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 of Invention I (claims 146-156) in the reply filed on 6 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 157-165 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6 July 2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 146-156 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,109,441. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application us directed to a therapeutic ultrasound system (TUS) including a wearable non-invasive elastic sleeve device comprises at least a first and second TUS transducer to be directed below the knee as well as a sensor configured to assess a presence of bone in a near field as set forth in at least claims 1 and 21 of the patent. The present application additionally discloses the limitation of selecting one of the first and second TUS transducers to direct ultrasonic energy toward the below-the-knee target site while avoiding directing ultrasonic energy towards the bone and adjusting a parameter of the ultrasonic energy such that the below-the-knee target site is in a near-field and the bone is in a far field as set forth in claims 15 and 16 of the patent, respectively. The independent claim of the patent includes additional features; however, claims 1, 15 and 16 anticipate claim 146 of the present application. Claims 147-149 are anticipated by claims 21 and 22 of the patent. Claims 151-152 are anticipated by claims 2 and 3 of the patent. Claim 153 is anticipated by claim 1 of the patent. Claim 154 discloses the features of a thermocouple configured to measure a temperature of the skin surface and control ultrasonic therapy in response. Claim 14 of the patent fails to explicitly disclose a thermocouple; however, the claim does disclose sensing the temperature and controlling therapeutic ultrasonic energy. The addition of a thermocouple is considered an obvious variant as it is a well-known and conventional structure for sensing temperature. Claim 156 is anticipated by claims 1 and 15 of the patent. Claim 150 includes the additional features of the cross-sectional shape of the transducers which are not disclosed in the patent; however, this feature is considered an obvious variant as the claim merely discloses a plurality of well-known and conventional shapes of transducers. Claim 155 discloses a perfusion sensing element which is not set forth in the patent; however, the patent is directed to vasodilation which is affects perfusion by increasing blood flow to tissues and therefore would be considered an obvious variant to sense changes.
Claims 146-156 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,638,841. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application is directed to a therapeutic ultrasound (TUS) system comprising a wearable non-invasive elastic sleeve comprises a first and second transducer configured for a below-the-knee target sit as set forth in claims 1 and 15 of the patent. The present application also discloses assessing the presence of a bone in a near field as set forth in claim 1 of the patent as well as directing ultrasonic energy toward the below-the-knee target site while avoiding directing ultrasonic energy towards the bone or adjust a parameter of the ultrasonic energy such that the target site is in a near-field and the bone is in a far field as set forth in claims 1 and 13 of the patent. Claims 147-149 are anticipated by claims 15-16 of the patent. Claims 151-152 are anticipated by claim 2 of the patent. Claim 153 is anticipated by claims 1 and 15 of the patent. Claim 154 discloses the features of a thermocouple configured to measure a temperature of the skin surface and control ultrasonic therapy in response. Claim 14 of the patent fails to explicitly disclose a thermocouple; however, the claim does disclose sensing the temperature and controlling therapeutic ultrasonic energy. The addition of a thermocouple is considered an obvious variant as it is a well-known and conventional structure for sensing temperature. Claim 156 is anticipated by claims 1, 12 and 15 of the patent. Claim 150 includes the additional features of the cross-sectional shape of the transducers which are not disclosed in the patent; however, this feature is considered an obvious variant as the claim merely discloses a plurality of well-known and conventional shapes of transducers. Claim 155 discloses a perfusion sensing element which is not set forth in the patent; however, the patent is directed to cavitation which is affects perfusion by producing shear forces that trigger vasodilation thereby increasing blood flow to tissues and therefore would be considered an obvious variant to sense changes.
Claim Objections
Claims 146-156 are objected to because of the following informalities: claim 146 states “select one of the first and second TUS transducers direct ultrasonic energy” in line 9 which should state “select one of the first and second TUS transducers to direct ultrasonic energy”. Appropriate correction is required.
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.
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) 146-147 and 150-152 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522).
