DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/17/26 has been entered.
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 16-18, 23, 24, 28, and 30 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.
In claims 16-18, ‘the plurality of independently controllable registers’ lacks antecedence.
In claim 16, line 4, it appears ‘the’ should be added before ‘ultrasound’.
In claim 23, ‘the first and second waveform generators’ lacks antecedence.
In claim 24, ‘the first and second waveform generators’ lacks antecedence.
In claim 24, the portion after ‘configured to store a frequency.’ should be deleted.
In claim 28, ‘the housing’ lacks antecedence.
In claim 30, line 4, ‘the’ should be added after ‘sampling’.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-15 and 17-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cogan et al (US Pub 20110060225) in view of Daft et al (US Pub 20090069686).
Re claims 11, 14, 25, 28: Cogan discloses an ultrasound device for placement on a subject, the ultrasound device comprising:
a semiconductor device [0022, figure 1; see the ASICs in the probe making the device a semiconductor device] including: a plurality of ultrasonic transducer elements [0022; see the transducer elements 24]; a plurality of pulsers coupled to the plurality of ultrasonic transducer elements [0022; see the pulsers 32]; and a plurality of waveform generators configured to drive the plurality of pulsers [0022; see waveform generators 26]; receive processing circuitry configured to process ultrasound signals received by the plurality of ultrasonic transducer elements [0027; see the receiver circuitry].
Cogan discloses all features except a hand-held housing to support the semiconductor device and in which the device is disposed. However, Daft teaches an ultrasound device with transducers formed in or on a semiconductor substrate (see paragraph [0009]), teaches an ultrasound device comprising a hand-held housing to support the plurality of ultrasonic transducer elements and the plurality of transmit control circuits [0034, 0035; see the substrate 12 is part of transducer 22, which is located within the hand-held housing]. It would have been obvious to one having ordinary skill in the art to modify the ultrasound device of Cogan to include the hand-held housing and semiconductor substrate of Daft, in order to enhance patient contact with the transducers, provide electrical isolation of the transducers, be shaped for handheld operation, provide a grip region sized and shaped for being held by a user, and use integrated electronics in the thin wafer of the CMUT to limit interconnection problems for the array, as recognized by Daft (see paragraph [0035]).
Re claims 12, 26: Cogan discloses the plurality of ultrasonic transducer elements comprise independently controllable ultrasonic transducer elements disposed on a semiconductor substrate of the semiconductor device (abstract; see the elements independently configured to transmit distinct waveforms).
Re claims 13, 19, 27: Cogan discloses all features including elements comprises a first and second ultrasonic transducer element, a first waveform generator of the plurality of waveform generators is coupled to the first ultrasonic transducer element and configured to provide a first ultrasound waveform to the first element, and a second waveform generator of the plurality of waveform generators is coupled to the second ultrasonic transducer element and configured to provide a second ultrasound waveform to the second element [0022; see the elements and generators 26 that provide ultrasound waveforms to the elements].
Cogan does not disclose that the elements are CMUTs. However, Daft teaches elements as CMUTs [0025; see the CMUT transducer elements]. It would have been obvious to one having ordinary skill in the art to modify the invention of Cogan to include the CMUTs and semiconductor substrate of Daft, in order to use integrated electronics in the thin wafer of the CMUT to limit interconnection problems for the array, as recognized by Daft.
Re claims 15, 29: Cogan discloses the plurality of waveform generators are configured to independently control the plurality of ultrasonic transducer elements [0022; see the generators 26 separately controlling the elements].
Re claims 17, 18, 23, 24: Cogan teaches independently controllable registers of the plurality of independently controllable registers is configured to store a phase or frequency of an ultrasound waveform generated by the plurality of waveform generators ([0027]; "In further embodiments, the LNA may output the amplified signal to a modulator with a selectable mixer clock phase, which selects an operating phase by shifting the frequency of the received signals. For instance, if a signal is received with a frequency of 5 MHz, and the clock frequency is 20 MHz, the modulator may generate a 25 MHz signal. In this way, the modulator may change the phase of the 20 MHz clock from channel to channel." See also paragraph [0033]: "FIG. 5 illustrates possible waveform outputs 60 that may be generated in conjunction with a unipolar pulser when exemplary initial values 62 are input into an exemplary 8-bit waveform counter 42 to produce various transmit waveform cycle lengths 64. The center frequency of the waveforms 60 are determined in large part by the clock frequency which runs the waveform counter 42.").
Re claim 20: Cogan discloses a controller configured to control values stored by a plurality of independently controllable registers [0020; see the secondary controller that controls analog and digital data].
