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 .
Response to Amendment
The amendments filed on 11/06/2025 has been entered. Claim 65 has been amended; claims 1-29, 31, 33, 35-44, and 61 have been cancelled; claims 66-69 have been added. Accordingly, claims 30, 32, 34, 45-60, and 62-69 are pending and under consideration.
Applicant's amendments to the claims have overcome each and every 35. U.S.C. 112(b) rejection previously set forth in the Non-final Office action mailed on 08/08/2025. Therefore, all 35 U.S.C. 112(b) rejections are hereby withdrawn.
Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating the criticality of compartment C and its arrangement on page 11-12 of Applicant’s remarks, Examiner acknowledged Applicant’s remarks, but respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the third compartment 36 of Freedman already provides mass exchange by convection, diffusion, which is well-known by one of ordinary skill in the art to operate under pressure gradient, and recirculation of the physiological fluid within compartment 36 (Col. 5, line 24-36 of Freedman). Therefore, a mere rearrangement of the compartments within the device is within the ambit of a skilled artisan; thus, the rejection is maintained. See rejection of claims below.
Regarding Applicant’s remarks stating that “Thus, the device of Jauregui serves as a hepatocyte reactor and Jauregui refers to a "device for growing and maintaining hepatocytes." On the other hand, Freedman explains that its chamber 36 is "designed to hold the physiological solution" or dialysate and provides examples of such physiological solutions, "such as 6 percent dextran in saline, or a fluid which can be tolerated in small amounts, such as soybean oil, flurocarbons, and silicon fluids." Freedman, col. 6, lines 59-60 and col. 5, lines 10-20. Replacing Freedman's chamber 36 with Jauregui's hepatocyte compartment 27 or vice versa renders each reference unsatisfactory for its intended purpose” on page 12 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Jauregui was not relied on for any modification including the hepatocytes attached on the surfaces of fibers 14. Rather, Jauregui was relied on for the positional aspect of the compartments, as it creates barriers between the compartments and accommodates more volume (as established previously and below). See rejection of claims below.
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.
Claims 30, 45-48, 52-54, and 62-69 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. US 3,682,172 A (previously cited, hereinafter Freedman) in view of Jauregui US 5,043,260 A (previously cited, hereinafter Jauregui).
Regarding claim 30, Freedman discloses a method of treatment or prevention of a condition (Col. 1, line 4-6 – dialysis of organisms), wherein the condition is
(iii) kidney disease (Col. 1, line 27-29 – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically… kidney failure”);
said method comprising:
connecting a first subject 12 (Fig. 1 – normal organism 12) to a first port (2) 32 (Fig. 1-3 – cannula tube 32) and a second port (3) 27 (Fig. 1-3 – cannula tube 27) of the blood perfusion device 25 (Fig. 1 – parabiotic dialysis apparatus 25) and connecting a second subject 10 (Fig. 1 – diseased organism 10) to the third port (5) 16 (Fig. 1-3 – cannula tube 16) and the fourth port (6) 18 (Fig. 1-3 – cannula tube 18) of said blood perfusion device 25 (Fig. 1 – parabiotic dialysis apparatus 25); wherein the blood perfusion device 25 (Fig. 1) comprises a perfusion chamber (1) 24+30+36 (Fig. 1 – chamber 24, 30, 36) comprising at least one compartment A 30 (Fig. 1 – chamber 30) and at least one compartment B 24 (Fig. 1 – chamber 24),
compartment A (4) 30 (Fig. 3) comprising a first opening O1 (see annotated Fig. 3 below) which is in direct fluid communication to a second opening O2 (see annotated Fig. 3 below – opening O1 and O2 are fluid coupled), wherein the first opening O1 (see annotated Fig. 3 below) of compartment A 30 (Fig. 3) is in direct fluid communication to the first port (2) 27 (see annotated Fig. 3 below – tube 27 fluidly couples to the annotated opening O1 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3) and the second opening O2 (see annotated Fig. 3 below) of compartment A 30 (Fig. 3) is in direct fluid communication to the second port (3) 32 (see annotated Fig. 3 below – tube 32 fluidly couples to the annotated opening O2 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3);
compartment B (7) 24 (Fig. 1 and Fig. 3) comprising a first opening O11 (see annotated Fig. 3 below) which is in direct fluid communication to a second opening O22 (see annotated Fig. 3 below – opening O11 and O22 are fluid coupled), wherein the first opening O11 (see annotated Fig. 3 below) of compartment B 24 (Fig. 3) is in direct fluid communication to the third port (5) 18 (see annotated Fig. 3 below – tube 18 fluidly couples to the annotated opening O11 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3) and the second opening O22 (see annotated Fig. 3 below) of compartment B 24 (Fig. 3) is in direct fluid communication to the fourth port (6) 16 (see annotated Fig. 3 below – tube 16 fluidly couples to the annotated opening O22 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3); wherein compartment A 30 (Fig. 3) is separated from compartment B 24 (Fig. 3) by at least one membrane 44, 46 (Fig. 3 – membrane 44, 46),
a compartment C (15) 36 (Fig. 1-3 – third chamber 36), wherein the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3) comprises an additional fifth port (10) 38 (Fig. 3 – tube 38, right side) and an additional sixth port (11) 38 (Fig. 3 – tube 38, left side), wherein the fifth port 38 (Fig. 3) is in direct fluid communication to a first opening O111 (see annotated Fig. 3 below) of compartment C 36 (see annotated Fig. 3 below – tube 38 fluidly couples to the annotated opening O111 of chamber 36) and the sixth port 38 (Fig. 3) is in direct fluid communication to a second opening O222 (see annotated Fig. 3 below) of compartment C 36 (see annotated Fig. 3 below – tube 38 fluidly couples to the annotated opening O222 of chamber 36), wherein said ports 38, 38 (Fig. 3) are connected outside the perfusion chamber 24+30+36 (Fig. 1 – tubes 38 create a loop outside chamber 36) to a circulation system (12) 38 (Fig. 1 – tube 38 on both sides of chamber 36 are externally connected in respect to the blood perfusion chambers 24+30+36, forming an outside circulation) comprising a pump (13) 48 (Fig. 1 – pump 48) for adding recirculation flow through compartment C 36 (Fig. 1 and Fig. 3) of the perfusion chamber 24+30+36 (Fig. 1 and Col. 5, line 37-38 – “A conventional pump 48 is shown adjacent tube 38 which maintains the circulation within chamber 36”), and
(b) allowing the blood of the first subject 12 (Fig. 1) to enter into compartment A (4) 30 (Fig. 1 and Col. 2, line 41-47– chambers are introduced with blood of human; Fig. 1 shows arrows indicating blood circulation in compartments 30) of the perfusion chamber 24+30+36 (Fig. 1 – chamber 24, 30, 36) and allowing the blood of the second subject 10 (Fig. 1) to enter into compartment B (7) 24 (Fig. 1 and Col. 2, line 41-47 – chambers are introduced with blood of human; Fig. 1 shows arrows indicating blood circulation in compartments 24) of the perfusion chamber 24+30+36 (Fig. 1 – chamber 24, 30, 36),
wherein said treatment comprises mass exchange of the first subject 12 and the second subject 10 (Fig. 1 and Col. 1 – line 62-67 and Col. 2, line 1 – “…blood from the diseased organism circulating through one chamber and blood from the normal organism circulating in the other chamber with exchange taking place across two substantially contiguous membrane…”), wherein the first subject 12 is a healthy subject (Col. 4, line 12-13 – normal organism 12) and the second subject 10 is in need of treatment (Col. 4, line 12-13 – diseased organism 10) of said condition (Col. 2, line 42-43 – “treatment of kidney failure…”).
