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 § 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 3, 4 and 18-20 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 pre-AIA the applicant regards as the invention.
These claims are unclear with the positive recitation of the frequency or wattage of the ablation signal, yet there is no ablation source positively recited. It is unclear how the ablation signal may be positively limited when there is no source recited to provide such a signal.
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 1-5, 8, 10-13 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ormsby et al (7,070,595).
Ormsby et al provide a device for treating/assessing tissue comprising an antenna (Figures 3A and 3B, for example). The antenna is configured to transmit and receive assessment signals and to transmit an ablation signal to tissue (Abstract). A high frequency output (336 – Figure 3) is configured to output the received assessment signal to a network analyzer and signal processor device (320). See, also, column 5, lines 1-14.
Regarding claim 2, there is a high frequency input (334) which receives the assessment signal from the network analyzer and signal processing device (320). See Figure 3. Regarding claim 3, the antenna is configured to deliver a wide range of frequencies. There is no ablation signal source claimed, but the system is inherently capable of delivering a signal anywhere in the microwave spectrum. Regarding claim 4, the ablation signal has a higher power (e.g. wattage) than the assessment signal (col. 6, line 63 to col. 7, line 15, and col. 7, lines 63-65, for example). Regarding claim 5, there is a low frequency input (334) configured to receive the ablation signal from the ablation generator (330). See Figure 3. Regarding claim 8, the antenna comprises a coaxial antenna having inner and outer electrodes separated by a dielectric (Figures 3A and 3B).
Regarding claim 10, Ormsby et al disclose a method for determining a property of tissue (i.e. impedance) comprising transmitting an assessment signal having a frequency of at least 1 MHz (signal is about 915 MHz – col. 8, lines 24-30) to tissue, receiving a received assessment signal, detecting with a processor of a network analyzer and signal processing device an electrical property (e.g. impedance) of the received (reflected) signal and determining a property of the tissue (impedance) based on the reflected signal which is then used to control the ablation signal delivered to tissue. Regarding claims 11 and 12, the network analyzer (320) sends a signal to the generator to generate the assessment signal and the ablation signal. Regarding claim 13, the ablation signal has a higher wattage (i.e. energy) than the assessment signal (col. 6). Regarding claim 16, the detected electrical property (impedance) of the received signal is indicative of a change in the electrical property of the antenna and infers a change in the property of the tissue (col. 7, lines 58-63, for example). Regarding claim 17, the property of tissue may be impedance (which is indicative of the degree of ablation). See, also, col. 8, lines 55-67.
Regarding claim 18, Ormsby et al provide an ablation device comprising at least one antenna (Figures 3A and 3B) configured to transmit and receive assessment signals having a frequency of at least 1 MHz (e.g. 900-930 MHz disclosed) and a high frequency output to output the received assessment signals to a network analyzer and signal processing device (320 – Figure 3), the antenna configured to also transmit an ablation signal as addressed above. The ablation signal may have any desired frequency, and it is noted there is no ablation signal source positively recited in the claim.
Regarding claims 19 and 20, there is a high frequency input to receive the transmitted assessment signal from the network as addressed with respect to claim 2 above, and the ablation signal has a higher energy (i.e. wattage) as addressed above.
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 6, 7, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ormsby et al (‘595) in view of the teaching of Brannan et al (8,242,782).
The Ormsby et al antenna device and method has been addressed above. Ormsby et al fail to disclose an antenna configured to receive a DC signal from the tissue, fail to show the specific coaxial antenna, and fail to teach the use of a S11, S21 or S12 measurement.
Brannan et al disclose a similar microwave antenna for ablation of tissue and measurement of microwave frequencies for treatment of tissue (Abstract). In particular, Brannan et al specifically teach that it is known for such an antenna to accommodate a DC component of a measurement signal (col. 13, lines 36-40 for example), and Brannan et al further specifically teach the use of S11 reflection coefficients when monitoring the measurement signal (col. 17, line 60, for example). The use of other known coefficients (e.g. S21 or S12 measurements) are deemed obvious to the skilled artisan. Finally, Brannan et al specifically disclose a coaxial microwave antenna as is commonly known in the art.
To have provided the Ormsby et al antenna device with a coaxial antenna, as is generally well known in the art, capable of transmitting/receiving DC signals and capable of measuring S11 reflection coefficients would have been an obvious consideration for one of ordinary skill in the art since Brannan et al teaches that such features are generally known in microwave antenna ablation devices.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ormsby et al (‘595) in view of the teaching of Rossetto et al (7,998,139).
Ormsby et al fail to disclose a microwave antenna having an inner electrode wound as a spiral and an outer electrode surrounding the outside of the spiral with a dielectric separating the turns of the spiral and the inner and outer electrodes.
Rosetto et al disclose another microwave ablation device having an antenna comprising an inner electrode wound as a spiral (16 – Figure 1), an outer electrode surrounding the outside of the spiral (26) an at least one dielectric (18,25) separating the coils of the spiral and the inner and outer electrodes.
To have provided the Ormsby et al device with any known microwave antenna, such as the spiral antenna of Rosetto et al, to treat tissue would have been an obvious design modification for one of ordinary skill in the art.
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 1-18 of U.S. Patent No. 10,888,274. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘274 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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,857,253. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘274 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. Behnke et al (8,246,615), Paulus (2010/0087808), Tallarida et al (7,311,702), Ormsby et al (6,190,382) and Carr (7,699,841) disclose other ablation systems that employ a microwave antenna capable of transmitting/receiving multiple frequencies of microwave energy and including a measurement system to monitor tissue conditions.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/October 16, 2025