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 .
Priority
This is a divisional application of U.S. Application No. 17/937,067, filed 09/30/2022, which is a continuation of U.S. Application No. 16/178,460, filed 11/01/2018, which claims priority to U.S. Provisional Application No. 62/580,834, filed 11/02/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/08/2024 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and all references are considered except where they were lined through.
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 16-34 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data that is compared to a control value of neurokinin from which the applicant or doctor will be able to identify a subject at risk of social isolation stress and to treat accordingly. Such an inference is not sufficient to transform the abstract idea of a mental process of comparing the neurokinin level to a control level of neurokinin and a law of nature of correlating the neurokinin level with identifying a subject at risk of social isolation stress and treatment into a patentable application.
The claims are ineligible because they recite at least one judicial exception, i.e., an abstract idea of a mental process (comparing neurokinin level to a control level), and a law of nature (correlating the neurokinin level with identifying a subject at risk of social isolation stress and treatment). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
Although there is a proposed treatment step in claims 16 and 29 it is a general step that does not add significantly more to the judicial exceptions of the instant application, and it is also a conditional step. Specifically, claim 16 recites “and to be in need of a neurokinin receptor antagonist” which is a general treatment that encompass a wide range of therapeutic agents such as NKR3 antagonists of osanetant, talnetant, fezolinetant, pavinetant, SB-222200, and SB-218795. The treatment step in claim 16 is also a conditional step as it recites “and to be in need of a neurokinin receptor antagonist if the level of neurokinin in the sample is greater than a control level of neurokinin”. Claim 29 also has a broad treatment as it recites ”administering an effective amount of the neurokinin receptor antagonist to the identified subject” which is also a general treatment because it does not specify what type of treatment is to be administered. Moreover, similar to claim 16, the treatment step in claim 29 is also conditional as it recites “and to be in need of treatment with a neurokinin receptor antagonist upon determining that the level of neurokinin in the sample is greater than a control level of neurokinin”. Thus, the steps in claims 16 and 29 do not add significantly more to the judicial exceptions of the instant application, and therefore, the judicial exceptions are not integrated into a practical application.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Example 43 of 2019 Revised Patent Subject Matter Eligibility Guidance (PEG) is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims (Subject matter eligibility | USPTO)
Regarding claim 1 of example 43 of the PEG and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, claim 16 of the instant application is also directed to a statutory class of a method of identifying a subject at risk of social isolation stress (Step 1: YES).
And claim 29 of the instant application is directed to a statutory class of a method of identifying a subject for treatment of social isolation stress (Step 1: YES).
(Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Claim 1 of example 43 of PEG recites judicial exceptions that are similar to claims 16 and 29 of the instant application. Specifically, and per Step 2A, prong 1, claim 1 of example 43 of PEG recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. And the grouping of “mathematical concepts” in PEG includes “mathematical calculations” as an exemplar of an abstract idea. PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) of claim 1 of PEG falls into the “mathematical concept” grouping of abstract ideas.
Similarly, claims 16 and 29 of the instant application also recite a judicial exception of an abstract idea of a mental process of comparing neurokinin level to a control level. Specifically, claim 16 recites “if the level of neurokinin in the sample is greater than a control level of neurokinin.” and claim 29 recites “upon determining that the level of neurokinin in the sample is greater than a control level of neurokinin”.
Also, limitation (a) of claim 1 of PEG describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a law of nature.
Furthermore, claims 16 and 29 also describe a naturally occurring relationship between neurokinin level and identifying a subject at risk of social isolation stress, and thus are considered to recite a law of nature. Specifically, claim 16 recites “identifying the subject to be at risk of social isolation stress and to be in need of neurokinin receptor antagonist if the level of neurokinin in the sample is greater than a control level of neurokinin” and claim 29 recites “identifying the subject to have or to be at risk of social isolation stress, and to be in need of treatment with a neurokinin receptor antagonist upon determining that the level of neurokinin in the sample is greater than a control level of neurokinin”.
