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 .
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 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al (2010/0069921).
Regarding claim 1, Miller et al provide a method of tissue assessment (Title, Abstract, for example) comprising the steps of determining a value of a parameter of a target tissue state by localizing a lesion which as been previously created (e.g. Abstract, assessing lesion formation by calculating an index response to tissue to assess lesion formation), determining a baseline dielectric property (e.g. impedance) based on a signal output from an electrical circuit comprising an electrode (para. [0104], for example) and comparing the measured values to a data structure (e.g. look-up table as per para. [0147-0148]) to provide feedback indicative of an estimate of the target state (e.g. ablated, partially ablated, not ablated as per para. [0104]).
Regarding claim 2, ablation parameters are determined based on the dielectric property (e.g. ECI) as disclosed at paragraph [0043], for example. Regarding claim 3, the feedback may indicate a gap within a lesion (para. [0105]). Regarding claims 4 and 5, the depth and volume (i.e. transmurality) may also be determined (para. [0104] and [0158], for example). Regarding claim 6, the controller automatically terminates ablation when tissue is adequately ablated (Figure 14b, for example) to prevent an adverse event (e.g. ablation of non-targeted tissue). Regarding claim 7, the target tissue is ablated tissue as per paragraph [0104]. Regarding claim 9, the determination of baseline dielectric properties (i.e. ECI) are performed iteratively (Figure 14b, for example). Regarding claim 10, the comparison of the measured data points to a data structure (i.e. look-up table) are performed iteratively as the procedure progresses. Regarding claim 11, the data is used to determine various parameters for the procedure including duration, power and frequency (para. [0043], for example). Regarding claim 12, the rate of ablation is also determined (para. [0069], for example). Regarding claim 13, the parameters may be controllably varied during the ablation (para. [0043], for example). Regarding claim 14, the device is performed with an electrode positioned in the body (Figure 1, for example). Regarding claim 15, the device is used to treat myocardial tissue (Figure 1) to determine gaps in a transmural lesion (para. [0104]). Regarding claim 16, the device is also used to determine a size of a lesion (para. [0104], for example). Regarding claim 17, the completeness (i.e. irreversibility) of a lesion is determined (para. [0104]). Regarding claim 18, Miller et al provides for estimating a dielectric parameter from a statistical correlation between vectors of dielectric parameters (para. [0149-0150], for example). Regarding claim 19, Miller et al provide for determining a baseline dielectric property using an analysis of frequency response behavior of the signal (para. [0230], for example). Regarding claim 20, the data structure (i.e. look-up table) accounts for different types of tissue (paragraphs [0061], [0104] and [0114], for example).
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 is rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (2010/0069921) in view of the teaching of Mansi et al (2014/0296842).
Regarding claim 8, Miller et al is silent with respect to using machine-learning to formulate and incorporate the data structure. The examiner maintains that it is generally well-known in the art to use machine-learning to formulate data tables for use in processing data to control ablation procedures. To that end, Mansi et al specifically teach of using machine learning to formulate data tables used to process information used during an ablation procedure. See, for example, paragraphs [0036] and [0075].
To have used machine learning to provide more sophisticated and accurate processing of the data used in the look-up tables of Miller et al would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Mansi et al fairly teach it is known to use machine learning in a device with a similar data structure.
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 1-51 of U.S. Patent No. 10,881,455. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘455 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. Keidar et al (7,306,593), Stewart et al (9,743,854) and Francischelli et al (6,989,010) disclose other RF systems used to assess tissue during RF ablation.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 5, 2026