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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/2025 has been entered.
Response to Amendment
Applicant’s amendments filed on 11/11/2025 has been fully considered. Claims 1-5, 7-9, and 11-13, 15-22 are pending. Claims 6, 10, and 14 are cancelled. Claims 1, 7, 12-13, and 21 are newly amended.
Response to Arguments
Applicant’s arguments with respect to amended independent claim(s) 1 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is: “a mechanism for signaling” in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification in paragraph 0009 that “a mechanism for signaling” is an alarm or any device/component that can notify a user. The language in claim 1 will be interpreted as requiring the disclosed structure in paragraph 0009 or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-2, 4-5, 7-8, 11, 15-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2), and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)).
Regarding claim 1, Gipson teaches a system for treating a patient having or at risk of having a blood clotting disorder (system is used for treatment of patient with cardiac failure – obvious that patients with cardiac failure are at risk with blood clotting; Paragraph 0003), the system comprising:
a continuous-flow pump (inflow flow controller 20 is a pump - obvious that extracorporeal blood circuits would require a continuous blood pump; Figure 1; Paragraph 0055) comprising an intake port and an outtake port for returning the filtered blood to the patient (fluid source 10/intake port takes blood from patient and is pulled through system by pump 20 to outlet 80; Figure 1; Paragraph 0055);
a disposable set comprising tubing (tubing – obvious that tubing are disposed/replaced after use because of biohazard concerns; Figure 3).
Gipson does not teach the intake port connecting to a vein, the outtake port using an artery.
However, an alternative embodiment of Gipson teaches wherein the system can be used for veno-arterial ECMO (Paragraph 0012 and 0024).
Gipson is analogous to the claimed invention because they are in the same field of blood treatment systems, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (system of Gipson) for another (veno-arterial ECMO system of Gipson) since the substitution of the connectors would have yielded predictable results, namely, a filtration device for veno-arterial treatment. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B).
The modified Gipson further teaches the intake port connecting to a vein, the outtake port using an artery (intake port 10 is connected to vein and outtake port 80 is connected to artery; Paragraph 0012; see combination above).
The modified Gipson further does not teach a filter for capturing blood clots; a sensor for detecting D-dimer in blood as a marker of clots and/or toxic blood substances; and
a mechanism for signaling when the filter is to be changed;
wherein the filter has a pore size and structure capable of capturing blood clots of size 100 micrometers or larger; and
wherein the sensor comprises an electrochemical impedance detector for monitoring D- dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer.
However, Laster teaches a filter for capturing blood clots (filter; Paragraph 0138) and a mechanism for signaling when the filter is to be changed (indicator mechanism when filter is clogged or failure – indicator that filter needs to be changed; Paragraph 0143); and wherein the filter has a pore size and structure capable of capturing blood clots of size 100 micrometers or larger (Laster; filter has a pore size of 1 micron – implicit that filter can catch blood clots of size 100 micrometers or larger; Paragraph 0138; Stiff; a typical platelet has a diameter of 3-4 microns – implicit that an emboli has a diameter greater than 3-4 microns since it comprises multiple platelets and other cells; NPL previously attached).
Gipson and Laster are both considered to be analogous to the claimed invention because they are in the field of blood filtration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson to incorporate the teachings of Laster and have the filter and signaling mechanism of Laster in the system of Gipson. This allows for the system to filter the blood flow through thoroughly and increases the life cycle of the system (Laster; Paragraph 0138).
The combination of Gipson in view of Laster does not teach a sensor for detecting D-dimer in blood as a marker of clots and/or toxic blood substances and wherein the sensor comprises an electrochemical impedance detector for monitoring D-dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer.
However, McCrea teaches a sensor for detecting D-dimer in blood as a marker of clots and/or toxic blood substances (DLT biomarker sensor used with system to detect D-dimer; Column 5, lines 4-15 and Column 17, line 39).
