DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This is a NON FINAL REJECTION in response to applicant’s claim amendments and arguments filed March 10, 2026. Claims 75-86 are currently amended. Claim 87 has been canceled from consideration. Claims 88-107 are withdrawn from consideration. Claim 108 is newly added. Claims 75-86 and 108 are pending review in this correspondence.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 10, 2026 has been entered.
Response to Amendment
Rejection of claims 75 and 86 as being unpatentable over Clague et al (US 2005/0233460 A1) in view of Gavin et al (US 5,504,011) is modified in view of applicant’s claim amendments and arguments.
Rejection of claims 76 and 77 as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Bullen (WO 2005/030033 A2) is maintained in view of applicant’s claim amendments and arguments.
Rejection of claims 78 and 79 as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Freeman et al (US 2003/0083686 A1) is maintained in view of applicant’s claim amendments and arguments.
Rejection of claims 80 and 81 as being unpatentable over Clague et al (US 2005/0233460 A1), Gavin et al (US 5,504,011), and Freeman et al (US 2003/0083686 A1) in view of Besemer et al (USP 5,104,813) is maintained in view of applicant’s claim amendments and arguments.
Rejection of claim 82 as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Egan et al (US 2010/0304359 A1) is maintained in view of applicant’s claim amendments and arguments.
Rejection of claims 83-85 as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Freeman et al (US 2003/0083686 A1) is maintained in view of applicant’s claim amendments and arguments.
Claim Rejections - 35 USC § 112
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 75-86 and 108 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. With respect to claim 75, applicant has recited a “blood testing console”. However, there is no obvious support for this newly added recitation in the specification. Additionally, it is not apparent from the figure which embodiment is intended to be encompassed by this recitation.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 75 and 86 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) in view of Gavin et al (US 5,504,011).
With respect to claim 75, Clague discloses a system comprising:
a blood testing console (test instrument 10, See Fig. 1 and Para. 0066); and
a cartridge (test cartridge 50, See Para. 0077, See Fig. 1) for use with the blood testing console, the cartridge comprising:
A housing (cartridge housing 52, See Para. 0077 and Figs. 1-5), wherein the housing includes a thermally conductive wall configured to allow a blood sample to be heated, the thermally conductive wall having an outer surface area and an inner surface area (See Para. 0078 for discussion of how the cartridge housing is formed of a transparent and relatively rigid thermoplastic material with upper and lower major sides 54 and 57);
A blood sample receiver (port receptacle 55) configured to receive the blood sample to be tested (See Para. 0078 and Figs. 2-3); and
A plurality of blood processing and testing paths arranged in parallel, each blood processing and testing path receiving a portion of the blood sample (See Paras. 0078-0079 for discussion of how filling channels or capillaries are machined or molded into the lower major side 56 extending from the port receptacle 55 to the test chamber 60 and 70; the combination of these three embodiments is being interpreted as the recited “blood processing and testing paths”), and each blood processing and testing path comprising:
A channel (See Fig. 5 reproduced below for a sideview depiction of a lower portion of the testing paths of the port receptacles) in fluid communication with the blood sample receiver, the channel having a selected internal volume to contain a predefined volume of blood sample from the blood sample container (Para. 0078 discusses receiving sample from a test sample dispenser such as a pipette or hypodermic needle), the channel including a portion at least partially defined by the inner surface area of the thermally conductive wall (See Para. 0078 and Figs. 2-3 for discussion/depiction of how the cartridge housing is formed a transparent and relatively rigid thermoplastic material) and the outer surface area of the thermally conductive wall is shaped to be held in at least partially conforming contact with or in close proximity to a heater to allow adjustment of a temperature of a blood sample flowing through the portion at least partially defined by the inner surface area of the thermally conductive wall (See Para. 0068 for discussion of the inclusion of a heating block that is designed to be mounted in operative relation with a cartridge receptacle 24 to apply heat to test cartridge 50 when it is mounted in the cartridge receptacle of the test instrument 10);
A mixing space (filling capillaries 71 and 61, See Paras. 0078-0079 and Fig. 4) having at least one reagent (See Para. 0091 for discussion of the reagents being alternatively deposited on the surfaces of the filling capillaries), the mixing space being configured to receive a predetermined volume of the blood sample and to mix the received blood with the at least one reagent; and
