DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to an ablation system, classified in A61B18/12.
II. Claims 15-20, drawn to a method of ablating tissue, classified in A61B18/12.
The inventions are independent or distinct, each from the other because: Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process such as one that only delivers the RF or high voltage pulses or where the signals are applied simultaneously to achieve just one lesion with one depth and size.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification.
the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Korbin Blunck on February 4, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claim15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/980015 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 17/980015 fails to provide support for claims 3-20.
Accordingly, claims 1-2 are given the priority date of 9/11/2022.
Accordingly, claims 3-20 are given the priority date of 8/30/2023.
Specification
The disclosure is objected to because of the following informalities: amend Par. [0001] with updated patent information.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: delete “uses” in ll. 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “so that the at least on electrode delivers” to -configured to deliver- in ll. 7. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “are applied” to -are configured to be applied- in ll. 2. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the radiofrequency include a frequency” to -the radiofrequency signals having a frequency- in ll. 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the radiofrequency signals are provided for a duration of” to -the radiofrequency signals are configured to be delivered for a duration of- in ll. 2. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “pulse” to -pulses- in ll. 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “PF burst” to –pulsed field (PF) burst- in ll. 1. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: amend “to tissue” to -to the organ tissue- in ll. 2. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: amend “the tissue” to -the organ tissue- in ll. 2-3. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: delete “same” in ll. 3 & 4 (twice). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the end effector comprising at least one electrode disposed on the end effector”. It is unclear how the end effector can both comprise at least one electrode but then also have the electrode be disposed on the end effector, or itself. It is suggested to delete “on the end effector”. The claim will be interpreted in this manner.
Claims 2-14 depend from claim 1 and are thus also rejected.
Claim 4 recites the limitation “in which the radiofrequency signals are applied with a contact force of approximately 5 grams or more”. First, the claim recites a method step in a product claim, and thus it is unclear if the claim is directed to a product or a method. Second, it is unclear how signals can be configured to apply a “contact force”. Third, the recitation of “or more” recites an unbounded range and is thus indefinite. Fourth, if the claim is rewritten such that it recites -the at least one electrode configured to apply a contact force of approximately 5 grams-, it is unclear how this would further limit the claim from which it depends since it fails to recite further structure, either implicitly or explicitly. For purposes of examination, the claim will be interpreted as -wherein the at least one electrode is configured to apply a contact force of approximately 5 grams-.
Claim 5 recites “the radiofrequency signals are provided with at least 25 Watts of power”. First, the claim recites a method step in a product claim, and thus it is unclear if the claim is directed to a product or a method. Second, it is unclear how signals can be provided with power. For purposes of examination, the claim will be interpreted as -where the radiofrequency signals are configured to be delivered with at least 25 Watts of power-.
Claim 8 recites the limitation “the high voltage pulse provides approximately 60 Joules or less”. It is unclear how the HV pulse provides the Joules since claim 1, upon which claim 8 depends, recites “a direct current (DC) signal generator configured to provide high voltage pulses” and “the at least one electrode delivers the high voltage pulses…to organ tissue”. Thus, the generator “provides” the HV pulses and the electrode “delivers”. Further, claim 8 recites just one “the high voltage pulse” when claim 1 recites “high voltage pulses”. Thus, it is unclear if each pulse or the plurality of pulses provides 60 Joules or less (the Examiner notes that the specification provides support for “pulse” and not “pulses”). For purposes of examination, the claim will be interpreted as -each of the high voltage pulses are configured to deliver-.
Claim 10 recites the limitation “a plurality of high voltage pulses”; however, claim 1, upon which claim 10 depends, recites “high voltage pulses”. It is unclear if the “plurality of high voltage pulses” in claim 10 are the same as or different from the “high voltage pulses” of claim 1. For the purposes of examination, they will be interpreted as being the same.
Claim 11 recites the limitation “adjacent pulse trains”; however, claim 10, upon which claim 11 depends, recites “a pulse train”. It is unclear if the “adjacent pulse trains” include the single “pulse train” recited in claim 10. For purposes of examination, the claim will be interpreted as -The ablation system of claim 10, wherein the pulse train comprises a plurality of pulse trains- in ll. 1 and -between adjacent pulse trains of the plurality of pulse trains- in ll. 2
Claim 12 recites the limitation “a plurality of pulse trains”; however, claim 10, upon which claim 12 depends, recites “a pulse train”. It is unclear if the “plurality of pulse trains” include the single “pulse train” recited in claim 10. For purposes of examination, the claim will be interpreted as -The ablation system of claim 10, wherein the pulse train comprises a plurality of pulse trains that in turn provide a pulsed field (PF) burst.
Claim 14 recites the limitation “at least 20% greater” which is regarded as an unbounded range and is thus indefinite.
