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 § 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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to an abstract idea without reciting elements that amount to significant more than
the abstract idea. The rationale for this rejection, under MPEP § 2106, for this finding is
explained below.
Step 1: Under step 1, the claims are analyzed to determine if the claim is directed to a
process, machine, article of manufacture, or composition of matter. For the claims in question, 1-8 and 10-16 are directed towards a machine, and claim 9 is directed towards a process.
Step 2A, Prong 1: Under step 2A, prong 1, the claims are evaluated to determine if the
claim recites a judicial exception, which includes the laws of nature, physical phenomena, or an
abstract idea. For independent claim 1 (and corresponding claims 8-10), the limitations regarding obtaining a lesion detection result and consequently performing a prevention function are directed towards a mental process. The limitation reciting obtaining a lesion detection result describes a process which is commonly performed by an individual (i.e., a profession, such as a radiologist or scientist, analyzing a medical image for a lesion) that is merely being automated through the usage of a computer. Additionally, the limitation related to a prevention function is broadly recited and interpreted as any act which prevents an appropriate interpretation of an image. This includes mislabeling an image, or blocking/occluding a portion of the image such that the image can no longer be appropriately interpreted.
Step 2A, Prong 2: Under step 2A, prong 2, the claims are evaluated to determine
whether the claim as a whole integrates the recited judicial exception into a practical application
of the exception (see MPEP 2106.04(d)). The examiner notes that MPEP 2106.05(a) -(c) and (e)
generally concern limitations that are indicative of integration, whereas 2106.05(f)-(h) generally
concern limitations that are not indicative of integration.
In regards to independent claims 1 and 8-10, the additional limitations of utilizing an apparatus and/or additional processors are recited at a high level of generality and are generic computing components, and do not constitute integration into a practical application or significantly more (see MPEP 2106.05(f)).
In regards to dependent claims 2-7 and 11-16, the additional limitations are broadly recited and further disclose steps used to perform the judicial exception with any clear indication or detail which would indicate integration into a practical application as noted in MPEP 2106.05(a) or MPEP 2106.05(e). Therefore, the additional limitations of claims 2-7 and 11-16 do not constitute integration into a practical application.
The examiner emphasizes MPEP 2106.05(a), which states that a limitation is indicative of integration into a practical application if the limitation identifies a manner in which an improvement is explicitly and specifically achieved and recited in the claims. The current claim language all are recited at a high level of generality which do not serve to integrate the limitations in view of MPEP 2106.05(f), and furthermore nothing precludes the current limitations from being interpreted under the mental processes grouping.
Furthermore, the examiner encourages the applicant to review the analysis of claim 2, example 47, of the Patent Eligibility Guidance from July 17, 2024 (https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility, titled “2024 AI Examples 47 through 49”), wherein using an artificial neural network trained on input data to detect anomalies was deemed ineligible due to steps (b), (d), and (e) of claim 2 being related to a mental process. In regards to the instant claims of this application, they are directed towards what is otherwise/historically a mentally performed process of identifying lesions on a medical image, which has merely been made automatic by the use of a machine learning model, which cannot in itself serve to integrate at step 2A, prong 2, as an inventive concept (see MPEP 2106.05(f)).
Step 2B: Under step 2B, the claims are evaluated as a whole to determine if it amounts to
significantly more than the recited exception (i.e., whether any additional element, or
combination of additional elements, adds an inventive concept to the claim). The considerations
of step 2A, prong 2 and step 2B overlap, but differ in that 2B also requires considering the claim
as a whole/combination of limitations, and with reference to MPEP 2106.05(d) whether the
claims feature any “specific limitation(s) other than what is well - understood, routine,
conventional activity in the field” (WURC). The examiner asserts that, even when considered in
combination, the additional elements of claims 1-16 represent mere instruction to apply a mental
process (identifying lesions in a medical image) at a high level of generality that is
generally linked to the field of analyzing and displaying medical images, and therefore does not provide a specifically recited inventive concept.
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 1-2 and 8-11 are rejected as being unpatentable over Morita (US 2023/0230246; hereinafter “Morita”) in view of Hayashi (JP5573106B2; hereinafter “Hayashi”).
Regarding Claim 1, Morita discloses a medical information display apparatus comprising a hardware processor that (see Figs. 2-5)
obtains a lesion detection process result obtained by a computer performing a lesion detection process on a medical image ([0046-0047], Morita discloses applying a lesion detection process using a CAD (computer aided diagnosis) lesion detection algorithm,), and
Morita does not explicitly disclose executes a prevention function of preventing user's inappropriate interpretation of the medical image.
Hayashi discloses executes a prevention function of preventing user's inappropriate interpretation of the medical image ([0056], [0061], Hayashi discloses displaying a warning (i.e., a prevention function) to a display when a user input is attempted prior to CAD information being loaded in. The Examiner notes that Hayashi states that the warning display prohibits the radiologist from ending the interpretation prematurely until all the display items are present (i.e., prevent an oversight/inappropriate interpretation).).
Morita and Hayashi are considered to be analogous to the claimed invention as they are in the same field of using display apparatuses to analyzing medical images. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Morita by incorporating Hayashi’s disclosure of a warning display to prevent an interpretation from premature ending. The motivation for this combination being the ability to set a fail-safe which ensures that all images are correctly and properly being analyzed.
Claims 8 (the system claim), 9 (the method claim), and 10 (the non-transitory computer-readable storage medium claim) corresponding to claim 1, and are similarly rejected (see Figs. 2, 10, Morita).
