CTNF 18/299,967 CTNF 74551 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25-01 AIA Applicant’s election without traverse of the Group I, claims 1-15 , in the reply filed on 8/21/2025 is acknowledged. 08-06 Claims 16-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/21/2025. Claims 1-15 as filed on 4/13/2023 are under examination in the instant office action. Claim Rejections - 35 USC § 112 Indefinite 07-34-01 Claim 10 is 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. 07-34-05 AIA Claim 10 recites the limitation " said volume " in in the method of claim 7 which does not recite any volume . There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-10 and 13-15 are rejected under 35 U.S.C. 102 ( a) (1 ) as being anticipated by US 5,389,547 (Tanaka et al) . The cited US 5,389,547 (Tanaka et al) discloses a method of detecting one or more blood-borne microbe in a subject at risk of microbial infection, wherein the method comprises steps of: obtaining platelet rich plasma (PRP) from a sample of whole blood drawn from said subject (col. 16, lines 25-28; col.12, lines 20-24; col. 20, lines 50-52); incubating the PRP at a temperature greater than room temperature or at 37°C for 10 min (col. 16, lines 33; col. 20, line 65) which is within the claim-recited interval for up to 5 days, wherein said incubating step occurs immediately after blood collection from subject/patient or less than 24 hours after said obtaining step within the meaning of the claims; and detecting the presence of one or more blood-borne microbes in said PRP using Limulus reagent for detection of fungal beta glucan and bacterial endotoxin as indication of microbial infection (entire document including abstract, table 5, table 8). Thus, the cited document US 5,389,547 (Tanaka et al) anticipates claim 1. As applied to claims 2-4: the blood-borne microbe comprises pathogenic microbes including bacteria (col. 26, line 45) and the subject suspected in septicemia (col.26, line 45), thus, exhibits symptoms of sepsis. As applied to claim 5: the subject comprises a human (all examples and col. 4, line 3). As applied to claims 6-7: in the cited method the original whole blood sample is contacted with anticoagulant prior to obtaining PRP which is heparin (examples and col. 4, line 33). As applied to claims 8-9: upon centrifugation of the whole blood sample the PRP sample which is subjected to testing is less than whole blood sample; and the sample of whole blood drawn is 2 ml (col.12, line 21) which is less than 20 ml in volume as recited in the claims. With respect to claims 10, 13-14: it is noted that these claims do not comprise any active steps but solely drawn to intended effects and/or intended benefits. The cited document clearly recognizes that the discloses method allows for rapid and early diagnosis of infections with fungal and gram-negative bacteria (col. 11, lines 29-32). With respect to claim 15: The cited document US 5,389,547 (Tanaka et al) clearly recognizes that culturing samples with microbes requires additional time for identification of species (col.16, lines 60-67). Thus, the cited document US 5,389,547 (Tanaka et al) anticipates the claimed invention . 07-15 AIA Claim s 1-3, 5, 8-10 and 13-15 are rejected under 35 U.S.C. 102 ( a) (1 ) as being anticipated by Vedy et al (“Bacterial contamination of platelet concentrates: pathogen detection and inactivation methods”. Hematology Reviews 2009, Volume 1:e5, pages 22-28) . The cited reference by Vedy discloses a method of detecting bacterial contamination in platelet concentrates, wherein the method comprises steps of: obtaining a platelet concentrate (same as platelet rich plasma PRP) which is routinely made from a sample of whole blood drawn from donor; incubating the platelet sample 37°C for up to 5 days, wherein said incubating step occurs at about 24 hours after said obtaining step (see page 23, col. 3, par. 2, lines 11-19) within the meaning of the claims; and detecting the presence, if any, of one or more blood-borne microbes or bacteria (see page 22, paragraph bridging col 2 and col 3). Thus, the cited reference by Vedy anticipates claims 1-3, 5, 9. With respect to claims 8, 10, 13-15: it is noted that these claims do not comprise any active steps but solely drawn to intended effects and/or intended benefits. The structural elements including volume (claim 8) and culture time (claim 15) are recited in relative terms that cannot be precisely determined in order to determine the differences, if any. Thus, the cited reference by Vedy anticipates the claimed invention . Claim Rejections - 35 USC § 103 07-20-aia AIA 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 to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-21-aia AIA Claim s 1-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,389,547 (Tanaka et al), Vedy et al (“Bacterial contamination of platelet concentrates: pathogen detection and inactivation methods”. Hematology Reviews 2009, Volume 1:e5, pages 22-28), Lee et al (“Rapid Detection of Bacterial Contamination of Platelet-Rich Plasma-Derived Platelet Concentrates Using Flow Cytometry”. Annals of Clinical and Laboratory Science, 2012, vol. 42, no. 2, pages 174-181), Yen