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) are:
“liquid delivery drive part” in claim 5: The examiner notes that this limitation will be interpreted to mean a drive member consisting of a drive motor, cam structure driven by the drive motor, and finger structure moved by the cam structure (Specification Paragraph [0067]), and functional equivalents thereof.
“urging member” in claim 6: The examiner notes that this limitation will be interpreted to mean a spring capable of urging the pressing member to have the pressing surface press the tube against the displacement sensor in a state which the door unit is closed with respect to the main body unit (Specification Paragraph [0059]), and functional equivalents thereof.
“notification unit” in claims 8 and 9: The examiner notes that this limitation will be interpreted as a display, speaker, vibrator (Specification Paragraph [0075]), and functional equivalents thereof.
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.
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 § 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) 1-4, 6-7, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US Patent 9,005,159).
Regarding claim 1, Lee discloses an infusion pump (liquid infusion apparatus in Figs. 2 and 3) comprising:
a displacement sensor comprising:
a groove portion (tube seating depression 12 in Fig. 4) to which an infusion tube (silicon tube 31) is attachable (Col. 6, lines 47-53),
a detection surface (protruding part 621) exposed to the groove portion (Col. 12, lines 18-21), the displacement sensor being configured to detect a pressure applied to the detection surface (Col. 12, lines 25-28; see below),
a first mask portion that covers a first end of the detection surface in a width direction of the groove portion (see below), and
a second mask portion that covers a second end of the detection surface in the width direction of the groove portion (see below).
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Regarding claim 2, Lee discloses the infusion pump according to claim 1, wherein:
the displacement sensor comprises a Hall element (Col. 12, lines 44-45), and a plunger (movable member 62) that is movable with respect to the Hall element and comprises a magnet (Col. 12, lines 45-48), and
the displacement sensor is configured to detect a pressure applied to the detection surface based on an amount of movement of the magnet with respect to the Hall element (Col. 12, lines 44-55).
For examination purposes, the Hall element is interpreted as a structure having a magnet movable relative to it (Specification Paragraph [0007]) and capable of detecting change in magnetic flux (Specification Paragraph [0046]). Lee discloses a magnetic force measurement sensor that successfully anticipates the Hall element based on these characteristics (Col. 5, lines 16-26).
Regarding claim 3, Lee discloses the infusion pump according to claim 1, wherein:
the groove portion, the first mask portion, and the second mask portion are parts of a mask member (see below), and
the mask member is detachable from a remainder of the displacement sensor (see below).
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Furthermore, it is interpreted that the coupling means S-2 is configured to detachably mount the displacement sensor to the mask member, because Lee discloses that the liquid infusion pump 40, front casing 10F, and the rear casing 10R can be easily removed from each other (Col. 8, lines 5-17).
Regarding claim 4, Lee discloses the infusion pump according to claim 1, wherein:
a distance between the first mask portion and the second mask portion in the width direction of the groove portion is equal to a width of the groove portion (see below).
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Regarding claim 6, Lee discloses the infusion pump according to claim 1, comprising:
a main body unit (main body 10 in Fig. 2) comprising the displacement sensor (Col. 6, lines 35-36); and
a door unit (door 20 in Fig. 2) that is openable and closable with respect to the main body unit (Col. 6, lines 36-43) and covers the displacement sensor in a state of being closed with respect to the main body unit (see below), wherein:
the door unit comprises:
a pressing member (compressing member 25; Col. 6, lines 55-58) comprising a pressing surface facing the displacement sensor in a state in which the door unit is closed with respect to the main body unit (see below), and
an urging member that urges the pressing member to cause the pressing surface of the pressing member to press the infusion ube against the displacement sensor in a state in which the door is closed with respect to the main body unit (as discussed above, this limitation is interpreted to mean a spring capable of urging the pressing member to have the pressing surface press the tube against the displacement sensor in a state which the door unit is closed with respect to the main body unit; Col. 6, lines 58-60 discloses an elastic member to urge forth the compressing member 25).
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Regarding claim 7, Lee discloses the infusion pump according to claim 6, wherein:
the pressing surface of the pressing member comprises a protruding portion (compressing member 25 in Fig. 4), and
the protruding portion is inserted into the groove portion (Col. 6, lines 55-58) from between the first mask portion and the second mask portion of the displacement sensor (see below) in a state in which the door is closed with respect to the main body unit.
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Regarding claim 10, Lee discloses the infusion pump according to claim 1, wherein:
the infusion pump is configured to hold the infusion tube substantially horizontally (“horizontal” is a relative term, and is not defined relative to anything else; in Fig. 4, silicon tube is horizontal since “horizontal” is relative).
