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 .
Response to Arguments
Claim Objections
Applicant’s arguments, see remarks and amended claim set, filed 9/17/25, with respect to the objection to claim 16 have been fully considered and are persuasive. The objection to claim 16 has been withdrawn.
Rejections under 35 U.S.C. 112(a)
Applicant's arguments filed 9/17/25 have been fully considered but they are not persuasive.
MPEP 2163.02 provides the standard for determining compliance with the written description requirement as follows:
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).
Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). (emphasis added).
Applicant first points to the disclosure in paragraph [0018] of the specification which lists a series of pharmaceutical products which can be used as a treatment regimen for multiple sclerosis. Remarks, P.6. The Office does not dispute that the applicant’s specification provides written description for several pharmaceutical products which can be used to treat multiple sclerosis. Rather the Office set forth on P.3-4 of the Non-Final Rejection of 3/17/25 that there is no disclosure of
the manner or means by which the treatment regimen is determined, let alone any written description of the means or manner by which the treatment regimen may be determined from the output and diagnosis of MS;
the manner or means by which the updated treatment regimen is determined based on progression of MS;
the manner or means by which progression of MS in response to a previous treatment is obtained let alone the manner or means by which the AFN model output indicates such; or
the manner or means by which the treatment regimen is determined, let alone the manner or means by which the treatment regimen may be determined from the duration of MS in the subject.
Applicant’s citation to paragraph [0018] does not “describe[e] the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Paragraph [0018] fails to disclose any means or manner by which the treatment regimen is determined from the AFN model output, diagnosis, progression, response to treatment, or duration of MS. Thus, paragraph [0018] fails to provide sufficient written description for the claim invention with all of its limitations.
Applicant next points to the disclosure in paragraph [0077] of the specification which describes the output may be a report “includ[ing] information on the last treatment regimen and if the treatment regimen has affected the progression or degree of MS in the patient.” Remarks, P.7The Office does not dispute that the applicant’s specification provides written description for the output/report including information on the last treatment regimen and its effect on progress or degree of MS. Rather the Office set forth on P.3-4 of the Non-Final Rejection of 3/17/25 that there is no disclosure of
the manner or means by which the updated treatment regimen is determined based on progression of MS; or
the manner or means by which progression of MS in response to a previous treatment is obtained let alone the manner or means by which the AFN model output indicates such.
Applicant’s citation to paragraph [0077] does not “describe[e] the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Paragraph [0077] fails to disclose any means or manner by which the updated treatment region is determined based on the progression of MS or any means or manner by which the progression information is obtained let alone that the AFN model output provides such information. Thus, paragraph [0077] fails to provide sufficient written description for the claim invention with all of its limitations.
Applicant further alleges that a PHOSITA would be able to fill the gaps to get from the AFN model output to determining a treatment regimen or an effectiveness of a treatment regimen. Remarks, P.7. Applicant presents mere arguments of counsel to support applicant’s contentions that the specification conveys with reasonable clarity to one having ordinary skill in the art as of the filing date sought that the applicant was in possession of the invention as now claimed. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." Ergo, as applicant has not presented evidence in the record to support applicant’s contentions, applicant’s arguments are unpersuasive.
Moreover, applicant’s specification does not “describe[e] the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” The absence of any disclosure connecting the AFN model output to the determination of the treatment regimen or an effectiveness of a treatment regimen would demonstrate to a PHOSITA that the applicant was not in possession of the claimed invention as of the effective filing date. Thus, applicant’s specification fails to provide sufficient written description for the claim invention with all of its limitations.
Furthermore, applicant’s assertion that a PHOSITA would understand that the determination involves using one or more of the pharmaceutical products based on the AFN model (Remarks, P.7) does not answer the question of the means or manner by which the determination of which of the one or more pharmaceutical products is performed let alone how the determination is made based on the AFN model let alone in conjunction with the current or past history of a subject. A PHOSITA would not be informed that the applicant was in possession of the means or manner by which the determination is made based on the AFN model upon review of applicant’s disclosure as the applicant’s disclosure is silent as to any means or manner of making the determination. In arguendo, even accepting the premise that a PHOSITA understands that determining a treatment regimen involves selecting one or more pharmaceutical products for treatment, applicant’s disclosure fails to inform the PHOSITA that the applicant had possession of a means or manner by which to select one or more pharmaceutical products for treatment based on an AFN model as of the effective filing date of the claimed invention. Thus, applicant’s specification fails to provide sufficient written description for the claim invention with all of its limitations.
