CTNF 18/252,301 CTNF 72468 DETAILED ACTION 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Species A in the reply filed on January 28, 2026 is acknowledged. 08-06 AIA Claim s 32 – 39 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026 . Claim Rejections - 35 USC § 112 07-30-02 AIA 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 applicant regards as his invention. Claims 21 – 30 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. With regard to claim 21, it is unclear how the “controller” would be capable of providing the two ‘measurement’ results, as the “impedance sensor” and “optical spectrometer” would more generally be considered as the elements typically used for obtaining a ‘measurement’. Additionally, while the claim is generally directed to a ‘smart syringe’, the claim does not recite a particular relation between any of claimed element, rendering it unclear whether the sensor and spectrometer are even interacting with a sample in the syringe device, of if Applicant intends them to be suitable for interacting with different samples. With regard to claim 29, it is unclear what is intended by referring to “at least one reservoirs” (plural), as this is not a standard phrasing but the claim language does not indicate why the plural term is in the phrase. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 21 – 25, 30, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sage (USPN 3,674,012) in view of Nishizawa et al. (USPN 8,554,295). Sage teaches an impedance measuring syringe (Figures 1, 7, 8 and the descriptions thereof) in which electrodes are present within the syringe for measuring impedance of body fluids collected therein and measured values may be analyzed for assessing coagulation test times (Summary of the Invention). Further, Nishizawa et al. teach an arrangement for providing optical measurement elements adjacent a syringe for measuring components within the syringe (Figures 4, 5, and the descriptions thereof, for example). The claims, as best understood in light of the rejections under 35 USC 112(b) as set forth above, do not require the measured impedance to influence the processing of the optical data, or vice versa. As such, it would have been within the skill level of the art before the effective filing date to have utilized Nishizawa et al. in combination with Sage, since it is well recognized that combining known elements into a common combination, where each element merely performs the same function as it does separately, is an obvious modification within the skill level of the art providing a predictable result. The combination, when used as intended, would perform the method steps of claim 40 . Allowable Subject Matter 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Valdespino et al. and Nishizawa et al. teach measuring arrangements for assessing aspects of samples in syringes, as discussed above. Further, Applicant cites several references for collecting and analyzing body fluid samples, including Holmes and Kunjan. Additionally, Valdespino et al. (USPN 4,553,552) and Yan et al. (USPN 12,023,142) teach syringes that incorporate electrodes for impedance measurements, while Karkar et al. (USPN 5,249,584), Enejder (USPN 6,510,330), and Raskas (USPN 6,922,576) teach arrangements for performing optical measurements on fluid samples, including hematocrit sensing. However, the prior art does not teach or suggest a syringe incorporating calibration configurations consistent with the details of claims 26 or 29, in combination with the other claimed elements . 07-43-02 AIA Claim s 26 - 30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm. 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, Chuck Marmor, II can be reached at 571-272-4730. 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. /ERIC F WINAKUR/Primary Examiner, Art Unit 3791 Application/Control Number: 18/252,301 Page 2 Art Unit: 3791 Application/Control Number: 18/252,301 Page 3 Art Unit: 3791 Application/Control Number: 18/252,301 Page 4 Art Unit: 3791 Application/Control Number: 18/252,301 Page 5 Art Unit: 3791
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