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 .
DETAILED ACTION
Status of Claims
Claims 1-2, 6-8, 12, 18-19, 23-24, 26-27, 31, 35, 37-38, 43-44 and 52-53 are pending. Claims 35, 37-38 and 52-53 have been withdrawn as drawn to non-elected inventions. Claims 1-2, 6-8, 12, 18-19, 23-24, 26-27, 31 and 43-44 have been examined.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 02/12/2026 is acknowledged.
Priority
This application, Serial No. 18/163,780 (PGPub: US2024/0110927) was filed 02/02/2023. This application is a CONTINUATION of PCT/US2021/044658 filed 08/05/2021, which claims benefit of 63/197,120 filed 06/04/2021 and claims benefit of 63/061,616 filed 08/05/2020.
Information Disclosure Statements
The Information Disclosure Statement filed 02/12/2026 has been considered by the Examiner.
Claim Objections
Claim 44 is objected to because of the following informalities:
Claim 44 at lines 19 and 24 should delete the “a” before “generate an adjusted…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 44 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 is indefinite because it appears that the “and/or” is separating various alternatives of method steps, however all of the step iii) of the claim recite “the adjusted values” and it is unclear where this plurality of adjusted values have originated since in the last three step ii), only a single adjusted value has been generated.
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 1-2, 6-8, 12, 18-19, 23-24, 26-27, 31 and 43-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) detecting a level of at least one rental decline marker and determining risk of developing renal decline based on correlating the marker with a standard or determining an approximate risk of renal decline. The claimed limitations of using the biomarker to determine the risk of renal disease is a concept performed in the human mind belonging to the mental process grouping of the abstract ideas judicial exception (see MPEP § 2106.04(a)(2), subsection III). The judicial exception is not integrated into a practical application, such as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (see MPEP § 2106.05(a)-(c), (e)-(h)) such that the invention does not preempt every observance of the natural phenomenon itself.
Eligibility Step 1:
Claims 1, 18 and 31 are directed to methods of determining risk of renal decline. Methods are one of the eligible statutory categories for invention (STEP 1: YES). However, eligibility of the claim is not self-evident, and therefore analysis must proceed to Step 2.
Eligibility Step 2A, Prong One:
The claims recites using the detecting biomarker levels to determine a risk or approximate risk of developing renal disease, which is an abstract mental concept that belongs to enumerated group (III) of the Abstract Idea Groupings described in MPEP § 2106.04(a)(2). Therefore, the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
Eligibility Step 2A, Prong Two:
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited within the claims. The remaining claims merely recite additional measuring and determining steps. Regarding the additional wherein clauses in claim 1 of specifying how to correlate the detected levels of the renal markers is insufficient to integrate the judicial exception(s) because the purpose is merely to obtain and analyze data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). There are no other additional elements that apply, rely on or use the judicial exception such to integrate it into a practical application. For example, there are no additional elements that apply the abstract idea judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, assessing renal decline. In this way the claims, as drafted, do not integrate the judicial exception into a practical application that would overcome monopolizing the exception. ((STEP 2A, Prong Two: NO).
Eligibility Step 2B:
Lastly, the examiner cites publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional element(s).
Regarding the steps/elements recited in addition to using the determined renal marker levels, Niewczas et al. (US 2018/0011109) teaches identifying subjects with renal decline based on serum markers of the TNF pathway or predict risks for developing renal disease based on serum or plasma markers (paragraph 0005). Therefore, the steps/elements recited in addition to the judicial exception were all well understood, routine, conventional activities in the field of assessing oral cancer prior to filing the application at hand (STEP 2B: NO). The claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not amount to significantly more than that which was routine and conventional in the art prior to filing.
