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 .
Election/Restrictions
Applicant’s election without traverse of claims 7-14 in the reply filed on 08 Jun 2026 is acknowledged.
Claims 1-6 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08 Jun 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date of 09 Sep 2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 Mar 2025 and 08 Jun 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Claim Objections
Claims 7-8, 11, and 13 are objected to because of the following informality:
“detecting and ablating lesion” should read “detecting and ablating a lesion” (claim 7);
“radiofrequency (RF)” should read “RF” (claims 8 and 13);
“transesophageal echocardiography (TEE)” should read “TEE” (claim 11); and
“transthoracic echocardiography (TTE)” should read “TTE” (claim 11).
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 7-14 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.
Claim 7 recites the preamble “detecting and ablating lesion using a multiple-modality system …” and also recites throughout the body of the claim “ if lesion is …”. It is unclear whether each “lesion” recited in the body of the claim is the same or different from “lesion” recited in the preamble of the claim. Claims 8-14 inherit the deficiency by the nature of their dependency on claim 7. For purposes of the examination, every “lesion” recited throughout the body of claim 7 is being given a broadest reasonable interpretation as “the lesion”.
Claim 7 recites the limitation “if lesion is detected, optimizing ablation power and pulse for the RF ablation catheter and proceeding to ablate the lesion”. The term “optimizing” is a relative term which renders the claim indefinite. The term “optimizing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 8-14 inherit the deficiency by the nature of their dependency on claim 7. For purposes of the examination, the limitation in claim 7 is being given a broadest reasonable interpretation as “if the lesion is detected, setting ablation power and pulse for the RF ablation catheter and proceeding to ablate the lesion”.
Claim 8 recites the limitation “optimizing ablation power and pulse for the radiofrequency (RF) ablation catheter and proceeding to ablate the lesion”. First, the term “optimizing” is a relative term which renders the claim indefinite. The term “optimizing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Second, it is unclear whether “ablation power and pulse” recited in the limitation is the same or different from “ablation power and pulse” recited in claim 7, to which claim 8 depends. For purposes of the examination, the limitation in claim 8 is being given a broadest reasonable interpretation as “if the lesion is detected, setting the ablation power and pulse for the RF ablation catheter and proceeding to ablate the lesion”.
Claim 10 recites “wherein the multiple-modality system further includes a transthoracic echocardiography (TTE)”. It is unclear what the multiple-modality system further including a TTE means. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the multiple-modality system further includes a TTE probe” in light of the specification of the instant application.
Claim 11 recites the limitation “generating an ultrasound image frame with a transesophageal echocardiography (TEE) catheter and a transthoracic echocardiography (TTE) catheter”. First, it is unclear what TTE catheter is. TTE is well known in the art to be performed by a probe positioned externally relative to a patient, and a catheter is well known in the art to be inserted inside a patient’s body. A review of the specification of the instant application discloses a TTE probe, not a TTE catheter. Second, it is unclear whether a single ultrasound image frame is being generated by the combination of TEE and TTE; an ultrasound image frame is being generated by each one of TEE and TTE; or whether the limitation should read generating an ultrasound image frame by either TEE or TTE. Claims 12-14 inherit the deficiency by the nature of their dependency on claim 11. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “generating an ultrasound image frame with a TEE catheter or a TTE probe”.
Claim 12 recites the limitation “detecting noise and determining if abnormal ultrasound noise is detected”. The term “abnormal” is a relative term which renders the claim indefinite. The term “abnormal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 13-14 inherit the deficiency by the nature of their dependency on claim 12. For purposes of the examination, the limitation in claim 12 is being given a broadest reasonable interpretation as “detecting a noise”, and each of dependent claims 13 and 14 is being given a broadest reasonable interpretation as “adjusting ultrasound control parameters and RF control parameters” and “analyzing noise frequency and auto filter generation”, respectively.
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.
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hennersperger et al. (US PG Pub No. 2021/0361258) – hereinafter referred to as Hennersperger – in view of Haines et al. (Haines et al. Near-Field Ultrasound Imaging During Radiofrequency Catheter Ablation: Tissue Thickness and Epicardial Wall Visualization and Assessment of Radiofrequency Ablation Lesion Formation and Depth. Circ Arrhythm Electrophysiol. 2017;10:e005295. doi: 10.1161/CIRCEP.117.005295. A copy attached to this Office action.) – hereinafter referred to as Haines.
