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 .
Status of Claims
Claims 15, 17, and 19, as recited in an RCE filed on September 12, 2025, were previously pending and subject to a non-final office action filed on October 6, 2025 (the “October 6, 2025 Non-Final Office Action”). On March 6, 2026, Applicant submitted amendments to claims 15 (the “March 6, 2026 Amendment”). As such, claims 15, 17, and 19, as recited in the March 6, 2026 Amendment, are currently pending and subject to the final office action below.
Response to Applicant’s Amendments and Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 112(a)
Applicant’s arguments, see Applicant’s Remarks/Arguments, p. 4, Claim Rejections under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), First Paragraph Section, filed March 6, 2026, with respect to rejections of claims 15, 17, and 19 under 35 U.S.C. § 112(a) have been fully considered, but they are not persuasive. Specifically, Applicant has amended the claims to clarify and add the limitations directed to: “comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score”. However, Applicant’s specification is silent on this limitation and does not mention (i) comparing the DepE score of an AD patient to a DepE score to a subject without Alzheimer’s Disease, or (ii) comparing the DepE score of an AD patient to a DepE score of the AD patient at a prior time point, in order to determine an increase in the DepE score. If the Applicant believes that there is written description support in the specification, the Examiner asks the Applicant to identify the specific paragraph numbers, language, and/or drawings that provide written description support for this limitation. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 112(a) Section below, for further clarification and complete analysis.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 112(b)
Applicant’s arguments, see Applicant’s Remarks/Arguments, pp. 4-5, Claim Rejections under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), Second Paragraph Section, filed March 6, 2026, with respect to rejections of claims 15, 17, and 19 under 35 U.S.C. § 112(b) have been considered, but they are moot in light of Applicant’s amendments to the claims. Specifically, Applicant amended the claims to overcome the lack of antecedent basis issue identified in the October 6, 2026 Final Office Action by clarifying that the term AD in the claims is referring to Alzheimer’s Disease. As such, the rejections under 35 U.S.C. § 112(b) for lack of antecedent basis are no longer necessary and are withdrawn.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks/Arguments, p. 5, Claim Rejections under 35 U.S.C. § 101 Section, filed March 6, 2026, with respect to the rejections of claims 15, 17, and 19 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance, (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 15, 17, and 19 are updated and maintained in this final office action.
First, Applicant asserts the claims now “amount to significantly more than the judicial exception by claiming with particularity ‘administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor…, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram.’” See Applicants Applicant’s Remarks/Arguments, at p. 5. Examiner respectfully disagrees. This argument is and limitation is similar to what was addressed in a previous office action. See pp. 4-8 of the October 6, 2025 Final Office Action. When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity. See MPEP § 2106.05(d)(I). Despite Applicant’s arguments, the claims do not recite the administration of unconventional treatment/activity. In the present case, the claims recite treatments that are well-understood, routine, and conventional for patients with Alzheimer’s Disease and depression and generally links the judicial exception to the field of treatments for Alzheimer’s Disease and depression.
For example, prior art publications appear to indicate that the step of “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” is well-understood, routine, and conventional. Specifically, Sepehry et al., Effect of Selective Serotonin Reuptake Inhibitors in Alzheimer’s Disease with Comorbid Depression: A Meta-Analysis of Depression and Cognitive Outcomes, Drugs & Aging 29, 793–806 (2012), https://doi.org/10.1007/s40266-012-0012-5 (hereinafter referred to as Sepehry), generally teaches that “pharmacotherapeutic guidelines for treating depression in [patients with] AD recommend that a pharmacological treatment with minimal and least severe adverse effects be used as a first-line approach”, where “[t]he treatments of choice are selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, paroxetine and sertraline (i.e., this disclosure explicitly teaches that selective serotonin reuptake inhibitors is a desired, first-line treatment for patients with Alzheimer’s Disease and Depression). See Sepehry, p. 794, Column 1 under Section 1.2 Pharmacotherapy for AD and Depression. Therefore, administering a selective serotonin reuptake inhibitor to patients with Alzheimer’s Disease and depression represents well-understood, routine, and conventional activity. For these reasons, this argument is not persuasive.
