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 11 May, 2026. Claims 1-5, 9, 13, 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, 13, 14, 16, 17, and 19) is noted. Claims 20-22, 24, and 27-29 stand withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.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 statement filed 11 May, 2026, has 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.
The previous rejection of claims 1-5, 9, 13, 14, 16, 17, and 19 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out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention, is hereby withdrawn in response to Applicant’s amendment and arguments.
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, 13, 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), CDC (2020), and Topkas et al. (2012). The claims are directed toward a method for detecting a respiratory pathogen comprising combining a nasal swab sample and saliva sample together into sample transport medium, incubating the sample at 60° to 100°C for 1-25 minutes, and performing a nucleic acid amplification reaction on the sample (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. Claim 13 references different experimental parameters (sample dilutions). 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.
As previously set forth, 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 was 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.
Both CDC (2020) and Topkas et al. (2012) provide detailed methodologies for collecting nasal or saliva samples, respectively. The CDC clearly states that nasal samples can be obtained through self-sampling of both nostrils (see p. 1, Sample Collection). Topkas and colleagues also teach that saliva samples can be obtained using a swab from sublingual or supralingual portions of the oral cavity (see Materials and methods, 2.2. Saliva collection devices, p. 1067).
Furthermore, 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.
Applicant’s traverse and submit the prior art doesn’t disclose the utilization of nasal samples. This argument is not persuasive in view of the CDC publication which provides detailed methodologies for obtaining nasal swab samples. It was further argued that the prior art failed to provide any motivation to combine both nasal and saliva samples into a single sample comprising UTM. This argument is not persuasive in view of Kim et al. (2017) who clearly state 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). The authors further added that the combined detection rate with NPS and saliva samples was higher than the individual sample rates (see bridging paragraph, pp. 229-230). The authors also stated that physically mixing both nasal and saliva samples only minimally increases cost while providing greater sensitivity (see Discussion, p. 230). Moreover, one of ordinary skill in the art would have been motivated to use nasal swabs, as compared to NPS samples, because nasal swabs are less invasive and easier for subject to perform. Finally, it was argued that a PHOSITA might have expected to combine NPS and saliva samples, but not nasal and saliva samples. This argument is not convincing in view of CDC who clearly teach that obtaining self-sampled nasal swabs are an efficient method of sample collection for SARS-CoV-2 PCR detection.
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 15 July, 2026
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