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 .
Applicant’s response filed 2/20/2026 has been received and entered into the case. Claims 1-16, 21-24 are pending. Claims 1-8 are withdrawn. Claims 9-16, 21-24 have been considered on the merits. All arguments and amendments have been considered.
All previous rejections are withdrawn in light of applicants claim amendments; however, the same prior art references are used in the amended rejections herein to address applicants claim amendments.
Claim Interpretation
The claims are drawn to a system comprising a cartridge containing a reagent comprising a polycation, and one or more processing devices. Independent claim 9 is amended to include the limitation of “wherein the system is configured to identify a presence or an estimated concentration…”. For examination purposes, a system which comprises the components of the system, is one which is “configured to” perform the claimed intended function. The intended use and function of the claimed system does not patentably distinguish the system, per se, since such undisclosed use and function is inherent in the reference system. In order to be limiting, the intended use and function must create a structural difference between the claimed system and the system of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims asystem in terms of function, and the system of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference system. The discovery of a previously unappreciated property of a prior art system, or of a scientific explanation for the prior art's functioning, does not render the old system patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
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.
Claim 9 and its dependent claims 10-16, 21-24 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. Specifically, the amendment “…wherein the system is configured to identify a presence or an estimated concentration of the direct oral Xa inhibitor at concentrations of 25 nanograms/milliliter (ng/mL) or less” introduces new matter, which is not described in the specification as originally filed. Applicant specification paragraph (0030) states “Polybrene can cause the reagent to have increased sensitivity to apixaban relative to reagents that do not include polybrene. In this regard, apixaban has heretofore been a challenging direct oral factor Xa inhibitor to identify using clotting assays, particularly at low concentrations (for example, at concentrations of 25 nanograms/milliliter {ng/mL} or less). The increased sensitivity of the reagent to apixaban enables low tissue factor assay to address the challenge of identifying apixaban at low concentrations”. The specification also teaches measuring a range of apixaban and rivaroxaban (a direct oral Xa inhibitor) from between 0-500 ng/mL (0039, 0040, Fig. 2 and 3); however, there is no teachings of how the system is configured to identify a presence or an estimated concentration of the direct oral Xa inhibitor at concentrations of 25 nanograms/milliliter (ng/mL) or less. It is not clear and there is no support for how the system is configured with regards to applicant' s invention. Therefore, the amendment changes the scope of the claims and applicants invention for which no support is provided. This is a new matter rejection.
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.
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) 9-16, 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US20220093223A1, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11).
Schafer teach a system to identify direct oral factor Xa (DOAC) inhibitors in a sample, wherein the DOAC is apixaban, rivaroxaban or edoxaban (0024, 0028). The system (ROTEM® device) allows one to perform viscoelastic tests to monitor the blood coagulation process and to detect anticoagulants with minor effects on clotting time, these tests are known as ROTEM® TFTEM and EXTEM® (0024, 0028, 0031). The system comprises a cartridge which receives the blood sample for carrying out the viscoelastic tests (0009, 0056). The system receives parameters from the tests and use them to detect the presence and effects of DOAC’s (0032). The system comprises processing devices, i.e. software modules, analyzer instruments, computing devices and ROTEM devices, for performing operations including clotting parameters based on the test sample with a reagent to identify the presence of DOAC’s (0013, 0024, 0033, 0040, 0055, 0064). The test sample is a blood sample (0024, 0056, 0058) and the reagent for performing the test comprises a reduced tissue factor (0028) calcium chloride, and polybrene as a heparin inhibitor (0031).
Regarding claim 10, the direct oral factor Xa inhibitor comprises apixaban, rivaroxaban or edoxaban (0024, 0028).
Regarding claim 11, the results comprise identifying the DOAC inhibitor (0028, 0032, 0036, 0057).
Regarding claim 12, the results include estimated concentrations of the DOAC inhibitor (0057).
Regarding claims 13 and 22, the polycation is polybrene (0031).
Regarding claim 15, the reagent comprises calcium chloride (0031).
