Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 21 December, 2025. Claims 1 and 3-8 are pending in the instant application. Applicant’s elected Group I (claims 1 and 3-5) without traverse. Accordingly, claims 6-8 stand withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 07 April, 2026, and 24 April, 2026, have been placed in the application file and the information referred to therein has been considered.
35 U.S.C. § 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 and 3-5 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, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Amended claim 1 is directed toward a method for detecting an RNA virus in a biological sample comprising the following steps: (1) keeping a sample solution containing the biological sample and proteinase K at room temperature and then subjecting the sample solution to high temperature treatment at 91°C to 99°C, (2) preparing a nucleic acid amplification reaction solution containing the sample solution prepared in step (1), and a polypeptide having reverse transcription activity and a polypeptide having DNA polymerase activity, or a polypeptide having reverse transcription activity and DNA polymerase activity, and (3) amplifying a nucleic acid of the RNA virus in the reaction solution prepared in step (2).
Claim 1 is vague and indefinite for failing to identify the length of the high temperature treatment. The minimum and maximum treatment times are not readily manifest. How long should the sample be subjected to high-temperature treatment? Absent further clarification, the metes and bounds of the patent protection cannot be readily ascertained.
35 U.S.C. § 102
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.
The previous rejection of claims 1-4 under 35 U.S.C. § 102(a)(1) as being clearly anticipated by Hongyan et al. (CN 104928402 (A), 2015), is hereby withdrawn in response to Applicant’s amendment and arguments.
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 103
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 of this title, 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.
Claims 1 and 3-5 are rejected under 35 U.S.C. § 103 as being unpatentable over Hongyan et al. (CN 104928402 (A), 2015) in view of Bengtsson et al. (WO 2008/135196 A1, published 13 November, 2008; listed as FP “BC” in the IDS filed 24 January, 2023).
Amended claim 1 is directed toward a method for detecting an RNA virus in a biological sample comprising the following steps: (1) keeping a sample solution containing the biological sample and proteinase K at room temperature and then subjecting the sample solution to high temperature treatment at 91°C to 99°C, (2) preparing a nucleic acid amplification reaction solution containing the sample solution prepared in step (1), and a polypeptide having reverse transcription activity and a polypeptide having DNA polymerase activity, or a polypeptide having reverse transcription activity and DNA polymerase activity, and (3) amplifying a nucleic acid of the RNA virus in the reaction solution prepared in step (2). Claim 3 encompasses the inclusion of guanidine, or a salt thereof. Claims specifies the origin of the biological sample (e.g., saliva, blood, stool, urine, nasal swab, etc.). Claim 5 further specifies the viral RNA to be detected (e.g., influenza, RSV, parainfluenza, coronaviruses, measles virus, HIV, etc. This teaching states that hepatitis B virus (HBV), human immunodeficiency virus (HIV), coronavirus, influenza virus, or avian influenza virus).
Hongyan et al. (2015) discloses the preparation of sample solution wherein a putative FMDV EV71 viral RNA sample was obtained from a throat swab (pharyngeal sample) and a protein denaturing solution was prepared comprising guanidine and proteinase K (see claim 4). A nucleic acid amplification solution was prepared comprising Mo-MuLV reverse transcriptase (RT) and Taq DNA polymerase. The FMDV viral RNA was reverse transcribed and amplified (see [0139]-[0149], pp. 21-22). This teaching states that the sample may be subjected to a preheating step at 55°C to 70°C for 10 to 15 minutes (see claim 3). This teaching further stipulates that suitable viruses for detection include HIV, coronaviruses, influenza A virus, avian influenza virus, and foot and mouth disease virus (FMDV). This teaching does not disclose a step involving preheating the sample at 91°C to 99°C.
Bengtsson et al. (2008) disclose an RT-PCR method for the detection of target RNA involving a treatment step utilizing both guanidine and proteinase K. A sample containing the target sample was subjected to treatment with both ingredients and preheated at 75°C to 85°C (see pages 16 and 17). This teaching does not disclose a step involving preheating the sample at 91°C to 99°C.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine experimentation to determine the optimum preheating temperature and time. Both references relied upon teach different ranges for the preheating step. Bengtsson et al. (2008) in particular disclose a maximum range that is sufficiently close to the claimed limitation. All that would be required to arrive at the claimed invention is routine experimentation to ascertain the optimal upper range.
Action Is Final
Applicant’s amendment necessitated any and all new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See M.P.E.P. § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 29 April, 2026
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