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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Claims 1-20 are cancelled. Claims 21-28 are new, and the Applicant notes that no new matter is added. Applicant’s election without traverse of claims 21-28 which relates to Group I of claims of 02/07/2022 (claims 1-7) in the reply filed on 01/12/2026 is acknowledged.
Thus claims 21-28 are pending and are under examination.
Priority
This application is a U.S. National Stage (371) application of PCT/US2020/045405 filed on 08/07/2020 which claims priority to U.S. Provisional Application No. 62/883,763 filed on 08/07/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/08/2022 have been received. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner and all references are considered except where they were lined through.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show labels and legends for Figure 4 as described in the specification and lack units of measurements for figures 14, 17 and 18. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 21 is objected to because of the following informalities: The claim recites “wherein prior to the transplantation the kidney to be transplanted was determined …”. Applicant is advised to add a comma after “wherein prior to the transplantation” so that the claim will read “wherein prior to the transplantation, the kidney to be transplanted was determined …”. Appropriate correction is required.
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 21-28 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 cutoff value from which the applicant or doctor will be able to identify a kidney as being viable for transplantation. Such an inference is not sufficient to transform the abstract idea of a mathematical calculation of a ratio of uromodulin (UMOD) to osteopontin (OPN), the abstract idea of a mental process of assessing the ratio of UMOD to OPN and a law of a nature (correlation of ratio of UMOD:OPN to the kidney being viable for transplantation) into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., abstract idea of a mathematical calculation (ratio of uromodulin (UMOD) to osteopontin (OPN)), an abstract idea of a mental process (assessing the ratio of UMOD to OPN and comparing it to a cutoff value) and a law of nature (correlation of ratio of UMOD:OPN to the kidney being viable for transplantation). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept. Although the proposed use of kidney viability for transplantation is specific, it is conditional which means a kidney might not be viable for transplantation if the ratio of UMOD:OPN is more than the cutoff value of 3.
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 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims.
Regarding claim 1 of example 43 of the “2019 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, claims 21 and 25 of the instant application are also directed to a statutory class of a method of human kidney transplantation by measuring the amounts of uromodulin and osteopontin to calculate a ratio for comparison and assessment to decide if the kidney is viable for transplantation based on the cutoff value (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 the “2019 PEG” recites judicial exceptions that are similar to claims 21 and 25 of the instant application. Specifically, and per Step 2A, prong 1, claim 1 of example 43 of the “2019 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 the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) of claim 1 of “2019 PEG” falls into the “mathematical concept” grouping of abstract ideas.
Similar to claim 1 of example 43 of the “2019 PEG”, claims 21 and 25 of the instant application also recite a judicial exception of calculating “a ratio of uromodulin (UMOD) to osteopontin (OPN)” after measuring UMOD and OPN. And according to BRI, an arithmetic calculation of a division is also required to obtain the ratio of UMOD:OPN which is used in claims 21 and 25 to identify a kidney that is viable for transplantation. This limitation therefore recites a mathematical calculation which falls under an abstract idea as noted above in “2019 PEG”.
In addition, regarding the ratio of C11 to C13 of limitation (a) of claim 1 of “2019 PEG” and the ratio of UMO:OPN of claims 21 and 25, the simple arithmetic calculation (division) can be practically performed in the human mind to calculate a ratio, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, the ratio of limitation (a) of claim 1 of “2019 PEG” and the ratio of claims 21 and 25 of the instant application also fall into the “mental process” groupings of abstract ideas.
Also, limitation (a) of claim 1 of “2019 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. Similarly, claims 21 and 25 of the instant application are also calculating the ratio of UMOD:OPN and associating such a ratio with the viability of kidney for transplantation. Thus, claims 21 and 25 of the instant application also describes a naturally occurring relationship between the ratio of UMOD:OPN and the kidney viability for transplantation, and thus is considered to recite a law of nature
Furthermore, claims 21 and 25 are also reciting an abstract idea of a mental process of assessing the ratio of UMOD:OPN by comparing it to a cutoff value, and a law of nature of correlating ratio of UMOD:OPN to the kidney being viable for transplantation “transplanting the kidney from the deceased donor having the ratio of UMOD:OPN of ≤ 3 into a human recipient”.
Accordingly, limitation (a) of claim 1 of “2019 PEG” recites three judicial exceptions (an abstract idea that falls within the mathematical concept, a mental process groupings in the “2019 PEG”, and a law of nature); whereas claims 21 and 25 of the instant application also recite four judicial exceptions of an abstract idea that falls within the mathematical concept, a first mental process, a second 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 the “2019 PEG” and claims 21 and 25 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 the “2019 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 the “2019 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 the “2019 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 “2019 PEG”, claims 21 and 25 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 measuring uromodulin (UMOD) and osteopontin (OPN) and calculating the ratio of UMOD:OPN to compare to a cutoff value to identify a kidney as being viable for transplantation, and these steps do not integrate the judicial exception into a practical application because they are data gathering steps to use in the calculation 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 claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d). Furthermore, similar to claim 1 of example 43 of the “2019 PEG”, claims 21 and 25 of the instant application has a specific proposed use of kidney viability for transplantation that is conditional. In the instant case, the use of kidney viability for transplantation is also conditional based on the assessment of claims 21 and 25 of the instant application which falls within an abstract idea that can be practically performed in the human mind.
Therefore, claims 21 and 25 of the instant application do not integrate the judicial exception 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 the “2019 PEG” and claims 21 and 25 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 “2019 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 21 and 25 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring uromodulin (UMOD) and osteopontin (OPN) from the urine of deceased kidney donor with a commercially available assay such as with ELISA (Specification, page 53, fifth paragraph). 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 21 and 25.
Thus, claims 21 and 25 are not eligible and are rejected under 35 USC 101.
Regarding claims 22-23 and 26-27, the claims state the type of assay to use for measuring uromodulin and osteopontin from the urine of the deceased kidney donor which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Regarding claims 24 and 28, the claims attempt to further define the type of capture agents to use to measure the amounts of uromodulin and osteopontin in the urine of the deceased kidney donor which does not integrate the judicial exception into a practical application, nor does it amount to significantly more.
Conclusion
No claims are allowed.
Claims 21-28 are rejected under 35 U.S.C. 101 but Mansour et al. that teaches the association of uromodulin to osteopontin ratio with kidney graft outcomes from deceased donor urine (Transplantation, volume 105, number 4, April 2021; abstract, conclusions). But Mansour does not teach or suggest identifying the viability of kidney for transplantation. Moreover, Mansour’s publication date of 04/01/2021 is after the effective filing date of the instant application of 08/07/2019.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678