Regarding claim 16, the clotting parameter includes time to clot or clotting time (CT) (0005, 0026, 0028, 0031, 0036, for example).
Regarding claim 21, the reagent comprises a diluted/reduced tissue factor (0028).
Schafer does not teach the assay concentration range of the polycation, i.e. polybrene to be within a range of 1-100 µg/mL according to claim 14.
Jakimczuk teach assays for monitoring the anticoagulant activity of rivaroxaban in the presence of heparin using polybrene and find that polybrene at concentrations of 10 and 50 µg/mL neutralize heparin and enoxaparin and enable the accurate measuring of anti-factor Xa activity and thrombin time in rivaroxaban containing samples (abstract, section 2.2- 2.4, 3.4). The polybrene concentrations were selected to not affect the results of the coagulation tests, to neutralize heparin and to allow accurate monitoring of rivaroxaban (discussion section, p. 7, last parag.-p. 9).
Therefore, it would have been obvious before the effective filing date of the claimed invention to use the polycation, polybrene, at a concentration range of 1-100 µg/mL, as Jakimczuk teach that concentrations falling within the claimed range allow one to effectively neutralize heparin in a test sample and accurately monitor clotting parameters relating to the presence of DOAC’s.
Regarding the limitation of “wherein the system is configured to identify a presence or an estimated concentration…”. For examination purposes, a system which comprises the components of the system, i.e., a cartridge containing a reagent comprising a polycation (in the claimed range), and one or more processing devices, is one which is “configured to” perform the claimed intended function.
Therefore, the system of Schafer with the reagent of Jakimczuk would be a system “configured to” identify a presence or concentration of the DOAC as claimed.
The intended use and function of the claimed system does not patentably distinguish the system, per se, since such undisclosed use and function is inherent in the reference system. In order to be limiting, the intended use and function must create a structural difference between the claimed system and the system of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a system in terms of function, and the system of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference system. The discovery of a previously unappreciated property of a prior art system, or of a scientific explanation for the prior art's functioning, does not render the old system patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
Claim(s) 9, 13-16, 21, 22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCluskey et al. (US10175225, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11).
Regarding claims 9, 13, and 22, McCluskey teaches a blood coagulation testing system comprising a cartridge to receive a test sample (col. 1, lines 60-col. 3, lines 1-27, for example). The cartridge contains a reagent to mix with the test sample, wherein the reagent comprising a heparin inhibitor comprising a polycation, specifically polybrene (col. 15, lines 42-col. 16, lines 1-4). The system comprises one or more processing devices for performing thromboelastometry and rotary thromboelastometry (known as TEM® and ROTEM®) operations comprising using clotting parameters to determine time to clot and clot formation time for the test sample (col. 1, lines 60-col. 3, lines 1-27, col. 6, lines 65-col. 7, lines 1-20, col. 20, lines 61-67, for example).
Regarding claim 15, the reagent comprises calcium chloride (col. 15, lines 42-col. 16, lines 1-4).
Regarding claim 21, the reagent comprises a tissue factor (col. 15, lines 42-44, 65, 66, col.16, lines 3, 4).
Regarding claim 22, the polycation is polybrene (col. 15, lines 42-col. 16, lines 1-4).
Regarding claims 24, the reagent is a bead and are lyophilized materials (col. 15, lines 36-42).
The processing devices of claim 9 are not claimed according to structure, but rather a function. When looking to applicants’ specification to determine the structure corresponding to the function, applicants’ specification states
[0050] An example system that may be used to implement the low tissue factor assay includes, but is not limited to, the system described in U.S. Pat. No. 10,175,225 (“Blood Testing System and Method”) that issued on Jan. 8, 2019, the contents of which are incorporated herein by reference. U.S. Pat. No. 10,175,225 describes a blood testing system that includes an analyzer console and one or more cartridges for performing tests, including a low tissue factor assay that may be used for identifying, and estimating an amount of, direct oral factor Xa inhibitors in a test sample using a reagent that includes a diluted tissue factor, CaCl.sub.2, and a heparin inhibitor including a polycation, such as polybrene or other polycations described above.
