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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a detaching-attaching member” in claim 1, line 1;
“a pressure increasing-decreasing unit” in claim 1, line 14;
“a driving unit” in claim 1, line 16;
“an opening-closing unit” in claim 3, line 3;
“an operation unit” in claim 6, line 1;.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The term “a detaching-attaching member” is interpreted to be a component/structure that allows for fluid to flow through, as referenced in Paragraph 0007 in the Specification of the instant application. The language of “a detaching-attaching member” in claim 1 will be interpreted as requiring the disclosed structure in paragraph 0007, a pump of paragraph 0074, or equivalents thereof.
The term “a pressure increasing-decreasing unit” is interpreted to be a component/structure that generates increasing and decreasing pressure, as referenced in Paragraph 0007 in the Specification of the instant application. The language of “a pressure increasing-decreasing unit” in claim 1 will be interpreted as requiring the disclosed structure in paragraph 0007 or equivalents thereof.
The term “a driving unit” is interpreted to be a component/structure that controls another component manually or automatically, as referenced in Paragraph 0007 in the Specification of the instant application. The language of “a driving unit” in claim 1 will be interpreted as requiring the disclosed function in paragraph 0007, controller of paragraph 0035 and 0075, or equivalents thereof.
The term “an opening-closing unit” is interpreted to be a component/structure that opens/closes flow, as referenced in Paragraph 0076 in the Specification of the instant application. The language of “an opening-closing unit” in claim 3 will be interpreted as requiring the disclosed function in paragraph 0076, a valve of paragraph 0076, or equivalents thereof.
The term “an operation unit” is interpreted to be a component/structure that controls the operation of the device, as referenced in Paragraph 0012 in the Specification of the instant application. The language of “an operation unit” in claim 6 will be interpreted as requiring the disclosed function in paragraph 0011, an operation panel of paragraph 0012 and 0080, or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-3, 5-6, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. (Publication No. US 2008/0216898 A1) in view of Beden (Publication No. US 2018/0024022 A1).
Regarding claim 1, Grant teaches a pressure measuring device (pod pump 100 with pressure actuation system; Figure 1A and 7; Paragraph 0223) to and from which a detaching-attaching member (pod pump 100 with top plate 106 and bottom plate 110; Figure 1A; Paragraph 0183 and 0219) including a fluid flow channel in which a fluid is flowable is attached and detached (inlet 102/fluid side/outlet 104 allows for the connection of a fluid to travel through; Paragraph 0184 and 0187-0188; Figure 1A and 7) and which measures pressure in a measurement target which is the attaching-detaching member (pressure is measured in the pod 100; Figure 7; Paragraph 0226; a measurement target is interpreted to be equivalent to a detaching-attaching member, as discussed in the language of claim 1), the pressure measuring device comprising:
a communication flow channel placed to allow communication of gas with the fluid flow channel (pneumatic port 114/pneumatic side that allows gas to interact with inlet 102/fluid side/outlet 104; Paragraph 0184; Figure 1A and 7);
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 (top plate 106 with membrane/connection portion is connected to the bottom plate 110/connection counterpart portion to connect fluid flow channel and communication flow channel; Figure 1A; Paragraph 0183 and 0219);
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 (pod pressure sensor measures pressure when top plate 106 with membrane and bottom plate 110 are connected; Paragraph 0183 and 0231-0232; Figure 1A and 7);
a pressure increasing-decreasing unit that increases or decreases pressure in the communication flow channel to discharge or suction gas outside (pressure actuation system that increases and decreases pressure on the pneumatic side to allow for vent to atmosphere; Figure 7; Paragraph 0223); and
a driving unit that causes the pressure increasing-decreasing unit to be driven manually or automatically (positive and negative pressure pumps; Figure 7; Paragraph 0227).
The embodiment of Figures 1A-7 of Grant does not teach the driving unit that causes the pressure increasing-decreasing unit to be driven manually or automatically at 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.
However, another embodiment, Figure 6A-6D of Grant teaches a first contact surface of the connection portion (gaskets 62/64 is an o-ring that is formed to connect the membrane to the top plate 106 and bottom plate 110; Paragraph 0219-0220; Figure 6A-6D), 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 (gaskets 62/64 is an o-ring that is formed to connect the membrane to the top plate 106 and bottom plate 110 – where the bottom plate 110 contains the gas/pneumatic side that is suctioned or added, membrane with o-ring is added during non-communication state; Paragraph 0219-0220; Figure 6A-6D).
Grant is considered to be analogous to the claimed invention because they are in the same field of pressure based flow control systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Grant to incorporate the teachings of the embodiment of Figures 6A-6D of Grant to have the O-ring/gasket between the connection portion and the connection counterpart portion of Grant. This would allow for the sealing of the membrane to the top and bottom plate of the device and prevent leaks (Grant; Paragraph 0219-0220).
The modified Grant 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, Beden 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 (Claim 23; compressed air 1003 automatically pumps air into the device – fully capable of delivering air when the device is disconnected; Figure 1; Paragraph 0082-0085).
Grant and Beden are considered to be analogous to the claimed invention because they are in the same field of pressure-based flow control devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Grant to incorporate the teachings of Beden to have the driving unit of Grant to deliver air before the connection of the connection portion/connection counterpart portion of Grant, as taught by Beden, by having the controller of Grant to operate with the instructions of Beden. This would allow for the device to determine if the connection within the device is proper or improper (Beden; Claim 23).
Regarding claim 2, Grant in view of Beden teaches the pressure measuring device of claim 1. Grant further 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 (membrane of connection portion and gasket are made of same flexible material; Paragraph 0214 and 0220).
