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 .
Claims 8-9 are canceled.
Claims 1, 13, and 20 are amended.
Claims 1-7 and 10-20 are being examined in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "the at least one pressure sensor". There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 7, 10, 12, 13, 15, 17, 19, 20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobson et al. (US 11135360 B1, herein Jacobson).
Regarding Claim 1, Jacobson discloses a control system for controlling operation of an infusion pump of an infusion pump system (abstract, Fig, 1A), the infusion pump system (100) comprising a first IV bag (110) and a first supply line (150), a second IV bag (120) and a second supply line (160), a cassette (Col. 10 Lines 16-18) and a common channel (140) in selective fluidic communication with the first supply line and the second supply line (Fig. 1A), and an infusion pump (130), wherein the infusion pump is operable to drive liquid through the cassette or cartridge and the common channel to a patient (Col. 9 Lines 10-11, Fig. 1A), the control system comprising:
one or more hardware processors (Col. 13 Lines 52-54); and
a memory (233) storing executable instructions that when executed by the one or more hardware processors (Col. 2 Lines 33-34), configure the infusion pump to:
draw liquid from the first IV bag and first supply line and into the cassette or cartridge (Col. 3 Lines 16-32);
automatically discontinue drawing liquid from the first IV bag and first supply line and begin drawing liquid from the second IV bag and second supply line, after determining that the first IV bag is in a depletion zone, such that the control system is capable of both transferring remaining liquid in the first IV bag out of the first IV bag and into the cassette or cartridge (Col. 3 Lines 24-40) in a manner that does not introduce air or vacuum from the first IV bag into the cassette or cartridge, and automatically purging air or vacuum from the first IV bag in the first supply line away from the cassette or cartridge (Col. 19 Lines 23-30), and
automatically discontinue drawing fluid from the second IV bag and second supply line and begin drawing fluid from the first IV bag and first fluid line upon determining that the second IV bag is in the depletion zone (Col. 3 Lines 5-32),
wherein the control system is configured to deliver to the patient substantially continuously fluid drawn including during transitions between the first fluid reservoir and the second fluid reservoir (Col. 3 Lines 5-32, Fig. 1A).
Regarding Claim 2, Jacobson discloses the control system of claim 1, wherein the infusion pump is configured to automatically draw fluid from at least the first supply line or at least the second supply line until the infusion pump receives a signal from an air-in-line sensor detecting air or a lack of liquid within a region of the cassette or cartridge inserted into the pump (Col. 19 Lines 16-31, junction being within the pump and cassette in Fig. 1A).
Regarding Claim 3, Jacobson discloses the control system of claim 1, wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on a period of time for at least one of the first IV bag and the second IV bag to enter the depletion zone based upon a container volume (Col. 23 Lines 34-40).
Regarding Claim 4, Jacobson discloses the control system of claim 3, wherein the container volume is determined by an electronically readable data source on the first IV bag or second IV bag (Col. 14 Lines 3-29).
Regarding Claim 7, Jacobson discloses the control system of claim 1, wherein the infusion pump draws fluid from the first IV bag only upon receiving an indication of first IV bag fluid availability (executable instructions are able to determine that infusion of first fluid has been completed by determining that the first reservoir has been depleted of a known amount, Col. 3 Lines 33-40), and wherein the infusion pump draws from the second IV bag only upon receiving an indication of second IV bag fluid availability (executable instructions able to compare a volume of fluid infused to a programmed volumed to infuse, Col. 3 Lines 16-23).
Regarding Claim 10, Jacobson discloses the control system of claim 1, wherein the infusion pump is configured to automatically draw fluid from at least one of the first IV bag and the second IV bag for a predetermined period of time (Col 23. Lines 34-40).
Regarding Claim 12, Jacobson discloses the control system of claim 1, wherein the infusion pump is further configured to back prime fluid from the common channel into the second IV bag when the second IV bag is depleted (Col. 19 Lines 16-30), and
wherein discontinuing drawing fluid from the second IV bag further comprises back priming fluid from the common channel into the second IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
Regarding Claim 13, Jacobson discloses an infusion pump system configured to perform a method for controlling operation of an infusion pump of the infusion pump system (abstract), the infusion pump system (100) comprising a first IV bag (110), a second IV bag (120), a cassette (Col. 10 Lines 16-18) and a common channel (140) in selective fluidic communication with the first IV bag and the second IV bag (Fig. 1A), and an infusion pump (130), wherein the infusion pump is operable to drive fluid through the cassette or cartridge and the common channel (Fig. 1A), the infusion pump system capable of executing the steps comprising:
drawing fluid from the first IV bag through the cassette or cartridge and into the common channel (Col. 3 Lines 16-32);
automatically discontinuing drawing fluid from the second IV bag and drawing fluid from the first IV bag through the common channel upon determining that the second IV bag is in a depletion zone (Col. 3 Lines 5-32);
preventing air or vacuum from being introduced into the cassette or cartridge (pump may remove air from the line before it enters the cassette, Col. 19 Lines 23-30); and
purging any air or vacuum from a fluid line into the second IV bag (Col. 19 Lines 23-30);
wherein fluid drawn from the first IV bag through the cassette or cartridge and into the common channel is substantially successively continuous with fluid drawn from the second IV bag through the cassette or cartridge and into the common channel (Col. 3 Lines 5-32).
