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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/13/26 has been entered.
Claims 1-20 remain pending, of which independent claims 1, 10, 13 were amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/20/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over FLANK (US 4838865) in view of IGARASHI (WO 2018/051982) both as provided by applicant on the IDS dated 3/28/22 in view of SUZUKI (JP 2008/000552) (newly cited), paragraph numbers based on English Translation document.
Regarding claim 1, 6, FLANK discloses a cassette 1, comprising a duct 30 (flow path) on the interior through which blood (a liquid containing at least one biological component) is allowed to flow (Col. 5, lines 1-4); a chamber 31 (storage space of liquid level target detection unit) which temporarily stores the liquid from the duct 30 and has walls configured to allow the liquid level to be detected (Col 6, lines 9-14), the chamber 31, having a cross sectional area for liquid storage that is greater than the cross sectional area of the duct 30 (Figs 1, 3), the cassette main body can be used with the planar direction oriented along a direction of gravity (Fig 3), and the chamber 31 has an upper and lower end (first and second end, respectively), in which the upper end connects to a duct 30 (first flow path) through which the liquid flows into the chamber (storage space) and to a nozzle 34 (second flow path) through which air (a gas) flows from the chamber; and the lower end connects to an outlet 36 (third flow path, plurality of flow paths through which the liquid is allowed to flow) through which the liquid flows out from the chamber 31 (Fig 3, Col. 6, lines 9-25).
FLANK discloses the cassette (Fig 3) and that the cassette may be adapted with a flexible wall but does not explicitly disclose the cassette main body is formed in a sheet shape that possesses flexibility.
However, IGARASHI discloses a blood component cassette 22 with a device main body 23 having a plurality of flow paths, the cassette main body made of a first sheet 38 and second sheet 39 (cassette main body formed in a sheet shape), these sheets being made of a soft material (possesses flexibility), the flow paths leading to a reservoir 47 that is associated with a reservoir sensor 57 (0007, 0046-49, Fig 1-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the cassette adapted with a flexible wall of FLANK to include the cassette main body being formed in a sheet shape that possesses flexibility as taught by IGARASHI because the soft material allows for autoclave sterilization as it exhibits heat resistance (0046-47).
FLANK discloses a liquid level target detection as stated above (Col 6, lines 9-14), but does not explicitly disclose the liquid level target detection portion has a check valve positioned in the second flow path to allow the gas flowing out to pass therethrough nor a clamp positioned in the second flow path between the liquid level target detection portion and the check valve.
However SUZUKI discloses a cassette body 2 comprising a plurality of flow paths 9k, 19, 39, 49, 59, (Fig 2); an air bubble removing device 50 that has liquid level sensors 52, 54 for detecting the upper and lower liquid levels (liquid level target detection portion), the air bubble removing device configured to temporarily store a liquid, and having a flow path 59 through which liquid flows into the device (first flow path), a valve 51 that sends out bubbles (second flow path through which gas flows out), and an exit flow path 59 through which liquid flows out of the device (third flow path), in which a check valve 51 is associated with the bubble (gas) exit path (second flow path) (0043, 0049-50 Fig 7); the check valve being provided with a myriad of hollow fibers (0051) and clamps are connected to the liquid outlet of the bubble removing device and further clamps for opening and closing the tubes are provided everywhere to prevent liquid leakage during setting (0044-45).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the chamber for liquid level detection and associated flow paths of FLANK to include the air bubble removing device with liquid level detection, check valve on the gas exit flow path and clamps everywhere (including between the liquid level detection and the check valve) as taught by SUZUKI because the check valve allows for aseptic release of bubbles formed in the fluid by the heater (0043) and the clamps on all tubes, including the hollow fibers of the check valve because it would prevent liquid leakage if the device is rotated (0045). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to place a clamp on all exit tubes including the bubble exit of SUZUKI since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 2, IGARASHI discloses the cassette a cassette holding section (frame) that is more rigid than the cassette main body to hold the cassette by sandwiching the peripheral edge of the cassette (frame configured to retain cassette), the holding section having concave portions that accommodate the cassette (Fig 4, 16).