Applicant further argues that a PHOSITA would be capable of creating a machine learning algorithm to perform automated diagnosis. Remarks, P.7. As an initial matter, applicant presents mere arguments of counsel to support applicant’s contentions that the specification conveys with reasonable clarity to one having ordinary skill in the art as of the filing date sought that the applicant was in possession of the invention as now claimed. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." Ergo, as applicant has not presented evidence in the record to support applicant’s contentions, applicant’s arguments are unpersuasive.
Furthermore, machine learning is not recited in the claimed invention. Moreover, the specification does not provide any disclosure that machine learning is employed as a means or manner by which the AFN model output is used to determine a treatment regimen or an effectiveness of a treatment regimen. Instead, applicant broadly asserts that a PHOSITA is capable of creating a machine learning algorithm to fill the gap to get from the AFN model output to the determination of a treatment regimen or an effectiveness of a treatment regimen. This is insufficient to demonstrate possession of the claimed invention as possession asks whether the applicant has “describe[d] the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” As discussed above, applicant has not provided any means or manner let alone a machine learning algorithm that bridges the gap between the AFN model output and determining a treatment regimen or an effectiveness of a treatment regimen. In arguendo, even accepting the premise that a PHOSITA is capable of creating such a machine learning algorithm, applicant’s disclosure fails to inform the PHOSITA that the applicant had possession of such a machine learning algorithm as of the effective filing date of the claimed invention. Thus, applicant’s specification fails to provide sufficient written description for the claim invention with all of its limitations.
Rejections under 35 U.S.C. 101
Applicant argues that the amendment to claim 1, lines 8-10 to recite “the AFN model comprising nodes defined by regions of grey matter atrophy in MS, and edges defined by healthy functional connectivity involving the nodes of the regions of grey matter atrophy in MS” is sufficient to distinguish the AFN model from the knowledge of a trained clinician. Remarks, P.8 and 9-10. As detailed in infra rejection, the BRI of these limitations requires a mathematical calculation. Namely, an arithmetic calculation (parcellation of MRI data of the brain into nodes defined by regions of grey matter atrophy and the calculation of functional connectivity edges by calculating the pairwise Pearson’s correlation coefficient between parcels) is required to generate an AFN model. These limitations hence recites a “mathematical calculation” and so falls in to the “mathematical concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2), subsection I.C. These limitations also fall into the “mental process” grouping because they require an assessment of the input rsfMRI data using the generated AFN model in order to provide a diagnosis of multiple sclerosis. Moreover, the recited mathematical calculation is simple enough that it can be practically performed in the human mind. Even if most humans would use a physical aid, like a pen and paper or a calculator, to make such calculations, the use of a physical aid would not negate the mental nature of this limitation. See MPEP 2106.04(a)(2), subsection III.B.
Further, in so far as applicant is asserting that the newly introduced limitation of “computing, by a processor using the AGN model, and output based on the preprocessed input” in claim 1, lines 11-12 requires the use of a processor (Remarks, P.8), the processor is recited at a high level of generality. The processor is used to perform an abstract idea, applying the AFN model to input rsfMRI data to create an output for diagnosis of MS, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f).
Further, in so far as applicant is asserting that the receiving and preprocessing of the input rsfMRI data in claim 1, lines 4-6, and the output of from the AFN model evaluation in claim 1, line 11, provides features that are significantly more than the judicial exception, as detailed in the Non-Final Rejection of 3/17/25, P.5 and infra rejections, the receiving and preprocessing of the input rsfMRI data and the output from the AFN model evaluation recites the extra-solutionary activity of mere necessary data gathering and output in that receiving and preprocessing of the rsfMRI data and output of the AFN evaluation is required for all uses of the recited abstract idea such that the functional connectivity and structural T1-weighed image data maps are available for review by the clinician/model for the diagnosis determination and subsequent use. As all uses of the recited judicial exceptions require such data gathering and output, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and output. See MPEP 2106.05.
