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 11/20/2025 has been entered. Claims 1, 6, and 11 have been amended; claim 2, 16, and 20 have been cancelled. Accordingly, claims 1, 3-15, 17-19, and 21 are pending and under consideration.
Response to Arguments
Applicant's arguments filed 04/23/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “Agnew specifically teaches a dual lumen catheter system in which two separate valves are needed to regulate the fluid flow through the cannula. As such, if one were to modify Marous with Agnew, the result would appear to include separate valves coupled to each of the first and second drainage tubes” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The rejection made on the Office Action mailed on 09/08/2025 had established that the modification of Marous is by a valve 260 of Agnew. The second valve 270 of Agnew was not relied for any teaching nor modification. See rejection of claims below.
Regarding Applicant’s remarks stating that “As Marous teaches a dual lumen system, the single lumen fitting of Gifford cannot simply be substituted for the dual lumen fitting of Marous because it is designed to connect a single lumen tube on each end of the fitting, and there is nothing to connect to the second lumen of Marous. The fitting of Gifford would not provide the function of connecting to the concentric lumens that appears to be needed in Marous” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. It has been established by the Office in the Office Action mailed on 09/08/2025 that conveyed blood from tube 12 and tube 14 will reach the same location that is pump 70 in the disclosure of primary reference Marous. Therefore, blood from both lumens of Marous are expected to join and mix at some point, and given that both Marous and Gifford’s connectors lead blood to the pump without directing blood to any other component for further processing, one of ordinary skill in the art would have found it obvious and have been motivated to have substituted Marous’s connector for the connector as taught by Gifford, with a reasonable expectation of success. In other words, one of ordinary skill in the art would have had the technological capability to find it obvious that substitution for a single lumen outlet will take place at the fluid-converging area, rather than configuration traversed by Applicant.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 8-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Marous III et al. US 2018/0228960 A1 (previously cited, hereinafter Marous) in view of Agnew US 2012/0143123 A1 (previously cited, hereinafter Agnew) and Gifford III et al. US 2022/0233840 A1 (previously cited, hereinafter Gifford).
Regarding claim 1, Marous discloses a veno-arterial extracorporeal oxygenation (VA ECMO) system 60 (Fig. 10 – VA ECMO system 60) comprising:
a dual lumen drainage cannula 10 (Fig. 1 and Fig. 10 – dual lumen drainage cannula 10; Examiner notes that both Fig. 1 and Fig. 10 use reference numeral 10 to depict the dual lumen drainage cannula 10; thus the drainage cannula 10 can be used in the system of Fig. 10) comprising:
a first drainage tube 12 (Fig. 1 – first drainage tube 12) having a proximal end 30 (Fig. 3 – first proximal end 30 of the first drainage tube 12), a distal end 32 (Fig. 3 – first distal end 32 of the first drainage tube 12), and at least one aperture 18 (Fig. 3-4 – first drainage apertures 18) defined near the distal end 32 (Fig. 3-4 and Par. 55 – “The plurality of first drainage apertures 18 is provided at the first distal end 32 of the first drainage tube 12”);
a second drainage tube 14 (Fig. 1 – second drainage tube 14) having a proximal end 42 (Fig. 5 – second proximal end 42 of the second drainage tube 14), a distal end 44 (Fig. 5 – second distal end 44 of the second drainage tube 14), and at least one aperture 20 (Fig. 5-6 – second drainage apertures 20) defined near the distal end 44 (Fig. 5-6 and Par. 58 – “The plurality of second drainage apertures 20 is provided at the second distal end 44 of the second drainage tube 14”); and
an outlet fitting 22 (Fig. 1-2 – connector 22) in fluid communication with the first drainage tube 12 (Fig. 1) and the second drainage tube 14 (Fig. 1 and Par. 53 – “ The connector 22 includes a first outlet portion 23 in fluid communication with the first drainage tube 12… The first outlet portion 23 of the connector 22 is also in fluid communication with the second drainage tube 14…”),
