DETAILED ACTION
This office action is in response to the communication received on 10/02/2025 concerning application no. 18/564,181 filed on 11/27/2023.
Claims 13-27 are pending.
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 filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant argues that “However, claim 14 depends from claim 13, which establishes the context of a medical procedure system, and the specification at paragraph [0145] clearly describes treatment of "tongue, tonsil, and/or other airway location" in the context of sleep apnea treatment. The term "other airway location" is sufficiently definite when read in light of the specification's disclosure of various airway structures including the hypoglossal nerve, soft palate, and uvula as treatment targets. One of ordinary skill in the art would understand that "other airway location" refers to airway anatomical structures beyond the specifically recited tongue and tonsil locations.”
Examiner respectfully disagrees. The rejection is a 112(b) rejection and not a 112(a) rejection. The language of the specification is not present in the instant claim or the independent claim. It is clear that the tongue and tonsils are not airways1. Again, as noted in the non-final rejection, filed 04/02/2025, “the independent claim and other elements of the instant claim do not establish an initial airway location”.
Examiner respectfully maintains the rejection.
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant argues “Regarding claim 17, the Office Action objects to "a volume of tissue" as indefinite, questioning whether it refers to the same volume established in claim 13. Claim 17 depends from claim 13, which recites "multiple target tissue locations are positioned within a volume of tissue comprising a non-homogenous structure." The specification at paragraph [0145] defines this volume of tissue as comprising "properties such as tissue type, tissue echogenicity, tissue cooling and/or other thermal properties". When read in proper dependency, claim 17's reference to "a volume of tissue" clearly refers back to the volume established in claim 13, providing the necessary antecedent basis. The claim limitations regarding length and width dimensions provide further specificity to the volume of tissue already established in the parent claim.”
Examiner respectfully disagrees. Again, the rejection is a 112(b) rejection and not a 112(a) rejection. If the Applicant considers the volume of interest of claim 17 to be the same as the volume of interest in claim 13, it should recite “the volume of interest” rather than “a volume of interest” to ensure that there is no ambiguity that it is referring to the same VOI.
Examiner respectfully maintains the rejection.
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant argues “Regarding claim 27, the Office Action objects to "non-sequential manner" as indefinite. The specification at paragraph [0087] describes the system's algorithm as being "configured to determine and/or modify one or more energy delivery parameters" for effective treatment. The term "non-sequential manner" in the context of energy delivery to multiple tissue locations refers to temporal delivery patterns that are not consecutive or ordered, which would be understood by one of ordinary skill in the art as referring to randomized, simultaneous, or otherwise non-consecutive delivery sequences. This interpretation is consistent with the specification's disclosure of sophisticated algorithmic control systems that can deliver energy in various patterns to optimize treatment effectiveness while avoiding damage to intervening tissue structures.”
Examiner respectfully disagrees. Again, the rejection is a 112(b) rejection and not a 112(a) rejection. Applicant’s arguments that one with ordinary skill in the art would understand is without support. Assuming, arguendo, the language of the specification limited the claim, the cited section does not even talk about non-sequential manner to be in the temporal context. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” If the energy delivery is in the temporal context, Applicant is encouraged to incorporate that into the claim to establish that. Applicant is reminded that no new matter can be introduced.
Examiner respectfully maintains the rejection.
Applicant’s arguments with respect to claim 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings were received on 10/02/2025. These drawings are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“control system configured to receive the control signals” in claim 13: Paragraph 0079 establishes “In some embodiments, EDD 100 is configured to receive one or more forms of energy, such as reflected energy used to produce image data ID, and/or energy representing control signals or other data that has been sent (e.g. wirelessly sent) to EDD 100. EDD 100 can comprise a handheld device, a catheter, a probe (e.g. a probe configured to be inserted through a laparoscopic port), and/or a robotically controlled device. In some embodiments, EDD 100 comprises multiple discrete components. EDD 100 comprises one or more housings, housing 101 shown, such as one or more housings that surround one or more components of EDD 100.”. Paragraph 0080 establishes “Energy can be delivered by CEDD 200 on a relative continuous basis, and/or on an intermittent basis, also as described herein. In some embodiments, CEDD 200 is configured to receive one or more forms of energy, such as reflected energy used to produce image data ID, or energy representing control signals and/or other data that has been sent (e.g. wirelessly sent) to CEDD 200. CEDD 200 comprises one or more housings, housing 201 shown, such as one or more housings that surround one or more components of CEDD 200.”. Paragraph 0084 establishes “System 10 can include console 500 shown, which can comprise one or more discrete components which operably interface with one or more other components of system 10, such as to provide energy and/or data (e.g. control signals), and/or to receive energy and/or data.”
