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 .
Status of Claims
Claims 1-12 and 14-23 are currently pending. Claims 2-6, 8-12, 14, and 18 have been currently amended. Claim 13 is cancelled. Claims 21-23 are newly added. No new subject matter is added.
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 17 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 17 recites the limitation "the second filter" in line 1. Claim 3, from which claim 17 depends from, does not mention a second filter. It is unclear if applicant is referring to another filter from the platelet filter. There is insufficient antecedent basis for this limitation in the claim. For examinations purposes the term “the second filter” will be interpreted as “the platelet filter”.
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.
Claims 1-4, 10, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (US 10065134 B2), hereinafter referred to as “Yoshida”.
Regarding Claim 1, Yoshida teaches a blood filtering apparatus (plasma separation filter device 63, see Figure 3) for recovering blood components from blood (see Abstract), the apparatus comprising
an inlet for the blood (blood inlet 65); and
a cell filter (Leukocyte/oxygen and/or carbon dioxide depletion media 67 and hydrophilic microporous membrane 73) configured for filtering a portion of the blood (wherein whole blood from container 61 may flow into the device via first inlet chamber 65 via conduit 85, see Col. 10 ln 29-47) and retaining as a retentate a fraction of the blood containing red blood cells and platelets (the oxygen and/or carbon dioxide, leukocyte and plasma depleted packed red blood cells are thereafter removed from filter device 63 via device outlet chamber 71 and thereafter stored in container or bag 81, see Col. 7 ln 46-50) and passing as a filtrate a fraction of the blood containing platelets and being depleted of red blood cells (separated plasma is removed from leukocyte, oxygen and/or carbon dioxide, and plasma separation filter device 63 via a conduit 75 disposed between hydrophilic microporous membrane 73 and outer chamber 77, and thereafter stored in plasma container or bag 79 Col. 7 ln 42-46);
However, Yoshida does not explicitly disclose wherein the cell filter has a pore size in a range of 2.2-2.7 microns.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of Yoshida from greater than 0.6 microns to between 2.2-2.7 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 8 ln 23-26 indicating the pore size “may” be within the claimed range).
Regarding Claim 2, Yoshida teaches all of the limitations as discussed above in claim 1. However, Yoshida does not explicitly disclose wherein the pore size is in a range of 2.2-2.5, microns.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of Yoshida from greater than 0.6 microns to between 2.2-2.5 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 8 ln 23-26 indicating the pore size “may” be within the claimed range).
Regarding Claim 3, Yoshida further teaches wherein the apparatus comprises a platelet filter for filtering a portion of the filtrate of the cell filter into a platelet rich fraction and a platelet depleted fraction (the oxygen and/or carbon dioxide, leukocyte, platelet, and plasma depleted packed red blood cells are thereafter removed from filter device 63 via device outlet chamber 71 and thereafter stored in container or bag 81, see Col. 7 ln 46-50).
Regarding Claim 4, Yoshida further teaches wherein a filter material of least the cell filter comprises a polymer layer (media 67 may comprise a macro porous structure designed to allow unpacked red blood cells to flow through the filter pores with minimal adhesion, while leukocytes are removed by adsorption and/or size exclusion. Structures according the present disclosure may be formed from fibrous or foam materials that can be organic or inorganic in nature, see Col. 7 ln 51-57; the leukoreduction materials can be blended with O.sub.2/CO.sub.2 absorbing materials and formed into a filter structure including polyolefins (PP, PE, PMP), polyamides (nylon 6, nylon 610, nylon 10, 11, 12), polyesters (PET, PBT) polymers may, see Col. 19 ln 64-67; Col. 20 ln 1-3).
Regarding Claim 10, Yoshida teaches wherein the inlet for the blood is connected to plural filter layers and/or comprising a first outlet for retentate of the cell filter optionally connected to plural filter layers (outlet chamber 71 connected to conduit 87, see Figure 3) and a second outlet for filtrate of the cell filter optionally to plural filter layers (outlet chamber 71 connected to conduit 83, see Figure 3).
