proximal end and a distal end for delivery of an ocular implant, wherein:
the delivery shaft assembly (300) comprises a delivery shaft (330) having a lumen configured for holding the ocular implant ([0102]), and an adapter (360) at the proximal end of the delivery shaft configured for attachment to an inserter tool (320) for deployment of the ocular implant ([0102]);
the delivery shaft comprises a distal section (330a);
the delivery shaft is provided with an axially longitudinal observation fenestration allowing visualization of the ocular implant from an anterior side of the delivery shaft (shaft 330 is transparent, where the transparent exterior is interpreted as an axially longitudinal observation fenestration, [0094], [0106]);
the delivery shaft comprises a distal tip section having an atraumatic pointed end ([0152]);
and the delivery shaft is formed from a compliant material formed into a bend-resistive tube (the hollow shaft may be made of rigid material, [0032]).
Vandiest does not explicitly disclose the delivery shaft comprises a distal compliant section that is repeatably bendable, compliant, and biased in a curve in a 1st plane, and a wall of the bend-resistive tube in the distal compliant section is provided with a plurality of flexibility slots and/or flexibility apertures that impart the bendability. Hiorth teaches an introducer (delivery shaft) for delivering an implant ([0070]) having a distal portion 10 (distal compliant section). The introducer includes an arrangement of control wires along with an elastic element 20. The elastic element 20 is formed of a flexible tube 20 with cuts 22 along its length to provide a required flexibility, and the cuts are formed by laser cutting ([0033]). The tube 20 may for example be formed from a suitably elastic metal such as nitinol ([0072]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the distal complaint section of Vandiest for the distal compliant section made of laser cut nitinol as taught by Hiorth, since the substitution would have yielded predictable results and providing a distal portion that holds an implant to be delivered at a target location and also provides the added benefit of articulating only at the distal portion for steering the delivery shaft as it passes through the bodily structures ([0071] of Hiorth).
Regarding claim 2, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, Hiorth further teaches wherein the compliant material is an opaque metal (section is made of nitinol an opaque metal, [0072]).
Regarding claim 3, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, Hiorth further teaches wherein the plurality of flexibility slots and/or flexibility apertures are provided by removal of material from the bend-resistive tube wall ([0033]).
Regarding claim 6, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1; yet, does not explicitly disclose wherein the observation fenestration is an axially-longitudinal aperture disposed on an anterior side of the bend-resistive tube. It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the claimed invention to have the observation fenestration be an axially-longitudinal aperture disposed on an anterior side of the tube, because Applicant has not disclosed the observation fenestration being an axially-longitudinal aperture provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the transparent tube of Vandiest and Applicant’s invention, to perform equally well with since the observation fenestration would perform the same function of visualizing the implant within the tube.
Regarding claim 7, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, and Hiorth further discloses wherein:
the flexibility slots in the distal compliant section are arranged in a row (see Fig. 8) confined within a posterior half of the transverse cross-section of the bend-resistive tube (proximal half of the section of cuts 22 and two distalmost cuts 22, see Fig. 8);
the wall of the bend-resistive tube in the distal compliant section is further provided with a plurality of flexibility apertures (distal half of the section of cuts 22, see Gig. 8) known as stent apertures that further impart a partial stent-like appearance to the bend-resistive tube and the bendability ([0072]);
the plurality stent apertures are disposed in two axial rows (each row is interpreted as two adjacent cuts 22, see Fig. 8), each row positioned either side of the observation fenestration (sides of the observation fenestration are interpreted as a proximal and distal end of the transparent tube, [0094]) and between the row of flexibility slots (row of apertures is selected between the row of slots by the slots being proximal to the cuts 22 that define the apertures and the distalmost cuts 22 being the slots, see Fig. 8).
Regarding claim 8, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 7, Hiorth further teaches wherein:
a majority of or all the stent apertures have the same shape (see Fig. 8)
Regarding claim 9, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, Hiorth further teaches wherein:
the bend-resistive tube in the distal tip section comprises a pair of axially-longitudinal open slots (cuts 22 at distalmost end, see Fig. 8) extending to a distal terminal end of the bend-resistive tube that define a pair of restricting jaws (jaws are interpreted as the material between the slots 22 at the distalmost end);
one restricting jaw is an anterior positioned restricting jaw and the other restricting jaw is a posterior positioned restricting jaw (the anterior jaw is interpreted as the material between cut 22 at distalmost end, and the posterior jaw is interpreted as the material between cut 22 at the cut 22 proximal to the distalmost end);
one or both of the anterior restricting jaw and posterior restricting jaw are angled closed towards a central axis of the bend-resistive tube (angled closed when the tube is curved in a direction toward the central axis, see Fig. 8); and
one or both of the anterior restricting jaw and posterior restricting jaw is disposed with a plurality of radial slits that form a living hinge (slits are interpreted as the cuts that form a hinge by the bendability with the material of the tube).
Regarding claim 10, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 9, wherein a closed end of an axially-longitudinal open slot is in the distal tip section (see Fig. 8).
