DETAILED ACTION
Summary
Claims 21-40 are pending in the application. Claims 21-40 are rejected under 35 USC 112(a). Claims 39 is rejected under 35 USC 112(b). Claims 21-36, and 38-40 are rejected under 35 USC 103. Claims 21-40 are rejected under non-statutory double patenting.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recite “a rigid portion of the housing body”. However, the originally filed disclosure does not describe the housing body, or a portion of the housing body, as “rigid”. Therefore, the amendment is new matter.
All claims dependent from the above claims rejected under 35 USC 112(a) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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 39 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 39 recites “in a range of 1 MHz to at least 20 MHz”. It is not clear if this is an unbounded range, or if this is an upper bound of the range. Clarification is required. For the purposes of examination, the former definition will be used.
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 (i.e., changing from AIA to pre-AIA ) 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.
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 21, 23, 31, 33-34, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet et al. (U.S PGPub 2015/0313572 A1) in view of Wegner et al. (U.S PGPub 2013/0123635 A1).
Regarding Claim 21, Gerbaulet teaches a method for acoustic imaging (Abstract), the method comprising:
transducing, at an array of acoustic transducer elements (Fig. 8, component 4) coupled to a rigid portion (Fig. 8, 2) [0126]+[0132] (the transducers 4 are coupled to the rigid frame with a reversible process [0132]) of in a housing body (Fig. 8, components 2 and 3) of an acoustic probe [0090]+[0093]-[0094], an acoustic waveform to be transmitted at a target in a biological receiving medium [0097]+[0157],
transmitting [0136], from the array of acoustic transducer elements (Fig. 7, components 3, 4) [0091], the acoustic waveform [0136] through an acoustic coupling article (Fig. 11, 6) that is physically and acoustically coupled to (i) each of the acoustic transducer elements of the array and (ii) the biological receiving medium (Fig. 11, component 6 is couple to transducer 4 and the biological receiving medium 7) [0152], wherein the acoustic coupling article comprises:
a semi-rigid material (Fig. 11, component 6) able to conform to both a surface of a biological receiving medium and to the acoustic transducer elements of the array of acoustic transducer elements [0152], such that the semi-rigid material is continuous and couples to multiple acoustic transducer elements of the array (Fig. 11, component 6 has no discontinuities, and thus continuously couples to the transducer array elements 4) [0152] and is operable to propagate acoustic signals between the multiple acoustic transducer elements and the biological receiving medium [0152],
receiving one or more returned acoustic waveforms that are returned from at least part of the target corresponding to the transmitted acoustic waveform [0137], wherein the receiving includes selecting at least some of the transducing elements of the array to receive the one or more returned acoustic waveforms [0137]; and
producing a tomographic image of the at least part of the target based on the one or more returned acoustic waveforms and the transmitted acoustic composite waveforms [0157]+[0166].
Gerbaulet fails to explicitly teach synthesizing, at a computing device comprising a processor and memory, a plurality of individual coded waveforms; forming, at the computing device, a composite waveform from at least some of the plurality of individual coded waveforms; wherein the acoustic waveform corresponds to the composite waveform formed at the computing device.
Wegner teaches a system for ultrasonic imaging (Abstract). This system synthesizing, at a computing device comprising a processor and memory [0020], a plurality of individual coded waveforms [0029]. This system then forms at the computing device, a composite waveform from at least some of the plurality of individual coded waveforms [0029], and the transmitted acoustic waveform corresponds to the composite waveform formed at the computing device [0025]+[0029]. The system further receives a waveform corresponding to the acoustic waveform [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to synthesize waveforms and generate a composite and generate a composite waveforms, as taught by Wegner, as using a larger bandwidth by using such waveforms allows for better image quality, as recognized by Wegner [0003]-[0004].
Regarding Claim 23, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the produced tomographic image is a three dimensional (3D) tomographic image [0166].
Regarding Claim 31, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the array of acoustic transducer elements is disposed along a curved trajectory in the housing body of the acoustic probe, and the curved trajectory is concave (Fig.8, component 4 is in a curved, concave trajectory in housing 2+3) [0133].
Regarding Claim 33, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches the semi-rigid material is able to be molded to match a three-dimensional polygon shape of the biological receiving medium (Fig. 8, 6 is molded to the shape of receiving medium 7+8) [0152]+[0161].
Regarding Claim 34, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the acoustic coupling article is included in a system for use in tomographic ultrasound imaging [0166]+[0171].
Regarding Claim 39, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the acoustic waveform includes a frequency in a range of 1 MHz to at least 20 MHz [0059]-[0060] (high frequency transducers).
