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, Claims 1-8, in the reply filed on 05 November 2025 is acknowledged. Claims 9-20, directed to Invention II, have been cancelled in the response.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4, and 10-15 of copending Application No. 18/796,426. Although the claims at issue are not identical, they are not patentably distinct from each other because the Claims 1-8 of the instant application are nearly verbatim duplicates of Claims 1, 4, and 10-15 of copending Application No. 18/796,426, where Claims 1-8 of the instant application are broader in scope.
Claim 1 of the instant application is nearly identical and broader in scope to Claim 1 of copending Application No. 18/796,426.
Claim 2 of the instant application is nearly identical to Claim 10 of copending Application No. 18/796,426.
Claim 3 of the instant application is nearly identical to Claim 11 of copending Application No. 18/796,426.
Claim 4 of the instant application is nearly identical to Claim 12 of copending Application No. 18/796,426.
Claim 5 of the instant application is nearly identical to Claim 13 of copending Application No. 18/796,426.
Claim 6 of the instant application generally corresponds to and is fully encompassed by Claims 1 and 4 of copending Application No. 18/796,426.
Claim 7 of the instant application is nearly identical to Claim 14 of copending Application No. 18/796,426.
Claim 8 of the instant application is nearly identical to Claim 15 of copending Application No. 18/796,426.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-6 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 and 6, 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
(ii) a distal tip disposed at a distal end of the elongate pusher body (delivery tool 112 has distal tip 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 pusher receiving structure is a collar comprising a lumen; and an elongate pusher device comprising the distal tip constructed and arranged to be coupleable with the pusher receiving structure.
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, 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 a thin electrode body (electrode array 10, Figs. 1, 2, 2A), wherein the pusher receiving structure is a collar comprising a lumen (receiving structure 12 and tip 23 form a circular lumen/collar at “attachment loop” 13, see Fig. 1, 2A, 3A); and an elongate pusher device (insertion tool 20; Figs. 1, 2, 2A; Col. 4, Lines 7-37, 52-60) comprising the distal tip constructed and arranged to be coupleable with the pusher receiving structure (Col. 4, Lines 7-37, 52-60; Col. 3, Lines 45-55, 60-67; 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 electrode body, wherein the pusher receiving structure is a collar comprising a lumen; and wherein the elongate pusher device comprises the distal tip constructed and arranged to be coupleable with the pusher receiving structure, 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 (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).
Regarding Claim 2, Gonzalez et al. further discloses the thin film spinal cord stimulation system 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 3, Gonzalez et al. further discloses the thin film spinal cord stimulation system 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 4, 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) 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 5, 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 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 7 and 8 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 7 and 8, 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 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796