DETAILED ACTION
This office action is in response to the communication received on 05/27/2026 concerning application no. 18/210,978 filed on 06/16/2023.
Claims 1-21 are pending (Claims 9-19 are withdrawn from consideration).
With regards to claim 21, notice claim objections below.
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 without traverse of Group I (Claims 1-8 and 18-20) and Species C (Fig. 10) in the reply filed on 05/27/2026 is acknowledged.
Drawings
The drawings are objected to because:
The drawings (Figs. 1-4, 6-9, 11-12, and 14-15) 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 Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 3 (the second recitation1) been renumbered to claim 21.
Claims 2-8 and 21 are objected to because of the following informalities:
Claims 2-8 and 21 recites “Claim”. This claim element should be amended to “claim”. This amendment will address improper capitalization.
Claims 2-8 and 21 recites “The system”. This claim element should be amended to “The high-precision neural stimulation system”. This amendment will consistent language. However, note the 112(b) rejection below regarding the term “high-precision”. The indefinite language should be addressed.
Appropriate correction is required.
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 1-8 and 18-21 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 1 is indefinite for the following reasons:
The term “high-precision” is a relative term which renders the claim indefinite. The term “high-precision” 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. It would be unclear to one with ordinary skill in the art what degree of precision is considered to be “high” and what degree of precision is not “high”.
The term “high voltage” is a relative term which renders the claim indefinite. The term “high voltage” 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. It would be unclear to one with ordinary skill in the art what degree of voltage is considered to be “high” and what degree of voltage is not “high”.
Claim 3 is indefinite for the following reasons:
The term “high voltage” is a relative term which renders the claim indefinite. The term “high voltage” 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. It would be unclear to one with ordinary skill in the art what degree of voltage is considered to be “high” and what degree of voltage is not “high”.
Claim 5 is indefinite for the following reasons:
The term “high voltage” is a relative term which renders the claim indefinite. The term “high voltage” 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. It would be unclear to one with ordinary skill in the art what degree of voltage is considered to be “high” and what degree of voltage is not “high”.
Recites “a globally distributed ramping analog voltage”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “globally distributed ramping analog voltage” is the same as the “globally distributed programmable level voltage” established in claim 4 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 18 is indefinite for the following reasons:
The term “high-precision” is a relative term which renders the claim indefinite. The term “high-precision” 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. It would be unclear to one with ordinary skill in the art what degree of precision is considered to be “high” and what degree of precision is not “high”.
Applicant is encouraged to provide consistent and clear language.
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 § 102
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 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 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hynynen et al. (PGPUB No. US 2010/0063422).
Regarding claim 1, Hynynen teaches a high-precision neural stimulation system, high-precision neural stimulation system comprising
a high voltage Application Specific Integrated Circuit (ASIC) with an array of transmit control cells; and a 2D array of ultrasound transducers coupled to the high voltage ASIC, wherein the high voltage ASIC is disposed to receive and store programmable voltage levels (Paragraph 0035-38 teaches the use of AIC chips that can be combined with the analog circuity. The transducer is controlled for ultrasound imaging via transmission and reception. See Figs. 5 and 7-8. Paragraph 0028-30 teaches the driving and control of the transducer based on the voltage and the reference voltage. Paragraphs 0032-34 teaches that the voltage is used to drive the transducer. Paragraph 0025 teaches that the connection for the transducer is via the flex circuit or circuit board).
Regarding claim 3, Hynynen teaches the system in claim 1, as discussed above.
Hynynen further teaches a system, wherein at least one of
the 2D array of ultrasound transducers is coupled to the high voltage ASIC via an electrical routing substrate; the 2D array of ultrasound transducers is coupled to the high voltage ASIC via a vertically integrated assembly (Paragraph 0035-38 teaches the use of AIC chips that can be combined with the analog circuity. The transducer is controlled for ultrasound imaging via transmission and reception. See Figs. 5 and 7-8. Paragraph 0028-30 teaches the driving and control of the transducer based on the voltage and the reference voltage. Paragraphs 0032-34 teaches that the voltage is used to drive the transducer. Paragraph 0025 teaches that the connection for the transducer is via the flex circuit or circuit board).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (PGPUB No. US 2010/0063422) in view of Rubin et al. (PGPUB No. US 2003/0195413).
