DETAILED ACTION
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 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.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 comprises the limitation “the apheresis or collection system reinfusion flow path”, which renders the claim indefinite, since while an apheresis system reinfusion flow path is defined within claim 7, no “collection system reinfusion flow path” is defined within this claim nor any claim upon which it depends. Therefore, the scope of the claim is rendered indefinite. For examination purposes, the “collection system” portion of the above cited limitation is interpreted within the context of claim 1 and the specification as being a synonymous rephasing of the “apheresis system” defined within claim 1, such that the limitation “the apheresis or collection system reinfusion flow path” refers to the same apheresis system reinfusion flow path structure. Appropriate clarification is, however, required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 9-13, 21-23, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oka (WIPO Pub. No. 2014/204001 A1).
Regarding claim 1, Oka discloses a bedside cell processing system (here, the term “bedside” does not convey any specific structural/configurational meaning, and is thus interpreted as reflective of intended use), comprising: an apheresis system (centrifuge 20) configured to collect from a patient a blood component (leukocyte/white blood cell fraction) comprising target cells (leukocytes/white blood cells, some of which may be abnormally activated cells – leukemia cells or leukemia progenitor cells, among others – see Fig. 5 and English Translation, pg. 22, ln 1-11, and pg. 26, ln 11 – pg. 27, ln 2); a cell processing system (cell sorter 30) configured to receive the target cells from the apheresis system and to process the target cells (by identifying, sorting, and removing abnormally activated cells – see Fig. 5 and English Translation, pg. 27, ln 1 – pg. 28, ln 14); and a reinfusion system (light irradiator/reinfusion system 40) configured to receive the processed target cells from the cell processing system and to return the processed cells to the patient (see Fig. 5 and English Translation, pg. 28, ln 5 – pg. 29, ln 11, and pg. 34, ln 1 – pg. 35, ln 5).
Regarding claim 2, Oka discloses that the apheresis system further comprises fluid communication access to the patient via a collection flow path (path originating at the blood collection needle installed within the patient, passing through blood collection line 10, and outputting into the centrifuge 20) (see Fig. 5 and English Translation, pg. 26, ln 11-13).
Regarding claim 3, Oka discloses that the collection flow path further comprises a connection to the patient via a needle (blood collection needle – see Fig. 5 and English Translation, pg. 26, ln 11-13).
Regarding claim 5, Oka discloses that the apheresis system further comprises fluid communication access to the patient to return to the patient cells that remain in the apheresis system after at least a portion of the target cells are received by the cell processing system (the red blood cell, plasma, and platelet fractions) via an apheresis system reinfusion flow path (originating at the centrifuge system 20, passing through first recirculation line 51, converging into third recirculation blood return line 53 at a Y-connection, and proceeding through third recirculation blood return line 53 to outlet within the patient - see Fig. 5 and English Translation, pg. 26, ln 14-18).
Regarding claim 9, Oka discloses that the cell processing system processes the target cells received from the apheresis system using light treatment (exciting individual particles with laser light and analyzing the resulting specific fluorescence – see English Translation, pg. 27, ln 4-6 and ln 9-12), cell separation (separating the cells contained within charged droplets using a charged deflection plate - see English Translation, pg. 27, ln 6-8 and ln 9-12) and washing (dispersing individual cells as fine particles in a fluid - see English Translation, pg. 27, ln 3-8).
Regarding claim 10, Oka discloses that the cell processing system further comprises fluid communication with the apheresis system via a collected target cells flow path (originating at the centrifuge system 20, passing through the first connecting line 61, and outleting into the cell sorter 30 - see Fig. 5 and English Translation, pg. 27, ln 1-2).
Regarding claim 11, Oka discloses that the reinfusion system further comprises fluid communication with the cell processing system via a processed target cells flow path (originating at the cell sorter 30, passing through the second connection line 62, and outleting at the light irradiator/recirculation system 40 - see Fig. 5 and English Translation, pg. 28, ln 5-6).
Regarding claim 12, Oka discloses that the reinfusion system further comprises fluid communication access to the patient to return to the patient processed target cells via a reinfusion system flow path (originating at the light irradiator/recirculation system 40, passing through the second recirculation blood return line 52, converging into third recirculation blood return line 53 at a Y-connection, and proceeding through third recirculation blood return line 53 to outlet within the patient - see Fig. 5 and English Translation, pg. 34, ln 11-18).
