DETAILED ACTION
This detailed action is in response to the application filed on 10/21/2024, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-20 are pending.
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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 reads “a lower filter chamber (120) removably attached and fluidly coupled to the upper filter chamber (110), configured to receive and contain filtered whole blood” in item b and “a fine filter mesh (135) disposed within the lower filter chamber (120), configured to filter the aspirated whole blood into filtered whole blood” in item d. The language “configured to receive and contain filtered whole blood” of item b implies that the filtered whole blood is generated prior to being received by the lower filter chamber, whereas the language of item d demonstrates the generation of filtered whole blood within the lower filter chamber. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is directed towards a method for preventing foam buildup while filtering clot material from whole blood, then lists steps of filtering clot material from whole blood. It is unclear which of these steps prevent foam buildup, rendering the claim indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 9-10, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) in view of U.S. Publication US20160151550A1 (‘Fisher’).
The Applicant’s claims are directed towards an apparatus (claims 1-3 and 9-10) and a method (claims 17 and 19).
Regarding Claims 1-3 and 9-10, Horowitz teaches a filter canister device (100) (Fig. 1a, pg. 3, section Methodology) for filtering clot material from whole blood (pg. 1, subsection Methods), the device (100) comprising:
a. an upper filter chamber (110) (Fig. 1a, section Methodology, chamber comprising Filter A), configured to receive and contain aspirated whole blood (pg. 4, subsection Study Part 1);
wherein the upper filter chamber (110) is at least partially transparent (Fig. 1a-1b);
b. a lower filter chamber (120) (Fig. 1a, pg. 3, section Methodology, chamber comprising Filter C) removably attached (Fig. 1a, gasket and Fig. 2, disassembled) and fluidly coupled to the upper filter chamber (110) (Fig. 1a), configured to receive and contain filtered whole blood (pg. 4, subsection Study Part 1, serially strained);
c. a coarse filter mesh (130) (Fig. 1a, section Methodology, Filter A) disposed within the upper filter chamber (110) (Fig. 1a), configured to capture the clot material from the aspirated whole blood (Fig. 2);
d. a fine filter mesh (135) (Fig. 1a, section Methodology, Filter C) disposed within the lower filter chamber (120) (Fig. 1a), configured to filter the aspirated whole blood into filtered whole blood (Fig. 2);
e. an inlet port (140) (Fig. 1a, quick connect inlet) fluidly coupled to the upper filter chamber (110) (Fig. 1a), configured to accept the aspirated whole blood and direct the aspirated whole blood into the upper filter chamber (110) (pg. 4, subsection Study Part 1); and
f. an outlet port (150) (Fig. 1a) fluidly coupled to the lower filter chamber (120) (Fig. 1a), configured to accept the filtered whole blood from the lower filter chamber (120) (Fig. 1a) and direct the filtered whole blood to an external source (Fig. 1d).
However, Horowitz does not teach that the device (100) comprises only two filter mesh layers.
Fisher also relates to a filter canister device (100) for filtering clot material from whole blood, the device (100) ([0030]) comprising: only two filter mesh layers ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Horowitz may comprise only two filter mesh layers, as demonstrated by Fisher, because both Horowitz and Fisher are concerned with a filter canister device for filtering clot material from whole blood (Horowitz, pg. 1, subsection Methods and Fisher, [0030]).
Additional Disclosures Included:
Claims 2-3: the inlet port (140) comprises a stopcock valve (Fisher, Fig. 4, [0044], inlet valve 302) and the outlet port (150) comprises a stopcock valve (Fisher, Fig. 4, [0046], outlet valve 242) (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the inlet port and outlet port of Horowitz and Fisher to comprise stopcock valves, as demonstrated by Fisher, to control fluid flow (Fisher, [0072])).
Claim 9: the inlet port (140) is configured to accept a syringe (Horowitz, pg. 4, subsection Study Part 1), a catheter, or a combination thereof.
Claim 10: the outlet port (150) is configured to accept a syringe, a catheter (Horowitz, Figs. 1b and 1d-1e), or a combination thereof.
