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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/22/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 6/22/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,029,615 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 1, 4 - 6, 8 - 11, 13 - 14, and 17 - 20 are 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 1 recites limitations directed towards ‘using an artificial intelligence (Al) model.’
The specification explains that machine learning is a field of artificial intelligence ([0101], as published), and discloses using a machine learning algorithm to automatically detect the MSP ([0020]), as published.
However, claim 1 broadly recites using the genus of artificial intelligence to detect the MSP, whereas the specification discloses only using the species of machine learning to detect the MSP. Claim 1 therefore improperly reads on species of artificial intelligence that were not disclosed.
Claim 1 thus lacks proper written description support by virtue of undue breadth. Examiner suggests amending the claim to be specific to machine learning instead of generic to all artificial intelligence.
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.
Claim 17 is 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 17 is indefinite because there is insufficient antecedent basis for “the reference plane”. It is unclear what is being referred to.
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, 4 - 6, 8 - 11, 13 - 14, and 17 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.
Independent claim 1:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., an ultrasound imaging apparatus.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
detecting a mid-sagittal plane (MSP) of a head of an object from the obtained ultrasound image data;
determining candidate planes that are perpendicular to the MSP; and
acquiring a measurement plane image corresponding to a measurement plane from among the plurality of candidate planes. Examiner notes that the ‘acquiring’ is interpreted as ‘selecting’.
The limitations, as drafted, amount to nothing more than a series of steps that can practically be performed in the human mind and/or with the aid of pen/paper. Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements involving:
a display, which is generic hardware for extra-solution activity.
a processor to perform the mental steps, which amounts to nothing more than an instruction to implement the judicial exception on a computer.
‘obtaining ultrasound image data acquired by an ultrasonic probe’, which is extra-solution activity (i.e., data gathering).
the acquisition/selection of the measurement plane image being ‘automatic’ and “by using an artificial intelligence (Al) model” which amounts to nothing more than an instruction to implement the judicial exception on a computer.
‘displaying the measurement plane image’, which is extra-solution activity.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards generic hardware for, and steps of, extra-solution activity, as well as an instruction to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Independent claim 14:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a method of controlling an ultrasonic imaging apparatus.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
detecting a mid-sagittal plane (MSP) of a head of an object from the obtained ultrasound image data;
determining candidate planes that are perpendicular to the MSP; and
acquiring a measurement plane image corresponding to a measurement plane from among the plurality of candidate planes. Examiner notes that the ‘acquiring’ is interpreted as ‘selecting’.
The limitations, as drafted, amount to nothing more than a series of steps that can practically be performed in the human mind and/or with the aid of pen/paper. Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements involving:
‘obtaining ultrasound image data acquired by an ultrasonic probe’, which is extra-solution activity (i.e., data gathering).
the acquisition/selection of the measurement plane image being ‘automatic’ and “by using an artificial intelligence (Al) model” which amounts to nothing more than an instruction to implement the judicial exception on a computer.
‘displaying the measurement plane image’, which is extra-solution activity.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards extra-solution activity and an instruction to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Independent claim 20:
The claim is directed to a non-transitory computer readable recording medium having recorded thereon a program, which when executed on a computer, performs the steps of the method of claim 14. The claim element amount to no more than an instruction to implement the judicial exception of claim 14 on a computer. Therefore, the additional limitations, when considered separately and in combination, do not integrate the judicial exception into a practical application, or result in the claims, as a whole, amounting to significantly more than the judicial exception.
Dependent claims:
Dependent claims 4 and 17 recite additional elements directed towards automatically detecting the MSP from the obtained ultrasound image data by using the AI model, which is merely an instruction to implement the judicial exception on a computer.
Dependent claims 5 - 6 and 18 recite additional elements directed towards extracting an anatomical feature from the obtained ultrasound image data, which reads on a mental step. The claims further recite limitations directed towards detecting the MSP from the obtained ultrasound image data by using the anatomical feature, which merely further specifies details of the mental step, and does not preclude the step from being practically performed in the human mind from and/or with the aid of pen/paper. Limitations directed towards the processor or AI model performing the recited steps are merely instructions to implement the judicial exception on a computer. Limitations directed towards characterizing the anatomical feature merely limit the judicial exception to a particular environment.
Dependent claims 8, 10, and 19 recite additional elements directed towards recognizing a biometric parameter, and acquiring a measured value thereof, which read on a mental step. The limitations directed towards displaying the measured value are extra-solution activity. The limitations directed towards the processor performing the recited steps are merely instructions to implement the judicial exceptions on a computer.