Regarding claim 3, IGARASHI discloses the frame retains the soft cassette main body in a flat state in a planar direction and includes a flat wall portion arranged a position in the chamber 47 that would face the liquid level target detection unit (Fig 9a).
Regarding claim 4, FLANK discloses the cassette main body can be used with the planar direction oriented along a direction of gravity (Fig 3). In reference to the claim limitation “the cassette main body is used” it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115.
Regarding claim 5, FLANK discloses the longitudinal direction of the chamber 31 (liquid level target detection unit) is orientated along the direction of gravity (Fig 3), but does not explicitly disclose that it is formed in a rectangular shape. However, IGARASHI discloses the reservoir 47 can be formed in a rectangular shape (Fig 1). It would have been an obvious matter of choice for a person of ordinary skill in the art to choose the chamber shape of FLANK to be rectangular as disclosed by IGARASHI, absent persuasive evidence that the particular configuration of the chamber was significant. See MPEP 2144.04.
Regarding claim 7, IGARASHI further discloses the cassette main body is formed by joining together a first and second sheet, in which the sheets can be vinyl chloride or polyolefin (resins), with the flow path disposed between them, and wherein in cross section along a thickness direction, the chamber 31 (liquid level target detection unit) includes a flat portion in which the pair of sheets extend in a flat shape and are configured to expand (separate) away from each other (0047, Fig 7, 9A).
Regarding claim 8, FLANK disclose a plurality of concavities and convexities are formed along a planar direction on a surface of the liquid level target detection unit (Fig 14) as does IGARASHI (Fig 3).
Regarding claim 9, FLANK disclose the liquid includes a blood (culture medium with cells) and wherein the system causes the blood to flow through chamber 31 (storage space) and past a level detecting means 32 (Col. 6, lines 5-16, Fig 3). In reference to the claim limitation “wherein the liquid includes” it is noted that the material or article worked upon does not further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115.
Regarding claim 10, FLANK discloses a kit comprising a tube 26, 28, 11 or 11’ (Fig 3) through which blood is allowed to flow; a cassette 1, comprising a duct 30 (flow path) on the interior through which blood (a liquid containing at least one biological component) is allowed to flow (Col. 5, lines 1-4); a chamber 31 (storage space of liquid level target detection unit) which temporarily stores the liquid from the duct 30 and has walls configured to allow the liquid level to be detected (Col 6, lines 9-14), the chamber 31, having a cross sectional area for liquid storage that is greater than the cross sectional area of the duct 30 (Figs 1, 3). and the chamber 31 has an upper and lower end (first and second end, respectively), in which the upper end connects to a duct 30 (first flow path) through which the liquid flows into the chamber (storage space) and to a nozzle 34 (second flow path) through which air (a gas) flows from the chamber; and the lower end connects to an outlet 36 (third flow path, plurality of flow paths through which the liquid is allowed to flow) through which the liquid flows out from the chamber 31 (Fig 3, Col. 6, lines 9-25).
FLANK discloses the cassette (Fig 3) and that the cassette may be adapted with a flexible wall but does not explicitly disclose the cassette main body is formed in a sheet shape that possesses flexibility.
However, IGARASHI discloses a blood component cassette 22 with a device main body 23 having a plurality of flow paths, the cassette main body made of a first sheet 38 and second sheet 39 (cassette main body formed in a sheet shape), these sheets being made of a soft material (possesses flexibility), the flow paths leading to a reservoir 47 that is associated with a reservoir sensor 57 (0007, 0046-49, Fig 1-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the cassette adapted with a flexible wall of FLANK to include the cassette main body being formed in a sheet shape that possesses flexibility as taught by IGARASHI because the soft material allows for autoclave sterilization as it exhibits heat resistance (0046-47).
FLANK discloses a liquid level target detection as stated above (Col 6, lines 9-14), but does not explicitly disclose the liquid level target detection portion has a check valve positioned in the second flow path to allow the gas flowing out to pass therethrough nor a clamp positioned in the second flow path between the liquid level target detection portion and the check valve.