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Annotated Fig. 3 of Freedman
However, Freedman does not disclose said membrane being configured to prevent cells from crossing the membrane and being permeable for proteins, wherein said membrane is a hollow fiber membrane system, wherein compartment A is inside a first hollow fiber membrane system that connects the first port (2) and the second port (3) and compartment B is inside a second hollow fiber membrane system that connects the third port (5) and the fourth port (6), wherein compartment A and compartment B are within a compartment C (15); wherein said treatment comprises mass exchange between blood plasma.
Jauregui, in the same field of endeavor of perfusion device (Title), teaches said membrane 14 (Fig. 4 and Fig. 5 – hollow semipermeable membrane fibers 14) being configured to prevent cells from crossing the membrane (Col. 4, line 33-34 – “maintain the cells, providing them with nutrients and oxygen”) and being permeable for proteins (Col. 4, line 48-49 – “blood component separation, e.g., plasma exchange”; Examiner also contends that semipermeable membrane also indicates a size selective system),
wherein said membrane 14 (Fig. 4) is a hollow fiber membrane system (Fig. 4, and Col. 2 line 40-41 – “a plurality of hollow semipermeable membrane fibers 14”), wherein compartment A 14’ (Fig. 5 – hollow fibers 14’) is inside a first hollow fiber membrane system 14’ (Fig. 4-5 – hollow fibers 14’ are exclusive to hollow fibers 14” since the material of hollow fiber 14’ enters and exits solely through ports 40) that connects the first port (2) 40 (Fig. 4 – port 40, left side) and the second port (3) 40 (Fig. 4 – port 40, right side) and compartment B 14” (Fig. 4-5 – hollow fibers 14”) is inside a second hollow fiber membrane system 14” (Fig. 4-5 hollow fibers 14” are exclusive to hollow fibers 14’ since the material of hollow fiber 14“ enters and exits solely through ports 42) that connects the third port (5) 42 (Fig. 4 – port 42, left side) and the fourth port (6) 42 (Fig. 4 – port 42, right side),
wherein compartment A 14’ and compartment B 14” are within a compartment C (15) (see annotated Fig. 4 below, and Col. 3, line 19-20 – “A further compartment is provided by the region inside of shell 12 and outside of fibers 14', 14"”);
wherein said treatment comprises mass exchange between blood plasma (Col. 4, line 46-49 – “The tubing set could also include connections for further extracorporeal blood treatment, e.g., dialysis or a procedure involving blood component separation, e.g., plasma exchange”).
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Annotated Fig. 4 of Jauregui
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman to use hollow fiber as the membrane, thereby forming compartments within said hollow fiber, as taught by Jauregui, since hollow fibers are well-known in the art (Col. 3, line 36-38 of Jauregui) for isolating cells from the patient’s immune defense system and have desired pore sizes so as to permit transfer of substances (Col. 1, line 24-27 of Jauregui).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of compartment C to so it was encompassing compartment A and B, as taught by Jauregu, in order to create a barrier between the insides of the hollow fibers (Col. 2, line 51-55 of Jauregui). One of ordinary skill in the art would have also appreciated the larger volume of compartment C so that more filtered substances are contained and recirculated for a mass exchange treatment. Additionally, since this claimed position of the compartment C does not change its ability to provide an intermediate region between two compartments and recirculate fluidic substances in a treatment. Since applicant has not given any criticality to why the position of the compartments disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Once the modification is made as discussed, compartment A 30 of Freedman will become the hollow fiber 14’ of Jauregui, more specifically the lumen of the fibers 14’; likewise, compartment B 24 of Freedman will become the lumen of hollow fibers 14” of Jauregui. Both compartments are within compartment C as taught by Jauregui which is the space between device and the exterior surfaces of hollow fibers 14.
