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
Applicant’s amendments filed on 01/28/2026 have been fully considered. Claims 1-18 are pending in this application. Claim 1, 5, and 10-12 are amended. Claims 13-18 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claim 1 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. The rejection of newly added claims 13-18 will be addressed in the rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1 and 3-18 are rejected under 35 U.S.C. 103 as being unpatentable over Stuva et al. (Publication No. US 2015/0306299 A1) in view of Los (Publication No. US 2019/0099539 A1) and DeVries et al. (Patent No. US 8,522,780 B2).
Regarding claim 1, Stuva teaches a pressure measuring device (pressure pod apparatus 412 with connection apparatus 540; Figure 4, 5A-5C, and 6A-6C; Paragraph 0054) to and from which a attaching-detaching member including a fluid flow channel, in which a fluid flows, is attached and detached (pressure pod apparatus 412/attaching-detaching member with inlet 415 and outlet 416 where fluid flows through; Figure 4, 5A-5C, and 6A-6C; Paragraphs 0062-0063) and which measures pressure in a measurement target which is the attaching-detaching member (pressure pod apparatus 412 measures pressure in the liquid side cavity /417; Figure 4, 5A-5C, and 6A-6C; Paragraphs 0062-0063), the pressure measuring device comprising:
a communication flow channel placed to allow communication of gas with the fluid flow channel (channel 152/572 has gas that is in communication with fluid flow channel 415/416; Paragraph 0056 and 0068; Figure 4 and 6C);
a connection portion to which a connection counterpart portion of the attaching-detaching member is connected to bring the fluid flow channel and the communication flow channel to a communication state or a non-communication state (receiving region 545/connection portion that connects portion 471 of pressure pod apparatus 412; Paragraph 0068; Figure 5C and 6A-6C);
a pressure sensor that measures pressure in the fluid flow channel and the communication flow channel in a case where the connection counterpart portion is connected to the connection portion to bring the fluid flow channel and the communication flow channel in the communication state (pressure transducer within the housing 555 is connected to channel 572 to measure pressure of fluid flow channel when pressure pod apparatus 412 is connected with connection apparatus 540 between connection portion/receiving region 545 and portion 471/connection counterpart portion; Figures 4, 5A-5C and 6A-6C; Paragraph 0056-0059 and 0069);
a pressure increasing-decreasing unit that increases or decreases pressure in the communication flow channel to discharge or suction gas outside (pump apparatus 14 increases or decreases the pressure in the communication flow channel; Paragraph 0038-0041); and
a driving unit that causes the pressure increasing-decreasing unit to be driven manually or automatically (controller 20 controls air pump 14 automatically when pressure pod apparatus 412 is connected to connection apparatus 540; Figures 4, 5A-5C, and 6A-6C; Paragraph 0039-0041 and 0066-0067). Stuva does not teach a timing at which a first contact surface of the connection portion to be brought into airtight contact with the connection counterpart portion is away from the connection counterpart portion, wherein
the first contact surface of the connection portion is formed at a location where gas is discharged or a location where gas is suctioned by the pressure increasing-decreasing unit increasing or decreasing the pressure in the non-communication state where the connection portion is away from the connection counterpart portion so that the gas is moved relative to the first contact surface as the connection portion and the connection counterpart portion are connected.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to switch the connecting piece of the port 471 and first end region 575 and have the port 471 of the pressure pod apparatus 412 to fit within the connection apparatus’ first end region 575, with the common function of having the port 471 being able to mate with the first end region 575 for measuring pressure, whether at the exterior surface or the interior surface, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.). Furthermore, Stuva discusses the port 471 component having an outer surface 478 that can mate with a portion of the connection apparatus of Figures 6A-6C and have a seal component inbetween the connection, such as an o-ring (Paragraph 0064; Figures 5A-5C and 6A-6C).
