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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Republic of Korea on 04/25/2025. It is noted, however, that applicant has not filed a certified copy of the KR10-2022-0141232 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/25/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are: “receiving, by an analysis apparatus, a brain image of a subject; identifying, by the analysis apparatus, a region of interest from the brain image; calculating, by the analysis apparatus, a volume or area of the region of interest; and calculating, by the analysis apparatus, a dementia-related index of the subject on the basis of the volume or area” and “receiving, by an analysis apparatus, a brain image of a subject; identifying, by the analysis apparatus, a region of interest from the brain image; and inputting, by the analysis apparatus, the region of interest into a pre-trained learning model to calculate a dementia-related index of the subject” in claims 1 and 6, respectively. Applicant’s specification at paragraph [0054] defines the analysis apparatus as having forms of a computer device, such as a personal computer (PC), a smart device, a network server, a chipset dedicated to data processing, and the like.
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 § 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, 6, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite “receiving, by an analysis apparatus, a brain image of a subject; identifying, by the analysis apparatus, a region of interest from the brain image; calculating, by the analysis apparatus, a volume or area of the region of interest; and calculating, by the analysis apparatus, a dementia-related index of the subject on the basis of the volume or area”, “inputting, by the analysis apparatus, the region of interest into a pre-trained learning model to calculate a dementia-related index of the subject” and “identify a region of interest from the brain image and calculate a dementia-related index on the basis of the region of interest”, respectively, which are mathematical concepts grouping and mental processes that can be performed in the human mind or by a human using pen and paper. This judicial exception is not integrated into a practical application because the computing device performing the instructions for this process does not add significantly more to the claim itself to overcome the rejection. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the gathering steps required to use the analysis apparatus do not add a meaningful limitation as they are insignificant extra-solution activity.
Claim Rejections - 35 USC § 102
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 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 6, 7, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirota et al. (Pub. No.: WO 2020/218460).
Consider claim 6, Hirota discloses a method of calculating a dementia-related index based on a volume of an extracerebral cerebrospinal fluid region (paragraph [0019], using the volume of each part of the subject's brain, and the degree of atrophy of the subject's brain in determining dementia), the method comprising:
receiving, by an analysis apparatus (paragraph [0004], Fig. 1, guessing/estimation device 20 is composed of a general-purpose computer), a brain image of a subject (paragraph [0006], captured MRI images of the subject's brain is stored in the image management server 30, and is acquired by the estimation device 20 and the diagnosis support device 10);
identifying, by the analysis apparatus, a region of interest from the brain image (paragraph [0003], Fig. 1, diagnostic support device 10 displays the information indicating the region of interest of the brain in the MRI image); and
inputting, by the analysis apparatus, the region of interest into a pre-trained learning model to calculate a dementia-related index of the subject (paragraph [0009], the second acquisition unit 12 acquires information indicating the region of interest of the brain in the image wherein the second acquisition unit 12 may acquire the estimation result of estimating the risk of developing dementia by the subject within a predetermined period based on the image of the brain using the first learned model 21b, see paragraph [0010], Fig. 2),
wherein the region of interest comprises an extracerebral cerebrospinal fluid region (paragraph [0069], the first region R1 of the first image IMG1 indicates a region near the occipital lobe in the whole brain, the second region R2 indicates a region near the frontal lobe, and the third image IMG3 is temporal).
Consider claim 7, Hirota discloses wherein the analysis apparatus identifies the region of interest by inputting the brain image into a pre-trained segmentation model (paragraph [0004], the estimation device 20 estimates the region of interest of the brain in the image on which the estimation result is based, using the trained model).
Consider claim 9, Hirota discloses wherein the region of interest is a subregion comprised in the extracerebral cerebrospinal fluid region, and the subregion comprises at least one of a frontal region, a temporal region, a parietal region, and an occipital region (paragraph [0069], the first region R1 of the first image IMG1 indicates a region near the occipital lobe in the whole brain, the second region R2 indicates a region near the frontal lobe, and the third image IMG3 is temporal).
