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 .
Response to Arguments
Applicant’s arguments and amendment have persuasively overcome the title objection, the drawing objection, the 112(a) rejections, many of the 112(b) rejections and the 102 rejection.
For the 112(a) issues, the examiner was persuaded primarily due to the combination of admissions in Applicant’s remarks and the present lack of guidance on 112(a) as applied to artificial intelligence inventions (e.g., the only case law that the examiner has found is non-precedential PTAB decisions).
The remaining issues are addressed below.
Applicant argues:
Claims 1-3, 5, 6, 8-13 and 15-20 have been amended to make some minor grammatical improvements and to correct some minor antecedent basis problems so as to put them in better form for issuance in a U.S. patent.
Examiner responds:
The examiner strongly disagrees with this characterization.
Specification
The amendment filed August 4, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the amendments to [0060] and [0111] because they add definitional guidance that was not previously present.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 1-3, 5, 6, 8-13, and 15-20 (all claims) 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.
Claims 1, 13 and 17-20 (all of the independent claims) recite “training ultrasound images each including a bone around the nerve root and in each of which the nerve root is marked and a ground truth label providing information about a position of the nerve root in the training ultrasound image.” The two instances of “each” are new matter. Applicant has not pointed out where the amended claim is supported, nor does there appear to be a written description of this claim limitation in the application as filed. MPEP 2163.04(I).
Dependent claims are likewise rejected.
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 1-3, 5, 6, 8-13, and 15-20 (all claims) are 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 1 recites how the ultrasound image was generated, but it is unclear if this is a required step, or if this is intended to be a product-by-process claim. MPEP 2111.05.
Claims 17-20 recite similar language and raise the same issue.
Claims 1 and 17-20 recite both interfacing with a trained model and performing inference, but it is not clear whether the intent is that the inference is performed by the trained model or is performed by something else.
Claim 13 recites “whereby the inference … is provided to an observer,” but it is unclear whether or not this is a required part of the configuration, and if it is, what that configuration would be.
Claims 1, 13, and 17-20 recite “around,” but it is unclear if this is intended in the sense of encircling or the sense of “near.” If “near” is meant, Applicant is advised to consider MPEP 2173.05(b).
Dependent claims are likewise rejected.
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 1-3, 5, 6, 8-13, and 15-20 (all claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Step 1: Claims 17 and 18 recite a method, and processes satisfy Step 1 of the eligibility test.
Claims 1-16 recite an apparatus, and machines satisfy Step 1 of the eligibility test.
Claims 19 and 20 recite a non transitory recording medium, and manufactures satisfy Step 1 of the eligibility test.
Step 2A, prong one: All of the elements of the claims are a mental process because a person look at an ultrasound image and see what’s shown. Further, the various models are also mental processes, see example 47, claim 2, element (d) (from the July 2024 AI subject matter eligibility examples). MPEP 2106.04(a)(2)(III)(C) explains that use of a generic computer or in a computer environment is still a mental process. In particular, this section begins by citing Gottschalk v. Benson, 409 US 63 (1972). “The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea.” In Benson the Supreme Court did not separately analyze the computer hardware at issue; the specifics of what hardware was claimed is only included in an appendix to the decision.
Because there are no additional elements, no further analysis is required for Step 2A, prong two or Step 2B.
MPEP 2106.05(g) provides examples of “mere data gathering,” and example vi. includes “See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis).”
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.
Claims 1-3, 5, 6, 8-13, and 15-20 (all claims) are rejected under 35 U.S.C. 103 as being unpatentable over US20240412360A1 (“Kosarek”) in view of Fan G, Liu H, Wu Z, Li Y, Feng C, Wang D, Luo J, Wells III WM, He S. Deep learning–based automatic segmentation of lumbosacral nerves on CT for spinal Intervention: a translational Study. American Journal of Neuroradiology. 2019 Jun;40(6):1074-81 (“Fan”)
1. An inference apparatus, comprising a hardware processor configured to: (Kosarek, claim 1, “one or more processors”)
acquire ultrasound image data on an ultrasound image generated based on a reflected wave of ultrasound transmitted to a subject; and (Kosarek, claim 1, “receiving two-dimensional ultrasound images from the probe”)
access a trained model which is trained to output, upon receiving as input ultrasound image data, output data, (Kosarek, claim 1, “feed the two-dimensional ultrasound images into a trained neural network to identify bone and other features in the two-dimensional ultrasound images;”)
input the ultrasound image data acquired from the subject to the trained model to receive from the trained model, output data outputted from the trained model for the ultrasound image data acquired from the subject; (Kosarek, claim 1, “feed the two-dimensionl ultrasound images into a trained neural network to identify bone and other features in the two-dimensional ultrasound images;”)
and perform inference on a nerve root in the ultrasound image of the subject based on the output data outputted from the trained model for the ultrasound image data acquired from the subject, (Kosarek, Fig. 7)
whereby the inference or information about the inference is provided to an observer of the generated ultrasound image of the subject. (Kosarek, claim 1, “feed the two-dimensional ultrasound images into a trained neural network to identify bone and other features in the two-dimensional ultrasound images;” See also, claim 9, “nerve root block”)
Kosarek is not relied on for the below claim language.
