DETAILED ACTION
Status
This communication is in response to the application filed on 15 November 2024. Claims 1-12 are pending and presented for examination.
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 .
Priority
Applicant’s claim for foreign priority to JP2022-082237, filed on 19 May 2022, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 15 November 2024 and 24 December 2024 were filed after the mailing date of the application on 15 November 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner’s Note
The Examiner notes the breadth of at least the independent claims: the claims acquire a first and second image imaging an internal body of a patient at different times, acquire an area corresponding to the first and/or second image, and then calculate a similarity, a cost, and a relative position. Since it would be improper for the Examiner to read limitations from the specification into the claims (see MPEP § 2111.01(II)), and there is little or no definition regarding what the claim terms mean otherwise, the claim terms and therefore the scope of the claims appears EXCEEDINGLY broad. For example, any X-ray, CT scan, MRI, or similar imaging of a patient that is compared to any earlier image would appear to infringe the claims – people have, for many years, compared such images to determine size and location of tumors, injuries, etc. and the claims appear to require little if anything more than that. However, MPEP § 2173.04 indicates that breadth is not indefiniteness. Therefore, the Examiner has attempted to find and place art that is as close to the understood intent of Applicant’s filing, but there is (or would be) such a huge volume of applicable art that it is almost impossible to find and reference the “best” or closest art available. Therefore, until such time as Applicant narrows the claims to what has actually invented, the Examiner notes that the claims will be interpreted with the broadest reasonable interpretation and the art may not reflect what Applicant intends, even though it meets the requirements of the claims.
The Examiner notes that the claims recite “a cost calculator … to calculate a cost” (at claim 1, similar or parallel phrasing at claims 11 and 12), where “cost” is not used in a monetary sense. Per Applicant’s description, the “cost” reflects risk (such as more or increased side effects) when a treatment such as radiation is applied to an area that is too large (or perhaps, too small). As such, the “cost” is related to the distance, area, or volume inconsistency between various areas of interest – see, e.g., Applicant ¶ 0069-0073 related to the cost function, and ¶ 0035 regarding the areas of interest. See also dependent claims 4 and 6.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a first image acquirer configured to acquire a first image”, “a second image acquirer configured to acquire a second image”, “ an area acquirer configured to acquire two or more areas”, “an image similarity calculator configured to calculate a similarity”, “a cost calculator configured to calculate a cost”; and “a registrator configured to calculate” at claim 1, “an approximate image calculator configured to calculate” “and a movement cost calculator configured to move the area” at claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 1-10 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 pre-AIA the applicant regards as the invention.
The recitations of “a first image acquirer configured to acquire a first image”, “a second image acquirer configured to acquire a second image”, “ an area acquirer configured to acquire two or more areas”, “an image similarity calculator configured to calculate a similarity”, “a cost calculator configured to calculate a cost”; and “a registrator configured to calculate” at claim 1, “an approximate image calculator configured to calculate” “and a movement cost calculator configured to move the area” at claim 2 may refer to merely or purely software as the means to perform the indicated functions, or may refer to hardware as performing the functions. Therefore, the claims are indefinite as to whether the medical image processing device at claims 1 and 2 is merely software or if it is required to have hardware.
Claims 2-10 depend from claim 1, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-10 are also indefinite.
As a remedy, the Examiner suggest amending at least claim 1, but also suggests amending claim 2, to recite “… comprising: a hardware processor executing a program including: …” the listed steps of claims 1 and 2 (as apparently supported at Applicant page 14, lines 7-22 as submitted, ¶ 0041 as published). Such recitation appears to not limit claim scope significantly, but recites hardware as performing the steps to prevent 112f invocation (and the related indefiniteness issues).