Claim Rejections - 35 USC § 102/103
The following is a quotation of 35 U.S.C. 102 which forms the basis for all obviousness rejections set forth in this Office action:
(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.
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.
Claim(s) 1-2, 4 & 7-13 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by Altmann et al. (2021/0161592), or, in the alternative, under 35 U.S.C. 103 as obvious over Altmann et al. (2021/0161592) in view of DEAC (2016/0270844).
Concerning claim 1, Altmann et al. disclose an ablation system for electrophysiology uses (multi-channel IRE system 20 used in an IRE ablation procedure; [0038]), the ablation system comprising:
an alternating current (AC) signal generator configured to provide radiofrequency signals at high power (generator 36 generates RF signal 308 at high power; [0007], [0060], [0062]);
a direct current (DC) signal generator configured to provide high voltage pulses (generator 36 generates trains of HV electrical pulses 310, 312; [0039], [0064]); and
a catheter having an end effector electrically coupled to the AC signal generator and the DC signal generator, the end effector comprising at least one electrode disposed on the end effector so that the at least one electrode delivers the high voltage pulses from the at least one electrode to organ tissue inside a body of a patient to first and second return electrodes coupled to the body of the patient and deliver the radiofrequency signal between the at least one electrode to one of the first or second return electrodes (ablation catheter 26 has a distal end 28 that comprises multiple ablation electrodes 26 that receive HV pulses 310, 312, and RF signal 308 such that the signals are delivered between electrodes 26 to external electrode/path 65; [0038], [0048], [0059-0062]).
While Altmann et al. disclose generator (36) generates both types of signals in a similar manner as Applicant discloses generator 50 produces both RF and PF signals (see Par. [0052] of specification) and the components of Altman et al.’s generator (36) can be considered to read upon each of the separately claimed generators, Altmann et al. fail to disclose two physical separate generators. However, DEAC discloses an ablation system comprising a generator configured to provide RF signals and a generator configured to provide electroporation signals, where the generator can be one or more energy sources. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Altmann et al. such that the generators are two separate physical generators since DEAC teaches energy sources for generating RF and electroporation signals can be a “one” generator or “or more” generators ([0029]) and since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. See also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Concerning claim 2, Altmann et al. disclose the radiofrequency signals and the high voltage pulses are applied either sequentially or simultaneously to the organ tissue ([0035-0036], [0062]; Fig. 4A).
Concerning claim 4, Altmann et al. disclose the radiofrequency signals are capable of being applied with a contact force of approximately 5 grams or more, or when the catheter is pressed against contact tissue (58) with the claimed force ([0054]).
Concerning claims 7-13, Altmann et al. disclose the high voltage pulses include an amplitude of at least 800 V, the high voltage pulse provides approximately 60 Joules or less, a duration of each of the high voltage pulse is less than 20 microseconds, a plurality of high voltage pulses provides a pulse train of approximately 100 microseconds, a time gap of any value selected from 0.3 to 1000 milliseconds is provided between adjacent pulse trains, a plurality of pulse trains provides a PF burst, the PF burst comprises any value from 2 to 100 pulse trains with a duration of the PF burst comprising any value selected from zero to 500 milliseconds ([0043], [0051], [0052]; Table 1).
Claim Rejections - 35 USC § 103
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (2021/0161592), or, in the alternative, under 35 U.S.C. 103 as obvious over Altmann et al. (2021/0161592) in view of DEAC (2016/0270844), as applied to claim 1, in further view of Sherman (2014/0066913) and Byron et al. (2017/0215802).
Concerning claim 3, Altmann et al., or in the alternative Altmann et al. in view of DEAC, fail to disclose the end effector comprising a distal tip electrode. However, Sherman discloses an ablation system comprising a catheter (10) having an end effector (24) that comprises a plurality of electrodes (26), where the plurality of electrodes may be of any number, configuration, or shape, for example, a plurality of discrete electrodes, band electrodes that partially or entirely circumscribe the elongate body 20 (as shown in FIG. 1) or balloon 27, longitudinally oriented electrodes (as shown in FIG. 2), a distal tip electrode (as shown in FIG. 2), or clusters of electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Altmann et al., or in the alternative Altmann et al. in view of DEAC such that the end effector comprises a distal tip electrode as Sherman teaches various configurations of an electrode array, including a distal tip electrode, to be equivalents in the art for the predictable result of treating tissue ([0017]; Fig. 1 & 3A-B). Altmann et al., or in the alternative Altmann et al. in view of DEAC, and in view of Sherman fail to disclose the end effector comprising a cylindrical member comprising the distal tip electrode and irrigation ports disposed on the cylindrical member to provide irrigation fluid proximate the distal tip electrode, the distal tip electrode being coupled to a force sensor. However, Byron et al. disclose an ablation system comprising a catheter (110) having a cylindrical member end effector (113) with a distal tip electrode (132) and irrigation ports (131) disposed on the cylindrical member (113) to provide irrigation fluid proximate the distal tip electrode (132), the distal tip electrode (132) being coupled to a force sensor (140). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Altmann et al., or in the alternative Altmann et al. in view of DEAC, and in view of Sherman such that the end effector comprises a cylindrical member comprising the distal tip electrode and irrigation ports disposed on the cylindrical member to provide irrigation fluid proximate the distal tip electrode, the distal tip electrode being coupled to a force sensor in order to provide the benefit of flushing the exterior volume adjacent the end effector and in order to provide the benefit of determining a magnitude of an axial component of a contact force exerted on the distal tip as taught by Byron et al. ([0058], [0061], [0073], [0081]; Fig. 3).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (2021/0161592), or, in the alternative, under 35 U.S.C. 103 as obvious over Altmann et al. (2021/0161592) in view of DEAC (2016/0270844), as applied to claim 1, in further view of Vaska (2008/0045946).