Regarding Claims 17 and 19, Horowitz teaches a method for filtering clot material from whole blood (pg. 1, subsection Methods), the method comprising:
a. aspirating whole blood from a patient (Fig. 1c);
b. directing (Fig. 1e) the aspirated whole blood through an inlet port (140) (Fig. 1a, quick connect inlet) into an upper filter chamber (110) (Fig. 1a, section Methodology, chamber comprising Filter A) of a filter canister device (100) (Fig. 1a, pg. 3, section Methodology);
c. directing (Fig. 1a, filtration direction) the aspirated whole blood through a coarse filter mesh (130) (Fig. 1a, section Methodology, Filter A) disposed in the upper filter chamber (110) such that the coarse filter mesh (130) captures the clot material from the aspirated whole blood (Fig. 2);
d. visualizing the clot material as captured by the coarse filter mesh (130) (Fig. 2);
e. directing (pg. 4, subsection Study Part 1) the aspirated whole blood into a lower filter chamber (120) (Fig. 1a, pg. 3, section Methodology, chamber comprising Filter C) of the device (100), removably and fluidly coupled to the upper filter chamber (110) (Fig. 1a, gasket and Fig. 2, disassembled);
f. directing (pg. 4, subsection Study Part 1) the aspirated whole blood through a fine filter mesh (135) (Fig. 1a, section Methodology, Filter C) disposed within the lower filter chamber (120), resulting in filtered whole blood (Fig. 2); and
g. directing the filtered whole blood to an external source (Fig. 1d-1e).
However, Horowitz does not teach that the device (100) comprises only two filter mesh layers.
Fisher also relates to a method for filtering clot material from whole blood, wherein the device (100) ([0030]) comprising: only two filter mesh layers ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Horowitz may comprise only two filter mesh layers, as demonstrated by Fisher, because both Horowitz and Fisher are concerned with a filter canister device for filtering clot material from whole blood (Horowitz, pg. 1, subsection Methods and Fisher, [0030]).
Additional Disclosures Included:
Claim 19: the inlet port (140) is configured to accept a syringe (Horowitz, pg. 4, subsection Study Part 1), a catheter, or a combination thereof.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) and U.S. Publication US20160151550A1 (‘Fisher’) as applied to claim 1 above, and further in view of Publication Should we use closed or open infusion containers for prevention of bloodstream infections? (‘Rangel-Frausto’, Annals of Clinical Microbiology and Antimicrobials 2010, 9:6).
The Applicant’s claim is directed towards an apparatus.
Regarding Claim 4, the combination of Horowitz and Fisher teaches the device of Claim 1, and suggests that the upper chamber (110) and the lower filter chamber (120) are non-vented (Horowitz, Fig. 1e and 4).
Rangel-Frausto teaches that closed infusion containers do not require or use any external vent (pg. 1 of 8). Note that the device of Horowitz is a closed system (Horowitz, caption of Fig. 1e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the upper filter chamber and lower filter chamber of Horowitz and Fisher is non-vented, as taught by Rangel-Frausto (Rangel-Frausto, pg. 1 of 8).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) and U.S. Publication US20160151550A1 (‘Fisher’) as applied to claim 1 above, and further in view of U.S. Patent US3849071A (‘Kayser’).
The Applicant’s claim is directed towards an apparatus.
Regarding Claims 5-6, the combination of Horowitz and Fisher teaches the device of Claim 1, except for one or more air vents fluidly coupled to the upper filter chamber (110);
wherein the one or more air vents comprise one or more float vents, each float vent (160) comprising:
a. an air port (162) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (110); and
b. a buoyant component (164) disposed in-line with the air port (162), configured to rise with a fluid level within the upper filter chamber (110) such that the buoyant component (164) blocks the air port (162) at a maximum fluid level in the upper filter chamber (110).