Regarding claim 11, Vandiest/Hiorth the delivery shaft assembly of claim 1, the modified invention discloses wherein:
the bend-resistive tube comprises a pair of axially-longitudinal open slots (cuts 22, see Fig. 8 of Hiorth) disposed on an anterior and posterior side of the bend-resistive tube and extending to a distal terminal end of the bend-resistive tube that define a pair of retaining arms (arms are interpreted as the material of the tube between the slots, see Fig. 8 of Hiorth) configured to retain the ocular implant prior to deployment (the lumen is capable of retaining an ocular implant, the distal portion of tube is intended to hold an ocular implant in Vandiest, [0111]);
the observation fenestration is one of the axially-longitudinal open slots disposed on an anterior side of the bend-resistive tube (the observation fenestration is interpreted as the slot and the slot can be used to view the implant inside the tube).
Regarding claim 12, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 11, the modified invention discloses wherein a closed end of an axially-longitudinal open slot is in the distal compliant section (see Fig. 8 of Hiorth).
Regarding claim 13, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1; yet, does not explicitly disclose wherein the bend-resistive tube at the distal tip section is beveled. Vandiest according to another embodiment teaches the distal tip section is beveled ([0033]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the tip of the bend-resistive tube of Vandiest/Hiorth to be a beveled tip in order to reduce damage and irritation to the eye during the implantation process ([0033] of Vandiest).
Regarding claim 16, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 2, Hiorth further teaches wherein the opaque metal is nitinol (section is made of nitinol, [0072]).
Regarding claim 17, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 3, Hiorth further teaches wherein the removal of material from the bend-resistive tube wall is performed by laser cutting ([0033]).
Regarding claim 18, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, Vandiest further discloses wherein the delivery shaft further comprises a proximal section adjacent to the compliant distal section, wherein a total axial length of the proximal section is non-compliant and straight ([0032], [0146], see Fig. 3).
Regarding claim 14, Vandiest discloses a method for manufacturing the delivery shaft assembly of claim 1, the method comprising:
providing the delivery shaft (330) having a proximal end and a distal end (see Fig. 4) comprising the lumen configured for holding the ocular implant ([0102]), wherein the delivery shaft is made from a compliant material formed into a bend-resistive tube (the hollow shaft may be made of rigid material, [0032]);
forming an atraumatic pointed end in the distal tip section ([0152]);
Vandiest is silent regarding introducing a curve at the distal end of the delivery shaft thereby forming a distal compliant section; introducing the plurality of flexibility slots in a distal compliant section to impart the compliance and bendability in the 1st plane by removal of tube material from the bend-resistive tube wall; introducing the observation fenestration by removal of tube material from the bend-resistive tube wall. Hiorth teaches an introducer (delivery shaft) for delivering an implant ([0070]) having a distal portion 10 (distal compliant section). The introducer includes an arrangement of control wires along with an elastic element 20. The elastic element 20 is formed of a flexible tube 20 with cuts 22 along its length to provide a required flexibility, and the cuts are formed by laser cutting ([0033]). The tube 20 may for example be formed from a suitably elastic metal such as nitinol ([0072]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the distal complaint section of Vandiest for the distal compliant section made of laser cut nitinol as taught by Hiorth, since the substitution would have yielded predictable results and providing a distal portion that holds an implant to be delivered at a target location and also provides the added benefit of articulating only at the distal portion for steering the delivery shaft as it passes through the bodily structures ([0071] of Hiorth). Where the material removed by laser cutting would form cuts 22 of Hiorth, that form the structures of the observation fenestration and flexibility slots.
Regarding claim 15, Vandiest/Hiorth makes obvious the method according to claim 14, Hiorth further teaches further comprising introducing axially-longitudinal open slots are introduced by a step of removal of tube material from the bend-resistive tube wall ([0033]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Vandiest (US2019/0038462) in view of Hiorth (US2022/0288356) as applied to claim 1, and further in view of Salahieh (US2012/0277730).
Regarding claim 4, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 1, Vandiest further discloses wherein the delivery shaft further comprises a proximal section adjacent to the distal compliant section (see Fig. 3). However, the combination does not disclose wherein the bend-resistive tube in the proximal section comprises one or more compliant portions. Salahieh teaches a delivery tube with a distal steerable portion 54 and a proximal portion 58 ([0089]). The proximal portion has a plurality of overlapping slots 60 (compliant portions) in the wall of the ube, which provide flexibility while keeping axial force and torque transmission characteristics ([0089], see Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal section of Vandiest/Hiorth with the one or more compliant sections as taught by Salahieh in order to allow the proximal section of the delivery shaft to flex without losing the axial force and torque characteristics needed to advance and deploy the implant ([0089] of Salahieh).
Regarding claim 5, Vandiest/Hiorth/Salahieh makes obvious the delivery shaft assembly of claim 4, Salahieh further teaches wherein each compliant portion comprises one or more flexibility slots (overlapping slots 60, [0089]).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
