DETAILED ACTION
Applicant’s preliminary amendment, filed April 17, 2024, is fully acknowledged by the Examiner. Currently, claims 21-28 are pending and newly added with claims 1-20 cancelled. The following is a complete response to the April 17, 2024.
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 (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.
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.
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 21 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hull et al. (US Pat. Pub. 2016/0184004 A1) further in view of Desai (US Pat. No. 5,657,755).
Regarding claim 21, Hull provides for a method of determining a location of a treatment device during an ablation procedure within a patient, the method comprising:
delivering ablation energy from an energy generator to an ablation electrode of the treatment device to an area of tissue (via the application of energy from 20 to the ablation electrode on the catheter 26),
delivering navigation energy to a plurality of external patch electrodes from a plurality of navigation energy sources, the navigation energy delivered by each of the plurality of navigation energy sources being a same frequency (via the navigation 16 functioning with the electrodes as in [0027] discussing the frequency of application; see also [0068] and [0072]-[0083] with 122),
and filtering the delivery of the ablation energy and the delivery of navigation energy using a first filter that is applied to an input of the navigation energy sources, the first filter allowing navigation energy to pass between the treatment device and the plurality of navigation energy sources while presenting a high impedance and preventing the ablation energy from entering the plurality of external patch electrodes (via the use of the filtering circuit 68 with the portion 78 as in [0057] to prevent ablation energy to enter other paths).
While Hull provides that the ablation energy provides RF energy, Hull fails to specifically provide that the ablation energy provides a pulsed electric field. Desai provides for a similar system as that of Hull and specifically contemplates the use of a pulsed electric field in the form of pulsed RF to treat cardiac tissue in the same manner as Hull (see col. 6; 26-36 providing for a series of electrical energy pulses). Therefore, it is the Examiner’s position that it would have been obvious to utilize a pulsed RF energy as in Desai as the RF energy as contemplated in Hull to provide for a known alternative manner of cardiac tissue in the art. Desai readily provides a known alternative to one of ordinary skill in the art that would function equally as well and with a reasonable expectation of success as the RF energy of Hull.
Regarding claim 24, Hull provides that the first filter is a band-reject filter that matches the frequency of the delivered ablation energy (via [0057] providing for the filtering as being at “a frequency of or near the frequencies used by the ablation generator”).
Regarding claim 25, Hull provides that the band-reject filter matches at least one of the following frequencies 460.8 kHz and 100 kHz (see [0052] providing for a range of the ablation signal to be 450-500 kHz thereby overlapping with the claimed value of 460.8 kHz; the filter s per [0057] would then focus on this value to perform the disclosed function).
Regarding claim 26, Hull provides for filtering the delivery of ablation energy from the energy generator with a second filter that is at the energy generator to prevent the ablation energy from interfering with the navigation energy (via the portion 76 providing filtering of the signals to provide the navigation energy from interfering with the ablation energy).
Regarding claim 27, Hull provides that the second filter is a band-reject filter that matches the frequency of the delivered navigation energy (see, again, paragraph [0056]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hull et al. (US Pat. Pub. 2016/0184004 A1) in view of Desai (US Pat. No. 5,657,755) as applied to claim 21 above, and further in view of Wittkampf (EP 0775466 A2).
Regarding claims 22 and 23, neither Hull nor Desai provide that the plurality of navigation energy sources are three alternating current energy sources that deliver energy at three separate frequencies, wherein the three separate frequencies are each at least 30 kHz, the three separate frequencies being delivered to the external patch electrodes.
Wittkampf provides for a similar system of catheter navigation/mapping as in Hull and specifically contemplates the use of a three alternative current sources at different frequencies of at least 30kHz (See col. 5; 8-22). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of navigation sources in the form of three alternating current energy sources that deliver energy at three separate frequencies, wherein the three separate frequencies are each at least 30 kHz. Such provides for the ability to provide for three dimensional navigation of a catheter within the body wherein the differing frequencies provide for a manner of distinguishing between the respective signal applied to a desired combination of electrodes.
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 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-14 of U.S. Patent No. US Pat. No. 11,918,280 B2 in view of Desai (US Pat. No. 5,657,755).
Regarding claim 21, patented claim 1 provides the following correlation to the instant claim language:
Instant claim 21
Patented claim 8
- delivering pulsed electric field ablation energy from an energy generator to an ablation electrode of the treatment device to an area of tissue
-delivering navigation energy to a plurality of external patch electrodes from a plurality of navigation energy sources, the navigation energy delivered by each of the plurality of navigation energy sources being a same frequency
-filtering the delivery of the ablation energy and the delivery of navigation energy using a first filter that is applied to an input of the navigation energy sources, the first filter allowing navigation energy to pass between the treatment device and the plurality of navigation energy sources while presenting a high impedance and preventing the ablation energy from entering the plurality of external patch electrodes
- delivering ablation energy from an energy generator to an ablation electrode of the treatment device to an area of tissue
-delivering navigation energy to a plurality of external patch electrodes from a plurality of navigation energy sources, the navigation energy delivered by each of the plurality of navigation energy sources being a same frequency
-filtering the delivery of the ablation energy and the delivery of navigation energy using a first filter that is applied to an input of the navigation energy sources, the first filter allowing navigation energy to pass between the treatment device and the plurality of navigation energy sources while presenting a high impedance and preventing the ablation energy from entering the plurality of external patch electrodes
The difference between instant claim 1 and patented claim 8 is that the patented claim is broader is some aspects and narrower in others. Specifically, patented claim 8 includes an additional step of “transmitting a plurality of voltage signals…” and “determining a location of the medical device …”. In these aspects, the patented claim is, in effect a “species” of the “generic” invention of instant claim 21. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993)
The instant claim is narrower in the aspect of the instant claim specifically requiring the ablation energy to be a “pulsed electric field”. Desai provides for a similar system as that of patented claim 1 and specifically contemplates the use of a pulsed electric field in the form of pulsed RF to treat cardiac tissue (see col. 6; 26-36 providing for a series of electrical energy pulses). Therefore, it is the Examiner’s position that it would have been obvious to utilize a pulsed RF energy as in Desai as the applied ablation energy in patented claim 8 to provide for a known alternative manner of cardiac tissue in the art. Desai readily provides a known alternative to one of ordinary skill in the art that would function equally as well and with a reasonable expectation of success as the generic ablation energy in the patented claim 1.
With respect to instant claim 22, see patented claim 9;
With respect to instant claim 23, see patented claim 10;
With respect to instant claim 24, see patented claim 11;
With respect to instant claim 25, see patented claim 12;
With respect to instant claim 26, see patented claim 13;
With respect to instant claim 27, see patented claim 14;
With respect to instant claim 28, see patented claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794