Kayser also relates to a filter canister device (100) (Fig. 2, C4/L19-22, blood-gas separator 4) for filtering clot material from whole blood (Fig. 2, C4/L26-29, screen or filter 10), including:
one or more air vents (Fig. 2, C4/L46-50, valve member 15) fluidly coupled to the upper filter chamber (110) (Fig. 2, C4/L43-50);
wherein the one or more air vents comprise one or more float vents (C4/L43-50, valve member 15 floats), each float vent (160) comprising:
a. an air port (162) (Fig. 2, C4/L43-55, second outlet 14 permits gas to exit chamber 6) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (110); and
b. a buoyant component (164) (C4/L43-50, valve member 15 floats) disposed in-line with the air port (162), configured to rise with a fluid level within the upper filter chamber (110) such that the buoyant component (164) blocks the air port (162) at a maximum fluid level in the upper filter chamber (110) (C5/L29-34, maximum restriction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the combination of Horowitz and Fisher to include one or more air vents, wherein the one or more air vents comprises one or more float vents, as demonstrated by Kayser, to prevent undissolved oxygen or other gases to flow with the blood to the patient (Kayser, C1/L17-41).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006), U.S. Publication US20160151550A1 (‘Fisher’) and U.S. Patent US3849071A (‘Kayser’) as applied to claim 5 above, and further in view of U.S. Patent US4445884A (‘Kurtz’).
The Applicant’s claim is directed towards an apparatus.
Regarding Claim 7, the combination of Horowitz, Fisher and Kayser teaches the device of Claim 5, wherein the one or more air vents comprise one or more check valves (Kayser, C4/L43-50, valve member 15 floats), each check valve (170) comprising: a. an air port (172) (Kayser, Fig. 2, C4/L43-55, second outlet 14 permits gas to exit chamber 6) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (110); except for b. a spring (174) disposed in-line with the air port (172), configured to move from an extended configuration to a compressed configuration when pressure is applied and move from the compressed configuration to the extended configuration when the pressure is released; and
c. a blocking component (176) coupled to the spring (174) such that the blocking component (176) is configured to block the air port (172) when the spring (174) is in the extended configuration, and the blocking component (176) is configured to release from the air port (172) when the spring (174) is in the compressed configuration such that air flow is permitted through the air port (172); wherein the aspirated whole blood, upon being directed into the upper filter chamber (110), generates the pressure in the upper filter chamber (110) such that the pressure is applied to the spring (174); wherein the filtered whole blood, upon being directed out of the lower filter chamber (120), releases the pressure in the upper filter chamber (110) such the pressure is released from the spring (174).
Kurtz also relates to a filter canister device (100) for filtering clot material from whole blood (C1/L65-C2/L5), including
b. a spring (174) (Fig. 4, C4/L1-6, compression spring 26) disposed in-line with the air port (172) (Fig. 4, C3/L63-66, air purge unit), configured to move from an extended configuration to a compressed configuration when pressure is applied and move from the compressed configuration to the extended configuration when the pressure is released (C4/L7-14 and C4/L34-46); and
c. a blocking component (176) (Fig. 4, C4/L1-14, spring housing 25) coupled to the spring (174) such that the blocking component (176) is configured to block the air port (172) when the spring (174) is in the extended configuration (C4/L7-14), and the blocking component (176) is configured to release from the air port (172) when the spring (174) is in the compressed configuration such that air flow is permitted through the air port (172) (C4/L7-14);
wherein the aspirated whole blood, upon being directed into the upper filter chamber (110), generates the pressure in the upper filter chamber (110) such that the pressure is applied to the spring (174) (C4/L34-42, spring pressed valve 25 is normally closed and is forced open when the internal pressure exceeds 50 mm of mercury); wherein the filtered whole blood, upon being directed out of the lower filter chamber (120) (Fig. 1, C3/L18-22, blood forced through tube 8), releases the pressure in the upper filter chamber (110) such the pressure is released from the spring (174) (C3/L11-22 and C4/L27-45, valve opens when internal pressure is excessive).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the combination of Horowitz, Fisher and Kayser to comprise one or more check valves, as demonstrated by Kurtz, in order to effectively prevent the possibility of air being reintroduced into the patient’s circulatory system (Kurtz, C1/L49-57).
Claims 8, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) and U.S. Publication US20160151550A1 (‘Fisher’) as applied to claim 1 above for Claim 8, and to claim 17 above for Claim 18 over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006), U.S. Patent US3849071A (‘Kayser’), U.S. Patent US4445884A (‘Kurtz’) and U.S. Publication US20160151550A1 (‘Fisher’) as applied to claim 11 above for Claim 12, and further in view of U.S. Publication US20040254514A1 (‘Gura’).