Regarding claim 7, Hennersperger discloses a method for detecting and ablating lesion using a multiple-modality system including an intracardiac echocardiography (ICE) catheter and a radiofrequency (RF) ablation catheter ([0118]: a bespoke rotational 3D-intracardiac echocardiography (ICE) catheter system using ultrafast imaging to provide a system fully tailored to the requirements of ablation procedures in the electrophysiology (EP) lab; Fig. 11-12: a catheter comprising ultrasound array 501-2 and ablation system 1104/ablation electrode tip 1204), the method comprising:
generating an ultrasound image frame with the ICE catheter ([0096]: imaging array 501-2 in its acoustic housing 501-3 used for capturing images during ablation procedure; Fig. 26B: generating an image); and
determining if lesion is detected using a lesion detection convolutional neural network (CNN; Fig. 26B-D: detecting lesion in pre- and post-ablation procedures; [0194]-[0195]: determining whether the lesion-spectral change value meeting lesion change criteria 2636 or not to generate or forego a lesion performance success message; [0079]: imaging protocols described are combined with convolutional neural network to enable fast analysis of data and extraction of results).
Hennersperger does not disclose:
if lesion is detected, optimizing ablation power and pulse for the RF ablation catheter and proceeding to ablate the lesion; and
if lesion is not detected, generating another ultrasound image frame with the ICE catheter.
Haines in the same field of detecting and ablating a lesion, however, teaches:
if lesion is detected, optimizing ablation power and pulse for the RF ablation catheter and proceeding to ablate the lesion (pg. 4: NFUS Catheter Ablation Protocol: titrate power and duration of RF ablation from an initial power and duration to termination if transmural lesion formation was apparent); and
if lesion is not detected, generating another ultrasound image frame with the ICE catheter (pg. 4: NFUS Catheter Ablation Protocol: NFUS and ICE images were recorded for postprocedure analysis off-line to standardize the methodology for these measurements.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Haines’s method of setting ablation power and pulse based on a lesion detection and generating another ultrasound image regardless of a lesion detection. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Haines are directed to detecting and ablating a lesion using an ultrasound imaging and radiofrequency ablation. The motivation for the combination would have been “to emulate clinical ablation by attempting to maximize lesion size safely and produce a transmural lesion”, as taught by Haines (pg. 4: NFUS Catheter Ablation Protocol).
Regarding claim 8, Hennersperger in view of Haines discloses all limitations of claim 7, as discussed above, and Hennersperger further discloses:
if lesion is detected, determining if deep-learning guided lesion imaging is needed (Fig. 26A and [0183]-[0186]: based on the pre-ablation acquisition containing a lesion, post-ablation imaging acquisition is performed; [0079]: imaging protocols described are combined with deep learning to enable fast analysis of data and extraction of results); and
if deep-learning guided lesion imaging is needed, rotating a tip of the ICE catheter using servo control and proceeding to determine if full lesion ablation is acquired ([0186]-[0187]: after the ablation procedure, circumferentially rotating the catheter and acquiring post-ablation reflection signals; [0094]: ultrasound transducer array 501-2 rotated by rotary motor 502-1).
Hennersperger does not disclose:
if full lesion ablation is acquired, optimizing ablation power and pulse for the radiofrequency (RF) ablation catheter and proceeding to ablate the lesion.
Haines in the same field of detecting and ablating a lesion, however, teaches:
optimizing ablation power and pulse for the radiofrequency (RF) ablation catheter and proceeding to ablate the lesion (pg. 4: NFUS Catheter Ablation Protocol: titrate power and duration of RF ablation from an initial power and duration to termination if transmural lesion formation was apparent).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Haines’s method of setting ablation power and pulse based on a lesion detection. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Haines are directed to detecting and ablating a lesion using an ultrasound imaging and radiofrequency ablation. The motivation for the combination would have been “to emulate clinical ablation by attempting to maximize lesion size safely and produce a transmural lesion”, as taught by Haines (pg. 4: NFUS Catheter Ablation Protocol).
It is noted that the contingent limitations in claim 8 are subject to interpretation per MPEP 2111.04.II.: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”. However, the Examiner notes above disclosure of Hennersperger and Haines for a clarity of record.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hennersperger in view of Haines, as applied to claim 7 above, and further in view of Lupotti et al. (WIPO Pub No. WO2013/123020, a copy attached to this Office Action.) – hereinafter referred to as Lupotti.
Regarding claims 9-11, Hennersperger in view of Haines discloses all limitations of claim 7, as discussed above, and Hennersperger does not disclose:
wherein the multiple-modality system further comprises a transesophageal echocardiography (TEE) catheter (claim 9);
wherein the multiple-modality system further includes a transthoracic echocardiography (TTE) (claim 10); and
generating an ultrasound image frame with a transesophageal echocardiography (TEE) catheter and a transthoracic echocardiography (TTE) catheter (claim 11).