McCrea and Gipson in view of Laster are both considered to be analogous to the claimed invention because they are in the field of blood filtration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson in view of Laster to incorporate the teachings of McCrea to place the sensor of McCrea in the system of Gipson in view of Laster. This allows for the system to detect biomarkers from the blood that suggests the onset or progression of sepsis and blood related diseases (McCrea; Column 5, lines 9-15 and Column 17, lines 10-58).
The combination of Gipson in view of Laster and McCrea does not teach wherein the sensor comprises an electrochemical impedance detector for monitoring D-dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer.
However, Chebil teaches the sensor comprises an electrochemical impedance detector for monitoring D-dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer (electrochemical impedance immunosensor for detecting D-dimer with biosensor that immobilizes a single-chain antibody on a transducer surface with a receptor layer; Abstract; Section 1, Section 2.2 and 2.3).
Gipson in view of Laster and McCrea and Chebil are both considered to be analogous to the claimed invention because they are in the field of biosensing in blood. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Gipson in view of Laster and McCrea to incorporate the teachings of Chebil and have the immunosensor with the biosensor of Chebil as the sensor of Gipson in view of Laster and McCrea. This allows for a rapid and sensitive biosensor that is able to detect D-dimer in human patient plasma samples (Abstract).
Regarding claim 2, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. Gipson further teaches further comprising an anti-thrombotic agent to reduce and/or eliminate build-up on pump surfaces that come into contact with blood (anti-coagulants, which is a type of anti-thrombotic, can be added to blood in system; Paragraph 0035).
Regarding claim 4, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. Gipson further teaches wherein the pump is capable of providing a continuous blood flow of at least 200 mL/min (pump allows for 5 L/min flow, which is greater than 200 mL/min; Paragraph 0045).
Regarding claim 5, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the filter comprises one or more members selected from the group consisting of cellulose, synthetic polymer, and graphene (filter can be made of cellulose; Paragraph 0123).
Regarding claim 7, Gipson teaches a method of treating a patient having or at risk of having a blood clotting disorder (method of system is used for treatment of patient with cardiac failure – obvious that patients with cardiac failure are at risk with blood clotting; Paragraph 0003 and 0012), the method comprising:
filtering blood of the patient (Paragraph 0012; Figure 1 and 3);
(iii) returning the filtered blood to the patient (Paragraph 0012; Figure 1 and 3),
wherein the filtering comprises:
drawing blood from the patient via a continuous-flow pump (inflow flow controller 20 is a pump - obvious that extracorporeal blood circuits would require a continuous blood pump, fluid source 10/intake port takes blood from patient and is pulled through system by pump 20 to outlet 80; Figure 1; Paragraph 0055).
Gipson does not teach returning the filtered blood to the patient using an artery and drawing blood from the patient using a vein.
However, an alternative embodiment of Gipson teaches wherein the system can be used for veno-arterial ECMO (Paragraph 0012 and 0024).
Since the prior art of Gipson recognizes the equivalency of veno-arterial ECMO as an extracorporeal blood treatment system in the field of blood filtration systems, it would have been obvious to a person having ordinary skill in the art to substitute the system of Gipson with the veno-artertial ECMO system of Gipson since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
The modified Gipson further teaches returning the filtered blood to the patient using an artery and drawing blood from the patient using a vein (intake port 10 is connected to vein and outtake port 80 is connected to artery; Paragraph 0012; see combination above).
The modified Gipson does not teach (i) filtering blood of the patient in order to capture blood clots,
wherein filtering comprises: (b) contacting the drawn blood with a filter having a structure capable of capturing blood clots of size 100 micrometers or larger.
However, Laster teaches (i) filtering blood of the patient in order to capture blood clots (implicit that the filter of 1 micron pore size would be able to filter emboli of size 100 micrometers or larger; Paragraph 0138 – Laster; Stiff; a typically platelet has a diameter of 3-4 microns – implicit that an emboli has a diameter greater than 3-4 microns since it comprises of multiple platelets and other cells; see NPL previously attached),
wherein filtering comprises: (b) contacting the drawn blood with a filter having a structure capable of capturing blood clots of size 100 micrometers or larger (implicit that the filter of 1 micron pore size would be able to filter emboli of size 100 micrometers or larger; Paragraph 0138 – Laster; Stiff; a typically platelet has a diameter of 3-4 microns – implicit that an emboli has a diameter greater than 3-4 microns since it comprises of multiple platelets and other cells; see NPL previously attached).
