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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2025 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This abstract idea is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
Step 1 of the 2019 Guidance requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to one of the statutory classes of a process or product as a computer implemented method or a computer system/product.
Step 2A of the 2019 Guidance is divided into two Prongs. Prong 1 requires the examiner to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Regarding claim 1, the independent claims is directed to a computer implemented method for identifying the type of a vessel of a subject based on Doppler ultrasound data acquired from the subject. The claim limitations of “segmenting a representation of a vessel of the subject from the color Doppler ultrasound data”; “applying a feature extracting algorithm to the pulse wave Doppler ultrasound data, thereby extracting a feature of the flow within the segmented vessel”; identifying the type of the vessel as an artery or a vein based on the extracted feature of the flow; performing a color distribution analysis on the color Doppler ultrasound data to obtain a color distribution of the vessel of the subject; and “classifying the vessel as an artery or a vein based on a combination of probe orientation data and color distributing of the vessel of the object” are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper.
The judicial exception is not integrated into a “practical application” as defined by the Subject Matter Eligibility Analysis documented in Federal Register 84(4), issued on 07 January 2019 and since documented in MPEP § 2106. While the claim recites that a “one or more processor” that performs the limitations encompassing mental processes.
Furthermore, the claim does not include additional elements which are sufficient to amount to significantly more than the abstract idea. The additional claim limitation of “receiving ultrasound data acquired from the subject”; “obtaining pulse wave Doppler ultrasound data from the segmented vessel representation”; “obtaining probe orientation data relating to the orientation of the ultrasound probe during the acquisition of the color Doppler ultrasound data” are directed to extra solution activity of data gathering and do not add significantly more than the abstract idea. Furthermore, using an ultrasound probe to scan the subject does not add significantly more than the abstract idea because an ultrasound probe is well known in the art (see prior art Sethurman). In consideration of each of the relevant factors and the claim elements both individually and in combination, claim 1 is directed to an abstract ideas without sufficient integration into a practical application and without significantly more.
Regarding claim 2, the clam limitations “identifying the center of the vessel based on the color Doppler ultrasound data; generating a sampling volume at the center of the vessel” are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper. The claim limitation “acquiring the pulse wave Doppler ultrasound data from the sampling volume” are directed to extra solution activity of data gathering and do not add significantly more than the abstract idea.
Regarding claims 3-5, the clams further recite limitations that are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper.
Regarding claim 6, the clam further recite limitations that are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper.
Regarding claim 7, the clam further recite limitations that are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper. The additional claim limitation “presenting the guidance instruction to the user” does not add significantly more than the abstract idea because presenting the guidance instruction is merely output result.
Regarding claim 8, the examiner notes that claim 8 is rejected under abstract idea as similar to claim 1 above. The additional claim element of a computer does not add significantly more than the abstract idea. Other than the generic computer, nothing identified in the claim is precluded from being practically performed in the mind, or with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Intellectual Ventures additionally established that if a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category of abstract ideas unless the claim cannot be practically performed in the mind. The additional elements of a generic computer component to execute the abstract ideas and does not add significantly more that the abstract idea because since a generic computer component with the computer being used as a tool for performing the abstract idea.
Regarding claim 9, the examiner notes that claim 9 is rejected under abstract idea as similar to claim 1 above. The additional claim element of a processor does not add significantly more than the abstract idea. Other than the generic computer component (processor), nothing identified in the claim is precluded from being practically performed in the mind, or with assistance of basic physical aids or with pen and paper. See MPEP § 2106.04(a)(2)(III)(B). Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Intellectual Ventures additionally established that if a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer component, then it is still in the mental processes category of abstract ideas unless the claim cannot be practically performed in the mind. The additional elements of a generic computer components to execute the abstract ideas and does not add significantly more that the abstract idea because since a generic computer component with the computer being used as a tool for performing the abstract idea.
Regarding claim 10, the clam limitations “identifying the center of the vessel based on the color Doppler ultrasound data; generating a sampling volume at the center of the vessel” are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper. The claim limitation “acquiring the pulse wave Doppler ultrasound data from the sampling volume” are directed to extra solution activity of data gathering and do not add significantly more than the abstract idea.
Regarding claim 11, the clam further recite limitations that are directed to an abstract because the claim limitations can be performed via mathematical concepts and mental process, with assistance of basic physical aids or with pen paper.
Regarding claims 12 and 15, the additional element of ultrasound patch does not add scientifically more than the abstract idea, and are well known in the art.