The Applicant’s claims are directed towards an apparatus (Claims 8 and 12) and a method (Claim 18).
Regarding Claims 8, 12 and 18, the combination of Horowitz and Fisher teaches the device of Claims 1 and the method of Claim 17, and the combination of Horowitz, Kayser, Kurtz and Fisher teaches the device of Claim 11, except a plurality of base legs disposed on the lower filter chamber (120), wherein the plurality of base legs is configured to support the device (100) on a leg of a patient, wherein the method further comprises supporting the device (100) on a leg of the patient.
Gura also relates to a filter canister device (100) for filtering whole blood (Fig. 6 and abstract), and a method for filtering whole blood ([0021]), including a plurality of base legs disposed (Fig. 6, [0039], fastening means) on the lower filter chamber (120), wherein the plurality of base legs is configured to support the device (100) on a leg of a patient (Fig. 6, [0039], wearable belt or strap), wherein the method further comprises supporting the device (100) on a leg of the patient ([0039] and [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the device and method of the combination of Horowitz and Fisher and the device of the combination of Horowitz, Kayser, Kurtz and Fisher to comprise a plurality of legs configured to support the device on a leg of the patient to perform continuous, steady and smooth filtration (Gura, [0016]).
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) in view of U.S. Patent US3849071A (‘Kayser’) and in further view of U.S. Patent US4445884A (‘Kurtz’) and in further view of U.S. Publication US20160151550A1 (‘Fisher’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 11 and 13-16, Horowitz teaches a filter canister device (100) (Fig. 1a, pg. 3, section Methodology) for filtering clot material from whole blood (pg. 1, subsection Methods), the device (100) comprising:
a. an upper filter chamber (110) (Fig. 1a, section Methodology, chamber comprising Filter A), configured to receive and contain aspirated whole blood (pg. 4, subsection Study Part 1);
wherein the upper filter chamber (110) is at least partially transparent (Fig. 1a-1b);
b. a lower filter chamber (120) (Fig. 1a, pg. 3, section Methodology, chamber comprising Filter C) removably attached (Fig. 1a, gasket and Fig. 2, disassembled) and fluidly coupled to the upper filter chamber (110) (Fig. 1a), configured to receive and contain filtered whole blood (pg. 4, subsection Study Part 1, serially strained);
c. a coarse filter mesh (130) (Fig. 1a, section Methodology, Filter A) disposed within the upper filter chamber (110) (Fig. 1a), configured to capture the clot material from the aspirated whole blood (Fig. 2);
d. a fine filter mesh (135) (Fig. 1a, section Methodology, Filter C) disposed within the lower filter chamber (120) (Fig. 1a), configured to filter the aspirated whole blood into filtered whole blood (Fig. 2);
e. an inlet port (140) (Fig. 1a, quick connect inlet) fluidly coupled to the upper filter chamber (110) (Fig. 1a), configured to accept the aspirated whole blood and direct the aspirated whole blood into the upper filter chamber (110) (pg. 4, subsection Study Part 1); and
f. an outlet port (150) (Fig. 1a) fluidly coupled to the lower filter chamber (120) (Fig. 1a), configured to accept the filtered whole blood from the lower filter chamber (120) (Fig. 1a) and direct the filtered whole blood to an external source (Fig. 1d).