Regarding Claim 16, Yoshida teaches all of the limitations as discussed above in claim 1. However, Yoshida does not explicitly disclose wherein the pore size is in a range of 2.3-2.4, microns.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of Yoshida from greater than 0.6 microns to between 2.3-2.4 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 8 ln 23-26 indicating the pore size “may” be within the claimed range).
Regarding Claim 17, Yoshida teaches wherein the platelet filter has a pore size in a range of about 0.3-0.4 microns (cell filter membranes according the present disclosure include porous membranes having various ranges, see Col. 10 ln 7-28; including less micropores may be greater than 0.2 and less than 2 microns., which include the range of 0.3-0.4 microns).
Regarding Claim 18, Yoshida teaches wherein the polymer layer is a polymer surface layer that is a polymer membrane comprising a polymer material selected from the group consisting of polyester polyurethane, polyethylene terephthalate, polyethylene furanoate, poly(propylene furan-2,5-dicarboxylate) (the leukoreduction materials can be blended with O2/CO2 absorbing materials and formed into a filter structure. For example, PET or polyethylene terephthalate, see Col. 19 ln 64-67; Col. 20 ln 1-3).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (US 10065134 B2) in view of Brown (US 20180133655 A1).
Regarding Claim 5, Yoshida teaches all of the limitations as discussed above in claim 1. However, Yoshida does not explicitly disclose wherein a filter material of the cell filter is a track-etched membrane.
Brown teaches a spinning membrane blood separation or fractionation system (see Figures 1-2) comprising a cell filter (system 10 and membrane 62), wherein the filter material of the cell filter is a track-etched membrane (membrane 62 may be a fibrous mesh membrane, cast membrane, track-etched membrane, see Paragraph [0026]).
Yoshida and Brown are analogous art because both teach a cell filter for filter blood components.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the membrane filter material of Yoshida and further include wherein the material is a track-etched membrane, as taught by Brown. Brown teaches the track-etched membrane creates a tortuous path through which only certain sized components will pass (see Paragraph 0026]).
Claims 6-7, 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (US 10065134 B2) in view of Kusters et al. (US 20150060363 A1), hereinafter referred to as “Kusters”.
Regarding Claim 6, Yoshida teaches all of the limitations as discussed above in claim 1 and further teaches wherein the cell filter comprises filter portions (67) defining a first flow path (69) for unfiltered blood (for whole blood) and
defining a second flow path (75) comprising plural second flow path portions (the membrane may form one or more inner chambers within the housing, see Col. 9 ln 16-17) extending between the filter portions of the first flow path (extending through chamber 77 different from chamber 65, see Figure 3), for collecting filtrate downstream of the filter portions (the separated plasma is removed from leukocyte, oxygen and/or carbon dioxide, and plasma separation filter device 63 via a conduit 75 disposed between hydrophilic microporous membrane 73 and outer chamber 77, and thereafter stored in plasma container or bag 79, see Col. 7 ln 42-46),
wherein the plural second flow path portions are in fluid communication with each other at least downstream of the cell filter (the downstream side of hydrophilic microporous membrane 73 may be connected to container 79 via a conduit 83, see Col. 9 ln 4-6).
However, Yoshida does not explicitly disclose wherein the cell filter comprises plural filter portions arranged opposite each other defining a first flow path and retentate located between the opposite filter portions.
Kusters teaches a cell filter (a unitary two stage spinning membrane separator 180, see Figure 5) wherein the cell filter comprises plural filter portions (first stage filter membranes 188 and second stage filter membranes 186) arranged opposite each other defining a first flow path (gap 196) for unfiltered blood (red blood cells exited through outlet 206, see Figure 5) and retentate located between the opposite filter portions (the plasma, platelets and a few remaining red blood cells flow through the first stage membrane and support 188/190 (as indicated by arrows 202) and out of the housing 182 through an outlet , see Paragraph [0043]).
Yoshida and Kusters are analogous art because both teaches a cell filter for filter blood components.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the cell filter of Yoshida and have plural filter portions arrange opposite of each other to define the first flow path, as taught by Kusters. Kusters teaches it is believed that processing times will be reduced from an average of 15-25 minutes to 5 minutes or less (see Paragraph [0045]).