“a feedback mechanism configured to monitor” in claim 13: A review of the original specification does not appear to set forth a corresponding structure for the claimed “feedback mechanism”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 13-27 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 13 is indefinite for the following reasons:
Recites “the processor configured to receive the image data and execute one or more algorithms to”. This claim element is indefinite. It would be unclear if the algorithms are actively being claimed as being present on the processor or as an intended use limitation. It is further unclear where the algorithms are situated if they are being actively claimed as they are merely being executed by the processor.
Applicant is encouraged to provide consistent and clear language.
Recites “automatically differentiate the multiple target tissue locations from non-target tissue locations within the non-homogenous structure based on an analysis of the image data”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if this differentiation is different from the differentiation defined as “wherein the system is configured to differentiate target tissue locations from non-target tissue locations based on the image data” or is referring to the same differentiation.
Applicant is encouraged to provide consistent and clear language.
Claim 14 is indefinite for the following reasons:
Lines 2, recite “other airway location”. This claim element is indefinite. It would be unclear what is the initial airway location such that this element is the airway location. That is, the independent claim and other elements of the instant claim do not establish an initial airway location.
Applicant is encouraged to provide consistent and clear language.
Claim 17 is indefinite for the following reasons:
Line 2, recite “a volume of tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “volume of tissue” is the same as the “volume of tissue” established in claim 13 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 27 is indefinite for the following reasons:
Lines 1-2, recite “wherein the focused energy is delivered to the multiple target tissue locations in a non-sequential manner”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if non-sequential manner refers to the temporal context or the spatial context or a third context with respect to the energy delivery.
Applicant is encouraged to provide consistent and clear language.
Claim limitation “feedback mechanism” (See claim 13) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It would be unclear to one with ordinary skill in the art what structural features or components are needed to satisfy this claimed “feedback mechanism”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
For purposes of examination, the Office is considering a processor as a “feedback mechanism”.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 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.
Claims 13-17, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628).
Regarding claim 13, Barthe teaches a system for performing a medical procedure on a patient, the system comprising:
an array of ultrasound transducers configured to (Col. 5, lines 28-39 teaches the use of a probe and transducer. Col. 8, lines 13-42 teaches the plurality of elements):
deliver ultrasound energy to produce image data of a volume of tissue comprising a non-homogenous structure (Abstract teaches the performance of ultrasound imaging of the region of interest (ROI). Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Col. 13, lines 28-49 teaches that the treatment can be of the oral and/nasal cavity. Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly. See Fig. 2); and
deliver focused ultrasound energy to ablate multiple target tissue locations within the volume of tissue (Col. 5, lines 62 to Col. 6, lines 10 teach the imaging for monitoring the results and indicating the therapy status. See Fig. 2C. Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Fig. 2B shows multiple treatment zones of varying dimensions surrounded by healthy tissue. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly):
wherein the image data comprises data related to the multiple target tissue locations and data related to one or more non-target tissue locations (Col. 5, lines 62 to Col. 6, lines 10 teach the imaging for monitoring the results and indicating the therapy status. See Fig. 2C. Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Fig. 2B shows multiple treatment zones of varying dimensions surrounded by healthy tissue. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly),
wherein the system is configured to differentiate target tissue locations from non-target tissue locations based on the image data (Col. 5, lines 62 to Col. 6, lines 10 teach the imaging for monitoring the results and indicating the therapy status. See Fig. 2C. Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Fig. 2B shows multiple treatment zones of varying dimensions surrounded by healthy tissue. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly), and
wherein the system is further configured to avoid delivery of the focused ultrasound energy to non-target tissue locations based on the image data (Fig. 2B shows multiple treatment zones of varying dimensions surrounded by healthy tissue. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly);
a control system operatively coupled to the processor and the array of ultrasound transducers, the control system configured to receive the control signals and, in response, modify energy delivery parameters to selectively deliver the focused ultrasound energy to the multiple target tissue locations and avoid delivery of the focused ultrasound energy to the non-target tissue locations (Col. 2, lines 52 to Col. 3, line 2 teaches control system and display system can also comprise various configurations for controlling probe and system functionality, including for example a microprocessor with software and a plurality of input/output and communication devices, a system for controlling electronic and/or mechanical scanning and/or multiplexing of transducers, a system for power delivery, systems for monitoring, systems for sensing the spatial position of the probe and/or temporal parameters of the transducers, and systems for handling user input and recording treatment input and results, among others. Col. 7, lines 63 to Col. 8, line 5 teaches a transducer probe can comprise a control interface, a transducer, coupling components, and monitoring/sensing components, and/or motion mechanism. The transducer probe can be configured and optimized in a variety of ways with more or less parts and components to provide ultrasound energy for controlled thermal injury of photoaged tissue. See Figs. 2 and 4. Fig. 2B shows multiple treatment zones of varying dimensions surrounded by healthy tissue. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly); and
