CTNF 18/716,805 CTNF 92208 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. Claim Rejections - 35 USC § 102/103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 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. 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-27-aia AIA Claim s 1-5 are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Uematsu (JP 2015-21931 A) . A machine translation of the description of Uematsu is provided with this action. With respect to claim 1 , Uematsu teaches a method for controlling a liquid chromatograph [0001-0002] in a system which has a liquid delivery pump (4) with connected flow path [Figs. 1-2], a plurality of streams in the flow path, and a pressure sensor (5) for detecting flow path pressure, and a separation column (8) for separating components [0056], as well as a switching valve (2a,b,c) for switching between flow paths. Uematsu teaches that the system can determine the status of a sample based on output changes, according to various recognizable error conditions [0036] including the presence of small or large amounts of air/bubbles in the sample path [0029-0030], including in cases by detecting a pressure fluctuation [0051]. Switching of the valve occurs during the normal process of use e.g. to control flow of eluent, such that at any point if/when air is detected and identified according to the principles discussed, the claimed method is satisfied. Given the broadest reasonable interpretation, the claimed method is therefore anticipated by – or at minimum obvious over – the teachings of Uematsu. PNG media_image1.png 336 652 media_image1.png Greyscale With respect to claim 2 , Uematsu teaches embodiments with multiple switching valves in series [Fig. 10] and teaches that the system can detect variations due to both injection switching and eluent switching [0024] such that the claimed behavior is anticipated or at minimum obvious over the taught control methods. If this is not considered sufficient, see alternatively the rejection of claims 2-6 below; the sensitivity of the system to detect e.g. leaks at different points during switching of specific valves would at least have been obvious in view of Quint. PNG media_image2.png 266 362 media_image2.png Greyscale With respect to claims 3 and 5 , Uematsu teaches storing reference information regarding elution behavior e.g. both time and peak variations from which to compare data; using this to compare to live data to detect the status e.g. bubbles is implicit or at minimum obvious. With respect to claim 4 , there is no distinction between operation or maintenance taught, and no requirements in the claim to distinguish the two, such that the limitation is anticipated or at minimum obvious over the taught control process . 07-21-aia AIA Claim s 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Uematsu in view of Quint et al (EP 3761038 A1) . With respect to claim 6 , Uematsu teaches as above, including a first switching valve (13) as an eluent switching valve and a second valve (6) as a sample injection valve. Uematsu does not specify that the eluent valve is an auto-purge valve. However, auto-purge switching valves are known in the art for use in chromatography systems. Quint teaches methods for identifying issues in chromatography systems such as clots or leaks [Abs] and teaches that each of the pumps can be connected to auto-purge valves [0055-0057] and teaches that the auto-purge valves can be switched in a manner that allows for detection of leaks or clogs in specific locations [0078-0080]. It would have been obvious to include auto-purge valves in the system of Uematsu as conventional valve configurations, or for specific benefits such as improved ability to detect leaks and clogs in specific segments of the system. With respect to claims 2-5 , see the rejections above. If the teachings of Uematsu are not sufficient to anticipate or render obvious the claimed process steps, at minimum they would have been obvious over Quint, which discusses detection of leaks and clots in specific sections of the device when actuating auto-purge valves at various locations in the system [0078-0080]. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY R SPIES whose telephone number is (571)272-3469. The examiner can normally be reached Mon-Thurs 8AM-4PM. 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, Jennifer Dieterle can be reached at (571)270-7872. 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. /BRADLEY R SPIES/Primary Examiner, Art Unit 1777 Application/Control Number: 18/716,805 Page 2 Art Unit: 1777 Application/Control Number: 18/716,805 Page 3 Art Unit: 1777 Application/Control Number: 18/716,805 Page 4 Art Unit: 1777 Application/Control Number: 18/716,805 Page 5 Art Unit: 1777
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