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a device (claims 1-10), method (claim 11), and non-transitory computer-readable medium (claim 12), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a medical image processing device comprising: a first image acquirer configured to acquire a first image which is captured by imaging an internal body of a patient; a second image acquirer configured to acquire a second image which is captured by imaging the internal body of the patient at a time point different from that of the first image; an area acquirer configured to acquire two or more areas corresponding to one or both of the first image and the second image; an image similarity calculator configured to calculate a similarity between the first image and the second image; a cost calculator configured to calculate a cost based on a positional relationship between the areas; and a registrator configured to calculate a relative position of the first image with respect to the second image to increase the similarity and to decrease the cost.
Claims 11 and 12 are analyzed similarly to claim 1 since claim 11 is directed to a method performed by a computer comprising the same or similar activities as at claim 1, and claim 12 is directed to a computer-readable non-transitory storage medium storing a program for causing a computer to perform the same or similar activities as at claim 1.
The dependent claims (claims 2-10) appear to be encompassed by the abstract idea of the independent claims since they merely indicate approximating an image based on patient posture degrees of freedom, calculate its cost, and determining movement (claim 2), acquiring the first and second images as integral images (claim 3), the cost is an area, volume, or distance of non-overlap (claims 4 and 6), increasing cost as non-overlap increases (claim 5), acquiring the second image by modifying the first area of the first image (claim 7), the areas comprise an irradiation field (claim 8) such as a tumor (claim 9), including a treatment device, an imaging device, a bed, and bed controller (claim 10).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of acquiring images and an area and calculating possible differences; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) based on the similarity, cost, and relative position calculations;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) based on the acquiring images and area – a person can view images mentally and form evaluations, judgments, or opinions regarding the areas.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are the claims to a device comprising: a first image acquirer, a second image acquirer, an area acquirer, an image similarity calculator, a cost calculator, and a registrator (at claim 1), the method being performed by a computer (at claim 11), and a computer-readable non-transitory storage medium storing a program for causing a computer to perform the same or similar activities (at claim 12). These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
The Examiner suggests, in order to consider this a practical application, that the independent claims be amended to indicate that the calculated similarity, calculated cost, and calculated relative position account for, or adjust for, movement of a patient and/or bed during administration of radiation treatment. This would appear to make the claims analogous to Thales and in the particular treatment and prophylaxis arena related to practical application analysis.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as currently phrased, the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirai et al. (WO 2018/051557 A1; hereinafter Hirai).
Claim 1: Hirai discloses a medical image processing device comprising:
a first image acquirer configured to acquire a first image which is captured by imaging an internal body of a patient (see Hirai at least at, e.g., ¶ 0010, “a medical image processing apparatus of an embodiment may include, but is not limited to, include a first image acquirer, a second image acquirer, a path acquirer, and a searcher. The first image acquirer acquires a three-dimensional first image of an object to be treated. The second image acquirer acquires a three-dimensional second image of the object to treated, captured at a time different from the first image”; citation hereafter by number only) ;
a second image acquirer configured to acquire a second image which is captured by imaging the internal body of the patient at a time point different from that of the first image (0010, “a medical image processing apparatus of an embodiment may include, but is not limited to, include a first image acquirer, a second image acquirer, a path acquirer, and a searcher. The first image acquirer acquires a three-dimensional first image of an object to be treated. The second image acquirer acquires a three-dimensional second image of the object to treated, captured at a time different from the first image”);
an area acquirer configured to acquire two or more areas corresponding to one or both of the first image and the second image (4:22-5:3, “The path acquirer acquires the path of a radio beam set in the first image. The searcher, based on first integrated values of the integrated pixel values of the three-dimensional first pixels through which the radiation path passes within the first image and on second integrated values of the integrated pixel values of the three-dimensional second pixels through which the path corresponding to the radiation path within the second image passes”);
an image similarity calculator configured to calculate a similarity between the first image and the second image (0037, “The comparator 122 compares the first integrated image and the second integrated image output from the integrated image calculator 121 and outputs information indicating the comparison result to the determiner 123”);
a cost calculator configured to calculate a cost based on a positional relationship between the areas (0010, “outputs a movement amount signal that indicates an amount of movement of the second image to adjust the position of the object to be treated appearing in the second image to the position of the object to be treated appearing in the first image”); and
a registrator configured to calculate a relative position of the first image with respect to the second image to increase the similarity and to decrease the cost (0020, “the medical image processing apparatus 100 outputs information for adjustment of the position of a lesion or tissue within the body of the patient P to be treated by radiotherapy. The processing in the medical image processing apparatus 100 to position the lesion or tissue is performed based on a CT image of the patient P captured before performing radiotherapy such as at the treatment planning stage and a current CT image of the patient P output from the CT imaging apparatus 12.”, 0021, “When this is done, the medical image processing apparatus 100, after virtually moving the position of the lesion or tissue in the body of the patient P, determines the tissue on the path of the treatment beam B to reach the lesion. That is, the medical image processing apparatus 100 determines whether or not there is coincidence of the tissue in the body of the patient P on the path (radiation path) through which the treatment beam B passes. This is to give notification of whether or not the amount of energy that is lost by the radiated treatment beam B passing through the tissue in the body of the patient P (the energy loss amount) is within an allowed range with respect to the energy loss amount calculated at the treatment planning stage”).
