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 1-28, in the reply filed on October 17, 2025 is acknowledged.
Claims 29-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 13 is objected to because of the following informalities: claim 13 recites “the shape memory housing,” in line 3, but should recite “the shape memory hook.” 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 11-15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “the implant housing comprises an attachment point, for example a hole.” The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the interest of compact prosecution, Examiner interprets a hole to be exemplary and not a requirement of the claim.
Claim 12 recites “the thread can be split, for example cut or untied.” The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the interest of compact prosecution, Examiner interprets cut or tied to be exemplary and not a requirement of the claim.
Claims 13-15 are rejected based upon their dependency from claim 11.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, 7-8, 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ward et. al. (WO 2020/043635 A2), hereinafter, “Ward.”
Regarding claim 1, Ward teaches an implant delivery device (Fig. 22) for implanting a medical implant (42 and 44 in combination; Fig. 22) in a patient, the medical implant comprising an implant housing (42; Fig. 22) and an elongate electrode lead (44; Fig. 22) extending from the implant housing, and wherein the implant delivery device comprises:
a handle (88; Fig. 22),
a first needle (80; Fig. 22) fixed to the handle (88) and extending in a longitudinal direction, the first needle (80) comprising a lumen adapted to receive the implant housing (42) of the medical implant (42, 44), and
a second needle (72; Fig. 22) having a higher gauge than the first needle (80, pp. [0058]), the second needle (72) being adapted to carry the elongate electrode lead (44) of the medical implant (42, 44), and
wherein the second needle (72) is retractably mounted to the handle (88) such that the second needle (72) is movable between:
an extended position (Fig. 25) in which the second needle (72) extends beyond the first needle (80) in the longitudinal direction such that during use the first needle (80) and the second needle (72) can simultaneously position the implant housing (42) at a first depth (pp. [0058]) and the electrode lead (44) at a second depth greater than the first depth (pp. [0058]), and
a retracted position (Fig. 26) in which the second needle (72) is retracted towards the handle (88) to release the electrode lead from the second needle (pp. [0058]).
Regarding claim 5, Ward teaches the invention as discussed above in claim 1. Ward further teaches the second needle (72) comprises an attachment point (75; Fig. 30) at or near a distal end of the second needle (72), and wherein the attachment point (75) is adapted to attach to the elongate electrode lead (44) such that the elongate electrode lead (44) is carried along a side of the second needle (72).
Regarding claim 7, Ward teaches the invention as discussed above in claim 1. Ward further teaches the second needle (72) is at least partly disposed in the lumen of the first needle (80, see Fig. 22).
Regarding claim 8, Ward teaches the invention as discussed above in claim 7. Ward further teaches the lumen of the first needle (80) comprises a primary portion (it is noted, “portion” means any part of the whole; e.g., the bottom proximal half of needle is a portion of the whole needle, see annotated Fig. 22 below) adapted to receive the implant housing (42) and a secondary portion (the bottom distal half of needle, see annotated Fig. 22 below) adapted to receive the second needle (72), the primary portion and the secondary portion each comprising a partially circular cross-section (because only the bottom half of the needle is considered for each portion, the cross-section is a half-circle which is partially circular).
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Regarding claim 27, Ward teaches the invention as discussed above in claim 1. Ward further teaches an implant deployment member comprising a pusher (74; Fig. 27) extending from adjacent to the handle (88) into the lumen of the first needle (80), the implant deployment member (74) being slidable relative to the first needle (80) to push the implant housing (42, 44) out of the first needle (80, pp. [0058]-[0059]).
Regarding claim 28, Ward teaches the invention as discussed above in claim 1. Ward further teaches a medical implant (42 and 44 in combination; Fig. 22) comprising an implant housing (42; Fig. 22) disposed in the lumen of the first needle (80) and an electrode lead (44; Fig. 22) extending from the implant housing (42) and carried by the second needle (72).
Claim(s) 1-10, 16, 21-25, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boggs et. al. (U.S. Pub. No. 2018/0104481), hereinafter, “Boggs.”
