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 .
Information Disclosure Statement
Applicant’s information disclosure statement, filed January 26, 2024, has been entered and the references cited therein have been considered by the examiner.
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)(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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McGee et al. (PCT Publication No. 95/10225).
In regard to claims 1-5, McGee et al. teach an ablation catheter (see page 3, lines 7-13) comprised of a guide tube 18 having a distal and a proximal end and a loop element 10 positioned at the distal section 24 of guide tube 18 (see Figs. 2 and 3). Loop element 10 is formed from an elongated body 12 that is preformed in a generally circular curved shape (see Fig. 2 and page 7, lines 27-32). The distal section 24 of the guide tube 18 can be remotely flexed or steered by the physician by way of a handle 20 that encloses a steering mechanism 26 (see Figs. 1 and 2 and page 10, lines 25-32). Body 12 also carries four ablation electrodes E1-E4 which are spaced at predetermined, equidistant intervals along the loop element 10 (see page 8, lines 22-30 and Fig. 4). Each ring electrode E1-E4 is electrically coupled to a signal wire (not shown) that extends through guide tube 18 into the handle 20 and one or more connectors 36 attach the proximal ends of the signal wires to an input plug 36 on a controller 34 (see Fig. 2 and page 11, lines 25-33). The controller 34 includes an energy generator module 42 that creates and transmits RF energy to the ring electrodes E1-E4 (see Fig. 2 and page 12, lines 12-15). In regard to claims 6-7, McGee et al. teach that the loop body 12 is about 1 to 2.5 cm (10-25 mm) in diameter (see page 9, lines 3-6). In regard to claim 8, the body 12 is formed from an inert, resilient plastic material, which is non-conductive (see page 7, lines 33-35).
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.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGee et al. (PCT Publication No. 95/10225) in view of Ryan (U.S. Patent Application Publication No. 2013/0144209).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 9 and 10, McGee et al. teach that the steering mechanism 26 can vary (see page 10, lines 33-34). Ryan teaches a similar catheter assembly 10 with a deflection stylet 24 and a handle 12 that includes a rack 72 and a pinion 74 that is operated by a control knob 54 (see Figs. 1 and 2 and para. 0036). Ryan thus demonstrates that it was well known in the art to use a rack and pinion steering mechanism that is operated by a control know for the purpose of deflecting a catheter. Accordingly, in view of McGee et al.’s teaching that the steering mechanism 26 vary, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to substitute the rack and pinion and control knob structure of Ryan as the steering mechanism 26 of McGee et al. in order to equip the device of McGee et al. with an art-recognized equivalent structure for steering the distal section 24.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGee et al. (PCT Publication No. 95/10225) in view of Meckes et al. (PCT Publication No. WO 2021/009648).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 11 and 12, McGee et al. are silent as to the distal section 24 being formed from a braid constructed from non-electrically conductive material. However, Meckes et al. teach a similar catheter 1 having a distal, deflectable shaft 6 formed from an elastomeric polymer braided tube 7 (see Figs. 2 and 3 and paras. 0039 and 0047). Meckes et al. thus demonstrate that the art is well aware of the distal, deflectable portions of catheter tubes being formed from elastomeric braided tubes in order to provide stiffness and resilience but yet be deflectable (see paras. 0060-0064). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the catheter of McGee et al. with the elastomeric braided tube 7 taught by Meckes et al. tubes in order to provide stiffness and resilience but yet allow the distal section 24 to be deflectable.
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 1-4, 11 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22, 25, 26, 32 and 33 of copending Application No. 18/257,760 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 22, 25, 26, 32 and 33 of the reference application recite all of the limitations recited in claims 1-4, 11 and 12 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/257,760 (the reference application) in view of McGee et al. (PCT Publication No. 95/10225).
Claim 1 of the reference application does not recite four electrodes (claim 5), the loop having a diameter no larger than 12 mm (claim 6), the loop having a diameter between 8 mm and 12 mm (claim 7) and the loop comprising a non-conductive material (claim 8). However, as set forth above, McGee et al. teach all of these features. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of the reference application with all of the features taught by McGee et al. in order to optimize and enhance the ability of the device to ablate tissue (four electrodes) and to be passed through the vascular system to be positioned within the heart (small diameter).
This is a provisional nonstatutory double patenting rejection.
Claims 9 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/257,760 (the reference application) in view of Ryan (U.S. Patent Application Publication No. 2013/0144209).
Claim 1 of the reference application does not recite a steering mechanism that comprises a rack and pinion (claim 9) or that the pinion is operated by a knob (claim 10). However, as set forth above, Ryan teaches all of these features. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of the reference application with all of the features taught by Ryan in order to provide a capable and reliable steering mechanism for the catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794