Horowitz does not teach g. one or more float vents fluidly coupled to the upper filter chamber (110), each float vent (160) comprising:
i. an air port (162) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (11 0); and ii. a buoyant component (164) disposed in-line with the air port (162), configured to rise with a fluid level within the upper filter chamber (110) such that the buoyant component (164) blocks the air port (162) at a maximum fluid level in the upper filter chamber (110); and h. one or more check valves fluidly coupled to the upper filter chamber (110), each check valve (170) comprising: i. a second air port (172) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (11 0); ii. a spring (174) disposed in-line with the air port (172), configured to move from an extended configuration to a compressed configuration when pressure is applied and move from the compressed configuration to the extended configuration when the pressure is released; and iii. a blocking component (176) coupled to the spring (174) such that the blocking component (176) is configured to block the air port (172) when the spring (174) is in the extended configuration, and the blocking component (176) is configured to release from the air port (172) when the spring (174) is in the compressed configuration such that air flow is permitted through the air port (172); wherein the aspirated whole blood, upon being directed into the upper filter chamber (110), generates the pressure in the upper filter chamber (110) such that the pressure is applied to the spring (174); wherein the filtered whole blood, upon being directed out of the lower filter chamber (120), releases the pressure in the upper filter chamber (110) such the pressure is released from the spring (174); wherein the device (100) comprises only two filter mesh layers.
Kayser also relates to a filter canister device (100) (Fig. 2, C4/L19-22, blood-gas separator 4) for filtering clot material from whole blood (Fig. 2, C4/L26-29, screen or filter 10), including:
h. one or more float vents (C4/L43-50, valve member 15 floats) fluidly coupled to the upper filter chamber (110) (Fig. 2, C4/L43-50), each float vent (160) comprising:
i. an air port (162) (Fig. 2, C4/L43-55, second outlet 14 permits gas to exit chamber 6) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (110); and
ii. a buoyant component (164) (C4/L43-50, valve member 15 floats) disposed in-line with the air port (162), configured to rise with a fluid level within the upper filter chamber (110) such that the buoyant component (164) blocks the air port (162) at a maximum fluid level in the upper filter chamber (110) (C5/L29-34, maximum restriction).
Kurtz also relates to a filter canister device (100) for filtering clot material from whole blood (C1/L65-C2/L5), including: h. one or more check valves fluidly coupled to the upper filter chamber (11) (Fig. 1, C3/L23-29), each check valve (170) comprising:
i. a second air port (172) (Fig. 1 and 4, C3/L23-29 and C3/L63-66, air purge unit) fluidly coupled to air surrounding the device (100) such that air flow is provided in the upper filter chamber (110);
ii. a spring (174) (Fig. 4, C4/L1-6, compression spring 26) disposed in-line with the air port (172) (Fig. 4, C3/L63-66, air purge unit), configured to move from an extended configuration to a compressed configuration when pressure is applied and move from the compressed configuration to the extended configuration when the pressure is released (C4/L7-14 and C4/L34-46); and
iii. a blocking component (176) (Fig. 4, C4/L1-14, spring housing 25) coupled to the spring (174) such that the blocking component (176) is configured to block the air port (172) when the spring (174) is in the extended configuration (C4/L7-14), and the blocking component (176) is configured to release from the air port (172) when the spring (174) is in the compressed configuration such that air flow is permitted through the air port (172) (C4/L7-14);
wherein the aspirated whole blood, upon being directed into the upper filter chamber (110), generates the pressure in the upper filter chamber (110) such that the pressure is applied to the spring (174) (C4/L34-42, spring pressed valve 25 is normally closed and is forced open when the internal pressure exceeds 50 mm of mercury); wherein the filtered whole blood, upon being directed out of the lower filter chamber (120) (Fig. 1, C3/L18-22, blood forced through tube 8), releases the pressure in the upper filter chamber (110) such the pressure is released from the spring (174) (C3/L11-22 and C4/L27-45, valve opens when internal pressure is excessive).
Fisher also relates to a filter canister device (100) for filtering clot material from whole blood, the device (100) ([0030]) comprising: only two filter mesh layers ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the device of Horowitz to include one or more float vents, as demonstrated by Kayser, to prevent undissolved oxygen or other gases to flow with the blood to the patient (Kayser, C1/L17-41). It would have been for the combination of Horowitz and Kayser to comprise one or more check valves, as demonstrated by Kurtz, in order to effectively prevent the possibility of air being reintroduced into the patient’s circulatory system (Kurtz, C1/L49-57).
It would have been obvious that the device of Horowitz, Kayser and Kurtz may comprise only two filter mesh layers, as demonstrated by Fisher, because both Horowitz and Fisher are concerned with a filter canister device for filtering clot material from whole blood (Horowitz, pg. 1, subsection Methods and Fisher, [0030]).