However SUZUKI discloses a cassette body 2 comprising a plurality of flow paths 9k, 19, 39, 49, 59, (Fig 2); an air bubble removing device 50 that has liquid level sensors 52, 54 for detecting the upper and lower liquid levels (liquid level target detection portion), the air bubble removing device configured to temporarily store a liquid, and having a flow path 59 through which liquid flows into the device (first flow path), a valve 51 that sends out bubbles (second flow path through which gas flows out), and an exit flow path 59 through which liquid flows out of the device (third flow path), in which a check valve 51 is associated with the bubble (gas) exit path (second flow path) (0043, 0049-50 Fig 7); the check valve being provided with a myriad of hollow fibers (0051) and clamps are connected to the liquid outlet of the bubble removing device and further clamps for opening and closing the tubes are provided everywhere to prevent liquid leakage during setting (0044-45).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the chamber for liquid level detection and associated flow paths of FLANK to include the air bubble removing device with liquid level detection, check valve on the gas exit flow path and clamps everywhere (including between the liquid level detection and the check valve) as taught by SUZUKI because the check valve allows for aseptic release of bubbles formed in the fluid by the heater (0043) and the clamps on all tubes, including the hollow fibers of the check valve because it would prevent liquid leakage if the device is rotated (0045). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to place a clamp on all exit tubes including the bubble exit of SUZUKI since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 11, IGARASHI discloses the cassette a cassette holding section (frame) that is more rigid than the cassette main body to hold the cassette by sandwiching the peripheral edge of the cassette (frame configured to retain cassette), the holding section having concave portions that accommodate the cassette (Fig 4, 16).
Regarding claim 12, FLANK discloses the cassette main body can be used with the planar direction oriented along a direction of gravity (Fig 3). In reference to the claim limitation “the cassette main body is used” it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115.
Regarding claim 13-14, FLANK discloses a kit comprising a tube 26, 28, 11 or 11’ (Fig 3) through which blood is allowed to flow; a cassette 1, comprising a duct 30 (flow path) on the interior through which blood (a liquid containing at least one biological component) is allowed to flow (Col. 5, lines 1-4); a chamber 31 (storage space of liquid level target detection unit) which temporarily stores the liquid from the duct 30 and has walls configured to allow the liquid level to be detected (Col 6, lines 9-14), the chamber 31, having a cross sectional area for liquid storage that is greater than the cross sectional area of the duct 30 (Figs 1, 3), in which there is a monitor housing 3 (biological component treatment device) in which the tube and cassette are set (Fig 1), the monitor housing including a level detecting means that can be an ultrasonic detector 32 (liquid level sensor) facing the chamber 31 (liquid level target detection unit) when paired with the cassette, the level detecting means configured to sense through the wall a liquid level in the chamber 31 (Col. 6, lines 9-14 and the chamber 31 has an upper and lower end (first and second end, respectively), in which the upper end connects to a duct 30 (first flow path) through which the liquid flows into the chamber (storage space) and to a nozzle 34 (second flow path) through which air (a gas) flows from the chamber; and the lower end connects to an outlet 36 (third flow path, plurality of flow paths through which the liquid is allowed to flow) through which the liquid flows out from the chamber 31 (Fig 3, Col. 6, lines 9-25).
FLANK discloses the cassette (Fig 3) and that the cassette may be adapted with a flexible wall but does not explicitly disclose the cassette main body is formed in a sheet shape that possesses flexibility.
However, IGARASHI discloses a blood component cassette 22 with a device main body 23 having a plurality of flow paths, the cassette main body made of a first sheet 38 and second sheet 39 (cassette main body formed in a sheet shape), these sheets being made of a soft material (possesses flexibility), the flow paths leading to a reservoir 47 that is associated with a reservoir sensor 57 (0007, 0046-49, Fig 1-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the cassette adapted with a flexible wall of FLANK to include the cassette main body being formed in a sheet shape that possesses flexibility as taught by IGARASHI because the soft material allows for autoclave sterilization as it exhibits heat resistance (0046-47).
FLANK discloses a liquid level target detection as stated above (Col 6, lines 9-14), but does not explicitly disclose the liquid level target detection portion has a check valve positioned in the second flow path to allow the gas flowing out to pass therethrough nor a clamp positioned in the second flow path between the liquid level target detection portion and the check valve.
