CTNF 18/250,689 CTNF 78204 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 1. Applicant’s election with traverse of group I (claims 1-9) in the reply filed on May 18, 2026 is acknowledged. The traversal is based on no burden to examine all the groups together. The arguments were found unpersuasive because the International search report established anticipation of the claimed invention over prior art reference which indicates lack of unity. Further lack of unity of invention is not dependent on search burden. For all the above the lack of unity is deemed proper. Status of the Application 2. Claims1-9 are considered for examination. Claim 10 is withdrawn from further consideration as being drawn to non-elected group. Priority 3. This application filed on April 26, 2023 is 371 of PCT/EP2021/079746 filed on October 27, 2021 which claims foreign priority to DE10 2020 213 472.3 filed on October 27, 2020. Informalities 4. The following informalities are noted: (i) claim 2 recites the terms (SDA, RPA, LAMP, RCA, MDA, NASBA, HAD, NEAR, NESA and HCR). Expanding the terms at least for the first time that they appear in the claims is suggested. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 5. 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 – 07-08-aia AIA (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. A. Claims 1-2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warthoe et al. (US 2015/0126382). Warthoe et al. teach a method of claim 1 for operating a microfluidic analysis device, comprising: providing a sample containing DNA; performing a PCR pre-amplification (first PCR) of the sample (para 0030-0041, 0058, 0168, 0172); dividing the sample into at least two reaction compartments; and performing at least one singleplex detection in each of the at least two reaction compartments, wherein the at least one singleplex detection is performed using an isothermal amplification system (para 0032-0048, 0169-0170, 0173-0174, 0058, 0123). With reference to claim 2, Warthoe et al. teach that the isothermal amplification system is LAMP, RCA, (para 0045-0048). With reference to claim 6, Warthoe et al. teach that the PCR pre- amplification is performed in a reaction volume in the range of 10 µl to 50 µl (para 0168). With reference to claim 7-8, Warthoe et al. teach that the PCR pre-amplification is performed using 2 to 100 target-specific primer pairs and the PCR pre-amplification is performed cyclically, undergoing 5 to 30 temperature cycles, wherein the sample is pumped back and forth between several chambers (para 0058, 0168). For all the above the claims are anticipated. B. Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barany et al. (WO 2018/183723). Barany et al. teach a method of claim 1 for operating a microfluidic analysis device, comprising: providing a sample containing DNA; performing a PCR pre-amplification of the sample (para 0126-0130, 0152, 0284, 0384-0389, 026-0028, 0216); dividing the sample into at least two reaction compartments; and performing at least one singleplex detection in each of the at least two reaction compartments, wherein the at least one singleplex detection is performed using an isothermal amplification system (para 0126-0130, 0152-0153, 0284-0292, 0384-0400, 0028). With reference to claim 2, Barany et al. teach that the isothermal amplification system is selected from a group consisting of SDA, RPA, LAMP, RCA, MDA, NASBA, HDA, NEAR, NESA, and HCR (para 0266, 0272). With reference to claim 3, Barany et al. teach that the at least two reaction compartments each have a volume of less than 1 µl (para 0391-0392). With reference to claim 4, Barany et al. teach that the at least two reaction compartments comprise 2 to 500 reaction compartments into which the sample is divided (para 0292). With reference to claim 5, Barany et al. teach the division of the sample takes place using at least partially fluorinated hydrocarbon (fluorinated oil) (para 0155). With reference to claim 6, Barany et al. teach that the PCR pre- amplification is performed in a reaction volume in the range of 10 µl to 50 µl (para 0391-0392). With reference to claim 7-8, Barany et al. teach that the PCR pre-amplification is performed using 2 to 100 target-specific primer pairs and the PCR pre-amplification is performed cyclically, undergoing 5 to 30 temperature cycles, wherein the sample is pumped back and forth between several chambers (para 0306, 0384-0400). With reference to claim 9, Barany et al. teach that between the PCR pre-amplification and the division of the sample, at least one constituent of the sample is inactivated (para 0129, 0269, 0284-0288, 0299). For all the above the claims are anticipated. Conclusion No claims are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm. 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, Gary Benzion can be reached at 571-272-0782. 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. Suryaprabha Chunduru Primary Examiner Art Unit 1681 /SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681 Application/Control Number: 18/250,689 Page 2 Art Unit: 1681 Application/Control Number: 18/250,689 Page 3 Art Unit: 1681 Application/Control Number: 18/250,689 Page 4 Art Unit: 1681 Application/Control Number: 18/250,689 Page 5 Art Unit: 1681 Application/Control Number: 18/250,689 Page 6 Art Unit: 1681
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