Next, Applicant argues that the claims recite a specific treatment tied to the increase in the DepE score in which specific active agents are provided in an amount that lowers the DepE score and improves cognitive function. See Applicant’s Remarks, at p. 5. Examiner respectfully disagrees. This argument was already made and addressed in previous office actions. See pp. 5-7 of the October 6, 2026 Non-Final Office Action; pp. 3-6 of the Final Office Action, filed June 12, 2025; pp. 3-5 of the Non-Final Office Action, filed January 27, 2025; pp. 3-5 of the Final Office Action, filed October 19, 2023. Again, this limitation is deemed to be an additional element, but it does not amount to integrating the abstract idea into a practical application by affecting a particular treatment or prophylaxis. When determining whether a claim applies or uses a recited judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant: (1) the particularity or generality of the treatment or prophylaxis; (2) whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s); and (3) whether the Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use. See MPEP § 2106.04(d)(2).
In analyzing the first factor, treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). See MPEP § 2106.04(d)(2). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. Id. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). Id. The claim also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” Id. This administration step is particular, and it integrates the mental analysis step into a practical application. Id. Conversely, consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” Id. This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Id. Thus, the administration step does not integrate the mental analysis step into a practical application. Id.
In the present case, Applicant’s claims have not described a particular treatment or prophylaxis. Specifically, Applicant’s claims recite “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram”. However, this recitation is not deemed to be “a particular treatment”, because Applicant has not described what amount of the selective serotonin reuptake inhibitors (SSRIs) is deemed to be “sufficient” for lowering a Dep E score and/or improving cognitive function. Where the example claim in § 2106.04(a) related to administering a beta blocker recited that the dosage of the beta blocker was “a lower than normal dosage”, Applicants claims merely recite that the amount of SSRIs is “a sufficient amount”. This description is deemed to be too broad, because it does not give any indication of what kind of dosage is used to treat the patients.
This example demonstrates that the limitation directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” does not describe any description of dosages, durations, and/or frequency of administering the SSRIs. Therefore, under the first factor, Applicant has not described a particular treatment. Rather, Applicant has provided an open-ended list of candidate drugs in a generic manner.
In analyzing the second factor, the treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). See MPEP § 2106.04(d)(2). In the present claims, the step for administering the SSRIs is not sufficiently tied to influencing the DepE score. It seems that the claims are merely trying any amount of an SSRI until the subject’s DepE score (i.e., an increased DepE score which is not well-defined by the claims) goes down. However, as analyzed under the first factor, the administration step does not describe a particular treatment because Applicant has not identified a specific drug, doses, durations, and/or frequencies of the treatment. Applicant has claimed the administration step in a generic manner. Therefore, the administration step is deemed to have a nominal relationship to the abstract idea.
Lastly, in analyzing the third factor, treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. See MPEP § 2106.04(d)(2). In the present case, the step directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” for subjects with an increased DepE score, described in claim 15, is generally linking the abstract idea to the field of an antidepressant treatment. Again, Applicant has not described meaningful limits to the use of the antidepressant, such as (i) identifying a specific antidepressant, (ii) using specific doses for different subjects, or (iii) describing specific durations that the subjects will take the antidepressant. Therefore, Applicant has not imposed meaningful limits on the judicial exception.
As such, the limitation directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” is not indicative of applying or using a recited judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition under Prong Two of Step 2A of the Alice/Mayo Test as described in the 2019 Revised PEG.
Next, Applicant generally asserts that under Prong Two of Step 2A of the Alice/Mayo Test, the claims include limitations that are indicative of integrating an abstract concept into a practical idea, because claim 15 recites limitations that apply or use the judicial exception in a meaningful way beyond generally linking the judicial exception to a particular technological environment “by identifying those subjects that will benefit from a specific treatment in an amount that decreases the DepE score. See Applicants Applicant’s Remarks/Arguments, at p. 4. Examiner respectfully disagrees. This arguments was already made and addressed in a previous office action, where this limitation was deemed to be an additional element, but it does not amount to integrating the abstract idea into a practical application. See pp. 7-8 of the October 6, 2026 Non-Final Office Action; pp. 6-7 of the June 12, 2025 Final Office Action; and pp. 4-5 of the Non-Final Office Action, filed April 9, 2024. Despite Applicant’s assertion, Applicant’s claimed invention is merely linking the abstract idea to the field of antidepressant treatments, namely selective serotonin reuptake inhibitors (SSRIs). Adding the step that subjects with increased DepE scores are administered “a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram”, simply refers to an existing audience of subjects. However, Applicant has not established a link between lowering DepE scores and a specific dosage (e.g., a description of a range of an SSRI that lowers a DepE score to some acceptable number/range) of SSRIs that improves cognitive function. Therefore, this step is not deemed to impose any meaningful limits on the abstract idea.