Regarding claims 13 and 14, the additional claim limitation providing guidance on the display does not add significantly more than the abstract idea because presenting the guidance instruction is merely output result.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8-10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sethurman et al. (WO 2020/115005; hereinafter Sethurman).
Regarding claims 1 and 8, Sethurman discloses a system and method for guided ultrasound data acquisition. Sethurman shows a computer-implemented method for identifying the type of a vessel of a subject based on Doppler ultrasound data acquired from the subject (see abstract), the method comprising: using an ultrasound probe to scan the subject in a region of the vessel (see 200 in fig. 3) receiving ultrasound data acquired from the subject by the ultrasound probe (see page 14, lines 24-25); generating color Doppler ultrasound data from the received ultrasound data (see page 14, pages 15, lines 3-5); segmenting a representation of a vessel of the subject from the color Doppler ultrasound data and obtaining pulse wave Doppler ultrasound data from the segmented vessel representation (page 13, lines 4-7, pages 15, lines 3-5, page 18, line 24 to page 19, line 6); a feature extraction algorithm to the pulse wave Doppler ultrasound data (see page 14, pages 15, lines 3-8), thereby extracting a feature of the flow within the segmented vessel; and identifying the type of the vessel as an artery or a vein based on the extracted feature of the flow (see page 14, pages 15, lines 3-8), wherein step of identifying the type of the vessel as an artery or a vein based on the extracted feature of the flow further comprises: performing a color distribution analysis on the color Doppler ultrasound data to obtain a color distribution of the vessel of the subject (see page 14, line 24 to page 15, line 14); obtaining probe orientation data relating to the orientation of the ultrasound probe during the acquisition of the color Doppler ultrasound data (see page 15, line 19 to page 16, line 3); and classifying the vessel as the artery or the vein based on a combination of probe orientation data and color distribution of the vessel of the object (see page 14, line 24 to page 15, line 14).
Regarding claim 2, Sethurman shows wherein obtaining the pulse wave Doppler ultrasound data from the segmented vessel comprises: identifying a center of the vessel based on the color Doppler ultrasound data (see page 15, lines 3-18); generating a sampling volume at the center of the vessel; and acquiring the pulse wave Doppler ultrasound data from the sampling volume (see page 15, lines 15-18).
Regarding claim 9, Sethurman discloses a system and method for guided ultrasound data acquisition. Sethurman shows an ultrasound imaging system including an ultrasound probe and a processor for identifying the type of a vessel of a subject based on Doppler ultrasound data acquired from a subject (see abstract and fig. 3), wherein the processor is adapted to: obtain ultrasound data from the subject by way of the ultrasound probe (see page 14, lines 24-25); generate color Doppler ultrasound data from the received ultrasound data (see page 14, pages 15, lines 3-5); segment a representation of the vessel of the subject from the color Doppler ultrasound data and obtain pulse wave Doppler ultrasound data from the segmented vessel representation (page 13, lines 4-7, pages 15, lines 3-5, page 18, line 24 to page 19, line 6); apply a feature extraction algorithm to the pulse wave Doppler ultrasound data (see page 14, pages 15, lines 3-5), thereby extracting a feature of the flow within the segmented vessel (see page 14, pages 15, lines 3-5); and identify the type of the vessel as an artery or a vein based on the extracted feature of the flow by performing a color distribution analysis on the color Doppler ultrasound data to obtain a color distribution of the vessel of the subject (see page 14, line 24 to page 15, line 14), obtaining probe orientation data relating to the orientation of the ultrasound probe during the acquisition of the color Doppler ultrasound data (see page 15, line 19 to page 16, line 3); and classifying the vessel as the artery or the vein based on a combination of probe orientation data and color Doppler data (see page 14, line 24 to page 15, line 14).
Regarding claim 10, Sethurman shows wherein when obtaining the pulse wave Doppler ultrasound data from the segmented vessel, the processor is adapted to: identify the center of the vessel based on the color Doppler ultrasound data (see page 15, lines 15-18); generate a sampling volume at the center of the vessel; and acquire the pulse wave Doppler ultrasound data from the sampling volume (see page 15, lines 15-18).
Regarding claims 12 and 15, Sethurman shows wherein the ultrasound probe comprises an ultrasound patch applied to the region of the vessel of the subject (see fig. 2-3, 7; page. 16, lines 19-31).
Regarding claim 13, Sethurman shows the system further comprises a display (see fig. 2-3 and 7), and wherein the processor is further adapted to generate a guidance instruction based on the identification of the type of the vessel and generate a display instruction to cause the display unit to display the guidance instruction (see fig. 2-3, 7; page. 16, lines 19-31).
