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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner Omar Ramadan , Art Unit 16 78 . Election/Restrictions Applicant’s election without traverse of Group II of claims (39-41 and 43-44) in the reply filed on 02/16/2026 is acknowledged. Claims 31-38 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 02/16/2026 . Claims 1-30 are cancelled at the Applicant’s request. Thus, claims 39-41 and 43-44 are under examination. Priority This application is a U.S. National Stage (371) application of PCT/IB2021/000715 filed on 10/11/2021 which claims priority to U.S. Provisional Application No. 63 / 089 , 635 filed on 1 0 /0 9 /20 20 . Information Disclosure Statement The information disclosure statements (IDS) submitted on 10 / 17 /2023 have been received. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner and all references are considered except where they were lined through. 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. Claims 39-41 and 43-44 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data that is compared to a cutoff value from which the applicant or doctor will be able to predict the possibility of a patient of having a bacterial or a viral infection . Such an inference is not sufficient to transform the abstract idea of a mental process ( comparing the measured values of biomarkers to a reference value to make a diagnosis of bacterial or viral infection ) and a law of nature (correlating selected biomarkers to bacterial or viral infection ) into a patentable application. The claims are ineligible because the claims recite at least one judicial exception, i.e., abstract idea of a mental process ( comparing the measured values of biomarkers to a reference value to make a diagnosis of a bacterial or a viral infection ) and a law of nature (correlating selected biomarkers to bacterial or viral infection ) . Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept. Although the re is a proposed treatment, it is conditional which means a patient might not be treated if the results of the diagnostic methods do not indicate a bacterial or a viral infection. Step 1: Is the claim to a process, machine, manufacture or composition of matter?) This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03. Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims. Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES). Similarly, c laim 39 of the instant application is also directed to a statutory class of a method for diagnosis of a bacterial infection or a viral infection in a subject as it recites “measuring the level of HLA-DR … measuring the level of MerTk … measuring the level of Metalloproteinase-8 … diagnosing that the subject suffers from a bacterial infection” (Step 1: YES). Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?) Claim 1 of example 43 of the “2019 PEG” recites judicial exceptions that are similar to claim 39 of the instant application. Specifically, and per Step 2A, prong 1 , claim 1 of example 43 of the “2019 PEG” recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. And the grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea . 2019 PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) of claim 1 of “2019 PEG” falls into the “mathematical concept” grouping of abstract ideas. Although claim 39 of the instant application does not recite a mathematical calculation as in claim 1 of example 43 of the “2019 PEG”, it is still similar to claim 1 of example 43 of the “2019 PEG” in reciting a judicial exception of a law of nature. C laim 39 of the instant application recites a judicial exception of a law of nature of correlating selected biomarkers with a bacterial infection , and limitation (a) of claim 1 of “2019 PEG” also recites a law of nature of correlating the ratio of C11 to C13 to the non-responder phenotype . Accordingly, limitation (a) of claim 1 of “2019 PEG” recites three judicial exceptions (an abstract idea that falls within the mathematical concept, a mental process groupings in the “2019 PEG”, and a law of nature) ; whereas claim 39 of the instant application recites a judicial exception of a law of nature, and the analysis must therefore proceed to Step 2A Prong Two. ( Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?) This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, claim 1 of example 43 of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception. Similar to claim 1 of example 43 of “2019 PEG”, c laim 39 of the instant application does not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claim has steps of measuring proteins levels of three or more biomarkers and diagnosing a subject of suffering from a bacterial infection , and these steps do not integrate the judicial exception into a practical application because they are data gathering steps to use in the measurement and comparison, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d). Furthermore, unlike claim 1 of example 43 of the “2019 PEG”, claim 39 of the instant application does not have