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 .
The examiner reviewing your application at the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to examiner Jehanne Sitton in art unit 1682.
Election/Restrictions
Applicant's election with traverse of Group II, and species 18S-GM1447 in the reply filed on 1/28/2026 is acknowledged. The traversal is on the ground(s) that no unity issue was raised in the international phase of the application. This is not found persuasive for the reasons made of record in the previous office action. The requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 1-5, 7, 9-13 and 18 is set forth herein. Claims 6, 8, 14-17, and 19 are withdrawn from consideration as being directed to non-elected inventions.
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, 9-13, and 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 recite methods of “identifying potentially relevant markers in cancer diagnosis, prognosis, and/or estimation of treatment benefit or therapy”, “identifying the prognostic”, and “estimating the benefit of a treatment” by measuring the 2’O methylation level of the 2’O ribose methylation positions of rRNAs. This recitation is a natural correlation between the methylation levels/status of the 2’O ribose methylation positions of rRNAs and cancer diagnosis, prognosis, estimation of treatment benefit etc. 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 a number of mathematical concepts including “estimating” a benefit, “a statistical approach”, etc as well as a number of elements that encompass mental steps such as “diagnosing”, “prognosing”, comparing”, etc. These recitations are directed to abstract ideas and mathematical concepts which are also judicial exceptions. It is therefore determined that the claims recite 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.
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 measuring 2’O methylation levels is generally recited and directed to well understood, routine and conventional activity. 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.
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.
Claims 1-5, 7, 9-13, and 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. Appropriate correction, including correction of all grammar mistakes is required.
The claims contain terms in quotation marks. However, the meaning of the quotation marks is not clear. It is not clear if this is intended to designate a data group or designation. Appropriate correction is required.
The claims require determining a “variable” status, however the claims do not provide any guidance as to the degree required for a position to be determined to have a “variable status”. Likewise, the recitation of “methylation status” is also confusing because the claims require determining the methylation status by comparing variability of 2’O ribose methylation patterns. Appropriate correction is required.
The term “the 106 2’O ribose methylation positions” lacks sufficient antecedent basis in the claims. Appropriate correction is required.
The recitation of “determining the prognostic” in claim 9 and the claims which depend from it is confusing because it is not clear what a “prognostic” is. Does it refer to a particular type of cancer, to a particular category of cancer, to prognosis of disease, etc? This issue is rendered more confusing because the term “prognostic” is grammatically incorrect.
Step c in claim 12 is confusing because it requires a comparison to a representative population which has a methylation level that measures “closer” to that of the tested patient. However, neither the claims nor the specification provide guidance as to the metes and bounds of the term “closer”. The methylation level required to be considered “closer” by the practitioner is unclear. Appropriate correction is required.
The claims also recite carrying out a position by position analysis or a whole profile analysis of all 2’O positions, however the claims do not make clear how to distinguish the different types of analysis. It is not clear if the “position by position” analysis is required for all of the 2’O positions or only for a select number. If it is, it is not clear how it is distinguished from “a whole profile” in terms of determining if a “variable” status is present or not.
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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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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