Regarding claim 45, Freedman discloses a method of treatment or prevention of a condition (Col. 1, line 4-6 – dialysis of organisms) wherein the condition is
(iii) kidney disease (Col. 1, line 27-29 – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically… kidney failure”);
using a blood perfusion device 25 (Fig. 1 and Col. 2, line 35 – parabiotic dialysis apparatus 25) comprising a circulation system 38 (Fig. 1 – tube 38 on both sides of chamber 36 are externally connected in respect to the blood perfusion chambers 24+30+36, forming an outside circulation) and a perfusion chamber (1) 24+30+36 (Fig. 1 – chamber 24, 30, 36) comprising at least one compartment A 30 (Fig. 1-3 – second chamber 30) and at least one compartment B 24 (Fig. 1-3 – first chamber 24) and at least one compartment C 36 (Fig. 1-3 – third chamber 36),
(a) compartment A (4) 30 (Fig. 1-3) comprising a first opening O1 (see annotated Fig. 3 above) which is in direct fluid communication to a second opening O2 (see annotated Fig. 3 above – opening O1 and O2 are fluid coupled), wherein the first opening O1 (see annotated Fig. 3 above) of compartment A 30 (Fig. 3) is in direct fluid communication to a first port (2) 27 (see annotated Fig. 3 above – tube 27 fluidly couples to the annotated opening O1 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1) and the second opening O2 (see annotated Fig. 3 above) of compartment A 30 (Fig. 3) is in direct fluid communication to a second port (3) 32 (see annotated Fig. 3 below – tube 32 fluidly couples to the annotated opening O2 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1); and
(b) compartment B (7) 24 (Fig. 1-3) comprising a first opening O11 (see annotated Fig. 3 above) which is in direct fluid communication to a second opening O22 (see annotated Fig. 3 above – opening O11 and O22 are fluid coupled), wherein the first opening O11 (see annotated Fig. 3 above) of compartment B 24 (Fig. 3) is in direct fluid communication to a third port (5) 18 (see annotated Fig. 3 above – tube 18 fluidly couples to the annotated opening O11 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1) and the second opening O22 (see annotated Fig. 3 above) of compartment B 24 (Fig. 3) is in direct fluid communication to a fourth port (6) 16 (see annotated Fig. 3 below – tube 16 fluidly couples to the annotated opening O22 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1);
wherein compartment A 30 (Fig. 1-3) is separated from compartment B 24 (Fig. 1-3) by at least one membrane 44, 46 (Fig. 2-3 – two membrane 44, 46),
wherein compartment C 36 (Fig. 3) of the perfusion chamber 24+30+36 (Fig. 1) is in direct fluid communication to the circulation system (12) 38 (Fig. 1 – tubes 38 create a loop outside chamber 36 and fluidly connects with chamber 36), wherein the circulation system (12) 38 (Fig. 1) comprises a pump (13) 48 (Fig. 1 – pump 48) for adding recirculation flow through compartment C 36 (Fig. 1 and Fig. 3) of the perfusion chamber 24+30+36 (Fig. 1 and Col. 5, line 37-38 – “A conventional pump 48 is shown adjacent tube 38 which maintains the circulation within chamber 36”),
said method (Col. 1, line 4-6) comprising
i. connecting a first subject 12 (Fig. 1 – normal organism 12) to the first port (2) 27 (Fig. 1-3) and the second port (3) 32 (Fig. 1-3) of the blood perfusion device 25 (Fig. 1) and connecting a second subject 10 (Fig. 1 – diseased organism 10) to the third port (5) 18 (Fig. 1-3) and the fourth port (6) 16 (Fig. 1-3) of said blood perfusion device 25 (Fig. 1); and
ii. allowing the blood of the first subject 12 (Fig. 1) to enter into compartment A (4) 30 (Fig. 1 and Col. 2, line 41-47 – chambers are introduced with blood of human; Fig. 1 shows arrows indicating blood circulation in compartments 30) of the perfusion chamber 24+30+36 (Fig. 1) and allowing the blood of the second subject 10 (Fig. 1) to enter into compartment B (7) 24 (Fig. 1 and Col. 2, line 41-47 – chambers are introduced with blood of human; Fig. 1 shows arrows indicating blood circulation in compartments 24) of the perfusion chamber 24+30+36 (Fig. 1),
wherein said treatment comprises mass exchange between the first subject 12 and the second subject 10 (Fig. 1 and Col. 1 – line 62-67 and Col. 2, line 1 – “…blood from the diseased organism circulating through one chamber and blood from the normal organism circulating in the other chamber with exchange taking place across two substantially contiguous membrane…”), wherein the first subject 12 is a healthy subject (Col. 4, line 12-13 – normal organism 12) and the second subject 10 is in need of treatment (Col. 4, line 12-13 – diseased organism 10) of said condition (Col. 2, line 42-43 – “treatment of kidney failure…”).
However, Freedman does not explicitly disclose said membrane being configured to prevent cells from crossing the membrane, wherein said membrane is a hollow fiber membrane system, wherein compartment A (4) and compartment B (7) are within compartment C (15), wherein said treatment comprises mass exchange between blood plasma.
Jauregui, in the same field of endeavor of perfusion device (Title), teaches said membrane 14 (Fig. 4 and Fig. 5 – hollow semipermeable membrane fibers 14) being configured to prevent cells from crossing the membrane (Col. 4, line 33-34 – “maintain the cells, providing them with nutrients and oxygen”), wherein said membrane 14 (Fig. 4) is a hollow fiber membrane system (Fig. 4, and Col. 2 line 40-41 – “a plurality of hollow semipermeable membrane fibers 14”), wherein compartment A (4) 14’ (Fig. 5 – hollow fibers 14’) and compartment B (7) 14” (Fig. 4-5 – hollow fibers 14”) are within compartment C (15) (see annotated Fig. 4 above, and Col. 3, line 19-20 – “A further compartment is provided by the region inside of shell 12 and outside of fibers 14', 14"”), wherein said treatment comprises mass exchange between blood plasma (Col. 4, line 46-49 – “The tubing set could also include connections for further extracorporeal blood treatment, e.g., dialysis or a procedure involving blood component separation, e.g., plasma exchange”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman to use hollow fiber as the membrane, thereby forming compartments within said hollow fiber, as taught by Jauregui, since hollow fibers are well-known in the art (Col. 3, line 36-38 of Jauregui) for isolating cells from the patient’s immune defense system and have desired pore sizes so as to permit transfer of substances (Col. 1, line 24-27 of Jauregui).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of compartment C to so it was encompassing compartment A and B, as taught by Jauregui, in order to create a barrier between the insides of the hollow fibers (Col. 2, line 51-55 of Jauregui). One of ordinary skill in the art would have also appreciated the larger volume of compartment C so that more filtered substances are contained and recirculated for a mass exchange treatment. Additionally, since this claimed position of the compartment C does not change its ability to provide an intermediate region between two compartments and recirculate fluidic substances in a treatment. Since applicant has not given any criticality to why the position of the compartments disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Once the modification is made as discussed, compartment A 30 of Freedman will become the hollow fiber 14’ of Jauregui, more specifically the lumen of the fibers 14’; likewise, compartment B 24 of Freedman will become the lumen of hollow fibers 14” of Jauregui. Both compartments are within compartment C as taught by Jauregui which is the space between device and the exterior surfaces of hollow fibers 14.