Therefore, the rejections of claims 15, 17, and 19 under 35 U.S.C. § 101 are maintained in this office action. Please see the amended rejections to claims 15, 17, and 19 under 35 U.S.C. § 101 below, for further clarification and analysis of the claims under the 2019 Revised PEG.
Claim Objections
Claims 15, 17, and 19 are objected to because of the following informalities:
- The term "parotexine" recited in claim 15 should be "paroxetine", because it appears to be referring to the drug that belongs to the class of medications known as selective serotonin reuptake inhibitors (SSRIs).
- Further, the term "escitralopram" recited in claim 15 should be "escitalopram", because it appears to be referring to the drug that belongs to the class of medications known as selective serotonin reuptake inhibitors (SSRIs). Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 15, 17, and 19 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 15 recites:
- "comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score".
Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. See MPEP § 2161.01. However, Applicant has not pointed out where this limitation is supported, nor does there appear to be a written description of this limitation in the specification. The specification lacks sufficient support in the disclosure describing “comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score” in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. Specifically, Applicant's specification is silent on this limitation and does not mention (i) comparing the DepE score of an AD patient to a DepE score to a subject without Alzheimer’s Disease or (ii) comparing the DepE score of an AD patient to a DepE score of the AD patient at a prior time point, to determine an increase in the DepE score. As such, claim 15 is rejected under 35 U.S.C. § 112(a) for failing to comply with the written description requirement.
Claims 17 and 19 (which individually depend on claim 15) are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the written description and enablement requirements for similar reasons as described in the § 112(a) lack of written description and enablement rejections of claim 15 above.
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 15, 17, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 15, 17, and 19 are directed to a method for determining if a drug treats a cognitive dysfunction, which is within one of the four statutory categories (i.e., a process). See MPEP § 2106.03.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: 1) Mathematical Concepts; 2) Certain Methods of Organizing Human Activity, and 3) Mental Processes. See MPEP § 2106.04(a).
Claim 15 is rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claim 15 includes limitations that recite an abstract idea. Specifically, independent claim 15 recites:
A method of treating an Alzheimer’s Disease (AD) patient with a depressive endophenotype (DepE), the method comprising:
generating a DepE score for the AD patient based on data selected from: feeling of worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating, when compared to refence levels in a population or subject without AD, wherein the DepE score is generated by summing the response to feeling worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating;
comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score;
administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mathematical Concepts” grouping of abstract ideas. See § 2106.04(a)(2)(I). The Mathematical Concepts grouping covers concepts which include mathematical relationships, mathematical formulas or equations, and mathematical calculations (i.e., a method for generating a DepE score for an Alzheimer’s Disease (AD) patient based on certain data in a questionnaire by summing up the responses to the questionnaire; and comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score). That is, other than reciting a step for administering one of various types of serotonin reuptake inhibitors (the foregoing limitations in claim 15 which are not underlined), the context of claim 15 encompasses concepts that comprise mathematical relationships, mathematical formulas or equations, and mathematical calculations (i.e., a method for generating a DepE score for an Alzheimer’s Disease (AD) patient based on certain data in a questionnaire by summing up the responses to the questionnaire; and comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score).