A test chamber (cylindrical test chambers 60 and 70, See Figs. 2-3), separate from the mixing space, for a viscoelastic test to be performed on respective mixed blood and reagent, via the blood testing console, to assess stiffness of the blood sample (See Paras. 0026-0027 for discussion of how an agitator vane of an agitator is mounted at a pivot point and is adapted to be swept about the pivot point and through the test sample in the test chamber when the test sample is not coagulated - a coagulation test time from the commencement of sweeping of the agitator vane until the detection of cessation or reduction of the sweeping movement is determinable) while the respective mixed blood and reagent reside in the test chamber (See Paras. 0081 and 0112-0115 for discussion of how the sample is tested in the test chambers, such as by determining a coagulation test time; measurement of degree of coagulation is being interpreted as a measurement in increasing clot stiffness; Para. 0092 discloses a plurality of reagents that can be used to perform coagulation time tests), wherein a first path of the plurality of blood processing and testing paths mixes the blood sample with a first reagent or combination thereof to activate coagulation, and wherein a second path of the plurality of blood processing and testing paths mixes the blood sample with a coagulation activator and platelet function inhibitor (See Para. 0025 for discussion of how the test sample can be mixed with a reagent, wherein the reagent is selected from coagulants or activating agents including calcium, kaolin, celite, ellagic acid, glass particles, thrombin, thromboplastin or other activating agents or from heparin neutralizing or deactivating agents including heparinase or protamine; Para. 0008 of applicant’s specification filed October 21, 2019 discloses that example reagents are selected from the group consisting of kaolin, celite, glass, abciximab, cytochalasin D, thrombin, recombinant tissue factor, reptilase, arachidonic acid (AA), adenosine diphosphate (ADP), and combinations thereof) wherein a platelet index is determined via the blood testing console as a differential between (i) a first viscoelastic measurement of the first path after a clot has formed and (ii) a second viscoelastic measurement of the second path, for an assessment of platelet function of the blood sample. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Clague and the apparatus of Clague is capable of the recitation of claim 75. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Clague (see MPEP §2114).
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Fig. 5 (magnification)
Clague fails to disclose that the reagents are lyophilized.
Gavin teaches a portable device for performing coagulation tests on a patient’s blood, wherein the blood is drawn into multiple conduits within a cuvette. Each of the conduits contains a dried or lyophilized activation reagent that is rehydrated by the blood (See abstract). A clot promoting reagent (28) is disposed in the conduits (30-34) within the cuvette (12), and the presence of blood in the conduits rehydrates the clot promoting reagent, thereby mixing (and activating) the clot promoting reagent with the blood (See Col. 6, lines 20-29).
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lyophilized reagents of Gavin into the reagents of Clague for the purpose of providing a reagent that can be rehydrated (and activated) by blood in close proximity to the test chamber (See Col. 6, lines 20-29 of Gavin).
With respect to claim 86, Clague discloses that the test chamber for viscoelastic testing comprises a movable element (See Para. 0085-0087 for discussion of the agitators 80 and 100).
Claims 76 and 77 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Bullen (WO 2005/030033 A2).
Refer above for the combined teachings of Clague and Gavin.
With respect to claim 76, the combination of Clague and Gavin fails to teach the incorporation of a vacuum port at an opposite end of the channels of the blood processing and testing paths, wherein the cartridge is configured to transport blood from the blood sample receiver to fill each of the channels when an external vacuum is applied to the vacuum port.
Bullen teaches a fluid sample test device that comprises a cartridge having one or more test chambers (See abstract). The cartridge also includes a vacuum port (50) in fluid communication with the test chambers for connecting a vacuum source to create a vacuum in the test chambers (See Pg. 6, lines 8-10). Any type of vacuum source suitable for generating a sufficient vacuum in the test chambers can be used (See pg. 6, lines 29-30). When testing is to be initiated, the vacuum source connected to the vacuum port is turned on (or a vacuum generator is activated) to create a vacuum in the test chambers. The vacuum in the test chambers, in turn, draws the fluid sample through the cartridge into the test chambers (See pg. 9, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the vacuum port and external vacuum source of Bullen into the cartridge of combined Clague and Gavin for the purpose of creating a vacuum in the test chambers, which in turn, drawn the fluid sample through the cartridge into the test chambers (See pg. 9, lines 1-5 of Bullen).