Regarding claim 46, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the circulation system (12) 38 (Fig. 1 of Freedman) comprises a detector 50 (Fig. 1 of Freedman – blood leak detector 50).
Regarding claim 47, Freedman in view of Jauregui discloses the invention of claim 46. Freedman in view of Jauregui further discloses wherein the detector 50 (Fig. 1 of Freedman) is for blood cells (Col. 6, line 3 of Freedman – “blood leak detector 50”; thus indicating monitoring of blood cells).
Regarding claim 48, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the membrane 14 (Fig. 4 of Jauregui) is semipermeable (Col. 2 line 40-41 – “a plurality of hollow semipermeable membrane fibers 14”).
Examiner notes that once the modification is made as discussed in claim 30, the hollow fiber of Jauregui will be incorporated entirely into the method of Freedman, including the semipermeability. Therefore, the limitation is met.
Regarding claim 52, Freedman in view of Jauregui discloses the invention of claim 30. However, Freedman in view of Jauregui does not disclose wherein the blood perfusion device is configured to allow a flow through compartment A which is counter-directional to the flow through compartment B.
Jauregui, in the same field of perfusion device (Title) and in another embodiment, teaches wherein the blood perfusion device is configured to allow a flow through compartment A which is counter-directional to the flow through compartment B (Col. 3, line 13-15 – “While concurrent flow is indicated in FIG. 4, counter-current flow can be used and may be preferred”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman in view of Jauregui to have the flows in compartment A and B to be counter-directional, as taught by Jauregui, as Jauregui teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 53, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the blood perfusion device 25 (Fig. 1 of Freedman) is configured so that the first opening O1 (see annotated Fig. 3 of Freedman above) of compartment A 14’ (Freedman’s compartment A with modified hollow-fiber membranes 14’ of Fig. 4-5 of Jauregui) which is in direct fluid communication to the first port (2) 27 (Fig. 3 of Freedman) is an inlet 27 of compartment A 14’ (Fig. 1 of Freedman – arrow shows that tube 27 introduces flow into the compartment) and the second opening O2 (see annotated Fig. 3 of Freedman above) of compartment A 14’ (Freedman’s compartment A with modified hollow-fiber membranes 14’ of Fig. 4-5 of Jauregui) which is in direct fluid communication to the second port (3) 32 (Fig. 3 of Freedman) is an outlet 32 of compartment A 14’ (Fig. 1 of Freedman – arrow shows that tube 32 removes flow out of the compartment), and
the first opening O11 (see annotated Fig. 3 of Freedman above) of compartment B 14” (Freedman’s compartment B with modified hollow-fiber membranes 14” of Fig. 4-5 of Jauregui) which is in direct fluid communication to the third port (5) 18 (Fig. 3 of Freedman) is an inlet 18 of compartment B 14” (Fig. 1 of Freedman – arrow shows that tube 18 introduces flow into the compartment) and the second opening O22 (see annotated Fig. 3 of Freedman above) of compartment B 14” (Freedman’s compartment B with modified hollow-fiber membranes 14” of Fig. 4-5 of Jauregui) which is in direct fluid communication to the fourth port (6) 16 (Fig. 3 of Freedman) is an outlet 16 of compartment B 14” (Fig. 1 of Freedman – arrow shows that tube 16 removes flow out of the compartment).
Examiner notes that once the modification is made as discussed in claim 30, the ports of each corresponding compartments of Jauregui will be incorporated entirely into the method of Freedman. Thus, the limitation is met.
Regarding claim 54, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the blood perfusion device 25 (Fig. 1 of Freedman) is configured so that the first opening O1 (see annotated Fig. 3 of Freedman above) of compartment A 14’ (Freedman’s compartment A with modified hollow-fiber membranes 14’ of Fig. 4-5 of Jauregui) which is in direct fluid communication to the first port (2) 27 (Fig. 3 of Freedman) is an inlet 27 of compartment A 14’ (Fig. 1 of Freedman – arrow shows that tube 27 introduces flow into the compartment) and the second opening O2 (see annotated Fig. 3 of Freedman above) of compartment A 14’ (Freedman’s compartment A with modified hollow-fiber membranes 14’ of Fig. 4-5 of Jauregui) which is in direct fluid communication to the second port (3) 32 (Fig. 3 of Freedman) is an outlet 32 of compartment A 14’ (Fig. 1 of Freedman – arrow shows that tube 32 removes flow out of the compartment).
However, Freedman in view of Jauregui does not disclose the first opening of compartment B which is in direct fluid communication to the third port (5) is an outlet of compartment B and the second opening of compartment B which is in direct fluid communication to the fourth port (6) is an inlet of compartment B.
Examiner notes that the device of Freedman in view of Jauregui currently has the first opening of compartment B being an inlet and the second opening of compartment B being an outlet, which is the opposite configuration of the claimed limitation.
While Freedman in view of Jauregui does not currently disclose the limitation above, Jauregui does disclose in Col. 3, line 13-15 that “While concurrent flow is indicated in FIG. 4, counter-current flow can be used and may be preferred”. With that teaching, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intended use of the first opening O11 (see annotated Fig. 3 of Freedman above) of compartment B 14” (Fig. 4 of Jauregui) which is in direct fluid communication to the third port 18 (Fig. 1-3 of Freedman) to be an outlet of compartment B 14” (Fig. 4 of Jauregui), instead of an inlet. Similarly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intended use of the second opening O22 (see annotated Fig. 3 of Freedman above) of compartment B 14” (Fig. 4 of Jauregui) which is in direct fluid communication to the fourth port 16 (Fig. 1-3 of Freedman) to be an inlet of compartment B 14” (Fig. 4 of Jauregui), instead of an outlet. One of ordinary skill in the art would have been motivated to make such modification because the flow direction of two types of fluids does not change the mass exchange function of the combined device. Also, since all the claimed elements were taught in the same prior art of Jauregui, one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143.A.