[0053] The diagnostic test instruments/clinical analyzers and assays described herein may be controlled using computing systems or any other appropriate computing device having one or more processing devices, such as one or more microprocessors, one or more microcontrollers, or programmable logic such as one or more field-programmable gate arrays (FGPAs) or one or more application-specific integrated circuits (ASICs).
Thus, the devices of McCluskey are taken to be devices which would perform the operations as claimed if the sample potentially contained the DOAC’s because the disclosed devices are taught to be one or more processing devices for performing thromboelastometry and rotary thromboelastometry (known as TEM® and ROTEM®) operations comprising using clotting parameters to determine time to clot and clot formation time for the test sample (col. 1, lines 60-col. 3, lines 1-27, col. 6, lines 65-col. 7, lines 1-20, col. 20, lines 61-67, for example).
McCluskey does not teach the assay concentration range of the polycation, i.e. polybrene to be within a range of 1-100 µg/mL according to claim 14.
Jakimczuk teach assays for monitoring the anticoagulant activity of rivaroxaban in the presence of heparin using polybrene and find that polybrene at concentrations of 10 and 50 µg/mL neutralize heparin and enoxaparin and enable the accurate measuring of anti-factor Xa activity and thrombin time in rivaroxaban containing samples (abstract, section 2.2- 2.4, 3.4). The polybrene concentrations were selected to not affect the results of the coagulation tests, to neutralize heparin and to allow accurate monitoring of rivaroxaban (discussion section, p. 7, last parag.-p. 9).
Therefore, it would have been obvious before the effective filing date of the claimed invention to use the polycation, polybrene, at a concentration range of 1-100 µg/mL, as Jakimczuk teach that concentrations falling within the claimed range allow one to effectively neutralize heparin in a test sample and accurately monitor clotting parameters relating to the presence of DOAC’s.
Regarding the limitation of “wherein the system is configured to identify a presence or an estimated concentration…”. For examination purposes, a system which comprises the components of the system, i.e., a cartridge containing a reagent comprising a polycation (in the claimed range), and one or more processing devices, is one which is “configured to” perform the claimed intended function.
Therefore, the system of McCluskey with the reagent of Jakimczuk would be a system “configured to” identify a presence or concentration of the DOAC as claimed.
The intended use and function of the claimed system does not patentably distinguish the system, per se, since such undisclosed use and function is inherent in the reference system. In order to be limiting, the intended use and function must create a structural difference between the claimed system and the system of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a system in terms of function, and the system of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference system. The discovery of a previously unappreciated property of a prior art system, or of a scientific explanation for the prior art's functioning, does not render the old system patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
Claim(s) 9, 13, 14, 16, 21, 22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viola et al. (US20180306774, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11).
Regarding claims 9, 16, Viola teach a system comprising a cartridge configured to receive a test sample and the cartridge contains a reagent (0007-0009, 0100) comprising a heparin inhibitor comprising a polycation, i.e. polybrene (0051, 0060, 0099, 0149) and calcium (0056) to mix with the test sample and one or more processing devices to perform operations, i.e. viscoelastic tests to assess the coagulation process (0062, 0063, 0098, 0102) including clot time measurements (0144, 0151, 0152). The system is disclosed to be a thromboelastometry-based system (0062).
Regarding claim 9, the reagent comprises a factor Xa inhibitor (0099).
Regarding claims 13 and 22, the polycation is polybrene (0051, 0099).
Regarding claim 21, the reagent comprises a tissue factor (0045, 0099).
Regarding claim 24, the reagent can be a bead/sphere, in lyophilized forms, or as dried surface coatings (0101).
The processing devices of claim 9 are not claimed according to structure, but rather a function. When looking to applicants specification to determine the structure corresponding to the function, applicants specification states
[0052] In another non-limiting example, the low tissue factor assay may be performed using the system described in U.S. Patent Publication No. 2018/0306774 (“Disposable System for Analysis of Hemostatic Function”) that published on Oct. 25, 2018, the contents of which are incorporated herein by reference. This patent publication describes the Ouantra® hemostasis analyzer. The low tissue factor assays may have a turnaround time of 15 to 20 minutes in some examples, making them suitable for point-of-care (POC) applications.