Regarding Claim 40, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the acoustic waveform includes a frequency greater than 4 MHz [0059]-[0060] (high frequency transducers).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Tsujita (U.S PGPub 2012/0087564 A1).
Regarding Claim 22, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the produced tomographic image is a two dimensional (2D) tomographic image.
Tsujita teaches a system for tomographic imaging (Abstract). This system generates 2D tomographic images [0018].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to generate a 2D tomographic image, as taught by Tsujita, because it makes it easier for the system to improve the visibility of a tissue of interest, as taught by Tsujita [0019].
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Altman et al. (U.S PGPub 2011/0008437 A1).
Regarding Claim 24, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article includes a shear modulus of 1 MPa.
Altman teaches a method of making hydrogels for medical uses (Abstract). These gels can have a shear modulus of 1 MPa [0105].
It would have been obvious to substitute the acoustic coupling article of Gerbaulet with the hydrogel with a shear modulus of 1 MPa, as taught by Altman, as the substitution for one known hydrogel with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a hydrogel with a shear modulus of 1 MPa are reasonably predictable.
Claims 25-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Vaezy et al. (U.S PGPub 2003/0233045 A1)
Regarding Claim 25, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article includes a density ranging from 1.00-1.20 g/cm3.
Vaezy teaches a system for coupling an acoustic coupler to an ultrasound probe (Abstract). The coupler of this system is operable to has a density ranging for 1.00-1.20 g/cm3 (Table 1) [0123].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute coupler material of the combination with the coupler material of a density ranging for 1.00-1.20 g/cm3, as taught by Vaezy, as the substitution for one known coupler material with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using coupler material with a density ranging for 1.00-1.20 g/cm3 are reasonably predictable.
Regarding Claim 26, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article is operable to propagate the acoustic signals with a longitudinal speed of sound at 1700 m/s or less at 20° C.
Vaezy teaches a system for coupling an acoustic coupler to an ultrasound probe (Abstract). The coupler of this system is operable to propagate acoustic signals with a longitudinal speed of sound at 1700 m/s or less at 20° C (Table 4B, temperature of 20° C is 1557.32 m/s) [0125].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute coupler material with the longitudinal speed of sound of the combination with the coupler material with a longitudinal speed of sound less than 1700 m/s, as taught by Vaezy, as the substitution for one known coupler material with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of coupler material with a longitudinal speed of sound less than 1700 m/s are reasonably predictable.
Regarding Claim 28, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article provides an acoustic impedance matching of 2.0 MRayls or less between the biological receiving medium and the acoustic transducer elements.
Vaezy teaches a system for coupling an acoustic coupler to an ultrasound probe (Abstract). The coupler of this system has an acoustic impedance matching of 2.0 MRayls or less (Table 1, Acryl 10% [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the impedance of the combination with an acoustic impedance matching of 2.0 MRayls or less, as taught by Vaezy, as the substitution for one known acoustic impedance with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of an acoustic impedance matching of 2.0 MRayls or less are reasonably predictable.
Regarding Claim 29, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article is operable to propagate the acoustic signals with an attenuation factor of 1.0 dB/MHz-cm or less.
Vaezy teaches a system for coupling an acoustic coupler to an ultrasound probe (Abstract). The coupler of this system has an attenuation factor of an attenuation factor of 1.0 dB/MHz-cm or less (Table 1, Acryl 10% [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the attenuation factor of the combination with an attenuation factor of 1.0 dB/MHz-cm or less, as taught by Vaezy, as the substitution for one known attenuation factor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of a coupler with an attenuation factor of 1.0 dB/MHz-cm or less are reasonably predictable.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Zhao et al. (U.S PGPub 2016/0176128 A1).
Regarding Claim 27, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the acoustic coupling article is capable to undergo a percent elongation of 100% or greater..
Zhao teaches a method for producing hydrogel (Abstract). This method stretches the hydrogel over 100% in order to reduce the shear modulus [0016].
It would have been obvious to one of ordinary skill in the art to have the acoustic coupling article be capable of undergoing an elongation of 100% or greater, as taught by Zhao, because this reduces the shear modulus of the hydrogel, thereby increasing its toughness, as recognized by Zhao [0016].
Claim 30 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Slayton et al. (U.S PGPub 2008/0281237 A1).
Regarding Claim 30, the combination of references teaches the invention substantially as claimed.
The combination fails to teach at least one bracket component to secure and conform the semi-rigid material to the array of acoustic transducer elements.