Regarding Claim 7, Yoshida and Kusters teach all of the limitation as discussed above in claim 6 and Kusters further teaches wherein at least some of the opposite filter portions are spaced by a retentate spacer layer (190) allowing flow of blood and retentate through the respective spacer layer (the plasma, platelets and a few remaining red blood cells flow through the first stage membrane and support 188/190, see Paragraph [0043]) and/or at least some of the opposite filter portions are spaced by a filtrate spacer layer allowing flow of filtrate through the respective spacer layer.
Regarding Claim 9, Yoshida and Kusters teach all of the limitation as discussed above in claim 6 and Kusters further teaches optionally further including a platelet filter and/or a second filter (second stage filter membrane 184), and wherein the platelet filter and/or the second filter comprise a plurality of filter portions (see Figure 5) stacked together in a stacking direction (stacked vertically, see Figure 5) and being configured for, seen in the stacking direction, providing alternating first flow paths (the platelet poor plasma to flow through the second stage membrane and support 184/186 into the gap 192 (as indicated by arrows 198) and out of the housing through an outlet (as indicated by arrows 200), see Paragraph [0044]) for retentate of the filter and second flow paths for filtrate of the filter (platelet rich plasma is retained in the gap 196 and then exited from the housing through an outlet, as indicated by arrow 206, see Paragraph [0044]).
Regarding Claim 21, Yoshida teaches all of the limitations as discussed above and Yoshida further teaches wherein a filter has a pore size in a range of 0.2-0.6 microns (cell filter membranes according the present disclosure include porous membranes having various ranges, see Col. 10 ln 7-28; including less micropores may be greater than 0.2 and less than 2 microns., which include the range of 0.2-0.6 microns). However, Yoshida does not explicitly wherein the apparatus comprises a second filter for filtering a portion of the filtrate of the cell filter.
Kusters teaches a cell filter (a unitary two stage spinning membrane separator 180, see Figure 5), wherein the cell filter comprises a first filter (first stage filter membranes 188) and a second filter (second stage filter membrane 184) for filtering a portion of the filtrate of the cell filter.
Yoshida and Kusters are analogous art because both teaches a cell filter for filter blood components.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the cell filter of Yoshida and further include a second filter for filtering a portion of the filtrate of the cell filter with a pore size in a range of 0.2-0.6 microns, as taught by Kusters. Kusters teaches the cell filter kit and method described above allows processing times to be reduced from an average of 15-25 minutes to 5 minutes or less. Further, because a closed system is provided, the platelet-rich plasma may be injected directly into the patient, thus decreasing the likelihood of contamination (see Paragraph [0045]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida and Kusters as applied to claim 7 above, and further in view of Brown (US 20180133655 A1).
Regarding Claim 8, Yoshida and Kusters teach all of the limitation as discussed above in claim 7. However, Yoshida and Kusters do not explicitly disclose wherein the spacer comprises or is at least one of a fibrous material, a mesh material, and a woven or knit cloth.
Brown teaches a spinning membrane blood separation or fractionation system (see Figures 1-2) comprising a cell filter (system 10 and membrane 62), wherein the spacer comprises or is at least one of a fibrous material, a mesh material, and a woven or knit cloth (membrane 62 may be a fibrous mesh membrane, cast membrane, track-etched membrane, etc. For example, the membrane 62 may have a polyester mesh ).
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the spacer layer of Kusters and replace it with the fibrous mesh membrane of Brown. Brown teaches the fibrous mesh layer creates a tortuous path through which only certain sized components will pass (see Paragraph 0026]).
Claims 11, 14-15, 19-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 20180133655 A1) in view of Nierich (EP 1897570 A1), and as evidence by (Platelet Count, published on 10/21/2024 on “https://my.clevelandclinic.org/health/diagnostics
/21782-platelet-count”).
