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 the Claims
Claims 1, 5, 7-11, 13, 15, 19-28, and 46 are pending and examined herein.
Priority
This application, filed 05/17/2023, is a 371 of PCT/US2021/059897, filed 11/18/2021, which claims benefit of PRO 63/115,407, filed 11/18/2020. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 11/18/2020.
Information Disclosure Statement
The Information Disclosure Statements filed 05/17/2023, 11/07/2023, and 11/05/2024 are acknowledged and have been considered.
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, 5, 7-11, 13, 15, 19-28, and 46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to§ 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is "directed to," we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a
fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical
application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an "'inventive concept' sufficient to 'transform"' the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not "well understood,
routine, conventional" in the field (see MPEP § 2106.0S(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 recites “determining a level of one or more biomarkers”, “correlating the one or more assay results to a likelihood that the subject will benefit from continued RRT or a likelihood that the subject will not benefit from continued RRT”, “administering continued RRT if the subject is at an increased likelihood from benefiting from continued RRT”, and “discontinuing RRT if the subject is not at an increased likelihood from benefiting from continued RRT”.
The step of “correlating the one or more assay results” is categorized as an abstract idea, namely it is a mental process/concept performed in the human mind. For example, “correlating” encompasses a practitioner simply observing the results and thinking about the quantified biomarker levels relative to a threshold. When given its broadest reasonable interpretation, the comparison of the biomarker level to a threshold is, itself, considered to be a mathematical concept. This step refers to making an evaluation, judgement or opinion (see MPEP 2106.04(a)(2) regarding groupings of abstract ideas). The claims, under broadest reasonable interpretation, cover performance of these steps solely within the human mind.
Step 2A, Prong 2
The above-discussed step of “correlating” is insufficient to integrate into a practical application. Specifically, the step corresponds to mental activity, which could be performed in a practitioner’s head, and mathematical concepts, are themselves judicial exceptions and not a practical application thereof.
Independent claim 1 further recites “detecting a level of one or more biomarkers”. However, this step fails to further amount to a practical application of the indicated judicial exception. Specifically, the “detecting” step is considered to be insignificant extra-solution activity, as it is a mere data gathering step (necessary in order to gather the data, namely the correlate step merely uses the detected biomarker level).
In addition to the judicial exceptions themselves, and the limitation directed to the gathering of the data (limitations considered directed to extra solution activity), independent claim 1 further recites “administering continued RRT if the subject is at an increased likelihood from benefiting from continued RRT”, and “discontinuing RRT if the subject is not at an increased likelihood from benefiting from continued RRT”. Although limitations which amount to applying or using a judicial exception to affect a particular treatment or prophylaxis for disease or medical condition are typically indicative of a practical application, in this case claim 1 recites treatment or discontinuation of treatment as conditional steps. Specifically, the claim recites “administering continued RRT if the subject is at an increased likelihood”. Under this scenario, the step of “administering continued RRT” encompasses doing nothing (taking no action), since the subject is already undergoing RRT. As such, the claim encompasses taking no action after the “correlating” step; therefore, it fails to integrate the judicial exception into a practical application.
Regarding the dependent claims, the limitations fail to practically apply the judicial exception. In particular, the dependent claims do not add any actionable step after the “correlating” step of claim 1. Claims 5 and 13 limit the treatments considered to be RRT and their timing; however, the claimed treatments are still described with a high level of generality. Claims 7, 8, 9, 10, 11, and 15 describe the mathematical process of “correlating”, which itself is a mathematical process, or the mathematical result of this process. Claims 19, 20, 21, 22, 23, 24, 25, 26, and 27 are directed to limiting the subjects selected for the method and the materials used for the “detecting a level of one or more biomarkers” step, which is considered to be insignificant extra-solution activity, as it is a mere data gathering step (necessary in order to gather the data, namely the correlate step merely uses the detected biomarker level).
ELIGIBILITY OF STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN “INVENTIVE CONCEPT”
Further, the additional elements of the claims (the active method steps/limitations recited in addition to the judicial exceptions themselves) do not add significantly more to the judicial exception(s); the additional recited claim elements are recited at a high level of generality, and are not, for example, limited to any particular testing technique or platform as claimed.
US 2019/0339289 A1, “METHODS AND COMPOSITIONS FOR EVALUATION AND TREATMENT OF RENAL INJURY AND RENAL FAILURE BASED ON C-C MOTIF CHEMOKINE LIGAND 14 MEASUREMENT” (published 11/07/2019, referred to herein as Kampf), as cited in more detail below under 35 U.S.C. 102, supports that assessing the likelihood that a subject will benefit from continued RRT by detecting a biomarker, correlating the result to the likelihood, and administering or discontinuing RRT was routine and conventional activity previously performed by those of skill in the art.