Slayton teaches a system of coupling acoustic energy (Abstract). This system uses a bracket in order to secure and conform the semi-rigid material to the transducer array [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to use a bracket to secure and conform the semi-rigid material to the transducer array, as taught by Slayton, because ultrasound is poorly transmitted through air, and securing the coupling member improves the transmission of the ultrasound, as recognized by Slayton [0003].
Regarding Claim 36, the combination of references teaches the invention substantially as claimed. The combination further teaches flexible support coupled to and capable of moving with respect to the housing body [0132] (the support is reversibly attached with mechanical means, which suggests the means for connecting the support to the body is capable of moving respect to the body as the support is being attached/detached).
The combination fails to teach at least one bracket component is included in a bracket.
Slayton teaches a system of coupling acoustic energy (Abstract). This system uses a bracket in order to secure and conform the semi-rigid material to the transducer array [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to use a bracket to secure and conform the semi-rigid material to the transducer array, as taught by Slayton, because ultrasound is poorly transmitted through air, and securing the coupling member improves the transmission of the ultrasound, as recognized by Slayton [0003]. One of ordinary skill would recognize the bracket of Slayton would be used as the mechanical means, as taught by Gerbaulet, and as such would be capable of moving with respect to the housing as the means can be detached.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Larson.
Regarding Claim 32, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches wherein the acoustic coupling article is physically and acoustically coupled to (i) each of the acoustic transducer elements of the array and (ii) the biological receiving medium (Fig. 11, component 6 is couple to transducer 4 and the biological receiving medium 7) [0152].
Gerbaulet fails to explicitly teach without an intervening fluid between the acoustic coupling article and the acoustic transducer elements or the biological receiving medium.
Larson teaches an ultrasonic coupling device (Abstract). This coupling device is able to couple ultrasound transducer and a biological receiving medium without an intervening fluid (Col 4, lines 34-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to not use an intervening fluid, as taught by Larson, because this increases the safety of the procedure by not leaving a residue with use, thereby reducing cleanup and an infection risk, as recognized by Larson (Col 4, lines 34-57).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Montecalvo et al. (U.S Patent 5,522,878).
Regarding Claim 35, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the biological receiving medium includes an anatomical structure of a living subject including an abdomen, a thorax, a neck including a throat, an arm, a leg, a knee joint, a hip joint, an ankle joint, an elbow joint, a shoulder joint, a wrist joint, a breast, a genital, or a head including the cranium.
Montecalvo teaches a system for ultrasound imaging (Abstract). This system images the abdomen (Fig. 6) (Col 7, lines 24-50).
It would have obvious to one of ordinary skill in the art to substitute the receiving modify of the combination to be an abdomen, as taught by Montecalvo, as the substitution for one known target with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of imaging an abdomen are reasonably predictable.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Gerbaulet in view of Wegner as applied to claim 21 above, and further in view of Larson (U.S Patent 6,039,694).
Regarding Claim 38, the combination of references teaches the invention substantially as claimed. Gerbaulet further teaches the acoustic coupling article is and able to conform to both the surface of the biological receiving medium and to the array of acoustic transducer elements [0152].
The combination fails to explicitly the acoustic coupling article further comprises: a flexible, continuous pad.
Larson teaches an acoustic coupler for ultrasound (Abstract). This coupler is a flexible continuous pad (Fig. 1, 3) (Col 4, lines 64-66).
It would have been obvious to one of ordinary skill in the art to substitute the flexible acoustic couple of Gerbaulet with a continuous pad, as taught by Larson, as the substitution for one known acoustic coupler with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a continuous pad to acoustically couple the transducer array are reasonably predictable.
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 21, 23-31, and 33-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,839,512 B2 in view of Wegner and Gerbaulet.
Regarding Claim 21, the Patent teaches a method for acoustic imaging (Claim 1, Col 21, lines 57-58), the method comprising:
transmitting, from the array of acoustic transducer elements, the acoustic waveform through an acoustic coupling article that is physically and acoustically coupled to (i) each of the acoustic transducer elements of the array and (ii) the biological receiving medium, (Claim 1, Col 21, lines 59-64)
wherein the acoustic coupling article comprises: a semi-rigid material able to conform to both a surface of a biological receiving medium and to the acoustic transducer elements of the array of acoustic transducer elements (Claim 1, Col 21-22, lines 65-2), such that the semi-rigid material is continuous and couples to multiple acoustic transducer elements of the array (Claim 1, Col 21, lines 66-67) and is operable to propagate acoustic signals between the multiple acoustic transducer elements and the biological receiving medium (Claim 1, Col 22, lines 2-5),
receiving one or more returned acoustic waveforms that are returned from at least part of the target corresponding to the transmitted acoustic waveform, wherein the receiving includes selecting at least some of the transducing elements of the array to receive the one or more returned acoustic waveforms; and (Claim 1, Col 22, lines 9-15)
producing a tomographic image of the at least part of the target based on the one or more returned acoustic waveforms and the transmitted acoustic waveforms (Claim 1, Col 22, lines 16-18).
