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
The numerous references cited in the multiple Information Disclosure Statements have been afforded a cursory review, similar to what would be expected of a classification search of the prior art. Should there be any references of particular relevance to the instant application claims, applicant is respectfully requested to identify such references for further examiner review.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 9-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Callas et al (9,700,368).
Regarding claim 1, Callas et al disclose a method of treating tissue comprising disposing a plurality of electrodes in target tissue (Figures 4 and 9, for example) and activating the generator to deliver electrical pulses to the target region. Trains of pulses are delivered between pairs of electrodes in a cyclic manner (col. 15, lines 5-45, for example), wherein a single cycle includes a train of pulses delivered between each pair of electrodes in a consecutive order and repeating the cycles until a desired number of pulses is achieved. In the cycle, no single electrode is activated more than two consecutive times. For example, see the cycle of electrodes (1-2, 2-3, 3-1, 2-1, 3-2 and 1-3) at column 15, line 17.
Regarding claim 2, see column 15, lines 10-15 which shows an example fitting the claim limitation with 10 pulses being delivered to each pair for a number of sequences that would fall within the 70-90 total pulses. Callas et al also disclose a delay between cycles as claimed (col. 15, lines 40-44). Regarding claim 3, Callas et al disclose the treatment of prostate tissue (col. 8, line 27) as well as pancreatic tissue (col. 7, line 17). Regarding claim 4, see column 15, lines 34-38 of Callas et al. Regarding claim 5, see again column 15, lines 40-44. Regarding claim 6, each pulse may comprise a burst of pulses. Regarding claim 7, the intent of the Callas et al method is to mitigate thermal damage (e.g. Claim 1, for example). Regarding claim 9, as Callas et al seek to avoid thermal damage, the ideal operation would be a 0% amount of thermally damaged tissue (which is less than 5%). Regarding claim 10, the cycles described at the above noted column 15 of Callas et al meet this limitation. Regarding claim 15, Callas et al expressly disclose causing electroporation and irreversible electroporation throughout the specification.
Regarding claim 12, Callas et al disclose a method comprising delivering a first subset of pulses toa first pair of electrodes, and delivering a second subset of pulses via a second pair of electrodes wherein the number of pulses to each pair is less than the total number of pulses (i.e. the treatment is repeated). See, again, column 15, lines 5-40. The example cited at column 15 includes the delivery of 70 to 90 pulses (i.e. 20-440 pulses depending on the number of times the cycle is repeated) with 10 pulses being applied for each subset.
Regarding claims 13-17, see above discussion regarding claims 3-7 above. Regarding claim 19, see discussion of claim 11 above.
Regarding claim 20, Callas et al disclose a method of irreversibly electroporating tissue (col. 2, lines 60-67, for example) comprising electrically coupling a plurality of electrodes to a generator and disposing the electrodes near target tissue (Figures 1, 4 and 6, for example) and activating the generator to deliver electrical pulses to the target tissue. The pulses are delivered in a cycled pulse sequence with the total number of pulses being delivered between subsets of electrical pulses, with the plurality of electrodes activated in a sequential order to deliver pulses to define a pulses cycle that may be repeated until a desired number of pulses are delivered. See, for example, the column 15 citation mentioned previously.
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.
Claim 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Callas et al (‘368) in view of the teaching of Mercader et al (9,014,789).
The Callas et al method has been addressed previously. Callas et al fail to expressly acknowledge that thermal damaged is evidenced by white tissue coagulation. The examiner maintains that it is generally known that “white tissue” (as opposed to red tissue) generally corresponds to thermally coagulated tissue. To that end, Mercader et al provide the general knowledge that “white tissue” refers to necrotic tissue after treatment to ablate tissue (see brief description of Figure 4D).
To have identified thermal effects during the Callas et al procedure by identifying “white tissue” as evidence of thermally coagulated tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Mercader et al provide the general teaching that it is known “white tissue” would evidence thermally necrotic tissue.
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 ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,950,385. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘385 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sano et al (10,471,254) discloses another method of treating tissue with pulses of energy to irreversibly electroporate tissue.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/January 8, 2026