Prosecution Insights
Last updated: October 25, 2026
Application No. 18/455,258

SPINAL CORD STIMULATION DEVICE IMPLANTATION METHODS AND RELATED SYSTEMS AND DEVICES

Final Rejection §103§112§DOUBLEPATENT
Filed
Aug 24, 2023
Priority
Aug 24, 2022 — provisional 63/400,428
Examiner
BAYS, PAMELA M
Art Unit
3796
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Neuroone Medical Technologies Corporation
OA Round
2 (Final)
72%
Grant Probability
Favorable
3-4
OA Rounds
8m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
413 granted / 575 resolved
+1.8% vs TC avg
Strong +37% interview lift
Without
With
+37.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
24 currently pending
Career history
610
Total Applications
across all art units

Statute-Specific Performance

§101
4.6%
-35.4% vs TC avg
§103
43.1%
+3.1% vs TC avg
§102
16.0%
-24.0% vs TC avg
§112
26.5%
-13.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 575 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
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 This Office Action is responsive to the amendment filed on 14 May 2026. As directed by the amendment: no claims have been amended, Claims 9-20 have been cancelled, and Claims 21-31 have been added. Claims 22-31 are withdrawn from consideration as explained below. Thus, Claims 1-8 and 21 are presently under consideration. Election/Restrictions Newly submitted Claims 22-31 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: New Claims 22-31 are directed to a distinct embodiment of a thin film spinal cord stimulation system comprising a pre-positioned/previously located stylet and an engageable pusher-receiving structure (Paragraphs [0122]-[0128] and [0132]-[0136] of the instant Specification describe these as distinct embodiments of the stimulation system). In addition, these new species are not obvious variants of each other based on the current record. Since the Applicant has received an action on the merits for the originally presented invention (embodiment of Claims 1-8, comprising the embodiment with the needle/expandable elements, see Paragraphs [0122]-[0128] and [0132]-[0136] of the instant Specification which describe these as distinct embodiments of the stimulation system), this invention has been constructively elected by original presentation for prosecution on the merits. The species of new Claims 22-31 are directed to distinct embodiments of the thin film spinal cord stimulation system, which would require different search strategies. Furthermore, Prior Art applicable to one Species would likely not be applicable to the other Species due to the distinct subject matter. Accordingly, Claims 22-31 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, the Applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should the Applicant traverse on the ground that the inventions are not patentably distinct, the Applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 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 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4, 10-16, and 20 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 and 21 of the instant application are nearly verbatim duplicates of Claims 1, 4, 10-16, and 20 of copending Application No. 18/796,426, where Claims 1-8 and 21 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. Claims 6 and 21 of the instant application generally corresponds to and is fully encompassed by Claims 1, 4, 11, and 20 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 § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 21 is 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. Regarding Claim 21, the claim recites “wherein the lumen is configured to receive and slide along a stylet inserted therethrough”. However, it is unclear and therefore indefinite as to how a lumen (which is a void space) can “slide along a stylet”, since this appears to be claiming a structural aspect of an empty component. Therefore this limitation is indefinite. For purposes of examination, this limitation will be interpreted to be, “wherein the lumen is configured to receive a stylet inserted therethrough, and the stylet is configured to slide through the lumen”. Appropriate correction or clarification is required. 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 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (US Publication No. 2018/0008821, previously cited) in view of Kuzma et al. (US Patent No. 6,205,361, previously cited). Regarding Claims 1, 6, and 21, 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, wherein the lumen is configured to receive and slide along a stylet inserted therethrough; 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), wherein the lumen (receiving structure 12 and tip 23 form a circular lumen/collar at “attachment loop” 13, see Fig. 1, 2A, 3A) is configured to receive and slide along a stylet inserted therethrough (insertion tool 20 includes stylet, which is received/slid onto lumen/collar 13; 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 electrode body, wherein the pusher receiving structure is a collar comprising a lumen, wherein the lumen is configured to receive and slide along a stylet inserted therethrough, 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). PNG media_image1.png 587 594 media_image1.png Greyscale 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, previously cited) in view of Kuzma et al. (US Patent No. 6,205,361, previously cited), further in view of Proctor et al. (US Publication No. 2022/0249005, previously cited). 