DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 3 and 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
6. Claim 3 recites the broad recitation “the first measurement comprises an impedance measurement between a first set of two electrodes of the catheter”, which is the narrower statement of the range/limitation since Claim 1 recites “a first measurement from a first set of one or more electrodes of a catheter”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 3 will be interpreted as follows: “the first measurement comprises an impedance measurement between a first electrode and a second electrode of the first set of one or more electrodes of the catheter”. Proper correction is required.
7. Claim 4 recites the broad recitation “the second measurement comprises an impedance measurement between a second set of two electrodes of the catheter”, which is the narrower statement of the range/limitation since Claim 1 recites “a second measurement from a second set of one or more electrodes of a catheter”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 4 will be interpreted as follows: “the second measurement comprises an impedance measurement between a first electrode and a second electrode of the second set of one or more electrodes of the catheter, wherein the first electrode and second electrode of the second set of one or more electrodes is different than the first electrode and second electrode of the first set of one or more electrodes of the catheter”. Proper correction is required.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1-7, 11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Haim U.S. 2021/0137409 (herein referred to as “Ben-Haim”).
10. Regarding Claim 1, Ben-Haim teaches a device (Figs. 1A and 2A) for controlling a collection of electrode calibration data (para 0119), the device comprising:
a. an input interface (Fig. 2A, ref num 270) configured to:
a.1 obtain a first measurement from a set of one or more electrodes (Fig. 2A, ref num 201 which also is depicted as Fig. 1A, ref num 10; para 0145, “a first electrical voltage, the measurement thereof is received in step 325, is a voltage difference between a reference electrode (e.g., 230) and the first catheter electrode (e.g., 10)”) of a catheter for insertion into a cavity of an anatomical structure (Fig. 1A, ref num 6; para 0115), responsive to a change in at least one of contact and distance between the first set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 205 is the measurement of impedance; para 0160), and
a.2 obtain a second measurement, from a second, different set of one or more electrodes of the catheter (Fig. 2A, ref num 202 which also is depicted as Fig. 1A, ref num 12; para 0037, “a second electrical voltage, which is a voltage difference measured between the reference electrode and the second catheter electrode”), responsive to a change in at least one of contact or distance between the second set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 207 is the measurement of impedance; para 0160), and
b. a processor (Fig. 2A, ref num 280) communicatively coupled to the input interface (Fig. 2; para 0120) and configured to:
b.1 determine a ratio between the first measurement and the second measurement (para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”), and
b.2 process the determined ratio to generate a predictive indicator that indicates a likelihood that the catheter is in contact with the anatomical structure (para 0160, 0168, 0189); and
b.3 generate a trigger signal that changes responsive to the predictive indicator (para 0187, 0190-0191).
11. Regarding Claim 2, Ben-Haim teaches the catheter is an ablation therapy catheter (para 0091, “distal end of ablation catheter”; para 0078), and the first set of one or more electrodes of the ablation therapy catheter comprise one or more electrodes used to apply an ablation treatment to the anatomical structure (para 0115, 0118, 0162).
12. Regarding Claim 3, Ben-Haim teaches the first measurement comprises an impedance measurement between a first set of two electrodes of the catheter (para 0138, “impedance evaluated… between the two electrodes… two electrodes can be… non-neighboring electrodes… 10 and 14”).
13. Regarding Claim 4, Ben-Haim teaches the second measurement comprises an impedance measurement comprises an impedance measurement between a second set of two electrodes of the catheter, wherein the second set of two electrodes of the catheter is different than the first set of two electrodes of the catheter (para 0138, “para 0138, “impedance evaluated… between the two electrodes… two electrodes can be the neighboring electrodes… 12 and 16”).
14. Regarding Claim 5, Ben-Haim teaches the processor is configured to process the determined ratio and the first measurement to generate the predictive indicator (para 0125, “processor 280 may run a program that solves equations that connect between the supplied current, measured voltages, and the various impedances”; para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”).
15. Regarding Claim 6, Ben-Haim teaches the input interface is configured to receive a physiological signal, the physiological signal responsive to at least one of a respiratory movement of the patient or a cardiac movement of the patient (para 0174, “the electrical field goes to the reference surface electrode through the lungs, lung volume changes due to breathing may change the values solved for impedances X and Y… monitoring X and Y may provide respiration rate and depth”); and the processor is configured to process the determined ratio and the physiological signal to generate the predictive indicator (para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”; para 0171, “impedance measurements may be indicative of tissue properties… these properties may assist… as a presentation of the measured property”).