a blood pump 70 (Fig. 10 – pump 70) having an inlet 68 (Fig. 10 – inlet 68 of the pump 70) connected to the outlet fitting 22 (Fig. 10 and Par. 62 – “the connector 22 may be directly connected to the inlet 68 of the pump 70”) of the dual lumen drainage cannula 10 (Fig. 1 and Fig. 10);
an oxygenator 78 (Fig. 10 – oxygenator 78) connected to an outlet 76 (Fig. 10 – pump outlet 76) of the blood pump 70 (Fig. 10 and Par. 62 – “The pump 70 further includes an outlet 76 for delivering blood to an oxygenator 78 at an oxygenator inlet 80”); and
an infusion cannula 88 (Fig. 10 – infusion cannula 88) connected to an outlet 86 (Fig. 10 – oxygenator outlet 86) of the oxygenator 78 (Fig. 10 and Par. 62 – “Oxygenated blood is delivered to an artery in the patient's body through an infusion cannula 88…”) and configured for insertion into the vasculature of a patient (Par. 62 – “…the infusion cannula 88 may be connected to the patient's femoral artery 92”),
wherein the distal end 44 (Fig. 7) of the second drainage tube 14 (Fig. 7) is secured to a portion of the first drainage tube 12 (Fig. 7) between the proximal 30 (Fig. 3) and distal ends 32 (Fig. 3) of the first drainage tube 12 (Fig. 7 – the distal end of tube 14 circumferentially surrounds a section of tube 12 that is some distance away the proximal end 30 of the tube 12, and Par. 60 – “the second distal end 44 of the second drainage tube 14 is fixedly attached to the first drainage tube 12 along the length…”).
However, Marous does not explicitly disclose a single valve positioned on the first drainage tube and configured to selectively control a ratio of fluid drained through the first drainage tube relative to fluid drained through the second drainage tube; an outlet fitting comprising a single outlet lumen; wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula.
Agnew, in the same field of endeavor of dual-lumen catheter for extracorporeal treatment (Par. 3), teaches a single valve 260 (Fig. 9 – valve member 260) positioned on the first drainage tube 224 (Fig. 9 – inner catheter 224) and configured to selectively control a ratio of fluid drained through the first drainage tube 224 (Fig. 9 – inner catheter 224, and Par. 60 – “A valve member 260 can be configured to be opened or closed for regulating fluid flow therethrough…”) relative to fluid drained through the second drainage tube 222 (Fig. 9 – outer catheter 222; Examiner contends that changing the flow within the inner catheter 224 via valve member 260 directly affects the ratio between flow in the inner catheter 224 and outer catheter 222; thus, the limitation is met).
Gifford, in the same field of endeavor of circulatory support system (Par. 2), teaches an outlet fitting 146 (Fig. 1 – connector 146) comprising a single outlet lumen 148 (Fig. 1 – tubing 148).
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 Marous to further include a valve on the first drainage tube as taught by Agnew, in order to regulating fluid flow therethrough and directing fluid (Par. 60 of Agnew). Once the modification is made as discussed, the combined device will have the valve 260 of Agnew as a single valve in the dual lumen drainage cannula system of Marous. Thus, “wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula” is suggested.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the double-lumened outlet fitting of Marous (Fig. 1 – first outlet portion 24 and second outlet portion 26) that allows blood to be withdrawn out of the first and second drainage tube to the next processing component, for the single lumen outlet fitting of Gifford, since these mechanisms perform the same function of delivering blood towards an extracorporeal pump and oxygenator. For example, Fig. 10 of Marous shows blood traveling through outlet fitting 22, reaching the pump 70, and ultimately reaching the oxygenation membrane 84 via the direction of arrows. Similarly, Fig. 1 of Gifford shows blood traveling through the single lumen outlet fitting 146, reaching the pump 180, and ultimately the oxygenator (Par. 176 – “the system 100 may include an oxygenator, the blood pulled from the circulation can pass through the oxygenator as well as the pressure source 180 before being returned to the arterial system“). Simply substituting one coupling/fitting means for another would yield the predicable result of allowing blood flow within said coupling toward the next component in the extracorporeal system. See MPEP 2143.
