DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 and 4 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Frey et al., (US PG Pub 2005/0203409).
Regarding claim 1, Frey, drawn to membrane ultrasound transducers (see Abstract) discloses an ultrasound device 10 (see paragraph [0021]: "FIGS. 1, 3 and 5 show membrane ultrasonic transducers for converting between electrical and acoustical energies.") comprising:
a plurality of independently controllable ultrasonic transducer elements 18 (see Fig. 1; (see paragraph [0025]: "Some electrodes 18, 20 are separate or electrically isolated from electrodes 18, 20 from other elements 24." Being "electrically isolated" from each other, the electrodes would therefore be independently controlled. Groupings of electrodes which are independently controlled between groups can also be seen in Fig. 3) disposed on a substrate 14 (see Fig. 1).
Regarding claim 2, Frey discloses the substrate 14 is a semiconductor substrate (see paragraph [0022]: "The membranes 14 are a semiconductor or other material supported on the substrate 12. For example, the membranes 14 are formed as a layer of plasma-enhanced chemical vapor deposition silicon nitride, but any other now known or later developed materials may be used. The membranes are formed through patterning, etching, and use of a sacrificial layer, such as aluminum or a low temperature oxide or glass.") and the plurality of ultrasonic transducer elements comprise capacitive micromachined ultrasonic transducers (CMUTs) (see paragraph [0021]: "The membrane ultrasonic transducer 10 includes a substrate 12, a plurality of membranes 14 disposed over voids 16, the electrodes 18 adjacent to the membranes 14, electrodes 20 adjacent to or within the voids 16, and other now known or later developed CMUT structures." See also paragraph [0028]: "Using spin deposition, sputter deposition, other forms of deposition, etching, patterning, lapping, evaporating, scribing, photolithographic patterning, or other now known or later developed techniques, the various layers and materials of the CMUT 10 are formed. Semiconductor, insulating and conducting layers are formed as part of the substrate 12.").
Regarding claim 4, Frey discloses transmit circuitry disposed on the substrate and configured to independently control the plurality of ultrasonic transducer elements (see paragraph [0027]: "For the electrodes 18 forming electrical connections to isolated groups (elements), any now known or later developed connectors may be used for the separate signal traces. For example, a flexible circuit is positioned adjacent to the membranes 14, contacting a signal trace associated with an element to the electrodes 18. Alternatively, the separate signal traces for each element extend to an edge of the substrate 12 on the top surface and terminate at a pad. Wire bonding or connection of the flex circuit to the pads of multiple elements provides electrical connection of separate signal traces for each element 24 to cables or imaging system circuitry.")
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 negatived by the manner in which the invention was made.
Claims 3 and 5 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Frey, and in further view of Daft et al., (US PG Pub 2009/0069686, hereinafter "Daft").
Regarding claim 3, Frey discloses the invention substantially as claimed, however is silent with regards to the ultrasound device comprising a hand-held housing in which the substrate is disposed.
Daft, drawn to an ultrasound device with transducers formed in or on a semiconductor substrate (see paragraph [0009]), teaches an ultrasound device (see Fig. 2) comprising a hand-held housing in which the substrate is disposed (see paragraph [0034]-[0035]: "The system includes a probe housing, the transducer 22, cables 38, and the imaging system 34...The probe housing encloses the transducer 22." Paragraph [0025] states "the multi-dimensional array of elements 14 is formed from silicon or other semiconductor material. The elements 14 are on silicon or other semiconductor substrate of the layer 12, such as being CMUTs formed in the surface of the substrate." As can be seen in Fig. 2, the substrate 12 is part of transducer 22, which is located within the housing, as stated in paragraph [0035]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the ultrasound device of Frey to include the hand-held housing of Daft, in order to enhance patient contact with the transducers, provide electrical isolation of the transducers, be shaped for handheld operation, and provide a grip region sized and shaped for being held by a user, as recognized by Daft (see paragraph [0035]).
Regarding claim 5, Frey is silent with regards to the transmit circuitry comprising analog and digital circuitry.
Daft teaches an ultrasound device (see Fig. 2) comprising transmit circuitry comprising analog and digital circuitry (see paragraph [0020]: “The arrays and/or system connections of the PZT and CMUT layers may be different. For example, a relatively low element count matrix PZT array connects through cables with transmitters in an imaging system. The transmitters may be arbitrary waveform generators rather than simple square wave transmitters suitable for location in a probe housing, saving cost and avoiding power usage limitations. A relatively high element count silicon CMUT array overlays the low element count PZT array. The die for the CMUT array is thinned to allow passing of ultrasound transmissions.”).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the transmit circuitry of Frey to include the analog and digital circuitry of Daft, in order to use integrated electronics in the thin wafer of the CMUT to limit interconnection problems for the matrix array, as recognized by Daft.