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 1, 6, 18, 23, 31 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,791,452. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claims 1, 6, 18, 23 and 43, Patent 452 recites a method of determining whether a human subject has an increased risk of developing chronic kidney disease (CKD), or end stage renal disease (ESRD), or both, the method comprising: obtaining a sample from a human subject who has proteinuria; detecting the presence of and measuring the level of soluble TNF receptor type 1 (sTNFR1) in the subject sample with an anti-sTNFR1 antibody and detecting binding and measuring the level of binding between sTNFR1 and the antibody; comparing the subject levels of sTNFR1 with reference levels of sTNFR1; and determining whether the subject has an increased risk of developing CKD or ESRD, or both, based on the comparison of the subject levels with the reference levels, wherein the presence of sTNFR1 in the subject sample at levels that are significantly higher than the reference levels indicates that the subject has an increased risk of developing CKD, ESRD or both, administering a therapy to subjects identified as having an increased risk of developing CKD or ESRD and monitoring said identified subjects for a reduction in the level of sTNFR1 (see patent claim 1).
Additionally, patent claim 2 reads on instant claim 31.
Claims 1, 6, 18, 23, 31 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,488,420. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claims 1, 6, 18, 23 and 43, Patent 420 recites a method of determining whether a human subject has an increased risk of developing chronic kidney disease (CKD), or end stage renal disease (ESRD), or both, the method comprising: obtaining a sample from a human subject who has normoalbuminuria (NA), microalbuminuria (MA), or proteinuria (PT); detecting the presence of and measuring the level of soluble TNF receptor type 1 (sTNFR1) in the subject sample with an anti-sTNFR1 antibody and detecting binding and measuring the level of binding between sTNFR1 and the antibody; comparing the subject levels of sTNFR1 with reference levels of sTNFR1; determining whether the subject has an increased risk of developing CKD or ESRD, or both, based on the comparison of the subject levels with the reference levels, wherein the presence of sTNFR1 in the subject sample at levels that are significantly higher than the reference levels indicates that the subject has an increased risk of developing CKD, ESRD, or both; and administering a therapy to any subjects identified as having an increased risk of developing CKD or ESRD and monitoring said identified subjects for a reduction in the level of sTNFR1 (See patent claim 1).
Additionally, patent claim 2 reads on instant claim 31.
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.
Claim(s) 1-2, 6-8, 12, 18-19, 23-24, 26, 31 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niewczas et al. (US 2018/0011109, Pub Date: 01/11/2018).
Regarding claim 1, Niewczas teaches throughout the publication a method for determining whether a human subject has or is at risk of developing renal decline (abstract), said method comprising detecting a level of at least one renal decline marker in a biological sample from the human subject, wherein the human subject has or is at risk of developing renal decline if the level of the at least one renal decline marker correlates with a known standard for a human subject who has or is at risk of developing renal decline, or wherein the human subject does not have or is not at risk of developing renal decline if the level of the at least one renal decline marker correlates with a known standard for a human subject who does not have or is not at risk of developing renal decline (paragraphs 0006 and 0017).
Regarding claim 2, Niewczas teaches the method further comprising comparing the level of the at least one renal decline marker from the biological sample from the human subject to a non-renal-decliner control level of the at least one renal decline marker; and determining whether the level of the at least one renal decline marker from the biological sample is equal to or higher than the level of the at least one renal decline marker of a non-renal- decliner control, wherein a higher level of the at least one renal decline marker from the biological sample from the human subject relative to the level of the at least one renal decline marker from the non-renal-decliner control indicates that the human subject has or is at risk of developing renal decline (paragraph 0021) and/or wherein the method further comprises contacting the biological sample from the human subject with a device for measuring the protein level of the at least one renal decline marker and/or wherein the device is capable of performing an immunoassay (paragraphs 0043-0044 and 0055-0056).
Regarding claim 6, Niewczas teaches the method wherein the at least one renal decline marker is a protein and includes at least one of TNF-R1 or TNF-R2 (paragraph 0030).
Regarding claim 7, Niewczas teaches the method further comprising measuring an estimated glomerular function rate (eGFR) slope of the human subject (paragraph 0052) and determining whether the eGFR slope of the human subject indicates that the human subject has or is at risk of developing renal decline (paragraph 0078).
Regarding claim 8, Niewczas teaches the method wherein an eGFR slope of at least < -5 ml/min/year indicates that the human subject has or is at risk of developing renal decline; and/or wherein an eGFR slope of at least < -10 mL/min/year indicates that the human subject has or is at risk of developing renal decline and/or wherein an eGFR slope of at least < -15 mL/min/year indicates that the human subject has or is at risk of developing renal decline (paragraph 0024).