The recitation of “using the AFN model” in claim 1, line 1 also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using the AFN model” limits the identified judicial exceptions “computing an output based on the preprocessed input; and based on the output, providing a diagnosis,” this type of limitation merely confines the use of the abstract idea to a particular technological environment (functional network models) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Applicant further argues that “the independent claims 1, 8, and 16 improve the functioning of a computer (i.e., processing MRI data with AFN model for computing diagnostic output).” Remarks, P.10. Applicant merely restates the abstract idea of applying the AFN model to the input rsfMRI data to create an output for diagnosis. Applicant does not point to an improvement to computer capabilities in the claim, but rather to the abstract idea itself. As stated in MPEP 2106.05(a) “It is important to note, the judicial exception alone cannot provide the improvement.” In so far as applicant is asserting that the improvement is the use of a processor to implement the abstract idea (“processing… for computing”). As set forth in MPEP 2106.05(a), subsection I., merely invoking computers as a tool to implement the abstract idea is not sufficient to establish an improvement in the functioning of a computer. As discussed above, the processor is recited at a high level of generality and is used to perform the abstract idea, applying the AFN model to input rsfMRI data to create an output for diagnosis of MS, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f).
Therefore, applicant’s arguments are not persuasive.
Rejections under 35 U.S.C. 103
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As detailed in infra rejections, claims 1-7 are rejected as being unpatentable over Chiang in further view of Hong; claims 8-15 are rejected as being unpatentable over Chiang in further view of Hong in further view of Tsukimoto; and claims 16-20 are rejected as being unpatentable over Chiang in further view of Hong in further view of Tsukimoto.
Information Disclosure Statement
Applicant is reminded of their duty to disclose all information known to be material to patentability to the Office. The inventors have a significant amount of undisclosed publication history in the fields of MRI, activation likelihood estimation, meta-analysis modeling, structural equation modeling, and brain disorders that predate the effective filing date of the claimed invention that have not been disclosed to the Office.
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 5, 8-15, and 16-20 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.
Claim 5 recites determining and transmitting a treatment regimen to a user that is based on the output and diagnosis of MS. A review of the originally filed specification, drawings, and claims does not provide sufficient written description to a PHOSITA that the inventors had possession of the claimed invention. The present application does not provide any written description of the manner or means by which the treatment regimen is determined, let alone any written description of the means or manner by which the treatment regimen may be determined from the output and diagnosis of MS.
Similar limitations are recited in claim 8, lines 15-16. For substantially the same reasons as above the present application does not provide sufficient written description.
Claims 8-13 are rejected as depending from claim 8.
Claim 14 recites to update a previously determined treatment regimen and transmitting the updated treatment regimen to a user based on progression of MS in the subject. A review of the originally filed specification, drawings, and claims does not provide sufficient written description to a PHOSITA that the inventors had possession of the claimed invention. The present application does not provide any written description of the manner or means by which the treatment regimen is determined, let alone any written description of the means or manner by which the treatment regimen may be determined from the output and diagnosis of MS. Furthermore, the present application does not provide any written description of the manner or means by which the updated treatment regimen is determined based on progression of MS.
Claim 15 recites the output indicates progression of MS in response to a previous treatment regimen. A review of the originally filed specification, drawings, and claims does not provide sufficient written description to a PHOSITA that the inventors had possession of the claimed invention. The present application does not provide any written description of the manner or means by which progression of MS in response to a previous treatment is obtained let alone the manner or means by which the AFN model output indicates such.
Claim 16, lines 10-12 recites to determine a treatment regimen based on the duration of MS in the subject and to transmit the treatment regimen to a user. A review of the originally filed specification, drawings, and claims does not provide sufficient written description to a PHOSITA that the inventors had possession of the claimed invention. The present application does not provide any written description of the manner or means by which the treatment regimen is determined, let alone the manner or means by which the treatment regimen may be determined from the duration of MS in the subject
Claims 17-20 are rejected as depending from claim 16.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations of claim 19 overlap with those of claim 16, lines 4-8. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 being illustrative:
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act of diagnosing and addressing multiple sclerosis. Thus, the claim is a process, which is a statutory category of invention. (Step 1: YES).