Concerning claims 5-6, Altmann et al. disclose the radiofrequency signals are provided from 350 kHZ-500 kHZ ([0060]). Altmann et al., or in the alternative, Altmann et al. in view of DEAC to disclose the radiofrequency signals are provided with at least 25 Watts of power for a duration of at least 1 second. However, Vaska discloses an ablation system comprising an AC signal generator configured to provide radiofrequency signals at high power, the radiofrequency signals are provided with at least 25 Watts of power, include a frequency from 350kHZ to about 500 kHZ and are provided for a duration of at least 1 second. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Altmann et al., or in the alternative, Altmann et al. in view of DEAC such that the radiofrequency signals are provided with at least 25 Watts of power for a duration of at least 1 second since Altman teaches these are typical/common parameter values to produce the predictable result of treating tissue with radiofrequency. ([0095])
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (2021/0161592), or, in the alternative, under 35 U.S.C. 103 as obvious over Altmann et al. (2021/0161592) in view of DEAC (2016/0270844), as applied to claim 1, in further view of Sherman (2014/0066913).
Concerning claim 14, while Altmann et al. disclose the at least one electrode (26) is configured to deliver the high voltage pulses and the radiofrequency signal to tissue to form a combined lesion in the tissue and combining the two signals can be advantageous ([0034]), Altmann et al. fail to disclose the combined lesion is at least 20% greater than a lesion formed by the same radiofrequency signal alone or the same high voltage pulses alone since energy can be applied for a greater extent of time to reach desired size. However, Sherman et al. disclose combining high voltage pulses and radiofrequency power such that a lesion is formed with a greater size, where energy is capable of being applied for a greater extent of time to reach desired size. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Altmann et al., or in the alternative, Altmann et al. in view of DEAC such that the combined lesion is greater than a lesion formed by the same radiofrequency signal alone or the same high voltage pulses alone in order to provide the benefit of achieving a desired lesion size as taught by Sherman ([0020]; Fig. 4). Altmann et al., or in the alternative, Altmann et al. in view of DEAC, and Sherman fail to disclose the combined lesion to be at least 20% greater. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Altmann et al., or in the alternative, Altmann et al. in view of DEAC, and Sherman such that the combined lesion is at least 20% greater since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Altmann et al., or in the alternative, Altmann et al. in view of DEAC, and Sherman would not operate differently with the claimed lesion size since Sherman teaches achievement of a desired lesion size ([0020]). Further, Applicant places no criticality on 20% and merely states the combined lesion “can be” 20% greater ([0058], [0065]).
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 1-2 & 4-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-15 of U.S. Patent No. 12,514,635. Although the claims at issue are not identical, they are not patentably distinct from each other because the both recite an ablation system for electrophysiology uses (system for applying pulsed field ablation to treat atrial fibrillation), the ablation system comprising: an alternating current (AC) signal generator configured to provide radiofrequency signals at high power (an alternating current (AC) signal generator configured to provide radiofrequency signals at high power;); a direct current (DC) signal generator configured to provide high voltage pulses (a direct current (DC) signal generator configured to provide high voltage pulses); and a catheter having an end effector electrically coupled to the AC signal generator and the DC signal generator, the end effector comprising at least one electrode disposed on the end effector so that the at least one electrode delivers the high voltage pulses from the at least one electrode to organ tissue inside a body of a patient to first and second return electrodes coupled to the body of the patient and deliver the radiofrequency signal between the at least one electrode to one of the first or second return electrodes (a catheter comprising a tip electrode controlled to emit either a pulsed electric field or a radiofrequency signal to biological tissue and ablate one or more locations of biological tissue of a pulmonary vein). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794