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 .
Detailed Action
The Amendments and Remarks filed 4/27/26 in response to the Office Action of 1/28/26 are acknowledged and 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 examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Rejections Withdrawn
The rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn.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, with the use of a confocal microscope, to amounts of acetylated tubulin in control 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 and a confocal microscope at Figure 3B, left column on page 420, and right column on page 426 of Serrador et al (Immunity, 2004, 20: 417-428), for example). Further, the instant specification acknowledges immunological methods used to detect acetylated tubulin “are known” (lines 7-24 on page 13, in particular). Further, the instant specification acknowledges mass spectrometry methods used to detect acetylated tubulin “can be carried out using any technique” (lines 11-12 on page 18, in particular), and goes on to discuss known mass spectrometry techniques (pages 18-19, in particular).
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 4/27/26, Applicant states claims 1 and 4 have been amended to recite “comparing” is done “with use of a confocal microscope” and states amounts of acetylated tubulin are compared by software integrated with a confocal microscope. Applicant further 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. Applicant further argues the claims are patent eligible because the claimed methods are not “performance in the mind and conventional and routine” but in line with Footnote 14.
The amendments to the claims and the arguments found in the Reply of 4/27/26 have been carefully considered, but are not deemed persuasive. In regards to the arguments that claims 1 and 4 have been amended to recite “comparing” is done “with use of a confocal microscope” and that amounts of acetylated tubulin are compared by software integrated with a confocal microscope, claims do not recite comparing using software integrated with a confocal microscope. However, it is noted it is conventional and routine to compare using software integrated with a confocal microscope (such as software used by the Leica TCS-SP confocal microscope of Serrador et al (Immunity, 2004, 20: 417-428), for example).
In regard to the citation of 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 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”, such as “obtaining” a sample from a subject, “detecting” acetylated tubulin in a cell of the sample by an immunological method using an antibody or mass spectrometry.
In regards with the argument that the claims are patent eligible because the claimed methods are not “performance in the mind and conventional and routine” but in line with Footnote 14, the examiner disagrees. 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, with the use of a confocal microscope, to amounts of acetylated tubulin in control 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 and a confocal microscope at Figure 3B, left column on page 420, and right column on page 426 of Serrador et al (Immunity, 2004, 20: 417-428), for example). Further, the instant specification acknowledges immunological methods used to detect acetylated tubulin “are known” (lines 7-24 on page 13, in particular). Further, the instant specification acknowledges mass spectrometry methods used to detect acetylated tubulin “can be carried out using any technique” (lines 11-12 on page 18, in particular), and goes on to discuss known mass spectrometry techniques (pages 18-19, in particular). 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. Further, “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”, such as “obtaining” a sample from a subject, “detecting” acetylated tubulin in a cell of the sample by an immunological method using an antibody or mass spectrometry.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
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.
The second to last lines of both claims 1 and 4 recite “…wherein the T cell is….” Claims 1 and 4 recite two different T cells: (i) a T cell obtained from a subject and (ii) a control T cell from a control subject. There is insufficient antecedent basis for “the T cell” in the claims.
Conclusion
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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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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