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 1, lines 7-12 recites “applying the preprocessed input to an atrophy-based functional network (AFN) model… computing… using the AFN model, an output based on the preprocessed input; and based on the output providing a diagnosis of MS in response to presence of altered functional connectivity involving localized brain regions in the subject based on the application of the application of the preprocessed input to the AFN model.” Under its broadest reasonable interpretation consistent with the specification, the plain and ordinary meaning of this limitation requires an evaluation of whether a subject has multiple sclerosis by applying an AFN model to the subject’s rsfMRI data. The AFN model as recited encompasses a trained clinician that reviews BOLD rsfMRI data including connectivity maps thereof of the rsfMRI data and determines whether the provided rsfMRI data including connectivity maps thereof reflect that the imaged subject has multiple sclerosis or not. In other words, the claim encompasses a clinician reviewing rsfMRI image and connectivity information of a subject’s brain and diagnosing the subject with MS. As this step requires an evaluation of the patient’s connectivity data, this limitation falls into the “mental process” grouping of abstract ideas because the evaluation can be practically performed in the human mind.
Claim 1, lines 8-10 recite “the AFN model comprising nodes defined by regions of grey matter atrophy in MS, and edges defined by healthy functional connectivity involving the nodes of the regions of grey matter atrophy in MS.” Under its BRI these limitations requires a mathematical calculation. Namely, an arithmetic calculation (parcellation of MRI data of the brain into nodes defined by regions of grey matter atrophy and the calculation of functional connectivity edges by calculating the pairwise Pearson’s correlation coefficient between parcels) is required to generate an AFN model. These limitations hence recites a “mathematical calculation” and so falls in to the “mathematical concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2), subsection I.C. These limitations also fall into the “mental process” grouping because they require an assessment of the input rsfMRI data using the generated AFN model in order to provide a diagnosis of multiple sclerosis. Moreover, the recited mathematical calculation is simple enough that it can be practically performed in the human mind. Even if most humans would use a physical aid, like a pen and paper or a calculator, to make such calculations, the use of a physical aid would not negate the mental nature of this limitation. See MPEP 2106.04(a)(2), subsection III.B.
Additionally, claim 1, lines 4-6 recite “preprocessing the input via one or more of motion correction, B0 warping, slice timing correction, and spatial smoothing to thereby form a preprocessed input including gradient-echo fieldmap data of the rsfMRI data or T1-weighted data.” Motion correction (alignment/registration), B0 warping (transformation), slice timing correction (shifting), and spatial smoothing (filtering) are mathematical operations. Therefore, these limitations recite a “mathematical calculation” and so falls in to the “mathematical concepts” grouping of abstract ideas.
As there are no bright lines between the types of judicial exceptions, and many of the concepts identified by the courts as exceptions can fall under several exceptions, MPEP 2106.04, subsection I instructs examiners to “identify . . . the claimed concept (the specific claim limitation(s) that the examiner believes may recite an exception) [that] aligns with at least one judicial exception.” While the limitations of claim 1, lines 4-15 can be categorized under several exceptions (a mathematical concept-type abstract idea and a mental process-type abstract idea), it is adequate for an examiner to identify the limitation as falling under at least one judicial exception and to base further analysis on that identification. The remainder of this discussion is premised on the recited exception as an abstract idea. See MPEP 2106.04, subsection II.B. (Step 2A, Prong One: YES).
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
The preamble, line 1, to the claim recites the additional element of “[a] method for diagnosing and addressing multiple sclerosis (MS).” This preamble merely provides the diagnosis made in lines 7-15 to the relevant audience (such as a physician or another medical professional) and at most adds a suggestion to take that diagnosis into account in addressing multiple sclerosis. The preamble may thus be understood as no more than an attempt to generally link the judicial exception to a field of use. See MPEP 2106.05(h). Therefore, the preamble fails to meaningfully limit the claim because it does not require any particular application of the abstract idea and therefore amounts only to a generic instruction to “apply” the exception or to a mere indication of the field of use or technological environment in which the abstract idea is performed.
The claim recites the additional element of “acquiring an input including functional MRI (rsfMRI) data, of a brain of a subject” in line 3. The additional element of “acquiring” rsfMRI data is an insignificant extra-solution activity that amounts to mere data gathering incidental to the abstract idea recited in claim 1, lines 7-15.
The additional element of “preprocessing the input… to thereby form a preprocessed input” recited in claim 1, lines 4-6. The additional element of “preprocessing” input rsfMRI data is an insignificant extra-solution activity that amounts to mere data gathering incidental to the abstract idea recited in claim 1, lines 7-15.
The additional element of “computing an output” in claim 1, line 11 are mere necessary output recited at a high level of generality, and thus is insignificant extra-solution activity.