Regarding claim 14, Sethurman shows wherein the ultrasound patch further comprises a guidance indicator (see fig. 3, 4, 6 and 8), and wherein the processor is further adapted to generate a guidance instruction based on the identification of the type of the vessel and control the guidance indicator to provide the guidance instruction to a user (see fig. 3, 4, 6 and 8).
Claim Rejections - 35 USC § 103
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.
Claims 3-5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sethurman et al. (WO 2020/115005; hereinafter Sethurman) in view of Patil et al. (WO 2017/108864; hereinafter Patil).
Regarding claim 3, Sethurman discloses the invention substantially as described in the 102 above, but fails to explicitly state extracting a maximum frequency envelope from the pulse wave Doppler ultrasound data; normalizing the extracted maximum frequency envelope; determining a feature of the normalized maximum frequency envelope; and extracting the feature of the normalized maximum frequency envelope as a feature of the flow.
Patil discloses a system and method for estimation of arterial blood gas. Patil teaches extracting a maximum frequency envelope from the pulse wave Doppler ultrasound data (see par. [0043]-[0045]); normalizing the extracted maximum frequency envelope (see par. [0043]-[0045]); determining a feature of the normalized maximum frequency envelope (see par. [0043]-[0045]); and extracting the feature of the normalized maximum frequency envelope as a feature of the flow (see par. [0043]-[0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of extracting a maximum frequency envelope from the pulse wave Doppler ultrasound data; normalizing the extracted maximum frequency envelope; determining a feature of the normalized maximum frequency envelope; and extracting the feature of the normalized maximum frequency envelope as a feature of the flow in the invention of Sethurman, as taught by Patil, to be able to effectively classify and localize the artery which can be used as tactile feedback for the ultrasound probe.
Regarding claim 4, Sethurman and Patil disclose the invention substantially as described in the 103 rejection above, furthermore, Patil teaches wherein determining a feature of the normalized maximum frequency envelope comprises generating a distribution of the normalized maximum frequency envelope with a histogram comprising a plurality of bins (see par. [0043]-[0045]).
Regarding claim 5, Sethurman and Patil disclose the invention substantially as described in the 103 rejection above, furthermore, Patil teaches wherein the feature of the normalized maximum frequency envelope comprises one or more of: a skewness of the envelope (see par. [0043]-[0045]).
Regarding claim 11, Sethurman discloses the invention substantially as described in the 102 above, but fails to explicitly state that the processor is adapted to extract a maximum frequency envelope from the pulse wave Doppler ultrasound data; normalize the extracted maximum frequency envelope; determine a feature of the normalized maximum frequency envelope; and extracte the feature of the normalized maximum frequency envelope as a feature of the flow.
Patil discloses a system and method for estimation of arterial blood gas. Patil teaches extracting a maximum frequency envelope from the pulse wave Doppler ultrasound data (see par. [0043]-[0045]); normalizing the extracted maximum frequency envelope (see par. [0043]-[0045]); determining a feature of the normalized maximum frequency envelope (see par. [0043]-[0045]); and extracting the feature of the normalized maximum frequency envelope as a feature of the flow (see par. [0043]-[0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching the processor is adapted to extract a maximum frequency envelope from the pulse wave Doppler ultrasound data; normalize the extracted maximum frequency envelope; determine a feature of the normalized maximum frequency envelope; and extract the feature of the normalized maximum frequency envelope as a feature of the flow in the invention of Sethurman, as taught by Patil, to be able to effectively classify and localize the artery which can be used as tactile feedback for the ultrasound probe.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sethurman et al. (WO 2020/115005; hereinafter Sethurman) in view of Vajinepalli et al. (WO 2013/088320; hereinafter Vajinepalli).
Regarding claim 6, Sethurman discloses the invention substantially as described in the 102 above, but fails to explicitly state wherein identifying the type of the vessel as the artery or the vein based on the extracted feature of the flow comprises applying a machine learning algorithm to the extracted feature.
Vajinepalli discloses an ultrasound device. Vajinepalli teaches wherein identifying the type of the vessel as an artery or a vein based on the extracted feature of the flow comprises applying a machine learning algorithm to the extracted feature (see page 9, lines 11-31).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein identifying the type of the vessel as an artery or a vein based on the extracted feature of the flow comprises applying a machine learning algorithm to the extracted feature in the invention of Sethurman, as taught by Vajinepalli, to be able to accurately characterize and classify the artery.