Regarding claim 13, Oka discloses that the reinfusion system further comprises fluid communication access to the patient to return to the patient processed target cells via a reinfusion system flow path (originating at the light irradiator/recirculation system 40, passing through the second recirculation blood return line 52, converging into third recirculation blood return line 53 at a Y-connection, and proceeding through third recirculation blood return line 53 to outlet within the patient - see Fig. 5 and English Translation, pg. 34, ln 11-18).
Regarding claim 21, Oka discloses that a method of operating a bedside cell processing system (here, the term “bedside” does not convey any specific structural/configurational meaning, and is thus interpreted as reflective of intended use) for a patient (English Translation, pg. 7, ln 12-16), the method comprising: connecting an apheresis system (centrifuge 20) to the patient via a collection flow path (see Fig. 5 and English Translation, pg. 26, ln 11-13); connecting the apheresis system to a cell processing system (cell sorter 30) via a collected target cells flow path (see Fig. 5 and English Translation, pg. 27, ln 1-2); connecting the cell processing system to a reinfusion system (light irradiator/reinfusion system 40) via a processed target cells flow path (see Fig. 5 and English Translation, pg. 28, ln 5-6); connecting the reinfusion system to the patient via a reinfusion system flow path (see Fig. 5 and English Translation, pg. 34, ln 11-18); operating the apheresis system to collect from the patient via the collection flow path a blood component (leukocyte/white blood cell fraction) comprising target cells (leukocytes/white blood cells, some of which may be abnormally activated cells – leukemia cells or leukemia progenitor cells, among others – see Fig. 5 and English Translation, pg. 19, ln 1-3, pg. 22, ln 1-11, and pg. 26, ln 11 – pg. 27, ln 2); operating the cell processing system to receive the target cells from the apheresis system via the collected target cells flow path and to process the target cells (by identifying, sorting, and removing abnormally activated cells – see Fig. 5 and English Translation, pg. 19, ln 3-7, pg. 23, pg. 27, ln 1 – pg. 28, ln 14); and operating the reinfusion system to receive the processed target cells from the cell processing system via the processed target cells flow path and to return the processed target cells to the patient via the reinfusion system flow path (see Fig. 5 and English Translation, pg. 28, ln 5 – pg. 29, ln 11, and pg. 34, ln 1 – pg. 35, ln 5).
Regarding claim 22, Oka discloses that the collection flow path further comprises a connection to the patient via a needle or catheter (see in re claim 3).
Regarding claim 23, Oka discloses that the apheresis system further comprises an apheresis system reinfusion flow path to return to the patient cells that remain in the apheresis system after at least a portion of the target cells are received by the cell processing system (see in re claim 5).
Regarding claim 28, Oka discloses that operating the bedside cell processing system further comprises processing the target cells received from the apheresis system using light treatment, cell separation, and washing (see in re claim 9).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4, 6-8, 14-18, 24-27, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Oka in view of Min (U.S. Pat. Pub. No. 2010/0217174 A1).