Regarding claim 62, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the second subject has multi-organ failure (Col. 1, line 27-29 of Freedman – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically liver…”and Col. 9, line 18 of Freedman – “a human 10 with a kidney disease”; thus, the method is fully capable of treating patient with two organ failures).
Regarding claim 63, Freedman discloses a blood perfusion device 25 (Fig. 1 – parabiotic dialysis apparatus 25) comprising a circulation system 38 (Fig. 1 – tube 38 on both sides of chamber 36 are externally connected in respect to the blood perfusion chambers 24+30+36, forming an outside circulation) and a perfusion chamber (1) 24+30+36 (Fig. 1 – chamber 24, 30, 36) comprising at least one compartment A 30 (Fig. 1-3 – second chamber 30) and at least one compartment B 24 (Fig. 1-3 – first chamber 24) and at least one compartment C 36 (Fig. 1-3 – third chamber 36),
(a) compartment A (4) 30 (Fig. 1-3) comprising a first opening O1 (see annotated Fig. 3 above) which is in direct fluid communication to a second opening O2 (see annotated Fig. 3 above – opening O1 and O2 are fluid coupled), wherein the first opening O1 (see annotated Fig. 3 above) of compartment A 30 (Fig. 3) is in direct fluid communication to a first port (2) 27 (see annotated Fig. 3 above – tube 27 fluidly couples to the annotated opening O1 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1) and the second opening O2 (see annotated Fig. 3 above) of compartment A 30 (Fig. 3) is in direct fluid communication to a second port (3) 32 (see annotated Fig. 3 below – tube 32 fluidly couples to the annotated opening O2 of chamber 30) of the perfusion chamber 24+30+36 (Fig. 1); and
(b) compartment B (7) 24 (Fig. 1-3) comprising a first opening O11 (see annotated Fig. 3 above) which is in direct fluid communication to a second opening O22 (see annotated Fig. 3 above – opening O11 and O22 are fluid coupled), wherein the first opening O11 (see annotated Fig. 3 above) of compartment B 24 (Fig. 1-3) is in direct fluid communication to a third port (5) 18 (see annotated Fig. 3 above – tube 18 fluidly couples to the annotated opening O11 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1) and the second opening O22 (see annotated Fig. 3 above) of compartment B 24 (Fig. 1-3) is in direct fluid communication to a fourth port (6) 16 (see annotated Fig. 3 below – tube 16 fluidly couples to the annotated opening O22 of chamber 24) of the perfusion chamber 24+30+36 (Fig. 1);
wherein compartment A 30 (Fig. 1-3) is separated from compartment B 24 (Fig. 1-3) by a membrane system 44, 46 (Fig. 2-3 – two membrane 44, 46);
wherein compartment C 36 (Fig. 3) of the perfusion chamber 24+30+36 (Fig. 1) is in direct fluid communication to the circulation system (12) 38 (Fig. 1 – tubes 38 create a loop outside chamber 36 and fluidly connects with chamber 36);
wherein the circulation system (12) 38 (Fig. 1) comprises a pump (13) 48 (Fig. 1 – pump 48) for adding recirculation flow through compartment C 36 (Fig. 1 and Fig. 3) of the perfusion chamber 24+30+36 (Fig. 1 and Col. 5, line 37-38 – “A conventional pump 48 is shown adjacent tube 38 which maintains the circulation within chamber 36”).
However, Freedman does not disclose wherein compartment A is separated from compartment B by a hollow fiber membrane system; wherein compartment A (4) and compartment B (7) are within compartment C (15).
Jauregui, in the same field of endeavor of perfusion device (Title), teaches wherein compartment A 14’ (Fig. 5 – hollow fibers 14’) is separated from compartment B 14” (Fig. 4-5 – hollow fibers 14”) by a hollow fiber membrane system (Fig. 4, and Col. 2 line 40-41 – “a plurality of hollow semipermeable membrane fibers 14”); wherein compartment A (4) 14’ (Fig. 5) and compartment B (7) 14” (Fig. 5) are within compartment C (15) (see annotated Fig. 4 above, and Col. 3, line 19-20 – “A further compartment is provided by the region inside of shell 12 and outside of fibers 14', 14"”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Freedman to use hollow fiber as the membrane, thereby forming compartments within said hollow fiber, as taught by Jauregui, since hollow fibers are well-known in the art (Col. 3, line 36-38 of Jauregui) for isolating cells from the patient’s immune defense system and have desired pore sizes so as to permit transfer of substances (Col. 1, line 24-27 of Jauregui).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of compartment C to so it was encompassing compartment A and B, as taught by Jauregui, in order to create a barrier between the insides of the hollow fibers (Col. 2, line 51-55 of Jauregui). One of ordinary skill in the art would have also appreciated the larger volume of compartment C so that more filtered substances are contained and recirculated for a mass exchange treatment. Additionally, since this claimed position of the compartment C does not change its ability to provide an intermediate region between two compartments and recirculate fluidic substances in a treatment. Since applicant has not given any criticality to why the position of the compartments disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Once the modification is made as discussed, compartment A 30 of Freedman will become the hollow fiber 14’ of Jauregui, more specifically the lumen of the fibers 14’; likewise, compartment B 24 of Freedman will become the lumen of hollow fibers 14” of Jauregui. Both compartments are within compartment C as taught by Jauregui which is the space between device and the exterior surfaces of hollow fibers 14.
Regarding claim 64, Freedman in view of Jauregui discloses the invention of claim 63. Freedman in view of Jauregui further discloses wherein compartment A 14’ (Fig. 5 of Jauregui – hollow fibers 14’) is inside a first hollow fiber membrane system 14’ (Fig. 4-5 of Jauregui – hollow fibers 14’ are exclusive to hollow fibers 14” since the material of hollow fiber 14’ enters and exits solely through ports 40) that connects the first port (2) 27 (Fig. 3 of Freedman) and the second port (3) 32 (Fig. 3 of Freedman) and compartment B 14” (Fig. 4-5 of Jauregui – hollow fibers 14”) is inside a second hollow fiber membrane system 14” (Fig. 4-5 of Jauregui – hollow fibers 14” are exclusive to hollow fibers 14’ since the material of hollow fiber 14“ enters and exits solely through ports 42) that connects the third port (5) 18 (Fig. 3 of Freedman) and the fourth port (6) 16 (Fig. 3 of Freedman).
