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 .
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 1-20 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10 and 12-15 of U.S. Patent No. 11,771,488. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the U.S. Patent No. 11,771,488 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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)(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.
(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.
Claims 15 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wittkampf et al (2012/0053581).
Referring to claim 15, Wittkampf et al teaches a method of body tissue ablation (paragraph 0002-0003), the method comprising: (a) defining an ultrahigh-power ultrashort-duration (UPUD) radiofrequency (RF) ablation protocol that specifies an ablation signal having (paragraphs 0030-0034, 0037 and 0071) (i) a target ablation power of at least 400 Watts per electrode and (ii) comprising setting a pulse duration for creating a specified lesion in tissue in a body of a patient, the tissue including cardiac tissue; (b) making contact between one or more electrodes of an ablation probe and the tissue; and (c) using the ablation probe, applying the ablation signal to the tissue according to the UPUD RF ablation protocol, which delivers the ablation signal having the specified target ablation power and duration (paragraphs 0030-0034, 0037 and 0071)
Referring to claim 16, Wittkampf et al teaches wherein the pulse duration does not to exceed a patient’s single heartbeat duration (paragraph 0037).
Claim Rejections - 35 USC § 103
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.
Claims 1, 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf et al (2012/0053581) in view of Panescu et al (2018/0289284).
Referring to claim 1, Wittkampf et al teaches a system for body tissue ablation, the system comprising: (a) an ablation probe with one or more electrodes configured to make contact with tissue (paragraphs 0059-0060 and 0066; Figures 1 and 2); (b) the system is configured to store values of an ultrahigh-power ultrashort-duration (UPUD) ablation protocol that specifies an ablation signal having (i) a target ablation power of at least 400 Watts per electrode and (ii) a pulse duration that does not exceed three seconds, for creating a specified lesion in tissue in a body of a patient; (c) an ultrahigh-power ultrashort-duration (UPUD) generator, which is configured to generate the ablation signal; and (d) controls the generator and the ablation probe to apply the ablation signal to the tissue according to the UPUD protocol, which delivers the ablation power having the specified target ablation power and duration (paragraphs 0030-0034, 0037 and 0071).
Wittkampf et al fails to expressly teach a memory and a processor. Panescu et al teaches an analogous system for body tissue ablation comprising a memory and a processor configured to control the generator and the ablation probe to apply the ablation signal to the tissue according to the UPUD protocol, which delivers the ablation power having the specified target ablation power and duration (paragraphs 0236 and 0307). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system, as taught by Wittkampf et al, to include a memory and a processor, as taught by Panescu et al, in order to perform operations and execute instructions (paragraph 0236).
Referring to claim 2, Wittkampf et al teaches wherein the pulse duration does not to exceed a patient’s single heartbeat duration (paragraph 0037).3. The system of claim 1, wherein the pulse duration includes: (a) a first pulse duration between 0.5 seconds and 0.7 seconds for low-depth lesion; and (b) a second pulse duration between 0.8 seconds and 0.9 seconds for medium-depth lesion.
Referring to claim 7, Wittkampf et al teaches that the patient’s single heartbeat duration is pre-measured (paragraph 0027).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf et al (2012/0053581) in view of Panescu et al (2018/0289284) as applied to claim 1 above, and further in view of Hoey et al (2014/0276713).
Referring to claims 4 and 5, Wittkampf et al fails to expressly teach resistive heating of tissue and avoiding conductive heating of tissue. However, Hoey et al teaches an analogous system of body tissue ablation comprising an ablation protocol of at least 400 watts wherein the ablation signal and the pulse duration are configured to generate resistive heating of tissue and avoid conductive heating of tissue (paragraph 0011). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wittkampf et al to generate resistive heating of tissue and avoid conductive heating of tissue, as taught by Hoey et al, because it is the use of known technique to improve similar methods in the same way (See MPEP 2143) to use various types of energy to achieve the desired result.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf et al (2012/0053581) in view of Panescu et al (2018/0289284) as applied to claim 1 above, and further in view of Govari et al (2018/0263689).
Referring to claim 6, Wittkampf et al teaches a processor, however fails to teach that the processor is configured to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min. Govari et al teaches an analogous system of body tissue ablation comprising a processor is configured to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min (paragraph 0048). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor, as taught by the modified Wittkampf reference, to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min, as taught by Govari et al, in order to provide both an idle and high irrigation flow rate (paragraph 0048).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf et al (2012/0053581) as applied to claim 15 above, and further in view of Hoey et al (2014/0276713).
Referring to claims 18 and 19, Wittkampf et al fails to expressly teach resistive heating of tissue and avoiding conductive heating of tissue. However, Hoey et al teaches an analogous method of body tissue ablation comprising an ablation protocol of at least 400 watts wherein the ablation signal and the pulse duration are configured to generate resistive heating of tissue and avoid conductive heating of tissue (paragraph 0011). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wittkampf et al to generate resistive heating of tissue and avoid conductive heating of tissue, as taught by Hoey et al, because it is the use of known technique to improve similar methods in the same way (See MPEP 2143) to use various types of energy to achieve the desired result.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf et al (2012/0053581) as applied to claim 15 above, and further in view of Govari et al (2018/0263689).
Referring to claim 20, Wittkampf et al teaches a processor, however fails to teach that the processor is configured to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min. Govari et al teaches an analogous method of body tissue ablation comprising a processor is configured to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min (paragraph 0048). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the processor, as taught by Wittkampf et al, to control irrigation flow to tissue during ablation at a rate between 2 ml/min and 30 ml/min, as taught by Govari et al, in order to provide both an idle and high irrigation flow rate (paragraph 0048).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794