[0053] The diagnostic test instruments/clinical analyzers and assays described herein may be controlled using computing systems or any other appropriate computing device having one or more processing devices, such as one or more microprocessors, one or more microcontrollers, or programmable logic such as one or more field-programmable gate arrays (FGPAs) or one or more application-specific integrated circuits (ASICs).
Thus, the devices of Viola are taken to be devices which would perform the operations as claimed if the sample potentially contained the DOAC’s because the disclosed devices are taught to be one or more processing devices for performing viscoelastic tests to assess the coagulation process (0062, 0063, 0098, 0102) including clot time measurements (0144, 0151, 0152). The system is disclosed to be a thromboelastometry-based system (0062).
Viola does not teach the assay concentration range of the polycation, i.e. polybrene to be within a range of 1-100 µg/mL according to claim 14.
Jakimczuk teach assays for monitoring the anticoagulant activity of rivaroxaban in the presence of heparin using polybrene and find that polybrene at concentrations of 10 and 50 µg/mL neutralize heparin and enoxaparin and enable the accurate measuring of anti-factor Xa activity and thrombin time in rivaroxaban containing samples (abstract, section 2.2- 2.4, 3.4). The polybrene concentrations were selected to not affect the results of the coagulation tests, to neutralize heparin and to allow accurate monitoring of rivaroxaban (discussion section, p. 7, last parag.-p. 9).
Therefore, it would have been obvious before the effective filing date of the claimed invention to use the polycation, polybrene, at a concentration range of 1-100 µg/mL, as Jakimczuk teach that concentrations falling within the claimed range allow one to effectively neutralize heparin in a test sample and accurately monitor clotting parameters relating to the presence of DOAC’s.
Regarding the limitation of “wherein the system is configured to identify a presence or an estimated concentration…”. For examination purposes, a system which comprises the components of the system, i.e., a cartridge containing a reagent comprising a polycation (in the claimed range), and one or more processing devices, is one which is “configured to” perform the claimed intended function.
Therefore, the system of Viola with the reagent of Jakimczuk would be a system “configured to” identify a presence or concentration of the DOAC as claimed.
The intended use and function of the claimed system does not patentably distinguish the system, per se, since such undisclosed use and function is inherent in the reference system. In order to be limiting, the intended use and function must create a structural difference between the claimed system and the system of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a system in terms of function, and the system of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference system. The discovery of a previously unappreciated property of a prior art system, or of a scientific explanation for the prior art's functioning, does not render the old system patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCluskey et al. (US10175225, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11) as applied to claims 9, 13-16, 21, 22, 24 above, and further in view of Schafer et al. (US20220093223A1, IDS).
The teachings of McCluskey are found above.
McCluskey differs from the claimed invention in that they do not teach specifically teach the processing device identifies the presence of the direct oral factor Xa inhibitor of claims 10-12.
Schafer teach a system to identify direct oral factor Xa (DOAC) inhibitors in a sample, wherein the DOAC is apixaban, rivaroxaban or edoxaban (0024, 0028). The system (ROTEM® device) allows one to perform viscoelastic tests to monitor the blood coagulation process and to detect anticoagulants with minor effects on clotting time, these tests are known as ROTEM® TFTEM and EXTEM® (0024, 0028, 0031). The system comprises a cartridge which receives the blood sample for carrying out the viscoelastic tests (0009, 0056). The system receives parameters from the tests and use them to detect the presence and effects of DOAC’s (0032). The system comprises processing devices, i.e. software modules, analyzer instruments, computing devices and ROTEM devices, for performing operations including clotting parameters based on the test sample with a reagent to identify the presence of DOAC’s (0013, 0024, 0033, 0040, 0055, 0064). The test sample is a blood sample (0024, 0056, 0058) and the reagent for performing the test comprises a reduced tissue factor (0028) calcium chloride, and polybrene as a heparin inhibitor (0031).
