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 Rejections - 35 USC § 102
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 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) 1-2 and 8-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Zheng (CN 211751512 U).
Regarding claim 1, Zheng discloses an infusion pump comprising:
a main body unit (housing assembly 10 in Fig. 1) comprising a tube attachment unit (mounting frame 40 in Fig. 1) to which an infusion tube (infusion tube 90 in Fig. 2) is attachable substantially horizontally; and
a door unit that is openable and closable with respect to the main body unit and covers the tube attachment unit in a state of being closed with respect to the main body unit (pump door 21 in Figs. 1-2); wherein:
the tube attachment unit comprises:
an indwelling portion (bubble detecting device 80 in Figs. 7, 13, 14) configured to place the infusion tube on an upper side of the main body unit in a height direction, and
a first protruding portion (contact surface 81b in Figs. 13-14; see below) that extends from the indwelling portion toward a lower side in the height direction of the main body unit, and includes a slope in which a degree of protrusion from the main body unit is larger at a position closer to the lower side in the height direction (paragraph [0070] discloses that 81a and 81b protrude outwards to support the infusion tube 90 in order to reduce the friction resistance between the tube 90 and the surface);
the door unit comprises a second protruding portion (pushing part 24 in Fig. 8) that protrudes toward the main body unit in a state in which the door unit is closed with respect to the main body unit; and
the second protruding portion is configured to lift the infusion tube to the upper side in the height direction along the slope of the first protruding and place the infusion tube on the indwelling portion when the door unit is closed with respect to the main body unit (paragraph [0069] discloses that by closing the door, the pushing part 24 pushes the infusion tube 90 to bring the infusion tube 90 into contact with 81a).
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Regarding claim 2, Zheng discloses the infusion pump according to claim 1, wherein the slope of the first protruding portion is curved in an arc shape such that the degree of protrusion from the main body unit is larger at a position closer to the lower side in the height direction (see Fig. 14).
Regarding claim 8, Zheng discloses an infusion pump comprising:
a main body (housing assembly 10 in Fig. 1) comprising a tube attachment unit (mounting frame 40 in Fig. 1) comprising a guide groove (see below) to which an infusion tube (infusion tube 90 in Fig. 2) is attachable substantially horizontally; and
a door that is openable and closable with respect to the main body and covers the tube attachment unit in a state of being closed with respect to the main body (pump door 21 in Figs. 1-2); wherein:
the tube attachment unit comprises:
an indwelling portion (bubble detecting device 80 in Figs. 7, 13, 14) forming a part of the guide groove (see below) and configured to place the infusion tube on an upper side of the main body in a height direction, and
a first protruding portion (contact surface 81b in Figs. 13-14; see below) that extends from the indwelling portion toward a lower side in the height direction of the main body unit, and includes a slope in which a degree of protrusion from the main body is larger at a position closer to the lower side in the height direction (paragraph [0070] discloses that 81a and 81b protrude outwards to support the infusion tube 90 in order to reduce the friction resistance between the tube 90 and the surface);
the door comprises a second protruding portion (pushing part 24 in Fig. 8) that protrudes toward the main body in a state in which the door is closed with respect to the main body; and
the second protruding portion is configured to lift the infusion tube to the upper side in the height direction along the slope of the first protruding portion and place the infusion tube on the indwelling portion when the door is closed with respect to the main body (paragraph [0069] discloses that by closing the door, the pushing part 24 pushes the infusion tube 90 to bring the infusion tube 90 into contact with 81a).
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Regarding claim 9, Zheng discloses a method of using an infusion pump, the method comprising:
providing an infusion pump comprising:
a main body (housing assembly 10 in Fig. 1) comprising a tube attachment unit (mounting frame 40 in Fig. 1) comprising a guide groove (see above) to which an infusion tube (infusion tube 90 in Fig. 2) is attachable substantially horizontally, and
a door that is openable and closable with respect to the main body and covers the tube attachment unit in a state of being closed with respect to the main body (pump door 21 in Figs. 1-2); wherein:
the tube attachment unit comprises:
an indwelling portion (bubble detecting device 80 in Figs. 7, 13, 14) forming a part of the guide groove (see below) and configured to place the infusion tube on an upper side of the main body in a height direction, and
a first protruding portion (contact surface 81b in Figs. 13-14; see below) that extends from the indwelling portion toward a lower side in the height direction of the main body unit, and includes a slope in which a degree of protrusion from the main body is larger at a position closer to the lower side in the height direction (paragraph [0070] discloses that 81a and 81b protrude outwards to support the infusion tube 90 in order to reduce the friction resistance between the tube 90 and the surface);
the door comprises a second protruding portion (pushing part 24 in Fig. 8) that protrudes toward the main body in a state in which the door is closed with respect to the main body; and
closing the door, which causes the second protruding portion to lift the infusion tube to the upper side in the height direction along the slope of the first protruding portion and place the infusion tube on the indwelling portion (paragraph [0069] discloses that by closing the door, the pushing part 24 pushes the infusion tube 90 to bring the infusion tube 90 into contact with 81a).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Barak (US Patent 6,106,249).
