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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/15/2025, with respect to the rejection(s) of claim(s) under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lupotti (US 20160317844, previously presented) in view of 20150273246 to Darlington et al. Additional references used for dependent claims. See details below.
Since this combination was not previously presented, the office action is being submitted as a non-final rejection.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 22, 24, 30 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20160317844 to Lupotti in view of US Pat Pub No. 20150273246 to Darlington et al. (hereinafter “Darlington”).
Regarding claim 22. (New) Lupotti discloses a system for performing a medical procedure on a patient (para 0009-0010, abstract), the system comprising: a tissue interface device (para 0010 “catheter”) comprising: an array of ultrasound transducers (para 0010 “an ultrasound transducer []”, para 0033 “multiple adjacent ultrasonic transducers”) configured to: deliver and receive imaging ultrasound energy (para 0010 “transmit and receive ultrasound waves that can be used to generate ultrasound images”); and deliver ablative ultrasound energy (para 0010 “ultrasound transducer configured to deliver ultrasound ablative energy”), and a console operably connected to the tissue interface device (para 0010 “electronic control unit (ECU)”), the console comprising: a processing unit comprising a processor and a memory storage component coupled to the processor (para 0010, “analysis module”, para 0020 “ECU 16 may comprise a programmable microprocessor []”, which includes both processor and memory storage component), wherein the memory storage component stores instructions for the processor to perform an algorithm (para 0020, 0034 “software algorithms”), wherein the console is configured to produce image data based on the delivered and received imaging ultrasound energy (para 0010 “The ECU includes an imaging module configured to cause the ultrasound transducer to generate and acquire at least one ultrasound image”), wherein the ablative energy delivered by the array of ultrasound transducers comprises HIFU energy configured to ablate one or more treatment targets (para 0022 “deliver high intensity focused ultrasound (HIFU) energy for ablative purposes’), wherein the algorithm is configured to, based on the image data, identify the one or more treatment targets to receive the ablation energy delivered by the array of ultrasound transducers (para 0034 “The tracking module 76 can cause ECU 16 to identify and track the region of interest (ROI)”, 0041, etc.), and wherein the system is configured to deliver the ablation energy to one or more of the treatment targets (para 0010, 0042 “delivering ablative HIFU energy to the target tissue in the ROI.”).
Lupotti discloses confirming the ROI (para 0042) but fails to disclose wherein the system comprises a confirmation routine configured to allow a clinician to confirm the identification of one or more of the one or more treatment targets identified by the algorithm
Darlington, from a similar field of endeavor an imaging transducer and HIFU transducer are combined as a single unit (para 0054) and teaches having a confirmation routine to allow a clinican the identification of the one or more treatment targets (para 0132 “the imaging of the desired treatment volume may be done with another type of imaging modality such as MRI, x-ray, infrared, or the like in a manner that allows a physician to confirm that the HIFU is being delivered to the area of desired target tissue volume”). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti with the teachings of Darlington, to provide the predictable result of confirming the target area.
Regarding claim 24. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, wherein the array of ultrasound transducers comprises a 1D or a 2D array of multiple ultrasound transducers (para 0034 “2D”).
Regarding claim 30. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, wherein the one or more treatment targets comprise tissue of the prostate (para 0019, 0031 “diagnosis and treatment of a variety of tissues, [] prostate tissue”).
Regarding claim 41. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, wherein the algorithm is further configured to identify tissue that has been ablated (para 0043 “The contrast in optical absorption between healthy tissue and tissue that has been ablated produces differences in the waves that can be detected by transducer 38”).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti as modified by Darlington as applied to claims 22-24, 30 and 41 above, and further in view of US Pat Pub No. 20210196229 to Boctor et al. (hereinafter “Boctor”).
Regarding claim 23. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, but fails to disclose wherein the algorithm comprises an artificial intelligence algorithm.
Boctor, from a similar field of endeavor teaches using machine learning model to perform various objectives, calculations, reconstructing images, etc. to provide a simple and low-cost system at a high frame rate (e.g., para 0087). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington with the teachings of Boctor, to provide the predictable result of provide a simple and low-cost system at a high frame rate.
Claim(s) 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti as modified by Darlington as applied to claims 22-24, 30 and 41 above, and further in view of US Pat Pub No. 20060229594 to Francischelli et al. (hereinafter “Francis” – previously presented).
Regarding claim 25. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, but fails to disclose wherein the HIFU energy comprises two or more HIFU beams configured to deliver HIFU energy to two or more of the treatment targets.
Francis from a similar field of endeavor, teaches that it is known to for the ablating member to have focusing configuration that cases the ablating energy to be focused a predetermined distance and location and wherein a plurality of single, discrete ablated tissue areas can be formed in the tissue in a single procedure or treatment performed at one time (para 0032). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Collins, with the known teachings of Francis, because doing so would provide the predictable result of generating ablation such that a plurality of ablated tissue areas are formed (para 0032).
Regarding claim 26. (New) Lupotti as modified by Darlington renders obvious the system according to claim 25, but fails to disclose wherein the two or more HIFU beams deliver HIFU energy to the two or more treatment targets simultaneously.
Francis from a similar field of endeavor, teaches that it is known to for the ablating member to have focusing configuration that cases the ablating energy to be focused a predetermined distance and location and wherein a plurality of single, discrete ablated tissue areas can be formed in the tissue in a single procedure (see para 0089 “six transducer elements 428 actuatable simultaneously or in unison to emit ultrasound energy”) or treatment performed at one time (para 0032). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Francis, because doing so would provide the predictable result of generating ablation such that a plurality of ablated tissue areas are formed (para 0032).
