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 06 August 2025 has been entered. Claim(s) 1 remain pending in the application; claims 2, 13, 17, and 23 are canceled. Applicant’s amendments and arguments have overcome each and every rejection under 35 U.S.C. 103 previously applied in the office action dated 26 February 2025.
In particular, 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”.
In review of the claims it was determined that a rejection under 35 U.S.C. 101 was missed. As such, prosecution is reopened and the rejection is presented below.
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) "a first grading criteria for handwriting impairment that defines symptoms of at least one adverse event selected from the group consisting of: micrographia, dysgraphia, and agraphia; wherein the first grading criteria for handwriting impairment defines the symptoms of at least two grades of severity of the 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; and a second grading criteria 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; wherein each of the first and second grading criteria define symptoms of at least one adverse event". 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 "a first grading criteria for handwriting impairment that defines symptoms of at least one adverse event selected from the group consisting of: micrographia, dysgraphia, and agraphia; wherein the first grading criteria for handwriting impairment defines the symptoms of at least two grades of severity of the 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; and a second grading criteria 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; wherein each of the first and second grading criteria define symptoms of at least one adverse event" are abstract ideas as they are directed to a mental process or method of organizing human activity. 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 “wherein the first and second grading criteria are stored in a non-transitory computer-readable medium”. Regarding “the first and second grading criteria 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 additional limitation of “wherein the first and second grading criteria are stored in a non-transitory computer-readable medium” 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, which Chin (US 20210057106 A1) describes as well-understood, routine, or conventional in its description of a “information handling system may include random access memory (RAM), one or more processing resources such as a central processing unit (CPU) or hardware or software control logic, ROM, and/or other types of nonvolatile memory” (Paragraph 0036-037) and “The computer-usable or computer-readable medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device. More specific examples (a non-exhaustive list) of the computer-readable medium would include the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a portable compact disc read-only memory (CD-ROM), an optical storage device, or a magnetic storage device. In the context of this document, a computer-usable or computer-readable medium may be any medium that can contain, store, communicate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device” (Paragraph 0152).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.
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 direct toward a mental process or method of organizing human activity. 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.
Conclusion
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
Prosecution Insights