Regarding Claim 11, Brown teaches a method of recovering blood components from blood (automated processing of a blood product via separator 108, see Abstract; Figure 3), comprising separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction (blood can be separated from plasma through the separator and the remaining blood components, primarily red blood cells, platelets and white cells, move to the exit region between the spinner and the shell and may be returned to the donor or collected for further processing, see Paragraph [0019]; in one embodiment, the retentate may be concentrated red blood cells, see Paragraph [0036]); and a red blood cell poor fraction (a filtrate collection container 112 in fluid communication with filtrate flow path for receiving filtrate separated by the separator 108, see Paragraph [0041]); and
wherein the red blood cell rich fraction comprises about 40-450 thousand platelets per microliter (normal platelet count range: Between 150,000 and 400,000 platelets per microliter, as evidence by my.clevelandclinic.org; it is to be understood that the platelets are filtered along with the red blood cells to form the rich blood cell fraction, as described in Paragraph [0019]).
However, Brown does not explicitly disclose wherein the red blood cell rich fraction has a hematocrit of at least 30% and/or the red blood cell rich fraction comprises at least 60% of the red blood cells of the amount of blood.
Nierich teaches a blood filtering device (1) for the recuperation of blood from wound drained blood (see Abstract), comprising separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction and a red blood cell poor fraction (this blood which preferably is as rich as possible in healthy red blood cells or erythrocytes, must be filtered out of the drained blood and freed or washed from impurities and/or contaminants before reinfusion, see Paragraph [0003]; the residue of the second filter 8 is collected at the exit port 6 and the filtrate is received in the reservoir 10 and is considered a waste product of the process, see Paragraph [0035]), wherein the red blood cell rich fraction has a haematocrit of at least 30% (reliable filtering device which may yield purified blood with a high haematocrit value, e.g. 70 % or even higher, for autologous blood transfusions, see Paragraph [0008]) and/or the red blood cell rich fraction comprises at least 60% of the red blood cells of the amount of blood.
Brown and Nierich are analogous art because both disclose a blood filtering device for treating blood in transfusions.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the separator device of Brown and further include separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction and a red blood cell poor fraction, wherein the red blood cell rich fraction has a hematocrit of at least 30%, as taught by Nierich. Nierich teaches in severely weaken patients to have a purified blood with a high haematocrit value for transfusion to enhance recovery of the patient and reduce morbidity and mortality (see Paragraph [0008]).
Regarding Claim 14, Brown and Nierich teach all of the limitations of claim 11 and Nierich further teaches obtaining blood from a donor that is recovering has recovered from an affliction for obtaining in the filtrate high levels of antibodies (a method for the recuperation of blood from wound drained blood, i.e., a patient has undergone an operation, specific wounds, e.g. thorax wounds after cardiac operations, in particular for an autologous blood transfusion, see Paragraph [0001]-[0002]).
Regarding Claim 15, Brown teaches a blood product for transfusion into a human recipient (processing of a blood product, see Abstract), comprises about 40-300 thousand platelets per microliter (normal platelet count range: Between 150,000 and 400,000 platelets per microliter, as evidence by my.clevelandclinic.org).
However, Brown does not explicitly disclose wherein the blood product has a haematocrit of at least 30% and wherein the blood product consists essentially of blood components of a single donor individual.
Nierich teaches a blood filtering device (1) for the recuperation of blood from wound drained blood (see Abstract), wherein the blood product has a haematocrit of at least 30% (reliable filtering device which may yield purified blood with a high haematocrit value, e.g. 70 % or even higher, for autologous blood transfusions, see Paragraph [0008]) and wherein the blood product consists essentially of blood components of a single donor individual (for autologous blood transfusions, see Paragraph [0008]).
Brown and Nierich are analogous art because both disclose a blood filtering device for treating blood in transfusions.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the blood product of Brown and further include wherein the blood product has a haematocrit of at least 30% and wherein the blood product consists essentially of blood components of a single donor individual, as taught by Nierich. Nierich teaches in severely weaken patients to have a purified blood with a high haematocrit value for transfusion to enhance recovery of the patient and reduce morbidity and mortality (see Paragraph [0008]).
