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 .
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1-17 are directed to statutory subject matter as the claim(s) recite(s) a method of evaluating neurocognitive function.
Step 2A, Prong One
Claim 1 recites the following steps or instructions for “collecting data…” and “using the data to generate a report…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III).
For example, the limitations concern data collection and generating a report based on data analysis and are nothing more than a medical professional making an analysis report based on observed data previously recorded or provided, which could be done mentally or by hand with pen and paper.
Accordingly, the above-identified claim recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong Two
The above-identified abstract idea in independent Claim 1 (and dependent claims 2-17) is not integrated into a practical application under MPEP 2106.04(d) because the there are no additional elements that alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) with no other elements required. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and dependent claims 2-17) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 1 (and dependent claims 2-17) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claim 1 (and dependent claims 2-17) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05 and claims 1-17 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Royall et al. (US 2013/0224117; hereinafter “Royall”).
Regarding claim 1, Royall teaches a method of evaluating neurocognitive function in at least one patient suspected of having or diagnosed with a neurodegenerative disease comprising, collecting data that indicates an ability of the at least one patient to complete a plurality of toileting tasks (e.g. ¶¶ 125 – “…ability to toilet (ADL1)…”); and using the data to generate a report that describes a neurocognitive function in the at least one patient, thereby using the plurality of the toileting tasks as nontraditional surrogate measures of the neurocognitive function in the at least one patient (e.g. ¶¶ 5 – “…the method results in a latent variable or score, "d" (dementia-relevant variance in cognitive task performance), that represents only a small fraction of the total variance in observed cognitive task performance, yet is associated with clinicians' assessments of dementia status and severity.”; ¶¶ 189 – with respect to neurocognitive function in a patient with Alzheimer’s disease).
Regarding claim 2, Royall discloses the step of collecting the data comprises collecting a first data set at a first time, and collecting a second data set at a second time, wherein the second data set indicates an ability of the at least one patient to complete the plurality of the toileting tasks at the second time, wherein the second time is at least two months after the first time, and wherein the step of using the data to generate a report comprises indicating a progression of the neurodegenerative disease in the at least one patient based on a comparison of the first data set and the second data set (e.g. ¶¶ 151-153, 163 – “latent hybrid variables generated by our method are not only strong predictors of an individual's current clinical diagnosis or status, but they can be used in second order analytical processes to estimate their rates of change in time”).
Regarding claim 3, Royall discloses the at least one patient comprises a first patient population, wherein the step of collecting the data comprises collecting a first data set, and wherein the method further comprises before collecting the first data set, administering a therapy to the first patient population, wherein the step of using the data to generate a report comprises indicating effectiveness of the therapy based on comparing the first data set to a second data for a control patient population, wherein the second data set indicates an ability of the control patient population to complete the plurality of the toileting tasks, wherein the control patient population includes patients suspected of having or diagnosed with the neurodegenerative disease, and wherein the control patient population has not received the therapy (e.g. ¶¶ 65-67, 76-78, 216 – where the control population is used in generating the report).
Regarding claim 17, Royall discloses the therapy comprises enzyme replacement, gene therapy, gene editing, a fusion protein, substrate reduction therapy, or a chaperone molecule (e.g. ¶¶ 95 – where the drug treatment is based on substrate reduction therapy when treating neurodegenerative diseases).
Regarding claim 4, Royall discloses the neurodegenerative disease comprises a lysosomal storage disease, Alzheimer's disease, Parkinson's disease, Huntington's disease, prion disease, or Lewy body disease (e.g. ¶¶ 8, 13, 18, etc.).
Regarding claim 5, Royall discloses the neurodegenerative disease comprises a lysosomal storage disease comprising a mucopolysaccharidosis, in particular mucopolysaccharidosis type II (MPS II) (e.g. ¶¶ 8, 13, 18, etc. – where the examiner notes that MPSII is recognized and treated in the same manner as Alzheimer’s or dementia as it is only different in that it affects younger patients).
Regarding claim 6, Royall discloses the plurality of the toileting tasks comprises at least two, at least three, at least four, at least five, at least six, or all of: initiate washing hands after using a toilet, initiate wiping after using the toilet, indicate during or after having a bowel movement, indicate before having to urinate, indicate before having a bowel movement, indicate during or after urinating, sit on the toilet when placed for at least 1 minute (e.g. ¶¶ 125 – where toileting would include both urination and bowel movements).
Regarding claim 7, Royall discloses the plurality of the toileting tasks comprises both of (a) initiate washing hands after using the toilet and (f) wash hands independently after using the toilet, or both of (b) initiate wiping after using the toilet and (g) wipe poop effectively by self (e.g. ¶¶ 125 – where these tasks are recognized in the art to fall under the general umbrella of toileting).
Regarding claim 8, Royall discloses the step of collecting the data comprises observing a patient while the patient completes a plurality of toileting tasks and assigning a score for each toileting task, where the score indicates the ability of the patient to complete the task (e.g. ¶¶ 125 – Likert scale).
Regarding claim 9, Royall discloses the step of collecting the data comprises receiving the data from the at least one patient, a caregiver, or a healthcare provider; or receiving the data from an individual or entity that received the data from the at least one patient, the caregiver, or the healthcare provider; or receiving the data from an individual or entity that receives, compiles, and/or stores health information related to a plurality of patients (e.g. ¶¶ 125 – “caregiver rated”).
Regarding claim 10, Royall discloses the step of collecting the data comprises receiving an individual numerical score for each individual patient and for each toileting task of the plurality of the toileting tasks or receiving data derived from one or more of the individual numerical scores, wherein each individual numerical score indicates an ability of the individual patient to complete the toileting task (e.g. ¶¶ 125 – Likert scale).
Regarding claim 11, Royall discloses the individual numerical scores comprise scores of from 1 to 3 on a Likert scale (e.g. ¶¶ 125).
Regarding claim 12, Royall discloses the step of using the data to generate a report comprises indicating a Toileting Abilities Percentage ("TAP") to represent one or more of the individual numerical scores as a percentage of a highest possible score (e.g. ¶¶ 125).
Regarding claim 13, Royall discloses administering a therapy to the at least one patient after collecting the first data set at the first time and before collecting the second data set at the second time (e.g. ¶¶ 95).
Regarding claim 15, Royall discloses the step of collecting the data further comprises collecting a third data set from the at least one patient at a third time, wherein the third data set indicates an ability of the at least one patient to complete a plurality of toileting tasks at the third time, wherein the third time is at least two months after the second time, and wherein the step of using the data to generate a report that describes the neurocognitive function in the at least one patient comprises indicating the progression of the neurodegenerative disease in the at least one patient based on a comparison of the first data set, the second data set, and the third data set (e.g. ¶¶ 159 – where the analysis is based on continuous data over the span of 3 years).
Regarding claims 14 and 16, Royall discloses the second time is about three months, about six months, about nine months, or about a year after the first time, wherein the third time is about three months, about six months, about nine months, or about a year after the second time (e.g. ¶¶ 159 – where the analysis is based on continuous data over the span of 3 years).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796