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 .
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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/306,760, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
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 10 and 17 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.
Here, the claim recites a machine learning algorithm, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “machine learning algorithm” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, How many and what types of layers are there? How is the data propagated? What logics are programmed to help the machine learning algorithm make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts used such as regression? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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 1-20 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 the limitation "the MR images" in Line 4. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the set of MR images’.
Claim 1 recites ‘a cohort of data’ and it is unclear where this data comes from or what the scope of this data is meant to be. For examination purposes it will be interpreted to be demographic data. This similarly applies to claim 11.
Claim 3 recites the limitation "the total number" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the demographics" in Line 9. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the set of demographic data’.
Claim 9 recites ‘a class, an age, a gender, and an education level’ and it is unclear who this is of.
Claim 10 recites ‘biomarker metrics’ and is dependent back to claim 1 which recites ‘a biomarker metric’ making it unclear if each recitation refers to the same element or not.
Claim 10 recites ‘neurodegenerative disease states’ and is dependent back to claim 1 which recites ‘a neurodegenerative disease state’ making it unclear if each recitation refers to the same element or not.
Claim 11 recites ‘cohort of data’ and is dependent back to claim 1 which recites ‘a cohort of data’ making it unclear if each recitation refers to the same element or not.
Claim 13 recites ‘a computer system’ and is dependent back to claim 1 which recites ‘at least one computing device’ making it unclear how the two structures are meant to be related.
Claim 14 recites ‘at least one computing device’ after reciting ‘a computing device’ making it unclear if they are meant to refer to the same element or not.
Claim 14 recites the limitation "the MR images" in Line 5. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the set of MR images’.
Claim 14 recites ‘a cohort of data’ and it is unclear where this data comes from or what the scope of this data is meant to be. For examination purposes it will be interpreted to be demographic data.
Claim 15 recites the limitation "the total number" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the possible pairwise comparisons" in Lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites ‘which when executed by a process’ and it is unclear what this is meant to mean. For examination purposes it will be treated as ‘which when executed by the processor’.
Claim 17 recites ‘a computing device’ and is dependent back to claim 14 which recites the same making it unclear if each recitation refers to the same element or not.
Claim 18 recites ‘which when executed by a process’ and it is unclear what this is meant to mean. For examination purposes it will be treated as ‘which when executed by the processor’.
Claim 18 recites ‘a computing device’ and is dependent back to claim 14 which recites the same making it unclear if each recitation refers to the same element or not.
Claim 19 recites the limitation "the demographics" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the set of demographic data’.
Claim 19 recites ‘a class, an age, a gender, and an education level’ and it is unclear who this is of.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a system (claims 13-20) and a method (claims 1-12).
Step 2A, Prong One
Regarding claims 1 and 14 the recited steps are directed mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Specifically from claim 1:
receiving, from at least one computing device, a set of magnetic resonance (MR) images related to a brain region;
determining, from the MR images, a volume of the brain region associated with cognitive decline;
determining a benchmark based on a biomarker metric for a neurodegenerative disease, wherein the biomarker metric compares the volume of the brain region to a cohort of data by treating the volume as a vector in n-dimensional space;
generating an assessment score, based on the benchmark, to predict a cognitive state.
Specifically from claim 14:
non-transitory computer readable medium comprising instructions, which when executed by a processor cause a computing device to at least:
receive, from at least one computing device, a set of magnetic resonance (MR) images related to a brain region;
determine, from the MR images, a volume of the brain region associated with cognitive decline;
determine a benchmark based on a biomarker metric for a neurodegenerative disease, wherein the biomarker metric compares the volume of the brain region to a cohort of data by treating the volume as a vector in n-dimensional space; and
generate an assessment score, based on the benchmark, to predict a cognitive state.
These underlined limitations above describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Step 2A, Prong Two
This judicial exceptions (abstract ideas) in claims 1-20 are not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for performing the abstract ideas merely invoke a computer as a tool.