Regarding Claim 19, Brown and Nierich teach all of the limitations of claim 11 and Brown further teaches the red blood cell rich fraction comprises at least 75% of the red blood cells of the amount of blood (the remaining blood components, primarily red blood cells, platelets and white cells, see Paragraph [0019]; it is to be understood that the plasma separated from the blood component does not contain red blood cells while the remaining blood components primarily contain all of the red blood cells);
the red blood cell rich fraction comprises about 70-400 thousand of the platelets per microliter (normal platelet count range: Between 150,000 and 400,000 platelets per microliter, as evidence by my.clevelandclinic.org); and
the red blood cell rich fraction comprises at least 50% of the platelets of the amount of blood (the remaining blood components, primarily red blood cells, platelets and white cells, see Paragraph [0019]; it is to be understood that the plasma separated from the blood component does not contain platelets while the remaining blood components primarily contain all of the platelets cells).
However, Brown and Nierich do not explicitly disclose wherein the haematocrit is in a range of 30%-60%.
Nierich teaches it is capable of providing a purified blood with a high haematocrit value for autotransfusion. As described in Paragraph [0008], the haematocrit value can be 70% as such the percentage of haematocrit is disclosed to be a result effective variable in that changing the percentage of the haematocrit changes the ability to provide healthy red blood cells which affects the recovery of the patient in regards to the ability to reduce morbidity and mortality. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range, as it involves adjusting haematocrit ranges disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Nierich by providing a blood product being capable of having haematocrit value in a range of 30-60% since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 20, Brown and Nierich teach all of the limitations of claim 15 and Brown further teaches the blood product contains about 70-150 thousand of the platelets per microliter (normal platelet count range: Between 150,000 and 400,000 platelets per microliter, as evidence by my.clevelandclinic.org).
However, Brown and Nierich do not explicitly disclose where the haematocrit is in a range of 30-60%.
Nierich teaches it is capable of providing a purified blood with a high haematocrit value for autotransfusion. As described in Paragraph [0008], the haematocrit value can be 70% as such the percentage of haematocrit is disclosed to be a result effective variable in that changing the percentage of the haematocrit changes the ability to provide healthy red blood cells which affects the recovery of the patient in regards to the ability to reduce morbidity and mortality. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range, as it involves adjusting haematocrit ranges disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Nierich by providing a blood product being capable of having haematocrit value in a range of 30-60% since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 22, Brown teaches a method of recovering blood components from blood (automated processing of a blood product via separator 108, see Abstract; Figure 3), comprising separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction (blood can be separated from plasma through the separator and the remaining blood components, primarily red blood cells, platelets and white cells, move to the exit region between the spinner and the shell and may be returned to the donor or collected for further processing, see Paragraph [0019]; in one embodiment, the retentate may be concentrated red blood cells, see Paragraph [0036]) and a red blood cell poor fraction (a filtrate collection container 112 in fluid communication with filtrate flow path for receiving filtrate separated by the separator 108, see Paragraph [0041]); and
the red blood cell rich fraction comprises at least 25% of the platelets based on the amount of blood (percentage of activated platelets within the range of 30 to 45%, and the platelets collected in the retentate container, see Claim 7).
However, Brown does not explicitly disclose wherein the red blood cell rich fraction has a hematocrit of at least 30% and/or the red blood cell rich fraction comprises at least 60% of the red blood cells of the amount of blood.
Nierich teaches a blood filtering device (1) for the recuperation of blood from wound drained blood (see Abstract), comprising separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction and a red blood cell poor fraction (this blood which preferably is as rich as possible in healthy red blood cells or erythrocytes, must be filtered out of the drained blood and freed or washed from impurities and/or contaminants before reinfusion, see Paragraph [0003]; the residue of the second filter 8 is collected at the exit port 6 and the filtrate is received in the reservoir 10 and is considered a waste product of the process, see Paragraph [0035]), wherein the red blood cell rich fraction has a haematocrit of at least 30% (reliable filtering device which may yield purified blood with a high haematocrit value, e.g. 70 % or even higher, for autologous blood transfusions, see Paragraph [0008]) and/or the red blood cell rich fraction comprises at least 60% of the red blood cells of the amount of blood.
