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 .
Response to Amendment
The Amendment filed 12/31/2025 in which claims 1, 4, 5, 11 and 14 were amended, has been entered. Claims 17-20 were previously withdrawn.
Claims 1-16 are under examination on the merits.
Drawings
(Previous objection, maintained) Applicant’s amendments to the Drawings submitted on 12/31/2025 have not overcome the objection previously set forth in the Non-Final Office Action mailed 10/01/2025 because the graphs presented in Figs. 1-19 do not indicate control samples. The descriptions of these graphs in the Specification (page 8) are still written in generic form and do not contain any information that would allow one of ordinary skill in the art to make sense of the data shown. As amended, Figs. 1-19 remain devoid of meaning.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 12/31/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 10/01/2025.
Claim Objections
(New objection) Claims 1, 5 are objected to because of the following informalities:
On claims 1, 5 the recitation of “SARS-CoV-2” should be followed by the word “virus”. Further, the recitations of “a fluorescent reporter” in claim 5 should read “the fluorescent reporter”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous rejection, withdrawn as to claims 1-16) Claims 1-16 were rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
See claims 1-16 as submitted on 12/31/2025.
Applicant’s amendment to the instant claims filed on 12/31/2025 has overcome previous rejection to claims 1-16.
Claim Rejections - 35 USC § 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, 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.
The factual inquiries 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.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 1, 2, 4-16) Claims 1, 2, 4-16 are rejected under 35 U.S.C. 103 as being unpatentable over Poetter et al., in view of Jung et al., and the following GenBank Accession NOs: KC703321 (influenza A), AB027489 (influenza B), MF104666 (RSV), MG652941 (human adenovirus), NC045512 (SARS-CoV-2), and M21374 (M. pneumoniae), prior art of record.
See claims 1, 2, 4-16 as submitted on 12/31/2025.
Regarding claim 1 the amended claim recites “in the first nucleic acid composition, the influenza A virus probe, the influenza B virus probe, and the respiratory syncytial virus probe are each labeled with a fluorescent group; in the second nucleic acid composition, the respiratory adenovirus probe, the SARS-CoV-2 probe, and the Mycoplasma pneumoniae probe are each labeled with a fluorescent group.” However, the cited prior art already teaches these limitations as follows.
As previously explained, Poetter et al. teach compositions and methods for detecting the presence of multiple respiratory pathogens via multiplex amino acid amplification (Abstract, ¶ [0009]). Poetter et al. further teach multiple primer-probe sets directed to an influenza A virus, and influenza B virus, a respiratory syncytial virus (RSV), a respiratory adenovirus, and a Mycoplasma pneumoniae (¶¶ [0009]-[0015], Table 1, page 10). Poetter et al. further teach a method for designing primers and probes specifically for detection of respiratory pathogens based on known sequences of said pathogens such that sequence conservation is maximized and degeneracy at the 3’ ends is minimized in highly conserved genomic regions (Example 1, page 57; Fig. 6). Poetter et al. further teach the use of probes comprising a fluorescent markers, wherein the signals of the fluorescent markers do not interfere with each other (¶¶ [0081], [0094]). Further, it is noted that it is well within the purview of one of ordinary skill in the art to include different fluorescent group labels which do not interfere with one another within each composition and also between both compositions.
Jung et al. are cited for teaching compositions comprising multiple primer probe sets directed to SARS-CoV-2 for nucleic acid amplification to allow sensitive and reliable laboratory confirmation of SARS-CoV-2 (Abstract, page 1, page 6).
While Poetter et al. and Jung et al. teach multiple primer-probe sets directed to the pathogens indicated above, neither Poetter et al. nor Jung et al. explicitly teach genomic sequences to serve as templates for design of primer-probe sets directed to an influenza A virus, and influenza B virus, an RSV, a respiratory adenovirus, SARS-CoV-2 virus and a Mycoplasma pneumoniae.