Claim 2: Hirai discloses the medical image processing device according to claim 1, wherein the registrator comprises: an approximate image calculator configured to calculate an approximate image which is generated by misaligning the first image by a predetermined width for each degree of freedom in which a posture of the patient changes (0162, “Given this, the user interface 330 generates one or a plurality of cross-sectional images corresponding to the first integrated image and the second integrated image and displays them on the display device. When this is done, the user interface 330, in order to facilitate viewing of a comparison of the first integrated image and the second integrated image, displays difference images of each of the cross-sectional images. The user interface 330 may make a color map display, applying colors in accordance with the size of the difference values of the cross-sectional images. The user interface 330 may also make an overlaid display of the outline of the PTV or PRV. The user interface 330 may also display as information the cost function value for each of the PTV and PRV. By doing this, the user can verify the cross-sectional images of the first integrated image and the second integrated image and can determine the offset between the first integrated image and the second integrated image’); and
a movement cost calculator configured to move the area by a predetermined width for each degree of freedom in which the posture of the patient changes and to calculate a change in cost from the area before movement as a movement cost (0162, “Given this, the user interface 330 … may also display as information the cost function value for each of the PTV and PRV. By doing this, the user can verify the cross-sectional images of the first integrated image and the second integrated image and can determine the offset between the first integrated image and the second integrated image”), and
wherein the registrator determines an amount of movement of the first image on a basis of an amount of misalignment between the first image and the second image using the approximate image and an amount of misalignment calculated from the movement cost and outputs a movement amount signal corresponding to the determined amount of movement (0010, “outputs a movement amount signal that indicates an amount of movement of the second image to adjust the position of the object to be treated appearing in the second image to the position of the object to be treated appearing in the first image”).
Claim 3: Hirai discloses the medical image processing device according to claim 1, further comprising an image converter configured to acquire the first image and the second image as integral images by converting an image of the internal body of the patient on a basis of an irradiation route of a treatment beam with which the patient is irradiated (0023, “.The medical image processing apparatus 100 shown in FIG. 2 has a first image acquirer 101, a second image acquirer 102, a path acquirer 110, and a searcher 120. The searcher 120 has an integrated image calculator 121”)
Claim 4: Hirai discloses the medical image processing device according to claim 1, wherein the cost is a value based on an area or a volume of a non-overlap part between the two or more areas (0162, “Given this, the user interface 330 … displays difference images of each of the cross-sectional images. The user interface 330 may make a color map display, applying colors in accordance with the size of the difference values of the cross-sectional images. The user interface 330 may also make an overlaid display of the outline of the PTV or PRV. The user interface 330 may also display as information the cost function value for each of the PTV and PRV. By doing this, the user can verify the cross-sectional images of the first integrated image and the second integrated image and can determine the offset between the first integrated image and the second integrated image”).