The receiving and preprocessing of the input rsfMRI data and output of the evaluation using the AFN model recites the extra-solutionary activity of mere necessary data gathering and output in that receiving and preprocessing of the rsfMRI data and output of the AFN model evaluation is required for all uses of the recited abstract idea such that the functional connectivity and structural T1-weighed image data maps are available for review by the clinician/model for the diagnosis determination and the result of the determination being output for further use. As all uses of the recited judicial exceptions require such data gathering and output, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and output. See MPEP 2106.05.
The claim recites the additional element of “computing, by a processor using the AFN model, and output based on the preprocessed input” in claim 1, lines 11-12. The processor is recited at a high level of generality. The processor is used to perform an abstract idea, applying the AFN model to input rsfMRI data to create an output for diagnosis of MS, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f).
The recitation of “using the AFN model” in claim 1, line 1 also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using the AFN model” limits the identified judicial exceptions “computing an output based on the preprocessed input; and based on the output, providing a diagnosis,” this type of limitation merely confines the use of the abstract idea to a particular technological environment (functional network models) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
While the disclosure states that invention “enables per-patient quantification of functional network-based disease burden in MS” (applicant’s specification paragraph [0008]) there is no improvement to the functioning of a computer nor to any other technology. At best, the claimed combination amounts to an improvement to the abstract idea of determining whether a subject has MS which may be performed by a clinician rather than to any technology. See MPEP 2106.05(a). Thus, even when considering the elements in combination, the claim as a whole does not integrate the recited exception into a practical application. (Step 2A, Prong Two: NO). Thus, claim 1 is directed to a judicial exception. (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole 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. MPEP 2106.05.
These additional elements should be re-evaluated in Step 2B, in which the extra-solution activity consideration takes into account whether or not an extra-solution activity is well-known.
The preamble fails to meaningfully limit the claim because it does not require any particular application of the abstract idea and therefore amounts only to a generic instruction to “apply” the exception or to a mere indication of the field of use or technological environment in which the abstract idea is performed.
The data gathering activities claim 1, lines 3-6 and the output in claim 1, lines 11-13 are recited at a high level of generality. These elements amount to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II.
The additional element of “using the AFN model” in claim 1, line 11 is at best mere instruction to “apply” the abstract ideas, which cannot provide an inventive concept. See MPEP 2106.05(f).
The recitation of a processor to perform the limitations of claim 1, lines 11-12 amounts to no more than mere instructions to apply the exception using a generic computer component.
Consequently, for the reasons discussed above, the additional elements individually or in combination with the judicial exception do not provide an inventive concept; so, the claim as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception. (Step 2B: NO). The claim is not eligible.
Regarding independent claim 8, the features not addressed below are addressed as above for claim 1. Independent claim 8, lines 21-22 further recites “[to] determine a treatment regimen or treatment effectiveness corresponding to the output for the subject.” This limitation fall into the “mental process” grouping because they require an assessment of the input rsfMRI data using the generated AFN model in order to provide a treatment or treatment effectiveness assessment for multiple sclerosis.
Further, although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated or what the treatment is, but instead covers any possible treatment that a medical professional decides to administer to the patient. As such, there are no meaningful constraints on the administering step such that the particular treatment or prophylaxis consideration would apply because it is not limited to any particular manner or type of treatment. See MPEP 2106.04(d)(2). Moreover, like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012), the claim merely provides the output made in claim 8, lines 17-20 to the relevant audience (such as a physician or another medical professional) and at most adds a suggestion to take that output into account when treating patients. Claim 8, lines 17-20 may thus be understood as no more than an attempt to generally link the judicial exception to a field of use. See MPEP 2106.05(h). Therefore, claim 8, lines 17-20 fails to meaningfully limit the claim because it does not require any particular application of the abstract idea and therefore amounts only to a generic instruction to “apply” the exception or to a mere indication of the field of use or technological environment in which the abstract idea is performed.
The preamble, lines 1-2, to claim 8 recites the additional element of “[a] system to select a treatment regimen for diagnosing and addressing multiple sclerosis (MS) of a subject.” This preamble merely provides the treatment and diagnosis made in lines 13-22 to the relevant audience (such as a physician or another medical professional) and at most adds a suggestion to take that diagnosis into account in addressing multiple sclerosis and its treatment. The preamble may thus be understood as no more than an attempt to generally link the judicial exception to a field of use. See MPEP 2106.05(h). Therefore, the preamble fails to meaningfully limit the claim because it does not require any particular application of the abstract idea and therefore amounts only to a generic instruction to “apply” the exception or to a mere indication of the field of use or technological environment in which the abstract idea is performed.