Gipson and Laster are both considered to be analogous to the claimed invention because they are in the field of blood filtration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson to incorporate the teachings of Laster and have the filter of Laster in the system of Gipson. This allows for the system to filter the blood flow through thoroughly and increases the life cycle of the system (Laster; Paragraph 0138).
The combination of Gipson in view of Laster does not teach (ii) monitoring for the presence of D-dimer in the blood being pumped as a marker of clots and/or other toxins in the blood by obtaining a measure of D-dimer in the blood of the patient.
However, McCrea teaches (ii) monitoring for the presence of D-dimer in the blood being pumped as a marker of clots and/or other toxins in the blood by obtaining a measure of D-dimer in the blood of the patient (DLT biomarker sensor used with system to detect D-dimer; Column 5, lines 4-15 and Column 17, line 39).
McCrea and Gipson in view of Laster are both considered to be analogous to the claimed invention because they are in the field of blood filtration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson in view of Laster to incorporate the teachings of McCrea to place the sensor of McCrea in the system of Gipson in view of Laster. This allows for the system to detect biomarkers from the blood that suggests the onset or progression of sepsis and blood related diseases (McCrea; Column 5, lines 9-15 and Column 17, lines 10-58).
The combination of Gipson in view of Laster and McCrea does not teach using an electrochemical impedance detector for monitoring D-dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer.
However, Chebil teaches using an electrochemical impedance detector for monitoring D-dimer association with a biosensor comprising a single-chain antibody (ScAb) immobilized on a transducer surface with a receptor layer (immunosensor for detecting D-dimer with biosensor that immobilizes a single-chain antibody on a transducer surface with a receptor layer; Abstract; Section 1, Section 2.2 and 2.3).
Gipson in view of Laster and McCrea and Chebil are both considered to be analogous to the claimed invention because they are in the field of biosensing in blood. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Gipson in view of Laster and McCrea to incorporate the teachings of Chebil and have the immunosensor with the biosensor of Chebil as the sensor of Gipson in view of Laster and McCrea. This allows for a rapid and sensitive biosensor that is able to detect D-dimer in human patient plasma samples (Abstract).
Regarding claim 8, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. Gipson further teaches further comprising administering an anticoagulant to the patient (Paragraph 0035).
Regarding claim 11, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches comprising replacing the filter upon capture of one or more clots from the blood (Paragraph 0143-0144 and 0159).
Regarding claim 15, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. The combination of Gipson in view of Laster, McCrea, and Chebil does not teach wherein the pump is configured to provide a flow at rates within a range bounded by a lower limit and/or an upper limit.
However, Laster teaches wherein the pump is configured to provide a flow at rates within a range bounded by a lower limit and/or an upper limit (Paragraph 0060).
Gipson in view of Laster, McCrea, and Chebil are all considered to be analogous to the claimed invention because they are in the field of blood filtration. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention to have modified Gipson in view of Laster, McCrea, and Chebil to incorporate the teachings of Laster and have the pump be operated with the flow rate as taught by Laster. This allows for the blood flow rate to be maintained as the blood exits and re-enters the body (Laster; Paragraph 0060).
Regarding claim 16, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the filter comprises a cartridge (Laster; device 16 has a filter 30; Paragraph 0119; Figure 3).
Regarding claim 17, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 16. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the cartridge comprises a membrane structure (Laster; filter 30 is a membrane/sheet structure; Paragraph 0119; Figure 3).
Regarding claim 18, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the filter comprises a cartridge comprising a membrane structure (Laster; device 16 has a filter 30 with a membrane structure; Figure 3; Paragraph 0119).
Regarding claim 19, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 18. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the membrane structure does not comprise an umbrella-shaped device or otherwise-shaped wire device (Laster; membrane filter are not umbrella or wire device; Figure 3; Paragraph 0119).
