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. Specification The disclosure is objected to because page 25, Table 5 of the specification contains embedded hyperlinks and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Information Disclosure Statement The information disclosure statements (IDS) submitted on 12/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Status of Claims Claims 1-6 are pending and under consideration . This is the first action on the merits. Claim Objections Claim 1 is objected to for not ending the claims with a period. See MPEP 608.01(m) "Each claim begins with a capital letter and ends with a period." Priority The applicant claims priority of US provisional applications NO. 63/378,366 and 63/378,365, both have filling date on October 04, 2022. Claim Rejections - 35 USC § 112(b) 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. Claims 1-6 are rejected under 35 U.S.C. 112(b), 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. A) Regarding claim 1 , it recites: "[a] direct from blood, without culture, reverse transcriptase polymerase chain reaction (RT-qPCR) test for bacteria causing bacteremia, based on the RNA identified in patients with bacteremia caused by these bacteria." This claim is indefinite because it is unclear which statutory category the claimed "test" falls under and what limitations define the claimed invention. An "RT-qPCR" test may refer to a process of performing the test comprising specific method steps, a kit comprising assay reagents (an article of manufacture), or a device configured to perform the test (a machine). However, the claim merely recites a "test" with an intended use ("for bacteria causing bacteremia, based on the RNA identified in patients with bacteremia caused by these bacteria"), without reciting any active steps, structural components, or compositional features. Therefore, the claim fails to clearly indicate whether it is directed to a process, manufacture, or machine, and it lacks limiting features that would permit a determination of its scope. A person of ordinary skill in the art therefore cannot reasonably ascertain the metes and bounds of the claimed subject matter, without applying considerable speculation and assumption. Consequently, claim 1 and its dependent claim 2 are excluded from prior art search in this examination, as any rejection based on prior art cannot be based on speculations and assumptions, see In re Steele, 305 F.2d 859, 862 (CCPA 1962). B) Regarding claim 3 , it recites "[a] direct from blood, without culture, reverse transcriptase polymerase chain reaction (RT-qPCR) test for bacteria causing pneumonia, based on the RNA identified in patients with pneumonia caused by these bacteria. " This claim is indefinite because it is unclear which statutory category the claimed "test" falls under and what limitations define the claimed invention. An "RT-qPCR" test may refer to a process of performing the test comprising specific method steps, a kit comprising assay reagents (an article of manufacture), or a device configured to perform the test (a machine). However, the claim merely recites a "test" with an intended use ("for bacteria causing pneumonia, based on the RNA identified in patients with pneumonia caused by these bacteria"), without reciting any active steps, structural components, or compositional features. Therefore, the claim fails to clearly indicate whether it is directed to a process, manufacture, or machine, and it lacks limiting features that would permit a determination of its scope. A person of ordinary skill in the art therefore cannot reasonably ascertain the metes and bounds of the claimed subject matter, without applying considerable speculation and assumption. Consequently, claim 3 and its dependent claim 4 are excluded from prior art search in this examination, as any rejection based on prior art cannot be based on speculations and assumptions, see In re Steele , 305 F.2d 859, 862 (CCPA 1962). C) Regarding claim 5, it recites "[a] direct from blood, without culture, reverse transcriptase polymerase chain reaction (RT-qPCR) test for the most common resistance genes expressed that would influence treatment of bacteria." This claim is indefinite because it is unclear which statutory category the claimed "test" falls under and what limitations define the claimed invention. An "RT-qPCR" test may refer to a process of performing the test comprising specific method steps, a kit comprising assay reagents (an article of manufacture), or a device configured to perform the test (a machine). However, the claim merely recites a "test" with an intended use ("for the most common resistance genes expressed that would influence treatment of bacteria"), without reciting any active steps, structural components, or compositional features. Therefore, the claim fails to clearly indicate whether it is directed to a process, manufacture, or machine, and it lacks limiting features that would permit a determination of its scope. A person of ordinary skill in the art therefore cannot reasonably ascertain the metes and bounds of the claimed subject matter, without applying considerable speculation and assumption. Consequently, claim 5 and its dependent claim 6 are excluded from prior art search in this examination, as any rejection based on prior art cannot be based on speculations and assumptions, see In re Steele , 305 F.2d 859, 862 (CCPA 1962). D) Regarding claims 1, 3, and 5 , all three claims recite "[a] direct from blood , without culture, reverse transcriptase polymerase chain reaction (RT-qPCR) test." This phrase is indefinite because it is unclear how an RT-qPCR test can be "direct from blood." As the claims are currently written, it is ambiguous whether this language is intended to describe an input sample sourcing method or something else. Furthermore, the claims do not include any steps that involve obtaining or using a test "direct from blood," adding to the lack of clarity. Claims 2, 4, 6 are rejected for depending from claims 1, 3, 5 and not remedying the indefiniteness. Applicant is required to point out the patentably novelty of the invention in full, clear, concise, and exact terms in the response to this office action, See 37 CFR 1.111 and MPEP § 714.02. Failure to do so will be treated as an incomplete reply under 37 CFR 1.111. 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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. Regarding claim 1 and its dependent claim 2, the claimed invention is directed to nonstatutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claim 1 is directed to a use of a test. Specifically, claim 1 recites an RT-qPCR test " for bacteria causing bacteremia, based on the RNA identified in patients with bacteremia caused by these bacteria ." This language merely states an intended use or purpose of the test. The claim does not recite any active steps defining how the test is performed for the stated purpose; nor does it recite any structural or compositional features that define a kit, device, or composition configured to directly support the intended use. Accordingly, claim 1 is directed to an intended use of a test and is not patent eligible. See MPEP 2173.05(q) " 'Use' claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)('one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101')." In conclusion, the claims are not patent eligible under 35 U.S.C. 101. Claims 3-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. Regarding claim 3 and its dependent claim 4, the claimed invention is directed to nonstatutory subject matter . The claims do not fall within at least one of the four categories of patent eligible subject matter because claim 3 is directed to a use of a test. Specifically, claim 3 recites an RT-qPCR test " for bacteria causing pneumonia, based on the RNA identified in patients with pneumonia caused by these bacteria ." This language merely states an intended use or purpose of the test. The claim does not recite any active steps defining how the test is performed for the stated purpose; nor does it recite any structural or compositional features that define a kit, device, or composition configured to directly support the intended use. Accordingly, claim 3 is directed to an intended use of a test and is not patent eligible. See MPEP 2173.05(q) " 'Use' claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton , 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)('one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101')." In conclusion, the claims are not patent eligible under 35 U.S.C. 101. Claims 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. Regarding claim 5 and its dependent claim 6, the claimed invention is directed to nonstatutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claim 5 is directed to a use of a test. Specifically, claim 5 recites an RT-qPCR test " for the most common resistance genes expressed that would influence treatment of bacteria ." This language merely states an intended use or purpose of the test. The claim does not recite any active steps defining how the test is performed for the stated purpose; nor does it recite any structural or compositional features that define a kit, device, or composition configured to directly support the intended use. Accordingly, claim 5 is directed to an intended use of a test and is not patent eligible. See MPEP 2173.05(q) " 'Use' claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton , 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)('one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101')." In conclusion, the claims are not patent eligible under 35 U.S.C. 101. Double Patenting- Same Invention A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 1-6 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6 of copending Application No. 19/339,171 (reference application, see claims filed 09/24/2025). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TIAN NMN YU whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4694 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30 am - 5:30 pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Gary Benzion can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0782 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TIAN NMN YU/ Examiner , Art Unit 1681 /AARON A PRIEST/ Primary Examiner, Art Unit 1681