Dependent claim 9 recites additional elements directed towards characterizing the biometric parameter, which merely limit the judicial exception to a particular environment.
Dependent claim 11 recites additional elements directed towards characterizing the nature of the planes, which merely limit the judicial exception to a particular environment.
Dependent claim 13 recites additional elements directed towards the apparatus comprising the probe. However, the probe is recited at a high level of generality, and therefore amounts to no more than generic hardware for extra-solution activity.
Therefore, the additional limitations of the dependent claims, when considered separately and in combination, do not integrate the judicial exception into a practical application, or result in the claims, as a whole, amounting to significantly more than the judicial exception.
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.
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 1, 4, 8 - 10, 13 - 14, 17, and 19 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee at al. (US 2011/0282202, of record, hereinafter "Lee ‘202”) in view of Lu et al. (US 2009/0074280, of record) and Lee (2013/0072797, of record, hereinafter “Lee ‘797”).
Regarding claims 1, 14, and 20, Lee ‘202 shows an ultrasound diagnosis apparatus and method of use thereof (“display system and method,” title, abstract), as well as a non-transitory computer-readable recording medium having stored therein a program for performing the method ([0058]). The system comprises a display (display system, [0037] - [0039] and fig. 2), and a processor ([0058]) configured to:
obtain ultrasound image data acquired by an ultrasonic probe (“apparatus that irradiates an ultrasound signal from a surface of a human body towards a target part”, [0005]; scanning, [0022]);
detect a reference plane comprising a sagittal plane (SP) from the obtained ultrasound image data (sagittal view, [0009] - [0014]; “side direction … side image … sagittal view”, [0023] - [0025]; [0040] - [0044]);
determine a plurality of candidate planes that are perpendicular to the reference plane (“top planes … planes of a fetus' head … top direction perpendicular to the side direction” …, [0028]);
automatically acquire a measurement plane image corresponding to a measurement plane (any of the planes used to measure the biparietal diameter (BPD), occipitofrontal diameter (OFD), head circumference (HC), a ratio between the BPD and OFD, and the like, [0010]; [0014]; [0030]) from among the plurality of candidate planes ([0028] - [0030]); and
display the measurement plane image on the display ([0037] – [0044] and fig. 2).
Lee ‘202 fails to show that the acquisition of the measurement plane image is achieved by using an artificial intelligence (AI) model. In addition, Lee ‘202 doesn’t explicitly state that the SP is a mid-sagittal plane (MSP).
Lu discloses medical diagnostic ultrasound imaging. Lu teaches acquisition of a measurement plane image achieved by using an AI model (“ …features are used by machine-learnt classifiers to detect the position of one or more desired views”, [0006]; [0039]; [0071]).
Lee ‘797 discloses a 3-dimensional ultrasound apparatus. Lee ‘797 teaches a SP that is an MSP ( mid sagittal plane with respect to an object is effectively detected”, [0013]; [0016] - [0019]; [0052]; [0059]; [0100]; [0103] – [0104]; [0112] - [0114]; [0122] – [0123]; [0125] - [0126]; [0129]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lee ‘202 to have the acquisition of the measurement plane image be achieved by using an AI model, as taught by Lu, in order to employ robust computational techniques to facilitate detecting standard views.
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lee ‘202 and Lu to have the SP be an MSP, as taught by Lee '797, in order to easily and accurately diagnose abnormalities of the fetus' head, as suggested by Lee ‘797 ([0113]), using standard imaging views that are used ubiquitously in the art.
Regarding claims 4 and 17, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above.
Lee ‘202 is not specific to the detection of the reference plane being achieved by using the AI model.
Lu teaches detection of a reference plane achieved by using the AI model (“ …features are used by machine-learnt classifiers to detect the position of one or more desired views”, [0006]; [0039]; [0071]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lee ‘202 to have the detection of the reference plane be achieved by using an AI model, as taught by Lu, in order to employ robust computational techniques to facilitate detecting standard views.
Alternatively, applicant admits that the claimed techniques for detecting the MSP (i.e., the “reference plane”) are well known in the art, to the point where detailed descriptions thereof are omitted ([0103], as published). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lee ‘202 and Lu to have the detection of the reference plane be achieved by using an AI model, as taught by applicant admitted prior art, in order to employ robust computational techniques to facilitate detecting the reference plane.
Regarding claims 8 and 19, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above. Lee ‘202 further shows acquiring a measured value by measuring a biometric parameter in the measurement plane image and indicating the measured value on the measurement plane image ([0010]; [0014]; [0030]; [0037] – [0044] and fig. 2).