Regarding claim 21, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. Gipson does not teach wherein the input connection connects to said vein at a location that is disposed downstream of a deep vein thrombosis (DVT), the DVT being disposed in a return flow of blood to the heart.
However, it would have been obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the input connection to be connected to the vein at a location that is downstream of a deep vein thrombosis. The system will perform the same function of filtering blood clots from the venous bloodstream when the input connection is placed at any given location on the vein. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Regarding claim 22, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 21. The combination of Gipson in view of Laster, McCrea, and Chebil further teaches wherein the input connection prevents the DVT from reaching the heart (input connection is located downstream of DVT to capture blood clots and prevent blood clots from travelling to the heart; see rejection of claim 21 above).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2), and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)), as applied to claim 1 above, and further in view of Zeng et al. (Efficacy of Heparinoid PSS in Treating Cardiovascular Diseases and Beyond—A Review of 27 Years Clinical Experiences in China, April 2016, Clinical and Applied Thrombosis/Hemostasis, Volume 22, Issue 3, Pages 222-229 (Year: 2016)).
Regarding claim 3, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 2. Gipson in view of Laster, McCrea, and Chebil does not teach wherein the anti-thrombotic agent comprises low- molecular weight propylene glycol alginate sodium sulfate (PSS).
However, Zeng teaches that PSS and heparin are both anti-thrombotic agents with identical administration of use due to the similarity of adverse reactions for patients with thrombotic ailments (Page 225, under “Adverse Reactions”). Zeng also teaches that PSS that is administered for treatment is typically treated with low-molecular weight (approximately 11 kDa) with its lower dosage than heparin (pages 223-224; under “Preparation, Chemical Structure, and Clinical Doses” and page 225, under “Adverse Reactions”).
Since the prior art of Zeng recognizes the equivalency of utilizing PSS and heparin as anti-thrombotic agents in the field of blood clotting treatments, it would have been obvious to a person having ordinary skill in the art to substitute heparin with low-molecular weight PSS since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2), and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)), as applied to claim 8 above, and further in view of Mullick et al. (Patent No. US 8,877,062 B2).
Regarding claim 9, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. The combination of Gipson in view of Laster in view of McCrea and Chebil does not teach wherein the anticoagulant comprises a member selected from the group consisting of heparin, warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban.
However, Mullick teaches further comprising administering an anticoagulant to the patient and wherein the anticoagulant comprises a member selected from the group consisting of heparin, warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban (heparin 160 is added to blood in drip chamber 115 to be delivered to the patient; Column 21, lines 61-67).
Since the prior art of Mullick recognizes the equivalency of heparin as an anticoagulant in the field of blood filtration systems, it would have been obvious to a person having ordinary skill in the art to substitute the anticoagulant of Gipson with the heparin of Mullick since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2), and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)), as applied to claim 1 above, and further in view of Toulon et al. (Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays, January 2009, Volume 123, Issue 3, Pages 543-549 (Year: 2009)).
Regarding claim 12, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 1. Gipson in view of Laster, McCrea, and Chebil teaches does not teach that the biosensor detects D-dimer using one or more members selected from the group consisting of: quantitative fluorescence immunoassay, quantitative microparticle enzyme immunoassay (MEIA), chemiluminescence, quantitative latex-enhanced immunoturbidimetric immunoassay, quantitative solid-phase immunochromatography, enzyme-linked immunosorbent assay (ELISA), and quantitative latex agglutination.
However, Toulon teaches that the biosensor detects D-dimer using one or more members selected from the group consisting of: quantitative fluorescence immunoassay, quantitative microparticle enzyme immunoassay (MEIA), chemiluminescence, quantitative latex-enhanced immunoturbidimetric immunoassay, quantitative solid-phase immunochromatography, enzyme-linked immunosorbent assay (ELISA), and quantitative latex agglutination (quantitative enzyme linked fluorescent assay is automated ELISA to detect D-dimer; Page 544, section Introduction).