Furthermore, Los teaches a first contact surface of the connection portion to be brought into airtight contact with the connection counterpart portion (inner surface of the o-ring 144 is located in seat 138a of plate 128a is to be brought into air tight contact with port of pump 160a; Paragraph 0147-0149, 0151-0153; Figure 3), wherein
the first contact surface of the connection portion is formed at a location where gas is discharged or a location where gas is suctioned by the pressure increasing-decreasing unit increasing or decreasing the pressure in the non-communication state where the connection portion is away from the connection counterpart portion so that the gas is moved relative to the first contact surface as the connection portion and the connection counterpart portion are connected (inner surface of o-ring 144 is located at the location where gas is delivered or discharged and the pressure is decreased when the groove 134a is disconnected with pump 162a; Figure 3; Paragraphs 0147-0149 and 0151-0153).
Stuva and Los are considered to be analogous to the claimed invention because they are in the same field of medical flow pressure sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stuva to incorporate the teachings of Los to have the O-ring with a seat structure in the connection portion of Stuva, as taught by Los, for receiving the connection counterpart portion of Stuva. This allows for an airtight and fluid tight connection between the pump and the manifold (Los; Paragraph 0153).
The combination of Stuva in view of Los does not teach the driving unit that causes the pressure increasing-decreasing unit to be driven manually or automatically at a timing at which the first contact surface of the connection portion to be brought into airtight contact with the connection counterpart portion is away from the connection counterpart portion.
However, DeVries teaches the driving unit that causes the pressure increasing-decreasing unit to be driven manually or automatically at a timing at which the first contact surface of the connection portion to be brought into airtight contact with the connection counterpart portion is away from the connection counterpart portion (pump has a pressure processor 471 that automatically activates purge function, such as for calibration – obvious that the pump with processor 471 can activate gas delivery at a timing when connection portion is away from connection counterpart portion; Column 12, lines 47-55 and Column 13, lines 53-63).
Stuva in view of Los and DeVries are considered to be analogous to the claimed invention because they are in the same field of medical flow pressure sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stuva in view of Los to incorporate the teachings of DeVries to have the pump with the processor/driving unit of Stuva in view of Los to have the air purge functionality, as taught by DeVries. This allows for the apparatus to periodically purge air for calibration of the pressure transducer (DeVries; Column 13, lines 53-63).
Regarding claim 3, Stuva in view of Los and DeVries teaches the device of claim 1. Stuva further teaches wherein
the communication flow channel includes an opening-closing unit that switches the pressure increasing-decreasing unit and the measurement target to a communicating state or a shut-off state (valves 88A-88C controls fluid communication between measurement target and pump; Paragraph 0072-0074; Figure 1), and
after the pressure in the communication flow channel is increased or decreased in the shut-off state, the opening-closing unit makes a switch to the communicating state, so that gas is blown onto the first contact surface of the connection portion (valves 88A-88C are located in communication flow channels to control flow communication between apparatus and pump and to blow onto the o-ring between the port 471 and connection apparatus 540; Figure 1; Paragraph 0072-0074).
Regarding claim 4, Stuva in view of Los and DeVries teaches the device of claim 1. Stuva further teaches wherein the pressure increasing-decreasing unit has a capability of not only normal-rotation driving to increase pressure in the communication flow channel, but also reverse-rotation driving to decrease pressure in the communication flow channel (pump can add/remove air; Paragraphs 0019, 0039-0041, and 0072).
Regarding claim 5, Stuva in view of Los and DeVries teaches the device of claim 1. Stuva further teaches a medical device comprising the pressure measuring device (extracorporeal blood treatment system comprises the pressure pod apparatus 412 with connector 545; Paragraph 0036, 0063-0064; Figure 1, 5A-5C and 6A-6C), wherein the fluid flow channel is a blood flow channel in which blood flows (fluid flow channel allows for blood to flow through; Paragraph 0053, 0063, and 0066; Figures 5A-5C),
the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (fluid flow channel allows for blood to flow through and pod body portion 422 and 424/chamber holds blood and gas; Paragraph 0053, 0063, and 0066; Figure 5C), and
the measurement target is an internal space of the chamber (transducer side cavity 413 is an internal space of the chamber 422/424; Paragraph 0064; Figure 5C).