Lupotti in the same field of detecting and ablating a lesion, however, teaches:
wherein the multiple-modality system further comprises a transesophageal echocardiography (TEE) catheter ([0025]: echographic probe 22 comprises transthoracic (TTE) echo probe);
wherein the multiple-modality system further includes a transthoracic echocardiography (TTE) ([0025]: echographic probe 22 comprises trans esophageal (TEE) echo probe); and
generating an ultrasound image frame with a transesophageal echocardiography (TEE) catheter and a transthoracic echocardiography (TTE) catheter ([0025]: echographic probe 22 provides real time imaging and visualization of tissue, is used to evaluate tissue, and comprises a transesophageal (TEE) echoprobe or transthoracic (TTE) echoprobe).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Lupotti’s TTE or TEE probe to generate an ultrasound image frame. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Lupotti are directed to detecting and ablating a lesion using an ultrasound imaging and radiofrequency ablation. The motivation for the combination would have been provide an additional imaging probe for a “real time imaging and visualization of tissue 12 and … evaluate tissue 112”, as taught by Lupotti ([0025]), during the RF ablation without interfering the ablation procedure.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hennersperger in view of Haines and Lupotti, as applied to claim 11 above, and further in view of Courtney et al. (US PG Pub No. 2018/0253830) – hereinafter referred to as Courtney.
Regarding claim 12, Hennersperger in view of Haines and Lupotti discloses all limitations of claim 11, as discussed above, and Hennersperger does not disclose:
detecting noise and determining if abnormal ultrasound noise is detected.
Courtney in the same field of generating an ultrasound image, however, teaches:
detecting noise and determining if abnormal ultrasound noise is detected ([0199]: detect noise within imaging band via one or more reference receive channels).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Courtney’s method of detecting noise in ultrasound imaging. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Courtney are directed to ultrasound imaging. The motivation for the combination would have been since “Many electrical components within the imaging system may pick up unwanted energy from environmental noise sources … (and there is a need) for noise reduction of an imaging signal in an ultrasound imaging system”, as taught by Courtney ([0221]).
Regarding claim 14, Hennersperger in view of Haines, Lupotti, and Courtney discloses all limitations of claim 12, as discussed above, and Courtney further teaches (also see claim 12 above):
analyzing noise frequency and auto filter generation (Fig. 5A and [0237]-[0240]: noise characterization performed using band pass filters to generate in-band imaging waveforms).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Courtney’s method of analyzing noise frequency and auto filter generation. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Courtney are directed to ultrasound imaging. The motivation for the combination would have been since “Many electrical components within the imaging system may pick up unwanted energy from environmental noise sources … (and there is a need) for noise reduction of an imaging signal in an ultrasound imaging system”, as taught by Courtney ([0221]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hennersperger in view of Haines, Lupotti, and Courtney, as applied to claim 12 above, and further in view of Waters et al. (US PG Pub No. 2013/0137980) – hereinafter referred to as Waters.
Regarding claim 13, Hennersperger in view of Haines, Lupotti, and Courtney discloses all limitations of claim 12, as discussed above, and Hennersperger does not disclose:
if abnormal ultrasound noise is detected, adjusting ultrasound control parameters and radiofrequency (RF) control parameters.
Waters in the same field of detecting and ablating a lesion, however, teaches:
adjusting ultrasound control parameters and RF control parameters to minimize noise ([0046]-[0047]: determine appropriate imaging frequency and ablation frequency for a particular treatment or application to minimize interferences between ablation and imaging).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hennersperger’s method to include Waters’s method of adjusting both ultrasound and RF control parameters. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success since both Hennersperger and Waters are directed to detecting and ablating a lesion using an ultrasound imaging and radiofrequency ablation. The motivation for the combination would have been for “ minimizing interference to the ultrasound imaging that may be caused by the ablation frequency, increasing the contrast between ablated tissue relative and un-ablated tissue in the ultrasound image, the resolution and depth penetration of the imaging frequency, and so on”, as taught by Waters ([0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schwartz et al. (US PG Pub No. 2018/0325597) discloses changing ablation parameters based on protective constraints, including efficiency of power application and practicability of the lesion plan (see at least [0098]);
Ben-Haim et al. (US PG Pub No. 2020/0060757) discloses changing ablation parameters based on effectiveness of ablation plan (see at least [0171]); and
Savery et al. (US PG Pub No. 2010/0168571) discloses changing ablation parameters based on a noise in ultrasound image ([0016]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 7/1/26
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