Claim 5: Hirai discloses the medical image processing device according to claim 4, wherein the cost calculator calculates the cost to increase the cost as the area or the volume of the non-overlap part increases (0096-0099 and Equation 11, with 0143-0144 and Equation15).
Claim 6: Hirai discloses the medical image processing device according to claim 1, wherein the cost is a shortest distance between the two or more areas (0096-0099 and Equation 11, with 0143-0144 and Equation15, where optimizing would be shortest distance).
Claim 7: Hirai discloses the medical image processing device according to claim 1, wherein the two or more areas comprise a first area corresponding to the first image and a second area corresponding to the second image, and the area acquirer acquires the second area by modifying the first area (0010, “outputs a movement amount signal that indicates an amount of movement of the second image to adjust the position of the object to be treated appearing in the second image to the position of the object to be treated appearing in the first image”).
Claim 8: Hirai discloses the medical image processing device according to claim 1, wherein the two or more areas comprise an irradiation field of a treatment beam with which the patient is irradiated (0059, “the energy, radiation direction, and shape of the radiation range of the treatment beam B (radio beam) with which the patient P is irradiated, and the distribution of the dose when the treatment beam B is to be radiated a plurality of times is established”).
Claim 9: Hirai discloses the medical image processing device according to claim 1, wherein the two or more areas comprise a tumor in the internal body of the patient (0059, “first, the proposer of the treatment plan (a physician or the like) specifies, for example, with respect to the CT image (first image) captured at the treatment planning stage, the boundary between the regions of a tumor (lesion) and of normal tissue, and the boundary between the tumor and important organs in the surrounding area. Then, in the treatment planning, based on the depth to the position of the tumor from the surface of the body of the patient P and the size of the tumor, calculated from the information specified regarding the tumor, the intensity, direction (path), and the like of the treatment beam B to be used in irradiation are determined”).
Claim 10: Hirai discloses a treatment system comprising: the medical image processing device according to claim 1; and a treatment device comprising an irradiator configured to irradiate the patient with radiation, an imaging device configured to capture the first image and the second image, a bed on which the patient is loaded and fixed, and a bed controller configured to control movement of the bed in response to a movement amount signal (0010, “a treatment system may, but is not limited to, include a medical image processing apparatus; and a treatment apparatus that includes a ray irradiator radiating the object to be treated with the treatment beam, the radiographic imaging apparatus capturing the first image and the second image, and a treatment bed controller controlling the movement of a treatment bed onto which the object to be treated is placed and fixed, in accordance with the movement amount signal”).
Claims 11 and 12 are rejected on the same basis as claim 1 above since Hirai discloses a medical image processing method that is performed by a computer and a computer-readable non-transitory storage medium storing a program for causing a computer to perform the medical image processing method comprising the same or similar activities as at claim 1 above (see Hirai at least at 0042).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marchant, T. E. et al., Measurement of inter and intra fraction organ motion in radiotherapy using cone beam CT projection images, 2008 Phys. Med. Biol., Vol. 53, No. 4, 1087-1098, DOI 10.1088/0031-9155/53/4/018, downloaded 16 January 2026 from https://pubmed.ncbi.nlm.nih.gov/18263960/, indicating “A method is presented for extraction of intra and inter fraction motion of seeds/markers within the patient from cone beam CT (CBCT) projection images. The position of the marker is determined on each projection image and fitted to a function describing the projection of a fixed point onto the imaging panel at different gantry angles. The fitted parameters provide the mean marker position with respect to the isocentre. Differences between the theoretical function and the actual projected marker positions are used to estimate the range of intra fraction motion and the principal motion axis in the transverse plane. The method was validated using CBCT projection images of a static marker at known locations and of a marker moving with known amplitude. The mean difference between actual and measured motion range was less than 1 mm in all directions, although errors of up to 5 mm were observed when large amplitude motion was present in an orthogonal direction. In these cases it was possible to calculate the range of motion magnitudes consistent with the observed marker trajectory. The method was shown to be feasible using clinical CBCT projections of a pancreas cancer patient.” (at Abstract).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685