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 .
It is noted the instant application is filed with the exact same claims 1-20 as parent application US Serial No. 17/575,228 (‘228 application). In the ‘228 application, independent claim 11 and dependent claims 12 and 13 were rejected under prior art, as were independent claim 14 and dependent claims 16, 17 and 20. All claims 1-20 were rejected under obvious double patenting. Applicant filed a response on June 20, 2024 in the ‘228 application stating that the allowable subject matter (i.e. subject matter not rejected under prior art) from claim 13 was incorporated into independent claim 11, and the allowable subject matter (i.e. subject matter not rejected under prior art) from claim 15 was incorporated into independent claim 14. An acceptable Terminal Disclaimer was received to obviate the double patenting rejection. The examiner erroneously allowed amended independent claim 11 (which incorporated the subject matter of rejected claim 13). As such, claims 11-14, 16, 17 and 20 will be rejected with the same prior art used to in the rejection issued in the first action of the ‘228 application (the Office action issued June 3, 2024).
Information Disclosure Statement
The large number of references filed with 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 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hascoet et al (5,234,004) in view of the teaching of Chornenky et al (6,994,706).
Hascoet et al provide a system including a non-transitory processor readable medium (e.g. computer as at col. 16, lines 41-52) storing code to operate the processor. The code allows the processor to receive a temperature signal associated with the urethra (col. 16, lines 41-43), and produce a control signal to a cooling unit to produce a flow of cooling fluid as well as deliver an output signal to control the delivery of energy to treat tissue (col. 16, lines 41-53). Hascoet et al fail to disclose providing pulsed voltage waveforms to treat tissue.
Chornenky et al disclose another device for treating prostate tissue, including means to control cooling of the tissue during treatment. In particular, Chornenky et al teach that it is known to provide pulsed voltage waveforms as the energy modality for treating the prostate tissue (see Abstract, for example).
To have provided the Hascoet et al system with a pulsed voltage waveform generator to deliver energy to treat prostate tissue would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Chornenky et al specifically disclose the use of such an energy modality for a similar treatment of prostate tissue with a cooled electrode device.
Regarding claim 12, Chornenky et al disclose delivery of pulses as well as RF heating of tissue.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hascoet et al (5,234,004) in view of the teaching of Chornenky et al (6,994,706) and further in view of the teaching of Knowlton (6,350,376).
While Hascoet et al and Chornenky et al both disclose cooling of the device, there is no express disclosure of providing a pulsed cooling.
Knowlton provides another device that provides cooling to tissue that is energized with electrical energy. In particular, Knowlton teach that the cooling may be controlled by sensed temperature, similar to the teachings of Hascoet et al and Chornenky et al , and further that the cooling may be pulsed or continuous thereby teaching that it is generally known to substitute pulsed cooling for constant cooling flow. See, for example, column 6, lines 5-35.
To have provided the Hascoet et al device, as modified by the teaching of Chornenky et al, with a pulsed cooling mechanism to control tissue temperature would have been an obvious design modification for one of ordinary skill in the art given the teaching of Knowlton who teaches that it is known to use either pulsed or continuous cooling to control tissue temperature during treatment.
Claims 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chornenky et al (6,994,706) in view of the teaching of Hascoet et al (5,234,004).
Chornenky et al provide an apparatus comprising a catheter (107) defining a flow passage (106) and a plurality of electrodes (103,104,105) coupled to a distal portion of the catheter shaft (Figure 3, for example). Chornenky et al disclose providing a plurality of pulses delivered to the electrodes, as well as temperature feedback to control the flow fluid and the delivery of pulses. See, for example, column 4, lines 4-35. While Chornenky et al discusses the temperature sensor may be used to control the delivery of coolant and energy, there is no express disclosure of a specific controller. It is deemed an inherent feature that is not disclosed due to the well known use of such controllers.
However, Hascoet et al, as addressed previously, specifically teach the use of a computer (i.e. controller) that is programmed to control the delivery of a cooling fluid and energy to another device also used to treat prostate tissue.
To have provided the Chornenky et al device with a computer/controller to control the delivery of fluid and energy in the Chornenky et al device is deemed an obvious consideration for one of ordinary skill in the art, particularly since Chornenky et al specifically disclose there is a control mechanism, and further since Hascoet et al specifically teach that it is known to use a computer to control such features in an analogous prostate treatment device.
Regarding claim 16, any element is deemed to be “disposable”. This limitation provides no specific structure to distinguish from any item that may be disposed. Regarding claim 17, Chornenky et al provides an RF source to heat tissue in response to measured temperature.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chornenky et al (6,994,706) in view of the teaching of Hascoet et al (5,234,004) and further in view of the teaching of Knowlton (6,350,276).
Knowlton provides another device that provides cooling to tissue that is energized with electrical energy. In particular, Knowlton teach that the cooling may be controlled by sensed temperature, similar to the teachings of Hascoet et al and Chornenky et al , and further that the cooling may be pulsed or continuous thereby teaching that it is generally known to substitute pulsed cooling for constant cooling flow. See, for example, column 6, lines 5-35.
To have provided the Chornenky et al device, as modified by the teaching of Hascoet et al, with a pulsed cooling mechanism to control tissue temperature would have been an obvious design modification for one of ordinary skill in the art given the teaching of Knowlton who teaches that it is known to use either pulsed or continuous cooling to control tissue temperature during treatment.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-10, 13 and 15 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-11 and 13 of prior U.S. Patent No. 12,161,397. This is a statutory double patenting rejection.
Claims 1-10 of the instant application are identical to claims 1-10 of the ‘397 patent. Claim 13 of the instant application is identical to claim 11 of the ‘397 patent. Claim 15 of the instant application is identical to claim 13 of the ‘397 patent.
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. 10,433,906. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘906 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘906 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 11, 12, 14 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,161,397. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘397 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘397 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. Stern (6,413,255) discloses another device that uses pulsed cooling to control tissue temperature in a treatment device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached on (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/October 1, 2026
/JONATHAN C TEIXEIRA MOFFAT/Group Director TC 3700
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