Regarding claim 7, Sethurman discloses the invention substantially as described in the 102 above, but fails to explicitly state wherein the method further comprises: generating a guidance instruction based on the identification of the vessel; and presenting the guidance instruction to a user.
Vajinepalli discloses an ultrasound device. Vajinepalli teaches wherein the method further comprises: generating a guidance instruction based on the identification of the vessel; and presenting the guidance instruction to a user (see page 12, lines 12-33).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the method further comprises: generating a guidance instruction based on the identification of the vessel; and presenting the guidance instruction to a user in the invention of Sethurman, as taught by Vajinepalli, to guide and help the user with the imaging procedure.
Response to Arguments
Applicant's arguments filed 06/05/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument on pages 6-7, with respect to claim rejection under 35 USC 101, the examiner respectfully disagrees. The examiner has maintained the rejection under 35 USC 101 of independent claims 1 and 9 because the claims are directed to an abstract idea without reciting claim limitations that are significantly more than the abstract. As stated in previous office action, The claims do not recite any limitations that ties the claims as a whole into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The Applicant cited case law (SIRF technology, inc. v. International Trade Commision, 601 F.3rd 1319, 94 USPQ2d 1607) and argues that claims and 1 and 9 recite limitations that are “tired to a particular machine ” that imposes meaningful limits to the claim’s scope. The examiner still maintains that an ultrasound probe does not add significantly more than the abstract idea because using ultrasound probe to scan a patient is well-understood, routine and conventional activity concepts, and scanning a patient is directed to extra solution activity. Therefore, the examiner maintains that the abstract ideas are not integrated into a particular practical application.
In response to Applicant’s arguments on pages 5-6, with respect to prior art rejection, the examiner respectfully disagrees. On pages 5-6, the Applicant argues that prior art Sethuraman does not expressly described obtaining “pulse wave” Doppler ultrasound data in the manner recited in the present independent claims, however, claim 1 merely recites “obtaining pulse wave Doppler ultrasound data from the segmented vessel representation” and does not further go in detail and limit how the pulse wave is obtained. Furthermore on page 6, the Applicant argues that acquiring and generating two different Doppler data, however, the independent claims do not limit scanning the subject two different times to acquire separate two different Doppler data. The independent merely limits obtaining pulse wave Doppler ultrasound data from segmented vessel representation, however, the claims do not limit “acquiring separately” two different Doppler data.
The examiner maintains that Sethurman does teach pulse wave Doppler ultrasound (page 13, lines 4-7, pages 15, lines 3-5, page 18, line 24 to page 19, line 6), segmenting a representation of a vessel of the subject from the color Doppler ultrasound data and obtaining pulse wave Doppler ultrasound data from segmented vessel representation (page 13, lines 4-7 states “The ultrasound data may include a variety of data. For example, the ultrasound data may include ultrasound image data, which may then be used to represent the data acquisition planes as 2D ultrasound images. Further, image segmentation may be employed to recognize and identify vessel cross sections.”; page 13, lines 20-24 states “Further, or alternatively, the ultrasound data may include pulsatility data, which represents the variance of the blood flow velocity within a given vessel. In the example of pulsatility data, the vessels may be identified by way of matching the captured pulsatility data to known pulsatility profiles, such as the typical pulsatility profile of a carotid artery or jugular vein”; pages 15, lines 3-8 states “The center of a vessel is identified from the centroid of the selected region and the RGB patterns of the selected region are analyzed to differentiate the laminar and turbulent flow within the vessel. Indeed, depending on the medical application this information may be used as a guide to maintain a current position or to move away from the bifurcation. A pulsatility measure is then computed from the Doppler color signal to confirm that the signal is from a given vessel, such as an artery”; page 18, line 24 to page 19, line 6 states segmenting to detect vessel from color Doppler data; page 19 states “To ensure that the segmented region 690 is indeed the desired vessel, such as 5 an artery and not a vein or a noise artifact, the sensor may also capture pulsatility data”).
Furthermore, Sethurman teaches performing a color distribution analysis on the color Doppler ultrasound data to obtain a color distribution of the vessel of the subject (page 14, line 24 to page 15, line 14 states Doppler color data is used to discriminate the artery and the vein from each other by converting the color Doppler flow image into HSV [Hue, Saturation, Value]), and classifying the vessel as the artery or the vein based on a combination of probe orientation data and color distribution of the vessel of the object (page 14, line 24 to page 15, line 14 states the B-mode data and the color Doppler data are used to discriminate the artery and the vein from each other by using HSV).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vajinepalli et al. (US 2014/0343431) disclose automatic blood vessel identification by name.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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.
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797