16. Regarding Claim 7, Ben-Haim teaches the processor is configured to process the determined ratio by comparing the determined ratio to at least one of one or more predetermined values or one or more first predetermined ranges to generate a predictive indicator that predicts whether or not the catheter is in contact with the anatomical structure (para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”; para 0120, “a processor 280, which processes the measurements to provide evaluation of impedance values for impedance Z, X, Y, R1, and/or R2”; para 0160, , 0187, 0189).
17. Regarding Claim 11, Ben-Haim teaches a system (Fig. 2A) comprising:
a. the device of Claim 1 (see Claim 1 rejection above; paragraph 10); and
b. processing circuitry (Fig. 2A, ref num 280) configured to:
b.1 receive the trigger signal output by the device (para 0120, “the readings of the measurement device(s) in electrical generator/measurer 270 are outputted from the electrical generator/measurer to a processor 280”); and
b.2 selectively obtain electrode calibration data, from one or more of the electrodes of the catheter, responsive to the trigger signal (para 0120, “outputted from the electrical generator/measurer to a processor 280, which processes the measurements to provide evaluation of impedance values”; see Figs. 2, 3, 4, and 6).
18. Regarding Claim 13, Ben-Haim teaches a computer-implemented method for controlling collection of electrode calibration data (para 0080, 0119), the method comprising:
a. obtaining a first measurement from a set of one or more electrodes (Fig. 2A, ref num 201 which also is depicted as Fig. 1A, ref num 10; para 0145, “a first electrical voltage, the measurement thereof is received in step 325, is a voltage difference between a reference electrode (e.g., 230) and the first catheter electrode (e.g., 10)”) of a catheter for insertion into a cavity of an anatomical structure (Fig. 1A, ref num 6; para 0115), responsive to a change in at least one of contact or distance between the first set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 205 is the measurement of impedance; para 0160), and
b. obtaining a second measurement, from a second, different set of one or more electrodes of the catheter (Fig. 2A, ref num 202 which also is depicted as Fig. 1A, ref num 12; para 0037, “a second electrical voltage, which is a voltage difference measured between the reference electrode and the second catheter electrode”), responsive to a change in at least one of contact or distance between the second set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 207 is the measurement of impedance; para 0160), and
c. determining a ratio between the first measurement and the second measurement (para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”), and
d. processing the determined ratio to generate a predictive indicator that indicates a likelihood that the catheter is in contact with the anatomical structure (para 0160, 0168, 0189); and
e. generating a trigger signal that changes responsive to the predictive indicator (para 0187, 0190-0191).
Regarding method claim 13, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 1, since operation of the prior art relied on to reject apparatus claim 1 would naturally result in the step of method claim 13 being satisfied.
19. Regarding Claim 14, Ben-Haim teaches a non-transitory computer-readable storage medium having stored a computer program product comprising instructions (para 0080, 0082-0084, 0087, 0119) which, when executed by a processor (Fig. 2A, ref num 280), causes the processor to:
a. obtain a first measurement from a set of one or more electrodes (Fig. 2A, ref num 201 which also is depicted as Fig. 1A, ref num 10; para 0145, “a first electrical voltage, the measurement thereof is received in step 325, is a voltage difference between a reference electrode (e.g., 230) and the first catheter electrode (e.g., 10)”) of a catheter for insertion into a cavity of an anatomical structure (Fig. 1A, ref num 6; para 0115), responsive to a change in at least one of contact or distance between the first set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 205 is the measurement of impedance; para 0160);
b. obtain a second measurement, from a second, different set of one or more electrodes of the catheter (Fig. 2A, ref num 202 which also is depicted as Fig. 1A, ref num 12; para 0037, “a second electrical voltage, which is a voltage difference measured between the reference electrode and the second catheter electrode”), responsive to a change in at least one of contact or distance between the second set of one or more electrodes and the anatomical structure (Fig. 2A, ref num 207 is the measurement of impedance; para 0160), and
c. determine a ratio between the first measurement and the second measurement (para 0168, “indicator of the contact angle may be a difference or ratio between Re(Y) and RE(X)”), and
d. process the determined ratio to generate a predictive indicator that indicates a likelihood that the catheter is in contact with the anatomical structure (para 0160, 0168, 0189); and
e. generate a trigger signal that changes responsive to the predictive indicator (para 0187, 0190-0191).
Regarding method claim 14, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 1, since operation of the prior art relied on to reject apparatus claim 1 would naturally result in the step of method claim 14 being satisfied.
Claim Rejections - 35 USC § 103
20. 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.
21. Claims 8-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim and in view of Sun U.S. 6,391,024 (herein referred to as “Sun”).
