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 .
Election/Restrictions
Applicant’s election of the target component combination of claim 3 in the reply filed on 5/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-8 are pending.
An action on the merits is set forth below.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 are 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.
Claims 1-8 are indefinite over the steps of claim 1. The step of elution is unclear for the phrase “introducing a sample containing a target component as a modified nucleoside”. It is not clear if the claim is intended that the sample comprise a component that is a modified nucleoside or if the target is modified by the nucleoside. Further, the phrase “having hydrophobicity increased by modification”. It is not clear as there is not modification step as it is not clear have the hydrophobicity effects the modified nucleoside.
The claims are further is unclear over “a step of calculating a ration between the detection value” in claim 1. The claims are unclear as it is not clear what “value” is intended to encompass. The claims require a step of detecting, but it is not clear the metes and bounds of “detection value”. The step of “mixing ratio” is unclear as it is not clear howe the change of rate effects the detection step in claim 1.
Claim 2 is unclear as it is not clear if the target can encompass any derivative of adenosine or if the claim is intending to encompass a “chemical structure in which threonine is bonded to the adenosine via a carbonyl group”.
Claim 3 is unclear over the further comprising step. It is not clear which index values would indicate “possibility” has COVID-19. Further, it is not clear which condition is becoming severe and the metes and bounds of the term severe. Furthermore, it is not clear how the index value is associated with the phenotype, and which index values would indicate the phenotype.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2,4-5,7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tomizawa et al. (US Patent Application Publication 2019/0345551 November 14, 2019).
With regard to claim 1, Tomizawa et al. teaches a method of detecting modified mt-tRNA (para 1). Tomizawa et al. teaches an elution step with a sample containing a modified nucleotide and a reference in a liquid chromatography analysis (para 91-103, 140-147). Tomizawa et al. teaches a step of mass spectrometry and calculating the ratio of each component (para 144-150), Tomizawa et al. teaches mixing rations and measuring the difference in time periods (para 144-150).
With regard to claim 2, Tomizawa et al. teaches an adenosine modification (para 83 and 91).
With regard to claim 4, Tomizawa et al. teaches that the sample can be urine, and the reference is adenosine (para 2).
With regard to claim 5, Tomizawa et al. teaches a method wherein the sample is plasma, and the reference can be adenosine (para 91 and 146).
With regard to claim 7-8, Tomizawa et al. teaches a method of reverse phase chromatography comprising washing steps of mixing solvents and measuring the change of rate at different time points (para 147-222).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tomizawa et al. (US Patent Application Publication 2019/0345551 November 14, 2019) in view of Stafford et al (US Patent Application Publication 20210015837 Jan 21, 2021).
Tomizawa et al. teaches a method of detecting modified mt-tRNA (para 1). Tomizawa et al. teaches an elution step with a sample containing a modified nucleotide having hyrdophcity and a reference in a liquid chromatography analysis (para 91-103, 140-147). Tomizawa et al. teaches a step of mass spectrometry and calculating the ratio of each component (para 144-150), Tomizawa et al. teaches mixing rations and measuring the different in time periods (para 144-150).
With regard to claim 3, Tomizawa et al. teaches that the target can be N6 threonylcabamoyladenosine and 2-methylthio n6 threonylcarbamoyladensine (para 73-91) to detect mt-tRNA, however, does not teach a step of measuring index values for COVID-19.
Stafford et al. teaches measuring index values for Covid 19 by measuring tRNA (para 3).
As such it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Tomizawa et al. to measure any index values from tRNA associated with known phenotypes to measure and determining changes in the levels. It would be obvious to one of ordinary skill as Stafford et al. teaches detection of rRNA levels.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tomizawa et al. (US Patent Application Publication 2019/0345551 November 14, 2019) in view of Disney et al. (US Patent Application Publication 2017/0143703 May 25, 2017).
Tomizawa et al. teaches a method of detecting modified mt-tRNA (para 1). Tomizawa et al. teaches an elution step with a sample containing a modified nucleotide having hydrophilicity and a reference in a liquid chromatography analysis (para 91-103, 140-147). Tomizawa et al. teaches a step of mass spectrometry and calculating the ratio of each component (para 144-150), Tomizawa et al. teaches mixing rations and measuring the different in time periods (para 144-150).
With regard to claim 6, Tomizawa et al. teaches a method of mobile phrase and the use of mobile phase and the use of a solution with acetonitrile and water (para 102-107) but does not teach formic.
With regard to claim 6, Disney et al. teaches performing a chromatography method such that acetonitrile, water and formic acid was used (para 121).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Tomizawa et al. to include known chemicals in MS analysis including the formic, acetonitrile and water as taught by Disney et al. The ordinary artisan would be motivated to use this known chemical combination as Disney et al. teaches RNA can be measured in mass spectrometry using this chemical combination (para 108).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. 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.
/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
Prosecution Insights