However, template sequences of the indicated pathogens were publicly available before the effective filing date of instant application as follows:
GenBank Accession No: KC703321 for influenza A, available since 05/17/2013
GenBank Accession No: AB027489 for influenza B, available since 03/06/2003
GenBank Accession No: MF104666 for RSV, available since 12/31/2017
GenBank Accession No: MG652941 for human adenovirus, available since 02/21/2018
GenBank Accession No: NC045512 for SARS-CoV-2, available since 01/13/2020
GenBank Accession No: and M21374 for Mycoplasma pneumoniae, available since 04/26/1996
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the teachings of Poetter et al., Jung et al. and the template sequences from GenBank indicated above to formulate a composition for PCR amplification comprising primer-probe sets directed to influenza A virus, and influenza B virus, an RSV, a respiratory adenovirus, SARS-CoV-2 virus and a Mycoplasma pneumoniae, given that Poetter et al. teach a method for designing primer-probe sets and all of the genomic sequences for the pathogens indicated above were publicly available from GenBank at the accession numbers indicated above. With respect to the specific sequences recited by the claims, as previously explained, the Specification (pages 13-17) evidences that the primer-probe sets of the present invention amplify areas comprising influenza A, influenza B, respiratory syncytial virus, a respiratory adenovirus, SARS-CoV-2, and Mycoplasma pneumoniae. As such, absent evidence to the contrary, SEQ ID NOs: 1-18 correspond to known genomic sequences of influenza A, influenza B, respiratory syncytial virus, respiratory adenovirus, SARS-CoV-2, Mycoplasma pneumoniae which are included in the sequences from GenBank provided above. Since the genomic sequences of the indicated pathogens were known in the art, and Poetter et al. teach a method for designing primers and probes specifically for detection of respiratory pathogens based on known sequences (Example 1, page 57; Fig. 6), it would have been obvious to a person skilled in the art using standard laboratory techniques available before the effective filing date to have formulated the claimed composition. One of ordinary skill in the art would have been motivated to combine the teachings of Poetter et al., Jung et al. and the template sequences from GenBank for the benefit of formulating a composition for nucleic acid amplification with maximized sequence conservation and minimized degeneracy at the 3’ ends of highly conserved genomic regions for reliable laboratory confirmation. Further motivation derives from the high unmet need of methods for testing the presence of SARS-CoV-2 in human samples before the effective filing date. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in combining the teachings of Poetter et al., Jung et al. and the template sequences from GenBank given that the methods of primer-probe design for PCR amplification and formulation of compositions for PCR amplification are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 2, it is noted that no amendments were introduced to claim 2 in the amendment filed on 12/31/2025. As previously explained, Poetter et al. teach the use of a primer-probe set for an internal control to adequate specimen amount and integrity (¶ [00154]). Further, Jung et al. teach the use of a primer-probe set for an internal control (page 4, 6).
Regarding claim 4, it is noted that the amendment was made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 12/04/2024. No new limitations were introduced in the amendment filed on 12/31/2025. Accordingly, the rejection under 35 U.S.C. 103 set forth in the previous Non-Final Office Action still applies to amended claim 4. As previously explained, Poetter et al. teach the use of probes comprising a fluorescent markers, wherein the signals of the fluorescent markers do not interfere with each other (¶¶ [0081], [0094]). Further, Poetter et al. teach and suggest the use of the specific fluorescent markers recited by claim 4, namely FAM®, HEX®, ROX®, VIC®, CY5®, 5-TMARA®, TET®, CY3® and JOE®, wherein the signals do not interfere with one another (¶ [0022]). Further, Jung et al. teach the use of probes comprising a fluorescent dye which serve as reporters of amplification (page 4).
Regarding claim 5, it is noted that the amendment was made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 12/04/2024. No new limitations were introduced in the amendment filed on 12/31/2025. Accordingly, the rejection under 35 U.S.C. 103 set forth in the previous Non-Final Office Action still applies to amended claim 5. As previously explained, the teachings of Poetter et al. and Jung et al. are described in detail above. Poetter et al. teach and suggest the use of fluorescent markers attached to probes wherein any fluorescent marker can be used with any sequence probe (¶¶ [0022], [0081], [0094]). Accordingly, the fluorescent markers taught by Poetter et al. are considered to be functional equivalents that can be used with any probe sequence. Therefore, it is maintained that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have included the fluorescent markers taught by Poetter et al., to the probe sequences to arrive with reasonable expectation of success at the claimed composition. Further, it is noted that there is no indication that any particular combination of probe-fluorescent marker presents any advantageous features over any other combination, because claim 1 already requires that the fluorescent markers do not interfere with each other.