Regarding Claim 15, Jacobson discloses the infusion pump system of claim 13, wherein the infusion pump draws fluid from the first IV bag only upon determining first IV bag fluid availability (executable instructions are able to determine that infusion of first fluid has been completed by determining that the first reservoir has been depleted of a known amount, Col. 3 Lines 33-40), and wherein the infusion pump draws from the second IV bag only upon determining second IV bag fluid availability (executable instructions able to compare a volume of fluid infused to a programmed volumed to infuse, Col. 3 Lines 16-23).
Regarding Claim 17, Jacobson discloses the infusion pump system of claim 13, wherein the infusion pump is configured to automatically draw fluid from at least one of the first IV bag and supply line and the second IV bag and supply line for a predetermined period of time (Col 23. Lines 34-40).
Regarding Claim 19, Jacobson discloses the infusion pump system of claim 13, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the second IV bag when the second IV bag is depleted (Col. 19 Lines 23-30) pump can employ a cassette, Col. 10 Lines 16-17, and can back-prime the line in between junction and second reservoir, junction 180 is within pump and cassette in Fig. 1A, and
wherein discontinuing drawing fluid from the second IV bag further comprises back priming fluid from the cassette or cartridge into the second IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
Regarding Claim 20, Jacobson discloses a control system for controlling operation of an infusion pump of an infusion pump system (abstract), the infusion pump system (100) comprising a first IV bag (110), a second IV bag (120), a common channel (140) in selective fluidic communication with the first IV bag and the second IV bag (Fig. 1A), and an infusion pump (130), wherein the infusion pump is operable to drive fluid through the cassette or cartridge and the common channel (Fig. 1A), the control system comprising:
one or more hardware processors (Col. 13 Lines 52-54); and
a memory (233) storing executable instructions that when executed by the one or more hardware processors (Col. 2 Lines 33-34), configure the infusion pump to:
draw fluid from the first IV bag through the cassette or cartridge and into the common channel (Col. 3 Lines 16-32, Fig. 1A);
automatically discontinue drawing fluid from the first IV bag and draw fluid from the second IV bag through the cassette or cartridge and into the common channel upon determining that the first IV bag is in a depletion zone, such that the control system is capable of both transferring remaining liquid in the first IV bag out the first IV bag and into the cassette or cartridge (Col. 3 Lines 24-40) in a manner that does not introduce air or vacuum from the first IV bag into the cassette or cartridge, or automatically purging air or vacuum from the first IV bag away from the cassette or cartridge (Col. 19 Lines 23-30); and
automatically discontinue drawing fluid from the second IV bag and draw fluid from the first IV bag through the cassette or cartridge and into the common channel upon receiving instructions to draw fluid from the first IV bag (Col. 3 Lines 5-32),
wherein fluid drawn from the first IV bag through the cassette or cartridge and into the common channel is substantially successively continuous with fluid drawn from the second IV bag through the cassette or cartridge and into the common channel (Col. 3 Lines 5-32).
Regarding Claim 22, Jacobson discloses the control system of claim 20, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the second IV bag when the second IV bag is depleted (Col. 19 Lines 16-30) pump can employ a cassette, Col. 10 Lines 16-17, and can back-prime the line in between junction and second reservoir, junction 180 is within pump and cassette in Fig. 1A, and
wherein discontinuing drawing fluid from the second IV bag further comprises back priming fluid from the cassette or cartridge into the second IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
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.
Claim(s) 5, 6, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobson in view of Vanderveen et al. (US 7561986 B2, herein Vanderveen).
Regarding Claim 5, Jacobson discloses the control system of claim 1.
Jacobson does not expressly disclose wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on a signal from a pressure sensor in communication with a respective IV bag and supply line.