The Patent fails to explicitly teach synthesizing, at a computing device comprising a processor and memory, a plurality of individual coded waveforms; forming, at the computing device, a composite waveform from at least some of the plurality of individual coded waveforms; transducing, at an array of acoustic transducer elements of a housing body of an acoustic probe, an acoustic waveform to be transmitted at a target in a biological receiving medium, wherein the acoustic waveform corresponds to the composite waveform formed at the computing device.
Wegner teaches a system for ultrasonic imaging (Abstract). This system synthesizes, at a computing device comprising a processor and memory [0020], a plurality of individual coded waveforms [0029]. This system then forms at the computing device, a composite waveform from at least some of the plurality of individual coded waveforms [0029], and transduces, at an array of acoustic transducer elements disposed in a housing body of an acoustic probe [0026]+[0029] (one of ordinary skill would recognize an acoustic probe contains a housing), acoustic waveform to be transmitted at a target in a biological receiving medium [0025]+[0029], wherein the acoustic waveform corresponds to the composite waveform formed at the computing device [0025]+[0029]. The system further receives a waveform corresponding to the acoustic waveform [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to synthesize waveforms and generate a composite and generate a composite waveforms, as taught by Wegner, as using a larger bandwidth by using such waveforms allows for better image quality, as recognized by Wegner [0003]-[0004].
The combination fails to explicitly teach the transducer elements are coupled to a rigid portion of a housing body.
Gerbaulet teaches and array of acoustic transducer elements (Fig. 8, component 4) coupled to a rigid portion (Fig. 8, 2) [0126]+[0132] (the transducers 4 are coupled to the rigid frame with a reversible process [0132]) of in a housing body (Fig. 8, components 2 and 3)
It would have been obvious to one of ordinary skill in the art to substitute portion of the housing the transducer are coupled to, as taught by the combination, with a rigid portion of the housing, as taught by Gerbaulet, as the substitution for one known type of housing portion with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a rigid portion of the housing body coupled to the transducers are reasonably predictable.
Regarding Claim 23, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the produced tomographic image is a three dimensional (3D) tomographic image.
Gerbaulet further teaches wherein the produced tomographic image is a three dimensional (3D) tomographic image [0166].
It would have been obvious to one of ordinary skill in the art to substitute the tomographic images of the Patent with 3D tomographic images, as taught by Gerbaulet, as the substitution for one known type of tomographic image with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using 3D tomographic images are reasonably predictable.
Regarding Claim 24, the combination teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article includes a shear modulus of 1 MPa (Claim 12).
Regarding Claim 25, the combination teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article includes a density ranging from 1.00-1.20 g/cm3 (Claim 12).
Regarding Claim 26, the combination teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article is operable to propagate the acoustic signals with a longitudinal speed of sound at 1700 m/s or less at 20° C (Claim 11).
Regarding Claim 27, the combination of reference teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article is capable to undergo a percent elongation of 100% or greater (Claim 13).
Regarding Claim 28, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article provides an acoustic impedance matching of 2.0 MRayls or less between the biological receiving medium and the acoustic transducer elements (Claim 9).
Regarding Claim 29, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article is operable to propagate the acoustic signals with an attenuation factor of 1.0 dB/MHz-cm or less (Claim 10).
Regarding Claim 30, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article further comprises: at least one bracket component to secure and conform the semi-rigid material to the array of acoustic transducer elements (Claim 1, Col 22, lines 6-8).
Regarding Claim 31, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the array of acoustic transducer elements is disposed along a curved trajectory in the housing body of the acoustic probe, and the curved trajectory is concave.
Gerbaulet further teaches wherein the array of acoustic transducer elements is disposed along a curved trajectory in the housing body of the acoustic probe, and the curved trajectory is concave (Fig.8, component 4 is in a curved, concave trajectory in housing 2+3) [0133].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a curved housing, as taught by Gerbaulet, because this allows for a cheaper, and more accurate, 3D ultrasonic imaging system, as recognized by Gerbaulet [0030]-[0031].
Regarding Claim 33, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the semi-rigid material is able to be molded to match a three-dimensional polygon shape of the biological receiving medium.
