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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug. 20, 2026. Claims 1-2, 4-12, and 14-22 are pending. Claims 2 and 20 are withdrawn. Claims 1, 4-12, 14-19 and 21-22 are currently examined.
Claim Rejections - 35 USC § 112
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.
(Previous Rejection – Maintained and Modified Necessitated by Amendment) Claims 1, 4-12, 19 and 21-22 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.
Base claim 1, as amended, recites “wherein the primer set is N-ID5 (Set-1), comprising SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 3, SEQ ID No. 4,SEQ ID No. 5, and SEQ ID No. 6; wherein SEQ ID No. 1 and SEQ ID No. 2 are each present in the reaction mixture in an amount of 0.2 mM; wherein SEQ ID No. 3 and SEQ ID No. 4 are each present in the reaction mixture in an amount of 1.6 mM; wherein SEQ ID. No.5 and SEQ ID No. 6 are each present in the reaction mixture in an amount of 0.4 mM”. This limitation specifies “amount” of primers to be present in the reaction mix. However, the unit used with the amount is “mM”, which is a concentration unit. Additionally, claim 1 uses concentration units, e.g., U/ml, and mM, for “amount” of other components to be included in the reaction mix. It is noted that “amount” of an component is not defined by a concentration value without a volume attached to it. The claims do not specify a volume for each component specified with a value of concentration, and, therefore, it is not clear how much of each component is included in the claimed reaction mix.
Claim Rejections - 35 USC § 102/103
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 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.
(Previous Rejection – Withdrawn) Claims 1 and 4-19 were rejected under 35 U.S.C. 102/103 as being unpatentable over CN 113684320 (Published on Nov. 23, 2021) or Luo et al. (Chemical Engineering Science 251(2022)117430).
This rejection is withdrawn in view of the amendments filed on Aug. 20, 2026.
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 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.
(Previous Rejection – Withdrawn) Claims 1 and 4-19 were rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann et al. (US 2022/0162686 A1, Pub. Date: May 26, 2022) and/or Diego et al. (Diagnostics 2021, 11, 438).
(Previous Rejection – Withdrawn) Claim 3 was rejected under 35 U.S.C. 103 as being unpatentable over CN 113684320 (Published on Nov. 23, 2021), Luo et al. (Chemical Engineering Science 251(2022)117430), Hoffmann et al. (US 2022/0162686 A1, Pub. Date: May 26, 2022) and/or Diego et al. (Diagnostics 2021, 11, 438), in view of Zhang et al. (Biotechniques. 2020 Sep;69(3):178-185).
These rejections are withdrawn in view of the amendments filed on Aug. 20, 2026.
(New Rejection – Necessitated by Amendment) Claim 1, 4-12, 14-19 and 21-22 rejected under 35 U.S.C. 103 as being unpatentable over CN 113684320 (Published on Nov. 23, 2021), Luo et al. (Chemical Engineering Science 251(2022)117430), Hoffmann et al. (US 2022/0162686 A1, Pub. Date: May 26, 2022), Diego et al. (Diagnostics 2021, 11, 438), and Zhang et al. (Biotechniques. 2020 Sep;69(3):178-185).
The references cited here are same as applied in the withdrawn rejection of claim 3, which is canceled.
Base claim 1 is amended to specify “amount” present in the reaction mix for various reaction reagents.
As indicated in the 112b rejection above, the claims specify “amount” of reagents with values in unit of concentration without specifying volumes to be included in the reaction mix. Therefore, the amount of each reagent in the reaction mix is not definite.
Relevance of CN 113684320, Luo, Hoffmann, Diego and Zhang is set withdrawn rejects in the previous Office. Table 3 of CN 113684320 shows the amplification reaction systems used in the invention, including reagents. See below:
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1124
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According to the table above, in the reaction mix, the reagents of the Bsm polymerase, Bsm 10xbuffer, dNTPs (2.5 mM), template, calcein (625 mM) are included in the reaction mix at 1 mL, 2.5 mL, 4 mL, 1 ml and 1 ml, respectively; and primers of F3, B3, FIP, BIP, LF, and LF, each of them is provided at a concentration of 20 mM, are included in the reaction mix at 0.4 mL, 0.4 mL, 0.8 mL, 0.8 mL, 0.8 mL and 0.8 mL, respectively.