Regarding claim 4, Oka discloses the cell processing system of claim 2. Oka fails to teach that the collection flow path further comprises a Y-connector, and a first flow path between the patient and the Y-connector and a second flow path between the Y-connector and the apheresis system, Oka instead teaching a collection/reinfusion configuration wherein blood is collected from the patient along a collection flow path (see in re claim 2) entirely separate from the combined reinfusion flow path (via recirculation line 50) along which it is returned (see in re claims 5 and 12), thus no Y-connector within the apheresis collection flow path (such as may allow reinfusion through the blood collection needle) is provided. However, it is well known within the art to alternatively configure such a device to collect and reinfuse blood through the same single needle/catheter, thereby necessitating that the collection flow path of the apheresis system and the combined reinfusion flow path are joined in the vicinity of the needle by a Y-connector. Min, for example, exhibits a cell processing system (apheresis system for collecting target cells, including red blood cells, platelets, or plasma) similar to that of Oka (see Fig. 1-3 and [0015-0024]) and teaches that such a system may be alternatively configured as either utilizing separate collection and return flow paths (dual needle configuration of Fig. 1 and [0032]), or as allowing collection and reinfusion through the same single needle (single needle configuration of Fig. 2-3 and [0024-0026] and [0033-0037]). Min further teaches that such a single collection/reinfusion needle configuration necessitates that the collection flow path of the apheresis system (extending from needle 70 to flow communication site 30, then through first flow path 18 to the inlet 14 of the apheresis system/blood processor 12) comprise a Y-connector (Y-connector at flow communication site 30), wherein a first flow path (extending from the flow communication site 30 through needle segment 68 and to the needle 70) exists between the patient and the Y-connector (see Fig. 2-3 and [0024-0026]) and a second flow path (first flow path 18) exists between the Y-connector and the apheresis system (see Fig. 2-3 and [0024-0026]), and wherein the combined reinfusion flow path (passing through second flow path 20) is also joined to the Y-connector, such that reinfusion may occur through the blood collection needle (see Fig. 2-3 and [0025]). Min teaches that this single collection/reinfusion needle configuration has the distinct advantage of requiring fewer punctures/access sites within the patient’s vascular system, thereby improving patient comfort and reducing stress on the patient’s vascular system as a result of the procedure ([0005], ln 7-12 and 20-22). It is thus clear that, based upon the teachings and example of Min, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the cell processing system of Oka such that, rather than utilizing separate collection and reinfusion flow paths, the cell processing system may be configured to collect and reinfuse blood through the same single blood collection/reinfusion needle, thereby necessitating that the collection flow path of the apheresis system (the apheresis system collection flow path) further comprises a Y-connector, wherein a first flow path (a first portion of the blood collection line 10 in Oka) may exist between the patient and the Y-connector and a second flow path (a second portion of the blood collection line 10 in Oka) may exists between the Y-connector and the apheresis system, and wherein the combined reinfusion flow path (recirculation line 50 in Oka) is also joined to the Y-connector, such that reinfusion may occur through the blood collection needle, as in the manner taught by Min. Such a configuration would have been obvious because it is known within the art (see in re Min) and because it is known to improve patient comfort and reducing stress on the patient’s vascular system as a result of the procedure in comparison to a double needle/access point configuration, as described by Min ([0005], ln 7-12 and 20-22).
Regarding claim 6, Oka discloses that the apheresis system further comprises fluid communication access to the patient via an apheresis system reinfusion flow path (originating at the centrifuge system 20, passing through first recirculation line 51, converging into third recirculation blood return line 53 at a Y-connection, and proceeding through third recirculation blood return line 53 to outlet within the patient - see Fig. 5 and English Translation, pg. 26, ln 14-18) to return to the patient cells that remain in the apheresis system (red blood cells) after at least a portion of the target cells are received by the cell processing system (see English Translation, pg. 26, ln 14-18).
Regarding claim 7, the proposed combination of Oka as modified by Min according to claim 4 further exhibits that the apheresis system reinfusion flow path (which converges into the combined reinfusion flow path) further comprises a connection to the Y-connector in the collection flow path (see in re claim 4), wherein the first flow path also is used for reinfusion (see in re claim 4).
Regarding claim 8, Oka discloses that the apheresis system reinfusion flow path further comprises a Y-connector (see Fig. 5 and English Translation, pg. 34, ln 13-18, wherein a Y-connector is provided at the convergence of first recirculation blood return line 51, which is part of the apheresis system reinfusion flow path, and second recirculation blood return line 52, these lines converging into the combined recirculation line 50), and a third flow path (first recirculation blood return line 51) between the apheresis system and the Y-connector in the apheresis system reinfusion flow path (see Fig. 5 and English Translation, pg. 34, ln 11-18). Upon the modification of Oka based upon the teachings of Min (see in re claim 4), Oka further comprises the Y-connector of claim 4, which connects the combined reinfusion flow path (recirculation line 50) to the first flow path (a first portion of the blood collection line 10), thereby allowing blood from the apheresis system and reinfusion system to be returned to the patient using the same needle (see in re claim 4). It then follows that, because the Y-connector provided within the apheresis system reinfusion flow path in Oka converges each reinfusion flow path (that of the centrifuge/apheresis system 20 and that of the light irradiator/reinfusion system 40) into a single combined reinfusion flow path (recirculation line 50), and since all fluid to be reinfused must pass through the Y-connector provided within the apheresis system collection flow path in order to enable collection and reinfusion through the same needle/catheter (see in re claim 4), it follows that this combined reinfusion flow path must then extend between the Y-connector in the apheresis system reinfusion flow path and the Y-connector in the apheresis system collection flow path, and may thus be designated a fourth flow path as claimed.
