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 .
Claim Objections
Claim 7 recites the limitations “each of the inlet and outlet ports” which should read “each of the blood inlet and blood outlet ports” to remain consistent with the language used in Claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the blood inlet" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the blood inlet opening”.
Claim 1 recites the limitation "the blood outlet opening" in line 17. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the blood outlet”. Claims 2-13 are also rejected based on their dependency on Claim 1.
Claim 9 recites the limitation "the remote monitoring unit" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding Claim 11, a H/C fluid inlet and outlet are claimed that are configured such that a H/C fluid may pass through the plurality of hollow fibers. However, this claim depends upon Claim 1 which indicates that the hollow fibers are fluidly coupled to the gas inlet and gas outlet. It is unclear if each mat layer, and therefore each hollow fiber, is in fluid communication with both the gas inlet and gas outlet as well as the H/C fluid inlet and H/C fluid outlet. Based on the specification (¶ [0008, 0051-0052, 0057] of published specification) it appears that the plurality of hollow fibers that form the fiber mats of the oxygenator are in fluid communication with the gas inlet and gas outlet, and the plurality of hollow fibers that form the fiber mats of the heat exchanger are in fluid communication with the H/C fluid inlet and H/C fluid outlet, not that every layer/every hollow fiber is in fluid communication with both fluid pathways.
Claim 14 recites the limitation "the blood inlet" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the blood inlet opening”.
Claim 14 recites the limitation "the blood outlet opening" in line 19. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the blood outlet”.
Claim 14 recites the limitation "outlet blood pressure signal" in line 29-30. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation “the outlet pressure sensor is configured to generate an inlet blood pressure signal” is interpreted as “the outlet pressure sensor is configured to generate an outlet blood pressure signal”. Claims 15-20 are also rejected based on their dependency on Claim 14.
Regarding Claim 15, a H/C fluid inlet and outlet are claimed that are configured such that a H/C fluid may pass through the plurality of hollow fibers. However, this claim depends upon Claim 14 which indicates that the hollow fibers are fluidly coupled to the oxygenator. It is unclear if each mat layer, and therefore each hollow fiber, is in fluid communication with both the gas inlet and gas outlet as well as the H/C fluid inlet and H/C fluid outlet. Based on the specification (¶ [0008, 0051-0052, 0057] of published specification) it appears that the plurality of hollow fibers that form the fiber mats of the oxygenator are in fluid communication with the gas inlet and gas outlet, and the plurality of hollow fibers that form the fiber mats of the heat exchanger are in fluid communication with the H/C fluid inlet and H/C fluid outlet, not that every layer/every hollow fiber is in fluid communication with both fluid pathways.
Claim 16 recites the limitation "the H/C outlet chamber" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the H/C fluid outlet chamber”
Claims 18 and 19 recite the limitation “wherein the remote monitoring unit is adapted to communicate with the remote monitoring unit”. It is unclear how the remote monitoring unit is adapted to communicate with itself. For the purpose of compact prosecution, these claims are interpreted as “wherein the communication circuitry is adapted to communicate with the remote monitoring unit”, which is similar to the language Claim 6.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Plott et al (US 2018/0078695).