Regarding claim 1, Boggs teaches an implant delivery device (Fig. 1) for implanting a medical implant (130; Fig. 1) in a patient, the medical implant (it is noted, the medical implant has not been positively recited, therefore the reference does not need to explicitly disclose the medical implant) comprising an implant housing (e.g., 138; Fig. 1) and an elongate electrode lead (134; Fig. 1) extending from the implant housing, and wherein the implant delivery device comprises:
a handle (422; Fig. 14A),
a first needle (150; Fig. 1) fixed to the handle (422, it is noted, first needle is shown as element 450 in Fig. 14A) and extending in a longitudinal direction, the first needle (150) comprising a lumen (120; Fig. 1) adapted to receive the implant housing (138) of the medical implant (130, see Fig. 1 showing implant 130 within the lumen of the first needle), and
a second needle (102; Fig. 1) having a higher gauge than the first needle (150, pp. [0162] & [0164]), the second needle (102) being adapted to carry the elongate electrode lead (134) of the medical implant (130), and
wherein the second needle (102) is retractably mounted to the handle (422) such that the second needle (102) is movable between:
an extended position (Fig. 2B) in which the second needle (102) extends beyond the first needle (150) in the longitudinal direction such that during use the first needle (150) and the second needle (102) can simultaneously position the implant housing (138) at a first depth and the electrode lead (134) at a second depth greater than the first depth (it is noted, the two needles are capable of moving relative to one another, and therefore are capable of implanting portions of an implant at different depths), and
a retracted position (Fig. 2A) in which the second needle (102) is retracted towards the handle (422) to release the electrode lead (134) from the second needle (102, pp. [0169]).
Regarding claim 2, Boggs teaches the invention as discussed above in claim 1. Boggs teaches the second needle (102) comprises a lumen adapted to receive the elongate electrode lead (134) of the medical implant (130).
Regarding claim 3, Boggs teaches the invention as discussed above in claim 2. Boggs further teaches the second needle (102) comprises a slot (110; Fig. 5) extending along one side and extending into the lumen (see Fig. 5).
Regarding claim 4, Boggs teaches the invention as discussed above in claim 3. Boggs further teaches the first needle (150) and the second needle (102) are non-concentrically arranged (see Figs. 1-2D showing the needles non-concentrical) such that a portion of the electrode lead (134) extends from the lumen of the second needle (102) through the slot (102) to the implant housing (138, see Fig. 5) during use.
Regarding claim 5, Boggs teaches the invention as discussed above in claim 1. Boggs further teaches the second needle (102) comprises an attachment point (110; Fig. 5) at or near a distal end of the second needle (102), and wherein the attachment point (110) is adapted to attach to the elongate electrode lead (134) such that the elongate electrode lead (134) is carried along a side of the second needle (102).
Regarding claim 6, Boggs teaches the invention as discussed above in claim 5. Boggs further teaches the attachment point (110) comprises a hole adapted to receive an end of the elongate electrode lead (134).
Regarding claim 7, Boggs teaches the invention as discussed above in claim 1. Boggs further teaches the second needle (102) is at least partly disposed in the lumen of the first needle (150).
Regarding claim 8, Boggs teaches the invention as discussed above in claim 7. Boggs further teaches the lumen of the first needle (150) comprises a primary portion (it is noted, “portion” means any part of the whole; e.g., the top half and bottom half of needle 150 is a portion of the whole needle, see annotated Fig. 1 below) adapted to receive the implant housing (it is noted, the claim does not positively recite the implant, therefore Boggs must only be capable of performing the recited function) and a secondary portion (the bottom half of needle, see annotated Fig. 1below) adapted to receive the second needle (102), the primary portion and the secondary portion each comprising a partially circular cross-section (because only the top half or bottom half of the needle is considered for each portion, the cross-section is a half-circle which is partially circular).
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Regarding claim 9, Boggs teaches the invention as discussed above in claim 1. Boggs further teaches a retaining member (protruding portion of distal end of first needle 150, see annotated Fig. 9B below) adapted to releasably secure the implant housing (it is noted, the claim does not positively recite the implant, therefore Boggs must only be capable of performing the recited function, the indented portion is capable of receiving an implant housing and is therefore capable of performing the recited function) in the lumen of the first needle (150).
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Regarding claim 10, Boggs teaches the invention as discussed above in claim 9. Boggs further teaches a retaining tab (protruding portion of distal end of first needle 150, see annotated Fig. 9B above) formed in a wall of the first needle (150) and adapted to engage the implant housing (it is noted, the claim does not positively recite the implant, therefore Boggs must only be capable of performing the recited function, the indented portion is capable of receiving an implant housing and is therefore capable of performing the recited function) in the lumen of the first needle (150).
Regarding claim 16, Boggs teaches the invention as discussed above in claim 1. Boggs further teaches an actuation tab (418; Fig. 14A) arranged adjacent to the handle (422), the actuation tab (418) being configured for actuation by a user to move the second needle (102) into the retracted position (pp. [0225]).