Regarding claim 2, Hynynen teaches the system in claim 1, as discussed above.
However, Hynynen is silent regarding a system, further comprising a local storage of individual phase delays for each respective transducer channel.
In an analogous imaging field of endeavor, regarding ultrasound system design, Rubin teaches a system, further comprising a local storage of individual phase delays for each respective transducer channel (Paragraph 0035 teaches the phase delay can be introduced and controlled for each transducer channel. Paragraph 0040 teaches that the phase shifrting and delay can be performed for each channel. See Fig. 3).
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 Hynynen with Rubin’s teaching of storage of individualized phase delays for ultrasound channels. This modified apparatus would allow the user to control the focal point delivery (Paragraph 0009 of Rubin). Furthermore, the modification simultaneously sum electrical signals, dynamically focus ultrasound, and continuously change the signal (Paragraph 0036 of Rubin).
Claims 4-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (PGPUB No. US 2010/0063422) in view of Koptenko (PGPUB No. US 2016/0011305).
Regarding claim 4, Hynynen teaches the system in claim 1, as discussed above.
However, Hynynen is silent regarding a system, wherein each transmit control cell of the array of transmit control cells comprises a locally integrated analog memory capturing a globally distributed programmable level voltage.
In an analogous imaging field of endeavor, regarding ultrasound system design, Koptenko teaches a system, wherein each transmit control cell of the array of transmit control cells comprises a locally integrated analog memory capturing a globally distributed programmable level voltage (Paragraph 0042 teaches the use of analog memory with capacitive storage. Paragraph 0045 teaches the operation of the capacitor with the voltage value. See Fig. 8-10).
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 Hynynen with Koptenko’s teaching of analog memory. This modified apparatus would allow the user to improve signal-to-noise ratio (SNR) and have a scalable system (Abstract of Koptenko). Furthermore, the modification provides better image quality combined with significant reduction in systems' size, power consumption and production cost (Paragraph 0035 of Kopetenko).
Regarding claim 5, modified Hynynen teaches the system in claim 4, as discussed above.
However, Hynynen is silent regarding a system, wherein at least one of:
the high voltage ASIC comprises an analog memory having capacitive sample and hold circuitry; the analog memory is programmed by sequential sampling of analog voltage levels on a globally distributed analog programming bus; the analog memory is programmed by sequential sampling of analog voltage levels on multiple globally distributed analog programming busses; or the analog memory is programmed by sampling of a globally distributed ramping analog voltage based on a digitally programmed time step value at each unit cell.
In an analogous imaging field of endeavor, regarding ultrasound system design, Koptenko teaches a system, wherein at least one of:
the high voltage ASIC comprises an analog memory having capacitive sample and hold circuitry; the analog memory is programmed by sequential sampling of analog voltage levels on a globally distributed analog programming bus; the analog memory is programmed by sequential sampling of analog voltage levels on multiple globally distributed analog programming busses; or the analog memory is programmed by sampling of a globally distributed ramping analog voltage based on a digitally programmed time step value at each unit cell (Paragraph 0042 teaches the use of analog memory with capacitive storage. Paragraph 0045 teaches the operation of the capacitor with the voltage value. See Fig. 8-10).
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 Hynynen with Koptenko’s teaching of analog memory. This modified apparatus would allow the user to improve signal-to-noise ratio (SNR) and have a scalable system (Abstract of Koptenko). Furthermore, the modification provides better image quality combined with significant reduction in systems' size, power consumption and production cost (Paragraph 0035 of Kopetenko).
Regarding claim 7, Hynynen teaches the system in claim 1, as discussed above.
However, Hynynen is silent regarding a system, wherein each transmit control cell comprises multiple locally integrated analog memory cells capturing multiple globally distributed programmable level voltages.
