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
Election Restrictions
1. Applicant’s election of Group I and species (IFIT1; symptomatic infection) in the reply filed on 12/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 9, 27, 56, 58-61, 64-66, 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 12/2/2025.
Claims 1, 5-7, 24-26, 30, 70 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 12/4/2022; 12/4/2022; 12/4/2022; 12/4/2022; 12/13/2022 4/23/2023; 9/10/2023; 9/18/2023; 12/12/2023; 2/4/2024; 2/20/2024; 4/14/2024; 6/2/202; 2/11/2025; 3/13; 2025; 6/12/2025; 6/24/2025; 9/17/2025; 1/27/2026; 2/19/2026; 3/24/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of a trademarked term has been noted in this application on p. 33. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
4. Claims 1, 5-7, 24-26, 30, 70 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.
See claims 1, 5-7, 24-26, 30, 70 as submitted 12/2/2025.
As to claim 1, it is not clear what a “bacterial subject” or a “viral subject” is. It is not clear if the claim intends to recite that they are bacterially infected or virally infected. Further, the claim only recites two outcomes – when the score is below a first predetermined level and when the score is above a second predetermined level. It is not clear what the outcomes or steps are if the score is above a first predetermined level or below a second predetermined level, or of the step is no treatment. Further, the claim recites “and/or”, so if the path is “(ii) when the score is above a second predetermined level”, it is not clear what the first predetermined level would be in that instance, of it would be the same as that recited in “(i)”.
Further as to claims 24, 25, the claims recite “test subject”. There is insufficient antecedent basis for this limitation in the claim.
Further as to claim 30, the claim recites “the level of no more than 10 RNA markers”. There is insufficient antecedent basis for this limitation in the claim.
As to claim 70, it is not clear what the outcome or step is if the score is below a predetermined level. Further, the claim recites “non-infectious subjects”. It is not clear if the claim intends to recite “non-infected” subjects or not.
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.
5. Claims 1, 5-7, 24-26, 30, 70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
See claims 1, 5-7, 24-26, 30, 70 as submitted 12/2/2025.
See also the 35 U.S.C. 112(b) rejection above as to claims 1, 70.
The instant claims are drawn to a method of treating an infection in a subject comprising measuring the amount of CD177 RNA and the amount of IFI44L RNA in a sample and generating a score, which is a statutory category of invention (Step 1: YES).
The instant claims are directed to the natural correlation between an amount of CD177RNA and an amount of IFI44L RNA in a sample and determining either a bacterial or viral infection. The instant claims further encompass the step of generating a score based on determined levels which are mathematical concepts and the mental steps of correlating score with infection to determine type of agent to be administered. As such, the instant claims recite judicial exceptions (JE) in the form of a law of nature and abstract ideas (Step 2A, Prong One: YES).
The crux of the claimed method is the natural correlation and determination thereof to diagnose infection. While the claims recite treatment of antiviral agent when the score is below a first predetermined level and/or treatment of antibiotic when the score is above a second predetermined level, the claim does not appear to recite any steps or treatment when the score is above a predetermined level and/or when the score is below a second predetermined level. As such, the claims read on additional embodiments wherein the determination or decision appears to be not to treat. As such, the instant claims read on embodiments that do not recite additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
Further, the claims do not recite additional elements that amount to significantly more than the judicial exception. As indicated below in Oved et al., Eden et al., Oved et al.-2, and Tsalik et al. and as the instant claims recite “comprising” and are interpreted in an open-ended fashion and do not exclude other RNAs (See MPEP 211), it is well-understood, routine, and conventional at the time of filing to use expression levels of RNA determinants including IFI44L (Table 3 in Eden et al.) and CD177 (Table 1 in Eden et al.), among many other RNAs, to compare, determine and diagnose type of infection. As such, beyond the JE, the instant claims only recite data-gathering steps. These data-gathering steps constitute insignificant extra-solution activity, and the instant claims also read upon embodiments wherein there is no apparent decision to treat (see above; see also the 35 U.S.C. 112(b) rejection above). As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35
U.S.C § 101.
Conclusion
6. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oved et al. (WO 2013117746 A1)(cited in applicant’s IDS submitted 12/4/2022):
teaches CD177 as an example of polypeptide determinant with an immunological role that does not differentiate between bacterial versus viral infected subjects (Table 1); as well as protein expression of IFI44L; wherein genes with differentially expressed mRNAs are not necessarily differentially expressed on the protein level (Fig 38A-1); wherein mRNA levels have been found to be differentially expressed in viral compared to bacterial infections, but their polypeptide levels in bacterial versus viral infected patients show no significant differential response [00075]; wherein mRNAs of IFI44L has been found to be differentially expressed in viral compared to bacterial infections; however when they measured and compared polypeptide levels in bacterial versus viral infected patients they did not observe a significant differential response [000333].
B. Eden et al. (WO2017149547A1)(See PTO-892: Notice of References Cited) teaches: comparing expression level of RNA in a sample derived from a bacterially infected subject and a sample from a virally infected subject at a plurality of exons, wherein that exon provides a differential expression between the subjects above a predetermined level is selected as the exon of the RNA whose expression is informative with respect to infection type; wherein CD177 and IFI44L are virally induced (Table 11)(but does not teach scoring or distinguishing between bacterial and viral for CD177 and IFI44l).
C. Oved et al. (WO 2017149548 A1)(hereinafter “Oved et al.-2”) (cited in applicant’s IDS submitted 12/4/2022) teaches: determining infection type (p. 3); wherein additional determinants include: CD177 (virally induced); IFI44L (virally induced), for differentiating between bacterial or mixed versus viral infected subjects (Table 8)(but does not teach increasing/decreasing functions or correlations for such RNAs).
D. Tsalik et al. (US20180245154)(See PTO-892: Notice of References Cited) teaches: determining etiology of respiratory infection in subject and methods of treating based in the determination (abstract); including gene sets (Table 2).
7. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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