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 22 October, 2025. Claims 1-5, 9, 11-14, 16, 17, 19-22, 24, and 27-29 are pending in the instant application. Applicant’s election without traverse of Group I (claims 1-5, 9, 11-14, 16, 17, and 19) is noted. Claims 20-22, 24, and 27-29 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
35 U.S.C. § 119
Acknowledgment is hereby made of Applicant’s claim for foreign priority based on KR 10-2020-0087107, filed 14 July, 2020. A non-English copy of the foreign priority document submitted under 35 U.S.C. § 119(a)-(d), has been received and placed of record in the file.
37 C.F.R. § 1.98
The information disclosure statements filed 05 January, 2023, and 22 October, 2025, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 05 January, 2023, have been reviewed and are acceptable.
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 1-5, 9, 11-14, 16, 17, and 19 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.
Claim 1 is directed toward a method for detecting a respiratory pathogen comprising performing a nucleic acid amplification reaction using sample transport medium wherein a “nostril swab sample and saliva sample are dipped together and a nucleic acid amplification reaction composition”. This claim is vague and indefinite because the actual method steps are unclear. It is not readily manifest if the two biological samples are individually placed into two independent transport samples and then combined into a single sample or if the two biological samples are both added to the same vial comprising universal transport medium. Moreover, it is not readily manifest if the transport medium comprises nucleic acid amplification reagents or if the two samples are added to a separate vial containing the amplification reagents. Appropriate correction is required.
Graham v. Deere
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 U.S.P.Q. 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 1-5, 9, 11-14, 16, 17, and 19 are rejected under 35 U.S.C. § 103 as being unpatentable over Tanner et al. (U.S. Pub. No. 2023/0407419 A1, published 21 December, 2023, and claiming priority to Prov. Appl. No. 62/988,696, filed 12 March, 2020; hereinafter referred to as “Tanner et al. (2023)”), in view of Kim et al. (2017). The claims are directed toward a method for detecting a respiratory pathogen, the method comprising: (a) performing a nucleic acid amplification reaction by using a sample transport medium in which a nostril swab sample and a saliva sample are dipped together and a nucleic acid amplification reaction composition; and (b) analyzing the results of the nucleic acid amplification reaction to determine the presence or absence of the respiratory pathogen (claim 1). Claims 2-5 are directed toward the swab samples (e.g., saliva swab (claim 2), self-sampled swab (claim 3), nostril swab (claim 4), or saliva swab (claim 5)). Claim 9 stipulates the sample is added to sample transport media comprising a cell maintenance buffer or cell inactivation buffer. Claims 11-13 reference different experimental parameters (nucleic acid isolation (claim 11), different incubation parameters (claim 12), and sample dilutions (claim 13)). Claims 14, 16, and 19 are directed toward the detection of respiratory pathogens, including SARS-CoV-2. Claim 17 simply references a real-time nucleic acid amplification reaction.
Tanner et al. (2023) disclose a multiplex real-time PCR reaction for the detection of respiratory pathogens such as coronavirus (e.g., SARS-CoV-2), rhinovirus, respiratory syncytial virus (RSV), influenza virus, parainfluenza virus, metapneumovirus, and adenovirus (see claims and working examples). In particular, a biological sample obtained from a nasal swab (see Examples 1 (p. 38) and 4 (p. 41)) or saliva, including the sublingual region (see ¶ [0216-0219]; Example 9, p. 44) was added to sample buffer, heated to 95°C, and added to an amplification reaction comprising one or more primer sets. Preferred primer and probe sets were set forth in Table 17 and included SARS-CoV-2 N- and S-specific primers/probes (see also Example 1 and paragraph [0024]). Direct detection of viral nucleic acids, as well as, the inclusion of an RNA purification step were disclosed (see paragraphs [0008-0015, 0033, 0041, 0213-0214, 0233-0234] and working embodiments). Details about sample isolation and preparation were provided in paragraphs [0022, 0048, 0059, 0071, and 0214-0221] and Examples 4 and 9. Self-sampling is also clearly set forth in Fig. 29. This teaching discloses or renders prima facie obvious all of the claimed experimental parameters except for the inclusion of both nasal and saliva specimens in the same amplification reaction.
However, Kim et al. (2017) performed a comparison between saliva and nasopharyngeal swab (NPS) specimens for the detection of respiratory viruses by multiplex reverse transcription-PCR (RT-PCR). Multiplex real-time RT-PCR was performed for the detection of IAV, IBV, PIV types 1, 2, 3, and 4, RSV types A and B, ADV, metapneumovirus, HRV, CoV-OC43, CoV-229E, and CoV-NL63 (see MATERIALS AND METHODS, Laboratory testing, pp. 231-232). This teaching also does not disclose the inclusion of both nasal and saliva specimens in the same amplification reaction. However, the authors concluded that “Mixing NPS and saliva specimens appears to be a promising strategy, considering the different detection patterns of the different types of specimens” (see DISCUSSION, p. 231).
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 modify the real-time RT-PCR amplification assay of Tanner et al. (2023), to incorporate both nasal and saliva samples into the same amplification reaction, because Kim et al. (2017), clearly state that including both samples in the reaction provides better coverage and more accurate detection results. The authors noted that saliva and NPS samples had comparable detection rates (see DISCUSSION, p. 229). Therefore, one of ordinary skill in the art had a reasonable expectation of success.
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 24 January, 2026
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