Consider claim 11, Hirota discloses wherein the analysis apparatus further inputs additional information of the subject to the learning model to calculate the dementia-related index, and the additional information comprises at least one of age, gender, education level, and APOE e4 genotype of the subject (paragraph [0010], the age of the subject, the gender of the subject used to make inferences related to dementia in the subject based on the images).
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 1-5, 8, 10, and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hirota et al. (Pub. No.: WO 2020/218460) in view of Wang et al. (Pub. No.: US 2020/0176120).
Consider claims 1, 12, 15, Hirota discloses a method of calculating a dementia-related index based on a volume of an extracerebral cerebrospinal fluid region (paragraph [0019], using the volume of each part of the subject's brain, and the degree of atrophy of the subject's brain in determining dementia), the method comprising:
receiving, by an analysis apparatus (paragraph [0004], Fig. 1, guessing/estimation device 20 is composed of a general-purpose computer), a brain image of a subject (paragraph [0006], captured MRI images of the subject's brain is stored in the image management server 30, and is acquired by the estimation device 20 and the diagnosis support device 10);
identifying, by the analysis apparatus, a region of interest from the brain image (paragraph [0003], Fig. 1, diagnostic support device 10 displays the information indicating the region of interest of the brain in the MRI image);
calculating, by the analysis apparatus, a volume or area of the region of interest (paragraph [0004], the estimation device 20 estimates the region of interest of the brain in the image wherein the diagnostic support device 10 determines the volume of each region of interest in each region of interest, see Background-Art section);
wherein the region of interest comprises an extracerebral cerebrospinal fluid region (paragraph [0069], the first region R1 of the first image IMG1 indicates a region near the occipital lobe in the whole brain, the second region R2 indicates a region near the frontal lobe, and the third image IMG3 is temporal).
Hirota does not specifically disclose calculating, by the analysis apparatus, a dementia-related index of the subject on the basis of the volume or area.
Wang discloses calculating, by the analysis apparatus, a dementia-related index of the subject on the basis of the volume or area (paragraph [0102], using the volume of the brain area to calculate the atrophy rate).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the analysis apparatus as disclosed by Hirota with the image analysis unit as taught by Wang to determine the atrophy rate (Wang, paragraph [0102]).
Consider claim 2, the combination of Hirota and Wang discloses wherein the dementia-related index comprises at least one of degree of brain atrophy, presence or absence of dementia, and degree of dementia progression (Wang, paragraph [0102], using the volume of the brain area to calculate the atrophy rate).
Consider claims 3, 13, the combination of Hirota and Wang discloses wherein the analysis apparatus identifies the region of interest using a mask produced by preprocessing the brain image (paragraph [0074], the estimation unit 24 generates a plurality of images of the whole brain in which only a part of the first image is different by using a masking the image (e.g., frontal lobe is masked)).
Consider claims 4, 10, Hirota does not specifically disclose wherein the region of interest further comprises a ventricular region, and the ventricular region comprises lateral ventricles.
Wang discloses wherein the region of interest further comprises a ventricular region, and the ventricular region comprises lateral ventricles (paragraph [0085], ventricles left and right lateral ventricles of the cerebral hemisphere).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the analysis apparatus as disclosed by Hirota with the device as taught by Wang to provide for landmarks and feature points of characteristic regions (Wang, paragraph [0085]).
Consider claim 5, the combination of Hirota and Wang discloses wherein the region of interest is a subregion comprised in the extracerebral cerebrospinal fluid region, and the subregion comprises at least one of a frontal region, a temporal region, a parietal region, and an occipital region (paragraph [0069], the first region R1 of the first image IMG1 indicates a region near the occipital lobe in the whole brain, the second region R2 indicates a region near the frontal lobe, and the third image IMG3 is temporal).
Consider claims 8, 17, 19, Hirota does not specifically disclose wherein the region of interest comprises the entire extracerebral cerebrospinal fluid region and a lateral ventricular region.
Wang discloses wherein the region of interest comprises the entire extracerebral cerebrospinal fluid region and a lateral ventricular region (paragraph [0075], Fig. 3, a ventricle and a cavity filled with cerebrospinal fluid (i.e., frontal lobe, parietal lobe, temporal lobe, and occipital lobe, see paragraph [0074]) may be the brain area to include left and right lateral ventricles, see paragraph [0085]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the analysis apparatus as disclosed by Hirota with the device as taught by Wang to provide for landmarks and feature points of characteristic regions (Wang, paragraph [0085]).