Regarding Claim 1, Plott discloses an oxygenation device (100, Figs. 1-10) for use in connection with extracorporeal blood circulation (¶ [0062]), the device (100, Figs. 1-10) comprising:
an oxygenator housing (110, Figs. 1-10) including a blood inlet end cap (inlet cover 140, Figs. 1-3 and 10) defining a blood inlet opening (see Image 1), a blood outlet end cap (outlet cover 160, Figs. 1-3 and 10) defining a blood outlet (see Image 1) and a blood flow path (328, Figs. 1-10) between the blood inlet and the blood outlet (see Image 1; ¶ [0064-0068, 0076]);
a plurality of stacked, mat layers (first fiber assembly 330 and second fiber assembly 350 are both made of a plurality of stacked fiber mats, Figs. 6-8; ¶ [0077-0080]) of hollow fibers (¶ [0077-0080]) disposed inside the housing (110, Figs. 1-10) and along the blood flow path (328, Figs. 1-10), the hollow fibers (¶ [0077-0080]) fluidly coupled to a gas inlet port (180, Figs. 1-10) and a gas outlet port (182, Figs. 1-10; ¶ [0080]);
a blood inlet port (144, Figs. 1-10) having a blood inlet lumen (see Image 1) defining an inlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072]) and fluidly coupled to the blood inlet opening (see Image 1) of the blood inlet end cap (140, Figs. 1-10), the blood inlet port (144, Figs. 1-10) including an inlet pressure sensor housing (sensor module 210, Figs. 4-5) in fluid communication with the blood inlet lumen (see Image 1) through the inlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072]), the inlet pressure sensor housing (210, Figs. 4-5) adapted to house an inlet pressure sensor (212, Figs. 4-5; ¶ [0072]), and
a blood outlet port (164, Figs. 1-10) having a blood outlet lumen (see Image 1) fluidly defining an outlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072-0073]) and fluidly coupled to the blood outlet opening (see Image 1) of the blood outlet end cap (160, Figs. 1-10), the blood outlet port (164, Figs. 1-10) including an outlet pressure sensor housing (sensor module 210, Figs. 4-5; ¶ [0072-0073]) in fluid communication with the blood outlet lumen (see Image 1) through the outlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072-0073]), the outlet pressure sensor housing (210, Figs. 4-5; ¶ [0072-0073]) adapted to house an outlet pressure sensor (212, Figs. 4-5; ¶ [0072-0073]);
wherein during operation of the oxygenation device (100, Figs. 1-10), each of the inlet pressure sensor and the outlet pressure sensor (212, Figs. 4-5) are configured to measure an inlet blood pressure and an outlet blood pressure, respectively (¶ [0072-0073]).
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Image 1: Annotated Fig. 3 of Plott
Plott is silent whether the inlet sensing hole is disposed less than 3 cm from the blood inlet opening on the blood inlet end cap.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Plott to have the inlet sensing hole be disposed less than 3 cm from the blood inlet opening on the blood inlet end cap since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Plott would not operate differently with the inlet sensing hole being less than 3 cm from the blood inlet opening on the blood inlet end cap and since changing the distance would merely change the compactness of the device, the device would function appropriately with an inlet sensing hole less than 3 cm from the blood inlet opening on the blood inlet end cap. Further, applicant places no criticality on the range claimed, indicating simply that the blood inlet sensing hole is less than 3 cm but does not say the device is non-functional with a distance greater than 3 cm (¶ [0061] of published Application).
Regarding Claim 2, Plott further discloses the oxygenator housing (110, Figs. 1-10) defines an oxygenator module (316, Fig. 6) and a heat exchanger module (314, Fig. 6), and further wherein the plurality of hollow fibers (¶ [0077-0080]) includes oxygenator fibers associated with the oxygenator module (316, Fig. 6; ¶ [0077-0080]) and heat exchanger fibers associated with the heat exchanger module (314, Fig. 6; ¶ [0077-0080]).
Regarding Claim 3, Plott further discloses the housing (110, Figs. 1-10) further comprises a separation grid (spacer 318, Figs. 6 and 10) positioned between the heat exchanger (314, Fig. 6) and the oxygenator module (316, Fig. 6).
Regarding Claim 4, Plott further discloses a remote monitoring unit (control chamber 124 and information panel 126, Figs. 3; these can be considered remote from the sensors themselves as there is an amount of separation between the two) communicatively coupled to each of the inlet pressure sensor and outlet pressure sensor (212, Figs. 4-5; ¶ [0072-0073]).
Regarding Claim 5, Plott further discloses communication circuitry coupled to each of the inlet and outlet pressure sensors (212, Figs. 4-5; ¶ [0072-0073]) and adapted to communicate with the remote monitoring unit (124 and 126, Fig. 3; ¶ [0072-0073]).
Regarding Claim 6, Plott further discloses the communication circuitry is adapted to communicate with the remote monitoring unit (124 and 126, Fig. 3) by wireless telemetry (¶ [0072-0073]).
Regarding Claim 7, Plott further discloses electrical terminals mechanically connected to each of the inlet and outlet ports (144 and 164, Figs. 1-10) and adapted for coupling at least one of the inlet and outlet pressure sensors (212, Figs. 1-10) with an electrical connector; ¶ [0072-0073]; an electrical terminal would be present within the sensor housing module 210 to allow the sensors to be coupled to an electrical connector, such as the ribbon cable that can bring the signal to the controller and display).