Additional Disclosures Included:
Claim 13: the inlet port (140) is configured to accept a syringe (Horowitz, pg. 4, subsection Study Part 1), a catheter, or a combination thereof.
Claim 14: the outlet port (150) is configured to accept a syringe, a catheter (Horowitz, Figs. 1b and 1d-1e), or a combination thereof.
Claims 15-16: the inlet port (140) comprises a stopcock valve (Fisher, Fig. 4, [0044], inlet valve 302) and the outlet port (150) comprises a stopcock valve (Fisher, Fig. 4, [0046], outlet valve 242) (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the inlet port and outlet port of Horowitz, Kayser, Kurtz and Fisher to comprise stopcock valves, as demonstrated by Fisher, to control fluid flow (Fisher, [0072])).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Publication Extra-Corporeal Processing of Bovine, Porcine and Human Blood in Preparation for Autologous Re-Infusion Using a Disposable Filtration System: Initial Proof of Concept Study and Potential Applications for Human Autologous Blood Reinfusion in the Civilian and Combat Casualty Care Settings (‘Horowitz’, Horowitz M, et al. J Biol Todays World, 2023,12(6),001-006) in view of U.S. Patent 7,591,812 B1 (‘Tamari’) and in further view of U.S. Publication US20160151550A1 (‘Fisher’).
The Applicant’s claim is directed towards a method.
Regarding Claim 20, Horowitz teaches a method while filtering clot material from whole blood (Fig. 1a, pg. 3, section Methodology), the method comprising:
a. aspirating whole blood from a patient (Fig. 1c);
b. directing the aspirated whole blood through an inlet port (140) (Fig. 1a, quick connect inlet) into an upper filter chamber (110) (Fig. 1a) of a filter canister device (100);
c. directing the aspirated whole blood through a coarse filter mesh (130) (Fig. 1a, section Methodology, Filter A) disposed in the upper filter chamber (110) such that the coarse filter mesh (130) captures the clot material from the aspirated whole blood (Fig. 2);
d. visualizing the clot material as captured by the coarse filter mesh (130) (Fig. 2);
e. directing the aspirated whole blood into a lower filter chamber (120) (Fig. 1a) of the device (100), removably and fluidly coupled to the upper filter chamber (110) (Fig. 1a, gasket and Fig. 2, disassembled);
f. directing the aspirated whole blood through a fine filter mesh (135) (Fig. 1a, section Methodology, Filter C) disposed within the lower filter chamber (120), resulting in filtered whole blood (subsection Study Part 1); and
g. directing the filtered whole blood to an external source (Fig. 1d-1e).
Horowitz does not teach that the method is for preventing foam buildup, and the filter canister device (100) being a vented, non-pressurized filter canister device (100), wherein the device (100) comprises only two filter mesh layers.
Tamari also relates to a method while filtering clot material from whole blood (C4/L3-10), wherein the method is for preventing foam buildup (abstract, air removal and C3/L49-51, air is exhausted to atmosphere passively). Tamari also teaches that, when operating by gravity drainage, air is removed passively to atmosphere (C9/55-62. Note that Horowitz operates by gravity, see pg. 1, subsection Methods).
Fisher also relates to a method while filtering clot material from whole blood ([0002]), wherein the device (100) comprises only two filter mesh layers ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the method of Horowitz to be for preventing foam buildup, as demonstrated by Tamari, in a vented, non-pressurized filter canister device, as demonstrated by Tamari, because both Horowitz and Tamari involve gravity-based blood filtration (Horowitz, pg. 1, subsection Methods and Tamari, C9/L55-62), which involves removing air passively to atmosphere (Tamari, C9/55-62), because foam can easily overwhelm active air removal systems and cause disastrous consequences (Tamari, C2/L33-36). It would have been obvious that the device of Horowitz and Tamari may comprise only two filter mesh layers, as demonstrated by Fisher, because both Horowitz and Fisher are concerned with a filter canister device for filtering clot material from whole blood (Horowitz, pg. 1, subsection Methods and Fisher, [0030]).
Conclusion
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
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