Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTIONS
2. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
3. Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
NON-PRIOR ART REJECTION
4. 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or correlation without significantly more. The claims recite a natural correlation between expression level of a composite biomarker and whether a subject has an infection. This judicial exception is not integrated into a practical application because data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the physical steps of loading a sample into a fluidic device, performing processes within the device, and measuring an expression level of a composite biomarker using the fluidic device were routine and conventional in the prior art, as indicated by Hodko et al. (US 2022/0307079), see paragraphs 0008-0019, 0029-0030, 0052, 0138, 0141, 0172, 0183, 0186, 0193-0195, 0198, and 0258-0259.
PRIOR ART REJECTIONS
5. 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.
6. 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 –
(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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hodko et al. (US 2022/0307079).
Regarding independent claim 1, Hodko discloses a method comprising: loading a blood sample into a fluidic device; performing nucleic acid related processes within the device, and measuring expression of a composite biomarker, wherein a subject is identified as having an infection, and wherein the method takes no more than 35 minutes (15 minutes is disclosed). See paragraphs 0008-0019, 0029-0030, 0052, 0138, 0141, 0172, 0183, 0186, 0193-0195, 0198, and 0258-0259.
Regarding claim 2, Hodko discloses methods which omit the use of DNase and omit performing amplification of genomic DNA (RNA-based detection is disclosed in paragraph 0186).
The claimed methods cannot be distinguished from the methods of Hodko.
7. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of Wille et al. (US 2006/0281092).
The teachings of Hodko are discussed above.
Hodko does not disclose use of an RNA stabilization solution.
Wille discloses use of an RNA stabilization solution. See paragraph 0017.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by using an RNA stabilization solution because Wille disclosed the advantage of using such a solution in RNA analysis. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
9. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of Bommarito et al. (US 2011/0097814).
The teachings of Hodko are discussed above.
Hodko does not disclose preparing reagents by convection drying.
Bommarito discloses preparing reagents by convection drying for use in devices. See paragraphs 0116-0117.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by preparing dried reagents using convection drying because Bommarito disclosed the advantage of using dried reagents prepared by convection drying. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
10. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of Zenhausern et al. (US 2010/0213063).
The teachings of Hodko are discussed above.
Hodko does not disclose use of bubble mixing.
Zenhausern discloses use of bubble mixing to facilitate binding of nucleic acids to beads. See paragraph 0227.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by using bubble mixing because Zenhausern disclosed the use of bubble mixing to facilitate binding of nucleic acids to beads within a fluidic device. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
11. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hodko.
The teachings of Hodko are discussed above.
Hodko does not disclose an exact volume of blood sample such as less than 500 microliters (claim 6), nor the use of the set of informative genes required in claim 7.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by using a blood sample volume of less than 500 microliters, and using the gene biomarker panel as recited in claim 7, because these would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P 2144.05). In other words, the skilled artisan would have routinely optimized the blood sample volume and biomarker panel for use in the method of Hodko according to the particulars of the assay, such as which organisms were desired to be detected. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
12. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742).
The teachings of Hodko are discussed above.
Hodko does not disclose coupling a collection tube with a fluidic device.
Reber discloses coupling a collection tube with a fluidic device. See paragraphs 0025-0028, 0033-0044, 0059-0070, 0079-0082, 0192-0216, 0345, 0349, 0392, and 0468-0487.
Macemon also discloses coupling a collection tube with a fluidic device. See column 2, lines 14-58 and claim 1.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by coupling a collection tube with a fluidic device because both Reber and Macemon disclosed the benefit of transferring a sample to a fluidic device in this manner. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
13. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of Solczynski et al. (US 2022/0241785).
The teachings of Hodko are discussed above.
Hodko does not disclose use of a valve and valve seat as recited.
Solczynski discloses use of a valve and valve seat in a fluidic device as required in the claim. See paragraphs 0012-0034 and 0045-0147.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by using a valve and valve seat as claimed in a fluidic device because Solczynski disclosed the advantages of such a valve and valve seat in analysis of nucleic acids using a fluidic device. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
14. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of Solczynski, and further in view of Miller et al. (US 2025/0144623).
The teachings of Hodko and Solczynski are discussed above.
These documents do not disclose the use of laser welding in forming fluidic devices.
Miller discloses use of laser welding in fluidic devices. See paragraph 0428.
One of ordinary skill in the art would have been motivated to modify the method of Hodko and Solczynski by applying laser welding to the fluidic device because Miller disclosed the use of laser welding in fluidic devices. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
15. Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742).