Regarding claim 6, Stuva in view of Los and DeVries teaches the device of claim 5. Stuva further teaches further comprising an operation unit for operating driving of the pressure increasing-decreasing unit (control/display screen 361; Paragraph 0045-0046; Figure 1).
Regarding claim 7, Stuva in view of Los and DeVries teaches the device of claim 5. Stuva further teaches wherein the driving unit automatically starts driving of the pressure increasing-decreasing unit once it is confirmed that a user performing operation is detected or operation performed by the user is detected (controller 20 is connected to pump and automatically controls operation based on user input through control screen 361; Paragraph 0045-0046, and 0052).
Regarding claim 8, Stuva in view of Los and DeVries teaches the device of claim 5. Stuva further teaches wherein the driving unit automatically stops driving of the pressure increasing-decreasing unit at a timing at which a value measured by the pressure sensor reaches a preset predetermined pressure (controller 20 has capability to stop the pump 14 when a pressure threshold is reached by the measurement of the pressure sensor; Paragraph 0011, 0039-0041, and 0074).
Regarding claim 9, Stuva in view of Los and DeVries teaches the device of claim 5. The combination of Stuva in view of Los and DeVries further teaches wherein immediately before the connection portion approaches and is linked to the connection counterpart portion, the pressure increasing-decreasing unit discharges or suctions gas between both of the first contact surface of the connection portion and a second contact surface of the connection counterpart portion (the o-ring/first contact surface of Los in the connector portion/region 545 of Stuva and the second contact surface being the outer surface of port 471 of Stuva, wherein the pump and controller of Los is capable of air purging as a calibration mode before the connection of the connection and connection counterpart portion, as taught by DeVries; see rejection of claim 1 above).
Regarding claim 10, Stuva in view of Los and DeVries teaches the device of claim 2. Stuva further teaches a medical device comprising the pressure measuring device (extracorporeal blood treatment system comprises the pressure pod apparatus 412 with connector 545; Paragraph 0036, 0063-0064; Figure 1, 5A-5C and 6A-6C), wherein the fluid flow channel is a blood flow channel in which blood flows (fluid flow channel allows for blood to flow through; Paragraph 0053, 0063, and 0066; Figures 5A-5C), the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (fluid flow channel allows for blood to flow through and pod body portion 422 and 424/chamber holds blood and gas; Paragraph 0053, 0063, and 0066; Figure 5C), and the measurement target is an internal space of the chamber (transducer side cavity 413 is an internal space of the chamber 422/424; Paragraph 0064; Figure 5C).
Regarding claim 11, Stuva in view of Los and DeVries teaches the device of claim 3. Stuva further teaches a medical device comprising the pressure measuring device (extracorporeal blood treatment system comprises the pressure pod apparatus 412 with connector 545; Paragraph 0036, 0063-0064; Figure 1, 5A-5C and 6A-6C), wherein the fluid flow channel is a blood flow channel in which blood flows (fluid flow channel allows for blood to flow through; Paragraph 0053, 0063, and 0066; Figures 5A-5C), the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (fluid flow channel allows for blood to flow through and pod body portion 422 and 424/chamber holds blood and gas; Paragraph 0053, 0063, and 0066; Figure 5C), and the measurement target is an internal space of the chamber (transducer side cavity 413 is an internal space of the chamber 422/424; Paragraph 0064; Figure 5C).
Regarding claim 12, Stuva in view of Los and DeVries teaches the device of claim 4. Stuva further teaches a medical device comprising the pressure measuring device (extracorporeal blood treatment system comprises the pressure pod apparatus 412 with connector 545; Paragraph 0036, 0063-0064; Figure 1, 5A-5C and 6A-6C), wherein the fluid flow channel is a blood flow channel in which blood flows (fluid flow channel allows for blood to flow through; Paragraph 0053, 0063, and 0066; Figures 5A-5C), the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (fluid flow channel allows for blood to flow through and pod body portion 422 and 424/chamber holds blood and gas; Paragraph 0053, 0063, and 0066; Figure 5C), and the measurement target is an internal space of the chamber (transducer side cavity 413 is an internal space of the chamber 422/424; Paragraph 0064; Figure 5C).
