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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 5/14/25 is acknowledged.
Claims 27 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/14/25.
Claims 1-26, 29-34 and 36 are examined on the merits. Claim 36 is newly presented.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/25 and 1/29/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless - (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Prior Rejection Withdrawn in view of Arguments) Claim(s) 1-26 and 29-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hoffmann et al. (US PGPub 20220162686)
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.
(Prior Rejection Maintained and extended to new claim 36) Claims 1-26, 29-34 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Claims 1-26, 29-34 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter “Myriad”).
Based upon an analysis with respect to the claims as a whole, claim(s) 1-26, 29-34 and 36 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See www.uspgo.gov for further guidance).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps found at www.uspto.gov, the claims are directed to an ineligible process as further detailed below.
In this case, claim(s) 1-26, 29-34 and 36 recite or are directed to a process (Step 1) and recite steps that are directed to judicial exceptions (in this case, abstract ideas)(Step 2A-Prong One). The claimed methods depositing a sample in an instrument, amplifying any nucleic acids present and calculating the amount of the analyte over time and comparing the quantity of the analyte over time. The comparison involves using laboratory equipment and mental processes to determine how much of a nucleic acid is present in the sample, and the nucleic acids are from a naturally occurring SARS-CoV-2 virus. However, the steps are interpreted to be mental steps with the addition of an instrument that can be used to amplify and detect any sequences present since the sequence amount calculating and comparison can be done by hand on a piece of paper or using a computer. Thus the claims are directed to a method in which mental steps/abstract ideas are claimed.
The claims also require step does not amount to significantly more as administering such immunogens would be routine and these steps are recited at a high level of generality. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention. Related to routine and conventional, Hoffmann et al. (see below) present a method that teaches a method that falls within the scope of the claimed method. The present claims only recite mental and computational method steps, except for the depositing of a sample.
When considering step 2A-Prong Two, the claim method does not recite any additional elements that integrate it into a practical application.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. The claims do not invoke any of the considerations that courts have identified as providing significantly more than the exceptions. Even when viewed as a combination, the additional elements fail to transform the exceptions into a patent eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception.
It is asserted that the claims are directed to judicial exceptions by reciting abstract ideas associated with an instrument that amplifies nucleic acid sequences, which is routine and conventional steps known in the art, without reciting more or additional elements that amount to significantly more than the judicial exception. Therefore, claim(s) 1-26, 29-34 and 36 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Response to arguments:
Applicant’s arguments are considered in full, however, they are not persuasive.
In response, while the claimed invention requires unconventional, not routine are unusual limitations, these limitations are not active steps, but mental steps and/or steps that rely on a generic instrument (line 2 of claims 1 and 36) or a more specific instrument/machine (line 2 of claim 6). Specifically related to claim 1, the receiving a plurality of signals; calculating for each instance of time; comparing a moving average; and related to claim 7, the sending a signal indicating a positive result based on the moving average are recited at a high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention. Moreover, the active step from claim 1 requires “depositing a sample in an instrument configured to selectively amplify an analyte” is taught by Hoffman et al. as their provisional application (63/117,932) supports such a teaching. For example, ‘932 on page 1 of the specification teaches:
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The corresponding sections of Hoffman et al. (US PGPub 2022/0162686) that teach parts i. and ii. from the provisional application presented above are the abstract and paragraphs 15, 17 and 82. Furthermore, the claimed limitations of “instrument configured to selectively amplify an analyte” [claims 1 and 36]; and “the instrument is a FLOS-LAMP instrument” [claim 6] are generic instruments and MPEP 2106.05(b) states:
“McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable"). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an 'inventive concept.'")”
As stated above, the active step of at least claim 1 where a sample is deposited in an instrument, maybe also require the use of a FLOS-LAMP instrument, however, the remaining limitations are recited at a high level of generality and are not active steps. Therefore, if they are unconventional, not routine or unusual limitations, they do not integrate the judicial exception with a particular application and do not recite additional elements that amount to significantly more than the judicial exception.
Conclusion
THIS ACTION IS MADE FINAL. 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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671