•The data-gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for performing the abstract ideas
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer to perform the abstract ideas. The claims do not apply the obtained measurements to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Step 2B
The additional elements are identified as follows: ‘at least one computing device’ in claim 1, ‘a machine learning algorithm’ in claim 10, ‘a computing system’ in claim 13, ‘a processor’ in claim 13, ‘a memory’ in claim 13, ‘a non-transitory computer readable medium’ in claim 14, ‘a processor’ in claim 14, ‘a computing device’ in claim 14, ‘at least one computing device’ in claim 14, ‘a computing device’ in claims 17-18, ‘a machine learning algorithm’ in claim 17.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant's specification (Paragraphs 0170-0178) which discloses that the processor and memory comprise generic computer components that are configured to perform the generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose each of the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 13 recites additional elements at a high level of generality which are conventional in the art
Claims 2-12 and 15-20 are steps that are also abstract as a mental process through additional data gathering or analysis
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
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.
Claim(s) 1, 4-9, 11-14, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray et al. (US 2019/0355439).
Regarding claim 1, Murray teaches a method (Abstract), comprising:
receiving, from at least one computing device, a set of magnetic resonance (MR) images related to a brain region (Figure 1; 114; Paragraphs 0097-0098 and 0104);
determining, from the MR images, a volume of the brain region associated with cognitive decline (Paragraphs 0072 and 0115);
determining a benchmark based on a biomarker metric for a neurodegenerative disease (Paragraphs 0073-0074), wherein the biomarker metric compares the volume of the brain region to a cohort of data by treating the volume as a vector in n-dimensional space (Paragraphs 0073-0074 and 0104);
generating an assessment score, based on the benchmark, to predict a cognitive state (Paragraphs 0065-0066).
Regarding claim 4, Murray teaches wherein the brain region is at least one of a cortical region and a sub-cortical region (Paragraph 0115).
Regarding claim 5, Murray teaches wherein the biomarker metric is adjusted hippocampal volume (AHV) (Paragraphs 0072-0074 and 0115).
Regarding claim 6, Murray teaches wherein the cognitive state is at least one of cognitively normal (CN), mild cognitive impairment (MCI), or Alzheimer’s Disease (AD) (Paragraphs 0065-0066 and 0083).
Regarding claim 7, Murray teaches further comprising determining a severity level, based on a second biomarker, when the cognitive state is indicative of Alzheimer’s Disease (AD) (Paragraphs 0034, 0075, and 0083).
Regarding claim 8, Murray teaches wherein the cohort of data comprises a set of demographic data (Paragraph 0104).
Regarding claim 9, Murray teaches wherein the demographics include at least one of a class, an age, a gender, and an education level (Paragraphs 0082 and 0211).
Regarding claim 11, Murray teaches wherein determining the benchmark further comprises applying a distance metric to the biomarker metric and cohort of data (Paragraphs 0065-0066, 0072-0075, 0104, and 0115).
Regarding claim 12, Murray teaches wherein the distance metric comprises at least one of a Euclidean metric, a Hausdorff metric, and a Frechet metric (Paragraphs 0115 and 0155).
Regarding claim 13, Murray teaches a computing system, comprising a processor and a memory storing instructions that, when executed by the processor, causes the computing system to execute the method of claim 1 (Paragraphs 0066 and 0177; see rejection of claim 1 above).
Regarding claim 14, Murray teaches non-transitory computer readable medium comprising instructions, which when executed by a processor cause a computing device (Abstract; Paragraphs 0066 and 0177) to at least:
receive, from at least one computing device, a set of magnetic resonance (MR) images related to a brain region (Figure 1; 114; Paragraphs 0097-0098 and 0104);
determine, from the MR images, a volume of the brain region associated with cognitive decline (Paragraphs 0072 and 0115);
determine a benchmark based on a biomarker metric for a neurodegenerative disease (Paragraphs 0073-0074), wherein the biomarker metric compares the volume of the brain region to a cohort of data by treating the volume as a vector in n-dimensional space (Paragraphs 0073-0074 and 0104); and
generate an assessment score, based on the benchmark, to predict a cognitive state (Paragraphs 0065-0066).
Regarding claim 18, Murray teaches further comprising instructions, which when executed by a process, cause a computing device to determine the benchmark further comprises applying a distance metric to the biomarker metric and cohort of data, wherein the distance metric comprises at least one of a Euclidean metric, a Hausdorff metric, and a Frechet metric (Paragraphs 0065-0066, 0072-0075, 0104, 0115, and 0155).
Regarding claim 19, Murray teaches wherein the cohort of data comprises a set of demographic data, and wherein the demographics include at least one of a class, an age, a gender, and an education level (Paragraphs 0082, 0104, and 0211).
