DETAILED ACTION
Applicant’s election without traverse of Species A.2, B.4, C.5, and D.10 in the reply filed on 07/30/2026 is acknowledged. Claims 7, 9, 12-14, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/30/2026.
Claims 1-6, 8, 10-11, 15-24, and 26-28 are pending and hereby under examination.
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 .
Claim Objections
Claims 10, 15, and 27 are objected to because of the following informalities:
Claim 10, line 2, “conducive” should read “conductive”.
Claim 15, line 3, “layer” should be added after “conductive”.
Claim 27, line 3, “layer” should be added after “conductive”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 17, 19, 24, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He (US 20160143541).
Regarding claim 1, He teaches a system comprising:
one or more ultrasound transducers (Fig. 11, ultrasound transducers 1113);
one or more electroencephalogram (EEG) electrodes (Fig. 11, EEG electrodes 1105); and
a holder unit that holds a particular EEG electrode of the one or more EEG electrodes in a predetermined position relative to an ultrasound pressure field of a particular ultrasound transducer of the one or more ultrasound transducers to reduce noise in EEG data (Fig. 11, the ultrasound transducers placed apart from the EEG electrodes on aluminum shielding structure 1101 within the head fixing next 1109; Paragraph 0061, “An aluminum shielding structure 1101 can be provided to improve the SNR performance of the acquired EEG signals”).
Regarding claim 6, He teaches the system of claim 1. He further teaches wherein at least one of the one or more EEG electrodes is connected to an electrically conductive channel that passes through non-conductive embedding material within the holder unit (Fig. 11, the EEG signals being read out through EEG signal cable 1107. The cable 1107, the electrically conductive channel, passes through the shielding structure 1101, the non-conductive embedding material, within the head fixing net 1109).
Regarding claim 17, He teaches the system of claim 1. He further teaches wherein embedding material within the holder unit is ultrasound transmissive (Fig. 11, ultrasound transducer 1113 focusing the ultrasound beam to the brain of the subject. The shielding helmet with supporting pillars 1108, head fixing net 1109, and ultrasound coupling gel 1104 all being transmissive to the ultrasound).
Regarding claim 19, He teaches a method comprising:
providing a holder unit (Fig. 11, aluminum shielding structure 1101); and
holding, using the holder unit, a particular EEG electrode from one or more EEG electrodes in a predetermined position relative to an ultrasound pressure field of a particular ultrasound transducer of the one or more ultrasound transducers to reduce noise in EEG data (Fig. 11, the ultrasound transducers placed apart from the EEG electrodes on aluminum shielding structure 1101 within the head fixing next 1109; Paragraph 0061, “An aluminum shielding structure 1101 can be provided to improve the SNR performance of the acquired EEG signals”).
Regarding claim 24, He teaches the method of claim 19. He further teaches wherein at least one of the one or more EEG electrodes is connected to an electrically conductive channel that passes through non-conductive embedding material within the holder unit (Fig. 11, the EEG signals being read out through EEG signal cable 1107. The cable 1107, the electrically conductive channel, passes through the shielding structure 1101, the non-conductive embedding material, within the head fixing net 1109).
Regarding claim 28, He teaches an apparatus comprising:
one or more ultrasound transducers (Fig. 11, ultrasound transducers 1113);
one or more electroencephalogram (EEG) electrodes (Fig. 11, EEG electrodes 1105); and
a holder unit that holds a particular EEG electrode of the one or more EEG electrodes in a predetermined position relative to an ultrasound pressure field of a particular ultrasound transducer of the one or more ultrasound transducers to reduce noise in EEG data (Fig. 11, the ultrasound transducers placed apart from the EEG electrodes on aluminum shielding structure 1101 within the head fixing next 1109; Paragraph 0061, “An aluminum shielding structure 1101 can be provided to improve the SNR performance of the acquired EEG signals”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 11, 20, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over He (US 20160143541) as applied to claims 1 and 10 above, and further in view of He (US 20160143541).
Regarding claims 2 and 20, He teaches the system and method of claims 1 and 19. He fails to explicitly define “electrically isolated areas”.
However, He discloses, in an alternate embodiment, an arrangement of electrodes spaced apart on the head (Fig. 2). Applicant defines “electrically isolated areas” as “islands”, wherein the islands are one or more electrodes/transducers grouped together (see Fig. 16 and paragraph 0075 of the instant application). Examiner interprets the EEG electrodes spaced apart as “islands” that are electrically isolated from each other. The spacing of the EEG electrodes are placed such that multiple areas of the brain can be measured. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He with the electrically isolated areas, the spacing of the electrically isolated areas allowing the system to measure different areas of the brain.
