DETAILED ACTION
A complete action on the merits of pending claims 1-19 appears below.
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.
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 1-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10463428. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of patent 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.
Claims 1-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11172984. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of patent 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.
Claims 1-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12108983. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of patent 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 § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Govari US 20170209211 in view of Koblish US 20190038349.
Regarding claims 1 and 5, Govari teaches selectively positioning an ablation catheter system at a treatment site comprising cardiac tissue (Fig. 1 and par. [0076] treating heart tissue); ablating cardiac tissue at the treatment site with the ablation catheter system using a first power setting of approximately 90W (par. [0024] power between 70W to 100W) applied to tissue for a first ablation time of approximately four (4) seconds to achieve a first target electrode temperature (par. [0029] first power for 3s to 6s); and achieving approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation, by the ablation catheter system (par. [0070] no steam pop incidents).
Govari does not explicitly teach the method used for all patients of a predetermined patient population suffering from paroxysmal atrial fibrillation (PAF), the step of ablating tissue comprises a point-by-point “kissing” ablation approach causing a continuous and transmural linear lesion line at an atrial wall with minimal over-lapped lesions. However, Govari teaches a lesion size between 4 and 5 mm (par. [0020]).
Koblish, in an analogous method, teaches where the device is used for persistent atrial fibrillation (par. [0784]). Koblish further teaches where the catheter is moved to overlap the ablation zones (par. [0659] and Figs. 37 and 38).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed modify the method of Govari to move the catheter approximately 4 mm to create a new lesion so that there are not gaps in the lesion formation to ensure an effective ablation procedure (par. [0659])
Regarding claim 2, Govari teaches wherein the first target electrode temperature is 60 ºC (par. [0019] temperature of 60 ºC).
Regarding claim 3, Govari teaches further comprising: adjusting power to the ablation catheter system during the first ablation time to maintain the first target electrode temperature (par. [0022] adjusting power if target temperature is exceeded).
Regarding claim 4, the combination of Govari and Koblish teaches repeated ablation of cardiac tissue with the ablation catheter system using the first power setting for repeated four (4) second applications (par. [0075] using first power level for 10 seconds, it is more than 8 seconds so 4 seconds at the first power level happens more than once) to create lesions around a perimeter of a pulmonary vein (Koblish par. [0643] pulmonary vein ablation around ostia).
Regarding claim 6, Govari teaches delivering, by and through an elongated body of the ablation catheter system, an infusion of treatment solution at a rate of approximately 8 milliliters/minute during the first ablation time (par. [0071] irrigation rate of 8-45 ml/min).
Regarding claim 7, Govari does not explicitly teach further comprising: delivering, by and through an elongated body of the ablation catheter system, a continuous infusion of approximately 2 milliliters/minute of treatment solution when not delivering radiofrequency energy during radiofrequency ablation. However, Govari teach delivering fluid at a rate of 8-45 ml/min (par. [0071]).
Koblish further teaches having a flow rate of 1 to 15 ml/min (par. [0430]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the method of Govari to have a flow rate of 2, 4, 8, or any ml/min, as taught by Koblish. Any flow rate can be chosen as long as the temperature along the electrode is maintained (Koblish par. [0128]).
Regarding claim 8, Govari teaches ablating cardiac tissue at the treatment site with the ablation catheter system using a second power setting of between approximately 25W and 50W for a second ablation time following the first ablation time (par. [0025] power between 20W and 60W).
Regarding claim 9, Govari teaches wherein ablating cardiac tissue at the treatment site with the ablation catheter system using a second power setting of between approximately 25W and 50W for a second ablation time following the first ablation time comprises: delivering, by and through an elongated body of the ablation catheter system, an infusion of treatment solution during the second ablation time, wherein the second power setting is between approximately 25W and 35W (par. [0071] providing irrigation for a second power range of 20 to 60 W).
Govari does not explicitly teach an infusion of treatment solution at a rate of approximately 4 milliliters/minute.
Koblish further teaches having a flow rate of 1 to 15 ml/min (par. [0430]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the method of Govari to have a flow rate of 2, 4, 8, or any ml/min, as taught by Koblish. Any flow rate can be chosen as long as the temperature along the electrode is maintained (Koblish par. [0128]).