The aforementioned claim limitations described in claim 15 are analogous to claim limitations directed toward concepts which comprise mathematical relationships, mathematical formulas or equations, and mathematical calculations, because they merely recite limitations which encompass a person adding up the “yes” response to a five-question questionnaire (i.e., addition is a basic mathematical relationship/calculation); and comparing DepE scores for a patient with Alzheimer’s Disease to a patient without Alzheimer’s Disease in order to determine if there is an increase (i.e., comparing two numbers to see if there is an increase in one of the scores is a basic mathematical relationship/calculation). If a claim limitation, under its broadest reasonable interpretation, covers concepts which include mathematical relationships, mathematical formulas or equations, and mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. See § 2106.04(a)(2)(I). Accordingly, claim 15 recites an abstract idea that falls within the Mathematical Concepts. Examiner notes that the limitations directed to: (1) “generating a DepE score for the AD patient based on data selected from: feeling of worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating, when compared to refence levels in a population or subject without AD, wherein the DepE score is generated by summing the response to feeling worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating”; and (2) “comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score”, recited in claim 15 could also be interpreted as falling within the “Mental Processes” (i.e., concepts performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper) groupings of abstract ideas, because these limitations represent observations, evaluations, judgments and/or opinions of a person mentally and/or manually adding up responses to a questionnaire (i.e., a type of observation, evaluation, judgment, and/or opinion where a person adds up the “yes” responses to a five-question questionnaire and compares two numbers (i.e., the DepE scores) in order to determine if one of the scores increased). If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See § 2106.04(a)(2)(III). Accordingly, claim 15 recites an abstract idea that falls within the Mathematical Concepts and Mental Processes groupings of abstract ideas.
Furthermore, Examiner notes that dependent claim 17 and 19 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 17 and 19 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 17 and 19 merely recite what the changes in the score indicates (i.e., these steps are deemed to be reasonably part of the mathematical concept or mental process, because they still comprise adding up the “yes” responses to the five-question questionnaire and comparing two numbers (i.e., the DepE scores) in order to determine if one of the scores increased).
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP § 2106.05 (f)-(h).
In the present case, for independent claim 15, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method of treating an Alzheimer’s Disease (AD) patient with a depressive endophenotype (DepE), the method comprising:
generating a DepE score for the AD patient based on data selected from: feeling of worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating, when compared to refence levels in a population or subject without AD, wherein the DepE score is generated by summing the response to feeling worse memory problems, feeling downhearted and blue, feeling worthless, frequently feel like crying, and trouble concentrating;
comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score;
administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that this additional element amounts to generally linking the abstract idea to a particular field of use or technological environment as noted below, see MPEP § 2106.05(h); and the Examiner further submits that such steps are not unconventional as they merely consist of immunizing a patient against a disease, as evidenced by the Classen Immunotherapies, Inc. v. Biogen IDEC case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)).
However, the recitation of these generic functions in claim 15 is recited at a high-level of generality (i.e., a method for generating a DepE score for an Alzheimer’s Disease (AD) patient based on certain data in a questionnaire by summing up the responses to the questionnaire; and comparing the DepE score from the AD patient to a DepE score in a subject without Alzheimer’s Disease or to the DepE score from the AD patient at a prior time point to determine an increase in the Dep E score), such that it amounts to no more than: (1) adding insignificant extra-solution activity to the judicial exception; and (2) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(g), (h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of an insignificant extra-solution activity (e.g., see MPEP § 2106.05(g)):
- Example of Mere Data Gathering/Mere Data Outputting:
- Performing clinical tests on individuals to obtain input for an equation, e.g., see In re Grams – similarly, the step directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram”, described in claim 15, is a necessary data gathering/outputting step in order to practice the invention (i.e., providing an antidepressant drug to subjects whose DepE score increased is an insignificant application, because it does not impose meaningful limits on the claim as several drugs, dosages, and other parameters (e.g., duration) could be administered to the patient which fall in the categories of “a selective serotonin reuptake inhibitor to improve cognitive function”).