Regarding Claim 8, Plott further discloses the electrical connector is configured to communicatively couple both of the pressure sensors with a remote monitoring unit (124 and 126, Fig. 3; ¶ [0072-0073]; an electrical terminal would be present within the sensor housing module 210 to allow the sensors to be coupled to an electrical connector, such as the ribbon cable that can bring the signal to the controller and display; both ribbon cables together can be considered the electrical connector).
Regarding Claim 9, Plott further discloses a second electrical connector and wherein the first electrical connector is adapted to couple the inlet pressure sensor (212, Figs. 4-5) to the remote monitoring unit (124 and 126, Fig. 3) and the second electrical connector is adapted to couple the outlet pressure sensor (212, Figs. 4-5) to the remote monitoring unit (124 and 126, Fig. 3; ¶ [0072-0073]; one ribbon cable is considered the first electrical connector and the other ribbon cable is the second electrical connector).
Regarding Claim 10, Plott further discloses the housing (110, Figs. 1-10) is configured such that a gas mixture may enter through the gas inlet port (180, Figs. 1-10), pass through the plurality of hollow fibers, and exit through the gas outlet (182, Figs. 1-10; ¶ [0077-0080]).
Regarding Claim 11, Plott further discloses the housing (110, Figs. 1-10) further defines a fluid inlet port (190, Figs. 1-10) and a fluid outlet port (192, Figs. 1-10) and is configured such that a H/C fluid may pass through the plurality of hollow fibers (¶ [0077-0080]).
Regarding Claim 12, Plott further discloses the remote monitoring unit (124 and 126, Fig. 3) includes a display (126, Fig. 3) adapted to display the inlet blood pressure, the outlet blood pressure and a pressure drop based on a difference between the inlet and outlet blood pressure (¶ [0072-0073]).
Regarding Claim 14, Plott discloses an oxygenation system (100, Figs. 1-10) for use in connection with extracorporeal blood circulation (¶ [0062]), the system (100, Figs. 1-10) comprising:
an oxygenator housing (110, Figs. 1-10) including a blood inlet end cap (inlet cover 140, Figs. 1-3 and 10) defining a blood inlet opening (see Image 1), a blood outlet end cap (outlet cover 160, Figs. 1-3 and 10) defining a blood outlet (see Image 1) and a blood flow path (328, Figs. 1-10) between the blood inlet and the blood outlet (see Image 1; ¶ [0064-0068, 0076]), the oxygenator housing (110, Figs. 1-10) defining a heat exchanger module (314, Fig. 6) and an oxygenator module (316, Fig. 6) adjacent the heat exchange module (314, Fig. 6);
a plurality of stacked, mat layers (first fiber assembly 330 and second fiber assembly 350 are both made of a plurality of stacked fiber mats, Figs. 6-8; ¶ [0077-0080]) of hollow fibers (¶ [0077-0080]) disposed inside the housing (110, Figs. 1-10) and along the blood flow path (328, Figs. 1-10), the hollow fibers (¶ [0077-0080]) fluidly coupled to the oxygenator module (316, Fig. 6; ¶ [0077-0078, 0080]);
a blood inlet port (144, Figs. 1-10) having a blood inlet lumen (see Image 1) defining an inlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072]) and fluidly coupled to the blood inlet opening (see Image 1) of the blood inlet end cap (140, Figs. 1-10), the blood inlet port (144, Figs. 1-10) including an inlet pressure sensor housing (sensor module 210, Figs. 4-5) in fluid communication with the blood inlet lumen (see Image 1) through the inlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072]), the inlet pressure sensor housing (210, Figs. 4-5) adapted to house an inlet pressure sensor (212, Figs. 4-5; ¶ [0072]), and
a blood outlet port (164, Figs. 1-10) having a blood outlet lumen (see Image 1) fluidly defining an outlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072-0073]) and fluidly coupled to the blood outlet opening (see Image 1) of the blood outlet end cap (160, Figs. 1-10), the blood outlet port (164, Figs. 1-10) including an outlet pressure sensor housing (sensor module 210, Figs. 4-5; ¶ [0072-0073]) in fluid communication with the blood outlet lumen (see Image 1) through the outlet sensing hole (the opening between the module housing 210 and the lumen of the port itself; Figs. 4-5; ¶ [0072-0073]), the outlet pressure sensor housing (210, Figs. 4-5; ¶ [0072-0073]) adapted to house an outlet pressure sensor (212, Figs. 4-5; ¶ [0072-0073]);
and a remote monitoring unit (control chamber 124 and information panel 126, Figs. 3; these can be considered remote from the sensors themselves as there is an amount of separation between the two) communicatively coupled to the inlet pressure sensor and outlet pressure sensor (212, Figs. 4-5; ¶ [0072-0073]), wherein during operation of the oxygenation system (100, Figs. 1-10), the inlet pressure sensor (212, Figs. 4-5) is configured to generate an inlet blood pressure signal (¶ [0072]) and the outlet pressure sensor (212, Figs. 4-5) is configured to generate an outlet blood pressure signal (¶ [0072-0073]), and wherein the monitoring unit (124 and 126, Fig. 3) is configured to receive the inlet blood pressure signal and outlet blood pressure signal and display corresponding blood pressure measurements (¶ [0072-0073]).