In an analogous imaging field of endeavor, regarding ultrasound system design, Koptenko teaches a system, wherein each transmit control cell comprises multiple locally integrated analog memory cells capturing multiple globally distributed programmable level voltages (Paragraph 0042 teaches the use of analog memory with capacitive storage. Paragraph 0045 teaches the operation of the capacitor with the voltage value. See Fig. 8-10. Paragraph 0037-38 teaches that the cells are in distinct rows or banks 132 and that have common signal lines and control switches and operates for beamforming).
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 Hynynen with Koptenko’s teaching of multiple analog memory cells. This modified apparatus would allow the user to improve signal-to-noise ratio (SNR) and have a scalable system (Abstract of Koptenko). Furthermore, the modification provides better image quality combined with significant reduction in systems' size, power consumption and production cost (Paragraph 0035 of Kopetenko).
Regarding claim 8, modified Hynynen teaches the system in claim 7, as discussed above.
However, Hynynen is silent regarding a system, wherein extended pulse trains of multiple independently programmed voltage levels are implemented by transmitting in turn pulses that are scaled to match the respective individual voltage levels stored in the multiple individual local analog memory cells.
In an analogous imaging field of endeavor, regarding ultrasound system design, Koptenko teaches a system, wherein extended pulse trains of multiple independently programmed voltage levels are implemented by transmitting in turn pulses that are scaled to match the respective individual voltage levels stored in the multiple individual local analog memory cells (Paragraph 0042 teaches the use of analog memory with capacitive storage. Paragraph 0045 teaches the operation of the capacitor with the voltage value. See Fig. 8-10. Paragraph 0037-38 teaches that the cells are in distinct rows or banks 132 and that have common signal lines and control switches and operates for beamforming).
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 Hynynen with Koptenko’s teaching of multiple analog memory cells. This modified apparatus would allow the user to improve signal-to-noise ratio (SNR) and have a scalable system (Abstract of Koptenko). Furthermore, the modification provides better image quality combined with significant reduction in systems' size, power consumption and production cost (Paragraph 0035 of Kopetenko).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (PGPUB No. US 2010/0063422) in view of Bappoo et al. (PGPUB No. US 2024/0180523).
Regarding claim 6, Hynynen teaches the system in claim 1, as discussed above.
However, Hynynen is silent regarding a system, wherein at least one of:
the programmable voltage levels are generated by a locally integrated noise- shaping DAC at each element; or the programmable voltage levels are generated by a single locally integrated noise-shaping DAC for the entire array.
In an analogous imaging field of endeavor, regarding ultrasound system design, Bappoo teaches a system, wherein at least one of:
the programmable voltage levels are generated by a locally integrated noise- shaping DAC at each element; or the programmable voltage levels are generated by a single locally integrated noise-shaping DAC for the entire array (Paragraph 0109 teaches the use of DAC and the noise filtering. The system can operate with respect to the ASIC chip and used in beamforming and multiplexing).
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 Hynynen with Bappoo’s teaching of DAC and noise filtering. This modified apparatus would allow the user to improve image visibility (Paragraph 0077 of Bappoo). Furthermore, the modification filter noise and have a reduced size for the system (Paragraphs 0108-09 of Bappoo).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (PGPUB No. US 2010/0063422) in view of Kim et al. (US Patent No. 10,302,964) as supported by Pugh (PGPUB No. US 2015/0148650).
Regarding claim 18, Hynynen teaches the system in claim 1, as discussed above.
Hynynen further teaches a system, comprising: the high-precision neural stimulation system of claim 1 (As discussed above).
However, Hynynen is silent regarding a system, comprising:
one or more fluid channels at least partially surrounding the high-precision neural stimulation device.
In an analogous imaging field of endeavor, regarding ultrasound system design, Kim teaches a system, comprising:
one or more fluid channels at least partially surrounding the high-precision neural stimulation device (Claim 1 teaches that the contact lens can have an inlet port for fluid collection).