Toulon and Gipson in view of Laster, McCrea, and Chebil are both considered to be analogous to the claimed invention because they are in the field of D-dimer detection/monitoring in blood. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson in view of Laster, McCrea, and Chebil to incorporate the teachings of Toulon and have the ELISA assay of Toulon as a biosensor of Gipson in view of Laster, McCrea, and Chebil. This would allow for the ELISA to detect the D-dimer of blood/plasma samples to detect blood clots (Toulon; Page 544, section Introduction).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2) and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)), as applied to claim 7 above, and further in view of Toulon et al. (Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays, January 2009, Volume 123, Issue 3, Pages 543-549 (Year: 2009)).
Regarding claim 13, Gipson in view of Laster, McCrea, and Chebil teaches the method of claim 7. The combination of Gipson in view of Laster, McCrea, and Chebil does not teach wherein obtaining a measure of D-dimer comprises using one or more members selected from the group consisting of: quantitative fluorescence immunoassay, quantitative microparticle enzyme immunoassay (MEIA), chemiluminescence, quantitative latex-enhanced immunoturbidimetric immunoassay, quantitative solid-phase immunochromatography, enzyme-linked immunosorbent assay (ELISA), and quantitative latex agglutination.
However, Toulon teaches wherein obtaining a measure of D-dimer comprises using one or more members selected from the group consisting of: quantitative fluorescence immunoassay, quantitative microparticle enzyme immunoassay (MEIA), chemiluminescence, quantitative latex-enhanced immunoturbidimetric immunoassay, quantitative solid-phase immunochromatography, enzyme-linked immunosorbent assay (ELISA), and quantitative latex agglutination (quantitative enzyme linked fluorescent assay is automated ELISA to detect D-dimer; Page 544, section Introduction).
Toulon and Gipson in view of Laster, McCrea, and Chebil are both considered to be analogous to the claimed invention because they are in the field of D-dimer detection/monitoring in blood. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson in view of Laster, McCrea, and Chebil to incorporate the teachings of Toulon and have the ELISA assay of Toulon as a biosensor of Gipson in view of Laster, McCrea, and Chebil. This would allow for the ELISA to detect the D-dimer of blood/plasma samples to detect blood clots (Toulon; Page 544, section Introduction).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gipson (Publication No. US 2020/0188571 A1) in view of Laster (Publication No. US 2017/0106132 A1), McCrea et al. (Patent No. US 10,537,280 B2), and Chebil et al. (Electrochemical detection of d-dimer as deep vein thrombosis marker using single-chain d-dimer antibody immobilized on functionalized polypyrrole, October 2010, Biosensors and Bioelectronics, Volume 26, Issue 2, Pages 736-742 (Year: 2010)), as applied to claim 7 above, and further in view of Hofmann et al. (Publication No. US 2018/0360479 A1).
Regarding claim 20, Gipson in view of Laster, McCrea, and Chebil teaches the system of claim 7. The combination of Gipson in view of Laster, McCrea, and Chebil does not teach further comprising obtaining, determining, and/or monitoring one or more procoagulation factors in the blood of the patient, the one or more procoagulation factors comprising at least one of Partial Thromboplastin Time (PTT), Prothrombin Time (PT), and fibrinogen.
However, Hofmann teaches further comprising obtaining, determining, and/or monitoring one or more procoagulation factors in the blood of the patient, the one or more procoagulation factors comprising at least one of Partial Thromboplastin Time (PTT), Prothrombin Time (PT), and fibrinogen (sensor measures fibrinogen that is used to monitor the restoration of blood flow or occlusion of vessel; Paragraph 0079).
Hofmann and Gipson in view of Laster, McCrea, and Chebil are both considered to be analogous to the claimed invention because they are in the field of D-dimer detection/monitoring in blood. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gipson in view of Laster, McCrea, and Chebil to incorporate the teachings of Hofmann and have the fibrinogen sensor of Hofmann in the device of Gipson in view of Laster, McCrea, and Chebil. This would allow for the system to monitor the restoration of blood flow or occlusion of the vessel (Hofmann; Paragraph 0079).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781