It does not appear to the be case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps received or performed in an unconventional or non-routine way, such as to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well-understood, conventional or routine in the field of treatment monitoring and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 7-11, 13, 15, 19-28, and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0339289 A1, “METHODS AND COMPOSITIONS FOR EVALUATION AND TREATMENT OF RENAL INJURY AND RENAL FAILURE BASED ON C-C MOTIF CHEMOKINE LIGAND 14 MEASUREMENT” (published 11/07/2019, referred to herein as Kampf).
Regarding claims 1 and 5, Kampf teaches a method for assessing the likelihood of persistent AKI in a subject (para. 0051, lines 3-9), followed by assigning the subject RRT) or not to treat with RRT (para. 0028, lines 1-7). Kampf teaches that this method can be used to monitor a course of treatment (para. 0100, lines 14-16), i.e. determine whether RRT should continuous. The method of determining the likelihood of persistent AKI which is directly used to administer or discontinue RRT, as taught by Kampf, is considered to be a method of assessing the likelihood that a subject will benefit from RRT. Kampf teaches assessing the likelihood of persistent AKI, which is then translated into a likelihood that a subject will benefit from RRT by the direct administration of RRT based on the assessment. Kampf teaches detecting the levels of C-C motif chemokine 14 to make this assessment (para. 0023, lines 1-10).
Regarding claims 7 and 8, Kampf teaches a method wherein the correlation comprises assigning the subject to a predetermined subpopulation by comparing the assay result to a threshold selected in a population study wherein first subpopulation has measurements above the threshold which has an increased predisposition for having AKI and therefore, has an increased predisposition for benefiting from continued RRT and has not successfully discontinued RRT (para. 0027, lines 1-8).
Regarding claim 9, Kampf teaches comparing the assay result to a baseline previously measuring in the subject (para. 0082, lines 5-8).
Regarding claim 10, Kampf teaches assigning the subject to the first or second subpopulation (para. 0027, lines 1-8).
Regarding claims 11 and 15, Kampf teaches using a baseline to measure temporal changes in a biomarker level (para. 0082, lines 5-8). An ordinary artisan would recognize that the result of this could be above or below the baseline.
Regarding claim 13, Kampf teaches administering RRT for up to 4 weeks, which includes more than 1, 2, or 3 days (para. 0012).
Regarding claim 19, Kampf teaches using an antibody (para. 0044, lines 1-3).
Regarding claims 20-22, Kampf teaches the sample can be serum or urine (para. 0044, lines 7-8).
Regarding claim 23, Kampf teaches the subject may have congestive heart failure, diabetes mellitus, hypertension, among other conditions (para. 0045, lines 10-15).
Regarding claim 24, Kampf teaches collecting the sample within 3 hours of surgery, which is within the claimed 12 hours (para. 0127, lines 1-4).
Regarding claim 25, Kampf teaches collecting the subject’s body fluid every 12 hours (para. 0162, lines 1-6) and monitoring after the subject is put on RRT (para. 0163, lines 12-16).
Regarding claims 26, 27, and 28, Kampf teaches collecting samples from subjects within 36 hours of meeting KDIGO stage 2 criteria and doing the assay on subjects with AKI Stage 2 or 3 (para. 0140, lines 1-7).
Regarding claim 46, Kampf teaches a kit comprising a binding reagent for C-C motif chemokine 14 (para. 0048, lines 1-6).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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 1, 5, 20-22, and 27-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 9, 10, and 14 of U.S. Patent No. 11,353,465 B2 (referred to herein as ‘465). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘465 anticipates the claims of the instant application.
Regarding claim 1, ‘465 discloses a method for evaluating the renal status in a subject diagnosed with AKI which meets the definition of KDIGO Stage 3, such as undergoing RRT, comprising detecting a level of a C-C motif chemokine 14 biomarker, correlating the result to a likelihood that the subject has persistent AKI, i.e. a likelihood that the subject will benefit from continued RRT, and administering RRT (‘465, claims 1 and 7).
Regarding claim 5, ‘465 discloses that RRT comprises hemodialysis (‘465, claim 5).
Regarding claims 20-22, ‘465 discloses that the sample is a serum or urine sample (‘465 claims 9, 10, and 14).
Regarding claims 27 and 28, ‘465 discloses selecting a subject that has AKI (‘465 claim 1).
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 15, 2026
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