DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. This Office Action is in response to the amendment filed 02 April 2026, wherein claims 1, 6, 8, 11-14, and 16-18 were amended; claim 15 was canceled; and claim 19 was added.
Claims 1-14 and 16-19 are under consideration.
Priority
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The instant application is being examined with the effective filing date of 30 Oct 2020.
Information Disclosure Statement
4. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections Withdrawn
Specification
5. The objection to the specification for improper nucleotide and/or amino acid sequence disclosures is withdrawn in view of Applicant’s amendments.
6. The objection to the specification for hyperlinks is withdrawn in view of Applicant’s amendments.
7. The objection to the specification for improper uses of trademarks is withdrawn in view of Applicant’s amendments.
Claim Objections
8. The objections to claims 4, 8, 12-14, and 16-18 for informalities are withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(b)
9. The rejections of claims 6-7 and 15-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 102
10. The rejection of claims 1-6, 10-13, and 15 under 35 U.S.C. 102(a)(2) as being anticipated by Sawyer (WO 2021236696 A1; 18 May 2020) (See PTO-892 filed 03 December 2025) is withdrawn in view of Applicant’s amendments.
Rejections Maintained
11. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections – 35 USC § 103
12. It is noted that Applicant amended the claims but reproduced claim scope that was present in at the time of the Non-Final Office Action mailed 03 December 2025.
13. Claims 1-14 and 16-19 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer (WO 2021236696 A1; 18 May 2020) (See PTO-892 mailed 03 December 2025) in view of Lalli (medRxiv, 06 August 2020, 1-34) (See IDS filed 21 April 2023).
Regarding claims 1-6, 9-13 and 19, Sawyer teaches a RT-LAMP test for SARS-CoV-2 RNA in a saliva sample (Page 2, lines 24-27). One embodiment of Sawyer uses a 2x saliva stabilization solution that includes 0.5 mM TCEP-HCl, 2 mM EDTA, and 100 µg/mL proteinase K (Page 29, lines 5-9 and Table 3). Saliva samples were collected in a tube, the 2x stabilization solution added in a 1:1 ratio, then shaken for 5-10 seconds, and incubated at 95°C for 10 min (Page 29, lines 13-17). It is clarified that the incubation step is for inactivation (Page 24, lines 3-5). In summary, Sawyer teaches a method of amplifying and detecting SARS-CoV-2 RNA from a saliva sample using RT-LAMP, wherein the sample is mixed and then heat-treated with a stabilization buffer that includes TCEP, EDTA, and Proteinase K to inactivate the sample, as claimed. Amplification of nucleic acids will occur even in one cycle. Sawyer does not teach a two-step heat inactivation.
However, Lalli teaches “A heat treatment of 55˚C for 15 minutes followed by 95˚C for 5 minutes further improved LAMP sensitivity (Fig. 2A, middle row). Identical heating steps plus the addition of proteinase K increase LAMP sensitivity relative to dilution alone (Fig. 2A, bottom row)” (Page 5). Both Sawyer and Lalli’s methods are for SARS-CoV-2 sample analysis with RT-LAMP and thus it would have been obvious to one of ordinary skill before the filing date to take the method of Sawyer and further replace their one-step heat treatment with Lalli’s two-step heat treatment. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claims 7-8, 14, and 16-18, Sawyer teaches the 2x saliva stabilization buffer as having TCEP-HCl, proteinase K, and EDTA, as discussed supra. Sawyer nor Lalli teach the exact concentrations, wt.%’s, or weight ratios that are claimed. However, it would have been obvious that the concentration of TCEP-HCl, wt.% of proteinase K, and the weight ratios between the two are clearly a result-effective parameter that a person of ordinary skill in the art would routinely optimize. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Response to Traversal
14. Applicant argues that Sawyer does not teach using the saliva stabilization solution with proteinase K and thus the combination of TCEP and proteinase K is not assessed, citing one embodiment on page 25, lines 21-29 of Sawyer. However, Examiner respectfully states that on page 8, section 15 of the Non-Final Office Action mailed 03 December 2025, it is stated that Sawyer teaches the 2x saliva stabilization buffer having both TCEP and proteinase K in another embodiment. See page 29, lines 5-9 and Table 3 of Sawyer.
Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
15. Applicant argues that there is no motivation to replace the heat treatment of Sawyer with the two-step heat protocol of Lalli in the presence of TCEP and proteinase K, and that doing so resulted in unpredictable results. Applicant also states that the combination of this heat treatment with TCEP and Proteinase K resulted in a detectable amount of RNA in fewer cycles.
However, this argument is not commensurate in scope with the claims. The claims do not require a detection step and some amount of amplification would occur in even one cycle. In addition, the “comprising” language of the claims allows for additional steps, which could encompass additional cycles. Thus, achieving Applicant’s results of “detectable amount” is still achievable in the obvious method.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, the motivation to combine Sawyer and Lalli is addressed in the art rejection supra. Also, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004).
New Objections
Claim Objections
16. Claims 1-2, 11, and 19 are objected to because of the following informalities:
Regarding claims 1 and 11, a semicolon should be added after “10 minutes or less” to clarify the break between the two options.
Regarding claim 2, “wherein the sample is subjected to a heat treatment…” should be rewritten as “wherein the heat treatment of step (ii) is in the presence of…”.
Regarding claim 19, “where” should be replaced with “wherein”.
Appropriate correction is required.
New Rejections
Claim Rejections - 35 USC § 112(b)
17. Claim 19 is 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.
Regarding claim 19, “requires no more than 29 cycles” is indefinite because “LAMP does not require thermal cycles” (See page 6, line 32 to page 7, line 1). Page 14 of the Instant Specification defines one cycle as 15 seconds, but it is unclear if the claim requires 29 cycles = 7 min 15 sec or if one cycle means one round of primer annealing, extension, and release. Therefore, there are multiple interpretations for this claim. In addition, the language of “requires no more than” does not further limit the claim as amplification occurs even with one cycle.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claim Rejections - 35 USC § 112(d)
18. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
19. Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 from which it depends recites “subjecting the sample” in step (ii). One of ordinary skill would envision a mixed sample with the compounds for the heat-treatment. Claim 6 recites “wherein step (ii) comprises preparing a sample mixture by mixing the sample with TCEP and proteinase K”. Therefore, the only difference between these claims is semantics.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form so long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
20. No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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, Michael Allen can be reached at (571) 270-3497. 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.
/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights