DETAILED ACTION
Status of claim rejections
The rejections of record under 35 USC 112(b) are withdrawn in view of Applicant’s amendments in the response filed 05/18/2026.
The rejections of record under 35 USC 103 are modified in view of Applicant’s amendments in the response filed 05/18/2026.
New Claim Rejections - 35 USC § 112 New Matter, Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 21-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Newly added claims 21, 28, and 29 recite “the second sidewall is positioned substantially opposite the first sidewall”, “the cuvette is formed integral to a structure of the disposable bioassay diagnostic cartridge”, and “the cuvette is formed separate from and operatively interfaceable with a structure of the disposable bioassay diagnostic cartridge” (respectively).
Neither the instant specification nor the originally filed claims appear to provide support for the recitation of any of the limitations as recited above. The instant specification is silent to the position of the second sidewall in comparison to the first, the cuvette being “formed integral to a structure of the disposable bioassay diagnostic cartridge” and the “cuvette is formed separate from and operatively interfaceable with a structure of the disposable bioassay diagnostic cartridge”. Applicant has failed to point to anywhere in the specification that provides support for these limitations, other than a cursory statement that “support for which may be found in the specification, as originally filed” (see Applicant’s remarks on pg. 7).
Thus, such a recitation constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for the recitation of “the second sidewall is positioned substantially opposite the first sidewall”, “the cuvette is formed integral to a structure of the disposable bioassay diagnostic cartridge”, and “the cuvette is formed separate from and operatively interfaceable with a structure of the disposable bioassay diagnostic cartridge” or to cancel the new matter.
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.
Claim 28 and 29 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 28 recites the limitation “the cuvette is formed integral to a structure of the disposable bioassay diagnostic cartridge”. It is unclear what the term “formed integral to a structure” of the cartridge means as the specification does not define or depict such a structure/feature (does Applicant mean that the cuvette is attached/fixed to some structure within the cartridge?). Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting that the cuvette is attached/fixed to some structure within the cartridge.
Claim 29 recites “the cuvette is formed separate from and operatively interfaceable with a structure of the disposable bioassay diagnostic cartridge”. It is unclear what the term “operatively interfaceable with a structure” of the cartridge means as the specification does not define or depict such a structure (does Applicant mean that the cuvette is removable from some structure within the assay device/cartridge?). Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting that the cuvette is removable from some structure within the cartridge.
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.
Claim interpretation
The examiner is interpreting the claims as follows: claim 1 has been amended to recite “a first sidewall configured to facilitate performance of a first optical detection reading therethrough at a first wavelength in a range of about 620-700 nm for monitoring anticoagulant activity in a mixture of the matrix, the plurality of microparticles, the activation agent, and the blood sample; and a second sidewall configured to facilitate performance of a second optical detection reading therethrough at a second wavelength in a range of about 500- 550 nm for monitoring anticoagulant activity in the mixture of the matrix, the plurality of microparticles, the activation agent, and the blood sample”. The limitations of “configured to facilitate performance of a first optical detection reading therethrough. . . for monitoring anticoagulant activity in a mixture of the matrix, the plurality of microparticles, the activation agent, and the blood sample” has been interpreted as an intended use of the cartridge sidewalls, such that, absent evidence to the contrary, the claimed cuvette will be able to perform the optical detection steps at the claimed wavelengths if the cuvette is present in the prior art product (see MPEP 2144.07).
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.
First rejection
Claims 1-2, 21, 25, 28-30, 32, 34-36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Holtlund et al (US 20140065646 A1; prior art of record) in view of Schwartz (US 5789261 A).
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 between 460 to (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). 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, 540 nm and 620 nm (see paragraph 0107, 0128, 0140, and Fig. 2) using, e.g., green, blue, and red LED (see paragraph 128-129).
Holtlund does not explicitly teach using uncoated latex microparticles which have not been reacted, exposed or coupled to a protein.
