DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 365(c) & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 17/349299, 15/795062, 15/341512, PCT/US2015/029734 & 61/996390 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 5/7/2014.
Specification
The disclosure is objected to because of the following informalities: update the first paragraph with appropriate patent information.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “such that an electric field capable of ablating tissue by irreversible electroporation is generated between the outer and inner electrodes” to -such that an electric field is generated between the outer and inner electrodes ablates the myocardial tissue by irreversible electroporation- in ll. 8-9 for grammatical purposes. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “an electric field” to -the electric field- in ll. 1. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “an electric field” to -the electric field- in ll. 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “generates an electric field capable of ablating” to -generates an electric field to ablate- in ll. 8-9. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “generates an electric field capable of ablating” to -generates an electric field to ablate- in ll. 9. Appropriate correction is required.
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, 12 & 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,690,671 in view of Stewart et al. (2013/0030430). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of treating tissue by electroporation using a system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the method to be for treating ventricular tachycardia by performing IRE ablation on myocardial tissue. However, Stewart et al. disclose a method of performing IRE ablation on myocardial tissue to treat ventricular tachycardia by applying a pulsed voltage waveform between at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the method is for treating ventricular tachycardia by performing IRE ablation on myocardial tissue in order to provide the benefit of treating life-threatening aberrant conductive pathways in the heart tissue as taught by Stewart et al. ([0005])
Claims 1, 12 & 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,178,503 in view of Stewart et al. (2013/0030430). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of treating tissue by electroporation using a system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the method to be for treating ventricular tachycardia by performing IRE ablation on myocardial tissue. However, Stewart et al. disclose a method of performing IRE ablation on myocardial tissue to treat ventricular tachycardia by applying a pulsed voltage waveform between at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the method is for treating ventricular tachycardia by performing IRE ablation on myocardial tissue in order to provide the benefit of treating life-threatening aberrant conductive pathways in the heart tissue as taught by Stewart et al. ([0005])
Claims 1, 12 & 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,329,447 in view of Stewart et al. (2013/0030430). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of treating tissue by electroporation using a system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the method to be for treating ventricular tachycardia by performing IRE ablation on myocardial tissue. However, Stewart et al. disclose a method of performing IRE ablation on myocardial tissue to treat ventricular tachycardia by applying a pulsed voltage waveform between at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the method is for treating ventricular tachycardia by performing IRE ablation on myocardial tissue in order to provide the benefit of treating life-threatening aberrant conductive pathways in the heart tissue as taught by Stewart et al. ([0005])
Claims 1, 12 & 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/346575 (reference application, now allowed) in view of Stewart et al. (2013/0030430). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of treating tissue by electroporation using a system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the method to be for treating ventricular tachycardia by performing IRE ablation on myocardial tissue. However, Stewart et al. disclose a method of performing IRE ablation on myocardial tissue to treat ventricular tachycardia by applying a pulsed voltage waveform between at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the method is for treating ventricular tachycardia by performing IRE ablation on myocardial tissue in order to provide the benefit of treating life-threatening aberrant conductive pathways in the heart tissue as taught by Stewart et al. ([0005])
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 12 & 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/664163 (reference application) in view of Stewart et al. (2013/0030430). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method of treating tissue by electroporation using a system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the method to be for treating ventricular tachycardia by performing IRE ablation on myocardial tissue. However, Stewart et al. disclose a method of performing IRE ablation on myocardial tissue to treat ventricular tachycardia by applying a pulsed voltage waveform between at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the method is for treating ventricular tachycardia by performing IRE ablation on myocardial tissue in order to provide the benefit of treating life-threatening aberrant conductive pathways in the heart tissue as taught by Stewart et al. ([0005])
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 2-11, 13-18 & 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 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).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teaches a method of treating ventricular tachycardia by performing ablation using IRE comprising: contacting myocardial tissue with a distal tip of a catheter shaft having a lumen, an inner electrode disposed inside the lumen, and an outer electrode disposed on an outside of the catheter shaft, the inner and outer electrodes spaced proximally from the shaft distal tip; and applying a pulsed volage waveform between the outer and inner electrodes such that an electric field is generated between the electrodes that ablates the myocardial tissue by IRE.
The closest prior art is regarded as: Woloszko et al. (7,879,034), Woloszko et al. (6,832,996), Sharkey et al. (2002/0049438) and Stewart et al. (2013/0030430). Woloszko et al. ‘034 & ‘996 and Sharkey et al. both disclose an external electrode on an outer surface of a shaft and an internal electrode internal to the shaft. Stewart et al. teaches irreversible electroporation of myocardial tissue to treat ventricular tachycardia to be preferable over cryogenic and RF applications in view of improvement of safety, treatment duration and efficacy ([0008]). However, it would not have been obvious to one of ordinary skill in the art to modify the invention of Woloszko et al. ‘034 & ‘996 or Sharkey et al. with the electroporation generator of Stewart et al. to generate an electric field since the target tissue is located external to the catheter and thus would not be located within the electric field generated between the electrodes to ablate the tissue by IRE.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights