DETAILED ACTION
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 § 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 (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 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.
Claim(s) 1,3-5, 7, 23, 24, 26, 27, 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Napolitano et al. (US 6,193,663, hereinafter Napolitano ‘663).
In re claim 1, Napolitano ‘663 teaches an ultrasound device comprising: an ultrasound scanner, the ultrasound scanner configured to: generate a first ultrasound signal comprising: a first polarity; and a first frequency (col. 4, lines 51-63; col. 12, lines 52-53); generate a second ultrasound signal comprising: a second polarity (col. 4, lines 51-63), the second polarity being an inverse of the first polarity (col. 4, lines 51-63); and the first frequency (col. 12, lines 52-53); transmit, at a first time (col. 7, lines 63-65; col. 10, lines 50-56; col. 11, lines 44-46; col. 13, line 65-col. 14, line 5; col. 16, lines 5-10; col. 16, lines 63-65; etc.), the first ultrasound signal at a region of interest (ROI) of a subject (col. 5 line 60-col. 6, line 9); transmit, at the first time (col. 7, lines 63-65; col. 10, lines 50-56; col. 11, lines 44-46; col. 13, line 65-col. 14, line 5; col. 16, lines 5-10; col. 16, lines 63-65; etc. Simultaneous is the SAME time, i.e. the same first time), the second ultrasound signal at the ROI of the subject; receive a first return signal based on the first ultrasound signal reflecting from the ROI; and receive a second return signal based on the second ultrasound signal reflecting from the ROI; one or more processors; and a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to generate: a combined signal based on the first return signal and the second return signal; and an output based on the combined signal (figs. 2, 20, 21, 28, col. 5, lines 27-50; col 5, line 60-col. 6, line 7; etc. ).
In re claim 3, Napolitano ‘663 teaches wherein: the first ultrasound signal comprises a first pulse; and the second ultrasound signal comprises a second pulse (col. 4, lines 51-63).
In re claim 4, Napolitano ‘663 teaches wherein: the first return signal comprises a first linear component and a first nonlinear component (col. 4, lines 62-col. 5 line 20; also note that these limitations are inherently taught by any reference that reads on claim 1 because so far claim 4 has not narrow anything in method or apparatus to allow the return signal to comprises anything that will not include linear component and a nonlinear component); the second return signal comprises a second linear component and a second nonlinear component (col. 4, lines 62-col. 5 line 20; also note that these limitations are inherently taught by any reference that reads on claim 1 because so far claim 4 has not narrow anything in method or apparatus to allow the return signal to comprises anything that will not include linear component and a nonlinear component); and the generating of the combined signal is based on a linear combination of the first return signal and the second return signal (col. 4, lines 62-col. 5 line 20; col. 7, line 40-43).
In re claim 5, Napolitano ‘663 teaches wherein the instructions further cause the one or more processors to generate the combined signal such that the combined signal retains information about a contrast agent within the ROI based on the first nonlinear component and the second nonlinear component (col. 5, lines 10-20; col. 16, lines 65-col. 17, line 4, note that harmonic components are non-linear components).
In re claim 7, Napolitano ‘663 teaches wherein: the ultrasound scanner is further configured to: wherein the combined signal is a first combined signal (fig. 12, C1); the ultrasound scanner is further configured to: generate a third ultrasound signal comprising: a third polarity; and a second frequency (fig. 12, T3 and T4);
generate a fourth ultrasound signal comprising:
a fourth polarity, the fourth polarity being an inverse of the third polarity; and the second frequency (fig. 12, T4);
transmit, at a second time, the third ultrasound signal at a region of interest (ROI) of a subject (fig. 12, T3 and T4);
transmit, at the second time, the fourth ultrasound signal at the ROI of the subject (fig. 12, T3 and T4, note that as shown above: col. 7, lines 63-65; col. 10, lines 50-56; col. 11, lines 44-46; col. 13, line 65-col. 14, line 5; col. 16, lines 5-10; col. 16, lines 63-65; etc. Simultaneous is the SAME time, i.e. the same first time);
receive a third return signal based on the third ultrasound signal reflecting from the ROI (fig. 12, R3); and receive a fourth return signal based on the fourth ultrasound signal reflecting from the ROI (fig. 12, R4); and the instructions further cause the one or more processors to generate: a second combined signal based on the third return signal and the FOURTH (Applicant has amended this claim, yet fails to mark up the amendment here) return signal (fig. 12, Summation of R3 and R4; get C3); and a second output based on the second combined signal (fig. 12, C3; col. 5, line 60-col. 6, line 7).
