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. Election/Restrictions Applicant’s election without traverse of Group II, in the reply filed on February 2, 2026 is acknowledged. Because the election was received with claim amendment which effectively changed all product claims into a method, the election is acknowledged, and all claims are directed to the elected invention. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The IDS received on June 5, 2023, November 27, 2024, and January 29, 2025 are proper and are being considered by the Examiner. Drawings New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because For example, some of the Figures (FIG. 13) contains figure texts which are too small and unclear to be legible; and some Figures contain foreign texts therein ( e.g., FIG. 6). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance. 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 9-13 are 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. Claims 9-13 are indefinite for the following reasons. Claim 9 has been amended from a product to claim to a method claim by changing of its preamble and dependency to parent claim 1, which is directed to a method. Because claim 9 had previously been a product claim, the structural elements of the product as recited in claim 9 are not coherently integrated into the method of claim 1. Therefore, claim 9 is confusing in how the elements of the thermocycler are to be employed in the method as recited in claim 1. For example, claim 9 should be amended refer to “one or more reaction containers” as “ said one or more reaction containers” since this feature was already recited in the parent claim ; and providing the proper context to the “stirring unit” for the actual “stirring” step in parent claim 1. Claims 9-10 should be amended to provide such a context that relates to the steps performed in claim 1. Claims 10-13 are also indefinite for this same reason. The Office has construed the claims to map the product elements into the method as best as possible. Conclusion Claims 1-8 are allowable. Claims 9-13 are rejected. Claims are free of prior art. Large-scale or bulk-PCR has been known in the art. For example, Orrling et al. ( Chem Commun ., 2004, pages 790-791 ) teach a method of performing a PCR reaction in large volume in milliliters range “ we decided to perform a proof-of-principle investigation on the potential of microwave-assisted PCR in the milliliter-scale … 2.5 mL PCR reaction was set up to mimic the conditions known to afford good results in a classic thermocycler: 95 o C denaturation for 15 s followed by 60 o C for 60 s in a combined annealing and extension step …” (page 790) The artisans teach manipulation of the conditions to achieve a better amplification outcome as well as scaling the reaction amount. “ the amplification effectiveness drastically improved … resulted in a final concentration of PCR product between 10-30 nM giving an amplification efficiency of 92-96% … We also performed a microwave experiment running a 15 mL PCR reaction … reaction revealed a concentration of PCR product comparable to the concentration achieved with 2.5 mL reaction and a calculated amplification efficiency close to 100%” ( page 791, 1 st paragraph) The artisans, however do not scale the reaction to 30 mL or greater, which is twice that of the amount disclosed by Orrling , nor teach that the reaction solution is stirred during the PCR reaction. The present application seeks to improve the large-scale PCR reaction by combination of stirring the reaction during the PCR reaction. “ it is presumably necessary to uniformize PCR reaction solutions in PCR reaction in solution bags, and adjust temperatures to set temperatures at the thermal denaturation, annealing and extension reaction stages when the amount of a PCR reaction solution is further increased. Accordingly, whether or not the problem could be solved by stirring a PCR reaction solution was tested” (section [0103], Specification ) “PCR was performed while the reaction solution was stirred by stirring the reaction container … For a control with no shake, one bag housing 50 mL of a reaction solution was installed in the thermal cycler where PCR was performed without shake” (section [0105], Specification ) “ it was confirmed that the nucleic acid was amplified by the stirring of the reaction solution even when the reaction solution had a volume as large as 100 to 300 mL … the temperature of thermal denaturation, or annealing and extension reaction was variable for the control with no shake shown in Figure 11D whereas the temperature was controlled at more nearly the set temperature for 100 mL, 200 mL, and 300 mL with shake” (section [0105], Specification ) There simply is no teaching for a PCR, wherein the PCR reaction solution is 30 mL or greater where the PCR is performed while the PCR reaction solution is being stirred or was there a motivation to do so before the effective filing date of the claimed invention. Inquiries Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7: 3 0 a.m. to 4:00 p.m (M- F ). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782. Papers related to this application may be submitted to Art Unit 16 81 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600. 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. 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. /YOUNG J KIM/ Primary Examiner Art Unit 1637 DATE \@ "MMMM d, yyyy" April 1, 2026 /YJK/