Regarding claim 6, Marous discloses a dual lumen drainage cannula 10 (Fig. 1 – dual lumen drainage cannula 10) configured for use in a veno-arterial extracorporeal membrane oxygenation (VA ECMO) system 60 (Fig. 10 – VA ECMO system 60; Examiner notes that both Fig. 1 and Fig. 10 use reference numeral 10 to depict the dual lumen drainage cannula 10; thus the drainage cannula 10 can be used in the system of Fig. 10), the dual lumen drainage cannula 10 (Fig. 1) comprising:
a first drainage tube 12 (Fig. 1 – first drainage tube 12) having a proximal end 30 (Fig. 3 – first proximal end 30 of the first drainage tube 12), a distal end 32 (Fig. 3 – first distal end 32 of the first drainage tube 12), and at least one aperture 18 (Fig. 3-4 – first drainage apertures 18) defined near the distal end 32 (Fig. 3-4 and Par. 55 – “The plurality of first drainage apertures 18 is provided at the first distal end 32 of the first drainage tube 12”);
a second drainage tube 14 (Fig. 1 – second drainage tube 14) having a proximal end 42 (Fig. 5 – second proximal end 42 of the second drainage tube 14), a distal end 44 (Fig. 5 – second distal end 44 of the second drainage tube 14), and at least one aperture 20 (Fig. 5-6 – second drainage apertures 20) defined near the distal end 44 (Fig. 5-6 and Par. 58 – “The plurality of second drainage apertures 20 is provided at the second distal end 44 of the second drainage tube 14”); and
an outlet fitting 22 (Fig. 1-2 – connector 22) in fluid communication with the first drainage tube 12 (Fig. 1) and the second drainage tube 14 (Fig. 1 and Par. 53 – “ The connector 22 includes a first outlet portion 23 in fluid communication with the first drainage tube 12… The first outlet portion 23 of the connector 22 is also in fluid communication with the second drainage tube 14…”),
wherein the distal end 44 (Fig. 7) of the second drainage tube 14 (Fig. 7) is secured to a portion of the first drainage tube 12 (Fig. 7) between the proximal 30 (Fig. 3) and distal ends 32 (Fig. 3) of the first drainage tube 12 (Fig. 7 – the distal end of tube 14 circumferentially surrounds a section of tube 12 that is some distance away the proximal end 30 of the tube 12, and Par. 60 – “the second distal end 44 of the second drainage tube 14 is fixedly attached to the first drainage tube 12 along the length…”).
However, Marous does not explicitly disclose a single valve positioned on the first drainage tube and configured to selectively control a ratio of fluid drained through the first drainage tube relative to fluid drained through the second drainage tube; an outlet fitting comprising a single outlet lumen; wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula.
Agnew, in the same field of endeavor of dual-lumen catheter for extracorporeal treatment (Par. 3), teaches a single valve 260 (Fig. 9 – valve member 260) positioned on the first drainage tube 224 (Fig. 9 – inner catheter 224) and configured to selectively control a ratio of fluid drained through the first drainage tube 224 (Fig. 9 – inner catheter 224, and Par. 60 – “A valve member 260 can be configured to be opened or closed for regulating fluid flow therethrough…”) relative to fluid drained through the second drainage tube 222 (Fig. 9 – outer catheter 222; Examiner contends that changing the flow within the inner catheter 224 via valve member 260 directly affects the ratio between flow in the inner catheter 224 and outer catheter 222; thus, the limitation is met).
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 device of Marous to further include a valve as taught by Agnew, in order to regulating fluid flow therethrough and directing fluid (Par. 60 of Agnew). Once the modification is made as discussed, the combined device will have the valve 260 of Agnew as a single valve in the dual lumen drainage cannula system of Marous. Thus, “wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula” is suggested.
