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 .
This is an NON FINAL REJECTION in response to applicant’s claim amendments and arguments filed December 11, 2025. Claims 1, 16, and 19-21 are currently amended. Claims 12 and 18 are canceled from consideration. Claim 22 is newly added. Claims 1-12, 14-17, and 19-22 are pending review in this correspondence.
Response to Amendment
Rejection of claims 1-17 and 19-21 for being rejected under 35 U.S.C. 101 is withdrawn.
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 applicant regards as his invention.
Claims 14-15 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 respect to claim 14, lines 1-2, the claim recites “A liquid sample analyzer adapted for performing a method of clot detection according to claim 1.…” A single claim which claims
both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). Further, in Katz, a claim directed to "[a] system with an interface means for providing automated voice messages to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings V. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.") (See MPEP 2173.05(p) II). In the specific instance, it is unclear if infringement would occur when clot detection occurs by the claimed method or occurs when a liquid sample analyzer has the claimed functionality. Therefore, the claim is indefinite.
Claim 15 is dependent upon claim 14, and thus, inherits the same deficiencies.
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansouri et al (US 2012/0090993 A1).
With respect to claim 14, Mansouri discloses a liquid sample analyzer adapted for performing a method of clot detection according to claim 1, the liquid sample analyzer (electrochemical sensor system 8) comprising:
A measurement chamber (sensor card) with inlet (sample inlet 13a) and outlet (waste 32) ports for feeding and discharging a liquid sample to and from the measurement chamber (See Fig. 1 and Paras. 0040 and 0044);
An analyte sensor (sensor assembly 10, See Fig. 1 and Para. 0040) facing the measurement chamber and arranged for measuring a physical parameter of the analyte in a liquid sample in the measurement chamber; and
A signal processor configured for receiving signals from the analyte sensor as an input, for performing a comparison of the initial and subsequent measurement results based on that input, and for determining present of absence of a clot in the measurement chamber based on the comparison (See Fig. 1 and Para 0048 for discussion of the inclusion of a microprocessor 40; Para. 0050 discusses how the microprocessor takes measurements provided by the electrode assembly and stores these values, takes the known values of the measured parameters contained within the internal reference solutions and effectively creates a calibration curve for each of the measured parameters such that, when a blood s ample is passed through the electrode assembly, the measurement made by the electrodes can be used to derive accurate measurements of the parameters of interest; and Paras. 0080, 0096, and 0114 discuss the system continuously monitors for failure patterns, in which a clot is the most typical cause of failure patterns).
With regard to the recitation of the apparatus being adapted for performing the method of claim 1, because Mansouri discloses the necessary recited structures, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized Mansouri at least suggesting the necessary structure to enable the claimed method recitations (and interpreted under 35 U.S.C. 112b, see above).
With respect to claim 15, Mansouri discloses how the liquid sample analyzer is adapted for the measurement of blood parameters in whole blood samples (See Para. 0040 for discussion of how blood samples to be analyzed by the system 8 can be taken via phlebotomy or on a periodic basis from an extracorporeal blood flow circuit connected directly to a patient and introduced to the sample inlet through automatic or manual means, such as by syringe).
Allowable Subject Matter
Claims 1-12, 16, 17, and 19-22 are allowed.
The following is an examiner’s statement of reasons for allowance: The following is an examiner’s statement of reasons for allowance: The closest cited prior art of reference fails to disclose or fairly teach the methods of claims 1 and 19, specifically:
In the step of removing the primary solution from the measurement chamber, and then at least partly filling the measurement chamber with a filling amount of a secondary solution having a pre-determined secondary composition with a secondary concentration of the analyte, wherein the filling amount of the secondary solution is metered to just fill the measurement chamber rather than to completely flush the chamber with the secondary solution (claim 1); and
In the step of at least partly filling the measurement chamber with a secondary solution having a pre-determined secondary composition with a secondary concentration of the analyte, the secondary concentration is different from the primary concentration, wherein the concentrations of the analyte contained in the primary and secondary solutions differ by at least a factor of 2, at least a factor of 5, at least a factor of 10, at least a factor of 20, at least a factor of 50, or a least a factor of 100 (claim 19).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments filed December 11, 2025, and pursuant to the interview conducted on December 9, 2025, with respect to the rejections made under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections of all pending claims under 35 U.S.C. 101 have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 March 20, 2026
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