Regarding claim 13, Stuva in view of Los and DeVries teaches the device of claim 1. Stuva further teaches wherein the connection counterpart portion and the connection portion form a joint that allows fluid to flow from the connection portion through the connection counterpart portion and into a circuit chamber (connection of portion 545/connection portion with port 471/connection counterpart portion forms a joint to allow for fluid such as gas to flow through and into the chamber 424; Paragraph 0038, 0059, and 0064; Figures 5A-5C and 6A-6C).
Regarding claim 14, Stuva in view of Los and DeVries teaches the device of claim 13. Stuva further teaches wherein the circuit chamber includes a pressure space and the fluid flows from the connection portion into the pressure space (chamber 424 has cavity 413 to have the gas/fluid flow from the connection portion 545 to the cavity 413; Figures 5A-5C and 6A-6C; Paragraph 0064-0067).
Regarding claim 15, Stuva in view of Los and DeVries teaches the device of claim 1. The combination of Stuva in view of Los and DeVries further teaches wherein the connection portion comprises a large diameter portion that includes a O-ring (Los; o-ring 144 is in seat 138a of plate 128a is to be brought into air tight contact with port of pump 160a; Paragraph 0147-0149 and 0151-0153; Figure 3; see rejection of claim 1 above).
Regarding claim 16, Stuva in view of Los and DeVries teaches the device of claim 15. The combination of Stuva in view of Los and DeVries further teaches wherein the connection counterpart portion extends through the O-ring into the large diameter portion to form the communication state (port 471 of Stuva extends through O-ring 144 located in seat 138a of Los to form communication state; Los; Figure 3; Paragraphs 0147-0149; Stuva; Figures 5A-5C and 6A-6C; Paragraphs 0064 and 0068).
Regarding claim 17, Stuva in view of Los and DeVries teaches the device of claim 1. The combination of Stuva in view of Los and DeVries further teaches wherein the gas is discharged to remove foreign matter from the first contact surface of the connection portion by blowing off the foreign matters (DeVries; purge function is to deliver gas to remove/clear foreign matter from pressure transducer comprising the first contact surface of Stuva in view of Los and DeVries; Column 13, lines 53-63; see rejection of claim 1 above).
Regarding claim 18, Stuva in view of Los and DeVries teaches the device of claim 17. The combination of Stuva in view of Los and DeVries further teaches further comprising an O-ring on the connection portion (Los; o-ring 144 is in seat 138a of plate 128a is to be brought into air tight contact with port of pump 160a; Paragraph 0147-0149 and 0151-0153; Figure 3; see rejection of claim 1 above), and the gas is discharged to blow the foreign maters off of the O-ring (DeVries; purge function is to deliver gas to remove/clear foreign matter from pressure transducer comprising the O-ring of Stuva in view of Los and DeVries; Column 13, lines 53-63; see rejection of claim 1 above).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stuva et al. (Publication No. US 2015/0306299 A1) in view of Los (Publication No. US 2019/0099539 A1) and DeVries et al. (Patent No. US 8,522,780 B2), as applied to claim 1 above, and further in view of Magnenat et al. (Publication No. US 2015/0217043 A1).
Regarding claim 2, Stuva in view of Los and DeVries teaches the device of claim 1. The combination of Stuva in view of Los and DeVries does not teach wherein the connection portion is fabricated of an elastic material so that the first contact surface is capable of coming into airtight close contact with the connection counterpart portion.
However, Magnenat teaches wherein the connection portion is fabricated of an elastic material so that the first contact surface is capable of coming into airtight close contact with the connection counterpart portion (O-ring 7 is made of an elastic material; Paragraph 0070; Figure 1).
Stuva in view of Los and DeVries and Magnenat are considered to be analogous to the claimed invention because they are in the same field of medical flow pressure sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stuva in view of Los and DeVries to incorporate the teachings of Magnenat to have the O-ring of Stuva in view of Los and DeVries to be made of an elastic material, as taught by Magnenat. This allows for the connection and disconnection of the pressure transducer 2 and to facilitate a fluid-tight sealed connection (Magnenat; Paragraph 0070-0071).
Conclusion
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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