In re claim 23, Napolitano ‘663 teaches wherein the instructions further cause the one or more processors to change one or more parameters of the first ultrasound signal or the second ultrasound signal (col. 7, 50-66; col. 8, lines 59-col. 9, line 5; col. 12, lines 18-25).
In re claim 24, Napolitano ‘663 teaches wherein the one or more parameters include a phase of the first pulse or the second pulse, an amplitude of the first pulse or the second pulse, the frequency, or a waveform of the first pulse or the second pulse (col. 7, 50-66; col. 8, lines 59-col. 9, line 5; col. 12, lines 18-25).
In re claim 26, Napolitano ‘663 teaches wherein the generation of the combined signal represents a beamforming of the first pulse and the second pulse at the ROI (fig.11; col. 3, lines 35-53).
In re claim 27, Napolitano ‘663 teaches wherein the first frequency and the second frequency are a same frequency (col. 4, lines 51-62, same wavelength = same frequency).
In re claim 28, Napolitano ‘663 teaches wherein the first frequency is different than the second frequency (col. 9, lines 53-58).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Napolitano ‘663 in view of Angelsen (US 2017/0343656, hereinafter Angelsen ‘656).
In re claim 6, Napolitano ‘663 fails to teach wherein: the configuring of the ultrasound scanner to transmit the first ultrasound signal and the second ultrasound signal at the ROI comprises determining: a coverage area of transmission of the first ultrasound signal and the second ultrasound signal; and a bisector of the coverage area; and the first ultrasound signal and the second ultrasound signal are configured to converge at a point on the bisector.
Angelsen ‘656 teaches the configuring of the ultrasound scanner to transmit the first ultrasound signal and the second ultrasound signal at the ROI comprises determining: a coverage area of transmission of the first ultrasound signal and the second ultrasound signal; and a bisector of the coverage area; and the first ultrasound signal and the second ultrasound signal are configured to converge at a point on the bisector (fig. 1, converge on overlapping region; 0050-0051).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Napolitano ‘663 to include the features of Angelsen ‘656 in order to provide maximal sensitivity to the frequency components in the nonlinear interaction scattered signal.
Claim(s) 8, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Napolitano ‘663 in view of Tamura (US 6,814,701, hereinafter Tamura ‘701).
In re claim 8, Napolitano ‘663 fail to teach wherein the ultrasound scanner is further configured to determine: a first coverage area of transmission of the first ultrasound signal and the second ultrasound signal; and a second coverage area of transmission of the third ultrasound signal and the fourth ultrasound signal, the second coverage area overlapping the first coverage area at least in part.
Tamura ‘701 teaches wherein the ultrasound scanner is further configured to determine: a first coverage area of transmission of the first ultrasound signal and the second ultrasound signal (col. 2, 2, line 58-col. 3, line 10); and a second coverage area of transmission of the third ultrasound signal and the fourth ultrasound signal, the second coverage area overlapping the first coverage area at least in part (col. 3, line 38-col. 4, line 34; col. 5, lines 20-50).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Napolitano ‘663 to include the features of Tamura ‘701 in order to add more sectors so that speckle patterns and image artifacts are more greatly reduced, resulting in better image uniformity and higher image contrast of more use in clinical diagnosis.
In re claim 30, Napolitano ‘663 teaches wherein the instructions further cause the one or more processors to: generate a third combined signal based on the first return signal, the second return signal, the third return signal, and the fourth return signal; and a third output based on the third combined signal (fig. 24 and fig. 13, note that the alternating complex phase angle embodiments can also implement a multiple receive beam acquisition scheme similar that to FIG. 13, in which multiple receive beams are required in response to each respective transmit beam. Also, multiple simultaneous transmit beams can be used. Hence, T1 to T4 and R1 to R4 can be used; col. 10, lines 38-56).
Claim(s) 21, 22, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Napolitano ‘663 in view of dos Santos Mendonca et al. (US 2016/0317127, hereinafter Mendonca ‘127).
In re claims 21, 22, 25, Napolitano ‘663 fails to teach wherein the ultrasound device is a wearable device; wherein the ultrasound device comprises a handheld device; wherein the changing of the one or more parameters is performed by a machine-learned model.
Mendonca ‘127 teaches wherein the ultrasound device is a wearable device (0024); wherein the ultrasound device comprises a handheld device (0024); wherein the changing of the one or more parameters is performed by a machine-learned model (0030, 0034, 0037, 0041, 0042).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Napolitano ‘663 to include the features of Mendonca ‘127 in order to provide smart, mobile and trainable diagnoses to a patient.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Napolitano ‘663 in view of Averkiou et al. (US 6,186,950, hereinafter Averkiou ‘950).