a feedback mechanism configured to monitor tissue parameters resulting from the delivered focused ultrasound energy and provide feedback data to the processor, wherein the processor is further configured to dynamically modify the energy delivery parameters based on the feedback data (Col. 4, line 54 to Col. 5, line 3 teaches that the changes in the ultrasound can be detected and use for feedback control to detect a desired effect on the tissue and used to control the exposure intensity, time, and/or position. Col. 6, lines 66 to Col. 7, line 19 teaches the use of a feedback cycle for the treatment and the use of the sensing and monitoring components).
However, Barthe is silent regarding a system, a processor operatively coupled to the array of ultrasound transducers, the processor configured to receive the image data and execute one or more algorithms to:
automatically differentiate the multiple target tissue locations from non-target tissue locations within the non-homogenous structure based on an analysis of the image data; and
generate control signals based thereon.
In an analogous imaging field of endeavor, regarding HIFU treatment, Dalal teaches a system, a processor operatively coupled to the array of ultrasound transducers, the processor configured to receive the image data and execute one or more algorithms to (Fig. 1 shows the processor working in conjunction with the imaging component and the ablation component. Paragraph 0166 teaches the use of memory suitable for storing computer-executable instructions for execution by the one or more processors. Paragraph 0049 teaches that the imaging component can be ultrasound and the ablation component can be HIFU):
automatically differentiate the multiple target tissue locations from non-target tissue locations within the non-homogenous structure based on an analysis of the image data (Paragraph 0049 teaches that the lesion, organs, and the critical regions can be segmented automatically using algorithms based on the image data. The segmentation produces a description of the volumetric regions associated with the specific objects. The optimization components identify the ablation position with orientations and spares the healthy tissue. Additional object volumes are segmented that denote `critical regions` of tissue or bone that are not to be ablated, and the optimization component attempts to generate either the fewest ablations or minimize collateral damage, while also avoiding these regions); and
generate control signals based thereon (Paragraph 0049 teaches that the PTV is determined and used in the optimization. The optimization component analyzes information associated with the PTV, particularly the dimensions, and for a given ablation probe defines a set of ablation positions with orientations. The optimization components identify the ablation position with orientations and spares the healthy tissue);
a control system operatively coupled to the processor and the array of ultrasound transducers, the control system configured to receive the control signals and, in response, modify energy delivery parameters to selectively deliver the focused ultrasound energy to the multiple target tissue locations and avoid delivery of the focused ultrasound energy to the non-target tissue locations (Paragraph 0049 teaches that the lesion, organs, and the critical regions can be segmented automatically using algorithms based on the image data. The segmentation produces a description of the volumetric regions associated with the specific objects. The optimization components identify the ablation position with orientations and spares the healthy tissue. Additional object volumes are segmented that denote `critical regions` of tissue or bone that are not to be ablated, and the optimization component attempts to generate either the fewest ablations or minimize collateral damage, while also avoiding these regions. The optimization component optimizes ablation techniques, ablation periods, probe size, temperature, PTV, ellipsoid volume, ellipsoid centers, PTV reductions and/or adjustments, protocols for minimizing PTV, probe entry angles and/or positions, and any other suitable information related to system performance); and
a feedback mechanism configured to monitor tissue parameters resulting from the delivered focused ultrasound energy and provide feedback data to the processor, wherein the processor is further configured to dynamically modify the energy delivery parameters in real-time based on the feedback (Paragraph 0049 teaches that the lesion, organs, and the critical regions can be segmented automatically using algorithms based on the image data. The segmentation produces a description of the volumetric regions associated with the specific objects. The optimization components identify the ablation position with orientations and spares the healthy tissue. Additional object volumes are segmented that denote `critical regions` of tissue or bone that are not to be ablated, and the optimization component attempts to generate either the fewest ablations or minimize collateral damage, while also avoiding these regions. The optimization component optimizes ablation techniques, ablation periods, probe size, temperature, PTV, ellipsoid volume, ellipsoid centers, PTV reductions and/or adjustments, protocols for minimizing PTV, probe entry angles and/or positions, and any other suitable information related to system performance. Paragraph 0071 teaches that the operation can be in real time and based on the feedback).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Barthe with Dalal’s teaching of an algorithm to discriminate between the target and other tissue and control the system accordingly. This modified apparatus would allow the user to minimizes surficial duration and proves specific, quantitative target locations and orientations (Paragraphs 0014-17 of Dalal). Furthermore, the modification results in faster ablation techniques with greater accuracy (Paragraph 0103 of Dalal).
