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
The amendment filed 05/11/2026 has been entered. Claims 1 and 3-36 remain pending in the application, claim 2 is cancelled, and claims 29-36 are withdrawn. Applicant’s amendments to the claims have overcome each 112(b) rejection previously set forth in the Non-Final Office Action mailed 02/11/2026, however has not overcome the prior art rejection.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive.
Applicant argues on page 9 that Boggs does not disclose an implant delivery device that is suitable for, or capable of, implanting a medical implant with an implant housing and an elongate electrode lead, as claimed. Applicant states that both of Boggs’s implant housing 130 and elongate electrode lead 134 are held in the inner sheath 102, whereas claim 1 recites that the first needle has a lumen that receives the implant housing, and the second needle includes a lumen that receives the elongate electrode lead. The Office respectfully disagrees. The claimed limitation is functional, and therefore Boggs’s first needle 150 need only to be capable of receiving the implant housing 138 in the lumen 120. This is seen in figure 1, as the implant housing 138 is within the second needle 102 which is within the first needle 150. Therefore, the rejection is maintained.
Applicant argues on page 10 that Ward’s figure 14 does not include a lumen adapted to receive the elongate electrode lead and that instead, the electrode 44 is coiled around the needle or carried on the outside. Only an end of the electrode 44 may be fitted into an end of the needle 100, and the elongate electrode lead is not received in a lumen of the needle, as claimed. The Office respectfully disagrees. The claimed limitation is functional, and therefore Ward’s needle 100 need only to be capable of receiving the elongate electrode lead in the lumen 101. This is seen in figure 14, and as disclosed in paragraph 52 “In another embodiment, as illustrated in Figure 14, the electrode 44 of the implantable neurostimulator 40 can be fitted into an opening at the distal end of the needle 100 and pushed out from this space during the deployment” (emphasis added). Thus, the electrode 44 is received in the lumen of the needle 100, and the rejection is maintained.
Although figure 14 is directed to single needle delivery systems, 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]). Therefore, there is motivation to make the substitution.
Claim Objections
Claims 14, 18, 22 and 28 are objected to because of the following informalities:
Claim 14 line 2 “onto and end” is suggested to read “onto an end” for better claim language clarity.
Claim 18 line 4 “the axial direction” is suggested to read “an axial direction” for better antecedent basis.
Claim 18 line 6 “an axial direction” is suggested to read “the axial direction” for better antecedent basis.
Claim 22 line 2 “a locking mechanism is configured” is suggested to read “a locking mechanism configured” for better claim language structure.
Claim 28 line 1 is suggested to add a comma after “The implant delivery device of claim 1” for better claim language structure and consistency.
Appropriate correction is required.
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.
Claims 1, 3-10, 16, 21-25, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boggs et al. (U.S. Pub. No. 2018/0104481), hereinafter known as “Boggs.”
With regards to claim 1, Boggs discloses 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) comprising a lumen adapted to receive 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]).
With regards to claim 3, Boggs discloses wherein the second needle (102) comprises a slot (110; Fig. 5) extending along one side and extending into the lumen (see Fig. 5).
With regards to claim 4, Boggs discloses wherein 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 (110) to the implant housing (138, see Fig. 5) during use.
With regards to claim 5, Boggs discloses wherein 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).
With regards to claim 6, Boggs discloses wherein the attachment point (110) comprises a hole adapted to receive an end of the elongate electrode lead (134).
With regards to claim 7, Boggs discloses wherein the second needle (102) is at least partly disposed in the lumen of the first needle (150).
With regards to claim 8, Boggs discloses wherein 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).
PNG
media_image1.png
504
646
media_image1.png
Greyscale
With regards to claim 9, Boggs discloses further comprising 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).
PNG
media_image2.png
251
654
media_image2.png
Greyscale
With regards to claim 10, Boggs discloses wherein the retaining member comprises 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).
With regards to claim 16, Boggs discloses further comprising 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]).
With regards to claim 21, Boggs discloses wherein 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]).