Consider claim 14, Hirota discloses wherein the computing device identifies the region of interest by inputting the brain image into a pre-trained segmentation model (paragraph [0004], the estimation device 20 estimates the region of interest of the brain in the image on which the estimation result is based, using the trained model).
Consider claim 16, Hirota discloses wherein the computing device calculates the dementia-related index by inputting the region of interest into a pre-trained learning model (paragraph [0009], the second acquisition unit 12 acquires information indicating the region of interest of the brain in the image wherein the second acquisition unit 12 may acquire the estimation result of estimating the risk of developing dementia by the subject within a predetermined period based on the image of the brain using the first learned model 21b, see paragraph [0010], Fig. 2).
Consider claim 18, Hirota discloses wherein the region of interest is a subregion comprised in the extracerebral cerebrospinal fluid region, and the subregion comprises at least one of a frontal region, a temporal region, a parietal region, and an occipital region (paragraph [0069], the first region R1 of the first image IMG1 indicates a region near the occipital lobe in the whole brain, the second region R2 indicates a region near the frontal lobe, and the third image IMG3 is temporal).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 6 of copending Application No. 19/398,339 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application contains each and every element of the examined application.
The highlighted portions reflect limitation anticipated by the copending application.
Examined Application
Copending Application No. 19/398,339
1. A method of calculating a dementia-related index based on a volume of an extracerebral cerebrospinal fluid region, the method comprising: receiving, by an analysis apparatus, a brain image of a subject; identifying, by the analysis apparatus, a region of interest from the brain image; calculating, by the analysis apparatus, a volume or area of the region of interest; and calculating, by the analysis apparatus, a dementia-related index of the subject on the basis of the volume or area, wherein the region of interest comprises an extracerebral cerebrospinal fluid region.
1. A method of deriving dementia-related information using volume predicted from brain CT, comprising: receiving, by an analysis apparatus, a brain CT (Computed Tomography) image of a subject;
extracting, by the analysis apparatus, regions of interest by inputting the brain CT image into a pre-trained segmentation model;
predicting, by the analysis apparatus, a volume of at least one region among the regions of interest by inputting pixel information of the at least one region into a pre-trained first learning model; and calculating, by the analysis apparatus, dementia-related information of the subject by inputting the volume of the at least one region into a pre-trained second learning model, wherein the regions of interest include a plurality of regions selected from frontal cerebrospinal fluid region, temporal cerebrospinal fluid region, parietal cerebrospinal fluid region, occipital cerebrospinal fluid region, anterior lateral ventricle region, posterior lateral ventricle region, and peri-hippocampal cerebrospinal fluid region.
An analysis apparatus configured to calculate a dementia-related index, the analysis apparatus comprising:
an input device configured to receive a brain image of a subject; and
a computing device configured to identify a region of interest from the brain image and calculate a dementia-related index on the basis of the region of interest, wherein the region of interest comprises an extracerebral cerebrospinal fluid region.
6. An analysis apparatus for deriving dementia-related information using volume predicted from brain CT, comprising:
an interface device for receiving a brain CT (Computed Tomography) image of a subject; a storage device for storing a segmentation model for extracting regions of interest from a brain CT image, a first learning model for receiving brain region of interest information and predicting volume, and a second learning model for calculating dementia-related information; and
a computing device for extracting regions of interest by inputting the received brain CT image into the segmentation model, predicting a volume of at least one region among the regions of interest by inputting pixel information of the at least one region into the first learning model, and calculating dementia-related information of the subject by inputting the volume of the at least one region into the second learning model, wherein the regions of interest include a plurality of regions selected from frontal cerebrospinal fluid region, temporal cerebrospinal fluid region, parietal cerebrospinal fluid region, occipital cerebrospinal fluid region, anterior lateral ventricle region, posterior lateral ventricle region, and peri-hippocampal cerebrospinal fluid region.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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