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 Amendment
The amendment filed 13 March 2026 has been entered. Claim(s) 1 remain pending in the application.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1, 4-11, 14-15, and 18-21 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "(v) a handwriting impairment grade, wherein the handwriting impairment grade is determined by comparing the baseline handwriting sample to the subsequent handwriting sample and determining a handwriting impairment grade according to a grading criteria for handwriting impairment, wherein the grading criteria for handwriting impairment defines symptoms of at least one adverse event selected from the group consisting of: micrographia, dysgraphia, and agraphia, and wherein the grading criteria for handwriting impairment defines the symptoms of at least two grades of severity of the at least one adverse event, comprising: a first grade defined as mildly smaller or slower writing or difficulty in completing a writing task from baseline, but most words are legible; and a second grade defined as moderate to severely smaller or slower writing or difficulty in completing a writing task from baseline, and most words are illegible;(vi) an impairment grade for the second symptom domain, wherein the impairment grade for the second symptom domain is determined by comparing the baseline sample for the second symptom domain to the subsequent sample for the second symptom domain, and determining an impairment grade for the second symptom domain according to a grading criteria for the second symptom domain, wherein the grading criteria for the second symptom domain defines symptoms of at least one adverse event for the second symptom domain". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "(v) a handwriting impairment grade, wherein the handwriting impairment grade is determined by comparing the baseline handwriting sample to the subsequent handwriting sample and determining a handwriting impairment grade according to a grading criteria for handwriting impairment, wherein the grading criteria for handwriting impairment defines symptoms of at least one adverse event selected from the group consisting of: micrographia, dysgraphia, and agraphia, and wherein the grading criteria for handwriting impairment defines the symptoms of at least two grades of severity of the at least one adverse event, comprising: a first grade defined as mildly smaller or slower writing or difficulty in completing a writing task from baseline, but most words are legible; and a second grade defined as moderate to severely smaller or slower writing or difficulty in completing a writing task from baseline, and most words are illegible;(vi) an impairment grade for the second symptom domain, wherein the impairment grade for the second symptom domain is determined by comparing the baseline sample for the second symptom domain to the subsequent sample for the second symptom domain, and determining an impairment grade for the second symptom domain according to a grading criteria for the second symptom domain, wherein the grading criteria for the second symptom domain defines symptoms of at least one adverse event for the second symptom domain" are abstract ideas as they are directed to a mental process or method of organizing human activity, as the actions of comparing and determining a grade may be performed in the human mind and the remaining limitations describing the grades serve simply as guidelines for how a person should mentally observe data and make the noted mental comparison. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “(i) a baseline handwriting sample;(ii) a baseline sample for a second symptom domain, wherein the second symptom domain is selected from the group consisting of: gait impairment; other movement abnormalities of extremities; impairment in an ability to perform self-care activities of daily living; and impairment in expression or motivation;(iii) a subsequent handwriting sample, wherein the subsequent handwriting sample is obtained after administration of the anti-BCMA CAR T-cell therapy;(iv) a subsequent sample for the second symptom domain, wherein the subsequent sample for the second symptom domain is obtained after administration of the anti-BCMA CAR T-cell therapy” and “wherein the baseline handwriting sample, the baseline sample for the second symptom domain, the subsequent handwriting sample, the subsequent sample for the second symptom domain, the grading criteria for handwriting impairment, and the grading criteria for the second symptom domain are stored in a non-transitory computer- readable medium”. However, these sample elements may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The various samples acquired lead ultimately to the limitation of “determining” a grade such that the end result of use of the system is only the generic determined grade which may be any generic output, or no output at all. As this grade determination is not defined as requiring any further action, such as an improvement to a computer or other technology or a form of prophylaxis or treatment such as performing a particular intervention upon determination of a particular grade, the claim limitations constitute mere generation of data, in this case handwriting and second symptom domain samples, such that the claim does not integrate the judicial exception into any practical application. See also the example of MPEP 2106.04(d)(2) which describes a claim reciting administering vaccines to cats followed by analyzing information about the vaccine schedules and observing the vaccinated animals for developing immune disorders, wherein the administration step serves as extra-solution activity; the instant claims follow a similar fact pattern of providing data (writing and second domain samples) which is a necessary precursor for all uses of the recited exception, as the comparisons and observations cannot be performed without data to observe and compare. Regarding the elements which are “stored in a non-transitory computer-readable medium”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The described claimed system may be seen as a method of organizing human activity in line with the examples giving in MPEP 2106.04(a)(2)(II)(C), which refers to managing personal interactions between people such as following rules or instructions in line with example iii. which refers to “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”. As the criteria are used by a human assessor to determine a toxicity grade, the claimed system may be seen as a system for following rules or instructions. Furthermore, the inclusion of storing the criteria in a non-transitory computer readable medium as with the examples of MPEP 2106.04(a)(2)(III)(A)-(C), merely uses a computer as a tool to perform a mental process, which is not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Furthermore, while the abstract idea itself may be an improvement over the existing technology such as other systems of grading toxicity, per Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable abstract idea itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered abstract idea cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. For this reason, the abstract limitations may not be seen as an improvement which integrates the judicial exception into a practical application. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner including visually observing a subject) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites the additional elements “(i) a baseline handwriting sample;(ii) a baseline sample for a second symptom domain, wherein the second symptom domain is selected from the group consisting of: gait impairment; other movement abnormalities of extremities; impairment in an ability to perform self-care activities of daily living; and impairment in expression or motivation;(iii) a subsequent handwriting sample, wherein the subsequent handwriting sample is obtained after administration of the anti-BCMA CAR T-cell therapy;(iv) a subsequent sample for the second symptom domain, wherein the subsequent sample for the second symptom domain is obtained after administration of the anti-BCMA CAR T-cell therapy” and “wherein the baseline handwriting sample, the baseline sample for the second symptom domain, the subsequent handwriting sample, the subsequent sample for the second symptom domain, the grading criteria for handwriting impairment, and the grading criteria for the second symptom domain are stored in a non-transitory computer- readable medium”. The additional limitations constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic non-transitory memory and patient samples, which Pullman (US 6454706 B1) describes as well-understood, routine, or conventional in its description of extensive prior art observing changes in writing and motor samples of patients having various disorders (Col. 2, line 37-Col. 4, line 16) and commercially available computer and tablet devices including memory (Col. 7, line 7-Col. 8, line 20). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 14 and 18 are rejected for similar reasons, where administering the anti-BCMA CAR T-cell therapy is additionally seen as extra-solution activity directed toward mere data gathering as it is a necessary precursor for all uses of the recited exception.
Claims 4-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 6 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1, claims 4-11 merely recite further limitations which are themselves abstract ideas directed toward a mental process or method of organizing human activity, as each claim recites further details describing the grades and thus serves simply as additional guidelines for how a person should mentally observe data and make the noted mental comparison of the independent claim. The claim elements of claims 4-11 are recited with a high level of generality (as written, the criteria may be known or used to grade a toxicity by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Claims 15 and 19-21 are rejected for similar reasons.
Response to Arguments
Applicant's arguments filed 13 March 2026 have been fully considered but they are not persuasive.
The newly added limitations relating to the collection of baseline and subsequent tests before/after administration of anti-BCMA CAR T therapy, as well as the administration of the therapy itself to permit evaluation of the user before and after therapy, may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The various samples acquired lead ultimately to the limitation of “determining” a grade such that the end result of use of the system is only the generic determined grade which may be any generic output, or no output at all. As this grade determination is not defined as requiring any further action, such as an improvement to a computer or other technology or a form of prophylaxis or treatment such as performing a particular intervention upon determination of a particular grade, the claim limitations constitute mere generation of data, in this case handwriting and second symptom domain samples, such that the claim does not integrate the judicial exception into any practical application.
See also the example of MPEP 2106.04(d)(2) which describes a claim reciting administering vaccines to cats followed by analyzing information about the vaccine schedules and observing the vaccinated animals for developing immune disorders, wherein the administration step serves as extra-solution activity; the instant claims follow a similar fact pattern of providing a therapy (administering the anti-BCMA CAR T therapy) and related data (writing and second domain samples) which are each a necessary precursor for all uses of the recited exception, as the comparisons and observations to evaluate a user response to the therapy cannot be performed without the claimed data to observe and compare. As a result, the limitations cited by the applicant cannot be seen to incorporate the abstract idea into a practical application.
Furthermore, while the claimed systems and methods may produce an output in the form of a grade, the claims at present provide no indication that the grade is used for a particular treatment or prophylaxis, for example altering administration doses or timing or providing some alternative treatment, rather than merely providing the grade to indicate the current state of a patient.
Conclusion
The claims are not rejected under 35 U.S.C. 102/103. As noted previously, the prior art of the record fails to disclose and/or fairly suggest, in combination with all other recited limitations “a system for assessing neurologic toxicity in a subject associated with an anti-BCMA CAR T-cell therapy, wherein the neurologic toxicity occurs after cytokine release syndrome (CRS) and immune effector cell- associated neurotoxicity syndrome (ICANS) resolution”.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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