Regarding claim 21, Boggs teaches the invention as discussed above in claim 16. Boggs further teaches the handle (422) comprises a guide member (e.g., the opening of the handle that allows tab 418 to move longitudinally) and wherein the actuation tab (418) is movable along the guide member (pp. [0225]).
Regarding claim 22, Boggs teaches the invention as discussed above in claim 21. Boggs further teaches the implant delivery device further comprises a locking mechanism (416; Fig. 14A) is configured to lock the actuation tab (418) at a position along the guide member (pp. [0225]).
Regarding claim 23, Boggs teaches the invention as discussed above in claim 22. Boggs further teaches a button (pp. [0225]) arranged to release the locking mechanism (416) for movement of the actuation tab (418) along the guide member.
Regarding claim 24, Boggs teaches the invention as discussed above in claim 16. Boggs further teaches a retaining member (protruding portion of distal end of first needle 150, see annotated Fig. 9B below) adapted to releasably secure the implant housing (138, it is noted, the claim does not positively recite the implant, therefore Boggs must only be capable of performing the recited function, the indented portion is capable of receiving an implant housing and is therefore capable of performing the recited function) in the lumen of the first needle (150), and wherein the retaining member (see annotated Fig. 9B below) is actuated by the actuation tab (418) to release the implant housing (it is noted, with coil 134 abutting the indented portion, proximal movement by the second needle 102 through proximal movement of the tab 418 would “actuate” the indented portion to bias the implant forward against the proximal movement and release the implant).
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Regarding claim 25, Boggs teaches the invention as discussed above in claim 24. Boggs further teaches movement of the actuation tab (418) through a first distance in a first direction moves the second needle (418) to the retracted position (pp. [0225], it is noted, any proximal movement of the second needle is Fig. 9B would be considered a retracted position), and further movement of the actuation tab (418) through a second distance in the first direction actuates the retaining member (see annotated Fig. 9B above, it is noted, further pulling the tab 418 would “actuate” the indented portion to bias the implant forward against the proximal movement and release the implant) to release the implant housing.
Regarding claim 28, Boggs teaches the invention as discussed above in claim 1. Boggs further teaches a medical implant (130; Fig. 1) comprising an implant housing (138; Fig. 1) disposed in the lumen of the first needle (150) and an electrode lead (134; Fig. 1) extending from the implant housing (138) and carried by the second needle (102).
Claim Rejections - 35 USC § 103
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 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) 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward.
Regarding claim 2, Ward teaches the invention as discussed above in claim 1. However, Ward does not explicitly disclose in the embodiment shown in Figs. 19-29 the second needle comprises a lumen as claimed. Wards teaches in the embodiment shown in Fig. 14 a needle (100; Fig. 14) comprises a lumen (101; Fig. 14) adapted to receive the elongate electrode lead (44) of the medical implant (42, 44). Ward teaches that the needles shown in Figs. 14, 17, 28, 29, and 31 are alternate embodiments (pp. [0052]), but any arrangement of specific embodiments can be substituted to achieve the same purpose (pp. [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second needle in the embodiment of Figs. 19-29 to incorporate the teachings of the needle in the embodiment of Fig. 14 by having a lumen in the needle to receive the elongate electrical lead. Doing so would be a simple substitution of one known configuration of a needle carrying an elongate electrical lead for another to obtain predictable results of providing a dual needle electrode delivery system with a reasonable expectation of success.
Regarding claim 6, Ward teaches the invention as discussed above in claim 5. However, Ward does not explicitly disclose in the embodiment shown in Figs. 19-29 the attachment point comprises a hole as claimed. Wards teaches in the embodiment shown in Fig. 14 a needle (100; Fig. 14) comprises an attachment point as a hole (101; Fig. 14) adapted to receive an end of the elongate electrode lead (44). Ward teaches that the needles shown in Figs. 14, 17, 28, 29, and 31 are alternate embodiments (pp. [0052]), but any arrangement of specific embodiments can be substituted to achieve the same purpose (pp. [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second needle in the embodiment of Figs. 19-29 to incorporate the teachings of the needle in the embodiment of Fig. 14 by having the attachment point as a hole to receive the elongate electrical lead. Doing so would be a simple substitution of one known configuration of a needle carrying an elongate electrical lead for another to obtain predictable results of providing a dual needle electrode delivery system with a reasonable expectation of success.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Kaplan et. al. (U.S. Pub. No. 2003/0233126), hereinafter, “Kaplan.”
Regarding claims 9-10, Ward teaches the invention as discussed above in claim 1. However, Ward does not explicitly teach a retaining member as claimed.