However, Schwartz (in a similar field of endeavor) teaches immunoassay solid negatively-charged polymer support and polyethyleneimine coating serves to eliminate nonspecific adsorption of biological molecules such as high molecular weight kininogen, which have affinity for solid surfaces and which interfere with immunoassays (see abstract, throughout). Schwartz teaches the use of uncoated carboxylated-modified latex microspheres in the absence of antibody coating (i.e., the latex microparticles are not reacted/exposed/coupled to a protein) and found that high molecular weight kininogen in patient blood plasma was capable of successfully binding to the latex particles without an antibody coating in lieu of antibody coated latex particles (col 22 lines 27-63).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the diagnostic cartridge antibody-coated latex microparticles of Holtlund by using the uncoated latex microparticles of Schwartz to arrive at the claimed invention. One of ordinary skill would have been motivated to make the modification because Schwartz explicitly teaches the successful use of uncoated latex microparticles in plasma immunoassays.
Regarding claim 2, Holtlund teaches using a well in the cartridge containing calcium chloride for coagulation assays (see paragraph 00143).
Regarding claim 21, Holtlund teaches the cuvette has a sidewall opposite the first wall (see Fig. 1 and 2).
Regarding claim 25, Schwartz teaches using carboxylate-modified latex microparticles.
Regarding claim 28-29, Holtlund teaches the cartridge wells can be fixed or removable (see paragraph 0088).
Regarding claim 30, Holtlund teaches using whole blood (see example 3), and Schwartz teaches using plasma.
Regarding claim 32, Holtlund teaches the latex microparticles are 120 nm.
Regarding claim 34, Holtlund teaches using 0.2% w/v latex beads (see example 11), and not 0.006&, 0.01% or 0.08% as claimed. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 35-36, Schwartz teaches using dluent buffers including sterile water (col 17 lines 57-col 18, lines 1-40).
Regarding claim 38, Holtlund teaches using capillary tipped pipettes (see throughout).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Second rejection
Claim 22-24, 26-27, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Holtlund and Schwartz as applied to claim above, and further in view of Zhang (US 20080019921 A1).
As discussed above, claims 1-2, 21, 25, 28-30, 32, 34-36 and 38 were rendered prima facie obvious by the teachings of Holtlund and Schwartz.
The references do not explicitly teach the latex microparticles have unreacted plain surface (claim 22), the microparticles are surface-functionalized with amidine or sulfate (claim 23-24), the first wavelength is 660 nm (claim 26), the second wavelength is 530 nm (claim 27), the microparticles comprise polystyrene (claim 31), and the particles have a diameter in a range of about 90-110 nm (claim 33).
However, Zhang teaches creation of microspheres for the measurement of blood flow using microspheres that are substantially uniform in diameter and have a hydrophobic surface, which allows them to circulate more freely throughout bloodstream, while reducing immunogenicity, particle aggregation and bioaccumulation (see abstract). Zhang teaches the creation of microparticles can be prepared using polymerization reaction to add polymerized styrenes (i.e., polystyrenes) which act as a “non-reactive” protection layer for the microspheres (see para 110), as well as the preparation to provide the microparticles with a variety of surface properties with functional groups including sulfate, carboxyl, and amidine (see paragraph 0198). Zhang teaches that the microspheres have an excitation and emission wavelength compatible with imaging at 300-800 nm and have a size range of 100-2000 nm (see para 0091-92 and 169). While Zhang does not explicitly teach using plain surface microparticles, Zhang does teach that the use of any surface groups can be selected to give the particles desried characteristics, such that the choice to include (or exclude) any surface modification (including no surface modification) would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing, absent evidence to the contrary (see MPEP 2144.05).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the microparticles of Holtlund and Schwartz by including the surface modifications as taught by Zhang to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Zhang explicitly teaches that microparticles can successfully have surface modifications to give them desired physical characteristics.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Third rejection
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Holtlund and Schwartz as applied to claims above, and further in view of Edmondson et al. (US 5008202 A), Deng (US 20110027771 A1), and Thermofisher Scientific ("FoamAway™ Irradiated AOF (animal origin-free) Antifoaming Agent" retrieved 06/13/2026 from https://www.thermofisher.com/order/catalog/product/A1036902).