Claims 6-10 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Cogan et al., (US PG Pub 2011/0060225, hereinafter "Cogan") and in further view of Daft et al., (US PG Pub 2009/0069686, hereinafter "Daft").
Regarding claim 6, Cogan, drawn to a handheld ultrasound probe (see Abstract) discloses a hand-held ultrasound device 10 (see Fig. 1) for placement on a subject, the hand-held ultrasound device 10 comprising:
a plurality of ultrasonic transducer elements 24 (see paragraph [0021]: "The probe 12 includes sub-arrays 22 of transducers 24 that are configured to produce and detect ultrasound waves. Each individual transducer 24 is generally capable of converting electrical energy into mechanical energy for transmission and mechanical energy into electrical energy for receiving purposes.");
a plurality of transmit control circuits (see annotated Fig. 1 below) comprising a plurality of waveform generators 26 [that drive a plurality of pulsers 32 coupled to the plurality of ultrasonic transducer elements 24 with a plurality of bias levels coupled to the plurality of ultrasonic transducer elements 24] (see paragraph [0024]: In some embodiments, each transducer 24 may be associated with a respective pulser which receives a signal from the MUX 28. For instance, a respective pulser 32 may receive control signals at a low voltage (e.g., 3.3V or 5.0V) and produce high voltage (e.g., negative 100V to positive 100V) signals that drive the transducer elements 24. The low voltage control signal may be a digitally encoded representation of the desired pulser state. Additionally, the pulser 32 having such functionality may receive a timing signal of a preset number of bits and generate a variety of independent signals from the information encoded in the received bits." The limitation as delineated above in bolded brackets is drawn to the intended use of the waveform generators. The pulser is not positively claimed as an element within the structure, and therefore the waveform generator must only be capable of driving the plurality of pulsers. It has been held in recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, USPQ2d 1647 (1987). As disclosed in Cogan and pointed out above, the waveform generators drive the pulsers, and therefore, the waveform generators of Cogan would be at least capable of "driving] a plurality of pulsers coupled to the plurality of ultrasonic transducer elements with a plurality of bias levels".).
Cogan discloses the ultrasound device comprises a handle portion (see paragraph [0019]: "In some embodiments, the probe 12 may include a handle portion (e.g., a grooved section designed for gripping) configured to facilitate use by an operator, such as a medical technician.") however is silent with regards to a specific hand-held housing in which the solid state semiconductor substrate is disposed.
Daft, drawn to an ultrasound device with transducers formed in or on a semiconductor substrate (see paragraph [0009]), teaches an ultrasound device (see Fig. 2) comprising a hand-held housing to support the plurality of ultrasonic transducer elements and the plurality of transmit control circuits (see paragraph [0034]-[0035]: "The system includes a probe housing, the transducer 22, cables 38, and the imaging system 34...The probe housing encloses the transducer 22." Paragraph [0025] states "the multi-dimensional array of elements 14 is formed from silicon or other semiconductor material. The elements 14 are on silicon or other semiconductor substrate of the layer 12, such as being CMUTs formed in the surface of the substrate." As can be seen in Fig. 2, the substrate 12 is part of transducer 22, which is located within the housing, as stated in paragraph [0035]).
At the time of the invention, 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 of Daft, in order to enhance patient contact with the transducers, provide electrical isolation of the transducers, be shaped for handheld operation, and provide a grip region sized and shaped for being held by a user, as recognized by Daft (see paragraph [0035]).
a housing to support the plurality of ultrasonic transducer elements and the plurality of transmit control circuits (see paragraph [0019]: "In some embodiments, the probe 12 may include a handle portion (e.g., a grooved section designed for gripping) configured to facilitate use by an operator, such as a medical technician. Additionally, it should be noted that the probe 12 may be manufactured to take on any of a number of geometries, such as a t-shape, a rectangle, a cylinder, and so forth.").
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Regarding claims 7 and 8, Cogan discloses the plurality of transmit control circuits comprise independently controllable storage for a time delay (see paragraph [0026]: "In some embodiments, the fine delay unit 38 may be comprised of multiple delay stages with independent Muxes. For example, in the first fine delay stage the Mux complexity may be reduced by accessing only a subset of the delay stages (e.g. every other). A second fine delay stage may create two delayed versions of the control signal that are separated by a single delay step. In some embodiments, this may reduce hardware complexity compared to an implementation with a single Mux with more inputs." See also paragraph [0029]).
Regarding claims 9 and 10, Cogan discloses the plurality of transmit control circuits comprise independently controllable storage for phase and frequency of a waveform (see paragraph [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.").
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 1-10 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 1-5 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 ‘364 feature additional limitations, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
Conclusion
This is a CON of applicant's earlier Application No. 17/890985 which is a CON of 15/638,331. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797