Regarding claim 10, Govari teaches wherein ablating cardiac tissue at the treatment site with the ablation catheter system using the second power setting of between approximately 25W and 50W for the second ablation time following the first ablation time comprises: delivering, by and through an elongated body of the ablation catheter system, an infusion of treatment solution at a rate of approximately 15 milliliters/minute during the second ablation time, wherein the second power setting is between approximately 36W and 50W (par. [0071] providing irrigation at a rate of 8-45 ml/min and a second power range of 20 to 60 W).
Regarding claim 11, the combination of Govari and Koblish teaches wherein ablating cardiac tissue at the treatment site with the ablation catheter system using the second power setting of between approximately 25W and 50W for the second ablation time following the first ablation time comprises (Govari par. [0025] second power levels): delivering, by and through an elongated body of the ablation catheter system, an infusion of treatment solution during the second ablation time (Govari par. [0020]); and automatically adjusting a flow rate of the treatment solution during the second ablation time to reach and maintain the second power setting within a second target electrode temperature (Koblish par. [0430] adjusting flow rate to maintain temperature).
Regarding claim 12, the combination of Govari and Koblish teaches wherein ablating cardiac tissue at the treatment site with the ablation catheter system using the second power setting of between approximately 25W and 50W for the second ablation time following the first ablation time comprises (Govari par. [0025] 20 to 60 W of power): ablating a left atrial posterior wall (Koblish par. [0661] left atrium and ostia of pulmonary vein treatment) with the ablation catheter system such that the second power setting does not exceed approximately 35W and the second ablation time does not exceed 30 seconds (Govari par. [0029] ablation time of less than 20 seconds).
Regarding claim 13, the combination of Govari and Koblish teaches repeated ablation of cardiac tissue with the ablation catheter system using the first power setting of approximately 90W for repeated applications up to four (4) seconds as a primary ablation mode (par. [0075] using first power level for 10 seconds, it is more than 8 seconds so 4 seconds at the first power level happens more than once) for creating pulmonary vein isolation (PVI) (Koblish par. [0466] pulmonary vein ablation); and ablating cardiac tissue at the treatment site with the ablation catheter system using a second power setting of between approximately 25W and 50W (Govari par. [0025]) for applications outside a PV ostia or for touch-up of the PVI (Koblish par. [0643] pulmonary vein ablation around ostia).
Regarding claim 14, Govari teaches repeated ablation of cardiac tissue with the ablation catheter system using the first power setting for repeated four (4) second applications to create lesions around a majority of a perimeter of a pulmonary vein (par. [0075] using first power level for 10 seconds, it is more than 8 seconds so 4 seconds at the first power level happens more than once); and ablating cardiac tissue at the treatment site with the ablation catheter system using a second power setting of between approximately 25W and 50W, following the repeated ablation using the first power setting, to perform touch up of the perimeter of the pulmonary vein (par. [0071] drop in power level).
Regarding claim 15, Govari teaches further comprising: moving the ablation catheter system approximately 4 millimeters if clinically effective ablation is achieved within 20 seconds (par. [0103] containing table 3 lesion depth of 1-5 mm between 3 and 7 seconds) as determined by electrogram reduction and/or impedance drop (par. [0094] monitoring impedance increasing or decreasing).
Regarding claim 16, Govari teaches the step of achieving complete pulmonary vein isolation further comprising a total ablation procedure time less than or equal to approximately 46 minutes (par. [0069] lesion formation in a minute).
Regarding claim 17, Govari teaches the step of achieving complete pulmonary vein isolation further comprising a total fluoroscopy time of less than or equal to approximately 6.5 minutes or less (par. [0069] lesion formation in a minute, Fig. 1 shows the video of the procedure using a scope device).
Regarding claim 18, Govari teaches the step of achieving complete pulmonary vein isolation further comprising a total radiofrequency application duration time of approximately 8 minutes or less (par. [0069] lesion formation in a minute).
Regarding claim 19, Govari teaches the step of achieving complete pulmonary vein isolation further comprising a total radiofrequency application duration time of 30 seconds on a posterior wall of the treatment site (par. [0029] ablation time of 20 seconds).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached Monday-Friday 7AM-3PM MT.
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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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