Regarding claim 10, the direct oral factor Xa inhibitor comprises apixaban, rivaroxaban or edoxaban (0024, 0028).
Regarding claim 11, the results comprise identifying the DOAC inhibitor (0028, 0032, 0036, 0057).
Regarding claim 12, the results include estimated concentrations of the DOAC inhibitor (0057).
Regarding claims 13 and 22, the polycation is polybrene (0031).
Regarding claim 15, the reagent comprises calcium chloride (0031).
Regarding claim 16, the clotting parameter includes time to clot or clotting time (CT) (0005, 0026, 0028, 0031, 0036, for example).
Regarding claim 21, the reagent comprises a diluted/reduced tissue factor (0028).
Thus, before the effective filing date of the claimed invention, one of ordinary skill in the art would have had a reasonable expectation of successfully using the system comprising a cartridge and processing devices of Schafer and McCluskey for performing the operations directed to the measuring or detecting the potential presence of direct oral factor Xa inhibitors given the combined art teachings of ROTEM systems comprising cartridges and processing devices for measuring clotting parameters as well as measuring said parameters in samples having DOAC’s present. The prior art systems are disclosed to comprise cartridges for receiving samples and a reagent comprising the claimed reagent components and devices for performing the disclosed function. Thus, it would have been obvious to one of ordinary skill in the art that the devices would perform the claimed clotting parameter operations when the DOAC’s are present.
Claim(s) 10-12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viola et al. (US20180306774, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11) as applied to claims 9, 13, 14, 16, 21, 22, 24 above, and further in view of Schafer et al. (US20220093223A1, IDS).
The teachings of Viola are found above.
Viola differs from the claimed invention in that they do not teach specifically teach the processing device identifies the presence of the direct oral factor Xa inhibitor of claims 10-12, 15.
Schafer teach a system to identify direct oral factor Xa (DOAC) inhibitors in a sample, wherein the DOAC is apixaban, rivaroxaban or edoxaban (0024, 0028). The system (ROTEM® device) allows one to perform viscoelastic tests to monitor the blood coagulation process and to detect anticoagulants with minor effects on clotting time, these tests are known as ROTEM® TFTEM and EXTEM® (0024, 0028, 0031). The system comprises a cartridge which receives the blood sample for carrying out the viscoelastic tests (0009, 0056). The system receives parameters from the tests and use them to detect the presence and effects of DOAC’s (0032). The system comprises processing devices, i.e. software modules, analyzer instruments, computing devices and ROTEM devices, for performing operations including clotting parameters based on the test sample with a reagent to identify the presence of DOAC’s (0013, 0024, 0033, 0040, 0055, 0064). The test sample is a blood sample (0024, 0056, 0058) and the reagent for performing the test comprises a reduced tissue factor (0028) calcium chloride, and polybrene as a heparin inhibitor (0031).
Regarding claim 10, the direct oral factor Xa inhibitor comprises apixaban, rivaroxaban or edoxaban (0024, 0028).
Regarding claim 11, the results comprise identifying the DOAC inhibitor (0028, 0032, 0036, 0057).
Regarding claim 12, the results include estimated concentrations of the DOAC inhibitor (0057).
Regarding claims 13 and 22, the polycation is polybrene (0031).
Regarding claim 15, the reagent comprises calcium chloride (0031).
Regarding claim 16, the clotting parameter includes time to clot or clotting time (CT) (0005, 0026, 0028, 0031, 0036, for example).
Regarding claim 21, the reagent comprises a diluted/reduced tissue factor (0028).
