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 large number of references cited in the 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 review by the examiner.
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.
Claims 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al (2013/0030430) in view of the teaching of Neal, II et al (2011/0106221).
Regarding claim 2, Stewart et al provide a medical system comprising a catheter including an elongate body (16) configured to pass through the vasculature, the elongate body having proximal and distal portions. The distal portion (20) includes an electrode structure (22) that includes a first and second set of electrodes, the distal portion being transitionable between a linear configuration and an expanded configuration (seen in Figure 1). The expanded configuration facilitates placement of the first and second electrodes sets into contact with tissue. See, also, paragraphs [0028-0029]. There is a generator (14) in electrical communication with the electrodes, the generator configured to deliver a pulse train of biphasic pulses to the electrodes (para. [0009]), for example) and the pulses may be delivered to individual electrode sets as desired (para. [0035], for example) in a bipolar manner. Stewart et al disclose the pulses may have a pulse width in the claimed range (para. [0009]) with each pulse having a positive and negative pulse and there is an inter-pulse delay (para. [0050]). There is no express disclosure of an inter-phase delay or the relationship between the inter-phase and inter-pulse delay as claimed.
Neal, II et al disclose another system for providing irreversible electroporation in tissue by delivering a sequence of pulses to tissue. In particular, Neal, II et al specifically discloses that there may be an inter-phase delay (i.e. a delay between the positive and negative pulse of a biphasic waveform) as shown in Figures 24A-24D. additionally, Neal, II also discloses that there may be an inter-pulse delay (i.e. a delay between pulse widths) as shown in Figures 24E-24G. Neal, II discloses a variety of lengths for the inter-pulse and inter-phase delays that may include the inter-phase delay being less than the inter-pulse delay (or vice versa).
To have provided the Stewart et al pulse train with an inter-phase delay and an inter-pulse delay to control the characteristics of the energy profile delivered to tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Neal, II et al fairly teach it is known to provide such control of a pulse train in an analogous treatment system.
Regarding claim 3, Stewart et al disclose the polarity of the electrodes/pulses may be controlled (para. [0038], for example). Regarding claims 4 and 5, Stewart et al disclose an inter-pulse delay (i.e. interval) of up to 20 microseconds (para. [0050]), and Neal, II disclose an inter-phase delay that may be equal to the pulse width (which is 5 microseconds in the Stewart et al example of para. [0050]). Regarding claim 6, Figure 1 of Stewart et al shows the device in the expanded state after being deployed from a linear configuration (i.e. straight when within outer sheath). Regarding claim 7, Stewart et al disclose the electrodes may be provided in an alternating (i.e. bipolar) configuration. Regarding claim 8, Stewart et al disclose the use of voltages within the claimed range (para. [0040]). Regarding claim 9, both Stewart et al and Neal, II disclose symmetrical positive and negative pulse components. Regarding claim 10, Stewart et al disclose a number of pulses in the claimed range (para. [0009]). Regarding claim 10, Neal, II discloses the use of constant inter-phase and inter-pulse delays (Figure 24, for example).
Regarding claim 12, Stewart et al provide a medical system comprising a catheter including an elongate body with an electrode structure on the distal end, the electrode structure transitionable between a linear configuration and an expanded configurations as addressed with respect to claim 2 above. There is a generator configured to deliver a pulse train of biphasic pulses having a predetermined frequency and a pulse width as claimed as addressed with respect to claim 2 above. Stewart et al fails to expressly disclose the inter-phase delay and the relationship to the inter-pulse delay as addressed previously.
Again, Neal, II et al disclose another system for providing irreversible electroporation in tissue by delivering a sequence of pulses to tissue. In particular, Neal, II et al specifically discloses that there may be an inter-phase delay (i.e. a delay between the positive and negative pulse of a biphasic waveform) as shown in Figures 24A-24D. additionally, Neal, II also discloses that there may be an inter-pulse delay (i.e. a delay between pulse widths) as shown in Figures 24E-24G. Neal, II discloses a variety of lengths for the inter-pulse and inter-phase delays that may include the inter-phase delay being less than the inter-pulse delay (or vice versa).
To have provided the Stewart et al pulse train with an inter-phase delay and an inter-pulse delay to control the characteristics of the energy profile delivered to tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Neal, II et al fairly teach it is known to provide such control of a pulse train in an analogous treatment system.
Regarding claims 13 and 14, see discussion of claims 4 and 5 above. Regarding claim 15, see discussion of claim 8 above. Regarding claim 16, see discussion of claim 10 above. Regarding claim 17, see discussion of claim 9 above. Regarding claim 18, see discussion of claim 3 above. Regarding claim 19, see discussion of claim 11 above. Regarding claim 20, Stewart et al discloses delivering a predetermined number of pulse trains (para. [0009], for example). Regarding claim 21, both Neal, II et al (para. [0011]) and Stewart et al (para. [0038], for example) disclose the use of variable voltages.
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,201,353. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘353 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘353 claims. Here, the more specific patent claims encompass the broader instant 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.
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Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,150,701. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘701 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘701 claims. Here, the more specific patent claims encompass the broader instant 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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,207,866. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘866 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘866 claims. Here, the more specific patent claims encompass the broader instant 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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,150,700. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘700 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘700 claims. Here, the more specific patent claims encompass the broader instant 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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,701,169. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘169 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘169 claims. Here, the more specific patent claims encompass the broader instant 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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,531,914. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘914 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘914 claims. Here, the more specific patent claims encompass the broader instant 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. Davalos et al (8,465,484) and Francischelli et al (8,221,411) disclose other devices that provide specific pulse parameters for a device used to treat tissue with electroporation energy.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/October 7, 2026
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