With regards to claim 22, Boggs discloses wherein 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]).
With regards to claim 23, Boggs discloses wherein the locking mechanism comprises a button (pp. [0225]) arranged to release the locking mechanism (416) for movement of the actuation tab (418) along the guide member.
With regards to claim 24, Boggs discloses further comprising 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).
PNG
media_image2.png
251
654
media_image2.png
Greyscale
With regards to claim 25, Boggs discloses wherein 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.
With regards to claim 28, Boggs discloses further comprising 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.
Claims 1, 5-8, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (WO 2020/043635 A2), hereinafter known as “Ward.”
With regards to claim 1, Ward discloses 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) adapted to receive 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]).
Ward does not explicitly disclose in the embodiment shown in Figs. 19-29 the second needle comprising a lumen.
However, Ward teaches in the embodiment shown in Fig. 14 a needle (100; Fig. 14) comprising 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 obvious for 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.
With regards to claim 5, Ward discloses wherein the second needle (100) comprises an attachment point (opening at the distal end; Fig. 14) at or near a distal end of the second needle (100), and wherein the attachment point 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 (100) (pp. [0052]).
With regards to claim 6, Ward discloses wherein the attachment point comprises a hole (101; Fig. 14) adapted to receive an end of the elongate electrode lead (44).
With regards to claim 7, Ward discloses wherein the second needle (100; akin to 72 in figures 19-29) is at least partly disposed in the lumen of the first needle (80, see Fig. 22).
With regards to claim 8, Ward discloses wherein 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 (100; akin to 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).
PNG
media_image3.png
289
878
media_image3.png
Greyscale
With regards to claim 27, Ward discloses further comprising 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]).
With regards to claim 28, Ward discloses further comprising 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 (100; akin to 72).
Claims 9-10 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 known as “Kaplan.”
With regards to claims 9-10, Ward discloses the device as claimed in claim 1. Ward is silent to further comprising a retaining member adapted to releasable secure the implant housing in the lumen of the first needle (claim 9); and wherein the retaining member comprises a retaining tab formed in a wall of the first needle and adapted to engage the implant housing in the lumen of the first needle (claim 10).
However, in a similar field of endeavor of electrode delivery systems, 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; claim 9); and
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; claim 10).
It would have been obvious for 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 for the purpose of ensuring that the electrode housing is not deployed too early during implantation.
Claims 9 and 11-15 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 known as “Kabe.”
With regards to claims 9 and 11, Ward discloses the device as claimed in claim 1. Ward is silent to further comprising a retaining member adapted to releasably secure the implant housing in the lumen of the first needle (claim 9); wherein the implant housing comprises an attachment point, and the retaining member extends from a part of the handle to the attachment point of the implant housing, the retaining member being detachable to release the implant housing (claim 11); wherein the retaining member comprises a thread that is looped through the attachment point of the implant housing, and wherein the thread can be split to release the implant housing (claim 12); wherein the retaining member comprises a shape memory member having a hook at an end adapted to engage the attachment point of the implant housing, and wherein an opposite end of the shape memory member is arranged to be moved to deform the hook to release the implant housing (claim 13); wherein the retaining member comprises a clamping cap and adapted to be push-fit onto and end of the implant housing (claim 14); and wherein a spring-loaded release mechanism is operable to separate the clamping cap from the implant housing (claim 15).
However, in a similar field of endeavor of electrode delivery systems, 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]; claim 9), and
the implant housing (104) comprises an attachment point (148; Fig. 7), 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]; claim 11);
wherein 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 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; claim 12);
wherein the retaining member (144) comprises a shape memory member having a hook at an 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 member (144) is arranged to be moved to deform the hook to release the implant housing (104, pp. [0077]; claim 13);
wherein 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]; claim 14); and
wherein a spring-loaded release mechanism is operable to separate the clamping cap (506, 508, 524) from the implant housing (148, pp. [0104]; claim 15).
It would have been obvious for 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 for the purpose of ensuring that the electrode housing is maintained within the first needle and not deployed too early during implantation.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Otten (U.S. Pat. No. 5255691).