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 to be 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). Response to Arguments The previous provisional Double Patenting Rejections have NOT been withdrawn. The Applicant has requested that the rejection be held in abeyance until allowable subject matter has been indicated (Page 6 of Amendment/Response filed 14 May 2026). The Applicant's arguments filed in the Amendment/Response filed 14 May 2026 with respect to the previous 35 U.S.C. 103 rejections of Claims 1-8 have been fully considered but they are not persuasive. The Applicant argues that neither the previously cited Gonzalez et al. nor Kuzma et al. disclose or teach all of the claimed elements of independent Claim 1. However, the Examiner disagrees with these arguments. The Applicant specifically argues (Page 7 of Remarks): A closer review of Gonzalez, particularly Paragraph [0070], demonstrates that no pusher device is disclosed. What Gonzalez actually discloses is a number of elements that are located about or within one another to arrive at a properly located sheath 114 that allows the thin film device to be rolled within and slid into place within the patient… There is no element of Gonzales that is used to push another element, as is required to meet the limitation of a "pusher device." However, the Examiner disagrees with these arguments. Gonzalez et al. discloses an elongate pusher device (delivery tool 112, Fig. 4, 6, 7; Paragraph 0070) comprising both an elongate pusher body (delivery tool 112 has elongate body, see Figs. 4, 6, 7; Paragraph 0070) and 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). Fig. 7 of Gonzalez et al. is reproduced below which shows an elongate pusher device 112 with an elongate pusher body and distal tip, which is being used to “push” the thin film lead into position: PNG media_image2.png 464 694 media_image2.png Greyscale The Applicant further argues (Pages 8-9 of Remarks): It is clear that a person of ordinary skill in the art would require substantial reconstruction of the delivery tool of Gonzalez to add the insertion tool of Kuzma thereto. The elements of Gonzalez are specifically designed to fit and slide within one another to locate the sheath to a place whereby the implantable thin film device can simply slide through to its desired location. It is unclear how the addition of the insertion tool of Kuzma would be required or add anything to that design. In fact, the addition of an insertion tool such as that of Kuzma would add more required space within the sheath of Gonzales to fit the rolled up implantable thin film device and the insertion tool. Further, the Examiner argued that the pusher receiving structure of Kuzma includes element 12. Element 12 of Kuzma is a "shape-memory element" that is made from metal or a polymer such that it is flexible or resilient to fold and then unfold into its shape as shown in FIG. 2A of Kuzma, below. However, the Examiner disagrees with these arguments. Firstly, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, with respect to Claims 1, 6, and 21 as described in detail above, the Examiner agrees that 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, wherein the lumen is configured to receive and slide along a stylet inserted therethrough; and an elongate pusher device comprising the distal tip constructed and arranged to be coupleable with the pusher receiving structure. Therefore, Kuzma et al. was only used to teach 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), wherein the lumen (receiving structure 12 and tip 23 form a circular lumen/collar at “attachment loop” 13, see Fig. 1, 2A, 3A) is configured to receive and slide along a stylet inserted therethrough (insertion tool 20 includes stylet, which is received/slid onto lumen/collar 13; Figs. 1, 2, 2A; Col. 4, Lines 7-37, 52-60). Therefore, the Examiner maintains that 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, wherein the lumen is configured to receive and slide along a stylet inserted therethrough, 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). With respect to dependent Claims 5 and 6, the Applicant additionally argues that (Page 10 of Remarks): A lumen is not simply a circular structure, and in fact it need not be circular at all. The term is used within the specification of the instant application as a hole through another element (i.e., it is used as a hole that is located "therethrough" throughout the specification) through which another element may pass. The "loop" of Kuzma as defined by the Examiner is not a lumen at all. It is a loop of string or other material that is fed through the insertion device and looped back around the "shape-memory element" to hold the insertion device to the shape- memory element. It is not a hole defined through another element, but rather a loop created by a flexible or otherwise manipulable element. However, the Examiner disagrees with these arguments. In response to the Applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which the Applicant relies (i.e., the structural limitations of “lumen” as defined in the arguments) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Lumen may be defined as “the cavity of a tubular organ or part”. (“Lumen.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/lumen. Accessed 14 Oct. 2026.) Therefore, the Examiner maintains that the lumen disclosed by Kuzma et al. (receiving structure 12 and tip 23 form a circular lumen/collar at “attachment loop” 13, see Fig. 1, 2A, 3A) is encompassed by the broadest reasonable interpretation of “lumen” as recited in the claim. The Applicant’s arguments (see Pages 11-12 of Remarks) with respect to new Claims 22-31 have been fully considered but are moot due to Claims 22-31 being withdrawn from consideration as being directed to a non-elected invention as described in detail above. See 37 CFR 1.142(b) and MPEP § 821.03. No additional specific arguments were presented with respect to the previous 35 U.S.C. 103 rejections of dependent Claims 2-4 and 7-8, nor with respect to the previously cited Proctor et al. reference. Therefore, Claims 1-8 and 21 are rejected as described in detail above. Conclusion The 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 PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 10:00am - 6:00pm EST. 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, Jennifer McDonald can be reached at 571-270-3061. 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. /PAMELA M. BAYS/Primary Examiner, Art Unit 3796
Read full office action

Prosecution Timeline

Aug 24, 2023
Application Filed
Jan 23, 2024
Response after Non-Final Action
Nov 15, 2025
Non-Final Rejection (signed) — §103, §112, §DOUBLEPATENT
Jan 16, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
May 14, 2026
Response Filed
Oct 16, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

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3y 5m to grant Granted Aug 11, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

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Prosecution Projections

3-4
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+37.4%)
3y 10m (~8m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 575 resolved cases by this examiner. Grant probability derived from career allowance rate.

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