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 .
IDS
2. Non-patent literature references numbered 1 and 4 have been lined-through by the examiner on the IDS filed 02/28/23 because no publication year is provided, as is required.
ELECTION
3. Applicant's election with traverse of Group I in the reply filed on 11/24/25 is acknowledged. The traversal is on the ground(s) that ‘the pending claims of the instant application do not present a serious search burden on the Examiner.’ This is not found persuasive because the restriction requirement provides evidence that searching more than one of the recited groups of inventions would present a serious search burden on the Examiner, and the traverse does not point to any alleged errors in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 9-10 and 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/24/25.
5. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
NON-PRIOR ART REJECTION
6. 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.
Claim 5 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. This claim is indefinite because it does not comprise a complete sentence, and thus the further limitation cannot be determined. Correction is required.
PRIOR ART REJECTIONS
7. 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.
8. 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.
9. Claims 1-3, 5, 7-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (WO 2015/183811) in view of Jackson et al. (US 2019/0144919).
Regarding independent claim 1, Fischer discloses a method comprising lysing a sample to be tested for a pathogen to release nucleic acids, extracting the lysed sample, and preparing a test solution for pathogen detection, wherein the lysate comprises TCEP (alternative embodiment B). See abstract and pages 4, 8-9, 16, and 29.
Fischer does not disclose required element A of controlling oxygen content in the extract to be less than 1%.
Jackson discloses the benefit of adding an oxygen scavenger to a nucleic acid extraction/lysis matrix for the purpose of stabilizing extracted nucleic acids for storage. See paragraphs 0002, 0005, 0028, and 0107-0109.
One of ordinary skill in the art would have been motivated to modify the method of Fischer by including an oxygen scavenger in the nucleic acid extract or lysate because Jackson disclosed that adding an oxygen scavenger when extracting nucleic acids provided the benefit of stabilizing and storing nucleic acids. As far as the limitation of controlling oxygen content to be less than 1%, 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). 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 methods.
Regarding claim 2, as noted above Fischer discloses adding an oxygen scavenger.
Regarding claims 3 and 5, Fischer discloses the use of a filter in extracting nucleic acids (see last paragraph on page 15).
Regarding claim 7, Jackson discloses the use of blood as a sample in paragraph 0003.
Regarding claims 8 and 11, Fischer discloses detecting a virus or bacterium in a human host (see abstract).
10. Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (WO 2015/183811) in view of Jackson et al. (US 2019/0144919), and further in view of Qian (US 2016/0097049).
The teachings of Fischer and Jackson are discussed above.
These references do not disclose the extraction device required in claim 4, nor the collection device required in claim 6.
Qian discloses the extraction device of claim 4 comprising a receptacle, removable cap, filter column, and shipping container. Qian also discloses the collection device of claim 6 comprising a sample collector and sample storage container detachably interconnected. See abstract and paragraphs 0008-0016 and 0034-0069.
One of ordinary skill in the art would have been motivated to modify the method of Fischer by using the extraction device as set forth in claim 4, or using the collection device as set forth in claim 6, because Qian disclosed that such an extraction device and collection device were useful in extracting and collecting/storing nucleic acids for 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 methods.
11. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (WO 2015/183811) in view of Jackson et al. (US 2019/0144919), and further in view of Zhao et al. (US 2021/0277488; priority to at least 03/16/20).
The teachings of Fischer and Jackson are discussed above.
These references do not disclose the use of a test solution prepared by the method of claim 1 wherein PCR detection is performed using primers targeting COVID-19 nucleic acid and one or more host nucleic acids.
Zhou discloses performing PCR analysis using a clinical sample from a human in which primers and probes target both COVID-19 nucleic acid and a host nucleic acid, RNase P gene or RP. See abstract and paragraphs 0002, 0004-0007, 0010, and 0019.
One of ordinary skill in the art would have been motivated to modify the method of Fischer by performing PCR in which the primers target both COVID-19 nucleic acid and a human host nucleic acid because Zhou disclosed that doing so provided the benefit of an internal or endogenous sample control. 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
12. No claims are free of the prior art.
13. 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.
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, 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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01/21/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681