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
The Applicant’s election without traverse of Invention I, directed to Claims 1-15, in the response filed on 12 May 2026 is acknowledged. Claims 16-20, directed to Invention II, have been cancelled in the response.
Claims 1-15 are presently pending in this application.
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.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (US Publication No. 2018/0008821) in view of Kuzma et al. (US Patent No. 6,205,361).
Regarding Claims 1, 2, and 9, Gonzalez et al. discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046) comprising:
(a) a spinal cord stimulation device (70, Fig. 1; Paragraph 0046) comprising:
(i) an elongate thin film lead body (200, Figs. 8-9; “thin film lead”, Paragraph 0073, 0074); and
(ii) a thin film electrode body (stimulation end 202 comprising electrode array 208, Fig. 8-9; Paragraph 0074-0076) disposed at one end of the elongate thin film lead body (200, Figs. 8-9; Paragraph 0074), the thin film electrode body comprising:
(A) at least two contacts (multiple electrodes in electrode array 208, Figs. 8-9; Paragraph 0074, 0058-0060) disposed on the electrode body; and
(b) an elongate pusher device (delivery tool 112, Fig. 4, 6, 7; Paragraph 0070) comprising:
(i) an elongate pusher body (delivery tool 112 has elongate body, see Figs. 4, 6, 7; Paragraph 0070), and a distal face disposed at a distal end of the elongate pusher body (delivery tool 112 has distal tip/face of elongate body, see Figs. 4, 6, 7; Paragraph 0070), the elongate pusher body having an outer shape comprising a smooth upper surface (delivery tool 112 has elongate body with a smooth outer shape/upper surface, see Figs. 4, 6, 7; Paragraph 0070).
Gonzalez et al. does not explicitly disclose a pusher receiving structure disposed on a distal portion of the thin film electrode body, the pusher receiving structure having a lumen extending therethrough, the pusher receiving structure having an outer shape comprising a smooth upper surface; and the elongate pusher body having a pusher lumen extending through a portion of the elongate pusher body; and the distal face of the elongate pusher body being constructed and arranged to be coupleable with a proximal end of the pusher receiving structure, wherein the outer shape of the elongate pusher body includes an outer surface that is complementary to the outer shape of the pusher receiving structure, wherein the outer shape of the pusher receiving structure and the outer surface of the elongate pusher body are configured to resist rotation of the spinal cord stimulation device during positioning of the spinal cord stimulation device.
Kuzma et al. teaches a thin spinal cord stimulation device (Abstract; Col. 4, Lines 1-10, 50-60) comprising a pusher receiving structure (element 12 and attachment loop 13 and ends 16, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1) disposed on a distal portion of the thin film electrode body (electrode array 10, Figs. 1, 2, 2A), the pusher receiving structure having a lumen extending therethrough (receiving structure 12 and tip 23/ends 16 form a circular lumen at “attachment loop” 13, see Fig. 1, 2A, 3A), the pusher receiving structure having an outer shape comprising a smooth upper surface (element 12 and attachment loop 13 and ends 16 have smooth upper surfaces, see Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1); and an elongate pusher device (insertion tool 20; Figs. 1, 2, 2A; Col. 4, Lines 7-37, 52-60) comprising an elongate pusher body having a pusher lumen (see lumen in tube 21 which holds string elements 22A/B, see Figs. 2, 2A, Col. 4, Lines 8-40) extending through a portion of the elongate pusher body; and the distal face of the elongate pusher body (20, 21, see Figs. 1, 2, 2A, 3A) being constructed and arranged to be coupleable with a proximal end of the pusher receiving structure (Col. 4, Lines 7-37, 52-60; Col. 3, Lines 45-55, 60-67; Claim 1), wherein the outer shape of the elongate pusher body includes an outer surface that is complementary to the outer shape of the pusher receiving structure see Figs. 1, 2, 2A, 3A; Col. 4, Lines 7-37, 52-60; Col. 3, Lines 45-55, 60-67; Claim 1), wherein the outer shape of the pusher receiving structure and the outer surface of the elongate pusher body are configured to resist rotation of the spinal cord stimulation device during positioning of the spinal cord stimulation device (Col. 4, Lines 7-37, 52-60; Col. 3, Lines 45-55, 60-67; Claim 1; Abstract; Col. 1, Line 40 – Col. 2, Line 33).