Regarding claims 146 and 150, Anand et al disclose a therapeutic ultrasound (TUS) system, comprising:
at least a first TUS transducer and a second TUS transducer (the ultrasound therapy unit comprises a multi-element ultrasonic transducer – [0022]), wherein the first and second TUS transducers are configured to be positioned proximate a skin surface of a patient at a target site (the transducers used in therapy can be outside the body – [0005]) and to direct ultrasonic energy towards the target site (the ultrasound therapy unit is adapted to insonify a target zone within a patient – [0021]);
a sensor configured to assess a presence of bone in a near field via an imaging modality (visible within the representation 578 of the first sub-near field region 534 is a region 590 which has a predicted attenuation above a predetermined threshold. the region 590 is caused by the obstruction 540. The region 590 may be identified using either the ultrasound diagnostic unit functionality of the ultrasound therapy unit 518 or by a MR thermographic image generated by the MR imaging unit 500 – [0066]); and
a controller configured to, in response to detection of the presence of bone in the near field, select one of the first and second TUS transducers direct ultrasonic energy toward the target site while avoiding directing ultrasonic energy towards the bone (if there is a local obstruction, such as a bone, in particular sub-near field region the obstruction may be avoided by deactivating a single element of the multi-element ultrasonic transducer – [0028]).
Anand et al fail to explicitly disclose a wearable non-invasive elastic sleeve, wherein the first and second TUS transducers are configured to be positioned proximate a skin surface of a patient at a below-the-knee target site and to direct ultrasonic energy towards the below-the-knee target site and wherein the first and second TUS transducers comprise a circular cross-section.
However, Chandraratna teaches in the same medical field of endeavor, a wearable non-invasive elastic sleeve comprises at least a first TUS transducer and a second TUS transducer (the device 10 is in the form of a flexible “quilt” designed to flexibly and adjustably conform to a body surface – [0030]; ultrasound quilt device 10…may be held in place by straps 36 and have ultrasound transducer elements 16a, 16b, 16c – [0032]. Examiner notes the device 10 is considered a sleeve as it wraps entirely around the leg of the patient – fig.3), wherein the first and second TUS transducers are configured to be positioned proximate a skin surface of a patient at a below-the-knee target site and to direct ultrasonic energy towards the below-the-knee target site (fig.3); and wherein the first and second TUS transducers comprise a circular cross-section (fig.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the TUS transducers on the exterior of the subject of Anand et al with a wearable non-invasive elastic sleeve and a target site below-the-knee and the TUS transducers having a circular cross-section as it would provide a specific target with a bone which can be worn to provide a deformable ultrasound emitting surface that can radiate ultrasound into a surface of highly varying contour.
Regarding claims 147, 151 and 152, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above. Chandraratna further teaches wherein the first and second TUS transducers are further configured to deliver ultrasonic energy at a frequency of between 500 kHz and about 5MHz, wherein the therapeutic ultrasonic energy has a frequency of between about 0.5 MHz and about 5 MHz and wherein the ultrasonic energy has a frequency of between about 1 MHz and about 3 MHz (operation frequencies of the transducer elements 16a, 16b, 16c will typically be in the range of between about 1.6 MHz to about 8MHz and/or about 40 KHz to about 400 kHz – [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the therapeutic ultrasonic energy of Anand et al with a frequency between about 500 kHz and about 5MHz as it would provide a frequency range appropriate for ultrasound therapy.
Claim(s) 148 and 149 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522) as applied to claim 146 above, and further in view of Payne et al (2016/0008024).
Regarding claims 148 and 149, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the first and second TUS transducers are further configured to deliver ultrasonic energy at a pulse rate frequency of between about 1Hz and about 3Hz and a pulse duration of between about 1 ms and about 10 ms.
