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 .
Information Disclosure Statement
The two Information Disclosure statements filed on 07/14/2026 have been entered and the references cited therein have been considered by the Examiner.
Response to Amendment
The amendment filed July 14th, 2026 has been entered. Applicant’s amendments to the Claims have overcome most of the 112(b) rejections, except for claim 17, reiterated below, and the double patenting rejections.
Response to Arguments
Applicant's arguments filed July 14th, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on pages 10-12 that the recited medical devices are not generic computer components that are instructed to perform the alleged abstract idea, the Examiner respectfully disagrees on the grounds that in view of the prior art, in particular the Allison reference (US 20170105798, previously cited), that the recited medical devices are seen as routine, well known and conventional due to their status as prior art.
Regarding Applicant’s arguments on pages 13-14 that the abstract idea cannot be merely performed in the human mind, the Examiner respectfully disagrees on the grounds that it does not matter how tedious or cumbersome the mathematical process may be, if it can be performed by hand is seen as being performed by the human mind. Applicant describes on page 13 that the claims are limited to applying the alleged abstract idea of mathematical formulas within the confines of physical media devices which affirms that despite a human taking a much longer time to compute these values, they are mathematical formulas that are capable of being computed by hand/by the mind.
Therefore, these arguments are not persuasive and the Examiner maintains the 101 rejections of claims 1 & 16 and their respective dependent claims. The amendment of “for calibration…” is seen as a functional limitation of the “compare…” step as the calibration is not positively recited as an active step carried out by the controller. Additionally, to overcome the 101 rejection, the claims need to recite an active use step describing what the comparison/calibration steps are doing in regards to the system. A human mind with pencil and paper can calculate with mathematical formulas the values for calibration, however, a human mind cannot necessarily apply or use the calibration.
Claim Objections
Claims 16 & 18 objected to because of the following informalities:
Claim 16, line 17: “calibrating” should read --calibration--,
Claim 18, line 2: “target tissue temperature” should read --a target tissue temperature--.
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 17-20 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 17 recites the limitation “the target tissue” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-20 are also rejected by virtue of their dependency on claim 17.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 & 6-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Claim 1 recite(s): “A system for calibration of a tissue ablation system, the system comprising: a catheter having a proximal region and a distal region; a switching antenna disposed at the distal region of the catheter, the switching antenna comprising a main antenna configured to switch between emitting energy to ablate target tissue and measuring a radiometer temperature generated as a result of the energy emission with a radiometer; a reference termination comprising a temperature sensor configured to measure a reference temperature at the distal region; and a controller operatively coupled to the switching antenna and the reference termination, the controller having instructions that, when executed by a processor of the controller, cause the controller to: cause the main antenna to emit energy at a first power level in an environment comprising a known constant environment temperature; measure a first output voltage generated by the reference termination in response to the energy emission by the main antenna at the first power level, the first output voltage corresponding to a first temperature of the reference termination; cause the main antenna to emit energy at a second power level in the environment comprising the known constant environment temperature; measure a second output voltage generated by the reference termination in response to the energy emission by the main antenna at the second power level, the second output voltage corresponding to a second temperature of the reference termination; and compare the first and second output voltages with the first and second power levels for calibration of the tissue ablation system to account for heating of the reference termination responsive to the energy emission via the main antenna during an ablation procedure”
The claim recites a system and is thus directed to a statutory category of invention
Step 2A, Prong One: claim 1 recites concepts that can be practically performed in the human mind, e.g., using pen and paper or recite a mathematical formula or calculation, including the following limitations: “cause the main antenna to emit energy at a first power level in an environment comprising a known constant environment temperature; measure a first output voltage generated by the reference termination in response to the energy emission by the main antenna at the first power level, the first output voltage corresponding to a first temperature of the reference termination; cause the main antenna to emit energy at a second power level in the environment comprising the known constant environment temperature; measure a second output voltage generated by the reference termination in response to the energy emission by the main antenna at the second power level, the second output voltage corresponding to a second temperature of the reference termination; and compare the first and second output voltages with the first and second power levels for calibration of the tissue ablation system to account for heating of the reference termination responsive to the energy emission via the main antenna during an ablation procedure” which can be performed by an operator (via turning a switch on to apply a signal at given power levels and/or to measure) and the human mind (calculating by hand the comparison). The Examiner notes that recitation of generic computer components does not preclude the claim from reciting an abstract idea.
Step 2A, Prong two: Claim 1 does not recite any additional elements that, when considered either alone or in an ordered combination, would integrate the abstract idea into practical application thereof.
Step 2B: claim 1 further recites the additional limitations of “a catheter having a proximal region and a distal region; a switching antenna disposed at the distal region of the catheter, the switching antenna comprising a main antenna configured to switch between emitting energy to ablate target tissue and measuring a radiometer temperature generated as a result of the energy emission with a radiometer; a reference termination comprising a temperature sensor configured to measure a reference temperature at the distal region”. These limitations do not amount to significantly more than the abstract idea as Allison (US 20170105798, cited in IDS) teaches a catheter with a switching antenna, the switching antenna comprising a main antenna configured to switch between emitting energy and measuring a radiometer temperature and a reference termination. Thus, claim 1, does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 2, the claim recites “wherein the controller is configured to: receive a radiometer temperature measured by the main antenna and a reference temperature measured by the temperature sensor; and calculate a target tissue temperature based on the measured radiometer temperature and the measured reference temperature while accounting for heating of the reference termination responsive to the energy emission via the main antenna during the ablation procedure” which can be done by the human mind (measurement & calculation). Thus, claim 2 recites the abstract idea of mental processes of making a measurement and calculation.