Regarding claim 3, Zheng discloses the infusion pump according to claim 1, but fails to disclose the specifics of the indwelling portion being provided at a position that is on a side surface in a width direction of the main body unit and is not covered by the door unit in a state in which the door unit is closed with respect to the main body unit.
However, Barak discloses an infusion pump (pump 10 in Fig. 1) comprising a main body unit (housing 12 in Fig. 1) to which an infusion tube (tube segment 42 in Fig. 1) is attachable substantially horizontally, a door unit that is openable and closeable with respect to the main body unit (door 28 in Fig. 1), and an indwelling portion (opening 44) configured to place the infusion tube on an upper side of the main body unit in a height direction. Barak further discloses that the indwelling portion is provided at a position that is on a side surface in a width direction of the main body unit and is not covered by the door unit in a state in which the door unit is closed with respect to the main body unit (see below).
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Barak teaches that this configuration is advantageous because protrusions can assist in pushing the tube tightly into the groove (Col. 3, lines 51-53). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known configuration of the indwelling portion not being covered by the door unit when the door unit is in a closed state to modify and improve the infusion pump of Zheng to better fit the tube into the groove portion.
Claim(s) 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Nakanishi (US Patent 9,616,170).
Regarding claim 4, Zheng teaches the infusion pump according to claim 1, but is silent to the tube attachment unit comprising a tube clamp part configured to clamp a part of the infusion tube to fix the infusion tube to the tube attachment unit, and the first protruding portion being located at a position where the first protruding portion is enabled to come into contact with the infusion tube in a case in which the infusion tube fixed by the tube clamp part is in a state of hanging down to the lower side in the height direction by its own weight.
Nakanishi teaches a tube attachment unit (tube attachment section 50 in Figs. 6A-6B) comprising a tube clamp part (tube clamp mechanism 500 in Figs. 6A-7B) configured to clamp a part of the infusion tube to fix the infusion tube to the tube attachment unit (Col. 8, lines 52-55).
While Nakanishi fails to teach the specifics of the first protruding portion being located at a position where the first protruding portion is enabled to come into contact with the infusion tube in a case in which the infusion tube fixed by the tube clamp part is in a state of hanging down to the lower side in the height direction by its own weight, this is a functional limitation of the first protruding portion, and the infusion tube is capable of coming into contact with the first protruding portion in a state in which the infusion tube is hanging down to the lower side in the height direction by its own weight (see below).
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Regarding claim 5, Zheng in view of Nakanishi teaches the infusion pump according to claim 4, and Nakanishi further teaches that the tube clamp part is configured to hold the infusion tube in an occlusion state in a state in which the door unit (access cover 5 in Fig. 3) is opened with respect to the main body unit (main body 2 in Fig. 3), and hold the infusion tube in an occlusion release state in a state in which the door unit is closed with respect to the main body unit (Col. 10, lines 17-29).
Nakanishi teaches that preventing the pump from feeding medicine when the access cover is opened and allowing the pump to pass medicine when the access cover is closed in order to safely feed the medicinal solution (Col. 2, lines 12-19). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known teaching of having the tube clamp part hold the infusion tube in an occlusion state in a state in which the door unit is opened and hold the infusion tube in an occlusion release state in a state in which the door unit is closed as taught by Nakanishi to modify and improve the infusion pump of Zheng to safely deliver the medicine to the patient.
Regarding claim 6, Zheng in view of Nakanishi teaches the infusion pump according to claim 4, and Nakanishi further teaches that the tube clamp part is detachable from the tube attachment unit (Col. 11, lines 6-13). Based on this teaching, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have the tube clamp part be detachable from the tube attachment unit in order to modify and improve the infusion pump as taught by Zheng.
Regarding claim 7, Zheng in view of Nakanishi teaches the infusion pump according to claim 4, but and further teaches that the second protruding portion is located on an opposite side from the tube clamp part with the first protruding portion interposed therebetween in the width direction of the main body unit, in a state in which the door unit is closed with respect to the main body unit (see below).
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While Zheng fails to teach the tube clamp part as referenced in claims 4-7, Nakanishi teaches the tube clamp part (tube clamp mechanism 500 in Figs. 6A-7B). Nakanishi teaches that this tube clamp mechanism is advantageous for ensuring safe delivery of the medicine, specifically by holding the infusion tube in an occlusion state in a state in which the door unit is opened with respect to the main body unit, and by holding the infusion tube in an occlusion release state in a state in which the door unit is closed with respect to the main body unit (Col. 10, lines 17-29), as discussed with respect to claim 5. The modifications made by the tube clamp member as taught by Nakanishi in order to motivate the combination with Zheng to meet the limitations of claim 5 result in the limitations of claim 4 and 7 being met by the combination.
Conclusion
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/AIDAN L NATHAN/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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