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 .
This action is in response to papers filed 7/16/2026.
Claims 1-2, 4, 6, 8-9 are pending. Claims 3, 5, 7 have been cancelled.
The following rejections are newly applied as necessitated by amendment.
This action is final.
Withdrawn Rejections
The 35 USC 112b and 35 USC 103 rejection made in the previous office action is withdrawn based upon amendments to the claims.
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 1-2, 4, 6, 8-9 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.
Claims 1-2, 4, 6, 8-9 are indefinite over the wherein steps. The wherein steps appear to be drawn to the course of infection, however, there is no indication that the sample has an infection and therefore it is not clear how to perform and determine the thresholds.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-2, 4, 6, 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation without significantly more. The claim(s) recite(s) a judicial exception of correlation of serum amyloid A mRNA level and infection progression. This judicial exception is not integrated into a practical application because the claims require steps of obtaining a swab, determining mRNA and normalizing which are considered routine steps for measuring mRNA analysis expression analysis and does not provide a step to integrate the judicial exception. For claim 9, treatment step must be “particular” i.e. specifically identified so it doesn’t encompass all applications of the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception to steps that are not considered routine and conventional steps.
These judicial exceptions are not integrated into a practical application because the claims only recite the natural correlation, wherein the step of comparing does not integrate the judicial expectation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are considered general and routine knowledge in the prior art as exemplified by the specification (p 2-3). The claims are drawn to using routine methods of expression detection and applying the data (level).
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, a natural phenomenon.
The correlation of level and progression is considered a natural correlation. The step of providing a sample, determining the amount of mRNA in the sample, is considered a routine and conventional step.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the steps require only routine and convention steps and does not integrate the judicial exception to a practical application.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No as the claims do not require any elements that integrate the judicial exception.
The steps that are not considered judicial expectations are the steps of determining the level mRNA. Lung et al (oncogene 2015 Vol 34 p. 878-889, previously cited) teaches a method of obtaining a nasopharyngeal sample and using RT-qPCR to detect atheamount of mRNA of SAA1 (serum amyloid A) (p. 886).
Even when viewed as a combination, the additional elements of the claims fail to transform the exception into patent-eligible applications of the exceptions as the treatment step is a generically broad step that appears to be performed regardless of the determining step. Thus, the claims as a whole do not amount to significantly more than the judicial exceptions themselves. The steps outlined above are merely well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, applied to the steps of detecting biomarkers in a sample and detecting the expression level and generally treating with a therapy. The claims do not recite additional elements that amount to significantly more than the judicial exceptions.
For those reasons, claims 1-2, 4, 6, 8-9 are rejected under section 101 as being directed to non-statutory subject matter.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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