In re claim 29, Napolitano ‘663 fails to teach wherein the instructions further cause the one or more processors to determine an overlapping region of the second ultrasound signal and the third ultrasound signal.
Averkiou ‘950 teaches wherein the instructions further cause the one or more processors to determine an overlapping region of the second ultrasound signal and the third ultrasound signal (col. 2, lines 30-65; fig. 3a, col. 4, line 63-col. 5, line 6).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Napolitano ‘663 to include the features of Averkiou ‘950 in order to be effective for harmonic separation of echoes produced by the target.
Response to Arguments
Applicant's arguments filed on June 24, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that:
Napolitano teaches away from the current invention. For example, Napolitano (col. 14, lines 41-44) discloses [emphasis added]: " common receive lines can be coincident yet multiple coincident transmit lines are avoided to eliminate any unnecessary decrease in the frame rate. Further, Napolitano (col. 16, lines 10- 13) discloses [emphasis added]: "The beamformers 12, 18 can also be of the simultaneous multi-beam transmit-multi beam receive type, particularly where simultaneous transmit beams are widely spaced. There would be no reason for a Person of Reasonable Skill in the Art to be motivated by Napolitano's disclosure that "multiple coincident transmit lines are avoided" and "widely spaced."
The Examiner disagrees. It is unclear why Applicant is arguing something Napolitano is teaching away when the claim is rejected under 102. Furthermore, Napolitano does NOT teach away, but rather teaches the exact limitation. Applicant first acknowledges that The beamformers 12, 18 can also be of the simultaneous multi-beam transmit-multi beam receive type. Simultaneous beam transmission is the same as “transmit, at a first time, the first ultrasound signal at the ROI of the subject … and transmit, at the first time, the second ultrasound signal at the ROI of the subject.” Both first and second ultrasound signal are transmitted at the first time; hence, that is simultaneous transmission by definition. Applicant cites “Napolitano (col. 14, lines 41-44) discloses [emphasis added]: " common receive lines can be coincident yet multiple coincident transmit lines are avoided to eliminate any unnecessary decrease in the frame rate” from the conclusion of Napolitano.” But Applicant fails to recognize that this is for “coincident transmit lines” which is NOT for simultaneous beam transmission because a coincident transmit line require a transmit line to be the same as well as the time to be the same, i.e. simultaneous. But a simultaneous beam transmission does NOT require a coincident transmit line. Even if somehow, a coincident transmit line is required for a simultaneous beam transmission, when frame rate is high enough, any decrease can be minor. All products has pros and cons, and clearly, Napolitano intends to have simultaneous beam transmission because Napolitano teaches these throughout the Specs. See. col. 7, lines 63-65; col. 10, lines 50-56; col. 11, lines 44-46; col. 13, line 65-col. 14, line 5; col. 16, lines 5-10; col. 16, lines 63-65; etc. Whereas, what Applicant cited col. 14, lines 41-44 is 4 lines that only appear in the conclusion about the pros and cons of a design. Hence, Napolitano does not teach away, but only teaches the pros and cons of various design based on the need.
Furthermore, Napolitano’s “simultaneous transmit beams are widely spaced” is not teaching away. Applicant has never limited the spaces between these transmit beams. Applicant listed ONE example of Napolitano while ignoring other examples that clearly teaches simultaneous transmit beam.” For example, Napolitano clearly teaches:
“all of these parameters can readily be modified as desired, depending on the application. Multiple simultaneous transmit beam techniques can be used if desired.” Col. 7, lines 63-66;
“multiple simultaneous transmit beams can be used.” Col. 10, lines 50-56;
“As before, these embodiments can also use multiple simultaneous transmit beam techniques and multiple simultaneous receive beam techniques.” Col. 11, lines 45-47. Etc.
Still furthermore, Applicant in the Spec describes that: the transducer 800 transmits a first pulse 808 and a second pulse 810 with the aperture 804-1 in a first position. The first pulse 808 and the second pulse 810, in some examples, are steered simultaneously from each aperture section of the aperture 804 as part of a transmit event. See para 0070, and fig. 8. Clearly from fig 8, 808 and 810 IS widely spaced. Applicant’s Spec’s simultaneous transmit beams are widely spaced. Hence, Napolitano reads on the claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
Prosecution Insights