Thus, before the effective filing date of the claimed invention, one of ordinary skill in the art would have had a reasonable expectation of successfully using the system comprising a cartridge and processing devices of Schafer and Viola for performing the operations directed to the measuring or detecting the potential presence of direct oral factor Xa inhibitors given the combined art teachings of ROTEM systems comprising cartridges and processing devices for measuring clotting parameters as well as measuring said parameters in samples having DOAC’s present. The prior art systems are disclosed to comprise cartridges for receiving samples and a reagent comprising the claimed reagent components and devices for performing the disclosed function. Thus, it would have been obvious to one of ordinary skill in the art that the devices would perform the claimed clotting parameter operations when the DOAC’s are present.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viola et al. (US20180306774, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11) as applied to claims 9, 13, 14, 16, 21, 22, 24 above, and further in view of Barrett et al. (Clinical and Applied Thrombosis/Hemostasis, vol. 19, p. 522-528, 2013). and Greenburg et al. (American Journal of Clinical Pathology, vol. 86, p. 484-489., 1986).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable McCluskey et al. (US10175225, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11) as applied to claims 9, 13-16, 21, 22, 24 above, and further in view of Barrett et al. (Clinical and Applied Thrombosis/Hemostasis, vol. 19, p. 522-528, 2013). and Greenburg et al. (American Journal of Clinical Pathology, vol. 86, p. 484-489., 1986).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable Schafer et al. (US20220093223A1, IDS) in view of Jakimczuk et al. (J. of Clin. Med, 3/16/2022, p. 1-11) as applied to claims 9-16, 21, 22 above, and further in view of Barrett et al. (Clinical and Applied Thrombosis/Hemostasis, vol. 19, p. 522-528, 2013). and Greenburg et al. (American Journal of Clinical Pathology, vol. 86, p. 484-489., 1986).
Each of Viola, McCluskey and Schafer teach the system of claim 9 comprising a calcium ion.
While the calcium ion assay concentration within a range of 9-15 mM is not taught by the prior art references, this is taken to be a result effective variable which can be optimized depending on the assay, amount of DOAC’s present, and/or to optimize (increasing or decreasing) clotting time in the assay. Support is provided by Barrett and Greenburg. Barrett teaches that calcium chloride concentrations added to assays for monitoring the anticoagulant activity of DOAC’s can be optimized depending on drug concentrations and to increase assay range and sensitivity (abstract, p. 523, for example). Greenburg additionally teaches that effect of calcium chloride on clotting time, that increasing concentration prolonged activated partial thromboplastin time (p.484, whole page, Discussion p. 487-488). Thus, the concentration is taken to be optimizable by one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive. Applicants’ arguments are only directed at the Schafer and Jakimczuk references.
As addressed above, the amendment to claim 9, drawn to a system comprising a cartridge containing a reagent comprising a polycation, and one or more processing devices. Independent claim 9 is amended to include the limitation of “wherein the system is configured to identify a presence or an estimated concentration…”. For examination purposes, a system which comprises the components of the system, is one which is “configured to” perform the claimed intended function. The intended use and function of the claimed system does not patentably distinguish the system, per se, since such undisclosed use and function is inherent in the reference system. In order to be limiting, the intended use and function must create a structural difference between the claimed system and the system of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a system in terms of function, and the system of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference system. The discovery of a previously unappreciated property of a prior art system, or of a scientific explanation for the prior art's functioning, does not render the old system patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
Applicant argues that Schafer teaches that the TFTEM CT assays is sensitive to low levels of DOAC (apixaban) but does not disclose the assay being sensitive to apixaban at a concentration of 25 ng/mL or less in the test sample. Applicant further cites the Groene reference (not relied upon herein) support their position that the TFTEM assay is sensitive to DOAC’s at a concentration of above 30 ng/mL, thus suggesting that the TFTEM assay of Schafer while sensitive to low concentration does not suggest levels of 25 ng/mL or less.
Applicant is reminded that the claims are drawn to a system and not an assay method. The current claim language reads that the system is “configured to identify a presence of or concentration of…”. Thus, combined art teachings of a system having the claimed system components would be one which is configured to “perform the function”. It should also be noted that the Groene reference applicants rely upon does not teach the system as claimed, for example, the system does not comprise a polycation and does not test any amounts less than 30 ng/mL. Thus, applicants’ arguments are not found persuasive.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
Prosecution Insights