Kaplan teaches a delivery system (Fig. 3A-D) comprising an electrode implant with a housing (302; Fig. 3C), and a needle (304; Fig. 3A) comprising a retaining member (328; Fig. 3B) adapted to releasably secure the implant housing (302) in the lumen of the needle (304), wherein the retaining member (328) comprises a retaining tab (“detent,” pp. [0045]) formed in a wall of the needle (304) and adapted to engage the implant housing (302) in the lumen of the needle (304).
Kaplan is considered to be analogous to the claimed invention because it is in the same field of electrode delivery systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first needle of Ward to incorporate the teachings of Kaplan by providing a retaining tab within the needle to engage the electrode housing. Doing so would ensure that the electrode housing is not deployed too early during implantation.
Claim(s) 9 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Kabe et. al. (U.S. Pub. No. 2018/0318590), hereinafter, “Kabe.”
Regarding claims 9 and 11, Ward teaches the invention as discussed above in claim 1. However, Ward does not explicitly teach a retaining member as claimed. Kabe teaches a delivery system (Fig. 2) comprising an electrode implant with a housing (104; Fig. 7), a delivery sheath (118; Fig. 2), and a retaining member (144; Fig. 7) adapted to releasably secure the implant housing (144) in the lumen of the delivery sheath (120, pp. [pp. 0075]), and
the implant housing (104) comprises an attachment point (148; Fig. 7), for example a hole, and the retaining member (144) extends from a part of the handle (122; Fig. 2) to the attachment point (148) of the implant housing (104, “retriever” 144 connects to “mandrels” which extend through the “torque shaft/steerable catheter” 114/118 which connects to handle 122, see Fig. 2 and pp. [0070] & [0078]), the retaining member (144) being detachable to release the implant housing (104, pp. [0077]).
Regarding claim 12, see the embodiment in Fig. 27 of Kabe, which further teaches the retaining member (144) comprises a thread (528; Fig. 27) that is looped through the attachment point (148) of the implant housing (shown as 300 in Fig. 27, pp. [0102]), and wherein the thread (528) can be split, for example cut or untied, to release the implant housing (300, it is noted, “tether” 528 is capable of being split by any tool of a hard enough material and sharp enough edge).
Regarding claim 13, Kabe further teaches the retaining member (144) comprises a shape memory member having a hooked end (see Fig. 7 showing “retriever” 144 with a curved hook shape, pp. [0076]) adapted to engage the attachment point (148) of the implant housing (104), and wherein an opposite end of the shape memory housing (144) is arranged to be moved to deform the hooked end to release the implant housing (104, pp. [0077]).
Regarding claims 14-15, see the embodiment in Fig. 27 of Kabe, which further teaches the retaining member (144) comprises a clamping cap (506, 508, 524 in combination; Fig. 27) and adapted to be push-fit onto and end of the implant housing (148, pp. [0104]), wherein a spring-loaded release mechanism is operable to separate the clamping cap (506, 508, 524) from the implant housing (148, pp. [0104]).
Kabe is considered to be analogous to the claimed invention because it is in the same field of electrode delivery systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery system of Ward to incorporate the teachings of Kabe by providing a retaining member comprising a thread, shape memory hooked member, or a spring loaded clamping cap to attach to the electrode housing. Doing so would ensure that the electrode housing is maintained within the first needle and not deployed too early during implantation.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Otten (U.S. Pat. No. 5255691).
Regarding claims 16-18, Ward describes generally a handle and actuation system may be used to control the needle delivery system without giving any specific details (see pp. [0058]).
Otten teaches an actuation tab (22; Fig. 6) arranged adjacent to a handle (16; Fig. 6), the actuation tab (22) being configured for actuation by a user to move an inner needle (20; Fig. 4) into a retracted position relative to an outer needle (10; Fig. 3, the “stylet” 20 movable within “introducer” 10, see Col. 5, line 56-66), and
a locking mechanism (18 and 24 in combination, see Figs. 4-6) adapted to lock the second needle (20) in the extended position (Col. 5, line 56 – Col. 6, line 2), and
the locking mechanism comprises a locking slot (18; Fig. 5) in the handle (16), and wherein the second needle (20) is adapted to engage the locking slot (18) such that in one rotational position of the second needle (20) relative to the handle (16) the second needle (20) is locked in the axial direction relative to the handle (16, see Fig. 6; Col. 5, line 56 – Col. 6, line 2), and in another rotational position of the second needle (20) relative to the housing (16) the second needle (20) is movable relative to the handle (16) in an axial direction (Col. 5, line 56 – Col. 6, line 2).