Brown and Nierich are analogous art because both disclose a blood filtering device for treating blood in transfusions.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the separator device of Brown and further include separating an amount of blood comprising red blood cells and platelets into a red blood cell rich fraction and a red blood cell poor fraction, wherein the red blood cell rich fraction has a hematocrit of at least 30%, as taught by Nierich. Nierich teaches in severely weaken patients to have a purified blood with a high haematocrit value for transfusion to enhance recovery of the patient and reduce morbidity and mortality (see Paragraph [0008]).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Brown and Nierich, as applied in claim 22 above, and in further view of Kusters (US 20150060363 A1).
Regarding Claim 23, Brown and Nierich teaches all of the limitations as discussed above in claim 22. However, Brown and Nierich does not explicitly disclose filtering a portion of the filtrate and providing a platelet rich fraction.
Kusters teaches a cell filter (a unitary two stage spinning membrane separator 180, see Figure 5) comprising: (a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma, see Abstract), wherein the cell filter comprises a first filter (first stage filter membranes 188) and a second filter (second stage filter membrane 184) for filtering a portion of the filtrate of the cell filter.
Brown, Neirich, and Kusters are analogous art because both teaches a cell filter for filter blood components.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the cell filter of Modified Brown and further include a second stage for further separating platelet rich plasma from plasma, as taught by Kusters. Kusters teaches the cell filter kit and method described above allows processing times to be reduced from an average of 15-25 minutes to 5 minutes or less. Further, because a closed system is provided, the platelet-rich plasma may be injected directly into the patient, thus decreasing the likelihood of contamination (see Paragraph [0045]).
Response to Arguments
Applicant’s arguments, see pg. 1, filed 08/21/2025, with respect to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see pg. 1-2, filed 08/21/2025, with respect to objection have been fully considered and are persuasive. The objections of claims 4-5, 10, 12, and 14 have been withdrawn.
Applicant’s arguments, see pg. 2, filed 08/21/2025, with respect to the 112(b) rejections have been fully considered and are persuasive. The 112(b) rejections of claims 1,9-10, 13, and 18 have been withdrawn.
Applicant's arguments filed 08/21/2025 have been fully considered but they are not persuasive.
Specifically Applicant argues in claim 1 that the pore range (2.2 -2.7 micrometers) is not obvious and that Yoshida only discloses relatively smaller pore sizes compared to the larger pore sizes required by applicants invention.
The examiner respectfully disagrees with the applicant that it would not be obvious to have larger pore size in the device of Yoshida. While Yoshida does not explicitly disclose the specific range of 2.2-2.7 micrometers, it discloses a micro pore size of 2 microns (see Col. 10 ln 17-21). There is also no mention of a maximum pore size. Prior art like Ameer et al. (US 6099730 A) teaches that pore sizes that go above 2 micrometers, between 0.2 and 3 micrometers, retain red blood cells. A skilled person would have not required inventive skills to use a filter with a pore size of 2.2 micrometers because its value is very close to 2 micrometers, which appears to be widely used pore size. Therefore, Claim 1 would still remain rejected in view of Yoshida.
Specifically Applicant argues in claim 1 that the permeation of the plasma is enable by creating a vortex by rotating the membrane and the claimed apparatus not employ any moving parts.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how the blood filtering apparatus does not employ moving parts) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Specifically Applicant argues in claims 6-9 that Brown and Kusters employ a system with spinning membranes, i.e. moving parts, which are based on totally different systems and purposes than the presently claimed device which does not have any moving components.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how the blood filtering apparatus does not employ moving parts) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Specifically Applicant argues in claim 11 that Nierich is directed to a blood separation deice that does not employ moving parts compared to Brown. The applicant further states that the moving components would cause damage to the red blood cells and platelets and cannot be considered analogous art to the system of Neirich.
In response to applicant's argument that Yoshida, Brown, and Kusters are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Brown is analogous art because it is reasonably pertinent to the particular problem with which the inventor was concerned. They all solve the problem of processing whole blood to produce blood products i.e. platelet rich plasma. Therefore, Claim 11 would still be rejected in view of Brown and Nierich. The prior art of Yoshida and Kusters would be analogous art for the same reasons.
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (12/18/2025)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781