Examiner notes that once the modification is made as discussed in claim 63, compartment A 30 of Freedman will become the hollow fiber 14’ of Jauregui, more specifically the lumen of the fibers 14’; likewise, compartment B 24 of Freedman will become the lumen of hollow fibers 14” of Jauregui, with no respective change of the attaching ports. Thus, ports 27 and 32 that connects with compartment 30 of Freedman will continue to connects with the hollow fiber 14’ of Jauregui, and ports 18 and 16 with hollow fiber 14”, in a similar fashion seen in Fig. 4 of Jauregui. Thus, the limitation is met.
Regarding claim 65, Freedman in view of Jauregui discloses the invention of claim 64. Freedman in view of Jauregui further discloses wherein the perfusion chamber 24+30+36 (Fig. 1 and Fig. 3 of Freedman) comprises an additional fifth port (10) 38 (Fig. 3 of Freedman – tube 38, right side) and an additional sixth port (11) 38 (Fig. 3 of Freedman – tube 38, left side), wherein the fifth port 38 (Fig. 3 of Freedman) is in direct fluid communication to a first opening O111 (see annotated Fig. 3 of Freedman above) of compartment C 36 (see annotated Fig. 3 of Freedman above – tube 38 fluidly couples to the annotated opening O111 of chamber 36) and the sixth port 38 (Fig. 3 of Freedman) is in direct fluid communication to a second opening O222 (see annotated Fig. 3 of Freedman above) of compartment C 36 (see annotated Fig. 3 of Freedman above – tube 38 fluidly couples to the annotated opening O222 of chamber 36), wherein said fifth and sixth ports 38, 38 (Fig. 3 of Freedman) are connected outside the perfusion chamber 24+30+36 (Fig. 1 of Freedman – tubes 38 create a loop outside chamber 36) to the circulation system (12) 38 (Fig. 1 of Freedman – tube 38 on both sides of chamber 36 are externally connected in respect to the blood perfusion chambers 24+30+36, forming an outside circulation).
Regarding claim 66, Freedman in view of Jauregui discloses the invention of claim 63. Freedman in view of Jauregui further discloses wherein the recirculation flow through compartment C 36 (Fig. 3 of Freedman) facilitates mass exchange (Col. 5, line 24-35 of Freedman – “With the circulation of the physiological fluid within chamber 36 and the circulation of blood within chambers 24 and 30, waste materials in blood of the diseased human 10, for example, may transfer by convection to chamber 24, diffuse through membrane 44 held between chamber 24 and chamber 36 into the recirculating physilogical fluid within chamber 36, transfer by convection across chamber 36 to membrane 46 held between chamber 36 and chamber 30, diffuse through membrane 46, and then enter the blood of the human 12 flowing within chamber 30”) between compartment A 30 (Fig. 1-3 of Freedman) and compartment B 24 (Fig. 1-3 of Freedman).
Regarding claim 67, Freedman in view of Jauregui discloses the invention of claim 66. However, Freedman in view of Jauregui does not disclose wherein the blood perfusion device is configured to allow a flow through compartment A which is counter-directional to the flow through compartment B.
Jauregui, in the same field of perfusion device (Title) and in another embodiment, teaches wherein the blood perfusion device is configured to allow a flow through compartment A which is counter-directional to the flow through compartment B (Col. 3, line 13-15 – “While concurrent flow is indicated in FIG. 4, counter-current flow can be used and may be preferred”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman in view of Jauregui to have the flows in compartment A and B to be counter-directional, as taught by Jauregui, as Jauregui teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 68, Freedman in view of Jauregui discloses the invention of claim 63. Freedman in view of Jauregui further discloses further comprising a detector 50 (Fig. 1 of Freedman – blood leak detector) for detecting the presence of a cell (Col. 6, line 3 of Freedman – “blood leak detector 50”; thus indicating monitoring of blood cells) in compartment C 36 (Fig. 1-3 of Freedman).
Regarding claim 69, Freedman in view of Jauregui discloses the invention of claim 68. Freedman in view of Jauregui further discloses wherein the cell is a red blood cell (Col. 6, line 3 of Freedman – “blood leak detector 50”; thus indicating monitoring of blood cells).
Claims 32 and 34 are rejected under 35 U.S.C. 103 fas being unpatentable over Freedman in view of Jauregui as applied to claim 30 above, and further in view of Sakai et al. US 5,192,499 A (previously cited, hereinafter Sakai) and further evidenced by Olgam Life “The Role of Plasma in Kidney Function and Disease” (previously cited, hereinafter Olgam Life).
Regarding claim 32, Freedman in view of Jauregui discloses the invention of claim 30. Freedman in view of Jauregui further discloses wherein the first subject 12 (Fig. 1 of Freedman) is characterized by normal functions and normal plasma composition (Col. 4, line 12-13 of Freedman – normal organism 12) and the second subject 10 (Fig. 1 of Freedman) is characterized by at least one deficient function and a deficient blood plasma composition (Col. 1, line 28-29 and Col. 4, line 12-13 of Freedman – diseased organism 10 of kidney failure; further evidenced by Olgam Life, Plasma Imbalances and Kidney Diseases section – kidney dysfunction is associated with plasma level drops).
Examiner notes that once the combination is made as discussed in claim 30, the two subjects of Freedman and their blood will be introduced into perfusion chamber as taught by Jauregui. Thus, the limitation is met.
However, Freedman in view of Jauregui does not explicitly disclose normal lung function and deficient lung function.