As discussed above, claims 1-2, 21, 25-30, 32-36 and 38 were rendered prima facie obvious by the teachings of Holtlund and Schwartz.
The references do not explicitly teach the liquid matrix comprises: 0.17M glycine at pH 10.0; 1.29M sodium chloride (NaCl); and 1% simethicone diluted with injection-grade purified water.
However, Edmondson teaches diluent buffers useful for analysis of blood samples (see abstract, claims). Edmonson teaches that in analyzing blood by an automated, blood-analysis instrument or other analytical method, it is essential that the diluent not adversely affect the chemical and physical integrity of the blood cells during the analysis (see col 1, lines 45-55). Edmonson teaches that sodium chloride is routinely used to adjust osmolality of diluents to appropriately maintain blood cell volume (see col 2 lines 24-32 and Table 1).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the matrix of Holtlund and Schwartz by including sodium chloride as taught by Edmonson to arrive at the claimed invention. One of ordinary skill would have been motivated to make the modification because Edmonson explicitly teaches that sodium chloride can be successfully used as an additive agent to maintain chemical and physical integrity of samples during blood analysis and maintain cell volume.
Moreover, Deng teaches that fragile cells have value for use in diagnosing many types of conditions including blood samples (see abstract, claims, throughout). Deng teaches various stabilizers in the composition, where the composition has a pH anywhere between 6-10 that can be used to maintain cells in solution, including glycine which advantageously acts as an antioxidant (see paragraph 0015, claim 10 and 17, paragraph 0084, 0094, and Example 1-2).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the matrix of Holtlund and Schwartz by including glycine as taught by Deng to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Deng explicitly teaches that glycine advantageously can be used as an antioxidant to stabilize cells in blood samples.
Furthermore, Thermofisher teaches FoamAway™ Irradiated AOF (animal origin-free) antifoaming agent (see pg. 1). Thermofisher teaches it is a ready-to-use antifoaming agent designed to offer high performance and convenience in cell culture and combatting foaming. Thermofisher teaches the formula is prediluted and pre-sterilized and formulated to a 4.0% simethicone concentration during manufacture, but that the final concentration may be variable in the finished product but is generally less than or equal to 4% simethicone (see pg. 2-3).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the matrix of Holtlund and Schwartz by including simethicone as taught by Thermofisher to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Thermofisher explicitly teaches simethicone can be used as a pre-sterilized defoaming agent for cells and cell culture.
Please note none of the references teach Applicant’s concentrations of glycine, NaCl or simethicone. However, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 05/18/2026 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. . . More specifically, Chen explicitly teaches that "[m]onoclonal antibodies against the hemagglutinin glycoprotein of H5N1 were covalently coupled onto the surface of carboxylated latex bead[s] using a water-soluble carbodiimide to obtain sensitized latex particles (SLP)." Chen: abstract. Consistently, Chen discloses that, in preparation of the SLPs, "[a]ffinity-purified antibody was coupled to carboxylated latex particles ... ." Chen: p. 156, 3rd full paragraph. The Applicant respectfully submits that Chen's latex particles, therefore, cannot reasonably be interpreted as not having been "reacted, exposed, or coupled to a protein," contrary to the limitations now claimed.”
In response, Applicant’s arguments with respect to the combination of Holtlund and Chen have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As set forth above, the combined teachings of Holtlund and newly cited Zhang, Lyapina, etc. render the claims prima facie obvious for the reasons set forth above (which will not be repeated here).
Conclusion
NO CLAIMS ALLOWED.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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