Regarding claims 11 and 26, He teaches the system and method of claims 1 and 19. He discloses, in an alternate embodiment, wherein at least one of the one or more EEG electrodes comprises a narrow conductive strand or mesh of strands with a cross-sectional dimension that is less than a wavelength of ultrasound waves generated by the one or more ultrasound transducers to reduce noise in the EEG data (Paragraph 0044, The electrodes are fabricated into a small volume (i.e. 2 mm×3 mm×1 mm), and are fixed to an elastic band 402). He discusses that the ultrasound has a working frequency above 20kHz (Paragraph 0052), which is a wavelength corresponding to greater than 1cm. As such, the dimensions of the EEG electrodes are less than a wavelength of the ultrasound waves.
Claims 3-5, 15, 17, 21-23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over He (US 20160143541) as applied to claim 1 above, and further in view of Wagner (US 8718758).
Regarding claims 3 and 21, He discloses the system and method of claims 2 and 20. He further discloses wherein a first subset of the plurality of electrically isolated areas correspond to the operation of one or more ultrasound transducers, and a second subset of the plurality of electrically isolated areas correspond to the operation of one or more EEG electrodes (Fig. 11, the ultrasound transducers 1113 separate from the EEG electrodes 1105).
He fails to explicitly disclose wherein the plurality of electrically isolated areas are electrically non-conductive.
He and Wagner are in the same field of ultrasound measurement. Wagner teaches an apparatus for stimulation of tissue (Abstract). The apparatus includes an electrode 12 positioned under the source of a mechanical source 16, e.g., an ultrasound device (Fig. 2). Wagner suggests that a fluid could be filled through a mechanical field 18 that is non-conducting to prevent the spread of the electric field into the fluid and instead into the underlying tissue. He would benefit from having areas that are non-conductive so that the mechanical field of the ultrasound is focused into the tissue rather than any of the other components of the system (Col 10, line 57 – Col 11, line 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He with the non-conductive area as taught by Wagner, the benefit in focusing the ultrasound into the tissue rather than any of the other components of the system.
Regarding claims 4 and 22, He discloses the system and method of claims 2 and 20 above.
He fails to explicitly disclose wherein a subset of the plurality of electrically isolated areas are electrically non-conductive.
He and Wagner are in the same field of ultrasound measurement. Wagner teaches an apparatus for stimulation of tissue (Abstract). The apparatus includes an electrode 12 positioned under the source of a mechanical source 16, e.g., an ultrasound device (Fig. 2). Wagner suggests that a fluid could be filled through a mechanical field 18 that is non-conducting to prevent the spread of the electric field into the fluid and instead into the underlying tissue. He would benefit from having areas that are non-conductive so that the mechanical field of the ultrasound is focused into the tissue rather than any of the other components of the system (Col 10, line 57 – Col 11, line 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He with the non-conductive area as taught by Wagner, the benefit in focusing the ultrasound into the tissue rather than any of the other components of the system.
Regarding claims 5 and 23, He teaches the system of claims 1 and 19. He fails to explicitly disclose wherein at least one of the one or more EEG electrodes is connected to an electrically conductive channel comprising acoustic properties matched to soft tissue.
He and Wagner are in the same field of ultrasound measurement. Wagner teaches an apparatus for stimulation of tissue (Abstract). The apparatus includes an electrode 12 positioned under the source of a mechanical source 16, e.g., an ultrasound device (Fig. 2). Wagner discusses that different combinations of the components of the apparatus may be altered/designed such that transmission of the fields through components if placed in one or another’s transmission paths (Col 9, lines 4-14). This combination would necessarily require that the electrode as positioned in Fig. 2 would comprise acoustic properties matching the soft tissue underneath such that the mechanical source transmission may pass through the electrode. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He to incorporate the alternate combination of components as taught by Wagner, the benefit being allowing transmission of the ultrasound through the components placed in the way of the transmission path.
Regarding claims 15 and 27, He teaches the system and method of claims 1 and 19. He further discloses wherein the one or more EEG electrodes comprises an electrically conductive layer (Paragraph 0034, wherein the sensors may be EEG; Fig. 11, EEG electrodes 1105. While He is silent as to the EEG having an electrically conductive layer, the electrode would necessarily require an electrically conductive layer in order to sense electrical signals from the brain).
He fails to disclose at least one layer of: ultrasound absorbing couplant, an ultrasound reflecting material, or any combination thereof.
He and Wagner are in the same field of ultrasound measurement. Wagner teaches an apparatus for stimulation of tissue (Abstract). The apparatus includes an electrode 12 positioned under the source of a mechanical source 16, e.g., an ultrasound device (Fig. 2). Wagner discusses that different combinations of the components of the apparatus may be altered/designed such that transmission of the fields through components if placed in one or another’s transmission paths (Col 9, lines 4-14). This combination would necessarily require that the electrode as positioned in Fig. 2 would comprise acoustic properties matching the soft tissue underneath such that the mechanical source transmission may pass through the electrode. In combination with He, the EEG electrode would comprise an electrically conductive layer to operate and collect EEG signals and a layer to permit ultrasound transmission through to the tissues (i.e., an ultrasound absorbing layer). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He to incorporate the alternate combination of components as taught by Wagner, the benefit being allowing transmission of the ultrasound through the components placed in the way of the transmission path.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over He (US 20160143541) as applied to claim 6 above, and further in view of Connor (US 11850052)
Regarding claim 8, He discloses the system of claim 1. He fails to disclose wherein the electrically conductive channel is made electrically conductive by electrically doping a portion of the non-electrically conductive embedding material.