With respect to claim 77, the combination of Clague, Gavin, and Bullen teaches that the channels of the blood processing and testing paths each comprise embedded barrier structures (See Fig. 6 reproduced below for depiction of the taper in the channel).
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Fig. 6 (reproduced)
Claims 78 and 79 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Freeman et al US 2003/0083686 A1).
Refer above for the combined teachings of Clague and Gavin.
With respect to claim 78, the combination of Clague and Gavin fails to disclose or fairly teach the incorporation of a first valve positioned in a given channel of a blood processing and testing path of the plurality of blood processing and testing paths, the first valve being configured to selectively open to allow blood sample to be transported through the given channel from the blood sample receiver to fill a given test chamber in respective series to the other blood processing and testing paths.
Freeman teaches a tissue penetration sampling device. Several of the miniature lancets may be located in a single sampling site, with corresponding sample flow channels to transfer blood to one or more reservoirs. The sample flow channels may optionally have valves for controlling flow of blood to the reservoirs (See Para. 0324).
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to incorporate the valve of Freeman into a testing path of the plurality of blood processing and testing paths for the purpose of controlling flow of blood to a given test chamber (See Para. 0324 of Freeman).
With respect to claim 79, Clague fails to specifically disclose or teach the incorporation of a second channel region between a first one of the blood processing and testing paths and a corresponding testing chamber.
Gavin teaches a disposable cuvette (12), wherein the cuvette has five channels or conduits (30-34) disposed on the body of the cuvette. Distal ends of each of the five conduits terminate at drive apertures (35). The ends of each of the conduits opposite the drive apertures each terminate at a common supply area (37) contained within the cuvette. Each conduit also contains a restricted area (42) where the internal area of the conduit rapidly narrows. A clot promoting reagent (28) is disposed in each of the conduits within the cuvette between the restricted areas and the drive apertures, and presence of the blood in the conduit rehydrates the clot promoting reagent, thereby mixing the clot promoting reagent with the blood (See Col. 5, line 66 – Col. 6, line 43). For the purposes of examination, the region between the common supply area and the restricted area is being interpreted as a first channel region, and the region between the restricted area and the drive apertures is being interpreted as the second channel region.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the second channel, such as taught by Gavin, into the modified channel/conduit configuration of modified Clague, for the purpose of providing a region for the incorporation of a clot promoting reagent that is closer to the test chamber (See Col. 5, lines 19-29).
Claims 80 and 81 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1), Gavin et al (US 5,504,011) and Freeman et al US 2003/0083686 A1) in view of Besemer et al (USP 5,104,813).
Refer above for the combined teachings of Clague, Gavin, and Freeman.
With respect to claim 80, the combination of Clague, Gavin, and Freeman fails to teach that the blood processing and testing paths comprise at least one vent port to vent to an ambient environment outside of the cartridge, the vent port being positioned to prevent flow through the second channel region when the vent is in a closed position. It should be noted that both Clague and Gavin do teach the incorporation of vents; however, there is no teaching in either Clague or Gavin of being able to actively open and close said vents.
Besemer teaches a dilution and mixing cartridge wherein a vent or other means is utilized to allow exit of trapped air, and said vent or other means is provided at every location in the apparatus in which the trapping of air would interfere with the passage of liquids between the various chambers and/or channels of the device (See Col. 12, lines 28-41). An external valve that can act as an external vent can be provided for the purpose of controlling a flow path for capillary fluid flow. When the external vent is closed, liquid cannot enter the capillary pathway because of air or other gases in the capillary pathway. Opening the vent allows liquid to enter the capillary pathway (See Col. 14, line 63 – Col. 15, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the external vent/valve configuration taught by Besemer into any one of the blood processing and testing paths of combined Clague, Gavin, and Freeman for the purpose of allowing trapped air/gas to escape the device, in addition to controlling the flow of fluid through the conduit(s)/flow path(s) (See Col. 14, line 63 – Col. 15, line 3 of Besemer).