Regarding claim 3, the claim recites “wherein the controller is configured to modulate the energy emission by the main antenna such that the calculated target tissue temperature is maintained within a predetermined threshold” which can be done by the human mind and by hand (calculation & operating a switch to turn power on/off or to increase/decrease power). Thus, claim 3 recites the abstract idea of calculating and operation.
Regarding claim 4, the claim recites “wherein the main antenna comprises a proximal radiating element, a distal radiating element, and a microwave choke arranged at a proximal end of the proximal radiating element configured to minimize fold back of a radiating field pattern along the main antenna” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Allison (US 20170172655, cited in IDS). Thus, claim 4 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 6, the claim recites “wherein the reference termination is disposed between the proximal radiating element and the distal radiating element” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Allison (US 20170105798, cited in IDS). Thus, claim 6 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 7, the claim recites “apply a radiometer signal to the main antenna to cause the main antenna to emit energy at a known power level in a first environment comprising a first known environment temperature; measure a third output voltage of the reference termination in response to the energy emission by the main antenna at the known power level in the first environment; apply the radiometer signal to the main antenna to cause the main antenna to emit energy at the known power level in a second environment comprising a second known environment temperature; measure a fourth output voltage of the reference termination in response to the energy emission by the main antenna at the known power level in the second environment; and compare the third and fourth output voltages with the first and second known environment temperatures to calibrate out an effect of the energy emission via the main antenna on an environment adjacent the main antenna” which can be done by hand (operating a switch to apply a signal at given power levels) and the human mind (measuring and comparing). Thus, claim 7 recites the abstract idea of operating a switch, measuring and comparing.
Regarding claim 8, the claim recites “wherein the controller is configured to: receive a radiometer temperature measured by the main antenna and a reference temperature measured by the temperature sensor; and calculate the target tissue temperature based on the measured radiometer temperature and the measured reference temperature while accounting for heating of the reference termination and the environment adjacent the target tissue responsive to the energy emission via the main antenna during the ablation procedure” which can be done by the human mind (calculation). Thus, claim 8 recites the abstract idea of calculating.
Regarding claim 9, the claim recites “impinge the main antenna with a first noise level to create a first known environment temperature; measure the first known environment temperature; impinge the main antenna with a second noise level to create a second known environment temperature; measure the second known environment temperature; and compare the first and second measured known environment temperatures with the first and second noise levels to calibrate out an effect of the energy emission via the main antenna on an environment adjacent the main antenna” which can be done by hand (switching a noise source on) and by the human mind (measuring & comparing). Thus, claim 9 recites the abstract ideas of switching, measuring, and comparing.
Regarding claim 10, the claim recites “wherein the controller is configured to: receive a radiometer temperature measured by the main antenna and a reference temperature measured by the temperature sensor; and calculate the target tissue temperature based on the measured radiometer temperature and the measured reference temperature while accounting for heating of the reference termination and the environment adjacent the target tissue responsive to the energy emission via the main antenna during the ablation procedure” which can be done by the human mind (calculating). Thus, claim 10 recites the abstract idea of calculating.
Regarding claim 11, the claim recites “measure a third output voltage of the reference termination in response to the impingement of the main antenna with the first noise level; measure a fourth output voltage of the reference termination in response to the impingement of the main antenna with the second noise level; and calculate degrees per volt sensitivity of the radiometer by dividing a difference between the first and second known environment temperatures by a difference between the difference between the third and fourth output voltages” which can be done by the human mind (measuring & calculating). Thus, claim 11 recites the abstract idea of measuring and calculating.