However, Fan teaches the trained model being trained using, as training data, training ultrasound images each including a bone around the nerve root and in each of which the nerve root is marked and a ground truth label providing information about a position of the nerve root in the training ultrasound image; (Fan, abstract, “A total of 50 cases of spinal CT were manually labeled for lumbosacral nerves and bones usingSlicer4.8.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Fan to the teachings of Kosarek such that Fan’s images are used for training Kosarek’s neural network for the purpose of segmenting bones and nerves for medical procedures. Compare Fan, abstract with Kosarek, [0010], where Kosarek says that it can be used for figuring out where to inject into the spine including nerve root blocks and Fan teaches training AI on images of bones and nerves in the spine for injection.
Based on the above, this is an example of “combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
Claim 2 is rejected as per claim 1.
3. The inference apparatus according to claim 1, wherein the hardware processor is further configured to: acquire blood flow information on a blood flow flowing in a blood vessel, the blood flow information being included in the ultrasound image of the subject, and infer the position of the nerve root based on the blood flow information. (Kosarek, claim 1, “while avoiding the injection needle encountering bone or neurovascular structure.” Kosarek’s neurovascular teaches the claimed blood flow. The nerve root block of Kosarek’s claim 9, mapped above, teaches the claimed nerve root.)
5. The inference apparatus according to claim 1, wherein the trained model has been trained by further using, as the training data, at least one bone of a fifth lumbar vertebra, a fourth lumbar vertebra or a sacrum included in the training ultrasound images. (Kosarek, [0007] “to generate a three-dimensional image of vertebrae in the spine.” Imaging the spine includes processing the fourth and fifth lumbar vertebrae. See also [0050] specifying the lumbar.)
6. The inference apparatus according to claim 1, wherein the trained model has been trained by further using, as the training data, blood flow information on a blood flow flowing in a blood vessel running in a direction parallel to the nerve root. (Kosarek, [0003] “Avoidance of important neurovascular structures along the path of injection is also an issue when performing these procedures.” Kosarek’s “along” teaches the claimed parallel.)
8. An ultrasound diagnostic apparatus, comprising:
the inference apparatus according to claim 1; (See the mapping of claim 1)
an ultrasound image generation unit that generates the ultrasound image of the subject; and (Kosarek, claim 1, “generate a three-dimensional image of vertebrae in the spine;”)
a display that displays the ultrasound imageof the subject, and displays the nerve root in the ultrasound image of the subject based on the inference. (Kosarek, Fig. 1A, display 125)
9. The ultrasound diagnostic apparatus according to claim 8, wherein the display displays, based on the inference, a nerve root position display element that is visually associated with a position of the nerve root in the ultrasound image of he subject in a superimposed manner in the ultrasound image of the subject. (Kosarek, [0078] “For example, one preferred embodiment highlights spinous processes in magenta, lamina in cyan, facets in green, and transverse processes in yellow, to provide strong contrasts against a grayscale ultrasound underlying the display.” Kosarek’s highlighting teaches the claimed superimposed manner.)
10. The ultrasound diagnostic apparatus according to claim 9, wherein the display highlights and displays the nerve root position display element in the ultrasound image of the subject. (Kosarek, [0078] “For example, one preferred embodiment highlights spinous processes in magenta, lamina in cyan, facets in green, and transverse processes in yellow, to provide strong contrasts against a grayscale ultrasound underlying the display.”)
11. The ultrasound diagnostic apparatus according to claim 9, wherein the display displays a first display of the ultrasound image of the subject on which the nerve root position display element is superimposed, and a second display of the ultrasound image of the subject on which the nerve root position display element is not superimposed, side by side. (Kosarek, [0079] “the operator 105 can view, side-by-side and in real time, … (2) whether an acoustic window is identified at the current location of the probe, and (3) what raw ultrasound data is currently being fed to the machine learning classifier.”)
12. The ultrasound diagnostic apparatus according to claim 9, wherein the display displays, in an area in which the nerve root position display element is not displayed in the ultrasound image of the subject, a label based on the inference. (Kosarek, [0078] “For example, one preferred embodiment highlights spinous processes in magenta, lamina in cyan, facets in green, and transverse processes in yellow, to provide strong contrasts against a grayscale ultrasound underlying the display.” Kosarek’s highlighting teaches the claimed label.)
Claims 13 and 15-20 are rejected as per their counterparts.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11666304 B2 – “Portable Ultrasound Based Nerve Imaging System”
US 11151721 B2 – “System And Method For Automatic Detection, Localization, And Semantic Segmentation Of Anatomical Objects”
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 DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached at 571-272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ORANGE/Primary Examiner, Art Unit 2663
