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 .
Status of Claims
Currently, claims 1-6, 13-14, and 16-18 are pending in the instant application. Claims 1-6 are withdrawn from consideration as being drawn to a non-elected invention and claims 16-18 are newly added. Claims 13, 14, and 16-18 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 either newly applied, as necessitated by amendment, or 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Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.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 13-14 and 16-18 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 a method of treating colorectal cancer, rectal cancer, or colorectal adenoma by measuring the methylation level of a CpG region of the LINC01798 gene and “identifying the human subject as having an increased level of methylation at the CpG region relative to a control and specifically and differentially diagnosing the human subject as having colon cancer, rectal cancer, or colorectal adenoma if the level of methylation at the CpG region is increased relative to the control”. This recitation is a natural correlation between the level of CpG methylation of LINC01798 and colorectal cancer, rectal cancer, or colorectal adenoma. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claims also recite steps or elements such as: “identifying” and “diagnosing” . However, these are considered a recitation of abstract ideas because they encompass conclusions and determinations 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 measuring methylation levels, 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. Although the claims have been amended to recite “administering an anti-cancer treatment for colon cancer, rectal cancer, or colorectal adenoma”, the treatment step appears appears to either be conditional “if the level of methylation… is increased relative to the control” or it is required regardless of the diagnosis. In either situation, the treatment step does not integrate the JE into a practical application because it is either conditional depending on methylation level and therefore not required, or it is required regardless of diagnosis and therefore is not specific to the JE. Additionally, the general recitation of “administering an anti-cancer treatment for colon cancer…” does not recite or require particular treatments. As such, the “administering” step is merely a generalized “treat” limitation with no particularity that integrates the judicial exception into a practical application. The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294.
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 steps of measuring CpG methylation levels, including by “PCR”, “pyrosequencing”, “bisulfite sequencing”, or any of the other assays listed in claims 8 and 14, 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 step 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. The response asserts that the claims have been amended to recite “a method of treating…”. This argument has been thoroughly reviewed but was not found persuasive for the reasons made of record above. The rejection is maintained.
Claim Rejections - 35 USC § 112
Claims 13-14 and 16-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 has been amended to recite three steps noted “(a)”, “(b)”, and “(d)”, skipping a step (c). It is not clear if this was a typographical error or if another step between steps “b” and “d” is required.
Claim 13 has been amended to recite “identifying the human subject as having an increased level of methylation at the CpG region relative to a control and specifically and differentially diagnosing the human subject as having colon cancer, rectal cancer, or colorectal adenoma if the level of methylation at the CpG region is increased relative to the control” in step b. However, given that the claims recites “if” and repeats the phrase “the level of methylation at the CpG region is increased relative to the control” it is not clear if the claim actually requires detecting “an increased level of methylation at the CpG region relative to a control”. As such, it is not clear if step b is conditional or not. Additionally, it is not clear if step d is conditional following step b, or if the administration occurs regardless of whether the subject is diagnosed or not.
Conclusion
Li (Li et al; Journal of Cellular Biochemistry; DOI:10.1002/jcb.29463, pages 1-10; January 13, 2020). Li teaches a study that analyzed the DNA methylation of lncRNAs in colon adenocarcinoma. Li teaches identifying 105 lncRNAs whose expression was upregulated and 116 lncRNAs whose expression was downregulated in patients with colon adenocarcinoma compared to normal tissue controls, as well as CpG methylation analysis of 70 upregulated lncRNAs. However, with regard to claims 7-9 and 13-15, none of the differentially regulated lncRNAs (either upregulated or downregulated) or differentially methylated lncRNAs identified by Li were LINC01798.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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