Regarding claim 3, Grant in view of Beden teaches the pressure measuring device of claim 1. Grant 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 (positive supply valve and vacuum supply valve switches on/off between the pumps and pneumatic side of the pod 100; Paragraph 0225; Figure 7), 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 (Paragraph 0225-0226).
Regarding claim 5, Grant in view of Beden teaches the pressure measuring device of claim 1. Grant further teaches a medical device (Figure 1500A ; Paragraph 0403) comprising the pressure measuring device according to claim 1 (see rejection of claim 1 above), wherein the fluid flow channel is a blood flow channel in which blood is flowable (Paragraph 0403; Figure 1A and 7),
the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (obvious that pod of Figure 1500A has chamber that contains both blood and gas; Figure 1A – chamber is the housing of pod 100; Paragraph 0183-0184), and
the measurement target is an internal space of the chamber (fluid side and pneumatic side of chamber is where pressure is measured; Figure 1A, 7, and 1500A).
Regarding claim 6, Grant in view of Beden teaches the medical device of claim 5. Grant further teaches further comprising an operation unit for operating driving of the pressure increasing-decreasing unit (controller controls pumps; Figure 7; Paragraph 0226-0227).
Regarding claim 8, Grant in view of Beden teaches the medical device of claim 5. Grant 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 (Paragraph 0226-0227).
Regarding claim 9, Grant in view of Beden teaches the medical device of claim 5. The combination of Grant in view of Beden 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 (Beden; Claim 23; compressed air 1003 automatically pumps air into the device – fully capable of delivering air when the device is disconnected or before attachment; Figure 1; Paragraph 0082-0085; see rejection of claim 1 above) between both of the first contact surface of the connection portion and a second contact surface of the connection counterpart portion (membrane is attached by O-ring/first contact surface of the connection portion/top plate which is in contact with the top surface of the bottom plate/second contact surface; Paragraph 0219; Figure 1A and 6A-6D; see rejection of claim 1 above).
Regarding claim 10, Grant in view of Beden teaches the pressure measuring device of claim 2. Grant further teaches a medical device (Figure 1500A ; Paragraph 0403) comprising the pressure measuring device according to claim 1 (see rejection of claim 1 above), wherein the fluid flow channel is a blood flow channel in which blood is flowable (Paragraph 0403; Figure 1A and 7),
the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (obvious that pod of Figure 1500A has chamber that contains both blood and gas; Figure 1A – chamber is the housing of pod 100; Paragraph 0183-0184), and
the measurement target is an internal space of the chamber (fluid side and pneumatic side of chamber is where pressure is measured; Figure 1A, 7, and 1500A).
Regarding claim 11, Grant in view of Beden teaches the pressure measuring device of claim 3. Grant further teaches a medical device (Figure 1500A ; Paragraph 0403) comprising the pressure measuring device according to claim 1 (see rejection of claim 1 above), wherein the fluid flow channel is a blood flow channel in which blood is flowable (Paragraph 0403; Figure 1A and 7),
the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (obvious that pod of Figure 1500A has chamber that contains both blood and gas; Figure 1A – chamber is the housing of pod 100; Paragraph 0183-0184), and
the measurement target is an internal space of the chamber (fluid side and pneumatic side of chamber is where pressure is measured; Figure 1A, 7, and 1500A).
Regarding claim 12, Grant in view of Beden teaches the pressure measuring device of claim 4. Grant further teaches a medical device (Figure 1500A ; Paragraph 0403) comprising the pressure measuring device according to claim 1 (see rejection of claim 1 above), wherein the fluid flow channel is a blood flow channel in which blood is flowable (Paragraph 0403; Figure 1A and 7),
the attaching-detaching member includes, as part of the blood flow channel, a chamber capable of retaining blood and gas (obvious that pod of Figure 1500A has chamber that contains both blood and gas; Figure 1A – chamber is the housing of pod 100; Paragraph 0183-0184), and
the measurement target is an internal space of the chamber (fluid side and pneumatic side of chamber is where pressure is measured; Figure 1A, 7, and 1500A).
Claim(s) 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. (Publication No. US 2008/0216898 A1) in view of Beden (Publication No. US 2018/0024022 A1), as applied to claim 1 above, and further in view of Fujiwara et al. (Publication No. US 2018/0110914 A1).
Regarding claim 4, Grant in view of Beden teaches the pressure measuring device of claim 1. The combination of Grant in view of Beden does not teach 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.
However, Fujiwara 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 (feed pump 38 is able to rotate forward and in reverse to increase and decrease pressure; Figure 6; Paragraph 0053).
Grant in view of Beden and Fujiwara are considered to be analogous to the claimed invention because they are in the same field of pressure-based flow control devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Grant in view of Beden to incorporate the teachings of Fujiwara to have the pump of Fujiwara be one of the pumps of Grant in view of Beden. This would allow for additional driving of the fluid flow during priming (Fujiwara; Paragraph 0053).
Regarding claim 7, Grant in view of Beden teaches the medical device of claim 5. The combination of Grant in view of Beden does not teach 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.
However, Fujiwara 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 (pump operate automatically after user’s instruction inputted into the control unit; Paragraph 0032).
Grant in view of Beden and Fujiwara are considered to be analogous to the claimed invention because they are in the same field of pressure-based flow control devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Grant in view of Beden to incorporate the teachings of Fujiwara to have the control unit and the instructions of Fujiwara in the device of Grant in view of Beden. This would allow for the user to control the operation of the device without the manual operation of the individual pumps (Fujiwara; Paragraph 0032).
Conclusion
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
/KAI H WENG/Primary Examiner, Art Unit 3781
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