DETAILED ACTION
This office action is in response to the communication received on 01/05/2026 concerning application no. 18/881,592 filed on 01/06/2025.
Claims 1-21 are pending (Claims 16-21 are withdrawn from consideration).
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 with traverse of Group I (Claims 1-15) in the reply filed on 01/05/26 is acknowledged. The traversal is on the ground(s) that “It is respectfully submitted that the inventions as claimed can be readily evaluated in one search without placing undue burden on the Examiner. That is, all the claims are so interrelated that a search of one group of claims will reveal art to the others. Were restriction to be effected between the claims of Groups I and II, a separate examination of the claims in these groups would require substantial duplication of work on the part of the U.S. Patent and Trademark Office. Even though some additional consideration would be necessary, the scope of analysis of novelty of all the claims of Groups I and II would have to be as rigorous as when only the claims of Group I, for example, were being considered by themselves. Clearly, this duplication of effort would not be warranted where these claims of different categories are so interrelated. Further, Applicant submits that for restriction to be effected between the claims in Groups I and II, it would place an undue burden by requiring payment of two separate filing fees for examination of the nonelected claims, as well as the added costs associated with prosecuting two applications and maintaining two patents”.
This is not found persuasive because of the following reasons. Applicant's statement that the Examiner of the PCT application did not find a lack of unity of invention is not the standard for the determination of unity. Unity of invention is based on the determination of a common technical feature and assessment of whether the common technical feature makes a contribution over the prior art as a whole. This analysis was correctly performed in the Requirement for Restriction, filed 11/05/2025. The allegation that “all the claims are so interrelated that a search of one group of claims will reveal art to the others” is not the assessment for a unity of invention analysis.
Regarding Applicant's argument about lack of burden, Applicant is reminded that the restriction requirement is under the Unity of Invention analysis. Applicant's recitation of MPEP 803 is not persuasive as the case's restriction is not done under standard US practice. MPEP 823 establishes "The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). See MPEP Chapter 1800, in particular MPEP § 1850, § 1875, and § 1893.03(d), for a detailed discussion of unity of invention under the Patent Cooperation Treaty (PCT). However, the guidance set forth in this chapter with regard to other substantive and procedural matters (e.g., double patenting rejections (MPEP § 804), election and reply by applicant (MPEP § 818), and rejoinder of nonelected inventions (MPEP § 821.04) generally applies to national stage applications submitted under 35 U.S.C. 371." The Unity of Invention analysis does not require a search burden consideration.
Similar to Applicant’s allegation that there is no burden on the Examiner, the “undue burden by requiring payment of two separate filing fees for examination of the nonelected claims, as well as the added costs associated with prosecuting two applications and maintaining two patents” is not the basis of assessing a unity of invention restriction. Again, the unity of invention analysis requires the assessment of the common technical feature and assessing it in light of the prior art. This analysis was performed in the Requirement for Restriction, filed 11/05/2025 and arguments about an “undue burden” of prosecuting two applications and maintaining two patents is not the consideration in this type of restriction.
Examiner respectfully maintains the restriction. The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because:
The drawings (Figs. 1-5) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7-9 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 is indefinite for the following reasons:
The term “about” is a relative term which renders the claim indefinite. The term “about” 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. The specification does not disclose what is the margin that is considered to be sufficient for the value to be “about” the claimed amount.
Claim 8 is indefinite for the following reasons:
The term “about” is a relative term which renders the claim indefinite. The term “about” 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. The specification does not disclose what is the margin that is considered to be sufficient for the value to be “about” the claimed amount.
Claim 9 is indefinite for the following reasons:
The term “about” is a relative term which renders the claim indefinite. The term “about” 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. The specification does not disclose what is the margin that is considered to be sufficient for the value to be “about” the claimed amount.
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 1-2 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ebbini (PGPUB No. US 2019/0308036) in view of Wong et al. (PGPUB No. US 2005/0251035).
