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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-13 in the reply filed on 12/12/2025 is acknowledged.
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claim Interpretation
Regarding limitations recited in claims 1-13 which are directed to a manner of operating the disclosed system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim. See Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969) that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.”
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.
Claim 11 is 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 11 recites the limitation "the fully recovered fibrin or platelet signal" in line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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 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 –
(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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rossi (SCALABLE, POINT-OF-CARE, MICROFLUIDIC APPROACH FOR ASSESSING THROMBOSIS AND HEMOSTASIS).
Regarding claim 1, Rossi discloses a system for detecting and quantifying drug and/or chemical interactions with a biological sample, the system comprising:
a detection instrument with computing capability (4.2.4. Platelet and fibrin detection during clotting, see: LED-based Lumascope 620, an epifluorescence microscope; and ImageJ, an image analysis software platform); and
an assay device capable of receiving a biological sample, wherein introduction of the biological sample into the assay device results in a biological process by which fibrin and platelets may accumulate at a reaction zone of the assay device (Figure 2.2, see: 8 by 1 PDMS device channel schematic which includes a reaction zone; Figure 3.1, see: 8-channel device);
wherein the assay device is capable of receiving one or more chemical reagents compatible with the biological sample and usable for detecting the accumulation of the fibrin and platelets within the reaction zone; wherein the assay device is capable of receiving one or more drug reagents compatible with the biological sample and usable for modifying the accumulation of the fibrin and platelets within the reaction zone; and wherein the fibrin and platelets, and their associated signals, accumulated at the reaction zone of the assay device are usable to determine at least one of a drug presence, a drug class, a drug level in relation to a threshold, or a drug concentration, within the biological sample (The remaining limitations are directed towards the intended use of the recited assay device. A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Since the recited functions do not require any further elements (see: “capable of receiving…” which does not require the scope of the claimed device to include the “chemical reagents”, “biological sample”, etc., and since the prior art device comprises a plurality of inlets/wells, it is the position of the Examiner that the prior art device is fully capable of performing the instantly recited functions).
Regarding claim 2, Rossi further discloses a fluorescent assembly capable of detection of the biological process by way of fluorescent labeling and detection of a resulting accumulating fluorescent signal (4.2.4. Platelet and fibrin detection during clotting, see: LED-based Lumascope 620, an epifluorescence microscope), and comprising a processing device configured to receive as input a measurement of the fibrin and platelets to determine at least one of the drug presence, the drug class, the drug level in relation to the threshold, or the drug concentration, within the biological sample, and the processing device is configured to correlate a measured fluorescent intensity with the accumulation of the fibrin and platelets in microfluidic flow paths of the assay device (4.2.4. Platelet and fibrin detection during clotting, see: ImageJ, an image analysis software platform which inherently requires a computer (processing device) to use).
Regarding claim 3, Rossi further discloses the one or more chemical reagents or the one or more drug reagents is a fluorescent reagent capable of labeling the fibrin and platelets from the biological sample that results in a fluorescent assembly that reports the accumulation of the fibrin and platelets (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. There is no positive recitation of “the one or more chemical reagents or the one or more drug reagents” in the claims, but rather the claims recite the functional capability of receiving them. Since the recited functions do not require any further elements (Claim 1, see: “capable of receiving…” which does not require the scope of the claimed device to include the “chemical reagents”, “biological sample”, etc., and since the prior art device comprises a plurality of inlets/wells, it is the position of the Examiner that the prior art device is fully capable of performing the instantly recited functions).
Regarding claim 4, Rossi further discloses a light source for monitoring clot development in microfluidic flow paths of the assay device and for detecting a fluorescent reaction of the one or more chemical reagents or the one or more drug reagents (4.2.4. Platelet and fibrin detection during clotting, see: LED-based Lumascope 620, an epifluorescence microscope).
Regarding claim 5, Rossi further discloses a first inlet port, a second inlet port, a third inlet port, and a fourth inlet port, each configured to receive the biological sample, wherein the biological sample is an unmodified sample including a platelet specific label and a fibrin specific label (Figure 3.1, see: Q1-8 inlet wells which are capable of performing the instantly recited functions); an outlet port (Figure 3.1, see: outlet port); and microfluidic flow paths fluidically connecting each of the first, second, third and fourth inlet ports with the outlet port (Figure 3.1, see: plurality of channels); wherein the introduction of the biological sample into the respective first, second, third and fourth inlet ports generates a fibrin signal and a platelet signal (4.2.4. Platelet and fibrin detection during clotting, see: fluorescence images to obtain kinetic data for platelet and fibrin accumulation).