an additional step that would integrate the judicial exception into a practical application. Therefore, claim 39 does not integrate the judicial exception into a practical application. ( Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?) Per Step 2B, claim 1 of example 43 of the “2019 PEG” and claim 39 of the instant application do not recite additional elements that amount to significantly more than the judicial exception . Specifically, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, claim 1 of example 43 of “2019 PEG” recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible. Similarly, c laim 39 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring the protein levels of three or more biomarkers by flow cytometry or immunoassays (Specification : page 9, lines 16 -19; page 10, lines 1-3 ). Furthermore, the claim itself is recited at a high level of generality in which any assay can be used as the measurement method for claim 39 . Thus, claim 39 is not eligible and is rejected under 35 USC 101. Regarding claim 40 , the claim teaches a judicial exception of an abstract idea of a mental process of comparing the levels of biomarkers to reference values which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more. Regarding claim 41, the claim teaches a judicial exception of a law of nature of correlating selected biomarkers with a viral infection which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more. Regarding claim 43, the claim teaches a method of selecting a therapy is a conditional treatment step because it depends on the results of the diagnostic methods which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more. Regarding claim 44 , the claim teaches a judicial exception of abstract idea of a mental process of comparing the levels of biomarkers to reference values which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more. Furthermore, the treatment step that the claim recites is a conditional step based on patients who display biomarker levels that are consistent with a bacterial infection “administering antibacterial agents to patients whose blood samples display …”. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art (PHOSITA) to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 39 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Parlato et al. (WO 2013/107826 A2) in view of Guignant et al. (Intensive Care Med (2013) 39:1556–1564) and Bermejo Martin et al. (US 2020/0225248 A1) . Claims 39 and 43 are drawn to an in vitro method for diagnosis of a bacterial infection or a viral infection in a subject in need thereof, said method comprising: a) measuring the level of HLA-DR (human leukocyte antigen DR) expression on the monocytes present in a blood sample of said subject, b) measuring the level of MerTk (Myeloid-epithelial-reproductive tyrosine kinase) expression on the neutrophils present in said blood sample, c) measuring the level of Metalloproteinase-8 (MMP8) in the plasma of said blood sample, and d) diagnosing that the subject suffers from a bacterial infection. Regarding claim 39, Parlato teaches an in vitro method for diagnosis of a bacterial infection in a subject in need ( Abstract; page 8, lines 25-27; page 9, lines 1-5 ; page 37, lines 20-23 ). And Parlato teaches measuring the level of HLA-DR (human leukocyte antigen DR) expression on the monocytes present in a blood samp l e of the subject (Page 55, lines 10-11; page 68, lines 21-23). Also, Parlato teaches diagnosing that the subject suffers from a bacterial infection (Page 9, lines 1-5, “In other terms, the methods of the invention enable to diagnose bacterially-induced infections in patients presenting at least two symptoms of SIRS”; page 74, lines 24-28). Moreover, r egarding claim 43 , Parlato teach es an in vitro method for selecting a therapy after diagnosing a patient with the method of claim 39 and administering an antimicrobial agent to the subject depending on the results of said diagnostic methods (Page 55, lines 17-28) Regarding claim 39, Parlato does not teach measuring the level of MerTk ( Myeloid-epithelial-reproductive tyrosine kinase ) expression on the neutrophils present in blood sample of the subject . And Parlato does not teach measuring the level of Metalloproteinase-8 (MMP8) in the plasma of blood sample of the subject . Regarding claim 39, Guignant teaches measuring the level of MerTk (Myeloid-epithelial-reproductive tyrosine kinase) expression on the neutrophils present in blood sample of the subject and notes its increased level of expression (Abstract; page 1558, right column, seventh paragraph, “Among the three study groups, only MerTk was differently expressed in circulating neutrophils (p<0.001). MerTk expression was increased in patients with septic shock on D1–2 in comparison with healthy volunteers and trauma patients (p<0.01)”). Regarding claim 39, Bermejo Martin teaches measuring the level of Metalloproteinase-8 (MMP8) in the plasma of blood sample of the subject (Abstract ; [0001], [0011] ). It would have been obvious for