Gerbaulet further teaches the semi-rigid material is able to be molded to match a three-dimensional polygon shape of the biological receiving medium (Fig. 8, 6 is molded to the shape of receiving medium 7+8) [0152]+[0161].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a semi rigid material which is molded to match a 3D polygon shape, as taught by Gerbaulet, because this allows for a cheaper, and more accurate, 3D ultrasonic imaging system, as recognized by Gerbaulet [0030]-[0031].
Regarding Claim 34, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article is included in a system for use in tomographic ultrasound imaging (Claim 1, Col 22, lines 16-18).
Regarding Claim 35, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the biological receiving medium includes an anatomical structure of a living subject including an abdomen, a thorax, a neck including a throat, an arm, a leg, a knee joint, a hip joint, an ankle joint, an elbow joint, a shoulder joint, a wrist joint, a breast, a genital, or a head including the cranium (Claim 19).
Regarding Claim 36, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the at least one bracket component is included a bracket coupled to and capable of moving with respect to the housing body (Claim 3) (the bracket component is necessarily a part of a bracket, and the bracket can attach (couple) to a housing and is capable of moving with respect to the housing (e.g. when the bracket is removed from the housing).
Regarding Claim 37, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the semi-rigid material is removably attachable to the housing body by the bracket (Claim 1, Col 22, lines 19-22)+(Claim 3), the bracket including at least one arch component to secure the semi-rigid material to interface each of the transducer elements of the array (Claim 1, Col 22, lines 19-22).
Regarding Claim 38, the combination of references teaches the invention substantially as claimed. The Patent further teaches a flexible, continuous pad and able to conform to both the surface of the biological receiving medium and to the array of acoustic transducer elements (Claim 1, Col 21, lines 59-64).
Regarding Claim 39, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the acoustic waveform includes a frequency in a range of 1 MHz to at least 20 MHz [0059]-[0060] (high frequency transducers).
Gerbaulet further teaches wherein the acoustic waveform includes a frequency in a range of 1 MHz to at least 20 MHz [0059]-[0060] (high frequency transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the frequency of the patent to be in a range of 1 MHz to at least 20 MHz, as taught by Gerbaulet, as the substitution for one known acoustic frequency with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using frequencies in that range are reasonably predictable.
Regarding Claim 40, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the acoustic waveform includes a frequency greater than 4 MHz.
Gerbaulet further teaches wherein the acoustic waveform includes a frequency greater than 4 MHz [0059]-[0060] (high frequency transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the frequency of the patent to be greater than 4 MHz, as taught by Gerbaulet, as the substitution for one known acoustic frequency with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using frequencies in that range are reasonably predictable.
Claim 22 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,839,512 B2 in view of Wegner and Gerbaulet and further in view of Tsujita.
Regarding Claim 22, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the produced tomographic image is a two dimensional (2D) tomographic image.
Tsujita teaches a system for tomographic imaging (Abstract). This system generates 2D tomographic images [0018].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to generate a 2D tomographic image, as taught by Tsujita, because it makes it easier for the system to improve the visibility of a tissue of interest, as taught by Tsujita [0019].
Claim 32 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,839,512 B2 in view of Wegner and Gerbaulet and further in view of Larson.
Regarding Claim 32, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein the acoustic coupling article is physically and acoustically coupled to (i) each of the acoustic transducer elements of the array and (ii) the biological receiving medium (Claim 1, Col 21, lines 61-64).
Gerbaulet fails to explicitly teach without an intervening fluid between the acoustic coupling article and the acoustic transducer elements or the biological receiving medium.
Larson teaches an ultrasonic coupling device (Abstract). This coupling device is able to couple ultrasound transducer and a biological receiving medium without an intervening fluid (Col 4, lines 34-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to not use an intervening fluid, as taught by Larson, because this increases the safety of the procedure by not leaving a residue with use, thereby reducing cleanup and an infection risk, as recognized by Larson (Col 4, lines 34-57).
Response to Arguments
Applicant's arguments filed 8/12/2025 have been fully considered but they are not persuasive.
Applicant argues that Gerbaulet does not teach “an array of acoustic transducer elements couple to a rigid portion of a housing body of an acoustic probe” of claim 21. The Examiner disagrees. The transducers are coupled, via the flexible support, to a rigid frame [0126]+[0132]. As such, by the broadest readable interpretation the claims are obvious over Gerbaulet, as detailed above. Therefore, the claim remains rejected under 35 USC 103. For similar reasons, claims 22-36 and 38-40. Applicant has not argued the rejection under non-statutory double patenting. The claims remain rejected under non-statutory double patenting for the reasons detailed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798