It would have been obvious before the effective filing date of the claimed invention to include a pusher receiving structure disposed on a distal portion of the thin film electrode body, the pusher receiving structure having a lumen extending therethrough, the pusher receiving structure having an outer shape comprising a smooth upper surface; and the elongate pusher body having a pusher lumen extending through a portion of the elongate pusher body; and the distal face of the elongate pusher body being constructed and arranged to be coupleable with a proximal end of the pusher receiving structure, wherein the outer shape of the elongate pusher body includes an outer surface that is complementary to the outer shape of the pusher receiving structure, wherein the outer shape of the pusher receiving structure and the outer surface of the elongate pusher body are configured to resist rotation of the spinal cord stimulation device during positioning of the spinal cord stimulation device, as taught by Kuzma et al., in the thin film spinal cord stimulation system disclosed by Gonzalez et al., in order to provide a secure attachment between the electrode body and the pusher device such as to accurately position the spinal cord stimulation device in an exact location without excess movement of the electrode body (see Kuzma et al., “Once thus deployed, the insertion tool 20 may be further pushed, and/or the electrode lead may be pulled, so as to manipulate the electrode array within the spinal cord cavity to rest in an optimum or desired position.” Col. 4, Lines 52-60; see Col. 1, Line 40 – Col. 2, Line 33).
Regarding Claims 3 and 4, Gonzalez et al. discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046), but does not explicitly disclose a pusher receiving structure disposed on a distal portion of the thin film electrode body, wherein the outer shape of the pusher receiving structure includes at least one rounded side surface. Kuzma et al. teaches a thin spinal cord stimulation device (Abstract; Col. 4, Lines 1-10, 50-60) comprising a pusher receiving structure (element 12 and attachment loop 13 and ends 16, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1) disposed on a distal portion of the thin film electrode body (electrode array 10, Figs. 1, 2, 2A), wherein the outer shape of the pusher receiving structure includes at least one rounded side surface (rounded surfaces of element 12 and attachment loop 13 and ends 16, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1).
It would have been obvious before the effective filing date of the claimed invention to include a pusher receiving structure disposed on a distal portion of the thin film electrode body, wherein the outer shape of the pusher receiving structure includes at least one rounded side surface, as taught by Kuzma et al., in the thin film spinal cord stimulation system disclosed by Gonzalez et al., in order to provide a secure attachment between the electrode body and the pusher device such as to accurately position the spinal cord stimulation device in an exact location without excess movement of the electrode body (see Kuzma et al., “Once thus deployed, the insertion tool 20 may be further pushed, and/or the electrode lead may be pulled, so as to manipulate the electrode array within the spinal cord cavity to rest in an optimum or desired position.” Col. 4, Lines 52-60, ee Col. 1, Line 40 – Col. 2, Line 33), and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, Kuzma et al. does teach the pusher receiving structure (element 12 and attachment loop 13 and ends 16, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1) having flat surfaces (e.g. flat surfaces of ends 16, Figs. 2, 2A, 3A; Col. 3). However, neither Gonzalez et al. nor Kuzma et al. explicitly disclose wherein the outer shape of the pusher receiving structure includes a generally flat upper surface. It would have been obvious before the effective filing date of the claimed invention to include a pusher receiving structure wherein the outer shape of the pusher receiving structure includes a generally flat upper surface, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claims 5-8, Gonzalez et al. further discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046), wherein a distal face disposed at a distal end of the elongate pusher body (delivery tool 112 has distal tip/face of elongate body, see Figs. 4, 6, 7; Paragraph 0070) comprises a blunt and angled face (delivery tool 112 has a flat angled distal tip/face of elongate body, see Figs. 4, 6, 7; Paragraph 0070). Gonzalez et al. does not explicitly disclose a pusher receiving structure disposed on a distal portion of the thin film electrode body, wherein the proximal end of the pusher receiving structure has a corresponding blunt or angled face configured to abut with the face of the elongate pusher body.
Kuzma et al. teaches a thin spinal cord stimulation device (Abstract; Col. 4, Lines 1-10, 50-60) comprising a pusher receiving structure (element 12 and attachment loop 13 and ends 16, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1) disposed on a distal portion of the thin film electrode body (electrode array 10, Figs. 1, 2, 2A), wherein the proximal end of the pusher receiving structure has a corresponding blunt or angled face (element 12 and attachment loop 13 and ends 16 has blunt and angled surfaces, Figs. 2, 2A, 3A; Col. 3, Lines 45-55, 60-67; Col. 4, Lines 7-37, 52-60; Claim 1) configured to abut with the blunt/angled face of the elongate pusher body (insertion tool 20 has blunt and angled surfaces which abut corresponding surfaces of pusher receiver structure 12/13/16; Figs. 1, 2, 2A; Col. 4, Lines 7-37, 52-60).
It would have been obvious before the effective filing date of the claimed invention to include a pusher receiving structure disposed on a distal portion of the thin film electrode body, wherein the proximal end of the pusher receiving structure has a corresponding blunt or angled face configured to abut with the face of the elongate pusher body, as taught by Kuzma et al., in the thin film spinal cord stimulation system disclosed by Gonzalez et al., in order to provide a secure attachment between the electrode body and the pusher device such as to accurately position the spinal cord stimulation device in an exact location without excess movement of the electrode body (see Kuzma et al., “Once thus deployed, the insertion tool 20 may be further pushed, and/or the electrode lead may be pulled, so as to manipulate the electrode array within the spinal cord cavity to rest in an optimum or desired position.” Col. 4, Lines 52-60; see Col. 1, Line 40 – Col. 2, Line 33).
