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
Claims 1, 4, 7-9, 11, 14 are objected to because of the following informalities:
Claim 4 recites “compliant distal section” should be changed to recite “distal compliant section”.
Claim 7 recites “the flexibility slots in the distal compliant section are arranged in a row confined within a posterior half of the transverse cross-section of the bend-resistive tube –
the wall of the bend-resistive tube in the distal compliant section is further provided with a plurality of flexibility apertures known as stent apertures that further impart a partial stent-like appearance to the bend-resistive tube and the bendability”.
Should be changed to recite “the flexibility slots in the distal compliant section are arranged in a row confined within a posterior half of the transverse cross-section of the bend-resistive tube;
the wall of the bend-resistive tube in the distal compliant section is further provided with a plurality of flexibility apertures known as stent apertures that further impart a partial stent-like appearance to the bend-resistive tube and the bendability”. Appropriate correction is required.
Claim 7 recites “each row positioned either side of the observation fenestration and between the row of flexibility slots.” Should be changed to recite “each row positioned on either side of the observation fenestration and between the row of flexibility slots”. Appropriate correction is required.
Claim 8 recites “the delivery shaft assembly of 7” should be changed to recite “the delivery shaft assembly of claim 7”. Appropriate correction is required.
Claim 9 recites “one or both the anterior restricting jaw and posterior restricting jaw are angled closed towards a central axis of the bend-resistive tube; and
one or both the anterior restricting jaw and posterior restricting jaw is disposed with a plurality of radial slits that form a living hinge.”
Should be changed to recite “one or both of the anterior restricting jaw and posterior restricting jaw are angled closed towards a central axis of the bend-resistive tube; 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.” Appropriate correction is required.
Claim 14 recites “providing the delivery shaft having a proximal end and a distal end comprising the lumen configured for holding the ocular implant wherein the delivery shaft is made from a compliant material formed into a bend-resistive tube”.
Should be changed to recite “providing the delivery shaft having a proximal end and a distal end comprising the lumen configured for holding the ocular implant, wherein the delivery shaft is made from a compliant material formed into a bend-resistive tube”. Appropriate correction is required.
Claim 14 recites “forming an atraumatic in the distal tip section” should be changed to recite “forming an atraumatic pointed end in the distal tip section”. Appropriate correction is required.
The claims 1, 4, 7, 8, 9, 11, 14 include unnecessary hyphens such as in claim 1 “a delivery shaft assembly having a proximal end and a distal end for delivery of an ocular implant, wherein: - the delivery shaft assembly comprises a delivery shaft having a lumen configured for holding the ocular implant, and an adapter at the proximal end of the delivery shaft configured for attachment to an inserter tool for deployment of the ocular implant; - the delivery shaft comprises a distal compliant section that is repeatably bendable, compliant, and biased in a curve in a 1st plane; - 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; - the delivery shaft comprises a distal tip section having an atraumatic pointed end; and - the delivery shaft is formed from a compliant material formed into a bend-resistive tube, 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”.
The claim 1 should be changed to read: “a delivery shaft assembly having a proximal end and a distal end for delivery of an ocular implant, wherein: the delivery shaft assembly comprises a delivery shaft having a lumen configured for holding the ocular implant, and an adapter at the proximal end of the delivery shaft configured for attachment to an inserter tool for deployment of the ocular implant; the delivery shaft comprises a distal compliant section that is repeatably bendable, compliant, and biased in a curve in a 1st plane; 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; the delivery shaft comprises a distal tip section having an atraumatic pointed end; and the delivery shaft is formed from a compliant material formed into a bend-resistive tube, 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.”
These hyphens should be removed from all the claims. 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.
Claim 5 and 15 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 pre-AIA the applicant regards as the invention.
Claim 5 recites “each compliant portion comprises one or more flexibility slots”; and claim 4 from which claim 5 depends recites “the tube in the proximal section comprises one or more compliant portions, or a total axial length of the proximal portion is non-compliant and straight”. It is unclear how claim 5 can include “compliant portions” when it is an optional feature in claim 4. For examination purposes the proximal section is interpreted as “non-compliant and straight”.
Claim 15 recites “axially-longitudinal open slots”. It is unclear if the claimed feature is the same or different from the previously recited “plurality of flexibility slots” in claim 14.
Claim 15 recites “wherein axially-longitudinal open slots, and/or a living hinge are introduced by a step of removal of tube material from the bend-resistive tube wall.; and claim 14 from which claim 15 depends previously recited “flexibility slots and/or flexibility apertures”. It is unclear how claim 15 can include “open slots” when it is an optional feature in claim 4.
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 1-17 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 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 compliant distal section, wherein: a total axial length of the proximal portion is non-compliant and straight ([0032], [0146], see Fig. 3).
Regarding claim 5, Vandiest/Hiorth makes obvious the delivery shaft assembly of claim 4, wherein each compliant portion comprises one or more flexibility slots (the distal compliant portion contains slots or cuts 22, [0072]).
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 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 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 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 wherein axially-longitudinal open slots are introduced by a step of removal of tube material from the bend-resistive tube wall ([0033]).
Conclusion
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.
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/M.A.M/ /THOMAS C BARRETT/Examiner, Art Unit 3774 SPE, Art Unit 3799