However, Payne et al teach in the same medical field of endeavor, wherein the first and second TUS transducers are further configured to deliver ultrasonic energy at a pulse rate frequency of between about 1Hz and about 3Hz and a pulse duration of between about 1 ms and about 10 ms (a range of 5-250 ms at a pulse repetition rate of 2Hz for 2 seconds – [0206]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first and second TUS transducers of Anand et al as modified by Chandraratna with a pulse rate frequency between about 1 Hz and about 3 Hz and a pulse duration of between about 1 ms and about 10 ms as it would provide sufficient parameters to elicit a response from the patient tissue.
Claim(s) 153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522) as applied to claim 146 above, and further in view of Guha et al (2018/0296859).
Regarding claim 153, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the therapeutic ultrasonic energy has a peak negative pressure of between about 1 MPa and about 4 MPa.
However, Guha et al teach in the same medical field of endeavor, wherein a therapeutic ultrasonic energy has a peak negative pressure of between about 1 MPa and about 4 MPa (the therapeutic ultrasound device was operated…peak negative pressure = 2.93 MPa - [0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the therapeutic ultrasonic energy of Anand et al as modified by Chandraratna with a peak negative pressure of between about 1 MPa and about 4 MPa as it would provide a specific focal length.
Claim(s) 154 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522) as applied to claim 146 above, and further in view of Chapelon et al (5,601,526).
Regarding claim 154, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above. Anand et al additionally disclose to measure a temperature at the skin surface and communicate the temperature to the controller, and wherein the controller is further configured to discontinue ultrasonic therapy if the temperature is greater than a predetermined value (shuts of the insonification of the ultrasound therapy unit when the local temperature value derived by the ultrasound diagnostic unit exceeds a temperature threshold value – [0034]).
Anand et al as modified by Chandraratna fail to explicitly disclose a thermocouple.
However, Chapelon et al teach in the same medical field of endeavor, a thermocouple (col.12, ll.48-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the temperature measurement of Anand et al as modified by Chandraratna as it would provide a well-known and conventional temperature measurement structure which is able to be extremely thin and disposed directly on the tissue regions of the interface.
Claim(s) 155 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522) as applied to claim 146 above, and further in view of Chomas et al (2008/0097206).
Regarding claim 155, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above, but fail to explicitly disclose a perfusion-sensing element configured to assess perfusion at the below-the-knee target site and output a parameter relating to perfusion onto a display.
However, Chomas et al teach in the same medical field of endeavor, a perfusion-sensing element configured to assess perfusion at a target site and output a parameter relating to perfusion onto a display (flow characteristics, such as color doppler signals or spectral values may indicate sufficient perfusion – [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the below-the-knee target site of Anand et al as modified by Chandraratna with sensing perfusion of Chomas et al as it would provide variable control of the ultrasound therapy device based on preferred parameters.
Claim(s) 156 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand et al (2012/0172708) in view of Chandraratna (2006/0241522) as applied to claim 146 above, and further in view of Barthe et al (2012/0016239).
Regarding claim 156, Anand et al as modified by Chandraratna disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the non-invasive elastic sleeve comprises a power sensor configured to sense reflected ultrasound power, and wherein the controller is further configured to discontinue ultrasonic therapy if the reflected power sensed by the power sensor is greater than a predetermined value.
However, Barth et al teach in an analogous field of endeavor, a power sensor configured to sense reflected ultrasound power, and wherein the controller is further configured to discontinue ultrasonic therapy if the reflected power sensed by the power sensor is greater than a predetermined value (if a fault occurs in reflective power for the load of the emitter-receiver module 200 is large as compared a forward power such as the emitter-receive module failure, or high reflective energy, then a system stop state would automatically be invoked – [0160]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ultrasonic therapy device of Anand et al as modified by Chandraratna with a power sensor to reflect power back as the transducer and discontinue therapy if it is greater than a predetermined value as it would provide a fail-safe if the device is not operating within desired parameters.
Conclusion
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/ROCHELLE D TURCHEN/ Primary Examiner, Art Unit 3797
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