a PHOSITA before the effective filing date of the application to combine Myeloid-epithelial-reproductive tyrosine kinase ( MerTk ) biomarker of Guignant with the diagnostic method of Parlato to achieve a more sensitive diagnosis of sepsis and infection in a patient because it would have been prima facie obvious to combine because it increases the detection of infection and sepsis . Similarly , a skilled artisan would have been further motivated to combine the Metalloproteinase-8 (MMP8) biomarker of Bermejo Martin with the biomarkers of Guignant and Parlato to further increase the sensitivity of diagnosing a patient with sepsis and infection because the method of Bermejo Martin also aims to achieve the same purpose as the combined methods of Guignant and Parlato . MPEP2144.06.I notes that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven , 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) . A PHOSITA would have had a reasonable expectation of success in combining the methods of Bermejo Martin , Guignant and Parlato because all methods detect biomarkers of sepsis and infection in a patient. Claim 40 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Parlato et al. (WO 2013/107826 A2) in view of Guignant et al. (Intensive Care Med (2013) 39:1556–1564) and Bermejo Martin et al. (US 2020/0225248 A1) as applied to claim 39 above, and further in view of Venet et al . ( Crit Care Med 2007 Vol. 35, No. 8 ). The combined teachings of Parlato , Guignant , and Bermejo Martin are as described earlier. Moreover, r egarding claim s 40 and 44 , Parlato teaches measuring the level of HLA-DR (human leukocyte antigen DR) expression on the monocytes present in a blood sample of the subject (Page 55, lines 10-11; page 68, lines 21-23). Guignant teaches an increased level of MerTk expression on the neutrophils (page 1558, right column, seventh paragraph). Bermejo Martin teaches an increased level of MMP8 in the plasma, as compared to reference levels ([0011]; [0034]; [0195]; page 22, claim 12). While Parlato does teach measuring of HLA-DR , he does not teach measuring a decreased level of HLA-DR. Venet teaches that the subject displays a decreased level of HLA-DR expression on the monocytes in severe septic shock (abstract) . It would have been obvious for a PHOSITA before the effective filing date of the application to combine the diagnostic criteria of decreased levels of HLA-DR expression on the monocytes of Venet to the combined methods of Bermejo Martin , Guignant and Parlato to provide a clear cutoff criter i a for diagnosing sepsis in a patient for treatment purposes because Venet teaches that HLA-DR expression is severely decreased on circulating monocytes in sepsis and that the duration and the intensity of this decrease are associated with severe septic complications and pejorative outcome (Page 1916, middle column, second paragraph). A PHOSITA would have had a reasonable expectation of success in combining the methods of Venet , Bermejo Martin , Guignant and Parlato because all methods detect biomarkers of sepsis and infection in a patient. Claim 4 1 is rejected under 35 U.S.C. 103 as being unpatentable over Parlato et al. (WO 2013/107826 A2) in view of Guignant et al. (Intensive Care Med (2013) 39:1556–1564) and Bermejo Martin et al. (US 2020/0225248 A1) as applied to claim 39 above, and further in view of Pachot et al. (The Journal of Immunology, Volume 180, Issue 9, May 2008, Pages 6421–6429) . The combined teachings of Parlato , Guignant , and Bermejo Martin are as described earlier. Moreover, r egarding claim 41, Parlato teaches measuring the level of CD64 expression on the neutrophils in the blood sample (Page 56, lines 20-26). And Parlato fu r ther teaches measuring the level of CD24 expression on the neutrophils in the blood sample (Page 57, lines 1-8). Bermejo Martin teaches diagnosing the subject to suffer from a viral infection [0104], [0142]. Parlato does not teach measuring the level of CX3CR1 expression on the monocytes in the blood sample and does not teach diagnosing the subject to suffer from a viral infection . Pachot teaches measuring the level of CX3CR1 expression on the monocytes in the blood sample (Abstract). It would have been obvious for a PHOSITA before the effective filing date of the application to combine the CX3CR1 biomarker of Pachot with the combined methods of Bermejo Martin, Guignant and Parlato to increase the sensitivity of detection of severe sepsis in patients because Pachot t eaches that CX3CR1 expression is severely reduced in sepsis patients with unfavorable outcome (Abstract) . A PHOSITA would have had a reasonable expectation of success in combining the methods of Pachot , Bermejo Martin , Guignant and Parlato because all methods detect biomarkers of sepsis and infection in a patient. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT OMAR RAMADAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0754 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8:30 am - 5:00 pm . 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