DETAILED ACTION
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 .
A complete action on the merits of pending claims 1-19 appears herein.
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 10, 12, and 14, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 16, and 18 of copending Application No. 18/734,269 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims comprise overlapping subject matter with minor grammatical differences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim 11 is 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.
Regarding claim 11, the claim recites the limitations “a first pulse” and “a second pulse.” This renders the claim unclear as to if the claimed “a first pulse” and “a second pulse” refers to the claimed “first and second pulses” previously recited in the claim or refer to a new set of pulses. For the purpose of examination, the claimed “a first pulse” and “a second pulse” is interpreted as referring to the previously claimed “first and second pulses”
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-4, 10, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Irasawa (US 2008/0114351 A1).
Regarding claim 1, Irasawa teaches a method for generating and providing controlled electrical power of a therapeutic signal to biological tissue in electrical communication with a surgical instrument, (Abstract) the method comprising:
measuring a current provided to the biological tissue during a therapeutic phase; (Claims 9-10 and Par. [0066]) and
controlling an energy delivery of the therapeutic signal provided to the biological tissue during the therapeutic phase; (Par. [0061]: The main control section (8) determines if the procedure should continue or if energy delivery should stop, and when the detected impedance exceeds a threshold value, main section 8 outputs a signal for stopping the HF energy output to the power source (2) and the waveform control section (7)) and
in response to the measured electrical current of the biological tissue satisfying a predetermined value, reducing the energy delivery during the therapeutic phase, (Par. [0061]-[0063]: Main control section (8) stops energy delivery when the threshold is reached or exceeded; Par. [0066]: Electric current can be used in place of impedance.) wherein the predetermined value is a change in current relative to an initial current measurement. (Claim 9 and Par. [0066])
Regarding claim 2, Irasawa further teaches controlling an electrical power of the therapeutic signal provided to the biological tissue. (Par. [0062]: Main control section (8) controls the electrical power at least in that it determines if the energy delivery should continue or stop)
Regarding claim 3, Irasawa further teaches controlling a voltage of the therapeutic signal provided to the biological tissue. (Par. [0062]: Main control section (8) controls the voltage at least in that it determines if the energy delivery should continue or stop.)
Regarding claim 4, Irasawa further teaches the therapeutic phase is a drying phase. (Par. [0004]: Generally, it is known that, when a tissue is modified, the water in the tissue is lost by dehydration and the impedance that is the electric resistance rises.)
Regarding claim 10, Irasawa teaches a method of generating and providing controlled electrical power of a therapeutic signal to biological tissue in electrical communication with a surgical instrument, (Abstract) the method comprising:
measuring an electrical parameter of the biological tissue during a therapeutic phase; (Claims 9-10 and Par. [0066])
controlling an energy delivery of the therapeutic signal provided to the biological tissue during a therapeutic phase; (Par. [0061]: The main control section (8) determines if the procedure should continue or if energy delivery should stop) and
in response to the measured electrical parameter of the biological tissue satisfying a predetermined value, reducing the energy delivery during the therapeutic phase, (Par. [0061]-[0063]; Par. [0066]) wherein the predetermined value is a threshold value that depends on a pulse count or a change in the electrical parameter relative to a measurement of the electrical parameter. (Claim 9 and Par. [0066])
Regarding claim 12, Irasawa further teaches controlling an electrical power of the therapeutic signal provided to the biological tissue. (Par. [0062]: Main control section (8) controls the electrical power at least in that it determines if the energy delivery should continue or stop)
Regarding claim 13, Irasawa further teaches the electrical parameter is a current. (Par. [0061]-[0063]; Par. [0066]: Electric current can be used in place of impedance.)
Regarding claim 14, Irasawa further teaches the electrical parameter is a voltage. (Par. [0061]-[0063]; Par. [0066]: Voltage can be used in place of impedance.)