Sakai, in the same field of endeavor of fluid processing apparatus for processing blood (Col. 1, line 6-11), teaches a method comprises a fluid processing apparatus 1 (Fig. 1) comprising hollow fibers 24 (Fig. 1) for material exchange (Col. 1, line 19-23). Sakai also discloses that this apparatus is considered to be applicable to be both an artificial kidney or artificial lung, as well as a plasma separator (Col. 6, first paragraph – “Although the fluid processing apparatus of the present invention has been described as being applied to a heat exchanger, it is also applicable to other artificial organ such as an artificial lung itself and an artificial kidney. Further, the fluid processing apparatus of the present invention is also applicable to a plasma separator”).
Examiner notes that it is recognized in the field that these artificial organ apparatuses can be used for equivalent functions of treating blood/removal of undesired blood components. In other words, one of ordinary skill in the art would have had the technological capability to realize that an artificial lung and artificial kidney can share the same base structure and function with the main difference being the characteristics of the hollow fiber membranes, as expressed in Col. 1, line 12-18 of Sakai – “…in an artificial organ such as an artificial lung, material-exchange fine tubes are provided. They are gas-exchange hollow fibers in an artificial lung or dialysis hollow fibers in an artificial kidney”. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman in view of Jauregui to not only provide treatment for kidney disease as established in claim 30, but also exchangeably provide treatment for lung disease as taught by Sakai, as it is well-known in the art of hollow fiber membrane blood treatment device to be applicable to both kidney and lung function (seen in Col. 6, first paragraph and Col. 1, line 12-18 of Sakai). See MPEP 2143.I.C
Furthermore, Examiner further notes that Freedman discloses in Col. 13, second to last paragraph, that “it will become immediately apparent to those skilled in the art that the parabiotic dialysis apparatus may be used for other applications such as an artificial placenta, an artificial intestine, or an adjunct to open heart surgery. Other applications of the parabiotic dialysis apparatus of the present invention may require modifications of the apparatus described above such as: membranes having larger or small pore sizes; membranes allowing transfer of blood substances having a specific range of molecular weight range such as by the insertion of multiple rather than single membranes; and, utilization of several parabiotic dialysis apparatus simultaneously, each having differing membrane permeabilities and thereby enabling a more selective membrane exchange across each parabiotic dialyzer”. Firstly, regarding the application of Freedman’s parabiotic dialysis apparatus in open heart surgery, one of ordinary skill in the art would have had the technological capability to comprehend that such said apparatus in open heart surgery is likely to be incorporated to continue the cardiopulmonary circulation as the heart is being operated; in other words, the parabiotic apparatus is implied to potentially perform as an artificial lung as the heart is currently interrupted in circulation system. Secondly, Freedman also discusses that it is known for modification of membrane sizes to accommodate the needs for each particular treatment. Therefore, Freedman established the foundational motivation for any modification of hollow fiber membrane size, such as the modification as taught by Sakai above, to create the desirable treatment function of the apparatus and the method, i.e. treatment of lung.
Once the modification is made as discussed above, the method of Freedman in view of Jauregui will be able to provide treatment or prevention of lung disease. Thus, the subjects involved in method will indeed be characterized such that “the first subject is characterized by normal lung function and the second subject is characterized by at least one deficient lung function”. Thus, the limitation is met.
Regarding claim 34, Freedman in view of Jauregui in view of Sakai discloses the invention of claim 32. The combination of Freedman, Jauregui, and Sakai the acute, acute on chronic, or chronic lung disease (Col. 3, line 2-3 of Sakai – “an artificial lung” implies a treatment for lung disease) is associated with one or more aberrant lung-related blood parameter (Col. 4, line 62-62 of Sakai – “The artificial lung 20… an assembly of gas-exchange hollow fibers 24”, which implies the need for treating gas in blood), wherein the parameter is selected from a group consisting of oxygen and carbon dioxide levels in the blood (Col. 6, line 24-27 of Sakai – “The blood comes into contact with the oxygen-containing gas through the hollow fibers 24 so that carbon dioxide is removed from and oxygen is added to the blood”; thus indicating that treatment is targeted to the level of oxygen and carbon dioxide in blood).
Once the modification is made as discussed in claim 32, the lung treating function of Sakai will be incorporated into the method of Freedman in view of Jauregui. Therefore, in a lung treatment function, the method of the combination will be directed to treating the oxygen and carbon dioxide level in the blood as taught by Sakai. Thus, the limitation is met.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Jauregui as applied to claim 30 above, and further in view of Russell et al. US 2019/0106545 A1 (previously cited, hereinafter Russell).
Regarding claim 49, Freedman in view of Jauregui discloses the invention of claim 30. However, Freedman in view of Jauregui does not disclose wherein the membrane has a molecular weight-cutoff of 10kDa-800kDa.
Russell, in the same field of endeavor of membranes having selective permeabilities used in medical field (Par. 3), teaches the membrane has a molecular weight-cutoff of 50kDa-150kDa (Par. 77).
Examiner notes that Par. 77 further elaborates that such molecular weight cut off can be fabricated for applications in hemodialysis.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of Freedman in view of Jauregui to have the molecular weight cutoff (MWCO) as taught by Russell, in order to provide a pore dimension range suitable for the purpose of dialysis treatment and blood purification (Par. 135 of Russell).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the MWCO of the combination of Freedman, Jauregui, and Russell from between 50kDa and 150kDa to between 10kDa and 800kDa, as applicant appears to have placed no criticality on the claimed range (Par. 71 of Applicant’s specification), and 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). In the instant case, the combined device would not operate differently with the claimed range, as the claimed range encompasses the working range taught by Russell. Therefore, one of ordinary skill in the art would have been motivated to modify the molecular weight cutoff of the combined device to selectively extract different desired particle types.
Claims 50 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Jauregui as applied to claim 30 above, and further in view of Bauermeister et al. US 6,271,023 B1 (previously cited, hereinafter Bauermeister).
Regarding claim 50, Freedman in view of Jauregui discloses the invention of claim 30. However, Freedman in view of Jauregui does not disclose wherein the membrane comprises a material selected from the group consisting of polysulfone, polyethersulfone, polypropylene, polyamide, and cellulose.