Regarding claims 6 and 7, it is noted that no amendments were introduced to claims 6 and 7 in the amendment filed on 12/31/2025. As previously explained, Poetter et al. teach the use of primers and probes at a concentration of 600 nM (0.6 µM) (¶ [00173]). Further, Jung et al. teach the use of a concentration of 300 nM for primers and probes for the target detection (page 5). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges recited in claims 6 and 7 merely represent obvious variants and/or routine optimization of the values of the cited prior art.
Regarding claims 8 and claim 9, it is noted that no amendments were introduced to claims 8 and 9 in the amendment filed on 12/31/2025. As previously explained, Jung et al. teach the use of the use of separate reactions comprising at least one primer-probe set and an internal control such that each primer-probe set has a different target and they are combined into one reaction (pages 5-6).
Regarding claims 10 and 11, it is noted that no new limitations were introduced to claims 10 and 11 in the amendment filed on 12/31/2025. As previously explained, Poetter et al. teach a kit comprising the primer-probe sets indicated above, and commercially available PRC reagents comprising nucleic acid release reagent, dNTPs, a reverse transcriptase, a DNA polymerase, a PCR buffer, and Mg2+ (¶¶ [0132]-[0136], [0168], [0170]). It is noted that the components of a nucleic acid release reagent, dNTPs, a reverse transcriptase, a DNA polymerase, a PCR buffer, and Mg2+ are included in commercially available RT-PCR kits. One such kit used by Poetter et al. (¶ [0170]) includes all of those components as evidenced by the Protocol for 1-step RT-qPCR (see PTO-892: Notice of References Cited). Further, Jung et al. teach compositions for assaying for the presence of SARS-CoV-2 in a sample comprising primer and probe sets for SARS-CoV-2 and commercially available PRC reagents for sensitive and reliable laboratory confirmation of SARS-CoV-2 (Abstract, page 6).
Regarding claims 12 and 13, it is noted that no amendments were introduced to claims 12 and 13 in the amendment filed on 12/31/2025. As previously explained, Poetter et al. teach the use of primers and probes at a concentration of 600 nM (0.6 µM) (¶ [00173]). Further, Jung et al. teach the use of a concentration of 300 nM for primers and probes for the target detection (page 5). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges recited in claims 12 and 13 merely represent obvious variants and/or routine optimization of the values of the cited prior art.
Regarding claims 14-16, it is noted that no new limitations were introduced to claims 14-16 in the amendment filed on 12/31/2025. As previously explained, the components of dNTPs, a reverse transcriptase enzyme and a DNA polymerase are included in commercially available RT-PCR kits. One such kit used by Poetter et al. (¶ [0170]) includes all of those components as evidenced by the Protocol for 1-step RT-qPCR (see PTO-892: Notice of References Cited). The amounts of such components recited in claims 14-16 are close enough to those recommended by the manufacturer’s instructions (of 0.4-0.6 mM of dNTPs, 0.25-1.5 U/µL of a reverse transcriptase, and 0.1-0.15 U/µL of a DNA polymerase [Protocol for 1-step RT-qPCR, page 2]) and one skilled in the art would have expected them to have similar properties. As indicated above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges recited in claims 14-16 merely represent obvious variants and/or routine optimization of the values of the cited prior art.
Accordingly, claims 1, 2, 4-16 were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
(Previous rejection, maintained as to claim 3) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Poetter et al., Jung et al., and GenBank Accession NOs: KC703321 (influenza A), AB027489 (influenza B), MF104666 (RSV), MG652941 (human adenovirus), NC045512 (SARS-CoV-2), and M21374 (M. pneumoniae), as applied to claims 1, 2, 4-16 above, further in view of Radonić et al. Prior art of record.
See claim 3 as submitted on 12/31/2025.