Regarding claim 1, Ebbini teaches wearable ultrasound transducer device, comprising:
an array of ultrasound transducers (UST array) configured for full-duplex transmit- receive operation, the UST array supported by a substrate configured for affixation to a body part of a wearer of the device (Paragraph 0056 teaches the system 100 may be described as a reconfigurable ultrasound system that includes patch 110, which can be connected to different circuitry interfaces (e.g., a fully capable clinical interface and a portable interface with “super” array elements when used as a wearable device). Transmitting long duration waveforms (e.g., long pulse duration or continuous waveforms) may be used to provide high focusing gain while maintaining low intensity outside the target volume, which may be facilitated by using circulators. Paragraph 0045 teaches the patch 110 may include lens 120 positioned between transducer 122 (e.g., transducer array of one or more elements) and the subject 102. Paragraph 0032 teaches to improve the DMUA's ability to characterize the tissue response to tFUS, front-end electronic circuitry may be configured to allow full-duplex transmit-receive operation. Figs. 1-2);
a controller operatively coupled to the UST array via a plurality of channel connectors, each of the channel connectors coupled to at least one ultrasound transducer of the UST array to define a plurality of channels (Paragraph 0041 teaches the ultrasound transducer system 100 may include controller 112 (e.g., a control circuit or circuitry) operably coupled to patch 110. Paragraph 0045 teaches each connector 124 may include a wired connection. In some embodiments, each connector 124 includes one or more conductors extending between patch 110 and controller 112 to provide an electrical connection. Paragraph 0046 teaches Each connector 124 may be associated with a channel of the system 100. As used herein the term “channel” refers to circuitry and/or operative couplings that enable controller 112 to generate one or more ultrasound wavefronts with patch 110 using one or more ultrasound waveforms. Figs. 1-2);
a multiplexer operatively coupled to the plurality of channel connectors and the controller, the multiplexer configured to selectively increase and decrease a number of channels enabled for operation (Paragraph 0089 teaches discrete excitation waveforms (e.g., pulses) and continuous excitation waveforms that may be provided on a channel of an ultrasound transducer system of the present application (e.g., using controller 112 having circulator 130) to a transducer element and expected reflection waveforms received on the same channel. Paragraph 0090 teaches the channel 200 may be used to transmit waveforms 202, 206 in sequence. Each waveform 202, 206 may be described as an ultrasound pulse or a discrete waveform. Paragraph 0043 teaches subject-specific customization may facilitate a dramatic reduction in the number of array elements needed to provide effective ultrasound energy deposition in the small target volume).
However, Ebbini is silent regarding a device, an input/output (I/O) coupler operatively coupled to the multiplexer and configured to communicatively couple to, and uncouple from, an imaging console coupler; and
a portable power source arranged to supply power to the device at least while the I/O coupler is uncoupled from the imaging console coupler.
In an analogous imaging field of endeavor, regarding ultrasound imaging, Wong teaches a device, an input/output (I/O) coupler operatively coupled to the multiplexer and configured to communicatively couple to, and uncouple from, an imaging console coupler (Paragraph 0103 teaches a ultrasound transducer is coupled to its associated ultrasound processing unit 572 via a cable, which is routed into an ultrasound transducer connector assembly 574 and, mates with a corresponding terminal located on ultrasound console); and
a portable power source arranged to supply power to the device at least while the I/O coupler is uncoupled from the imaging console coupler (Paragraph 0005 teaches a battery providing power to the processor housing and the transducer array. A preferred embodiment includes a console of a cart system to provide control features of the modular system. Paragraph 0129 teaches the system gets its power from the notebook computer via the single Firewire cable. No additional power supply is needed. The combination of the peripheral 16, 26 and the notebook computer can both run on the battery of the computer, making the system very portable).
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 Ebbini with Wong’s teaching of an input/output coupler that couples with an imaging console coupler and a portable power supply to supply the device when it is uncoupled. Wong, in paragraph 0064, further teaches that the beamforming can be performed via multiplexing. This modified apparatus would allow the user to have a very portable system that can operate via a battery (Paragraph 0064 of Wong). Furthermore, the modification will improve connectivity and ease of use (Abstract of Wong).
Regarding claim 2, modified Ebbini teaches the wearable ultrasound transducer device in claim 1, as discussed above.
However, Ebbini is silent regarding a device, wherein:
the portable power source is disabled while the I/O coupler is coupled to the imaging console coupler; and
a power supply of the imaging console is arranged to supply power to the device while the I/O coupler is coupled to the imaging console coupler.