Plott is silent whether the inlet sensing hole is disposed less than 3 cm from the blood inlet opening on the blood inlet end cap.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Plott to have the inlet sensing hole be disposed less than 3 cm from the blood inlet opening on the blood inlet end cap since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Plott would not operate differently with the inlet sensing hole being less than 3 cm from the blood inlet opening on the blood inlet end cap and since changing the distance would merely change the compactness of the device, the device would function appropriately with an inlet sensing hole less than 3 cm from the blood inlet opening on the blood inlet end cap. Further, applicant places no criticality on the range claimed, indicating simply that the blood inlet sensing hole is less than 3 cm but does not say the device is non-functional with a distance greater than 3 cm (¶ [0061] of published Application).
Regarding Claim 15, Plott further discloses the heat exchanger module (314, Fig. 6) includes an H/C fluid inlet chamber (190, Figs. 1-10) and an H/C fluid outlet chamber (192, Figs. 1-10), and the oxygenator module (316, Figs. 1-10) includes a gas inlet port (180, Figs. 1-10) and a gas outlet port (182, Figs. 1-10).
Regarding Claim 16, Plott further discloses the H/C fluid may pass from the H/C fluid inlet chamber (190, Figs. 1-10) through the plurality of fibers and exit through the H/C outlet chamber (192, Figs. 1-10; ¶ [0077-0080]).
Regarding Claim 17, Plott further discloses a gas mixture may pass from the gas inlet port (180, Figs. 1-10) through the plurality of fibers and exit through the gas outlet port (182, Figs. 1-10; ¶ [0077-0080]).
Regarding Claim 18, Plott further discloses the communication circuitry is adapted to communicate with the remote monitoring unit (124 and 126, Fig. 3) by wireless telemetry (¶ [0072-0073]).
Regarding Claim 19, Plott further discloses the communication circuitry is adapted to communicate with the remote monitoring unit (124 and 126, Fig. 3) via electrical connectors mechanically coupled between the inlet and outlet pressure sensors (212, Figs. 4-5) and the remote monitoring unit (124 and 126, Fig. 3; ¶ [0072-0073]).
Claim(s) 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Plott et al (US 2018/0078695) in view of Steffens et al (US 2018/0126057).
Regarding Claims 13 and 20, Plott further discloses the remote monitoring unit (124 and 126, Fig. 3) includes a display (126, Fig. 3).
Plott is silent whether the remote monitoring unit comprises an alarm configured to alert a user upon any of the inlet blood pressure, the outlet blood pressure and a difference between the inlet and outlet blood pressure achieving a certain set value.
Steffens teaches an oxygenator for extracorporeal systems, thus being in the same field of endeavor, with a controller (60, Fig. 2) and communication device (62, Fig. 2), where the communication device comprises an alarm configured to alert a user upon any of the inlet blood pressure, the outlet blood pressure and a difference between the inlet and outlet blood pressure achieving a certain set value (¶ [0022, 0024-0026, 0029]). This allows the nurse to note when the oxygenator is beginning to clot but does not yet need to be changed, so specialists can be ready when needed rather than needing to call them as an emergency (¶ [0029]).
Therefore, it would have been obvious to modify the remote monitoring unit of Plott to include an alarm configured to alert a user upon any of the inlet blood pressure, the outlet blood pressure and a difference between the inlet and outlet blood pressure achieving a certain set value, as taught by Steffens, to allow the nurse to note when the oxygenator is beginning to clot but does not yet need to be changed, so specialists can be ready when needed rather than needing to call them as an emergency (as motivated by Steffens ¶ [0029]).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781