Regarding claim 12, Niewczas teaches the method further comprising measuring a urine albumin to creatinine ratio (ACR) of the human subject, and/or wherein the human subject has type I diabetes (T1D) or type 2 diabetes (T2D) (paragraphs 0024 and 0047-0048).
Regarding claim 18, Niewczas teaches a method for determining whether a human subject has or is at risk of developing end-stage renal disease (ESRD), said method comprising detecting the level of at least one ESRD marker in a biological sample from the human subject, wherein the human subject has or is at risk of developing ESRD if the level of the at least one ESRD marker correlates with a known standard for a human subject who has or is at risk of developing ESRD, or wherein the human subject does not have or is not at risk of developing ESRD if the level of the at least one ESRD marker correlates with a known standard for a human subject who does not have or is not at risk of developing ESRD (paragraph 0007).
Regarding claim 19, Niewczas teaches the method further comprising comparing the level of the at least one ESRD marker from the biological sample from the human subject to a non-ESRD control level of the at least one ESRD marker (paragraph 0007); and determining whether the level of the at least one ESRD marker from the biological sample is equal to or higher than the level of the at least one ESRD marker of a non-ESRD control, wherein a higher level of the at least one ESRD marker from the biological sample from the human subject relative to the level of the at least one ESRD marker from the non-ESRD control indicates that the human subject has or is at risk of developing ESRD (paragraph 0021) and/or wherein the method further comprises contacting the biological sample from the human subject with a device for measuring the protein level of the at least one ESRD marker and/or wherein the device is capable of performing an immunoassay (paragraphs 0043-0044 and 0055-0056).
Regarding claim 23, Niewczas teaches the method wherein the at least one ESRD marker includes at least one of TNF-R1 (paragraph 0007).
Regarding claim 24, Niewczas teaches the method further comprising measuring a urine albumin to creatinine ratio (ACR) of the human subject (paragraph 0024), wherein the method further comprises determining a baseline renal function of the human subject (paragraph 0022).
Regarding claim 26, Niewczas teaches the method further comprising measuring an estimated glomerular function rate (eGFR) slope of the human subject and determining a time to onset of ESRD for the human subject using the level of the at least one ESRD marker and/or the eGFR slope of the human subject (paragraphs 0052 and 0078).
Regarding claim 31, Niewczas teaches the method wherein the human subject has type I diabetes (T1D) or type 2 diabetes (T2D) (paragraph 0007).
Regarding claim 43, Niewczas teaches a method of determining the approximate risk of renal decline (RD) or end- stage renal disease (ESRD) in a human subject (paragraph 0005), the method comprising: a) detecting, in a biological sample from the human subject, the level of at least two RD- associated proteins of a biomarker panel or at least two ESRD-associated proteins of a biomarker panel, wherein the biomarker panel comprises at least two proteins selected from the group consisting of TNF-R1, TNF-R2 (paragraphs 0030 and 0058); and b) determining the approximate risk of renal decline (RD) for the human subject, and/or the risk of end-stage renal disease (ESRD) of the human subject (paragraphs 0040-0041).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Niewczas et al. (US 2018/0011109, Pub Date: 01/11/2018).
Regarding claim 27, Niewczas teaches the method wherein the methods are useful for intervention protocols for high-risk patients that may be more effective if implemented 5-10 years earlier in the disease course (paragraph 0018) and wherein the kidney function and stage of CKD can be correlated to various levels of GFR (paragraph 0024). While the reference does not explicitly teach the method wherein an eGFR slope of at least < -15 ml/min/year indicates that the time to onset of ESRD for the human subject is 2-6 years; an eGFR slope of between < -15 ml/min/year and < -10 ml/min/year indicates that the time to onset of ESRD for the human subject is 6-10 years; and an eGFR slope of between < -10 ml/min/year and < -5 ml/min/year indicates that the time to onset of ESRD for the human subject is 10-20 years, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 27 are for any particular purpose or solve any stated problem, and the prior art teaches that GFR levels can provide information about kidney conditions. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the diagnostics art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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