In an analogous imaging field of endeavor, regarding ultrasound imaging, Wong teaches a device, wherein:
the portable power source is disabled while the I/O coupler is coupled to the imaging console coupler (Paragraph 0134 teaches docking mechanism is a simple, cable-less mating connection, very much like the desk top docking station for a notebook computer. This easy docking scheme allows the user to quickly attach or detach the suitcase to convert the system between stationary use (cart), and portable use); and
a power supply of the imaging console is arranged to supply power to the device while the I/O coupler is coupled to the imaging console coupler (Paragraph 0138 teaches the portable system 1000 has one or more connector and beamformer system 1014 with 1394 interface an EKG port 1208, a microphane port 1204, ethernet port 1203, USB port 1202, Svideo port 1207 and power access 1201. The console 1118 has power access 1211, ethernet 1212, USB port 1213, microphane 1216 and EKG port 1214. DC 1302 and USB 1306 connections run from the console to the lower base unit6 1300.).
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 Ebbini with Wong’s teaching of a power supply that powers the device during connection and the disabling of the portable power source. This modified apparatus would allow the user to have a very portable system that can operate via a battery (Paragraph 0064 of Wong). Furthermore, the modification will improve connectivity and ease of use (Abstract of Wong).
Regarding claim 11, modified Ebbini teaches the wearable ultrasound transducer device in claim 1, as discussed above.
Ebbini further teaches wearable ultrasound transducer device, wherein the device is configured to operate in an ambulatory neurostimulation mode and the UST array is configured to deliver neurostimulation therapy to target tissue of the body part (Paragraph 0009 teaches the use of a neuromodulation system via wearable).
However, Ebbini is silent regarding a device, during which the I/O coupler is uncoupled from the imaging console coupler.
In an analogous imaging field of endeavor, regarding ultrasound imaging, Wong teaches a device, during which the I/O coupler is uncoupled from the imaging console coupler (Paragraph 0103 teaches a ultrasound transducer is coupled to its associated ultrasound processing unit 572 via a cable, which is routed into an ultrasound transducer connector assembly 574 and, mates with a corresponding terminal located on ultrasound console).
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 Ebbini with Wong’s teaching of a uncoupled relationship to the imaging console coupler. This modified apparatus would allow the user to have a very portable system that can operate via a battery (Paragraph 0064 of Wong). Furthermore, the modification will improve connectivity and ease of use (Abstract of Wong).
Regarding claim 12, modified Ebbini teaches the wearable ultrasound transducer device in claim 1, as discussed above.
Ebbini further teaches wearable ultrasound transducer device, wherein:
the substrate comprises or supports a flexible printed circuit board (Paragraph 0076 teaches the use of a flexible printed circuit board); and
the UST array is configured as a conformable, wearable patch (Paragraph 0009 teaches employing light-weight, conformable (e.g., sufficiently flexible), and wearable patches of ultrasound transducers for delivery, monitoring, and spatiotemporal control of localized tFUS).
Regarding claim 13, modified Ebbini teaches the wearable ultrasound transducer device in claim 1, as discussed above.
Ebbini further teaches wearable ultrasound transducer device, wherein the controller comprises:
a plurality of circulators each operatively coupled to a transmit circuit, a receive circuit, and one or more ultrasound transducers of the UST array (Abstract teaches operation via a circulator. Paragraph 0010 teaches transmission and reception via the circulator), each of the circulators comprising:
a first port configured to receive an excitation waveform from the transmit circuit; a second port configured to: provide the excitation waveform to the one or more ultrasound transducers to provide a transmit ultrasound wavefront, and receive a reflection waveform from the one or more ultrasound transducers corresponding to a reflection of the transmit ultrasound wavefront during or after providing the excitation waveform; and a third port configured to provide the reflection waveform to the receive circuit during or after receiving the excitation waveform from the transmit circuit (Paragraph 0010 teaches the circulator includes a first port configured to receive an excitation waveform from a transmit circuit. The circulator also includes a second port configured to: provide the excitation waveform to the ultrasound transducer to provide a transmit ultrasound wavefront and receive a reflection waveform from the ultrasound transducer corresponding to a reflection of the transmit ultrasound wavefront during or after providing the excitation waveform. The circulator further includes a third port configured to provide the reflection waveform to a receive circuit during or after receiving the excitation waveform from the transmit circuit).
Regarding claim 14, modified Ebbini teaches the wearable ultrasound transducer device in claim 1, as discussed above.
