DETAILED ACTION
Status of claim rejections
The objections of record to the specification are withdrawn in view of Applicant’s filing of a substitute/amended specification in the response filed 11/24/2025.
The objections of record to the drawings are withdrawn in view of Applicant’s filing of a substitute/amended drawings in the response filed 11/24/2025.
The rejections of record under 35 USC 103 are maintained in view of Applicant’s arguments/amendments in the response filed 11/24/2025.
This action is Final, as necessitated by Applicant’s amendments.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/07/2026 was filed after the mailing date of the Non-Final Office Action on 07/23/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
New Claim Rejections - 35 USC § 112(b), Necessitated by Amendment
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 1, 2, and 4 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.
Claim 1 has been amended to recite the limitations "wherein the cuvette has: a first sidewall configured to facilitate performance of a first optical detection reading therethrough for monitoring anticoagulant activity: and a second sidewall configured to facilitate performance of a second optical detection reading therethrough for monitoring anticoagulant activity wherein the disposable bioassay diagnostic cartridge is configured such that, in operation thereof for monitoring anticoagulant activity: at least some of the matrix, at least some of the plurality of microparticles, and a blood sample are first mixed together within the third well of the disposable bioassay diagnostic cartridge and subsequently at least some of a resultant mixture and at least some of the activation agent are then mixed together within the cuvette of the disposable bioassay diagnostic cartridge.”
Per MPEP 2173.05 (p)(II), 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). 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.
The findings in Katz are instructive. Claim 1 is an instance in which statutory categories—product and process—are mixed. Claim 1, drawn to a disposable bioassay diagnostic cartridge (composition), recites, inter alia, “in operation thereof for monitoring anticoagulant activity: at least some of the matrix, at least some of the plurality of microparticles, and a blood sample are first mixed together within the third well of the disposable bioassay diagnostic cartridge and subsequently at least some of a resultant mixture and at least some of the activation agent are then mixed together within the cuvette of the disposable bioassay diagnostic cartridge.” All of the described mixing steps are process steps. Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting that the claimed cuvette, absent evidence to the contrary, will be able to perform the mixing steps, if the cuvette is present in the prior art product. Please note that dependent claim 2 and 4 are also indefinite for being dependent on indefinite claim 1.
As above, claim 4 has been amended to recite “the first optical detection reading is performed via a first light-emitting diode (LED) configured to emit at a wavelength in the range of 500-550 nm; and a second wall capable of facilitating the second optical detection reading is performed via a second LED configured to emit at a wavelength in the range of 620- 700 nm.” These claim limitations are method/process steps drawn to an optical reading measurement, dependent on claim 1 (which is a product/apparatus). Claim 4 is an instance in which the statutory categories -product and process- are mixed. Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting that, absent evidence to the contrary, the claimed cuvette will be able to perform the optical detection steps at the claimed wavelengths.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Maintained 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 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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Holtlund et al (US 20140065646 A1) in view of Chen et al. (A Latex Agglutination Test for the Rapid Detection of Avian Influenza Virus Subtype H5N1 and its Clinical Application. Journal of Veterinary Diagnostic Investigation. 2007;19(2):155-160; hereinafter “Chen”).
Holtlund teaches a diagnostic assay cartridge (as in claim 1) comprising at least two wells (i.e., at least a first well and a second well as in claim 1) (see claim 1, and paragraphs 0007-0008). The wells can be pre-filled with reagents required for the particular assay or assays to be performed using that cartridge and where two or more reagents are required, these may be pre-filled into different wells in the cartridge (see paragraph 0018). The reagents will be prefilled into the wells in measured quantities including liquids (i.e., liquid matrix as in claim 1), powders (drying matrix as in claim 1), beads, coatings on the well walls, coatings on beads, etc. (see paragraph 0018). Specifically, Holtlund teaches use of 120 nm latex beads in one of the cartridge wells (plurality of microparticles in a second well as in claim 1), that the diagnostic cartridge can be used for coagulation assays in blood or plasma (see paragraph 0069 and Example 11; Fig. 11). In example 8, Holtlund teaches a cartridge where one well contains citrate buffer (liquid matrix) and another a calcium salt solution (i.e., a third well comprising activation agent; the activation agent is calcium ions as in claim 1), and a third well containing a dried thrombin-specific chromogenic substance (see paragraph 0156 and Fig. 11). Holtlund also teaches a cartridge (i.e., an integrated cartridge/cuvette) that can contain a reading well where the absorption of light passing through a liquid in the well is to be measured (see paragraph 0037), and that the reading well is capable of optical detection readings (see paragraph 0107, 0140, and Fig. 2). Holtlund further teaches assays using various samples (blood, serum, urine, etc.) including coagulation assays (see Examples 1-3, Example 5).
The difference between Holtlund and the instant claims is that Holtlund does not explicitly teach the latex beads are uncoated latex with at least one surface type chosen from unreacted plain, sulfate, carboxylate, and amidine.
However, Chen (in a similar field of endeavor of diagnostic assay cartridges) teaches use of carboxylated latex particles/beads for agglutination and immunochromatographic assays (see abstract). Chen specifically teaches that using carboxylate-modified latex particles are superior to unmodified latex particles for use in agglutination tests (i.e., testing the sticking together of particles in suspension) because they are more hydrophilic, more stable in aqueous solutions, and contain reactive sites for covalent conjugation of proteins (see pg. 159, col 1).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the diagnostic assay cartridge of Holtlund with the carboxylated latex particles of Chen to arrive at the claimed invention. As the claimed invention required the creation of a diagnostic assay cartridge with latex particles, one of ordinary skill would have been motivated to perform a simple substitution of one known element (the latex particles of Holtlund) for another (the carboxylated latex particles of Chen) with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Chen explicitly teaches that carboxylate-modified latex particles are advantageously superior to unmodified latex particles because they are more hydrophilic, more stable in aqueous solutions, and contain reactive sites for covalent conjugation of proteins.
Regarding claim 2, Holtlund teaches using a well in the cartridge containing calcium chloride for coagulation assays (see paragraph 00143).
Regarding claim 4, Holtlund teaches a cartridge (i.e., an integrated cartridge/cuvette) that can contain a reading well where the absorption of light passing through a liquid in the well is to be measured (see paragraph 0037), and that the reading well is capable of optical detection readings at 460 nm and 620 nm (see paragraph 0107, 0140, and Fig. 2) using, e.g., green, blue, and red LED (see paragraph 128-129).
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
On pg. 10 of the remarks, Applicant argues “Applicant does not concede that Holtlund and Chen can be combined properly. Nevertheless, even if the noted combination is made as proposed by the Office, the Applicant respectfully submits that Holtlund and Chen do not disclose or otherwise fairly suggest the above-noted claim limitations and, thus, fail to disclose each and every limitation of amended claim 1 alone or in combination with one another.”
In response, the examiner disagrees. As discussed above, the additional limitations added to claim 1 (i.e., the mixing method steps as discussed in the 112(b) rejection above) regarding the claimed cuvette, absent evidence to the contrary, will be able to perform the mixing steps, if the cuvette is present in the prior art product. As further discussed above, Holtlund teaches the claimed cuvette with the ability to facilitate optical detections of the samples within the cartridge, such that the combination of Holtlund and Chen renders the claims prima facie obvious. Thus, the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
JP6316369B2: discusses microfluidic substrates and methods that are useful for performing biological, chemical and diagnostic assays. The substrates can include a plurality of electrically addressable, channel bearing fluidic modules integrally arranged such that a continuous channel is provided for flow of immiscible fluids, using, e.g., latex beads and cuvettes for optical detection (see abstract, throughout document).
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672