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 .
Election/Restrictions
Applicants election without traverse of species: CaMK4, RT-PCR/qRT-PCR/northern blot/microarray, and glomerulonephritis in the reply filed on 4/13/2026 is acknowledged.
Claims 1-2, 4-10, and 12-21 are pending and under examination.
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, 4-10, and 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites methods of identifying or diagnosing active lupus nephritis flare as well as monitoring the response to treatment of a subject with an active lupus nephritis flare by measuring the level of CaMK4 and/or podocytes in urine samples of patients. This recitation is a natural correlation between expression levels of CaMK4 and/or podocytes levels and lupus nephritis. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites “identifying”, “diagnosing”, “monitoring”, “determining” etc which are a recitation of an abstract idea because it encompasses conclusions, determinations, and comparisons which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of detecting CaMK4 expression as well as measuring levels of podocytes in urine, however these steps do not integrate the JEs into a practical application because they are mere data gathering steps to use the correlations and do not add a meaningful limitation to the methods.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the step of obtaining a sample or nucleic acids is considered insignificant post solution activity. The steps of determining expression levels or measuring podocyte levels are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. These steps are not only mere data gathering steps, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Additionally, the cited prior art in this office action illustrates the routine nature of measuring levels of podocytes in urine. Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore, these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fahmy (Fahmy et al; WO 2020/014208; 1/16/2020; cited in the IDS filed 12/14/2023).
Fahmy teaches obtaining samples from subjects, isolating cells, including podocytes, from the sample, and measuring mRNA expression of CaMK4 using real time PCR (see pages 33-42). Fahmy teaches that CaMK4 expression was increased in patients with LN and FGFS (see whole documents, figures).
Claims 1, 2, 4, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ichinose (Ichinose et al; Arthritis Rheumatol, vol 68, 2016; author’s manuscript pages 1-17, cited in the IDS filed 12/14/2023).
Ichinose teaches obtaining samples from subjects, isolating cells, including podocytes, from the sample, and measuring mRNA expression of CaMK4 using real time PCR (see pages 3-6) in patients with SLE and LN. Ichinose teaches that CaMK4 expression was increased in patients vs controls) (see whole documents, figures).
Claims 17, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goytia (Bollain-y-Goytia et al; Indian Journal of Nephrology, vol 21, 2011, pages 166-171).
Goytia teaches a method of obtaining a urine sample from a subject, isolating podocytes from the urine sample, and determining the level of isolated podocytes (see page 169, col 2). Goytia teaches patients with LN (lupus nephritis) exhibited 10 to 70 podocytes per microscopic electric field and that ELISA revealed a significant increase in optical density. Goytia teaches using antibodies for the podocyte marker WT-1 (see whole document). Goytia teaches the subjects had symptoms of glomerulonephritis as well as being diagnosed with SLE.
Claims 17 and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansur (Mansur et al; Renal Failure, vol 38, pages 643-647, 2016).
Mansur teaches urine specimens were collected and centrifuged. Mansur teaches the supernatant was discarded and the sediment resuspended. Mansur teaches cytocentrifugation was performed on filter paper attached to a slide, the prepared slides were fixed and then treated. Mansur teaches after a further washing step, the slides were incubated with a primary antibody specific for podocytes, an anti-podocin rabbit antibody (Sigma-Aldrich, St. Louis, MO) at 1:250 dilution (see page 644, col 1). Mansur teaches the patients had symptoms of glomerulonephritis as well as being diagnosed with SLE (see whole documents). Mansur teaches measuring podocytes in the urine of patients with lupus nephritis and teaches that the levels were higher in those patients than in control patients (see abstract, whole document).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-6, 9-10, 12-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fahmy and Ichinose in view of Mansur.
Fahmy teaches obtaining samples from subjects, isolating cells, including podocytes, from the sample, and measuring mRNA expression of CaMK4 using real time PCR (see pages 33-42). Fahmy teaches that CaMK4 expression was increased in patients with LN and FGFS (see whole documents, figures). Ichinose also teaches obtaining samples from subjects, isolating cells, including podocytes, from the sample, and measuring mRNA expression of CaMK4 using real time PCR (see pages 3-6) in patients with SLE and LN. Ichinose teaches that CaMK4 expression was increased in patients vs controls) (see whole documents, figures). Fahmy and Ichinose also teach that CaMK4 inhibition studies suggest that it obviates the development of LN. Although Fahmy and Ichinose teach isolation of podocytes, they do not teach isolating podocytes from urine using anti-podocin antibodies, Mansur teaches urine specimens from patients with SLE and LN were collected and centrifuged. Mansur teaches the supernatant was discarded and the sediment resuspended. Mansur teaches cytocentrifugation was performed on filter paper attached to a slide and that prepared slides were fixed and then treated. Mansur teaches after a further washing step, the slides were incubated with a primary antibody specific for podocytes, an anti-podocin rabbit antibody (Sigma-Aldrich, St. Louis, MO) at 1:250 dilution (see page 644, col 1). Mansur teaches the patients had symptoms of glomerulonephritis as well as being diagnosed with SLE (see whole documents). Mansur teaches measuring podocytes in the urine of patients with lupus nephritis and teaches that the levels were higher in those patients than in control patients (see abstract, whole document). Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have used anti-podocin antibodies in the methods of podocyte analysis of Fahmy and Ichinose with a reasonable expectation of success because Mansur teaches that the method allowed for the successful isolation of podocytes from urine samples from patients with LN and SLE. It would have additionally been prima facie obvious to have measured levels of CaMK4 in the method of Mansur because both Fahmy and Ichinose teach that it was expressed at a higher level in patients with LN than in healthy controls. It would also have been prima facie obvious to the ordinary artisan to have monitored treatment of LN in patients by measuring the level of CaMK4 in isolated cells from patients with LN because Fahmy and Ichinose demonstrate that CaMK4 is a marker of proteinuria in patients with LN and that CaMK4 inhibition studies suggest that it obviates the development of LN.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/ Primary Examiner, Art Unit 1682
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