Regarding claim 14, Barthe teaches the system in claim 13, as discussed above.
Barthe further teaches a system, wherein the multiple target tissue locations comprise locations within the tongue, tonsil, and/or other airway location (Col. 13, lines 28-49 teaches that the treatment can be of the oral and/nasal cavity).
Regarding claim 15, Barthe teaches the system in claim 13, as discussed above.
Barthe further teaches a system, wherein the focused ultrasound energy comprises high intensity focused ultrasound (HIFU) energy (Col. 4, lines 54 to Col. 5, lines 3 teaches high frequency focused ultrasound).
Regarding claim 16, Barthe teaches the system in claim 15, as discussed above.
Barthe further teaches a system, wherein the HIFU energy is delivered at a frequency between 5MHz and 10MHz (Col. 4, lines 11-37 teaches therapy energy can be delivered at frequencies from approximately 2 to 50 MHz, with 2 MHz to 25 MHz being typical).
Regarding claim 17, Barthe teaches the system in claim 13, as discussed above.
Barthe further teaches a system, wherein each of the multiple target tissue locations comprises a volume of tissue comprising a length and a width, wherein the length is no more than 0.5 mm and the width is no more than 3.0 mm (Col. 5, lines 20-39 teaches the treatment depth of approximately 0 to 5 mm or less. Fig. 2B shows the width to be narrower than the depth).
Regarding claim 21, Barthe teaches the system in claim 13, as discussed above.
Barthe further teaches a system, further comprising a spacing element configured to be positioned between the array of ultrasound transducers and a tissue surface proximate the multiple target tissue locations (Col. 8, lines 43-59 teaches the use of cooling system that are between the transducer array and the patient based on heat sinks or natural conduction and convection or via active cooling such as with Peltier thermoelectric coolers, refrigerants, or fluid-based systems comprised of pump, fluid reservoir, bubble detection, flow sensor, flow channels/tubing. See Fig. 11 and 2).
Regarding claim 23, modified Barthe teaches the system in claim 13, as discussed above.
However, Barthe is silent regarding a system, wherein the system is further configured to identify and track ablated tissue versus unablated tissue based on the image data.
In an analogous imaging field of endeavor, regarding ablation therapy, Dalal teaches a system, wherein the system is further configured to identify and track ablated tissue versus unablated tissue based on the image data (Paragraph 0049 teaches that the lesion, organs, and the critical regions can be segmented automatically using algorithms based on the image data. The segmentation produces a description of the volumetric regions associated with the specific objects. The optimization component considers the unablated regions and alerts the user. Paragraph 0096 teaches that the unablatable areas are presented to a physician (e.g., via the GUI 18 or the like) as being highlighted so that the physician can take appropriate action).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Barthe with Dalal’s teaching of tracking of unablated tissue based on image analysis. This modified apparatus would allow the user to minimizes surficial duration and proves specific, quantitative target locations and orientations (Paragraphs 0014-17 of Dalal). Furthermore, the modification results in faster ablation techniques with greater accuracy (Paragraph 0103 of Dalal).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Qiu et al. (PGPUB No. US 2022/0313346).
