DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/6/2024 has been entered.
Status of Claims
Currently, 89, 91-98, 100-101, 103-104, 106-113, 115, and 117-119 are pending. Claims 92, 97, 107 and 113 are withdrawn from consideration as being directed to non- elected species. Claims 89, 91, 93-96, 98, 100-101, 103-104, 106, 108-112, 115, and 117-119 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are reiterated. They constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 101
Claims 89, 91, 93-96, 98, 100-101, 103-104, 106, 108-112, 115, and 117-119 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 for selecting a human subject for treatment to reduce the risk of developing renal failure as well as selecting a subject in need of screening for renal disease by detecting risk alleles in APOL1 (as defined by the specification at table 1: SEQ ID NO: 1 risk allele is a G, SEQ ID NO: 2 risk allele is a G, and SEQ ID NO: 3 risk allele is del6), which is a natural correlation between risk alleles in APOL1 and renal disease. 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 “selecting a human subject”, which is a recitation of an abstract idea because it encompass conclusions and decisions 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 two steps. The first step involves the use of generic nucleic acids (eg: probe) to detect the APOL1 risk alleles, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method. The same analysis holds for elements such as “biannual or annual screening” (claim 104). The second step is directed to “selecting a human subject” which is an abstract idea and recites the natural correlation. Therefore, this step does not integrate the JE into a practical application because it is merely a recitation of the JE itself.
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 limitations directed to samples are considered insignificant post solution activity. The steps of “contacting a biological sample from the human subject with a nucleic acid probe” or a “primer” as well as “detecting [determining] formation of a hybridization complex” 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. This is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). 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.
Response to Arguments
The response traverses the rejection and asserts that under Step 2A prong 2, the office failed to “give weight to all of the claimed additional elements in Prong 2, even if those elements represent well understood, routine, and conventional activity”. This argument has been thoroughly reviewed but was not found persuasive because detecting amplification or hybridization is a literal recitation of data gathering. The steps of using a probe or primer and detecting hybridization or amplification, respectively, are both well understood, routine, and conventional activity either alone or in combination. These generally recited methods (probe hybridization, amplification with primers) of detecting known nucleic acids have been used in the field of genetic analysis for multiple decades. Not only have these been deemed well understood, routine, and conventional by the courts (see MPEP 2106.05(d)(II)), but the specification at page 24 cites primer software dating back to 1991 and states “PCR primer pairs can be derived from a known sequence by using computer programs intended for that purpose such as Primer…”. Merely adding a step of detecting or determining that hybridization or amplification has occurred is not new, that is the purpose of the methods, to use a primer or probe to detecting hybridization and/or amplification. The remainder of the “selecting” step recites the natural correlation between the presence of the recited alleles and risk of developing renal failure. It should further be noted that the selecting step is also an abstract idea as “selecting a subject” encompasses making a decision that a subject is at risk of developing renal failure and should be treated. However, the claims do not add any steps beyond making that decision that integrate the JE’s into a practical application or add significantly more to the JE’s recited. At their most basic characterization, the claims are simply directed to gather data by detecting known mutations and make a decision. The actual gathering of the data uses well understood, routine, and conventional techniques that have been acknowledged as such by the courts and also in the instant specification. For these reasons and the reasons already made of record, the rejection is maintained.
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 89, 91, 93-96, 98, 100-101, 103-104, 106, 108-112, 115, and 117-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10-37 of U.S. Patent No. RE49,076, in view of Pays.
The ‘076 claims are directed to treating renal disease in a subject with risk alleles of APOL1, including the G3 inversion, S342G, I384M (SEQ ID NOS 1 and 2) and deletion of amino acids N388-Y389 (SEQ ID NO 3). It would have been prima facie obvious to the ordinary artisan to first detect the risk alleles and to screen subjects for renal disease or renal failure prior to treatment as set forth in the ‘076 claims. Although the ‘076 claims do not teach obtaining a sample and using nucleic acid probe hybridization or primer amplification techniques to detect the APOL1 alleles, Pays teaches methods of obtaining a sample and detecting the same APOL1 alleles recited in the claims using probe hybridization or primer amplification techniques (para 0013). Therefore, it would have been prima facie obvious to the ordinary artisan to use the probe hybridization methods of detecting APOL1 alleles taught by Pays with a reasonable expectation of success, to detect the APOL1 alleles of the ‘076 claims.
Claims 89, 91, 93-96, 98, 100-101, 103-104, 106, 108-112, 115, and 117-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent No. 10,130,632, or claims 1-13 of US Patent 10, 940,151, or claims 1-9 of US Patent 9,023,355, (herein referred to as “patented claims) each in view of Pays.
The patented claims are directed to treating renal disease in a subject with risk alleles of APOL1, including S342G and I384M (SEQ ID NOS 1 and 2). It would have been prima facie obvious to the ordinary artisan to first detect the risk alleles and to screen subjects for renal disease or renal failure prior to treatment as set forth in the patent claims. Although the patent claims do not teach obtaining a sample and using nucleic acid probe hybridization or primer amplification techniques to detect the APOL1 alleles, Pays teaches methods of obtaining a sample and detecting the same APOL1 alleles using probe hybridization and primer amplification techniques (para 0013). Therefore, it would have been prima facie obvious to the ordinary artisan to use the probe hybridization methods of detecting APOL1 alleles taught by Pays with a reasonable expectation of success, to detect the APOL1 alleles of the patented claims.
Claims 89, 91, 93-95, 100-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,828,637. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘637 are directed to detecting APOL1 risk alleles including S342G, I384M (SEQ ID NOS 1 and 2), and deletion of amino acids N388-Y389 (SEQ ID NO: 3) using nucleic acid hybridization probes to detect the presence or absence of the alleles. It is further noted that the claims of the ‘637 patent recite the same SEQ ID NOS 1-3 as those claimed as well as methods of detecting the same alleles with nucleic acid probes for the purpose of producing a profile for kidney transplantation.
Response to Arguments
The response traverses the rejections under nonstatutory double patenting and asserts that Pays provides no disclosure of the use of any probes or primers that hybridize to SEQ ID NO: 1-3. This argument has been thoroughly reviewed but was not found persuasive because Pays teaches to detect the same polymorphisms as those recited in SEQ ID NOS 1-3 using nucleic acid hybridization with probes and or primers (see para 0013). The instant claims are not directed to any particular probes or primers, while the patented claims define the same alleles as those claimed corresponding to the nucleic acid sequence of the APOL1 nucleotide sequence. Accordingly, applicants arguments that there is no teaching or suggestion in Pays for the use of probes or primers that hybridize to the claimed SEQ ID NOS is not found persuasive. It is further noted that the rejection with regard to the ‘637 patent did not cite to Pays because the claims recite the same SEQ ID NOS as those claimed as well as method of detecting the alleles with nucleic acid probes. For these reasons and the reasons already made of record, the rejections are maintained.
Conclusion
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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 is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682