With respect to claim 81, the combination of Clague, Gavin, Freeman, and Besemer teaches that, when the vent port is configured to be selectively opened, the cartridge is configured to let blood flow through the second channel region when the vent port is in an open position (See Col. 14, line 63 – Col. 15, line 3 of Besemer for discussion of how opening the vent allows liquid to enter the capillary pathway).
Claim 82 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Egan et al (US 2010/0304359 A1).
Refer above for the combined teachings of Clague and Gavin.
Although Clague does disclose that the reagent is selected from coagulants or activating agents including calcium, kaolin, celite, ellagic acid, glass particles, thrombin, thromboplastin, or other activating agents or from heparin neutralizing or deactivating agents including heparinase or protamine (See Para. 0025 of Clague), and Gavin teaches the benefits of utilizing dried reagents (See Col. 6, lines 20-29 of Gavin), the combination of Clague and Gavin fails to teach that the mixing space of at least one of the blood processing and testing paths comprises reagent beads in solid form that dissolve when contacted with the blood to provide the mixed blood and reagent in the testing chamber.
Egan teaches a system for detecting multiple analytes from a sample (See abstract) wherein an extracted sample is transferred from a sample collection device to a test device that contains at least one reagent bead (See Para. 0214). The bead may contain both capture and detection reagents (See Para. 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the reagent bead of Egan into the reagents taught by combined Clague and Gavin for the purpose of allowing for rehydration of the chosen reagent just prior to the start of testing (See Para. 0080 of Egan and Col., 6, lines 20-29 of Gavin).
Claims 83-85 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Prabhu et al (US 2007/0231213 A1).
Refer above for the combined teachings of Clague and Gavin.
With respect to claim 83, the combination of Clague and Gavin fails to teach that each of the blood processing and testing paths comprises a conduit for transporting the mixed blood and reagent from the viscoelastic blood testing chamber to an output port.
Prabhu teaches a microfluidic chip (10) that contains sample/reagent handling and control means and provides microenvironments for different analyzing/processing operation, where the fluidic network comprises a plurality of sealable fluid inlet ports for introduction of fluidic samples to be analyzed/processed into a plurality of micro-reaction chambers, a plurality of sealable fluid outlet ports for outputting of the analyzed/processed fluidic samples from the plurality of micro-reaction chambers, a plurality of microfluidic channels for fluid transport, a plurality of passive microvalves disposed at the inlet and outlet of each reaction chamber for flow control, and a plurality of membrane actuated push-flow means that are activated by appropriate actuators such as but not limited to mechanical or pneumatic solenoids actuated in a to and fro motion. After a reaction is completed, at least one of the membrane actuated push-flow means can be actuated by the solenoid to displace fluids out of the chamber into the outlet channels for collection or further downstream analysis (See Para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the outlet ports of Prabhu into the outlet port of combined Clague and Gavin for the purposes of transporting reacted fluids for further downstream analysis (See Para. 0037 of Prabhu).
With respect to claim 84, the combination of Clague, Gavin, and Prabhu teaches that the blood processing and testing paths comprise a valve positioned in the output port, the valve being configured to prevent the flow of mixed blood and reagent through the conduit when in a closed position and to allow the flow of the mixed blood and reagent through the conduit when in an open position (See Para. 0037 of Prabhu for the discussion of the incorporation of microvalves disposed at the inlet and outlet of each reaction chamber for flow control; Para. 0038 further discusses that each micro-reaction chamber 15 is connected to an outflow fluidic bus 16 via a passive valve 14).
With respect to claim 85, the combination of Clague, Gavin, and Prabhu teaches that the output port forms a pressure application port, wherein the output port is positioned, such that, when an outside pressure is applied to the pressure application port and the valve is in an open position, the mixed blood and reagent from the testing chamber is transported through the conduit (See Para. 0037 for discussion of how the incorporation and activation of a plurality of membrane actuated push-flow means displaces fluids out of the chamber, through the outlet channels and microvalves for collection or further downstream analysis).
Claim 108 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clague et al (US 2005/0233460 A1) and Gavin et al (US 5,504,011) in view of Cohen (US 2011/0117586 A1).
Refer above for the combined teachings of Clague and Gavin.