He and Connor are in the same field of EEG devices. Connor teaches an EEG electrode with conductive protrusions to make good electromagnetic contact with the skin (Abstract). The distal portion of the electrode can be made with one or more materials, such as an inherently-nonconductive polymer (e.g. PDMS) made conductive by doping such as with carbon structures (Col 10, lines 35-45). One of ordinary skill would have been motivated to substitute one conductive component with a non-conductive component doped to be conductive to control the overall conductivity of the material, and the results of having a conductive component would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He to have the non-conductive component doped to be conductive, and the results of having a conductive component would have been predictable to one of ordinary skill in the art.
Regarding claim 10, He discloses the system of claim 1. He fails to disclose wherein at least one of the one or more EEG electrodes is made electrically conductive by electrically doping a portion of the non-electrically conductive embedding material.
He and Connor are in the same field of EEG devices. Connor teaches an EEG electrode with conductive protrusions to make good electromagnetic contact with the skin (Abstract). The distal portion of the electrode can be made with one or more materials, such as an inherently-nonconductive polymer (e.g. PDMS) made conductive by doping such as with carbon structures (Col 10, lines 35-45). One of ordinary skill would have been motivated to substitute one conductive component with a non-conductive component doped to be conductive to control the overall conductivity of the material, and the results of having a conductive component would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He to have the non-conductive component doped to be conductive, and the results of having a conductive component would have been predictable to one of ordinary skill in the art.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over He (US 20160143541) as applied to claim 1 above, and further in view of Zafra (US 20250017507).
Regarding claim 16, He teaches the system of claim 1. He fails to disclose a stack of ultrasound transmissive layers comprising at least one electrically insulating layer and at least one electrically conductive shielding layer.
He and Zafra are in the same field of EEG measurement. Zafra teaches a multi-layered shielded cable 3, 30 that comprises a conductive layer 31 to transmit the signal obtained by the EEG, insulating layers 32 to isolate the conductive layer, and conductive shielding layers 33 (Paragraphs 0116-0120; Figs. 5-6). Zafra discusses that these layers are for protecting the EEG signals from electrical and electromechanical interferences (Paragraph 0131). As He is concerned with a system using ultrasound and EEG measurements, He would benefit from the shielded cable to reduce any electromechanical interferences from the ultrasound. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He to incorporate the shielded cable as taught by Zafra to reduce electromechanical interferences.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over He (US 20160143541) as applied to claim 1 above, and further in view of Law (US 20170080255).
Regarding claim 18, He teaches the system of claim 1. He fails to further disclose a ground shielding layer connected to a grounding wire, wherein the ground shielding layer provides electrical isolation from electrical noise.
He and Law are in the same field of ultrasound devices. Law teaches an ultrasound phased array (Abstract), wherein a transducer element 48 comprises a ground electrode 49b connected via a trace or wire to a ground (Paragraph 0090 and Fig. 4A). The ground is used to limit acoustic energy transmission between individual elements and serves as a return path for current from different components (Paragraph 0103). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of He with the ground electrode and wire as taught by Law, the benefit being limiting acoustic energy transmission between the other elements.
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 1, 19, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 10 of co-pending Application No. 18/783,245 in view of HE (US 20160143541). The co-pending application is directed towards a holder unit comprising an ultrasound system with at least one ultrasound transducer and an electroencephalogram system with at least one EEG electrode. The at least one EEG electrode and the at least one ultrasound transducer would necessarily be placed in a predetermined position relative to one another (see claim 1). As the system requires a holder unit with at least one ultrasound transducer and at least one EEG electrode, the positions of the ultrasound transducer and the EEG electrode would necessarily be placed in a predetermined position relative to each other. The co-pending Application is silent as to the placement being to reduce noise in EEG data.
He is analogous art as it is directed towards ultrasound/EEG systems. He teaches an arrangement wherein the EEG electrodes 1105 and the ultrasound transducers 1113 are spaced apart on aluminum shielding structure 1101 to improve SNR performance of EEG signals (Paragraph 0061; Fig. 11). The co-pending application discloses the EEG/ultrasound system on a holder unit, and He teaches an improved arrangement on an aluminum shielding structure for better SNR performance of EEG signals. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the co-pending application to incorporate the shielding structure taught by He to improve the SNR performance of EEG signals.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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