CTNF 18/919,897 CTNF 95423 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 2. 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 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. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 3. 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 – 07-08-aia AIA (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. 07-15 AIA 4. Claim s 18-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Ku U.S. 2014/0276748 (herein referred to as “Ku”) . 5. Regarding Claim 18, Ku teaches a medical device (Fig. 1) comprising: a. a non-conductive base component for a tissue penetration device (Fig. 1 and 2, ref num 24, para 0078), the non-conductive base component defining a longitudinal axis therethrough (see Fig. 1, 3A, 3B, ref num 24 defines a longitudinal axis); b. a first layer of conductive material disposed around an outer surface of the non-conductive base component in a spiral pattern (Fig. 3A, ref num 22, para 0044, para 0065, “helical push wire electrodes 22 may be formed of electrically conductive material”); c. a second layer of conductive material disposed around an outer surface of the non-conductive base component in a spiral pattern (Fig. 3A, ref num 22, plurality of helical electrodes, para 0044, “one or more helical push wire electrodes and transmits the treatment energy to one or more helical push wire electrodes 22”; para 0065 for material); and, d. wherein the first and second layers of conductive material are electrically insulated from one another (para 0064, “having a plurality of conductive sections separated by the insulating portions”); and, e. wherein the first and second layers of conductive material are configured to contact tissue (Fig. 3A, expanded state, ref nums 22 are found in contact with tissue; para 0064, “electrodes 22, when deployed, create a circumferentially continuous contact with the inner wall 55 of the renal artery”). 6. Regarding Claims 19 and 20, the first and second layers of conductive material are the same or they are different (para 0065) . Claim Rejections - 35 USC § 103 07-20-aia AIA 7. 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. 07-23-aia AIA 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. 07-21-aia AIA 8. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mirigian U.S. 2016/0374755 (herein referred to as “Mirigian”) and in view of Hancock U.S. 2021/0378738 (herein referred to as “Hancock”) . 9. Regarding Claim 11, Mirigian teaches a system comprising: A non-conductive base component (Fig. 2B, ref num 210, para 0062) attached to a distal end of an electrosurgical sheath (Fig. 2B, ref num 202) A conductive material disposed on an outer surface of the non-conductive base component around a distal opening of the electrosurgical sheath (Fig. 2B, ref num 218, para 0063); and A strip of conductive disposed on an outer surface of the non-conductive base component along the longitudinal axis (Fig. 2B, ref num 208). Mirigian fails to teach an access cannula disposable within a lumen of the electrosurgical sheath and extendable through the lumen and out the distal opening of the non-conductive base component. Hancock teaches a system of analogous art (Fig. 1, 2a, 2b), comprising a non-conductive base component (Fig. 2a, ref num 222, para 0099, “the plug [222] may be made of PEEK or some other insulating material”) attached to a distal end of an electrosurgical sheath (Fig. 2a, ref num 222 is attached to distal end of ref num 204). The system also comprises an access cannula (Fig. 2a, ref num 202), which is disposable within a lumen of the electrosurgical sheath (see Fig. 2a/b, ref num 202 is disposable within lumen of ref num 204) and extendable through the lumen and out a distal opening of the non-conductive base component (Fig. 2b, ref num 202 as shown extends out an opening of ref num 222, opening = 234). This allows for deployment of any surgical device that may need to be delivered to the target tissue (para 0105). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mirigian to include an access cannula that extends through a lumen of the sheath and out the distal opening of the non-conductive base in order to deliver any working end to target tissue and successfully treat the target area . 07-21-aia AIA 10. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mirigian and Hancock, and further in view of Lees U.S. 11,309,140 (earliest filing date 1/4/2019; herein referred to as “Lees”) . 11. Regarding Claim 12, Mirigian fails to teach one or more of the conductive material and the strip of conductive material are applied sputter-coating. Lees teaches a device of analogous art, in which there is a first and second layer of conductive material (Fig. 3, ref num 50, first layer being the top portion, second layer being the bottom portion) that are sputter-coated onto the base component (Col. 4 lines 10-22, “contact 32 of each reed blade 24 may be coat, e.g., by sputtering, with a plurality of layers. For example, a base conductive layer 50”). The sputtering of these materials in the layers allows for a significant increase in electrical performance (Col. 3 lines 21-23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mirigian in order to have the conductive layers sputter coated in order to improve the electrical significance of the device . 07-21-aia AIA 12. Claim s 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mirigian and Hancock, and further in view of Eggers U.S. 2019/0099210 (herein referred to as “Eggers”) . 13. Regarding Claim 13, Mirigian fails to teach a channel formed within the outer surface of the non-conductive base component along the longitudinal axis, wherein the strip of the conductive material extends through the channel. Eggers teaches a channel formed within the outer surface of the non-conductive base component along the longitudinal axis (Fig. 2, ref num 46 see channel), wherein the strip of the conductive material extends through the channel (Fig. 2, ref nums 52a/b and 54a/b all extend through said channel). The plurality of conductive materials bonded to the non-conductive base component is to aid in the regulation of heat through the device (para 0047). Mirigian discusses temperature regulation of the medical device (see Mirigian, para 0047), however it does not offer a solution with regards to the materials of the device of how to regulate said temperature. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mirigian with a plurality of conductive materials bonded to the non-conductive component in order to regulation the heating and temperature of the medical device for proper use of the device during treatment. 14. Regarding Claim 14, Mirigian fails to teach the channel is disposed within a distal portion of the electrosurgical sheath. Eggers teaches the channel is disposed within a distal portion of the electrosurgical sheath (Fig. 2, ref num 46 is shown at the distal end of the sheath, Fig. 1, ref num 40). Mirigian discusses temperature regulation of the medical device (see Mirigian, para 0047), however it does not offer a solution with regards to the materials of the device of how to regulate said temperature. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mirigian with a plurality of conductive materials bonded to the non-conductive component within the channel in order to regulation the heating and temperature of the medical device for proper use of the device during treatment. 15. Regarding Claim 15, Mirigian teaches a distal portion of a conductive wire disposed within the channel (Fig. 2B, ref num 234 is within the channel of ref num 204). 16. Regarding Claim 16, Mirigian teaches the conductive wire extends along the electrosurgical sheath and a proximal end of the conductive wire is connectable to an electrosurgical generator (Fig. 2B, ref num 234 extends along the sheath; Fig. 1, ref num 128 = generator, which is connected to the wire via the catheter ref num 114) . 07-21-aia AIA 17. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mirigian and Hancock, and further in view of Roeder U.S. 2018/0228538 (herein referred to as “Roeder”) . 18. Regarding Claim 17, Mirigian fails to teach a guidewire is extendable through a lumen of the access cannula. Roeder teaches a device of analogous art, in which there is a guidewire (Fig. 1, ref num 46) extendable through a lumen of the access cannula (Fig. 1, ref num 40; para 0037 “a first guidewire 46 may be inserted within a cannula lumen of the inner cannula 40”). The guidewire provides for the tip of the device to be steerable during the actuation of the treatment (para 0037). Therefore, it would haven obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mirigian to include a guidewire for having control of the tip of the device . Double Patenting 08-33 AIA 19. 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). 20. 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). 21. 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. 22. 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. 08-34 AIA 23. Claim s 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-14 of U.S. Patent No. 12,150,690 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent anticipate the claims of the instant application. Here, the more specific patent claims encompass the broader instant application claims. For example, Claims 1 and 11 of the instant application discusses a generic device/system comprising a non-conductive base component and a conductive material disposed on an outer surface of the non-conductive base component, which is a broader recitation compared to the limitations outlined in the reference patent. Following the rationale in In re Goodman cited in the preceding paragraph, wherein the applicant has once been granted a patent containing a claim for the specific narrow invention, the applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer . Allowable Subject Matter 24. Claims 1, 2, 4-10 have allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: a medical device with a non-conductive base component, a conductive material disposed on an outer surface of the non-conductive base component, and a strip of conductive material along a longitudinal axis of the device is well known in the art. This is supported by at least the references cited during the prosecution of this case, as well as other references in the general area that could be located with minimal effort. However, the prior art of record fails to specifically teach the non-conductive base component having a channel formed within an outer surface along the longitudinal axis, wherein the strip of conductive material is disposed in the channel, while the conductive material disposed on an outer surface of the non-conductive base material is around a distal opening of a lumen of the non-conductive base component. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination. 07-43-03 AIA 25. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Conclusion 26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM 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, Joseph Stoklosa can be reached at 571-272-1213. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANNIE L SHOULDERS/Examiner, Art Unit 3794 Application/Control Number: 18/919,897 Page 2 Art Unit: 3794 Application/Control Number: 18/919,897 Page 3 Art Unit: 3794 Application/Control Number: 18/919,897 Page 4 Art Unit: 3794 Application/Control Number: 18/919,897 Page 5 Art Unit: 3794 Application/Control Number: 18/919,897 Page 6 Art Unit: 3794 Application/Control Number: 18/919,897 Page 7 Art Unit: 3794 Application/Control Number: 18/919,897 Page 8 Art Unit: 3794 Application/Control Number: 18/919,897 Page 9 Art Unit: 3794 Application/Control Number: 18/919,897 Page 10 Art Unit: 3794 Application/Control Number: 18/919,897 Page 11 Art Unit: 3794 Application/Control Number: 18/919,897 Page 12 Art Unit: 3794 Application/Control Number: 18/919,897 Page 13 Art Unit: 3794
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