Claim 8, lines 2-3 further recite that the input of rsfMRI data is provided by “a magnetic resonance imaging (MRI) device.” The additional element of providing rsfMRI data from an MRI device is an insignificant extra-solution activity that amounts to mere data gathering incidental to the abstract idea.
Claim 8, lines 5-8 further recite “a Network-based Functional Imaging Output in Multiple Sclerosis (NETFIO-MS) device connected to and in signal communication with the MRI device,
wherein the NETFIO-MS device is configured to: receive the input from the MRI device.” The NETFIO-MS device is a processor recited at a high level of generality. The processor is used to perform an abstract idea, applying the AFN model to received input rsfMRI data to create an output for diagnosis of MS and treatment or evaluation of treatment effectiveness of MS, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f).
Claim 8, lines 23-24 further recite “[to] transmit the output and the treatment regimen or the treatment effectiveness to a user.” These are mere necessary output recited at a high level of generality, and thus is insignificant extra-solution activity.
The receiving and preprocessing of the input rsfMRI data and output of the evaluation using the AFN model recites the extra-solutionary activity of mere necessary data gathering and output in that receiving and preprocessing of the rsfMRI data and output of the AFN model evaluation is required for all uses of the recited abstract idea such that the functional connectivity and structural T1-weighed image data maps are available for review by the clinician/model for the diagnosis determination and the result of the determination being output for further use. As all uses of the recited judicial exceptions require such data gathering and output, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and output. See MPEP 2106.05.
Further, the data gathering activities claim 8, lines 3-12, and the outputs in claim 8, lines 18-20 and 23-24 are recited at a high level of generality. These elements amount to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II.
Therefore, the claim is not eligibles.
Regarding independent claim 16, the features not addressed below are addressed as above for claims 1 or 8. Independent claim 16 further recites “[a] non-transitory machine-readable storage medium storing processor-executable instructions that, when executed by at least one processor, cause the at least one processor to.” The non-transitory machine-readable storage medium and processor are recited at a high level of generality. The storage medium and processor are used to perform an abstract idea, applying the AFN model to input rsfMRI data to create an output for diagnosis and determination of treatment or treatment effectiveness of MS, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f).
Turning to the dependent claims:
Claim 2 merely specifies that the clinician/model incorporates a review/knowledge of regions of the brain likely to experience atrophy and, therefore, altered functional connectivity in subjects suffering from MS from a meta-analysis, i.e., a review/read of other publications and data, of MS subjects and healthy controls.
Claim 3 recites the abstract ideas of the mathematical concept and the mental process (aided by pen and paper) of model fitting using the RMSEA equation, i.e., removing consideration of the connectivity of regions of the brain that have too large of a magnitude of deviation from the mean in deciding whether the subject has MS.
Claim 4 recites the abstract ideas of the mathematical concept and the mental process (aided by pen and paper) of model fitting using structural equation modeling edge weights, i.e., removing consideration of the connectivity of regions of the brain that are insignificant or confounding in deciding whether the subject has MS.
Claim 5 recites the abstract idea of the mental process (aided by pen and paper) of clinician decision making in selecting a treatment regimen based on whether the clinician has determined that the subject has MS.
Claim 6 merely recites the extra-solutionary activity of necessary data gathering using a MRI device.
Claim 7 merely recites the extra-solutionary activity of necessary data gathering using a user interface and/or the mental process (aided by pen and paper) of a user interacting with a user interface.
Claim 9 merely specifies the technological field of the extra-solutionary activity of necessary data gathering to be BOLD signal imaging.
Claim 10 merely specifies that a generic processor and storage medium for storing software to automate the mathematical concepts and mental process (aided by pen and paper) of a clinician determining the treatment regimen based on acquired rsFMRI data.
Claim 11 merely specifies that the clinician/model incorporates a review/knowledge of regions of the brain likely to experience atrophy and, therefore, altered functional connectivity in subjects suffering from MS from a review/read of other publications and data of MS subjects and healthy controls.
Claim 12 recites the abstract idea of the mental process (aided by pen and paper) of a clinician/model being trained/informed from the literature such that the clinician/model can determine which nodes/regions of the brain from the rsfMRI data have connectivity that indicate MS or potential for development of MS.