Otten is considered to be analogous to the claimed invention because it is in the same field of dual needle systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle and actuation system of Ward to incorporate the teachings of Otten by providing an actuation tab and locking mechanism with a locking slot. Doing so would provide a control mechanism to move the inner second needle relative to the outer first needle and lock the second needle in place during penetration as taught by Otten (Col. 5, line 67 – Col. 6, line 2).
Claim(s) 16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Townley (U.S. Pub. No. 2022/0022951)(priority to 06/26/2020).
Regarding claims 16 and 19-20, Ward describes generally a handle and actuation system may be used to control the needle delivery system without giving any specific details (see pp. [0058]).
Townley teaches an inner second member (“end effector” 214; Fig. 6) that is movable relative to an outer first member (116; Fig. 6) via control of a handle (102; Fig. 5) with an actuation tab (126; Fig. 5) arranged adjacent to the handle (102), the actuation tab (126) being configured for actuation by a user to move the second member (214) into the retracted position (pp. [0134]), and
the actuation tab (126) is moveable in a first direction to move the second member (214) in a second direction opposite to the first direction (pp. [0134]), and a rack and pinion mechanism (152 & 154; Fig. 8B) operably coupled between the actuation tab (126) and the second member (214, pp. [0134]).
Townley is considered to be analogous to the claimed invention because it is in the same field of dual cannula systems in which the internal cannula is movable relative to the outer cannula. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle and actuation system of Ward to incorporate the teachings of Townley by providing a tab for controlling a rack and pinion mechanism. Doing so would provide a control mechanism to move the inner second needle relative to the outer first needle.
Claim(s) 16 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Bruszewski et. al. (U.S. Pub. No. 2009/0125097), hereinafter, “Bruszewski.”
Regarding claims 16 and 21-23, Ward describes generally a handle and actuation system may be used to control the needle delivery system without giving any specific details (see pp. [0058]).
Bruszewski teaches an actuation tab (2300; Fig. 26, it is noted, “tab” is given its broadest reasonable interpretation to mean an attached piece of material) arranged adjacent to a handle (2200; Fig. 26), the actuation tab (2300) being configured for actuation by a user to move an inner needle (502; Fig. 29) into a retracted position relative to an outer member (202; Fig. 29, pp. [0114]), and
the handle (2200) comprises a guide member (2302; Fig. 26) and wherein the actuation tab (2300) is movable along the guide member (2302, pp. [0112] & [0114]),
the implant delivery device further comprises a locking mechanism which comprises a button (2318; Fig. 26) arranged to release the locking mechanism for movement of the actuation tab (2300) along the guide member (2302, pp. [0112] & [0114]).
Bruszewski is considered to be analogous to the claimed invention because it is in the same field of dual cannula systems in which the internal cannula is movable relative to the outer cannula. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle and actuation system of Ward to incorporate the teachings of Bruszewski by providing an actuation tab and locking mechanism with a release button. Doing so would provide a control mechanism to move the inner needle relative to the outer needle and prevent any unwanted movement of the needle within the body.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs in view of Drake et. al. (U.S. Pub. No. 2020/0353243), hereinafter, “Drake.”
Regarding claim 26, Boggs does not explicitly disclose the retaining member as claimed.
Drake teaches an actuator (e.g., 252, Fig. 10A) capable of releasing a retaining member (18; Fig. 5B, e.g., using a button 260, pp. [0120]) comprising a clamping cap (36 and 38 in combination; Fig. 5B) adapted to be push-fit onto an implant housing (14; Fig. 5B, e.g., retaining member must be pushed toward implant in order to receive and close around it as seen in Fig. 5D), and further comprising a spring-loaded release mechanism (60; Fig. 5B) operable to separate the clamping cap (36, 38) from the implant housing (14) when actuated by the actuator (pp. [0085]), and wherein the actuator (252) is also able to proximally remove the outer sheath (20; Fig. 4B, e.g., the equivalent of second needle 102 of Boggs) after the retaining member has been released (pp. [0071]).
Drake is considered to be analogous to the claimed invention because it is in the same field of electrode delivery systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle and actuation system of Boggs to incorporate the teachings of Drake by providing a restraining mechanism with a push cap and spring loaded release as well as an actuation tab capable of moving the second needle proximally and distally and also having a button to release the restraining mechanism. Doing so would provide a control mechanism that ensures the electrode remains within the delivery device during delivery and is not deployed too early as well as a simple way to deploy the electrode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771