The combination of Clague and Gavin fails to teach that the platelet function inhibitor comprises abciximab.
Cohen teaches the use of a hemostasis analyzer (10) to measure a clot’s physical properties. The hemostasis analyzer uses a special stationary cylindrical cup 12 that holds a blood sample 13. The cup 12 is coupled to a drive mechanism that causes the cup to oscillate through an angle. Each rotation cycle lasts 10 seconds. A pin 14 is suspended in the blood sample 13 by a torsion wire 15, and the pin 14 is monitored for motion. The torque of the rotating cup 12 is transmitted to the immersed pin 14 only after fibrin-platelet bonding has linked the cup 12 and pin 14 together. The strength of these fibrin-platelet bonds affects the magnitude of the pin motion, such that strong clots move the pin 14 directly in phase with the cup motion. Thus, the magnitude of the output is directly related to the strength of the formed clot. As the clot retracts or lyses, these bonds are broken and the transfer of cup motion is diminished. The rotational movement of the pin 14 is converted by a transducer 16 to an electrical signal, which can be monitored by a computer (not shown in FIG. 2) including a processor and a control program. Clinically, these measurements provide a vehicle for monitoring anticoagulation therapy (e.g. bivalirudin, heparin or warfarin, which elongate the R parameter and reduce α), thrombolytic therapy (e.g. tPA, streptokinase, urokinase, which increase LY30), effect of antifibrinolytics, trasylol (aprotinin), tranexamic acid (TX), which reduce LY30), effect of anti-platelet agents (e.g. abciximab), eptifibatide, tirofiban, which reduce MA), blood component transfusion therapy (which enhances the blood coagulation profile), thrombotic risk assessment in cancer and infection, high risk surgery and other conditions which could possibly lead to excessive clotting (hypercoagulable conditions) or excessive bleeding (hypocoagulable conditions). In accordance with the invention then, the hemostasis analyzer 10 is useful in testing the clinical efficacy of drug therapy to stop fibrinolysis, or the efficacy of thrombolytic drugs to monitor thrombolysis, efficacy of anti-platelet agents to monitor platelet inhibition, ischemic or bleeding complications (See Paras. 0030-0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize abciximab as the platelet function inhibitor, such as taught by the device Cohen, to more precisely determine thrombotic risk assessment in cancer and infection and high risk surgery and other conditions which could possibly lead to excessive clotting or excessive bleeding (See Para. 0035 of Cohen).
Response to Arguments
Applicant's arguments filed March 10, 2026 have been fully considered but they are not persuasive.
APPLICANT ARGUES: “As an initial matter, Applicant respectfully reiterates that neither Clague nor Gavin provide cartridges that are configured to perform viscoelastic tests. Rather, each of the tests discussed in Clague and Gavin, such as platelet count (PLT), thrombin time (TT), prothrombin time (PT), partial thromboplastin time (aPTT), activated clotting time (ACT), fibrinogen level (FIB), fibrinogen degradation product concentrations, and general purpose clotting (GPC) time, are endpoint coagulation assays and not viscoelastic tests for assessing stiffness of the blood sample. This difference is further evident from the fact that Clague and Gavin are both silent regarding the use of any platelet function inhibitors as presently claimed.
The Office states that "Clague clearly describes in Paras. 0025-0027 the incorporation of vane elements that react to a change in stiffness/thickness of a sample as coagulation of the sample proceeds." Office Action, page 18. Applicant respectfully disagrees and maintains that the cited paragraphs describe coagulation time, not measurements of stiffness. See, e.g., Clague, [0026]-[0027] ("A coagulation test time from the commencement of sweeping of the agitator vane until the detection of cessation or reduction of the sweeping movement is determinable. In determining a coagulation time, a timer is started after a test sample is deposited in the test chamber and the agitator vane movement is commenced. The sweeping movement mixes the test sample, and the agitator vane initially sweeps through the test sample without encountering significant resistance. Resistance to agitator vane movement signifies coagulation of the test sample. The elapsed time measured from starting the sweeping movement and the detection of resistance constitutes a coagulation time."). However, coagulation time does not equate to a measurement of viscoelastic properties, such as stiffness, of the sample.