Regarding claim 15, Irasawa teaches a surgical generator (Fig. 1, Char. 1: power supply apparatus) configured to generate and provide controlled electrical power of a therapeutic signal to biological tissue in electrical communication with a surgical instrument, (Fig. 1, Char. 12: electrodes) the surgical generator comprising:
a measurement circuit (Claim 1: parameter monitoring section) coupled to a control circuit Claim 1: control section) and configured to measure a voltage at the biological tissue during a therapeutic phase; (Claims 1-2 and Page 5, Par. [0066]) and
the control circuit in communication with an electrical-energy source, (Claim 1, and Fig. 1, Char. 3: high-frequency energy generating section) the electrical-energy source electrically coupled to the instrument (Fig. 1) and configured to generate the therapeutic signal, (Par. [0038]: The high-frequency electric current generated by the high-frequency energy generating section 3 is transmitted to electrode 12 by way of output leads 10, 11; Par. [0059]: The third embodiment has a configuration basically same as the first embodiment (FIG. 1)) the control circuit configured to:
control an energy delivery of the therapeutic signal provided to the biological tissue during a therapeutic phase; (Par. [0061]: The main control section (8) determines if the procedure should continue or if energy delivery should stop.) and
in response to the measured voltage at the biological tissue satisfying a predetermined value, reduce the energy delivery during the therapeutic phase, Par. [0061]-[0063]; Page 5, Par. [0066]: Voltage can be used in place of impedance.) wherein the predetermined value is a threshold value that depends on a pulse count or a change in voltage relative to an initial voltage measurement. (Claim 9 and Par. [0066])
Regarding claim 16, Irasawa further teaches the control circuit is configured to: control an electrical power of the therapeutic signal provided to the biological tissue. (Par. [0062]: Main control section (8) controls the electrical power at least in that it determines if the energy delivery should continue or stop)
Claim Rejections - 35 USC § 103
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.
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) 5, 6, 8, 9, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Irisawa (US 2008/0114351 A1), as applied to claims 4 and 15 respectively above, in view of Jarrard (US 2005/0101947 A1).
Regarding claim 5, Irasawa, as applied to claim 4 above, teaches
measuring a first electrical current conducted by the biological tissue and measuring a second electrical current conducted by the biological tissue during the drying phase; (Par. [0054] - [0055]; and Par. [0066]: Electric current can be used in place of impedance)
providing a drying signal to the biological tissue during the drying phase; (Par. [0054]-[0055]: The electrosurgical energy dehydrates the target tissue) and
reducing the drying signal in response to a relationship of the measured first electrical current to the measured second electrical current exceeding a predetermined factor indicating a phase change of liquid in the biological tissue. (Par. [0055]-[0056])
Irasawa, as applied to claim 5 above, is silent regarding the relationship between the measured first electrical current and the measured second electrical current being a ratio of the measured first electrical current to the measured second electrical current.
Jarrard, in a similar field of endeavor, teaches representing a relationship between a first and second current as a ratio of the first current to the second current. (Par. [0017])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Irasawa, as applied to claim 5 above, to incorporate the teachings of Jarrard, and use a ratio of the first and second current measurements to determine the condition of the tissue in place of using the difference between the first and second current measurements. Doing so would be a simple substitution of one representation of a relationship between two measured values for another for the predictable result of comparing the first measured value to the second measured value.
Regarding claim 6, the combination of Irasawa/Jarrard, as applied to claim 5 above, teaches controlling the drying signal according to a drying schedule. (Irasawa: Fig. 7)
Regarding claim 8, the combination of Irasawa/Jarrard, as applied to claim 5 above, teaches measuring electrical current conducted by the biological tissue during the drying phase. (Par. [0054] - [0055]; and Par. [0066]: Electric current can be used in place of impedance; The electrosurgical energy dehydrates the target tissue)
Regarding claim 9, the combination of Irasawa/Jarrard, as applied to claim 5 above, teaches the predetermined factor is a change in current relative to an initial current measurement. (Par. [0063]: The main control section uses the difference in two impedance measurements to determine if the output energy is to be intercepted or continued; Par. [0066]: Current can be used instead of impedance)
Regarding claim 17, Irasawa, as applied to claim 15 above, teaches the measurement circuit is configured to:
measure a first electrical voltage conducted by the biological tissue and measure a second electrical voltage conducted by the biological tissue during a drying phase; (Par. [0054] - [0055]; and Par. [0066]: Voltage can be used in place of impedance) and
wherein the control circuit is configured to:
control the electrical-energy source to provide a drying signal to the biological tissue during the drying phase; (Par. [0054]-[0055]: The electrosurgical energy dehydrates the target tissue) and
reduce the drying signal in response to a relationship of the measured first electrical voltage to the measured second electrical voltage exceeding a predetermined factor indicating a phase change of liquid in the biological tissue. (Irasawa: Page 4, Par. [0055]-[0056])
Irasawa, as applied to claim 17 above, is silent regarding the relationship between the measured first electrical voltage and the measured second electrical voltage being a ratio of the measured first electrical voltage to the measured second electrical voltage.