With regards to claims 16-18, Ward discloses the device as claimed in claim 1. 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]). Ward is silent to further comprising an actuation tab arranged adjacent to the handle, the actuation tab being configured for actuation by a user to move the second needle into the retracted position (claim 16); further comprising a locking mechanism adapted to lock the second needle in the extended position (claim 17); and the locking mechanism comprises a locking slot in the handle, and wherein the second needle is adapted to engage the locking slot such that in one rotational position of the second needle relative to the handle the second needle is locked in the axial direction relative to the handle, and in another rotational position of the second needle relative to the housing the second needle is movable relative to the handle in an axial direction (claim 18).
However, in a similar field of endeavor of dual needle systems, 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 the second needle (20; Fig. 4) into the retracted position (10; Fig. 3, the “stylet” 20 movable within “introducer” 10, see Col. 5, line 56-66; claim 16),
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; claim 17); 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; claim 18).
It would have been obvious for 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 for the purpose of providing 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).
Claims 16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Townley (U.S. Pub. No. 2022/0022951).
Regarding claims 16 and 19-20, Ward discloses the device as claimed in claim 1. 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]). Ward is silent to further comprising an actuation tab arranged adjacent to the handle, the actuation tab being configured for actuation by a user to move the second needle into the retracted position (claim 16); wherein the actuation tab is moveable in a first direction to move the second member in a second direction opposite to the first direction (claim 19); and further comprising a rack and pinion mechanism operably coupled between the actuation tab and the second member (claim 20).
However, in a similar field of endeavor of dual cannula systems in which the internal cannula is movable relative to the outer cannula, Townley teaches an inner second member (“end effector” 214; Fig. 4) that is movable relative to an outer first member (116; Fig. 4) via control of a handle (102; Fig. 3) with an actuation tab (126; Fig. 3) 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]; claim 16),
wherein 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]; claim 19); and
further comprising a rack and pinion mechanism (152 & 154; Fig. 8B) operably coupled between the actuation tab (126) and the second member (214, pp. [0134]; claim 20).
It would have been obvious for 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 for the purpose of providing a control mechanism to move the inner second needle relative to the outer first needle.
Claims 16 and 21-23 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 known as “Bruszewski.”
Regarding claims 16 and 21-23, Ward discloses the device as claimed in claim 1. 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]). Ward is silent to further comprising an actuation tab arranged adjacent to the handle, the actuation tab being configured for actuation by a user to move the second needle into the retracted position (claim 16); wherein the handle comprises a guide member and wherein the actuation tab is movable along the guide member (claim 21); wherein the implant delivery device further comprises a locking mechanism is configured to lock the actuation tab at a position along the guide member (claim 22); and wherein the locking mechanism which comprises a button arranged to release the locking mechanism for movement of the actuation tab along the guide member (claim 23).
However, in a similar field of endeavor of dual cannula systems in which the internal cannula is movable relative to the outer cannula, 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]; claim 16);
wherein 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]; claim 21);
the implant delivery device further comprises a locking mechanism (2318; Fig. 26) is configured to lock the actuation tab (2300) at a position along the guide member (2302; claim 22); and
wherein the locking mechanism 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]; claim 23).
It would have been obvious for 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 for the purpose of providing 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 26 is 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 known as “Drake.”
With regards to claim 26, Boggs discloses the device as claimed in claim 24. Boggs is silent wherein the retaining member comprises a clamping cap adapted to be push-fit onto an implant housing, and further comprising a spring-loaded release mechanism operable to separate the clamping cap from the implant housing when actuated by the actuator, and wherein the actuator is also able to proximally remove the outer sheath after the retaining member has been released.
However, in a similar field of endeavor of electrode delivery systems, 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]).
It would have been obvious for 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 for the purpose of providing 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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, Jackie Ho can be reached at 571-272-4696. 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.
/MOHAMMED S ADAM/Examiner, Art Unit 3771
08/06/2026
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
Prosecution Insights