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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 12/8/25 and 11/25/25 have been entered.
Claims 1 and 4 are pending.
Claims 1 and 4 have been amended by Applicant.
Claims 1 and 4 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action contains New Rejections Necessitated by Amendments.
Objections Withdrawn
The objections are withdrawn.
Rejections Withdrawn
The rejections under 35 U.S.C. 102(a)(1) are withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 101
Claims 1 and 4 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. Abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claims 1 and 4 are directed to natural phenomenon and abstract ideas because the claims recite natural phenomenon and abstract ideas (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” includes: amounts of acetylated tubulin in T cells as compared to amounts of acetylated tubulin in control cells that are not T cells are indications of T cell lymphoma. The abstract ideas include the “preparing data” and “preparing a data” and “comparing” steps (mentally processes). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional steps of detecting acetylated tubulin in cells from a subject (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance). Detecting acetylated tubulin in cells from subjects is conventional and routine in the art (see detecting acetylated tubulin using anti-acetylated tubulin antibody T7451 at Fig. 3A of Vogl et al (Clin Cancer Res, 2017, 23(13): 3307-3315), see detecting acetylated tubulin using anti-acetylated tubulin antibody at [0021] of Trepel et al (US 2007/0054260 A1; 3/8/07; 5/21/24 IDS), and see detecting acetylated tubulin using anti-acetylated tubulin antibody at Figure 3B and left column on page 420 of Serrador et al (Immunity, 2004, 20: 417-428), for example).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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Here, the claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting acetylation) are routinely performed in the art to obtain data regarding acetylation. Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…." Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Response to Arguments
In the Reply of 11/25/25, Applicant cites Footnote 14 of the 2019 PEG (“If a claim, under its broadest reasonable interpretation, covers performance in the mind but for recitation of generic computer component, then it is still in the mental process category unless the claim cannot be practically performed in the mind.”) and indicates the claims are patent eligible because the claimed method cannot be practically performed in the mind.
The amendments to the claims the argument found in the Reply of 11/25/25 have been carefully considered, but are not deemed persuasive. In regards to the citation of Footnote 14 of the 2019 PEG and indication the claims are patent eligible because the claimed method cannot be practically performed in the mind, the examiner disagrees. Footnote 14 does not apply to the instant claims as the instant claims are not drawn to a claim that under its broadest reasonable interpretation, covers performance in the mind “but for” recitation of generic computer component. The claim covers performance in the mind and conventional and routine detection steps that are not “recitation of generic computer component.”
New Rejections Necessitated by Amendments
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.
Claims 1 and 4 are 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 1 and 4 both recite “…wherein when an amount of acetylated tubulin in the T cell is larger than the amount of acetylated tubulin in the control cell this is an indicator of T cell lymphoma….” It is unclear what “this” (the indicator of T cell lymphoma) is. There is insufficient antecedent basis for “this” in the claims. In an effort to expedite prosecution, it is noted this suggested amendment could obviate this rejection: “…wherein an amount of acetylated tubulin in the T cell larger than the amount of acetylated tubulin in the control cell is an indicator of T cell lymphoma….” However, it is noted such an amendment would not obviate any other rejection or render the claims allowable.
Claim Rejections - 35 USC § 112
Claims 1 and 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER rejection.
Claims 1 and 4 recite methods of detecting acetylated tubulin in a T cell obtained from a subject and a control cell that is not a T cell, comparing the detected acetylated tubulin in the T cell and the control cell, wherein when an amount of acetylated tubulin in the T cell that is larger than the amount of acetylated tubulin the control cell this this is an indicator of T cell lymphoma. Descriptions of methods of detecting acetylated tubulin in a T cell obtained from a subject and a control cell that is not a T cell, comparing the detected acetylated tubulin in the T cell and the control cell, wherein an amount of acetylated tubulin in the T cell that is larger than the amount of acetylated tubulin the control cell is an indicator of T cell lymphoma are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642