Jarrard, in a similar field of endeavor, teaches representing a relationship between a first and second measured electrical parameter as a ratio of the first parameter to the second parameter. (Par. [0017])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Irasawa, as applied to claim 17 above, to incorporate the teachings of Jarrard, and use a ratio of the first and second voltage measurements to determine the condition of the tissue in place of using the difference between the first and second voltage measurements. Doing so would be a simple substitution of one representation of a relationship between two measured values for another for the predictable result of comparing the first measured value to the second measured value.
Regarding claim 18, the combination of Irasawa/Jarrard, as applied to claim 17 above, teaches controlling the drying signal according to a drying schedule. (Irasawa: Fig. 7)
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Irisawa (US 2008/0114351 A1) in view of Jarrard (US 2005/0101947 A1), as applied to claims 6 and 16 above respectively, and further in view of Keller (US 2017/0333110 A1).
Regarding claims 7 and 19, the combinations of Irasawa/Jarrard, as applied to claims 6 and 18 respectively above, is silent regarding the drying schedule is a monotonically-increasing electrical-power schedule.
Keller, in a similar field of endeavor, teaches determining if a sensed electrosurgical parameter is above or below a target value for said parameter; (Page 6, Par. [0079]) and in response to the determination, increasing a power with a constant gradient until the target value is reached; (Page 6, Par. [0080]) wherein the steepness of the power curve is selected such that neither tissue bursts nor thermal damages nor a sudden desiccation of the tissue occur. (Page 6, Par. [0082])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combinations of Irasawa/Jarrard, as applied to claims 6 and 18 respectively above, to incorporate the teachings of Keller, and configure the main control section (8) of Irasawa to monotonically increase the power applied to tissue until the measured electrosurgical parameter (difference in electrical current) reaches the target value (the threshold value at T3). Doing so would reduce the risk of tissue bursts and unwanted thermal damages from occurring, as suggested in Keller. (Page 6, Par. [0080])
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Irisawa (US 2008/0114351 A1), as applied to claim 10 above, in view of Goble (US 2002/0052599 A1).
Regarding claim 11, Irasawa further teaches the therapeutic signal, further comprising:
measuring first and second electrical parameters of the biological tissue during therapeutic energy delivery; (Claims 9-10 and Page 5, Par. [0066] )
controlling an energy delivery of the therapeutic signal provided to the biological tissue during the therapeutic energy delivery; (Par. [0061]: The main control section (8) determines if the procedure should continue or if energy delivery should stop.)
in response to the measured first electrical parameter of the biological tissue meeting a first predetermined threshold value, modifying the energy delivery during therapeutic energy delivery, (Par. [0061]-[0063]; Par. [0066]: The first electrical parameter would be the impedance during a first timeframe) wherein the first predetermined threshold value is a change in the first electrical parameter relative to a measurement of the first electrical parameter; (Par. [0063]: The main control section uses the difference in two impedance measurements to determine if the output energy is to be intercepted or continued) and
in response to the measured second electrical parameter of the biological tissue meeting a second predetermined threshold value, modifying the energy delivery during therapeutic energy delivery, (Par. [0061]-[0063]; Par. [0066]: The first electrical parameter would the impedance during a second timeframe) wherein the second predetermined threshold value is a change in the second electrical parameter relative to a measurement of the second electrical parameter. (Par. [0063]: The main control section uses the difference in two impedance measurements to determine if the output energy is to be intercepted or continued)
Irasawa, as applied to claim 11, is silent regarding the therapeutic signal having a plurality of therapeutic pulses delivered to biological tissue in electrical communication with a surgical instrument.
Goble, in a similar field of endeavor, teaches delivering therapeutic energy to a target tissue in the form of a plurality of therapeutic pulses delivered to biological tissue in electrical communication with a surgical instrument. (Par. [0080])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Irasawa, as applied to claim 11 above, to incorporate the teachings of Goble, and configure the therapeutic energy of Irasawa to be delivered in the form of a plurality of therapeutic pulses. Doing so would minimize the thermal conduction from heated tissue to the device contacting said tissue, as suggested in Goble. (Par. [0067])
In this combination, due to the impedance being continuously monitored during energy delivery, the impedance would be measured during a first and second timeframe including when the first and second pulses are delivered respectively. Furthermore, due to the impedance being continuously monitored during energy delivery, if the impedance difference threshold is met during the first and/or second pulses, the energy delivery would be immediately intercepted/paused by the main control section of Irasawa during said pulses.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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