Regarding claim 6, Rossi further discloses at least one of the first, second, third and fourth inlet ports is configured to receive a molar excess of drug to provide a fully attenuated fibrin or platelet signal (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection).
Regarding claim 7, Rossi further discloses at least one of the first, second, third and fourth inlet ports is configured to receive a first reversal drug to identify a first class of drug present in the biological sample, and wherein at least one of the first, second, third and fourth inlet ports is configured to receive a second reversal drug to identify a second class of drug present in the biological sample (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection).
Regarding claim 8, Rossi further discloses the drug is a direct-acting oral anticoagulant (DOAC), and wherein the first and/or second reversal drug inhibits, antagonizes or attenuates the activity of a Xai or DTi class DOAC (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection).
Regarding claim 9, Rossi further discloses the drug is an anti-platelet medication, and wherein the first and/or second reversal drug inhibits, antagonizes or attenuates an activity of the anti-platelet medication (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection).
Regarding claim 10, Rossi further discloses a processing device (4.2.4. Platelet and fibrin detection during clotting, see: LED-based Lumascope 620, an epifluorescence microscope) configured to manipulate the biological sample and monitor a direct response of the biological sample to at least one of (i) the first and/or second reversal drug to identify the drug class present in the biological sample, and (ii) a molar excess of the fibrin or platelet attenuating drug to identify a drug or chemical level or concentration present in the biological sample (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection).
Regarding claim 11, Rossi further discloses a processing device (4.2.7. Statistical analysis, see: GraphPad Software) configured to compare the fibrin or platelet signal to the fully recovered fibrin or platelet signal, compare the fibrin or platelet signal to the fully attenuated fibrin or platelet signal, and compare all other coincident signals for all reactions to determine the drug presence, the drug class, the drug level in relation to the threshold, or the drug concentration, in the biological sample (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see: rejection of claims 1 and 3 above; 4.2.5. DOAC reversal and detection; 4.2.6. DOAC concentration and prediction).
Regarding claim 12, Rossi further discloses the reaction zone comprises at least one of (i) a single flow path with separate clot sites in a serial configuration having different tissue factor (TF) concentrations (optional limitation), and (ii) two flow paths in parallel alone the same plane, each of the flow paths having different tissue factor (TF) concentrations (5.1.2.1 Device Design, Fabrication and Preparation, see: plurality of parallel channels coated with collagen and either tissue factor or vWF, which means some channels have a zero concentration of tissue factor, which is a different concentration from the channels coated with tissue factor).
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rossi (SCALABLE, POINT-OF-CARE, MICROFLUIDIC APPROACH FOR ASSESSING THROMBOSIS AND HEMOSTASIS), in view of Hu et al. (US 2002/0074271 A1).
Regarding claim 13, Rossi further discloses the flow paths each having a clot site in a non-overlapping configuration relative to each other having different tissue factor (TF) concentrations (5.1.2.1 Device Design, Fabrication and Preparation, see: plurality of parallel channels coated with collagen and either tissue factor or vWF, which means some channels have a zero concentration of tissue factor, which is a different concentration from the channels coated with tissue factor).
Rossi does not explicitly disclose the flow paths being on separate planes of the assay device.
Hu teaches an plurality of analogous multilevel microfluidic flow structure configurations (Fig. 1C, Fig. 3). It would have been obvious to rearrange the parts of the device disclosed by Rossi, into a multilevel arrangement as taught by Hu, in order to provide for a higher density device in a smaller footprint, thereby providing a reduction in the size of fluid handling and detection devices (Hu: [0006]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rossi et al. (Scalable manufacture of a disposable, storage-stable eight-channel microfluidic device for rapid testing of platelet, coagulation, and drug function under whole blood flow) discloses an analogous microfluidic device.
Diamond et al. (Point of care whole blood microfluidics for detecting and managing thrombotic and bleeding risks) discloses an analogous microfluidic device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797