Regarding Claim 10, Gonzalez et al. further discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046), further comprising an introduction needle (102, Fig. 2; Paragraph 0068-0069) comprising a lumen sized to receive the spinal cord stimulation device and the elongate pusher device therethrough (needle lumen [e.g. positionable in tissue] large enough to receive device 80 and delivery tool 112, see Figs. 4-7).
Regarding Claim 11, Gonzalez et al. further discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046), further comprising a steerable stylet (stylet positioned within needle, Paragraph 0043, 0067, 0068) configured to be positionable through the introduction needle (102, Fig. 2; Paragraph 0068-0069).
Regarding Claim 12, Gonzalez et al. further discloses a thin film spinal cord stimulation system (Abstract; spinal cord stimulation (SCS), Paragraph 0042, 0046), further comprising an introduction sheath (sheath 114, Figs. 4-7; Paragraph 0067, 0070-0071) comprising a lumen having a larger inner diameter than the lumen of the introduction needle (sheath 114 lumen larger to accommodate inner dilator 118 and guidewire 108, in addition to other components, see Figs. 4-7, Paragraph 0069-0071).
Regarding Claim 13, Gonzalez et al. further discloses the thin film spinal cord stimulation system further comprising an introduction sheath (sheath 114, Figs. 4-7; Paragraph 0067, 0070-0071), but does not explicitly disclose further comprising a funnel comprising a lumen and a distal end.
Kuzma et al. teaches a thin spinal cord stimulation device (Abstract; Col. 4, Lines 1-10, 50-60) comprising a funnel (see Fig. 3 annotated below) comprising a lumen and a distal end (Col. 4, Lines 23-37).
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It would have been obvious before the effective filing date of the claimed invention to include a funnel comprising a lumen, as taught by Kuzma et al., in the thin film spinal cord stimulation system disclosed by Gonzalez et al., in order to allow for easier insertion of the stimulation device by guiding the components through wider opening of the funnel.
Gonzalez et al. and Kuzma et al. in combination do not explicitly disclose wherein the distal end of the funnel is coupleable to a proximal end of the introduction sheath. Kuzma et al. instead teaches that the sheath 30 and the funnel are one integral structure (see Fig. 3 annotated above). However, it would have been obvious before the effective filing date of the claimed invention to include separate coubleable elements, wherein the distal end of the funnel is coupleable to a proximal end of the introduction sheath in the structure taught by Kuzma et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (US Publication No. 2018/0008821) in view of Kuzma et al. (US Patent No. 6,205,361), further in view of Proctor et al. (US Publication No. 2022/0249005).
Regarding Claims 14 and 15, Gonzalez et al. further discloses the thin film spinal cord stimulation system further comprising a deployment device (sheath 114, Figs. 4-7; Paragraph 0067, 0070-0071) comprising an elongate deployment device body (sheath 114 with elongate body, Figs. 4-7; Paragraph 0067, 0070-0071). However, Gonzalez et al. and Kuzma et al. in combination do not explicitly disclose wherein an expandable structure is disposed at a distal end of the elongate deployment device body, the expandable structure configured to move between a retracted configuration and an expanded configuration, wherein the expandable structure comprises two expandable wings or an expandable sleeve.
Proctor et al. teaches a thin spinal cord stimulation system (Paragraph 0084) comprising an elongate deployment device body (120, 130, Fig. 4; elongate sections attached to expandable structure 100, 20, Figs. 1-3), an expandable structure (100, 20, Figs. 1-3; Paragraph 0108, 0109, 0112, 0116-0120) which is disposed at a distal end of the elongate deployment device body (120, 130, Fig. 4; elongate sections attached to expandable structure 100, 20, Figs. 1-3), the expandable structure configured to move between a retracted configuration and an expanded configuration (see retracted and expanded states in Figs. 2A and 2B; Paragraph 0070, 0096, 0099), wherein the expandable structure (100, 20, Figs. 2, 3) comprises two expandable wings (symmetrical wings on either side of 100, 20, Figs. 2, 3; Paragraph 0096, 0099).
It would have been obvious before the effective filing date of the claimed invention to include an expandable structure is disposed at a distal end of the elongate deployment device body, the expandable structure configured to move between a retracted configuration and an expanded configuration, wherein the expandable structure comprises two expandable wings or an expandable sleeve, as taught by Proctor et al., in the spinal cord stimulation device disclosed by Gonzalez et al. and Kuzma et al. in combination, in order to reduce the necessary incision size for implantation in order allow for the benefits of a larger/paddle electrode coverage of tissue while reducing the need for “a risky and expensive surgical procedure under general anesthesia” (Proctor et al.; Paragraph 0005), and “such that the device can be rolled or otherwise compressed to allow for implantation through a small incision” (Proctor et al.; Paragraph 0012).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 10:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