Ebbini further teaches wearable ultrasound transducer device, comprising a wireless communication device operatively coupled to the controller, the wireless communication device configured to transmit UST array data to an external electronic device (Paragraph 0054 teaches feedback control may be operably coupled to signal processing and communication processor. Signal processing and communication processor may be configured to produce sensing and imaging data and, for example, transmit wirelessly to a mobile device. In particular, signal processing and communication processor may be configured to interpret a reflection waveform from receive circuit for storage or processing).
Regarding claim 15, modified Ebbini teaches the wearable ultrasound transducer device in claim 14, as discussed above.
Ebbini further teaches wearable ultrasound transducer device, wherein the external electronic device comprises one or more of a personal digital assistant, a smartphone, a tablet, a laptop, and a wireless network interface (Paragraph 0054 teaches feedback control may be operably coupled to signal processing and communication processor. Signal processing and communication processor may be configured to produce sensing and imaging data and, for example, transmit wirelessly to a mobile device. In particular, signal processing and communication processor may be configured to interpret a reflection waveform from receive circuit for storage or processing).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ebbini (PGPUB No. US 2019/0308036) in view of Wong et al. (PGPUB No. US 2005/0251035) further in view of Bartlett (PGPUB No. US 2010/0240991).
Regarding claim 4, modified Ebbini teaches the device in claim 1, as discussed above.
However, the combination of Ebbini and Wong is silent regarding a device, wherein the controller is configured to cause the multiplexer to:
enable all channels for operation in an imaging mode in response to the I/O coupler being coupled to the imaging console coupler; and
disable at least some of the channels for operation in an ambulatory mode in response to the I/O coupler being uncoupled from the imaging console coupler.
In an analogous imaging field of endeavor, regarding ultrasound imaging, Bartlett teaches a device, wherein the controller is configured to cause the multiplexer to:
enable all channels for operation in an imaging mode in response to the I/O coupler being coupled to the imaging console coupler; and disable at least some of the channels for operation in an ambulatory mode in response to the I/O coupler being uncoupled from the imaging console coupler (Paragraph 0060 teaches that the interface configures the protocol for the channel according to the connection. Paragraph 0056 teaches that the modes can be set as a standby mode and an active mode).
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 Ebbini and Wong with Bartlett’s teaching of the operation mode according to the connection with the interface. This modified apparatus would allow the user to improve connection to the interface (Paragraphs 0005-08 of Bartlett). Furthermore, the modification addresses the issue of high power consumption (Paragraphs 0005-08 of Bartlett).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ebbini (PGPUB No. US 2019/0308036) in view of Wong et al. (PGPUB No. US 2005/0251035) further in view of Slack (PGPUB No. US 2022/0054026).
Regarding claim 10, modified Ebbini teaches the device in claim 1, as discussed above.
However, the combination of Ebbini and Wong is silent regarding a device, wherein the device is configured to operate in an ambulatory mode during which the I/O coupler is uncoupled from the imaging console coupler and the UST array is configured to monitor target tissue of the body part.
In an analogous imaging field of endeavor, regarding ultrasound imaging, Slack teaches a device, wherein the device is configured to operate in an ambulatory mode during which the I/O coupler is uncoupled from the imaging console coupler and the UST array is configured to monitor target tissue of the body part (Paragraph 0047 teaches that the ambulatory monitoring can be performed. The operation is based on a disconnection of the electrodes from the module. Paragraph 0037 teaches operability via ultrasonic).
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 Ebbini and Wong with Slack’s teaching of an ambulatory monitoring based on an uncoupled state. This modified apparatus would allow the user to minimize artifacts and have cleaner signals (Paragraph 0005 of Slack). Furthermore, the modification allows for more accurate diagnosis (Paragraph 0005 of Slack).
Allowable Subject Matter
Claims 3 and 5-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 7-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chiang et al. (PGPUB No. US 2008/0294046): Teaches the control of channels with respect to each mode. Teaches coupling to an interface.
Wegener (PGPUB No. US 2010/0331689): Teaches the increase in the amount of data upon connection with a console.
Kruse et al. (PGPUB No. US 2017/0100092): Teaches the control of channels with respect to each mode. Teaches coupling to an interface.
Adachi et al. (PGPUB No. US 2022/0110611): Teaches increase and decrease of channels.
Mniece et al. (PGPUB No. US 2020/0275909): Teaches increase and decrease of channels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798