Regarding claim 18, modified Barthe teaches the system in claim 13, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein the system is configured to avoid the creation of a scab.
In an analogous imaging field of endeavor, regarding ablation therapy, Qiu teaches a system, wherein the system is configured to avoid the creation of a scab (Paragraphs 0080-81 teaches the control of the ablation system to avoid scabs).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Qiu’s teaching of avoiding scabbing. This modified apparatus would allow the user to address the issue of sharp changes in impedance, excessively high ablation temperature, ensure relatively uniform and continuous ablation, and scabbing (Paragraphs 0005-06 of Qiu). Furthermore, the modification is such that the radiofrequency ablation can be performed relatively uniformly in a circulating manner, thereby obtaining a satisfied therapeutic effect (Paragraph 0019 of Qiu).
Regarding claim 19, modified Barthe teaches the system in claim 18, as discussed above.
Barthe further teaches a system, wherein each of the multiple target tissue locations comprises a subsurface tissue location and one or more of the non-target tissue locations comprise a surface tissue location (Col. 7, lines 34-62 teaches the targeting for generation of multiple lesions. Fig. 2B shows multiple treatment zones of varying dimensions beneath the skin. Claim 17 teaches targeting of multiple target areas and adjusting the probe accordingly. Col. 2, lines 52 to Col. 3, lines 2 tjeaches that treatment is according to user input).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Francischelli et al. (PGPUB No. US 2006/0229594).
Regarding claim 20, modified Barthe teaches the system in claim 13, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein one or more of the non-target tissue locations comprises a blood conduit.
In an analogous imaging field of endeavor, regarding ablation therapy, Francischelli teaches a system, wherein one or more of the non-target tissue locations comprises a blood conduit (Paragraph 0204 teaches the avoiding damage to the atrial walls, pulmonary veins, and the pulmonary arteries).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Francischelli’s teaching of avoiding blood conduits. This modified apparatus would allow the user to deliver treatment based on the desired ablative effect, for the desired duration and control the thermal size and effect (Paragraph 0029 of Francischelli). Furthermore, the modification engages organ tissue and allows a surgeon to easily position, manipulate, stabilize and/or hold an organ during a controlled intermittent asystole, guided or navigated ablation procedure (Paragraph 0028 of Francischelli).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Vaezy et al. (PGPUB No. US 2008/0051656).
Regarding claim 22, modified Barthe teaches the system in claim 21, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein the spacing element comprises a fluid containing structure constructed and arranged to expand and/or contract when fluid is added and/or removed.
In an analogous imaging field of endeavor, regarding ablation therapy, Vaezy teaches a system, wherein the spacing element comprises a fluid containing structure constructed and arranged to expand and/or contract when fluid is added and/or removed (Paragraph 0088 teaches the use of an expandable member that is inflated with liquid and supports the HIFU propagation. This material can be a balloon or a latex condom. See Fig. 17).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Vaezy’s teaching of an inflatable spacing element that holds the fluid. This modified apparatus would allow the user to perform treatment that is expected to compare favorably with the costs for the current drug related therapy for the treatment of uterine fibroids and its efficacy should compare favorably with the higher success rate of the current surgical procedures, but without the attendant risks (Paragraph 0004 of Vaezy). Furthermore, the modification will enhance the propagation (Paragraph 0007 of Vaezy).
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Karczmar et al. (PGPUB No. US 2010/0106005).
Regarding claim 24, modified Barthe teaches the system in claim 13, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein the array of ultrasound transducers is further configured to deliver marking energy comprising ultrasound energy configured to cause detectable modifications to tissue.
In an analogous imaging field of endeavor, regarding ablation therapy, Karczmar teaches a system, wherein the array of ultrasound transducers is further configured to deliver marking energy comprising ultrasound energy configured to cause detectable modifications to tissue (Paragraph 0007 teaches that ablation markings can be generated in a pattern. Paragraph 0032 teaches that the pattern can be recognized via image recognition. Paragraphs 0017 and 0020 teaches imaging can be performed via ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Karczmar’s teaching of marking with an ablative pattern for image recognition. This modified apparatus would allow the user to improve radiation site selection and treatment follow-up (Paragraph 0017 of Karczmar). Furthermore, the modification will accurately determine tumor boundaries and `high risk` areas within tumors (Paragraph 0021 of Karczmar).