Gifford, in the same field of endeavor of circulatory support system (Par. 2), teaches an outlet fitting 146 (Fig. 1 – connector 146) comprising a single outlet lumen 148 (Fig. 1 – tubing 148).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the double-lumened outlet fitting of Marous (Fig. 1 – first outlet portion 24 and second outlet portion 26) that allows blood to be withdrawn out of the first and second drainage tube to the next processing component, for the single lumen outlet fitting of Gifford, since these mechanisms perform the same function of delivering blood towards an extracorporeal pump and oxygenator. For example, Fig. 10 of Marous shows blood traveling through outlet fitting 22, reaching the pump 70, and ultimately reaching the oxygenation membrane 84 via the direction of arrows. Similarly, Fig. 1 of Gifford shows blood traveling through the single lumen outlet fitting 146, reaching the pump 180, and ultimately the oxygenator (Par. 176 – “the system 100 may include an oxygenator, the blood pulled from the circulation can pass through the oxygenator as well as the pressure source 180 before being returned to the arterial system“). Simply substituting one coupling/fitting means for another would yield the predicable result of allowing blood flow within said coupling toward the next component in the extracorporeal system. See MPEP 2143.
Regarding claim 11, Marous discloses a method of providing veno-arterial extracorporeal membrane oxygenation (VA ECMO) of a heart (Par. 12 – “a method of providing VA ECMO of a heart…”), the method (Par. 12) comprising:
providing a dual lumen drainage cannula 10 (Fig. 1 and Fig. 10 – dual lumen drainage cannula 10, and Par. 12 – “…providing a dual lumen drainage cannula“) comprising:
a first drainage tube 12 (Fig. 1 – first drainage tube 12) having a proximal end 30 (Fig. 3 – first proximal end 30 of the first drainage tube 12), a distal end 32 (Fig. 3 – first distal end 32 of the first drainage tube 12), and at least one aperture 18 (Fig. 3-4 – first drainage apertures 18) defined near the distal end 32 (Fig. 3-4 and Par. 55 – “The plurality of first drainage apertures 18 is provided at the first distal end 32 of the first drainage tube 12”);
a second drainage tube 14 (Fig. 1 – second drainage tube 14) having a proximal end 42 (Fig. 5 – second proximal end 42 of the second drainage tube 14), a distal end 44 (Fig. 5 – second distal end 44 of the second drainage tube 14), and at least one aperture 20 (Fig. 5-6 – second drainage apertures 20) defined near the distal end 44 (Fig. 5-6 and Par. 58 – “The plurality of second drainage apertures 20 is provided at the second distal end 44 of the second drainage tube 14”); and
an outlet fitting 22 (Fig. 1-2 – connector 22) in fluid communication with the first drainage tube 12 (Fig. 1) and the second drainage tube 14 (Fig. 1 and Par. 53 – “ The connector 22 includes a first outlet portion 23 in fluid communication with the first drainage tube 12… The first outlet portion 23 of the connector 22 is also in fluid communication with the second drainage tube 14…”),
wherein the distal end 44 (Fig. 7) of the second drainage tube 14 (Fig. 7) is secured to a portion of the first drainage tube 12 (Fig. 7) between the proximal 30 (Fig. 3) and distal ends 32 (Fig. 3) of the first drainage tube 12 (Fig. 7 – the distal end of tube 14 circumferentially surrounds a section of tube 12 that is some distance away the proximal end 30 of the tube 12, and Par. 60 – “the second distal end 44 of the second drainage tube 14 is fixedly attached to the first drainage tube 12 along the length…”);
inserting the dual lumen drainage cannula 10 (Fig. 1 and Fig. 10) into a first site 94 (Fig. 10 – jugular vein 94, and Par. 66 – “a percutaneous entry needle… is used to access the patient's internal jugular vein 94…”) in a patient's vasculature (Par. 12 – “The method may further include inserting the dual lumen drainage cannula into a first site in a patient's vasculature”);
maneuvering the dual lumen drainage cannula 10 (Fig. 10) through the patient's vasculature 94 (Fig. 10 - cannula 10 is forwarded further into the jugular vein 94) such that the distal end 32 (Fig. 3) of the first drainage tube 12 (Fig. 10) is at least within proximity of the patient's pulmonary artery (see annotated Fig. 10 below – distal end 32 with apertures 18 of the first drainage tube 12 is near the annotated pulmonary artery) and such that the distal end 44 (Fig. 5) of the second drainage tube 14 (Fig. 10) is at least within proximity of the patient's right atrium (see annotated Fig. 10 below – distal end 44 with apertures 20 of the first drainage tube 14 is near the annotated right atrium);
draining blood through the first drainage tube 12 and the second drainage tube 14 (Fig. 10 – arrows near apertures 18 and apertures 20 indicate inflow of blood into the tubes 12, 14) to a blood pump 70 (Fig. 10 – pump 70; downward arrows going toward the pump 70 indicate drained blood entering the blood pump 70);
pumping drained blood through an oxygenator 78 (Fig. 10 – oxygenator 78; right-bound arrow indicates blood flowing from the pump 70 to the oxygenator 78) to reduce carbon dioxide content of the blood (Par. 12 – “…pumping withdrawn blood through an oxygenator to reduce carbon dioxide content of the blood…”); and
delivering oxygenated blood with reduced carbon dioxide content to a second site 92 (Fig. 10 – femoral artery 92, and Par. 62 – “…the infusion cannula 88 may be connected to the patient's femoral artery 92”) in the patient's vasculature (Par. 12 – “…delivering oxygenated blood with reduced carbon dioxide content to a second site in the patient's vasculature”).