Regarding claim 9, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above. Lee ‘202 further shows that the biometric parameter comprises head circumference (HC), biparietal diameter (BPD), or occipital frontal diameter (OFD) ([0010]; [0014]; [0030]; [0037] – [0044] and fig. 2).
Regarding claim 10, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above. Lee ‘202 further shows that the measured value is indicated by displaying the measured value on the measurement plane image using text ([0010]; [0014]; [0030]; [0037] – [0044] and fig. 2).
Regarding claim 13, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above. Lee ‘202 further suggests that the system includes the probe (“apparatus that irradiates an ultrasound signal from a surface of a human body towards a target part”, [0005]; scanning, [0022]).
Claims 5 - 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee ‘202, Lu, and Lee ‘797 as applied to claims 1 and 14 above, and further in view of Lee et al. (US 2011/0224546, of record, hereinafter “Lee ‘546”).
Regarding claims 5 - 6 and 18, the combined invention of Lee ‘202, Lu, and Lee ‘797 discloses the claimed invention substantially as noted above.
Lee ‘202 fails to show that the detecting of the reference plane is by using an anatomical feature extracted from the ultrasound image data, wherein the anatomical feature comprises a falx or Thalami.
Lee ‘546 discloses a three-dimensional ultrasound system. Lee ‘546 teaches detecting of a reference plane by using an anatomical feature extracted from ultrasound image data, wherein the anatomical feature comprises a falx ([0015]; [0022]; [0058] - [0060]; [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lee ‘202, Lu, and Lee ‘797 to have the detecting of the reference plane be by using an anatomical feature extracted from the ultrasound image data, wherein the anatomical feature comprises a falx, as taught by Lee ‘546, in order to facilitate obtaining an accurate sagittal view from ultrasound data, as discussed by Lee ‘546 ([0010]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee ‘202, Lu, and Lee ‘797 as applied to claim 1 above, and further in view of Lee (US 2011/0054324, of record, hereinafter “Lee ‘324").
Regarding claim 11, the combined invention of Lee ‘202 and Lu discloses the claimed invention substantially as noted above.
Lee ‘202 is silent as to the measurement plane comprising a Trans-Thalamic Plane (TTP), a Trans-Ventricular Plane (TVP), or a Trans-Cerebellar Plane (TCP).
Lee ‘324 teaches a measurement plane that comprises a TTP, a TVP, or a TCP ([0005]; [0031]; [0036] and fig. 7; [0042]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lee ‘202, Lu, and Lee ‘797 to have the measurement plane comprise a TTP, a TVP, or a TCP, as taught by Lee ‘324, in order to facilitate diagnose abnormalities of the fetus' brain, as suggested by Lee ‘324 ([0005]), using standard imaging views that are used ubiquitously in the art.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not entirely persuasive and/or are moot in view of new grounds of rejection.
Claim Rejection Under 35 U.S.C. § 101
Step 2A, Prong 1
Applicant argues on page 5 that the claims do not recite a judicial exception.
Examiner respectfully disagrees. The judicial exception is identified in the 101 rejections above.
Step 2A, Prong 2
Applicant argues on page 6 (top) that the “independent claims integrate any allegedly abstract idea into a practical application.”
Examiner respectfully disagrees for reasons explained in the 101 rejections above.
Applicant argues on page 6 (2nd par.) that the features directed towards ‘detecting the MSP’, ‘determining candidate planes’, and ‘acquiring the measurement plane image’ reflect technical improvement.
Examiner respectfully disagrees because these limitations are directed tot the judicial exception. The “judicial exception alone cannot provide the improvement”1. The improvement must instead be provided by one or more additional elements that provide integration/amount to significantly more.
Step 2B
Applicant argues on page 7 (top) that “all the additional elements individually, and in combination, claims as a whole amount to significantly more than the abstract idea.”
Examiner respectfully disagrees for reasons explained in the 101 rejections above.
Claim Rejection Under 35 U.S.C. § 103
Applicant argues on page 7 that “in Lee '202, the disclosed sagittal view merely represents a viewing direction or imaging plane without teaching or suggesting detection of an MSP of a fetal head”.
This argument is moot in view of the new ground of rejection.
Applicant argues on page 7 that “Lee '202 further does not disclose or suggest using such an MSP as a reference plane for determining candidate measurement planes.”
In response, examiner notes that the claims do not recite that the using “an MSP as a reference plane for determining candidate measurement planes”.
In response to applicant's arguments against Lu individually on page 7, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 MPEP 2106.05(a)