However SUZUKI discloses a cassette body 2 comprising a plurality of flow paths 9k, 19, 39, 49, 59, (Fig 2); an air bubble removing device 50 that has liquid level sensors 52, 54 for detecting the upper and lower liquid levels (liquid level target detection portion), the air bubble removing device configured to temporarily store a liquid, and having a flow path 59 through which liquid flows into the device (first flow path), a valve 51 that sends out bubbles (second flow path through which gas flows out), and an exit flow path 59 through which liquid flows out of the device (third flow path), in which a check valve 51 is associated with the bubble (gas) exit path (second flow path) (0043, 0049-50 Fig 7); the check valve being provided with a myriad of hollow fibers (0051) and clamps are connected to the liquid outlet of the bubble removing device and further clamps for opening and closing the tubes are provided everywhere to prevent liquid leakage during setting (0044-45).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the chamber for liquid level detection and associated flow paths of FLANK to include the air bubble removing device with liquid level detection, check valve on the gas exit flow path and clamps everywhere (including between the liquid level detection and the check valve) as taught by SUZUKI because the check valve allows for aseptic release of bubbles formed in the fluid by the heater (0043) and the clamps on all tubes, including the hollow fibers of the check valve because it would prevent liquid leakage if the device is rotated (0045). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to place a clamp on all exit tubes including the bubble exit of SUZUKI since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 15, FLANK discloses the level detecting means can be an ultrasonic detector or light beam and photo cell sensor (Col. 6, lines 9-14) but does not explicitly disclose the liquid level sensor is a capacitance sensor. However, it would have been obvious to one of ordinary skill in the art to modify the liquid level detecting means of FLANK to be a capacitance sensor, because it would involve simple substitution of one known element for another to obtain predictable liquid level results.
Regarding claim 16, IGARASHI further discloses the cassette main body is formed by joining together a first and second sheet, in which the sheets can be vinyl chloride or polyolefin (resins), with the flow path disposed between them, and wherein in cross section along a thickness direction, the chamber 31 (liquid level target detection unit) includes a flat portion in which the pair of sheets extend in a flat shape and are configured to expand (separate) away from each other (0047, Fig 7, 9A) and FLANK discloses the level detecting sensor as discussed in the above rejection of claim 13, but neither explicitly disclose the sensor includes an upper and lower sensor, respectively located on an upper and lower part of the flat portion. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to duplicate the sensor and place one at each the upper and lower portion, to achieve a more accurate level detection when the chamber is either close to full or close to empty. Additionally, it would be obvious to one of ordinary skill in the art since it merely represents a duplication of parts already known in the art and a rearrangement of parts without substantially affecting functionality or operation, and therefore is prima facie obvious. See MPEP 2144.04
Regarding claim 17, IGARASHI discloses the cassette a cassette holding section (frame) that is more rigid than the cassette main body to hold the cassette by sandwiching the peripheral edge of the cassette (frame configured to retain cassette), the holding section having concave portions that accommodate the cassette (Fig 4, 16).
Regarding claim 18, FLANK discloses the cassette main body can be used with the planar direction oriented along a direction of gravity (Fig 3). In reference to the claim limitation “the cassette main body is used” it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115.
Regarding claim 19, FLANK disclose a plurality of concavities and convexities are formed along a planar direction on a surface of the liquid level target detection unit (Fig 14) as does IGARASHI (Fig 3).
Regarding claim 20, FLANK disclose the liquid includes a blood (culture medium with cells) and wherein the system causes the blood to flow through chamber 31 (storage space) and past a level detecting means 32 (Col. 6, lines 5-16, Fig 3). In reference to the claim limitation “wherein the liquid includes” it is noted that the material or article worked upon does not further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. Further, it has been held that "[i]inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP 2114 and 2115.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argued the combination of FLANK and IGARASHI did not teach the check valve to allow the gas flowing out nor the clamp positioned in the second flow path limitations, both of which are now addressed by the newly cited art SUZUKI (see above rejections of claims 1, 10, 13).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional references US20120130298 was cited as it pertains to the state of the art of applicant’s endeavor as it teaches a cassette with a liquid level detector and associated valves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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