Regarding claim 12, the claim recites “a cooling sleeve disposed over at least the distal region of the catheter and coupled to a source of coolant, the cooling sleeve configured to permit the coolant to flow over the reference termination to maintain a constant temperature of the reference termination at both the first and second known environment temperatures” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Brannan (US 20200305974, cited in IDS). Thus, claim 12 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 13, the claim recites “a switch electrically coupled to the main antenna and the reference termination, wherein the controller is configured to selectively switch the main antenna to measure the radiometer temperature and the reference termination to measure the reference temperature in an alternating manner via the switch” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Allison (US 20170105798, cited in IDS). Thus, claim 13 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 14, the claim recites “wherein the controller is configured to selectively switch the main antenna to emit the energy and measure the radiometer temperature and the reference termination to measure the reference temperature in an interleaving manner” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Allison (US 20170105798, cited in IDS). Thus, claim 14 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 15, the claim recites “wherein the controller is configured to selectively switch the main antenna to emit the energy for a first time period, and the main antenna to measure the radiometer temperature and the reference termination to measure the reference temperature in the alternating manner for a second time period” which an additional element that does not amount to significantly more than the abstract idea since the recited additional limitation is known in the art as taught by Allison (US 20170105798, cited in IDS). Thus, claim 15 does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 16:
Step 1: Claim 16 recite(s): “A method for calibrating a tissue ablation system, the method comprising: positioning a switching antenna disposed at a distal region of a catheter in an environment comprising a known constant environment temperature; causing a main antenna of the switching antenna to emit energy at a first power level in the environment while maintain the known constant environment temperature; measuring a first output voltage generated by a reference termination disposed at the distal region of the catheter in response to the energy emission by the main antenna at the first power level, the first output voltage corresponding to a first temperature of the reference termination; causing the main antenna to emit energy at a second power level in the environment while maintain the known constant environment temperature; measuring a second output voltage generated by the reference termination in response to the energy emission by the main antenna at the second power level, the second output voltage corresponding to a second temperature of the reference termination; and comparing the first and second output voltages with the first and second power levels for calibrating of the tissue ablation system to account for heating of the reference termination responsive to the energy emission via the main antenna during an ablation procedure”.
The claim recites a method and is thus directed to a statutory category of invention.
Step 2A, Prong One: claim 16 recites concepts that can be practically performed in the human mind, e.g., using pen and paper or recite a mathematical formula or calculation, including the following limitations: “causing a main antenna of the switching antenna to emit energy at a first power level in the environment while maintain the known constant environment temperature; measuring a first output voltage generated by a reference termination disposed at the distal region of the catheter in response to the energy emission by the main antenna at the first power level, the first output voltage corresponding to a first temperature of the reference termination; causing the main antenna to emit energy at a second power level in the environment while maintain the known constant environment temperature; measuring a second output voltage generated by the reference termination in response to the energy emission by the main antenna at the second power level, the second output voltage corresponding to a second temperature of the reference termination; and comparing the first and second output voltages with the first and second power levels for calibrating of the tissue ablation system to account for heating of the reference termination responsive to the energy emission via the main antenna during an ablation procedure” which can be performed by an operator (via turning a switch on to apply a signal at given power levels and/or to measure) and the human mind (calculating by hand the comparison). The Examiner notes that recitation of generic computer components does not preclude the claim from reciting an abstract idea.
Step 2A, Prong two: Claim 16 does not recite any additional elements that, when considered either alone or in an ordered combination, would integrate the abstract idea into practical application thereof.
Step 2B: claim 16 further recites the additional limitations of: “positioning a switching antenna disposed at a distal region of a catheter in an environment comprising a known constant environment temperature”. These limitations do not amount to significantly more than the abstract idea as Tofighi (US 20130272339, previously cited). Thus, claim 16, does not amount to significantly more than the abstract idea since the recited additional elements do not provide for an inventive concept.
Regarding claim 17, the claim recites “performing a radiometer calibration to account for heating of an environment adjacent the target tissue during the energy emission via the main antenna” which can be done by the human mind (measuring & calculating). Thus, claim 17 recites the abstract idea of measuring and calculating.
Regarding claim 18, the claim recites “calculating the target tissue temperature based on a radiometer temperature measured by the main antenna and a reference temperature measured by on the reference termination while accounting for heating of the reference termination and the environment adjacent the target tissue responsive to the energy emission via the main antenna during the ablation procedure” which can be done by the human mind (measuring & calculating). Thus, claim 18 recites the abstract idea of measuring and calculating.
Regarding claim 19, the claim recites “wherein performing the radiometer calibration comprises: positioning the switching antenna in a first environment comprising a first known environment temperature; applying a radiometer signal to the main antenna to cause the main antenna to emit energy at a known power level in the first environment; measuring a third output voltage of the reference termination in response to the energy emission by the main antenna at the known power level in the first environment; positioning the switching antenna in a second environment comprising a second known environment temperature; applying the radiometer signal to the main antenna to cause the main antenna to emit energy at the known power level in the second environment; measuring a fourth output voltage of the reference termination in response to the energy emission by the main antenna at the known power level in the second environment; and comparing the third and fourth output voltages with the first and second known environment temperatures to calibrate out an effect of the energy emission via the main antenna on an environment adjacent the main antenna” which can be done by hand (switching the power on/off) & the human mind (measuring & comparing). Thus, claim 19 recites the abstract idea of switching, measuring and comparing.
Regarding claim 20, the claim recites “wherein performing the radiometer calibration comprises: impinging the main antenna with a first noise level to create a first known environment temperature; measuring the first known environment temperature; impinging the main antenna with a second noise level to create a second known environment temperature; measuring the second known environment temperature; and comparing the first and second measured known environment temperatures with the first and second noise levels to calibrate out an effect of the energy emission via the main antenna on an environment adjacent the main antenna” which can be done by hand (switching a noise source on/off) & the human mind (measuring & comparing). Thus, claim 20 recites the abstract idea of switching, measuring and comparing.
Allowable Subject Matter
Claims 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 1-4 & 6-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Claim 5 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/ Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/ Primary Examiner, Art Unit 3794
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