Regarding claim 26, modified Barthe teaches the system in claim 24, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein the system is further configured to deliver the marking energy in a particular pattern to mark tissue and to identify the pattern based on the imaging data.
In an analogous imaging field of endeavor, regarding ablation therapy, Karczmar teaches a system, wherein the system is further configured to deliver the marking energy in a particular pattern to mark tissue and to identify the pattern based on the imaging data (Paragraph 0007 teaches that ablation markings can be generated in a pattern. Paragraph 0032 teaches that the pattern can be recognized via image recognition. Paragraphs 0017 and 0020 teaches imaging can be performed via ultrasound).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Karczmar’s teaching of marking with an ablative pattern for image recognition. This modified apparatus would allow the user to improve radiation site selection and treatment follow-up (Paragraph 0017 of Karczmar). Furthermore, the modification will accurately determine tumor boundaries and `high risk` areas within tumors (Paragraph 0021 of Karczmar).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Karczmar et al. (PGPUB No. US 2010/0106005) further in view of Rosenbegr (PGPUB No. US 2014/0005658).
Regarding claim 25, modified Barthe teaches the system in claim 24, as discussed above.
However, the combination of Barthe, Dalal, and Karczmar is silent regarding a system, wherein the focused ultrasound energy comprises a first set of energy delivery settings, wherein the marking energy comprises a second set of energy delivery settings, and wherein the first set of energy delivery settings is different than the second set of energy delivery settings.
In an analogous imaging field of endeavor, regarding ablation therapy, Rosenbegr teaches a system, wherein the focused ultrasound energy comprises a first set of energy delivery settings, wherein the marking energy comprises a second set of energy delivery settings, and wherein the first set of energy delivery settings is different than the second set of energy delivery settings (Paragraphs 0056-57 teach the varying treatment setting for ablative and non-ablative targets. Fig. 10).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe, Dalal, and Karczmar with Rosenbegr’s teaching of varying delivery settings based on ablation purposes. This modified apparatus would allow the user to implement treatment in a cost-effective manner (Paragraph 0005 of Rosenbegr). Furthermore, the modification provides correction of almost all cosmetic skin defects such as signs of aging, wrinkles, discolorations, acne scars, tattoo removal, and other skin defects (Paragraph 0005 of Rosenbegr).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US Patent No. 8,641,622) in view of Dalal et al. (PGPUB No. US 2011/0015628) further in view of Coleman (PGPUB No. US 2004/0015106).
Regarding claim 27, modified Barthe teaches the system in claim 13, as discussed above.
However, the combination of Barthe and Dalal is silent regarding a system, wherein the focused energy is delivered to the multiple target tissue locations in a non-sequential manner.
In an analogous imaging field of endeavor, regarding ablation therapy, Coleman teaches a system, wherein the focused energy is delivered to the multiple target tissue locations in a non-sequential manner (Paragraph 0014 teaches the implementation of an ablation device that is able to generate patterns of lesions of various irregular or discontinuous patterns).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Barthe and Dalal with Coleman’s teaching of ablation delivery in a non-sequential manner. This modified apparatus would allow the user to enhance the efficacy of focused ultrasound ablation procedures and customize lesion generation (Paragraph 0014 of Coleman). Furthermore, the modification will form a lesion within the tissue having the desired size and/or configuration (Abstract of Coleman).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ebbini et al. (PGPUB No. US 2019/0160309): Teaches real time feedback for HIFU procedures and controlling the system according to image recognition of the tissue.
Ergün et al. (PGPUB No. US 2019/0076674): Teaches real time feedback for HIFU procedures and controlling the system according to image recognition of the tissue.
Breen et al. (PGPUB No. US 2006/0184163): Teaches real time feedback for HIFU procedures and controlling the system according to image recognition of the tissue.
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 extension fee 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 date of this final action.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1Definition of tongue: An organ, possessed by man and by most vertebrates, occupying the floor of the mouth, and attached at its base to the hyoid bone; often protrusible and freely movable (Link: https://www.oed.com/dictionary/tongue_n?tl=true)
Definition of tonsil: Each of two oval lymphoid glands situated one on each side of the fauces between the anterior and posterior arches. (Link: https://www.oed.com/dictionary/tonsil_n?tab=meaning_and_use#17979650)