However, Marous does not explicitly disclose a single valve positioned on the first drainage tube and configured to selectively control a ratio of fluid drained through the first drainage tube relative to fluid drained through the second drainage tube; an outlet fitting comprising a single outlet lumen; draining blood through the first drainage tube and the second drainage tube through the single outlet lumen to a blood pump; wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula.
Agnew, in the same field of endeavor of dual-lumen catheter for extracorporeal treatment (Par. 3), teaches a valve 260 (Fig. 9 – valve member 260) positioned on the first drainage tube 224 (Fig. 9 – inner catheter 224) and configured to selectively control a ratio of fluid drained through the first drainage tube 224 (Fig. 9 – inner catheter 224, and Par. 60 – “A valve member 260 can be configured to be opened or closed for regulating fluid flow therethrough…”) relative to fluid drained through the second drainage tube; an outlet fitting comprising a single outlet lumen 222 (Fig. 9 – outer catheter 222; Examiner contends that changing the flow within the inner catheter 224 via valve member 260 directly affects the ratio between flow in the inner catheter 224 and outer catheter 222; thus, the limitation is met).
Gifford, in the same field of endeavor of circulatory support system (Par. 2), teaches an outlet fitting 146 (Fig. 1 – connector 146) comprising a single lumen 148 (Fig. 1 – tubing 148).
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 Marous to further include a valve on the first drainage tube as taught by Agnew, in order to regulating fluid flow therethrough and directing fluid (Par. 60 of Agnew). Once the modification is made as discussed, the combined device will have the valve 260 of Agnew as a single valve in the dual lumen drainage cannula system of Marous. Thus, “wherein the single valve positioned on the first drainage tube is the only valve coupled to the dual lumen drainage cannula” is suggested.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the double-lumened outlet fitting of Marous (Fig. 1 – first outlet portion 24 and second outlet portion 26) that allows blood to be withdrawn out of the first and second drainage tube to the next processing component, for the single lumen outlet fitting of Gifford, since these mechanisms perform the same function of delivering blood towards an extracorporeal pump and oxygenator. For example, Fig. 10 of Marous shows blood traveling through outlet fitting 22, reaching the pump 70, and ultimately reaching the oxygenation membrane 84 via the direction of arrows. Similarly, Fig. 1 of Gifford shows blood traveling through the single lumen outlet fitting 146, reaching the pump 180, and ultimately the oxygenator (Par. 176 – “the system 100 may include an oxygenator, the blood pulled from the circulation can pass through the oxygenator as well as the pressure source 180 before being returned to the arterial system“). Simply substituting one coupling/fitting means for another would yield the predicable result of allowing blood flow within said coupling toward the next component in the extracorporeal system. See MPEP 2143. Once the modification is made as discussed, the blood drained through the first and second drainage tube will travel through said single outlet lumen of Gifford to a blood pump. Thus, the limitation “draining blood through the first drainage tube and the second drainage tube through the single outlet lumen to a blood pump” is met.
Emphasis added: Examiner notes that in comparison with the disclosure of the instant application, which depicts the reference numeral 62 to be the pulmonary artery and 64 to be the right atrium, the anatomy of the heart from the provided NPL of Britannica (see comparison between Fig. 11 of the instant application and the Figure of Britannica below) agrees with the instant application regarding the location of the pulmonary artery and the right atrium.