Regarding claim 27. (New) Lupotti as modified by Darlington renders obvious the system according to claim 25, but fails to disclose wherein the two or more treatment targets are located at varying distances from the array of ultrasound transducers.
Francis from a similar field of endeavor, teaches that it is known to for the ablating member to have focusing configuration that cases the ablating energy to be focused a predetermined distance and location and wherein a plurality of single, discrete ablated tissue areas can be formed in the tissue in a single procedure or treatment performed at one time (para 0032, 0066 “The transducers may have varying focal lengths or frequencies at differing, converging angles.”). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Francis, because doing so would provide the predictable result of generating ablation such that a plurality of ablated tissue areas are formed (para 0032).
Regarding claim 28. (New) Lupotti as modified by Darlington renders obvious the system according to claim 25, but fails to disclose wherein the array of ultrasound transducers comprises two or more arrays of ultrasound transducers, and wherein each of the two or more arrays of ultrasound transducers is configured to deliver one, two, or more of the two or more HIFU beams to the target tissue.
Francis from a similar field of endeavor, teaches that it is known to for the ablating member to have focusing configuration that cases the ablating energy to be focused a predetermined distance and location and wherein a plurality of single, discrete ablated tissue areas can be formed in the tissue in a single procedure or treatment performed at one time (para 0032, 0063 “The transducers elements 28.”). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Francis, because doing so would provide the predictable result of generating ablation such that a plurality of ablated tissue areas are formed (para 0032).
Regarding claim 29. (New) Lupotti as modified by Darlington renders obvious the system according to claim 25, but fails to disclose wherein two or more of the two or more treatment targets comprise neighboring treatment targets, and wherein the system is configured to avoid simultaneous delivery of HIFU energy to neighboring treatment targets.
Francis from a similar field of endeavor, teaches that it is known to for the ablating member to have focusing configuration that cases the ablating energy to be focused a predetermined distance and location and wherein a plurality of single, discrete ablated tissue areas can be formed in the tissue in a single procedure or treatment performed at one time (para 0032, 0072, 0079, fig. 3). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Francis, because doing so would provide the predictable result of generating ablation such that a plurality of ablated tissue areas are formed (para 0032).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti as modified by Darlington as applied to claims 22-24, 30 and 41 above, and further in view of US Pat Pub No. 20070219448 to Seip et al. (hereinafter “Seip”)
Regarding claim 31. (New) Lupotti as modified by Darlington renders obvious the system according to claim 30, but fails to disclose wherein the system is configured to diagnose and/or treat benign prostatic hyperplasia (BPH).
Seip, from a similar field of endeavor, teaches a similar ultrasound system and that it is known for the HIFU to be used in the treatment of benign prostate hyperplasia (para 0003). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Seip, because doing so would provide predictable result of the added benefit associated with treating benign prostate hyperplasia.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti as modified by Darlington as applied to claims 22-24, 30 and 41 above, and further in view of US Pat Pub No. 20050222565 to Manstein.
Regarding claim 32. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, but fails to disclose wherein the tissue interface device further comprises a spacer configured to provide a space between the array of ultrasound transducers and the surface of the skin of the patient.
Manstein, from a similar field of endeavor, teaches having a spacer substrate to provide cooling to cool a skin surface to reduce or eliminate pain (para 0070). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the known teachings of Manstein, because doing so would provide predictable result of reducing pain.
Regarding claim 33. (New) Lupotti as modified by Darlington and Manstein renders obvious the system according to claim 32, wherein the spacer is further configured to cool tissue proximate the array of ultrasound transducers (Manstein, para 0070).
Claim(s) 34-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti as modified by Darlington as applied to claims 22-24, 30 and 41 above, and further in view of US Pat Pub No. 20170007310 to Rajagopalan et al (hereinafter “Rajagopalan”).
Regarding claim 34. (New) Lupotti as modified by Darlington renders obvious the system according to claim 22, but fails to disclose wherein the algorithm comprises a bias.
Rajagopalan, from a similar field of endeavor, teaches its algorithm to comprise a bias which tends to choose a smaller functional assembly (para 0214). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Lupotti as modified by Darlington, with the teachings of Rajagopalan to provide the predictable result of allow the algorithm to tend toward a certain outcome as desired.
Regarding claim 35. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 34, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the bias comprises a bias toward delivering the ablative energy to all of a volume of a treatment target to sufficiently ablate the perimeter of the volume. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Regarding claim 36. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 34, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the bias comprises a bias toward delivering the ablative energy to a limited volume of a treatment target to avoid delivery of energy to non-target tissue proximate the volume. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Regarding claim 37. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 34, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the bias can comprise a conservative energy delivery bias or an aggressive energy delivery bias. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Regarding claim 38. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 37, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the bias of the algorithm can be adjusted between conservative and aggressive by an operator of the system. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Regarding claim 39. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 37, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the algorithm is configured to set the bias based on the location of the treatment target. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Regarding claim 40. (New) Lupotti as modified by Darlington and Rajagopalan renders obvious the system according to claim 37, Rajagopalan teaches that it is known to provide a bias in the algorithm to achieve a desired outcome (see para 0214). Rajagopalan fails to explicitly disclose wherein the algorithm is configured to set the bias based on the type of treatment provided by the system. However, changing the bias from one behavior to another is understood to be obvious to try and simple substitution of one known element for another to obtain predictable result (See MPEP 2143). Furthermore, the applicant’s specification has not demonstrated any criticality for this specific limitation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANA SAHAND/Examiner, Art Unit 3796