Claim 13 recites the extra-solutionary activity of outputting the gathered rsfMRI data as well as labels of the regions of interest and connectivity from the rsfMRI data.
Claim 14 recites the abstract idea of the mental process (aided by pen and paper) of a clinician/model using the output of the gathered rsfMRI data to determine and track the progression of MS in a subject and the clinican/model determining whether any updates to a treatment regimen previously determined by the clinician/model are needed.
Claim 15 recites the abstract idea of the mental process (aided by pen and paper) of a clinican/model using the output of the gathered rsfMRI data to determine whether MS has progressed after a previous treatment regimen.
Claim 17 recites the abstract ideas of the mathematical concept and the mental process (aided by pen and paper) of model fitting using structural equation modeling model fit including path correlations/edges, i.e., removing consideration of the connectivity of regions of the brain that are insignificant or confounding in deciding whether the subject has MS.
Claim 18 recites the abstract ideas of the mathematical concept and the mental process (aided by pen and paper) of model fitting using the RMSEA equation, i.e., removing consideration of the connectivity of regions of the brain that have too large of a magnitude of deviation from the mean in deciding whether the subject has MS.
Claim 19 recites the extra-solutionary activity of necessary data gathering involving preprocessing the gathered rsfMRI data and the abstract idea of the clinician/model reviewing the gathered and preprocessed rsfMRI data.
Claim 20 merely specifies the technological field of the extra-solutionary activity of necessary data gathering to be BOLD signal imaging.
Therefore, claim 1-20 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang et al. (“Localised grey matter atrophy in multiple sclerosis is network-based: a coordinate-based meta-analysis” 2019), hereinafter “Chiang,” in further view of Hong et al. (“A connectome-based mechanistic model of focal cortical dysplasia” 2019), hereinafter “Hong.”
Regarding claim 1, Chiang discloses a method for diagnosing and addressing multiple sclerosis (MS) (the meta-analytic model is used as markers for diagnosis and monitoring treatment response in multiple sclerosis and presented to the clinician for decisionmaking, P.e19, P.e20, ¶4-5, P.e26, ¶3-4, P. e27, ¶2-3; see also visualizations of atrophy, connectivity, and co-activation in Figs.2-4b including applying the node-and-edge model to predict disease-related changes in resting-state fMRI), the method comprising:
acquiring an input including functional MRI (rsfMRI) data, of a brain of a subject (acquire an input including resting-state fMRI data, P.e20, ¶4-5, P.e26, ¶3-4);
applying the input to an atrophy-based functional network (AFN) model (disease-specific functional network model that models multiple sclerosis atrophy applied to resting state fMRI data, P.e20, ¶4-5), the AFN model comprising nodes defined by regions of grey matter atrophy in MS, and edges defined by healthy functional connectivity involving the nodes of the regions of grey matter atrophy in MS (the disease-specific functional network model comprises nodes defined by regions of grey matter atrophy in MS, and edges defined by healthy functional connectivity involving the nodes of the regions of grey matter atrophy in MS, P.e20, ¶4-5, P.e21, ¶4 – P.e22, ¶4, Table 1, P.e24, ¶2 – P.e25, ¶6, Table 2, Figs. 4a-4b, P.e26, ¶3-4);
computing, by a processor (software implemented on a computer processor including BrainMap Sleuth software, P.e20, ¶7, GingerALE software, P.e21, ¶4, MANGO software, P.e22, ¶4, and BrainNet Viewer software, P.e25, ¶1) using the AFN model, an output based on the input (the meta-analytic model is applied to rsfMRI data to evaluate markers for diagnosis and monitoring treatment response in multiple sclerosis and presented to the clinician for decisionmaking, P.e19, P.e20, ¶4-5, P.e26, ¶3-4, P. e27, ¶2-3; see also visualizations of atrophy, connectivity, and co-activation in Figs.2-4b including applying the node-and-edge model to predict disease-related changes in resting-state fMRI); and
based on the output, providing a diagnosis of MS in response to presence of altered functional connectivity involving localized brain regions in the subject based on the application of the input to the AFN model (the meta-analytic model is applied to rsFMRI data to evaluate markers for diagnosis and monitoring treatment response in multiple sclerosis and presented to the clinician for decisionmaking, P.e19, P.e20, ¶4-5, P.e26,