However, Fig. 10 of Marous (as well as Fig. 9 which Examiner is not relying on for the rejection) and Par. 61 of Marous appear to have swapped the locations of the pulmonary artery and the right atrium, even though the patient’s heart is in the same orientation in all figures. For examining purposes, Examiner currently interprets the reference numeral 64 of Marous to be the pulmonary artery, and reference numeral 62 of Marous to be the right atrium, as seen in annotated Fig. 10 of Marous below, so that it is consistent with the conventional anatomy provided by the Applicant’s disclosure and Britannica.
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Comparison between the heart’s anatomy between the instant application and Britannica
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Annotated Fig. 10 of Marous
Regarding claim 3 and claim 8, Marous in view of Agnew in view of Gifford discloses the invention of claim 1 and claim 6, respectively. The combination further discloses wherein the at least one aperture 18 (Fig. 1 of Marous) of the first drainage tube 12 (Fig. 1 of Marous) is spaced apart from the at least one aperture 20 (Fig. 1 of Marous) of the second drainage tube 14 (Fig. 1 of Marous) by a distance D (Fig. 1 of Marous – distance D between the first apertures 18 and the second apertures 20) such that the at least one aperture 18 (Fig. 1 of Marous) of the first drainage tube 12 (Fig. 1 of Marous) is positionable within a pulmonary artery of the patient to drain blood from the pulmonary artery (see annotated Fig. 10 of Marous below – first apertures 18 are positioned within a pulmonary artery for drainage, and Par. 61 of Marous – “…blood may enter the respective lumens… of the first and second drainage tubes 12, 14 through the plurality of first and second drainage apertures 18, 20, respectively”) while the at least one aperture 20 (Fig. 1 of Marous) of the second drainage tube 14 (Fig. 1 of Marous) is positionable within a right atrium of the patient to drain blood from the right atrium of the patient (see annotated Fig. 10 of Marous below – second apertures are positioned within a right atrium for drainage, and Par. 61 of Marous – ““…blood may enter the respective lumens… of the first and second drainage tubes 12, 14 through the plurality of first and second drainage apertures 18, 20, respectively”).
Emphasis added: Examiner notes that in comparison with the disclosure of the instant application, which depicts the reference numeral 62 to be the pulmonary artery and 64 to be the right atrium, the anatomy of the heart from the provided NPL of Britannica (see comparison between Fig. 11 of the instant application and the Figure of Britannica above) agrees with the instant application regarding the location of the pulmonary artery and the right atrium.
However, Fig. 10 of Marous (as well as Fig. 9 which Examiner is not relying on for the rejection) and Par. 61 of Marous appear to have swapped the locations of the pulmonary artery and the right atrium, even though the patient’s heart is in the same orientation in all figures. For examining purposes, Examiner currently interprets the reference numeral 64 of Marous to be the pulmonary artery, and reference numeral 62 of Marous to be the right atrium, as seen in annotated Fig. 10 of Marous above, so that it is consistent with the conventional anatomy provided by the Applicant’s disclosure and Britannica.
Regarding claim 4, claim 9, and claim 13, Marous in view of Agnew in view of Gifford discloses the invention of claim 1, claim 6, and claim 11, respectively. The combination further discloses wherein the first drainage tube 12 (Fig. 1 of Marous) extends coaxially relative to the second drainage tube 14 (Fig. 1 of Marous, and Par. 49 of Marous – “The first drainage tube 12 is disposed within the second drainage tube 14 in a coaxial arrangement centered about a central axis 16”).
Regarding claim 5, claim 10, and claim 15, Marous in view of Agnew in view of Gifford discloses the invention of claim 1, claim 6, and claim 11, respectively. The combination further discloses wherein the proximal end 30 (Fig. 3 of Marous) of the first drainage tube 12 (Fig. 1 of Marous) is positioned distally of the outlet fitting 146 (Fig. 1 of Gifford).