Peng Ho et al (“Identification of pathogens by mass spectrometry”. Clinical Chemistry, 2010, 56:4, pages 525-536) . The cited US 5,389,547 (Tanaka et al) is relied upon as explained above for disclosure of a method for detecting one or more blood-borne microbe in a subject suspected to have microbial or bacterial infection and exhibiting symptoms of sepsis, wherein presence of microbial or bacterial infection is detected in a sample of a platelet rich plasma (PRP) made from a sample of whole blood drawn from the subject (col. 16, lines 25-28; col.12, lines 20-24; col. 20, lines 50-52). In particular, the presence of microbial infection is detected by using Limulus reagent for detection of bacterial endotoxin as indication of microbial/bacterial infection presence (entire document including abstract, table 5, table 8). But the cited US 5,389,547 (Tanaka et al) is silent about other methods for bacterial detection. However, prior art teaches the use of various methods for detection of microbes in clinical samples including PRP samples, wherein the detection methods include culturing the PRP samples (see Vedy as explained above), flow cytometry and RCR techniques (see abstract of Lee and page 178, col. 2) and mass spectrometric analysis (see abstract and figure 1 of Yen Peng Ho et al). Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to use various methods for detection of microbial or bacterial presence with a reasonable expectation of success in detection of blood borne pathogens in clinical samples including PRP samples as clearly evidenced by the cited prior art references. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary. The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103. Further, as applied to the scope of claims 8, 10 and 13-15, the cited reference by Lee clearly recognizes that culturing of blood samples have limitations and/or drawbacks such as large volumes of samples and relatively long incubation times of samples (page 178, col. 2, par. 2) relatively to rapid detection methods. The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103 . 07-22-aia AIA Claim s 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,389,547 (Tanaka et al), Vedy et al (“Bacterial contamination of platelet concentrates: pathogen detection and inactivation methods”. Hematology Reviews 2009, Volume 1:e5, pages 22-28), Lee et al (“Rapid Detection of Bacterial Contamination of Platelet-Rich Plasma-Derived Platelet Concentrates Using Flow Cytometry”. Annals of Clinical and Laboratory Science, 2012, vol. 42, no. 2, pages 174-181), Yen Peng Ho et al (“Identification of pathogens by mass spectrometry”. Clinical Chemistry, 2010, 56:4, pages 525-536) as applied to claim s 1-10 and 12-15 above, and further in view of White (IDS reference; Am J Pathol., 1968, 53(2), pages 281-289) and Spielvogel (“An ultrastructural study of the mechanisms of platelet-endotoxin interaction”. Journal of experimental medicine, 1967, vol. 126, no. 2, pages 235-250; abstract STN Medline accession number 1967177380) . The cited references US 5,389,547 (Tanaka et al), Vedy et al, Lee et al and Yen Peng Ho et al as above. They are silent about treating blood samples with agent inducing biconcave platelet shape change into spheres or sphering of platelets. However, the prior art recognizes a link or association between adherence of bacterial endotoxin to sphering platelets (see abstract of Spielvogel); and the agents inducing shape change in platelets are knonw in the prior art (see IDS reference by White). Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to treat blood sample comprising platelets with an agent inducing sphering of platelets in the method of US 5,389,547 (Tanaka et al) with a reasonable expectation of success in detection of blood borne pathogens in clinical PRP sample because method of US 5,389,547 (Tanaka et al) is based on detection of bacterial endotoxin as an indicator of bacterial presence/contamination in blood samples and because prior art (Spielvogel) recognizes association of presence of bacterial endotoxin and platelets sphering/platelet shape changing. One of skill in the art would have been motivated to induce sphering of platelets in test samples in order to optimize or to maximize detection of bacterial endotoxin in blood-derived samples due to binding or association of endotoxin with sphering platelets as described by Spielvogel. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary. The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103. Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Vera Afremova September 3, 2025 /VERA AFREMOVA/ Primary Examiner, Art Unit 1653 Application/Control Number: 18/299,967 Page 2 Art Unit: 1653 Application/Control Number: 18/299,967 Page 3 Art Unit: 1653 Application/Control Number: 18/299,967 Page 4 Art Unit: 1653 Application/Control Number: 18/299,967 Page 5 Art Unit: 1653 Application/Control Number: 18/299,967 Page 6 Art Unit: 1653 Application/Control Number: 18/299,967 Page 7 Art Unit: 1653 Application/Control Number: 18/299,967 Page 8 Art Unit: 1653 Application/Control Number: 18/299,967 Page 9 Art Unit: 1653 Application/Control Number: 18/299,967 Page 10 Art Unit: 1653