Furthermore the Office's interpretation of "degree of coagulation" as including
measurements of increasing clot stiffness ignores its use in the context of the entire disclosure. Gavin describes a method of performing a prothrombin time (PT) test whereby the time it takes a blood sample to move from a first to a second position is recorded until a predetermined degree of coagulation occurs. In this regard, the "degree of coagulation" mentioned in Gavin (and therefore Clague) merely marks an endpoint in the context of the recordation of a coagulation time, and is not utilized in determining viscoelastic properties of the sample. Again, Applicant respectfully notes that "[e]ndpoint biochemical assays such as the prothrombin time (PT) and the partial thromboplastin time (PTT) are widely used to assess coagulation. However, these tests measure only a part of the hemostatic process and operate under non-physiological conditions incorporating only the function of plasma. As a result of these limitations, complications such as postoperative bleeding often occur despite normal perioperative PT and PIT measurements." PCT Specification, [0003]. Accordingly, Applicant respectfully submits that one of ordinary skill in the art would have no reason to modify the endpoint coagulation assays of Clague and Gavin to include a first testing path having a first reagent or combination thereof to activate coagulation, and a second testing path having a coagulation activator and a platelet function inhibitor as presently claimed.
To the extent the Office ignores several claims elements as allegedly being non-limiting functional language, Applicant respectfully disagrees and submits that "[f]eatures of an apparatus may be recited either structurally or functionally" and that a "functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used." See MPEP §§ 2114(I) & 2173.05(g). It is clear from the plain language of claim 75: Applicant's claims recite meaningful structural differences that are not taught or suggested by the cited references. For example, endpoint coagulation assays would generally not include a platelet function inhibitor (e.g., abciximab) as these tests do not measure clot strength” (See Pgs. 11-12 of applicant’s remarks/arguments).
EXAMINER’S RESPONSE: The examiner respectfully disagrees with applicant’s above assertions. Specifically, applicant’s recitation of “a test chamber….for a viscoelastic test to be performed…” is strictly functional language that does not differentiate the claimed invention from the currently cited prior art of reference. More specifically, when functional language is incorporated in lieu of clear structural features, prior art that teaches something that would be “capable of” performing said functional language suffices to read upon said functional language. Applicant has not provided for any specific structure that would function to perform a viscoelastic test, but the primary reference does provide for various features that, under the instruction of a processor and/or computer program, would be more than capable of performing a viscoelastic test. The final paragraph of claim 75 has a plurality of recitations that only seem to be capable of being performed under the direction of some kind of computer and/or processor, or some other software implemented mechanism. It is suggested that the applicant consider the incorporation of structural features that would further differentiate the current claim(s) from the cited prior art.
APPLICANT ARGUES: “Beyond this, Applicant has amended claim 75 to recite a system comprising a blood testing console and a cartridge for use with the blood testing console, such that a viscoelastic test is performed on respective mixed blood and reagent, via the blood testing console, to assess stiffness of the blood sample while the respective mixed blood and reagent reside in the test chamber and wherein a platelet index is determined via the blood testing console as a differential between (i) a first viscoelastic measurement of the first path at a fixed time point after a clot has formed and (ii) a second viscoelastic measurement of the second path, for an assessment of platelet function of the blood sample. Thus, claim 75 and the claims depending therefrom include both hardware and enabling software, which limits the functionality of the claimed system. See MPEP § 2114(V) ("computer-implemented functional claim limitations may narrow the functionality of the device, by limiting the specific structure capable of performing the recited function."). Clague and Gavin, viewed alone or in combination, fails to disclose all elements of claim 75 as amended” (See Pg. 12 of applicant’s arguments/remarks).
EXAMINER’S RESPONSE: As discussed in the 112a rejection made above, it is unclear from applicant’s specification what is intended to encompass the newly recited console. Additionally, applicant has not positively recited any hardware and enabling software, and there is no inference in the claims that hardware of software is what is intended to be encompassed by any of the current recitations. Applicant is encouraged to utilize to recite said language if that is what is intended to be encompassed by any of the currently claimed structural limitations.
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.
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, 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.
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.
/BRITTANY I FISHER/Examiner, Art Unit 1796 March 26, 2026
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