Bauermeister, in the same field of endeavor of hollow-fiber module (Title), teaches wherein the membrane comprises a material selected from the group consisting of polysulfone, polyethersulfone, polyamide, and cellulose (Col. 12, line 30-49 – polysulfone, polyethersulfone, polyamide, and cellulose).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the hollow fiber membrane of Freedman in view of Jauregui out of polysulfone, polyethersulfone, polyamide, or cellulose, as taught by Bauermeister, because all claimed materials are well known in the art of hollow fiber membrane module. Modifying Freedman in view of Jauregui to be made out of polysulfone, polyethersulfone, polyamide, or cellulose would not change the device’s function of mass exchange between mediums. Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the hollow fiber membrane of Freedman in view of Jauregui out of the claimed materials, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 51, Freedman in view of Jauregui discloses the invention of claim 30. However, Freedman in view of Jauregui does not disclose wherein the membrane comprises polyethersulfone.
Bauermeister, in the same field of endeavor of hollow-fiber module (Title), teaches wherein the membrane comprises polyethersulfone (Col. 12, line 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the hollow fiber membrane of Freedman in view of Jauregui out of polysulfone, as taught by Bauermeister, because all claimed materials are well known in the art of hollow fiber membrane module. Modifying Freedman in view of Jauregui to be made out of polysulfone would not change the device’s function of mass exchange between mediums. Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the hollow fiber membrane of Freedman in view of Jauregui out of the claimed material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 55-60 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Jauregui as applied to claim 30 and 45 above, and further in view of Sakai.
Regarding claim 55 and 58, Freedman in view of Jauregui discloses the invention of claim 30 and 45, respectively. However, Freedman in view of Jauregui does not disclose wherein the condition is lung disease, acute lung disease, acute on chronic lung disease, or chronic lung disease; said second subject is affected from the lung disease, acute lung disease, acute on chronic lung disease, or chronic lung disease.
Sakai, in the same field of endeavor of fluid processing apparatus for processing blood (Col. 1, line 6-11), teaches a method comprises a fluid processing apparatus 1 (Fig. 1) comprising hollow fibers 24 (Fig. 1) for material exchange (Col. 1, line 19-23). Sakai also discloses that this apparatus is considered to be applicable to be both an artificial kidney or artificial lung, as well as a plasma separator (Col. 6, first paragraph – “Although the fluid processing apparatus of the present invention has been described as being applied to a heat exchanger, it is also applicable to other artificial organ such as an artificial lung itself and an artificial kidney. Further, the fluid processing apparatus of the present invention is also applicable to a plasma separator”).
Examiner notes that it is recognized in the field that these artificial organ apparatuses can be used for equivalent functions of treating blood/removal of undesired blood components. In other words, one of ordinary skill in the art would have had the technological capability to realize that an artificial lung and artificial kidney can share the same base structure and function with the main difference being the characteristics of the hollow fiber membranes, as expressed in Col. 1, line 12-18 of Sakai – “…in an artificial organ such as an artificial lung, material-exchange fine tubes are provided. They are gas-exchange hollow fibers in an artificial lung or dialysis hollow fibers in an artificial kidney”. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Freedman in view of Jauregui to not only provide treatment for kidney disease as established in claim 30 and 45, but also exchangeably provide treatment for lung disease as taught by Sakai, as it is well-known in the art of hollow fiber membrane blood treatment device to be applicable to both kidney and lung function (seen in Col. 6, first paragraph and Col. 1, line 12-18 of Sakai). See MPEP 2143.I.C
Furthermore, Examiner further notes that Freedman discloses in Col. 13, second to last paragraph, that “it will become immediately apparent to those skilled in the art that the parabiotic dialysis apparatus may be used for other applications such as an artificial placenta, an artificial intestine, or an adjunct to open heart surgery. Other applications of the parabiotic dialysis apparatus of the present invention may require modifications of the apparatus described above such as: membranes having larger or small pore sizes; membranes allowing transfer of blood substances having a specific range of molecular weight range such as by the insertion of multiple rather than single membranes; and, utilization of several parabiotic dialysis apparatus simultaneously, each having differing membrane permeabilities and thereby enabling a more selective membrane exchange across each parabiotic dialyzer”. Firstly, regarding the application of Freedman’s parabiotic dialysis apparatus in open heart surgery, one of ordinary skill in the art would have had the technological capability to comprehend that such said apparatus in open heart surgery is likely to be incorporated to continue the cardiopulmonary circulation as the heart is being operated; in other words, the parabiotic apparatus is implied to potentially perform as an artificial lung as the heart is currently interrupted in circulation system. Secondly, Freedman also discusses that it is known for modification of membrane sizes to accommodate the needs for each particular treatment. Therefore, Freedman established the foundational motivation for any modification of hollow fiber membrane size, such as the modification as taught by Sakai above, to create the desirable treatment function of the apparatus and the method, i.e. treatment of lung.
Once the modification is made as discussed above, the method of Freedman in view of Jauregui will be able to provide treatment or prevention of lung disease. Thus, the “condition is lung disease” and “said second subject” involved in the method is indeed ”affected from lung disease”. Thus, the limitation is met.
Regarding claim 56 and 59, Freedman in view of Jauregui in view of Sakai discloses the invention of claim 55 and 58, respectively. Freedman in view of Jauregui in view of Sakai further discloses wherein said second subject 10 (Fig. 1 of Freedman) has at least one additional deficient organ function (Col. 1, line 27-29 of Freedman – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically liver…”; thus, the method is fully capable of treating patient with two organ failures).
Regarding claim 57, Freedman in view of Jauregui in view of Sakai discloses the invention of claim 56. Freedman in view of Jauregui in view of Sakai further discloses wherein the additional deficient organ function is deficient kidney function or deficient liver function or multi-organ failure (Col. 1, line 27-29 of Freedman – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically liver and kidney failure”; thus, the method is fully capable of treating patient with two organ failures).
Regarding claim 60, Freedman in view of Jauregui in view of Sakai discloses the invention of claim 59. Freedman in view of Jauregui in view of Sakai further discloses wherein the additional deficient organ function is deficient liver function (Col. 1, line 27-29 of Freedman – “Parabiotic dialysis apparatus also provides the means for treatment of diseases, specifically liver…”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Betts-LaCroix US 20200173982 A1
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781