Regarding independent claim 13, Hodko discloses a method comprising: loading a blood sample into a fluidic device; performing nucleic acid related processes within the device, and measuring expression of a composite biomarker, wherein a subject is identified as having an infection, and wherein the method takes no more than 35 minutes (15 minutes is disclosed). See paragraphs 0008-0019, 0029-0030, 0052, 0138, 0141, 0172, 0183, 0186, 0193-0195, 0198, and 0258-0259. Hodko additionally discloses performing LAMP. See paragraph 0183.
Regarding claim 14, Hodko discloses methods which omit the use of DNase and omit performing amplification of genomic DNA (RNA-based detection is disclosed in paragraph 0186).
Hodko does not disclose coupling a collection tube with a fluidic device, or an exact volume of blood volume, such as 600 microliters.
Reber discloses coupling a collection tube with a fluidic device. See paragraphs 0025-0028, 0033-0044, 0059-0070, 0079-0082, 0192-0216, 0345, 0349, 0392, and 0468-0487.
Macemon also discloses coupling a collection tube with a fluidic device. See column 2, lines 14-58 and claim 1.
One of ordinary skill in the art would have been motivated to modify the method of Hodko by coupling a collection tube with a fluidic device because both Reber and Macemon disclosed the benefit of transferring a sample to a fluidic device in this manner. One of ordinary skill in the art would have been motivated to modify the method of Hodko by using a blood sample volume of less than 600 microliters because this would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P 2144.05). In other words, the skilled artisan would have routinely optimized the blood sample volume in the method of Hodko according to the particulars of the assay, such as which organisms were desired to be detected. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
16. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742), and further in view of Bommarito et al. (US 2011/0097814).
The teachings of Hodko, Reber, and Macemon are discussed above.
These references do not disclose preparing reagents by convection drying.
Bommarito discloses preparing reagents by convection drying for use in devices. See paragraphs 0116-0117.
One of ordinary skill in the art would have been motivated to modify the method of Hodko as modified by either of Reber or Macemon by preparing dried reagents using convection drying because Bommarito disclosed the advantage of using dried reagents prepared by convection drying. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
17. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742), and further in view of Wille.
The teachings of Hodko, Reber, and Macemon are discussed above.
These references do not disclose use of an RNA stabilization solution.
Wille discloses use of an RNA stabilization solution. See paragraph 0017.
One of ordinary skill in the art would have been motivated to modify the method of Hodko as modified by either Reber or Macemon by using an RNA stabilization solution because Wille disclosed the advantage of using such a solution in RNA analysis. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
18. Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742).
The teachings of Hodko, Reber, and Macemon are discussed above.
These references do not disclose the use of the set of informative genes required in claim 17, nor detecting expression of housekeeping and control genes.
One of ordinary skill in the art would have been motivated to modify the method of Hodko as modified by Reber or Macemon by using the gene biomarker panel as recited in claim 17, and using housekeeping and control genes, because these would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P 2144.05). In other words, the skilled artisan would have routinely optimized the biomarker panel and selection of housekeeping/control genes for use in the method of Hodko according to the particulars of the assay, such as which organisms were desired to be detected. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
19. Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hodko in view of either of Reber et al. (US 2023/0311130) or Macemon (US 9,995,742), further in view of Solczynski, and further in view of Miller.
The teachings of Hodko, Reber, and Macemon are discussed above.
These references do not disclose use of a valve and valve seat as recited, nor the use of laser welding.
Solczynski discloses use of a valve and valve seat in a fluidic device as required in the claim. See paragraphs 0012-0034 and 0045-0147.
Miller discloses use of laser welding in fluidic devices. See paragraph 0428.
One of ordinary skill in the art would have been motivated to modify the method of Hodko as modified by either Reber or Macemon by using a valve and valve seat in a fluidic device because Solczynski disclosed the advantages of such a valve and valve seat in analysis of nucleic acids using a fluidic device. One of ordinary skill in the art would have been motivated to modify the method of Hodko as modified by Reber or Macemon, and Solczynski, by applying laser welding to the fluidic device because Miller disclosed the use of laser welding in fluidic devices. Regarding claim 20, adjusting the cracking pressure to greater than 10 kPa would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P 2144.05). It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
CONCLUSION
20. No claims are free of the prior art.
21. Lofquist et al. (US 2016/0090588) and Nie et al. (US 11,104,946) are made of record as references of interest.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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11/14/25
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681