Regarding claim 14, Oka further discloses that the reinfusion system flow path further comprises a fifth flow path (second recirculation blood return line 52) between the reinfusion system and the Y-connector in the apheresis system reinfusion flow path (see in re claim 8, and see Fig. 5 and English Translation, pg. 34, ln 11-18).
Regarding claim 15, Oka further discloses that the reinfusion system flow path further comprises the fifth flow path between the reinfusion system and the Y-connector in the apheresis system reinfusion flow path (see in re claim 14), and the proposed combination of Oka as modified by Min exhibits the fourth flow path between the Y-connector in the apheresis system reinfusion flow path and the Y-connector in the apheresis system collection flow path (see in re claim 8) and the first flow path between the Y-connector in the apheresis system collection flow path and the patient (see in re claim 4).
Regarding claim 16, while Oka fails to explicitly teach that the reinfusion system further comprises a controller having a microprocessor and memory, such features are well known within the art to be necessary components for enabling the processes described by Oka. For example, Min exhibits a cell processing system (see Fig. 1-3 and [0015-0017]) similar to that of Oka (wherein blood collected from a patient is separated and sorted into target cells/components, some target cells/components are removed, and the remainder is reinfused to the patient), wherein the reinfusion system comprises at least one pump (flow control pump 80) to deliver processed target cells to the patient (see Fig. 1-3 and [0026]), and wherein a controller is provided (see [0031]) to operate the pump of the reinfusion system based upon observed pressures within the collection and return flow paths as measured by pressure sensors (P1-P3), thereby preventing reinfusion at unsafe pressure to the patient and detecting potential blockages within the flow paths of the system ([0028-0031]). While Min does not explicitly teach that the controller comprises a microprocessor and memory, such components are well known within the art to be essential components of such as controller (this is so commonly understood as to be taken on Official Notice). Thus, based at least upon the teachings of Min, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to configure the reinfusion system of Oka to comprise a controller having a microprocessor and memory, such as may be in communication with a pump of the reinfusion system configured for delivering processed target cells to the patient, in order to facilitate operational control of the reinfusion system. Such may be implemented in the manner taught by Min, wherein pressure sensors may be further provided, such that the controller may operate the pump based upon observed pressure within the return flow path, thereby preventing reinfusion at unsafe pressure to the patient and detecting potential blockages within the flow paths of the system, as described by Min ([0030-0031]).
Regarding claim 17, Oka as modified by Min according to claim 16 exhibits that the reinfusion system may comprise a pump (see in re claim 16).
Regarding claim 18, Min teaches that such a reinfusion system may further comprise a pressure sensor (P3) and a clamp (one of the array 54 of clamps which is provided within the return flow path 20 for controlling flow through the return flow path 20 – see Fig. 1-3, [0022], ln 4-7, [0025], and [0026], ln 5-8) in communication with the controller ([0031]), in order to thereby enable the controller to facilitate the collection and reinfusion of blood to the patient through the single needle (clamp 54 of the return flow path 20 is required in this configuration, since during collection, the clamp 54 on the return flow path must be closed to prevent backflow of blood through the system, and it must be opened during reinfusion to allow blood to pass through to the patient) and to enable operational control of the reinfusion system based upon the observed pressure within the return flow path as measured by pressure sensor ([0031]), thereby preventing reinfusion at unsafe pressure to the patient and allowing the potential blockages within the return flow path of the system to be detected by the controller ([0030-0031]). Based on these teachings of Min, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further configure the reinfusion system of Oka as modified above in re claim 16 to comprise a pressure sensor and a clamp in communication with the controller, in order to thereby enable the controller to facilitate the proper operation of collection and reinfusion of blood through the single blood collection/reinfusion needle, and to enable operational control of the reinfusion system based upon the observed pressure within the return flow path as measured by the pressure sensor, thereby preventing reinfusion at unsafe pressure to the patient and allowing the potential blockages within the reinfusion flow path of the system to be detected by the controller, as described by Min ([0030-0031]).
