DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 2/18/2025 have been received and entered into the case. Claims 2 and 6-23 have been canceled, Claims 24-34 have been added. Claims 1, 3-5 and 24-34 are pending, Claims 3 and 5 have been withdrawn, and Claims 1, 4 and 24-34 have been considered on the merits, insofar as they read on the elected species of a transplant recipient and a solid organ transplant patient diagnosed with graft dysfunction. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments – Claim 2 has been canceled.
Withdrawn Rejections
Rejections of Claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments – Claim 2 has been canceled.
Rejections of Claims 1-2 and 4 under 35 U.S.C. 101 are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-2 and 4 under 35 U.S.C. 103 as being unpatentable over Stylli (US 2018/0238894 A1; 8/23/2018.) in view of Harris et al (Trends in Immunology. 2002;23(3):144- 150.) and Ponticelli (Kidney International. 2000;57(75):S62-S70.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 1 is 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 contains subject matter which was not described in the specification as originally filed, in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation of “increasing an immunosuppressant dose of the kidney transplant patient classified as under-immunosuppressed, or decreasing the immunosuppressant dose of the kidney transplant patient classified as over-immunosuppressed” is not described in the specification as originally filed. The instant specification discloses an analyzing method, a treating method or a treating method step is not disclosed. Thus, the limitation is considered new matter.
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 1, 4 and 24-34 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (MPEP 2164.01(a)).
The above factors, regarding the present invention, are summarized as follows:
The breadth of the claims / The Nature of the invention – The breadth and nature of the claims is drawn to a method of analyzing an immune system response of a kidney transplant patient using nuclear magnetic resonance (NMR) spectroscopy to analyze metabolites in a urine sample from the kidney transplant patient.
The state of the prior art / The predictability or lack thereof in the art – The prior art teaches that NMR has poor detection limitations in urine samples. For example, Capati et al (Magnetic Resonance Insights. 2017;10:1-12.) teaches the large concentration of water in urine makes it difficult to see metabolites that are present at a very low concentration, resulting in a distorted spectrum (p.3 col right – para 3).
The relative skill of those in the art – The relative skill of those in the art is high, with a typical practitioner possessing commensurate degree level, as well as several years of professional experience.
The amount of direction or guidance present – The instant specification discloses data in Examples as well as in Figures. However, there is a large overlap of metabolite levels measured by NMR spectroscopy for levels of metabolite resonances between an immune system response (ISR) patients and control patients. For example, in Figure 3B – metabolite resonances at 3.009_32.551, for a single patient, when looking at 0.5 (normalized intensity), one would not be able to tell whether the data represents an ISR patient or a control patient, since 0.5 is present for both the ISR patient and the control patient.
The presence or absence of working examples – Figures 1, 3, 5, 7, 9, 11, and 13 in the instant specification demonstrate a large overlap of metabolite levels measured by NMR spectroscopy for levels of metabolite resonances between an immune system response (ISR) patients and control patients. For example, in Figure 3B – metabolite resonances at 3.009_32.551, for a single patient, when looking at 0.5 (normalized intensity), one would not be able to tell whether the data represents an ISR patient or a control patient, since 0.5 is present for both the ISR patient and the control patient.
The quantity of experimentation needed – The quantity of experimentation needed is undue experimentation. First, one needs to identify metabolites for analyzing an immune system response of a kidney transplant patient. Second, one needs to determine metabolite concentrations. Third, one needs to overcome NMR poor detection limit issues in urine samples. Because of above factors, it would take undue experimentation to use the invention as claimed.
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, 4 and 24-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 recites a series of steps or acts, including obtaining a urine sample from a kidney transplant patient, and using nuclear magnetic resonance (NMR) spectroscopy to analyze metabolites in the urine sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. Steps c-e could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, steps c-e in the claim is directed to at least one exception (Step 2A Prong One: YES), which may be termed an abstract idea. Besides the abstract idea, the claim recites additional elements of “obtaining a urine sample from a kidney transplant patient” in step a, and “using nuclear magnetic resonance (NMR) spectroscopy to analyze metabolites in the sample related to the immune system response to obtain a result” in step b. The limitation of obtaining a urine sample is recited at such a high level of generality, and the use of NMR spectroscopy to analyze metabolites is well understood, routine, and conventional in the field. Therefore, these limitations, individually or in combination, represent mere instructions to apply an exception and insignificant extra-solution activity, and do not amount to significantly more. Accordingly, limitations in steps a-e do not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A Prong Two: YES). As explained with respect to Step 2A Prong Two, the claim recites additional elements in steps a-b, which do not require any particular application of the recited analysis 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). Accordingly, claim 1 is not eligible and should be rejected under 35 U.S.C. § 101.
Claim 4 recites an additional element of “wherein the patient is a solid organ transplant patient diagnosed with graft dysfunction, transplant rejection, or organ failure”. This limitation fails to meaningfully limit the claim because it does not require any particular application of the recited analysis, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, this limitation does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception. The claim recites an additional element, which do not require any particular application of the recited analysis 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. Accordingly, claim 4 is not eligible and should be rejected under 35 U.S.C. § 101.
Claims 24-34 recite “wherein”, which further provides data points for classifying the patient. These limitations fail to meaningfully limit the claims because they do not require any particular application of the recited analysis, and are at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, these limitations do not integrate the recited judicial exception into a practical application and the claims are therefore directed to the judicial exception. These claims recite additional elements, which do not require any particular application of the recited analysis and are 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. Accordingly, claims 24-34 are not eligible and should be rejected under 35 U.S.C. § 101.
Response to Arguments
Applicant argues that the step of administering a treatment to a patient diagnosed with a medical condition was found to make the claim patent eligible, and that the amended claim 1 is analogous to the claim presented in Example 29 and should be similarly found to be patent eligible.
These arguments are not found persuasive because the amended claim 1 does not recite an administering step. In addition, the instant specification does not disclose a treating method or a treatment comprising an administering step.
Applicant argues that cited references fail to describe or suggest any method of analyzing an immune system response of a kidney transplant patient using NMR spectroscopy to monitor levels of metabolites in a urine sample to classify the kidney transplant patient as under-immunosuppressed, over-immunosuppressed, or stable using a machine learning model, as claimed. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759