- The following are examples of generally linking the use of a judicial exception to a particular technological environment or field of use (e.g., see MPEP § 2106.05(h)):
- (1) Specifying that the abstract idea of monitoring audit log data relates to transactions or activities that are executed in a computer environment, because this requirement merely limits the claims to the computer field, i.e., to execution on a generic computer, FairWarning v. Iatric Sys.; (2) Specifying that the abstract idea of using advertising as currency is used on the Internet, because this narrowing limitation is merely an attempt to limit the use of the abstract idea to a particular technological environment, Ultramercial, Inc. v. Hulu; and (3) Requiring that the abstract idea of creating a contractual relationship that guarantees performance of a transaction (a) be performed using a computer that receives and sends information over a network, or (b) be limited to guaranteeing online transactions, because these limitations simply attempted to limit the use of the abstract idea to computer environments, buySAFE Inc. v. Google, Inc. - similarly, the step directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” amounts to limiting the abstract idea to the field of antidepressant treatments, namely selective serotonin reuptake inhibitors – see MPEP 2106.05(h).
Thus, the additional elements in independent claim 15 are not indicative of integrating the judicial exception into a practical application. Further, Examiner notes that dependent claims 17 and 19 do not recite any additional elements beyond the above identified abstract idea. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, the additional elements in claims 15, 17, and 19, when considered as a whole: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP §§ 2106.05(e) and 2106.04(d)(2)). Thus, claims 15, 17, and 19 as a whole do not integrate the above-noted at least one abstract idea into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 15, 17, and 19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claim 15 amount to no more than: (1) adding insignificant extra-solution activity to the judicial exception; and (2) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(g), (h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claim 15, as recited, the steps of: “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram”, is a generic function. See MPEP § 2106.05(d)(II).
- Regarding the step of “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Immunizing a patient against a disease, e.g., see Classen Immunotherapies, Inc. v. Biogen IDEC – the limitation directed to “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” is similarly deemed to be well-understood, routine, and conventional activity in the medical field, because the treatment is not specifically identified so that it does not encompass all applications of the judicial exception. - Further, prior art publications appear to indicate that the step of “administering to the subject with an increased Dep E score a selective serotonin reuptake inhibitor, in an amount sufficient to lower the Dep E score and improve cognitive function, where the selective serotonin reuptake inhibitor is selected from fluoxetine, fluvoxamine, sertraline, parotexine, citalopram, and escitralopram” is well-understood, routine, and conventional.
- For example, Sepehry et al., Effect of Selective Serotonin Reuptake Inhibitors in Alzheimer’s Disease with Comorbid Depression: A Meta-Analysis of Depression and Cognitive Outcomes, Drugs & Aging 29, 793–806 (2012), https://doi.org/10.1007/s40266-012-0012-5 (hereinafter referred to as Sepehry), generally teaches that “pharmacotherapeutic guidelines for treating depression in [patients with] AD recommend that a pharmacological treatment with minimal and least severe adverse effects be used as a first-line approach”, where “[t]he treatments of choice are selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, paroxetine and sertraline (i.e., this disclosure explicitly teaches that selective serotonin reuptake inhibitors is a desired, first-line treatment for patients with Alzheimer’s Disease and Depression); serotonin–noradrenaline (norepinephrine) reuptake inhibitors (SNRIs), including venlafaxine; or other newer agents, including mirtazapine”. Sepehry, p. 794, Column 1 under Section 1.2 Pharmacotherapy for AD and Depression. Further, in the Abstract, Sepehry proposed in 2012 that adding an antidepressant to existing treatment for AD [Alzheimer’s Disease] could provide relief for not only depressive by also cognitive symptoms (i.e., the use of antidepressants, including SSRIs, could provide alleviation of comorbid depression as well as cognitive decline in patients with Alzheimer’s Disease). Therefore, Sepehry teaches that it would have been beneficial treat patients with Alzheimer’s Disease and depression with SSRIs in order to improve cognitive functions. As such, the use of SSRIs for patients with Alzheimer’s Disease and depression in order to improve cognitive functions is deemed to be well-understood, routine, and conventional in the field of treatments for Alzheimer’s Disease and depression.
Thus, taken alone, the additional elements of claim 15 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional and generic implementation. Therefore, whether taken individually or as an ordered combination, claim 15 is nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 17 and 19 (which individually depend on claim 15 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 17 and 19 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claim 15. Dependent claims 17 and 19 merely add limitations that further narrow the abstract idea described in independent claim 15. Therefore, claims 15, 17, and 19 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Conclusion
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).
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686