Regarding claim 20, Murray teaches wherein the brain region is at least one of a cortical region and a sub-cortical region (Paragraph 0115).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2019/0355439) in view of Wadayama et al. (Item 4 on IDS filed 09/04/2024).
Regarding claim 2, Murray teaches the biomarker metric being computed based on a Euclidean distance (Paragraph 0155) but is silent on a Z-weight Euclidean distance. Wadayama teaches a Z-weighted Euclidean distance (ZWE), according to: ZWE=∑i=1NR=[(wiT–wiS)zi]2 (Section 3.1, Page 3). It would have been obvious to one of ordinary skill in the art to have modified Murray with Wadayama because it would provide an efficient implementation of the algorithm for computing the Euclidean/Hamming joint weight distributions (Page 2, Top of 1st column of Wadayama).
Regarding claim 15, Murray teaches the biomarker metric being computed based on a Euclidean distance (Paragraph 0155) but is silent on a Z-weight Euclidean distance. Wadayama teaches wherein the biomarker metric is computed based on a Z-weighted Euclidean distance (ZWE), according to: ZWE=∑i=1NR=[(wiT–wiS)zi]2, where zi refers to an average of z-transformed p-value across possible pairwise comparisons for a given region, i, and NR denotes the total number of regions (Section 3.1, Page 3). It would have been obvious to one of ordinary skill in the art to have modified Murray with Wadayama because it would provide an efficient implementation of the algorithm for computing the Euclidean/Hamming joint weight distributions (Page 2, Top of 1st column of Wadayama).
Claim(s) 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2019/0355439) in view of Wadayama et al. (Item 4 on IDS filed 09/04/2024) and in further view of Arzy (US 2019/0167179).
Regarding claim 3, Murray is silent on a Z-weight Euclidean distance and the pairwise comparisons. Wadayama teaches wherein zi refers to an average of z-transformed p-value across possible pairwise comparisons for a given region, i, and NR denotes the total number of regions (Section 3.1, Page 3), and
Arzy teaches wherein the possible pairwise comparisons include cognitively normal versus mild cognitive impairment, cognitively normal versus Alzheimer’s Disease, and mild cognitive impairment versus Alzheimer’s Disease (Paragraph 0098 and 0101).
It would have been obvious to one of ordinary skill in the art to have modified Murray with Wadayama because it would provide an efficient implementation of the algorithm for computing the Euclidean/Hamming joint weight distributions (Page 2, Top of 1st column of Wadayama).
It would have been obvious to one of ordinary skill in the art to have modified Murray with Arzy because it allows for identifying cognitive deterioration before significant impairment to the brain occurs and can allow users to maintain orientation based on their digital footprint and assessment (Paragraph 0013 of Arzy).
Regarding claim 16, Murray is silent on the pairwise comparisons. Arzy teaches wherein the possible pairwise comparisons include cognitively normal versus mild cognitive impairment, cognitively normal versus Alzheimer’s Disease, and mild cognitive impairment versus Alzheimer’s Disease (Paragraph 0098 and 0101). It would have been obvious to one of ordinary skill in the art to have modified Murray with Arzy because it allows for identifying cognitive deterioration before significant impairment to the brain occurs and can allow users to maintain orientation based on their digital footprint and assessment (Paragraph 0013 of Arzy).
Claim(s) 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2019/0355439) in view of Arroyo-Gallego et al. (US 2021/0236044).
Regarding claim 10, Murray is silent on the machine learning algorithm. Arroyo-Gallego teaches wherein determining the benchmark comprises applying a machine learning algorithm trained on associations between biomarker metrics and neurodegenerative disease states (Paragraph 0159; Figure 10). It would have been obvious to one of ordinary skill in the art to have modified Murray with Arroyo-Gallego because it would allow for the assessing of the presence, severity or probability of, or a change in, one or more diseases and allow proper treatment (Paragraph 0012-0013 of Arroyo-Gallego).
Regarding claim 17, Murray is silent on the machine learning algorithm. Arroyo-Gallego teaches further comprising instructions, which when executed by a process, cause a computing device to: apply a machine learning algorithm trained on associations between biomarker metrics and neurodegenerative disease states (Paragraph 0159; Figure 10). It would have been obvious to one of ordinary skill in the art to have modified Murray with Arroyo-Gallego because it would allow for the assessing of the presence, severity or probability of, or a change in, one or more diseases and allow proper treatment (Paragraph 0012-0013 of Arroyo-Gallego).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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