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 Hynynen with Kim’s teaching of fluid channels. It would have been obvious to one with ordinary skill in the art that the channels can be arranged about the ultrasound transducers and integrated into a contact lens. This integration of ultrasound would provide for feedback and analysis without significant delay as noted in Pugh (Paragraph 0007). It would be clear to one with ordinary skill in the art that this integration for contact lens systems would allow for the assessment of cardiac conditions, diabetes, and cardiac rhythm as noted in Pugh (Paragraph 0077). This modified apparatus would allow the user to provide necessary treatment (Col. 1 of Kim). Furthermore, the modification does not have be burden of collection of tear and has clinical purpose (Col. 1 of Kim).
Regarding claim 19, modified Hynynen teaches the system in claim 18, as discussed above.
However, Hynynen is silent regarding a system, further comprising:
one or more fluid inlets defining an opening between one or more of the fluid channels and an environment.
In an analogous imaging field of endeavor, regarding ultrasound system design, Kim teaches a system, further comprising:
one or more fluid inlets defining an opening between one or more of the fluid channels and an environment (Claim 1 teaches that the contact lens can have an inlet port for fluid collection).
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 Hynynen with Kim’s teaching of fluid inlets for fluids. It would have been obvious to one with ordinary skill in the art that the channels can be arranged about the ultrasound transducers and integrated into a contact lens. This integration of ultrasound would provide for feedback and analysis without significant delay as noted in Pugh (Paragraph 0007). It would be clear to one with ordinary skill in the art that this integration for contact lens systems would allow for the assessment of cardiac conditions, diabetes, and cardiac rhythm as noted in Pugh (Paragraph 0077). This modified apparatus would allow the user to provide necessary treatment (Col. 1 of Kim). Furthermore, the modification does not have be burden of collection of tear and has clinical purpose (Col. 1 of Kim).
Regarding claim 20, modified Hynynen teaches the system in claim 19, as discussed above.
However, Hynynen is silent regarding a system, the environment comprising one or more of an ambient environment and an in vivo environment.
In an analogous imaging field of endeavor, regarding ultrasound system design, Kim teaches a system, the environment comprising one or more of an ambient environment and an in vivo environment (Abstract teaches placement of the contact lens on the eyeball).
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 Hynynen with Kim’s teaching of placement of the contact lens in an environment. It would have been obvious to one with ordinary skill in the art that the channels can be arranged about the ultrasound transducers and integrated into a contact lens. This integration of ultrasound would provide for feedback and analysis without significant delay as noted in Pugh (Paragraph 0007). It would be clear to one with ordinary skill in the art that this integration for contact lens systems would allow for the assessment of cardiac conditions, diabetes, and cardiac rhythm as noted in Pugh (Paragraph 0077). This modified apparatus would allow the user to provide necessary treatment (Col. 1 of Kim). Furthermore, the modification does not have be burden of collection of tear and has clinical purpose (Col. 1 of Kim).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (PGPUB No. US 2010/0063422) in view of Tyler (PGPUB No. US 2012/0289869).
Regarding claim 21, Hynynen teaches the system in claim 1, as discussed above.
However, Hynynen is silent regarding a system, wherein at least one of:
the ultrasound transducers are micromachined; or the ultrasound transducers are sectioned using a dicing saw.
In an analogous imaging field of endeavor, regarding ultrasound system design, Tyler teaches a system, wherein at least one of:
the ultrasound transducers are micromachined; or the ultrasound transducers are sectioned using a dicing saw (Paragraph 0006 teaches use of CMUT).
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 Hynynen with Tyler’s teaching of CMUT transducers. This modified apparatus would allow the user to treat the patient and improve learning and memory (Paragraph 0083 of Tyler). Furthermore, the modification allows for the desired ultrasound application on the subject (Paragraph 0006 of Tyler).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kim et al. (PGPUB No. US 2010/0076352): Teaches micromachining ultrasound transducers.
Pugh (PGPUB No. US 2018/0132818): Teaches ultrasound integration with contact lenses.
Putha et al. (US Patent No. 11,278,260): Teaches ultrasound integration with contact lenses.
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
1 Referring to the claim that recites “The system of Claim 1, wherein at least one of: the ultrasound transducers are micromachined; or the ultrasound transducers are sectioned using a dicing saw.”
Prosecution Insights