Examiner notes that the first drainage tube 12 of Marous is already positioned at the distal end of the outlet fitting 22 in order to provide attachment with said tube to provide non-leaked flow (Fig. 1 of Marous and Par. 54 of Marous – “The first proximal end 30 includes a first connector portion 34 for coupling the first drainage tube 12 to the first outlet portion 23 of the connector 22…”). Thus, once the combination is made as discussed in claim 1 and claim 6, the first drainage tube 12 will be positioned distally of outlet fitting 146 of Gifford. Thus, the limitation is met.
Regarding claim 12, Marous in view of Agnew in view of Gifford discloses the invention of claim 11. The combination further discloses wherein the outlet fitting 146 (Fig. 1 of Gifford) of the dual lumen drainage cannula 10 (Fig. 10 of Marous) is connected to an inlet 68 (Fig. 10 of Marous – inlet 68 of the pump 70) of the blood pump 70 (Fig. 10 of Marous).
Examiner notes that once the substitution is made as discussed in claim 11, the outlet fitting 22 which connects to the pump 70 of Marous will be replaced by the outlet fitting 146 of Gifford. The outlet fitting 146 of Gifford will still attach to the inlet 68 of the blood pump 70 of Marous. Thus, the limitation is met.
Claims 7, 14, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Marous in view of Agnew in view of Gifford as applied to claim 1, claim 6, and claim 11 above, and further in view of DeFonzo et al. US 2008/0312578 A1 (previously cited, hereinafter DeFonzo).
Regarding claim 7, Marous in view of Agnew in view of Gifford discloses the invention of claim 6. However, the combination does not disclose a retainer for indexing the first drainage tube within the second drainage tube.
DeFonzo, in the same field of endeavor of multi-lumen catheter (Par. 3), teaches a retainer “R” (see annotated Fig. 9A below – retainer “R”) for indexing the first drainage tube (see annotated Fig. 9A below) within the second drainage tube (see annotated Fig. 9A below; Fig. 9A shows the retainer “R” allows containment of the first drainage tube within the second drainage tube).
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 first and second drainage tube of the combination to have the retainer as taught by DeFonzo, in order to facilitate large lumens for blood flow (Par. 28 of DeFonzo) as the retainer provides infrastructure for the two tubes to enter and stay within a patient’s body. It is also well-known in the art that multi-lumen configurations have been optimized by one of ordinary skill in the art (Par. 28 of DeFonzo), such as side-by-side D-shaped forms or inflow/outflow concentric tubes (Par. 28 of DeFonzo), and the claimed configuration falls under the inflow/outflow concentric tube configuration. Once the combination is made as discussed, a retainer “R” as taught by DeFonzo will be placed between the first drainage tube 12 and the second drainage tube 14 of Marous, and said retainer “R” will run along the length of the two drainage tubes. The construct of the retainer “R” reinforced by the radial posts separating the lumens 66a-66e of DeFonzo (see annotated Fig. 9A of DeFonzo below) will also be incorporated into the device of Marous in view of Agnew in view of Gifford.
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Annotated Fig. 9A of DeFonzo
Regarding claim 14, Marous in view of Agnew in view of Gifford discloses the invention of claim 11. However, the combination does not disclose wherein the dual lumen drainage cannula further comprises a retainer for indexing the proximal end of the first drainage tube within the proximal end of the second drainage tube.
DeFonzo, in the same field of endeavor of multi-lumen catheter (Par. 3), teaches a retainer “R” (see annotated Fig. 9A above – retainer “R”) for indexing the first drainage tube (see annotated Fig. 9A above) within the second drainage tube (see annotated Fig. 9A above; Fig. 9A shows the retainer “R” allows containment of the first drainage tube within the second drainage tube).
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 first and second drainage tube of the combination to have the retainer as taught by DeFonzo, in order to facilitate large lumens for blood flow (Par. 28 of DeFonzo) as the retainer provides infrastructure for the two tubes to enter and stay within a patient’s body. It is also well-known in the art that multi-lumen configurations have been optimized by one of ordinary skill in the art (Par. 28 of DeFonzo), such as side-by-side D-shaped forms or inflow/outflow concentric tubes (Par. 28 of DeFonzo), and the claimed configuration falls under the inflow/outflow concentric tube configuration. Once the combination is made as discussed, a retainer “R” as taught by DeFonzo will be placed between the first drainage tube 12 and the second drainage tube 14 of Marous, and said retainer “R” will run along the length of tube 14, since the retainer “R” has to accommodate housing for tube 12. On that account, the proximal end 30 of the first drainage tube 12 will be within the proximal end 42 of the second drainage tube 14 given to the modification of retainer “R” being between two said tubes to provide a structure for tube 12 to extend coaxially within the tube 14. Thus, the limitation “for indexing the proximal end of the first drainage tube within the proximal end of the second drainage tube” is met.