Regarding Claim 2, Morita in view of Hayashi teaches the medical information display apparatus according to claim 1, wherein in response to not obtaining the lesion detection process result, the hardware processor, as the prevention function, causes a display to display information on whether to wait for the lesion detection process result to be obtained ([0056], [0061], Hayashi discloses displaying a warning (i.e., a prevention function) to a display when a user input is attempted prior to CAD information being loaded in.).
Claim 11 is the non-transitory computer-readable storage medium claim corresponding to claim 2 and is similarly rejected.
Claims 3-4, 6-7, 12-13, and 15-16 are rejected as being unpatentable over Morita in view of Hayashi in view of Sato (US 2024/0346797; hereinafter “Sato”).
Regarding Claim 3, Morita in view of Hayashi teaches the medical information display apparatus according to claim 1.
Morita in view of Hayashi does not explicitly disclose wherein the hardware processor as the prevention function, performs control to disable user's interpretation of the medical image until the lesion detection process is completed and after the lesion detection process is completed, performs control to enable the user's interpretation.
Sato discloses wherein the hardware processor as the prevention function, performs control to disable user's interpretation of the medical image until the lesion detection process is completed ([0085-0086], Sato discloses displaying a warning message indicating than an ongoing detection process is occurring.), and after the lesion detection process is completed, performs control to enable the user's interpretation ([0089], Sato discloses updating the warning screen when the detection process status changes from pending to complete.).
Morita, Hayashi, and Sato are considered to be analogous to the claimed invention as they are in the same field of using display apparatuses to analyzing medical images. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Morita in view of Hayashi by further including Sato’s warning screen and specifically the update procedure to update the warning screen to enable user interpretation when the status is complete. The motivation for this combination being the ability to update the display apparatus such that it is responsive to the processing updates.
Claim 12 is the non-transitory computer-readable storage medium claim corresponding to claim 3 and is similarly rejected.
Regarding Claim 4, Morita in view of Hayashi in view of Sato teaches the medical information display apparatus according to claim 3, wherein the control to disable the user's interpretation is control that is performed by the hardware processor to cause a display not to display an examination related to the medical image (Fig. 6, Sato discloses a warning screen with no additional image.).
Claim 13 is the non-transitory computer-readable storage medium claim corresponding to claim 3 and is similarly rejected.
Regarding Claim 6, Morita in view of Hayashi in view of Sato teaches the medical information display apparatus according to claim 3, wherein the control to disable the user's interpretation is control that is performed by the hardware processor to cause a display to display a warning related to the user's interpretation (Fig. 6, Sato discloses a warning screen.).
Claim 15 is the non-transitory computer-readable storage medium claim corresponding to claim 6 and is similarly rejected.
Regarding Claim 7, Morita in view of Hayashi in view of Sato teaches the medical information display apparatus according to claim 3,
wherein the lesion detection process includes a plurality of lesion detection processes (Fig. 5, [0053], [0088], Morita discloses multiple lesion detection processes occurring across multiple images. Also note [0033-0034], Figs. 6-7, wherein Hayashi further identifies multiple lesions.), and
wherein the hardware processor
performs the control to disable the user's interpretation until the plurality of lesion detection processes is completed ([0085-0086], Sato discloses displaying a warning message indicating than an ongoing detection process is occurring.), and
performs the control to enable the user's interpretation after the plurality of lesion detection processes is completed ([0089], Sato discloses updating the warning screen when the detection process status changes from pending to complete.).
Claim 16 is the non-transitory computer-readable storage medium claim corresponding to claim 7 and is similarly rejected.
Claims 5 and 14 are rejected as being unpatentable over Morita in view of Hayashi in view of Sato in view of Hiasa (US 2023/0334665; hereinafter “Hiasa”).
Regarding Claim 5, Morita in view of Hayashi in view of Sato teaches the medical information display apparatus according to claim 3, wherein the control to disable the user's interpretation is control that is performed by the hardware processor (note the combination made in claim 3 regarding disabling the user’s interpretation.) (Note the combination made in claim 3 wherein Sato discloses a warning message which disables the user interpretation during an ongoing detection process.).
Morita in view of Hayashi in view of Sato does not explicitly disclose to cause a display to display an examination related to the medical image but disable the user’s interpretation to be started (italicized for context).
Hiasa discloses to cause a display to display an examination related to the medical image (Figs. 9-10, [0132-0135], Hiasa discloses indicating on a display when an image (i.e., display an examination) is inappropriate for further processing.) but disable the user’s interpretation to be started (italicized for context).
Morita, Hayashi, Sato, and Hiasa are considered to be analogous to the claimed invention as they are in the same field of using display apparatuses to analyzing medical images. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Morita in view of Hayashi in view of Sato such that when a user’s interpretation is to be disabled, as taught by Morita in view of Hayashi in view of Sato, an image is still displayed based on the disclosure of Hiasa. The motivation for this combination being the ability to visualize the image which is in the process of being analyzed.
Claim 14 is the non-transitory computer-readable storage medium claim corresponding to claim 5 and is similarly rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2024/0331149 (Wada et al.)
US 2024/0312019 (Higa)
US 2013/0121556 (Matsumoto)
US 7,174,515 (Marshall et al.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PROMOTTO TAJRIAN ISLAM whose telephone number is (703)756-5584. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chan Park can be reached at (571) 272-7409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PROMOTTO TAJRIAN ISLAM/Examiner, Art Unit 2669 /CHAN S PARK/Supervisory Patent Examiner, Art Unit 2669
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