Diego further teaches details of the RT-LAMP reaction, including amounts of various reagents included in the reaction mix. Briefly, RT-LAMP reaction mixtures (15 uL) contained 1.6 uM FIP/BIP primers, 0.2 uM F3/B3 primers, 0.4 uM LF/LB primers (if applicable), 1.4 mM of each dNTP, (BIORON GmBH, Römerberg, Germany) 0.13 M of D-(+)-Trehalose dihydrate (Sigma-Aldrich, USA) (from now on, trehalose), 6mM MgSO4, and 1x Isothermal Amplification Buffer II (20 mM Tris-HCl (pH 8.8), 150 mM KCl, 10 mM (NH4)2SO4, 2 mM MgSO4, 0.1% Tween20) for Bst 3.0 DNA polymerase (0.32 U/uL) or 1x Amplification Buffer (20mM Tris-HCl (pH 8.8), 50 mM KCl, 10 mM (NH4)2SO4, 2 mM MgSO4, 0.1% Tween20) for Bst 2.0 WS (0.32 U/uL) and RTx WS (0.3 uL), with 1 uL of template RNA (C+, for positive control; ultrapure water for negative control). See page 5, last para.
Accordingly, CN 113684320, Luo, Hoffmann, Diego, and Zhang teach that all reagents as claimed can be used in RT-LAMP reactions, and various amounts/concentrations can be used.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to combine the teachings of CN 113684320, Luo, Hoffmann, Diego, and Zhang to arrive at the invention as claimed. One would have been motivated to do so to improve the efficacy of the RT-LAMP reaction through routine experimental optimization.
Regarding claims 9-11 and 13-18, since the cited references combined suggest the invention as claimed, one of skill in the art would have expected that the RT-LAMP assay system can be optimized to produce the same detection efficacy as claimed.
Regarding claim 19, one of skill in the art would have found it obvious to treat a subject whose sample tests positive for SARS-CoV-2.
Regarding new claims 21 and 22, Diego teaches that different reactions times and temperatures can be tested to establish the optimal reaction conditions, including times of 45, 60 and 80 min. One of skill in the art would have readily expected that a “time-to-reaction” time as claimed can be reached/determined in the routine optimization process.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(Previous Rejection – Withdrawn) Claims 1-19 were provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Application 18489441 in view of the prior art references cited in the art rejections above.
This rejection is withdrawn in view of the terminal disclosure filed on Aug. 19, 2026.
Prior Art References Not Used in the Rejections
The following is a list of relevant prior art references that are relevant to the claimed invention not used in current rejections:
1) CN114657282, 2) CN111088406, 3) CN111088406, and 4) US Application 17508751.
Response to Applicant’s Arguments
Applicant’s arguments filed on Aug. 20, 2026 have been fully considered. Arguments regarding withdrawn rejections are moot. Applicant’s arguments relevant to the current rejections are addressed as follows.
Applicant argues that the cited references teach different ratios of primers used in the LAMP reactions that are different from the one as claimed, which is 1:8:2 for pairs of primers F3/B3, FIP/BIP and LF/LB, respectively. Applicant argues that the presently claimed method has a reaction mix comprising reagents that are different from those of Diego. Applicant argues that Diego teaches that the N5 gene has a longer detection time than the N15 gene, while the instant disclosure established that N5 gene is detected faster than the N15 gene. Applicant argues that Diego teaches that Bst 3.0 polymerase results in non-specific amplification and irregular, non-reproducible data. Applicant argues that Diego teaches away. Applicant argues that other cited references are entirely silent the use of Bst 3.0.
Applicant’s arguments are not persuasive.
As indicated in the rejections above, the cited references together teach all of the reagents specified in the method as claimed. As to the claimed “amounts” of each claimed reagent, including primers, the references teach that different amounts can be used, suggesting that amounts that are functional may vary and may be optimized through routine experimental optimization, unless there is evidence that the claimed “amounts” (which are not clear based on the discussion in the 112b rejection above) are critical.
As to Applicant’s argument that Diego teaches away. MPEP section 2145 X.D relates to assertions that the art teaches away from the claimed invention. Such teachings are not considered to be a teaching away merely by indicating that something is in some manner inferior to another. In essence, a teaching away must criticize, discredit, or otherwise discourage the solution. Here, Diego does not indicate that Bst 3.0 polymerase must not be used in RT-LAMP.
Conclusion
No claims are 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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671
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