Accordingly, limitation (a) of claim 1 of PEG recites three judicial exceptions (an abstract idea that falls within the mathematical concept, a mental process groupings in PEG, and a law of nature); whereas claims 16 and 29 of the instant application also recite two judicial exceptions of an abstract idea of a mental process and a law of nature, and the analysis must therefore proceed to Step 2A Prong Two.
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
Per Step 2A, prong 2, claim 1 of example 43 of PEG and claims 16 and 29 of the instant application as a whole do not integrate the recited judicial exception into a practical application of the exception. Specifically, this evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, claim 1 of example 43 of PEG recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. 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 doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of PEG fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of PEG does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similar to claim 1 of example 43 of PEG, claims 16 and 29 of the instant application do not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claims have steps of determining the neurokinin level to compare to a control level of neurokinin to identify the subject to have or to be at risk of social isolation stress to treat accordingly, and these steps do not integrate the judicial exceptions into a practical application because they are data gathering steps to use in the measurement and comparison, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claim does not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d). In the instant case, the doctor is not required to perform any further action based on the assessment of the subject as in claims 16 and 29 if the neurokinin level is not greater than a control level of neurokinin. Therefore, claims 16 and 29 of the instant application do not integrate the judicial exceptions into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
Per Step 2B, claim 1 of example 43 of PEG and claims 16 and 29 of the instant application do not recite additional elements that amount to significantly more than the judicial exception. Specifically, 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. As explained with respect to Step 2A Prong Two, claim 1 of example 43 of PEG recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, claims 16 and 29 of the instant application simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as determining the level of neurokinin with a commercially available assay such as with ELISA (Specification, pages 6-7, [0006]; page 36, [0064]). Furthermore, the claims themselves are recited at a high level of generality in which any assay can be used as the measurement method for claims 16 and 29.
Thus, claims 16 and 29 are not eligible and are rejected under 35 USC 101.
Regarding claim 17, the claim describes neurokinin to include neurokinin B which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 18, the claim describes the neurokinin receptor antagonist as an NK3R antagonist which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 19, the claim describes the source of neurokinin control which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 20, the claim describes storage site of neurokinin control level which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 21 and 30, the claims describe the detection method which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 22 and 32, the claims describe the source of the sample which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 23, the claim describes the subject’s condition which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 24, the claim describes administering a general and conditional treatment to the subject which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 25 and 33, the claims describe the condition of treatment which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 26 and 34, the claims describe the subject which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claim 27, the claim describes different conditions of the subject which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 28 and 31, the claims describe multiple medications which do not integrate the judicial exception into a practical application, nor do they amount to significantly more.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-19, 26-29, 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 11-17 and 20-21 of U.S. Patent No. US 11,458,129 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 16 pertaining to a method of identifying a subject at risk of social isolation stress by obtaining from the subject a sample from a peripheral tissue that is outside of the central nervous system, detecting a level of neurokinin in the sample and identifying the subject to be at risk of social isolation stress and to be in need of a neurokinin receptor antagonist if the level of neurokinin in the sample is greater than a control level of neurokinin, ‘129 teaches identifying a subject as suffering from social isolation stress and in need of inhibiting, ameliorating, reducing the severity of, or treating one or more symptoms caused by the social isolation stress by obtaining from the subject a sample from a peripheral tissue that is outside of the central nervous system, detecting a level of neurokinin B in the sample and wherein the subject exhibits a greater level of neurokinin B than the subject had prior to the induction of neurokinin B in response to the lack of social interaction or contact (See claims 1, 2, 4, 5 and 11 of ‘129).
Regarding claim 17 pertaining to that the neurokinin comprises neurokinin B, ‘129 teaches detecting a level of neurokinin B (See claims 1, 2, 4, 5, 11 of ‘129).
Regarding claim 18 pertaining to that the neurokinin receptor antagonist is an NK3R antagonist, ‘129 teaches that the neurokinin receptor antagonist is an NK3R antagonist (See claims 1, 5 and 6-7 of ‘129).
Regarding claim 19 pertaining to the control level is a level of a control sample of an individual that does not suffer from social isolation stress, or a control sample collected from the subject when the subject is not experiencing physical isolation and/or a lack of social interaction or contact for at least 1 week, ‘129 teaches that the lack of social interaction or contact is for at least 1 week (See claims 5, 14 and 17 of ‘129). ‘129 further teaches the subject, before administering the NK3R antagonist, exhibits a greater level of neurokinin B than the subject had prior to the induction of neurokinin B in response to the lack of social interaction or contact (See claim 5 of ‘129).
Regarding claims 26 and 34 pertaining to that the subject is a human subject, ‘129 teaches that the subject is a human subject (See claims 20-21 of ‘129).
Regarding claim 27 pertaining to that the lack of social interaction or contact comprises lack of social interaction or contact due to grieving in isolation, residing as a patient in a skilled nursing facility, being in quarantine, imprisonment, solitary confinement, or experiencing feelings of isolation as an adolescent, ‘129 teaches that the lack of social interaction or contact comprises physical separation of the subject from other individuals. ‘129 further teaches that the lack of social interaction or contact comprises lack of social interaction or contact due to grieving in isolation, residing as a patient in a skilled nursing facility, being in quarantine, imprisonment, solitary confinement, or experiencing feelings of isolation as an adolescent (See claims 12-13 and 15-16 of ‘129).
Regarding claims 28 and 31 pertaining to that the NK3R antagonist is selected from the group consisting of: osanetant, talnetant, fezolinetant, pavinetant, SB-222200, and SB-218795, or a combination thereof, ‘129 teaches that the neurokinin receptor antagonist is an NK3R antagonist selected from the group consisting of: osanetmt, talnetant, fezolinetant, pavinetant, SB-222200, and SB-218795, or a combination of two or more of the listed items (See claims 6-7 of ‘129).
Regarding claim 29 pertaining to a method of identifying a subject for treatment of social isolation stress by obtaining from a subject a sample from a peripheral tissue of the subject that is
outside of the central nervous system, wherein the subject the subject does not exhibit a symptom caused by social isolation stress, and is commencing or is in the course of physical isolation or social isolation, detecting a level of neurokinin in the sample, identifying the subject to have or to be at risk of social isolation stress, and to be in need of treatment with a neurokinin receptor antagonist upon determining that the level of neurokinin in the sample is greater than a control level of neurokinin, and administering an effective amount of the neurokinin receptor antagonist to the identified subject, ‘129 teaches identifying a subject as suffering from social isolation stress and in need of inhibiting, ameliorating, reducing the severity of, or treating one or more symptoms caused by the social isolation stress by obtaining from the subject a sample from a peripheral tissue that is outside of the central nervous system, detecting a level of neurokinin B in the sample and wherein the subject exhibits a greater level of neurokinin B than the subject had prior to the induction of neurokinin B in response to the lack of social interaction or contact (See claims 1, 2, 4, 5 and 11 of ‘129).
Conclusion
No claims are allowed.
Claims 16-34 are rejected under 35 U.S.C. 101, but no claims are rejected by prior art because there is no prior art that teaches or suggests the method of identifying a subject at risk of social isolation stress by detecting the level of neurokinin in sample from a peripheral tissue that is outside of the central nervous system and comparing the detected neurokinin level to a control to determine if the subject is in need of treatment. The closest prior art is Ressler et al. (US 2017 /0296528 A1) that teaches managing conditioned fear and conditions induced by experiencing or witnessing an extreme traumatic event using neurokinin receptor antagonists (Abstract). But Ressler does not teach or suggest identifying a subject at risk of social isolation stress by detecting the level of neurokinin in sample from a peripheral tissue that is outside of the central nervous system and comparing the detected neurokinin level to a control to determine if the subject is in need of treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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