22. Regarding Claims 8 and 10, Ben-Haim fails to teach the processor is configured to process the determined ratio using a probability function to calculate a probability that the catheter is in contact with the anatomical structure; and generate the trigger signal responsive to the calculated probability (claim 8); and the processor is configured to generate the trigger signal to carry the calculated probability (claim 10).
Sun teaches a device of analogous art (Fig. 1), wherein the device comprises a processor (Fig. 4-1, ref num 58 which is part of controller, Fig. 1, ref num 30), such that the processor is configured to determine and process a ratio between a first measurement and second measurement of contact with respective electrodes (Col. 19, lines 49-52, “the PCS microprocessor analyzes the first-frequency impedance and the second-frequency impedance by calculating the ratio of the two impedances”). The determined ratio is processed using a probability function to calculate a probability that the catheter is in contact with an anatomical structure (Col. 19, lines 52-54, “the assessment ratio is then compared to an expected, i.e., “calibration” ratio, value indicative of no electrode/tissue contact”; see Col. 19, lines 60-67 – Col. 20, lines 1-11 for explanation of calculating probability of contact); and then the processor generates a trigger signal responsive to the calculated probability, such that it carries the calculated probability (Col. 17, lines 18-22, “the PCS microprocessor analyses the assessment impedance and the reference impedance and provides an indication of the state of the electrode/tissue contact. This indication may be provided on the front panel of the power control system through a display device”). By processing a probability function of the contact with the tissue and generating the trigger signal thereof, a user is able to obtain an accurate assessment of the degree of contact between electrodes and tissue, resulting in providing treatment to the tissue based on the degree of contact, while also monitoring the tissue state (Col. 3, lines 16-24). Therefore, 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 Ben-Haim to have the processor utilize a probability function to calculate the probability of tissue contact, as this aids in adjusting tissue treatment as necessary.
23. Regarding Claim 9, Ben-Haim fails to teach the probability function defines a predetermined mapping between possible values for the determined ratio and possible values for the probability.
Sun teaches the probability function defines a predetermined mapping between possible values for the determined values and possible values for the probability (Col. 6, lines 28-31, “a processor responsive to the first and second assessment impedance signals for comparing the impedances to a predetermined value indicative or electrode/tissue contact”; Claim 29 – “a comparator configured to compare the percentage difference to a plurality of predetermined contact assessment criteria and provide an indication result”; Col. 19, lines 52-60). By processing a probability function of the contact with the tissue and mapping possible values, a user is able to obtain an accurate assessment of the degree of contact between electrodes and tissue, resulting in providing treatment to the tissue based on the degree of contact, while also monitoring the tissue state (Col. 3, lines 16-24). Therefore, 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 Ben-Haim to have the processor utilize a probability function to calculate the probability of tissue contact, as this aids in adjusting tissue treatment as necessary.
24. Regarding Claim 12, Ben-Haim fails to teach the processing circuitry is configured to obtain the electrode calibration data in response to a calculated probability, contained in the trigger signal, exceeding a predetermined probability threshold.
Sun teaches a system of analogous art (Fig. 1), wherein the system comprises a processor (Fig. 4-1, ref num 58 which is part of controller, Fig. 1, ref num 30), such that the processor is configured to obtain electrode calibration data (Fig. 1, ref num 42 between ref nums 14 and 30; Col. 8, lines 57-62, “CAD 14 collects data 42 from the catheter system 18 and provides it to the controller 30. This data 42 is used to assess the adequacy of the contact between the catheter system 18 electrode or electrodes… and the biological tissue”; Col. 19, lines 49-52). The data is obtained in response to a calculated probability, contained in a trigger signal, exceeding a predetermined probability threshold (Col. 19, lines 52-54, “the assessment ratio is then compared to an expected, i.e., “calibration” ratio, value indicative of no electrode/tissue contact”; see Col. 19, lines 60-67 – Col. 20, lines 1-11 for explanation of calculating probability of contact compared to a threshold; Col. 17, lines 18-22, “the PCS microprocessor analyses the assessment impedance and the reference impedance and provides an indication of the state of the electrode/tissue contact. This indication may be provided on the front panel of the power control system through a display device”). By processing a probability function of the contact with the tissue, a user is able to obtain an accurate assessment of the degree of contact between electrodes and tissue, resulting in providing treatment to the tissue based on the degree of contact, while also monitoring the tissue state (Col. 3, lines 16-24). Therefore, 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 Ben-Haim to have the processor utilize a probability function to calculate the probability of tissue contact, as this aids in adjusting tissue treatment as necessary.
Conclusion
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794