Regarding claim 24, the proposed combination of Oka as modified by Min (see in re claim 4) further exhibits that the apheresis system reinfusion flow path (extending from the apheresis system along the first recirculation blood return line 51, through the Y-connector of the apheresis system, along the combined recirculation blood return line 50, through the Y-connector of the apheresis collection system, and through the first flow path portion of the blood collection line 10 to the single blood collection/reinfusion needle – see in re claims 5 and 8, and see also Fig. 5, English Translation, pg. 34, ln 11-18), includes a portion of the apheresis system collection flow path (the first flow path portion, extending between the Y-connector of the apheresis system collection flow path and the single blood collection/reinfusion needle – see in re claim 4).
Regarding claim 25, the proposed combination of Oka as modified by Min (see in re claim 4) further exhibits that the portion of the apheresis system collection flow path included in the apheresis system reinfusion flow path (the first flow path portion) further comprises a connection to the patient via a needle (the single blood collection/reinfusion needle – see in re claim 4).
Regarding claim 26, the proposed combination of Oka as modified by Min (see in re claim 4) further exhibits that the reinfusion system flow path (extending from the light irradiator/reinfusion system 40 along the second recirculation blood return line 52, through the Y-connector of the apheresis system, along the combined recirculation blood return line 50, through the Y-connector of the apheresis collection system, and through the first flow path portion of the blood collection line 10 to the single blood collection/reinfusion needle – see in re claims 4, 7, 8, and 14, and see also Fig. 5 and English Translation, pg. 34, ln 11-18) includes a portion of the apheresis system reinfusion flow path (Y-connector of the apheresis system and the combined recirculation blood return line 50 portions, which are shared by both the apheresis system reinfusion flow path and the reinfusion system flow path) and a portion of the apheresis system collection flow path (the Y-connector of the apheresis collection system provided in the proposed modification in re claim 4, the first flow path portion of the blood collection line 10, and the single blood collection/reinfusion needle, which are shared by both the reinfusion system flow path and the apheresis system collection flow path).
Regarding claim 27, the proposed combination of Oka as modified by Min (see in re claim 4) further exhibits that the portion of the apheresis system collection flow path included in the apheresis system reinfusion flow path (the first flow path portion) further comprises a connection to the patient via a needle (the single blood collection/reinfusion needle – see in re claim 4).
Regarding claim 29, the proposed combination of Oka as modified by Min (see in re claim 16) further exhibits that the reinfusion system may comprise a pump for delivering processed target cells to the patient (see in re claim 16), therefore, it would have been obvious to one of ordinary skill in the art to correspondingly modify the method of Oka such that the step of operating the reinfusion system further comprises having a controller operate a pump to deliver the processed target cells to the patient.
Regarding claim 30, the proposed combination of Oka as modified by Min (see in re claim 16) further exhibits that the reinfusion system may comprise a controller for operatively controlling the reinfusion system, including the pump (see in re claim 16). While neither Min nor Oka explicitly teach that the controller may comprise a microprocessor and memory, such components are well known within the art to be essential components of such as controller (this is so commonly understood as to be taken on Official Notice), therefore, it would have been obvious to one of ordinary skill in the art to implement the controller of Oka as modified by Min to include such features as merely providing essential components of the device.
Regarding claim 31, the proposed combination of Oka as modified by Min (see in re claim 18) further exhibits that the reinfusion system may further comprise a sensor and a clamp (see in re claim 18).
Claim(s) 19 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Oka as modified by Min according to claims 18 and 31 respectively, and in further view of Mitschulat (U.S. Pat. Pub. No. 2019/0167889 A1).