Regarding claim 11, Lee discloses an infusion pump (liquid infusion apparatus in Figs. 2 and 3) comprising
a displacement sensor comprising:
a detection surface (see below), and
a mask member comprising:
a groove portion (tube seating depression 12) to which the detection surface is exposed and an infusion tube (silicon tube 31) is attachable (Col. 6, lines 47-53),
a first mask portion that covers a first end of the detection surface in a width direction of the groove portion (see below), and
a second mask portion that covers a second end of the detection surface in the width direction of the groove portion (see below),
a Hall element (Col. 12, lines 44-45), and
a plunger (movable member 62) that is movable with respect to the Hall element and comprises a magnet (Col. 12, lines 45-48), wherein:
the mask member is detachable from the Hall element and the plunger (see below); wherein:
the displacement sensor is configured to detect a pressure applied to the detection surface based on an amount of movement of the magnet with respect to the Hall element (Col. 12, lines 44-55).
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Regarding claim 12, Lee discloses a method for using an infusion pump, comprising:
providing the infusion pump (liquid infusion apparatus in Figs. 2 and 3), which comprises:
a displacement sensor comprising:
a groove portion (tube seating depression 12) to which an infusion tube (silicon tube 31) is attachable (Col. 6, lines 47-53),
a detection surface exposed to the groove portion (see below), the displacement sensor being configured to detect a pressure applied to the detection surface (Col. 12, lines 44-55),
a first mask portion that covers a first end of the detection surface in a width direction of the groove portion (see below),
a second mask portion that covers a second end of the detection surface in the width direction of the groove portion (see below),
a Hall element (Col. 12, lines 44-45), and
a plunger (movable member 62 in Fig. 17) that is movable with respect to the Hall element and comprises a magnet (Col. 12, lines 45-48); and
detecting a pressure applied to the detection surface based on an amount of movement of the magnet with respect to the Hall element (Col. 12, lines 44-55).
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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) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Shimizu (US Patent 10,022,494).
Regarding claim 5, Lee discloses the infusion pump according to claim 1, comprising:
a liquid delivery drive part (as discussed above, this limitation is interpreted to mean a drive member consisting of a drive motor, cam structure driven by the drive motor, and finger structure moved by the cam structure; Col. 7, lines 1-10 disclose the liquid infusion pump 40 includes a finger module 40M, cam shaft 42, and cam shaft drive means 40D) configured to deliver liquid in the infusion tube (Col. 6, lines 28-34).
Lee is silent as to the specifics of the displacement sensor being located on both sides of the liquid delivery drive part in a liquid delivery direction of the liquid delivery drive part.
However, Shimizu teaches an infusion pump (infusion pump 1 in Fig. 3) with a displacement sensor (upstream occlusion sensor 52 and downstream occlusion sensor 53 in Fig. 3) located on both sides of the liquid delivery drive part in a liquid delivery direction of the liquid delivery drive part (see below).
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Shimizu teaches that having sensors on both sides of the infusion tube is advantageous to detect occlusion on both the upstream and downstream sides of the infusion tube, which may occur in delivery of drugs with high viscosity and/or concentration (Col. 8, line 61 – Col. 9, line 4). 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 sensors on both sides of the liquid delivery part as disclosed by Shimizu to modify and improve the infusion pump of Lee to better detect occlusion on either side of the liquid delivery part.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Masaru (JP 2012200545 A).
Regarding claim 8, Lee discloses the infusion pump according to claim 1.
Lee is silent to a notification unit configured to output a warning in a case in which erroneous attachment of the infusion tube is detected on a basis of the pressure detected by the displacement sensor.
However, Masaru teaches an infusion pump, comprising a notification unit (as discussed above, this limitation is interpreted to mean a display, speaker, vibrator, or functional equivalent thereof; speaker 131 qualifies as such) configured to output a warning in a case in which erroneous attachment of the infusion tube is detected on a basis of the pressure detected by the displacement sensor (Page 15, Paragraph 6, lines 4-8). The control unit 100 contains information on the displacement detected by the sensors (Page 13, Paragraph 3, lines 5-7). 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 provide a notification unit to output a warning when erroneous attachment of the infusion tube is detected in order to modify and improve the infusion pump as taught by Lee.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Masaru as applied to claim 8 above, and further in view of Shimizu.
Regarding claim 9, Lee in view of Shimizu and in further view of Masaru discloses the infusion pump according to claim 8, however fails to disclose that the unit id configured to output a warning in a case in which occlusion of the infusion ube is detected on a basis of the pressure detected by the displacement sensor.
Shimizu discloses the notification unit is configured to output a warning in a case in which occlusion of the infusion tube is detected on a basis of the pressure detected by the displacement sensor (Col. 10, lines 23-31). 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 provide a notification unit to output a warning when occlusion of the infusion tube is detected in order to modify and improve the infusion pump as taught by Lee.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AIDAN L NATHAN whose telephone number is (571)270-0798. The examiner can normally be reached Monday-Friday 10:00 AM - 7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AIDAN L NATHAN/ Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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