Re claims 21, 22: Cogan discloses all features including a first chip and a second chip, the second chip comprising digital processing circuitry forming part of the receive processing circuitry [0022; see the ASICs which comprise a first and second chip], but do not discloses the device includes: a first ADC forming part of the receive processing circuitry and coupled to a first ultrasonic transducer element of the plurality of ultrasonic transducer elements and configured to convert an analog signal provided by the first ultrasonic transducer element into a digital signal; a second ADC forming part of the receive processing circuitry and coupled to a second ultrasonic transducer element of the plurality of ultrasonic transducer elements and configured to convert an analog signal provided by the second ultrasonic transducer element into a digital signal; and a serial data output port configured to communicate a digital stream of data that includes the digital signals from the first and second ADCs from the hand-held ultrasound device to an external device. However, Daft teaches a first ADC forming part of the receive processing circuitry and coupled to a first ultrasonic transducer element of the plurality of ultrasonic transducer elements and configured to convert an analog signal provided by the first ultrasonic transducer element into a digital signal; a second ADC forming part of the receive processing circuitry and coupled to a second ultrasonic transducer element of the plurality of ultrasonic transducer elements and configured to convert an analog signal provided by the second ultrasonic transducer element into a digital signal; and a serial data output port configured to communicate a digital stream of data that includes the digital signals from the first and second ADCs from the hand-held ultrasound device to an external device [0048, figure 3; see the plurality of ADCs 48 that comprise a first and second ADC and see the data lines to communicate digital signals to an external device]. It would have been obvious to the skilled artisan to modify Cogan, to use ADCs and a serial data port as taught by Daft, in order to efficiently transfer the received data to an external device.
Claims 16 and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cogan and Daft, as applied to claim 11, further in view of Burlison et al (US 6,880,137).
Re claims 16, 30: Cogan and Daft disclose all features except wherein a first independently controllable register of the plurality of independently controllable registers is configured to store a signal sampling event control parameter for sampling ultrasound signals received by the plurality of ultrasonic transducer elements. However, Burlison, drawn to a programmable waveform generator (see Fig. 13 and Abstract), teaches a waveform generator 1310 with at least one first configurable operational parameter 1315, a second waveform generator (see annotated Fig. 13 below) with at least one second configurable operational parameter 1320, and a controller 1370 configured to control values of the first and second configurable operational parameters and storing parameters for a time delay of the waveform (see Col. 6, lines 36-48: "Each waveform generator 1310 comprises a programmable delay element (e.g., delay element A 1315, delay element B 1320, and delay element C 1325), which delays both the rising and falling edges of the clock input waveform, a serial in/parallel out shift register (e.g., shift register A 1330, shift register B 1335, and shift register C 1340) of which the parallel output contains the rising and falling delay values for the delay element, an AND gate (e.g., AND gate A 1345, AND gate B 1350, and AND gate C 1345) which enables the output of the delay element. For waveform generator 1310, shift register A 1330 is serially loaded with serial data A from the pattern memory 1370 when its associated load enable A signal is asserted.").
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the ultrasound probe of Cogan/Daft to include the independently controllable registers of Burlison, in order to allow for the utilization of data for specifying the relative timing positions for the waveform generators between different scan patterns for different transmit controls, as taught by Burlison.
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 11-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,439,364. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘364 features a handheld ultrasound device with a substrate having transducer elements that are independently controllable. Further, the claims recite a plurality of pulsers and waveform generators, along with a housing. While the claims of ‘364 feature additional limitations such as 1,000 elements, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
Claims 11-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,076,189. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘189 features a handheld ultrasound device with a substrate having transducer elements that are independently controllable. Further, the claims recite CMUTs and ADCs. While the claims of ‘189 feature additional limitations, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
Claims 11-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,521,991. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘991 features a semiconductor die with transducer elements that are independently controllable. Further, the claims recite a plurality of pulsers, waveform generators, and circuitry for receiving ultrasound signals. While the claims of ‘991 feature additional limitations such as first and second components that impact a delay length, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
Response to Arguments
Applicant's arguments filed 4/17/26 have been fully considered but they are not persuasive. Applicant has canceled all claims and submitted new claims 11-30. The new claims are rejected with the same art and same grounds of rejection as previously applied to original claims 6-10 (Cogan in view of Daft) in the instant application. The same art and same grounds of rejection have also previously been applied in parent application 15/638,331 (see the 9/2/20 rejection applying Cogan/Daft/Burlison). It is noted that instant claim 11 includes the same limitations claim 11 of as direct parent 17/890,985, only without the allowable feature: a plurality of controllable registers configured to store a plurality of different parameters for the waveform generators. This action is made Non-Final due to the inclusion of new 112 rejections.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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