Regarding claim 17, Marous in view of Agnew in view of Gifford discloses the invention of claim 1. However, the combination does not disclose a retainer extending between the first drainage tube and the second drainage tube to index the first drainage tube within the second drainage tube.
DeFonzo, in the same field of endeavor of multi-lumen catheter (Par. 3), teaches a retainer “R” (see annotated Fig. 9A above – retainer “R”) extending between the first drainage tube (see annotated Fig. 9A above) and the second drainage tube (see annotated Fig. 9A above – Examiner contends that since the inner lumen can receive a guidewire 20, it is also capable of receiving a drainage tube) to index the first drainage tube within the second drainage tube (see annotated Fig. 9A above shows the retainer “R” allows containment of the first drainage tube within the second drainage tube).
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 first and second drainage tube of the combination to have the retainer as taught by DeFonzo, in order to facilitate large lumens for blood flow (Par. 28 of DeFonzo) as the retainer provides infrastructure for the two tubes to enter and stay within a patient’s body. It is also well-known in the art that multi-lumen configurations have been optimized by one of ordinary skill in the art (Par. 28 of DeFonzo), such as side-by-side D-shaped forms or inflow/outflow concentric tubes (Par. 28 of DeFonzo), and the claimed configuration falls under the inflow/outflow concentric tube configuration. Once the combination is made as discussed, a retainer “R” as taught by DeFonzo will be placed between the first drainage tube 12 and the second drainage tube 14 of Marous, and said retainer “R” will run along the length of the two drainage tubes. The construct of the retainer “R” reinforced by the radial posts separating the lumens 66a-66e of DeFonzo (see annotated Fig. 9A of DeFonzo above) will also be incorporated into the device of Marous in view of Agnew in view of Gifford.
Regarding claim 18 and claim 21, Marous in view of Agnew in view of Gifford in view of DeFonzo discloses the invention of claim 17 and claim 7, respectively. The combination further discloses wherein the retainer “R” (see annotated Fig. 9A of DeFonzo above) includes one or more spokes “S” (see annotated Fig. 9A of DeFonzo above – spokes “S” separating the lumens 66a-66e) extending radially (see annotated Fig. 9A of DeFonzo above – spokes “S” extends from an outer diameter to an inner diameter) between the first drainage tube 12 (Fig. 1 of Marous) and the second drainage tube 14 (Fig. 1 of Marous).
Examiner notes that once the combination is made as discussed in claim 17 and claim 7, the retainer “R” with radial posts/spokes “S” as annotated in Fig. 9A above of DeFonzo will be incorporated between the first drainage tube 12 and the second drainage tube 14 of Marous in view of Agnew in view of Gifford. Thus, the limitation is met.
Regarding claim 19, Marous in view of Agnew in view of Gifford in view of DeFonzo discloses the invention of claim 18. The combination further discloses wherein the one or more spokes “S” (see annotated Fig. 9A of DeFonzo above) index the first drainage tube 12 (Fig. 1 of Marous) so as to be coaxial with the second drainage tube 14 (Fig. 1 of Marous).
Examiner notes that once the combination is made as discussed in claim 17 and claim 18, the spokes “S” of DeFonzo reinforces the retainer “R” present between the first drainage tube 12 and the second drainage tube 14 of Marous in view of Gifford, and the spokes “S” of DeFonzo are present along the length of tube 12 and tube 14 of Marous in view of Agnew in view of Gifford, which allows the first drainage tube 12 to extend coaxially with the second drainage tube 14 in the combined device. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prosl US 6352521 B1
Stevens et al. US 5584803 A
Esminger et al. US 5531684 A
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781