Regarding claim 3, it is noted that no amendments were introduced to claim 3 in the amendment filed on 12/31/2025. As previously explained, the teachings of Poetter et al., Jung et al., and GenBank Accession NOs: KC703321 (influenza A), AB027489 (influenza B), MF104666 (RSV), MG652941 (human adenovirus), NC045512 (SARS-CoV-2), and M21374 (M. pneumoniae) are described above and render claim 1 prima facie obvious. It is noted that instant SEQ ID NOs: 19-20 recite sequences for amplification of a human housekeeping gene GAPDH, which is used in the claimed invention as an internal control (Specification, page 5).
While Poetter et al. and Jung et al. teach the use of internal controls comprising human housekeeping genes. Neither of them explicitly teach the use of GAPDH.
Radonić et al. teach primer-probe sets for a conserved region of a GAPDH as an internal control for RT-PCR commonly used for normalization of amplification in human samples (page 2, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated a primer-probe set for the GAPDH gene as taught by Radonić et al. for the benefit of formulating a composition for detection of human pathogens comprising an internal control for normalization in human samples. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)
One of ordinary skill in the art would have had reasonable expectation of success in incorporating a GAPDH internal control into the composition of claim 1 given that the methods of PRC amplification and normalization to a GAPDH internal control are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
With respect to instant SEQ ID NOs: 19-20, absent evidence to the contrary, these sequences are suggested by the teachings of Radonić et al. because they teach sequences of a conserved region of a human GAPDH gene that serve as internal controls. Accordingly, the sequences of SEQ ID NOs: 19-20 represent functional equivalents of the sequences taught by Radonić et al. See MPEP 2144.06. Substituting Equivalents Known For The Same Purpose.
Accordingly, claim 3 was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant contends on page 12 of the Remarks submitted on 12/31/2025:
“(1) The prior art lacks teachings and motivation for the "Combined detection of 6 specific pathogens"
One of the core innovations of claim 1 lies in the targeted selection of 6 clinically prevalent respiratory pathogens with highly overlapping symptoms (influenza A virus, influenza B virus, respiratory syncytial virus (RSV), respiratory adenovirus, SARS-CoV-2, and Mycoplasma pneumoniae) for combined detection. However, the prior art completely fails to address the basis for selecting this specific combination and the corresponding technical needs.”
In response:
The Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated and had a reasonable expectation of success to formulate a composition for detection of the specific combination of pathogens as recited by the instant claims given that Poetter et al. already teaches such composition comprising all of the pathogens required by the claims except SARS-CoV-2, which had not been identified prior to Poetter et al.’s disclosure. A composition further comprising SARS-CoV-2 primers and probe set as taught by Jung et al. is an obvious embodiment of the composition of Poetter et al. given that the sequences of the SARS-CoV-2 virus were known before the effective filing date and there was a high unmet need for such a composition due to the global pandemic associated with SARS-CoV-2.
Applicant contends on page 13 of the Remarks submitted on 12/31/2025:
“(2) The combination of prior art involves insurmountable technical obstacles. Obstacle in the specific optimization of primer-probe sequences… Obstacle in avoiding cross-interference between multiple pathogens… (3) The technical effects of the present invention possess strong industrial applicability and significantly enhance clinical detection value. Dramatically improved detection efficiency… Reduced operational risk… Support for epidemic prevention and control…”
In response:
The instant rejection is in view of the instant claims merely reciting or reading on a composition. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The arguments cited above are unpersuasive for the following reasons. First, the cited prior art expressly teaches the embodiment instantly claimed. Second, the conserved regions of the 6 specific pathogens were known in the art, see the disclosure of Poetter et al. and Jung et al., and they are not required by the instant claim language. Third, primer-probe set design and optimization are routinely practiced in the art and thus it would have been well within the purview of one of ordinary skill in the art to arrive at the claimed invention in view of the teachings of Poetter et al. and Jung et al. Finally, with respect to the industrial applicability, such arguments of detection efficiency, operational risk, and epidemic prevention and control are not required by instant claims and are therefore irrelevant. Thus, in view of the instant claim language, it is maintained that one of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the claimed invention in view of the teachings of Poetter et al., Jung et al., and the cited sequences.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 CFR 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 date of this final action.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
Prosecution Insights