Regarding claim 19, Oka as modified by Min according to claim 18 exhibits the cell processing system of claim 18. While Oka fails to explicitly teach that the reinfusion system further comprises an input device and an output device, such features are well known within the art to be necessary components for enabling a controller to perform the processes described by Oka (which must, at the very least, be initiated and terminated by some form of input, and which, upon modification to include a controller of the type taught by Min, must also comprise some sort of output means for indicating an anomalous pressure measurement). For example, Mitschulat exhibits a cell processing system (for collecting blood from a patient, separating stem cells and/or lymphocytes from the blood via apheresis, and reinfusing the remainder to the patient) similar to that of Oka, wherein the system may include a controller (processor device) in communication with an input device (front panel 100 comprising graphic user interface 101, on button 102, and off button 103) for activating the blood/cell processing procedure and several output devices (printer 3 and donor display 4) for providing real-time monitoring of the procedure as well as recorded data which may be reviewed in detail (see [0025], [0094-0095], and [0097-0098]). Based on the teachings and example of Mitschulat, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to implement the cell processing system of Oka as further including an input device in communication with the controller for activating the blood/cell processing procedure upon user input of parameters and an output device in communication with the controller for providing real-time monitoring of the procedure as well as recorded data which may be reviewed in detail, as described by Mitschulat, such features being clearly essential and/or advantageous to the proper use and monitoring of such as device.
Regarding claim 33, Oka may be modified by Min and Mitschulat (see in re claim 19) to comprise an input device in communication with the controller for activating the blood/cell processing procedure. It therefore follows that one of ordinary skill in the art would have found it obvious, based upon the teachings of Mitschulat, to correspondingly modify the method of operating the reinfusion system to further comprise entering parameters into the controller via an input device in order to thereby enable the controller (by activation at the very least) to perform the processes described by Oka.
Claim(s) 20 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Oka as modified by Min and Mitschulat according to claims 19 and 31 respectively, and in further view of Pages (U.S. Pat. Pub. No. 2011/0178453 A1).
Regarding claim 20, Oka as modified by Min and Mitschulat according to claim 19 exhibits the cell processing system of claim 19. Here, while Min teaches that such a reinfusion system may comprise several pressure sensors and clamps in communication with the controller, in order to thereby enable the controller to facilitate operational control of the reinfusion system based upon observed pressures within the system (see in re claim 18). These sensors may include a first pressure sensor (P1) provided within the blood collection flow path (first flow path 18) for measuring its pressure and a second pressure sensor (P2) provided within the return flow path (return line 20) for measuring its pressure (see Fig. 1-3 and [0029-0031]). While Min does not explicitly teach that such sensors may serve as venous pressure sensors (i.e. sensors configured to measure pressure at the venous access site), Pages (which exhibits a blood processing system similar to that of Oka and Min) teaches that such a configuration may be configured to accurately determine the venous pressure of the patient ([0042-0043]), and that the controller may be operated to control flow rate and maintain pressures within the system in response to this measurement ([0029], [0043], and [0064]). Pages also teaches that such a measurement is critical to patient safety, since a venous pressure that is too low may unnecessary lengthen the blood processing procedure, leading to patient discomfort, whereas a venous pressure that is too high may lead to harmful vein lesions within the patient ([0004] and [0042]). Thus, based upon the teachings of Pages and Min, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the sensors of Oka as modified by Min, or else provide additional sensors, such that a first pressure sensor provided within the blood collection flow path and a second pressure sensor provided within the return flow path may be configured to accurately determine venous pressure (i.e. may be configured as venous pressure sensors), in order to thereby allow the controller to operatively control the reinfusion system based upon this measurement, avoiding both unnecessary lengthening of the procedure (venous pressure too low, leading to discomfort) or harmful vein lesions (veinous pressure too high), as described by Pages ([0004] and [0042]).
Regarding claim 32, Oka as modified by Min and Mitschulat according to claim 31 may be further modified according to the teachings of Pages (see in re claim 20 above) such that that a first pressure sensor provided within the blood collection flow path and a second pressure sensor provided within the return flow path may be configured to accurately determine venous pressure (i.e. may be configured as venous pressure sensors), in order to thereby allow the controller to operatively control the reinfusion system based upon this measurement, avoiding both unnecessary lengthening of the procedure (venous pressure too low, leading to discomfort) or harmful vein lesions (veinous pressure too high), as described by Pages (see in re claim 20).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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