Vanderveen teaches wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on a signal from a pressure sensor (225) in communication with a respective IV bag (205) and supply line (Col. 7 Lines 37-47, Fig. 4).
Therefore It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the control system as disclosed by Jacobson wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on a signal from a pressure sensor in communication with a respective IV bag and supply line as taught by Vanderveen so that it is able to determine when an I.V. Bag is empty via sensor (Col. 7 Lines 43-47).
Regarding Claim 6, modified Jacobson in view of Vanderveen discloses the control system of claim 5, wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on an upstream pressure measured by the at least one pressure sensor (Col. 7 Lines 37-47, Fig. 4).
Therefore It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the control system as disclosed by Jacobson wherein the steps of determining that the first IV bag is in the depletion zone or determining that the second IV bag is in the depletion zone is based on an upstream pressure measured by the at least one pressure sensor as taught by Vanderveen so that it is able to determine when an I.V. Bag is empty via sensor (Col. 7 Lines 43-47).
Regarding Claim 14, Jacobson discloses the infusion pump system of claim 13.
Jacobson does not expressly disclose wherein the determination that the first IV bag is depleted and the determination that the second IV bag is depleted are based on an upstream pressure measured by the at least one pressure sensor.
Vanderveen teaches wherein the determination that the first IV bag is depleted and the determination that the second IV bag is depleted are based on an upstream pressure measured by the at least one pressure sensor (Col. 7 Lines 37-47, Fig. 4).
Therefore It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion pump system as disclosed by Jacobson wherein the determination that the first IV bag is depleted and the determination that the second IV bag is depleted are based on an upstream pressure measured by the at least one pressure sensor as taught by Vanderveen so that it is able to determine when an I.V. Bag is empty via sensor (Col. 7 Lines 43-47).
Claim(s) 11, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobson.
Regarding Claim 11, Jacobson discloses the control system of claim 1, wherein the infusion pump is further configured to back prime fluid from the common channel into the second IV bag when the second IV bag is depleted (Col. 19 Lines 16-30), and
wherein discontinuing drawing fluid from the second IV bag further comprises back priming fluid from the common channel into the second IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
Jacobson does not expressly disclose back priming fluid from the common channel into the first IV bag when the first IV bag is depleted, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the common channel into the first IV bag.
Examiner interprets that It would have been obvious to one of ordinary skill in the art at the time of the invention that the infusion pump disclosed by Jacobson is configured to reverse the back priming of a fluid into the first reservoir, wherein the infusion pump is further configured to back prime fluid from the common channel into the first IV bag when the first IV bag is depleted, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the common channel into the first IV bag, since a mere reversal of essential working parts of a device involves only routine skill within the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). The motivation being to allow the user to provide medical fluid from either of the fluid sources when a first source is depleted.
Regarding Claim 18, Jacobson discloses the infusion pump system of claim 13, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the second IV bag when the second IV bag is depleted (Col. 19 Lines 16-30) pump can employ a cassette, Col. 10 Lines 16-17, and can back-prime the line in between junction and second reservoir, junction 180 is within pump and cassette in Fig. 1A, and
wherein discontinuing drawing fluid from the second IV bag further comprises back priming fluid from the cassette or cartridge into the second IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
Jacobson does not expressly disclose wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the first IV bag when the first IV bag is depleted, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the cassette or cartridge into the first IV bag.
It would have been obvious to one of ordinary skill in the art at the time of the invention to reverse the back priming of a fluid into the first reservoir, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the first IV bag when the first IV bag is depleted, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the cassette or cartridge into the first IV bag, since a mere reversal of essential working parts of a device involves only routine skill within the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). The motivation being to allow the user to provide medical fluid from either of the fluid sources when a first source is depleted.
Regarding Claim 21, Jacobson discloses the control system of claim 20, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the second IV bag upon determining that the second IV bag is in a depletion zone (Col. 19 Lines 16-30) pump can employ a cassette, Col. 10 Lines 16-17, and can back-prime the line in between junction and second reservoir, junction 180 is within pump and cassette in Fig. 1A, executable instructions are able to determine a depletion zone by comparing volumes of fluids infused Col. 3 Lines 33-40, and
wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the cassette or cartridge into the first IV bag (sensor is able to detect if air is in the line between junction and second reservoir, determining if second reservoir is depleted, proceeding to back-priming. Col. 19 Lines 16-30).
Jacobson does not expressly disclose wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the first IV bag upon determining that the first IV bag is in a depletion zone, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the cassette or cartridge into the first IV bag.
It would have been obvious to one of ordinary skill in the art at the time of the invention to reverse the back priming of a fluid into the first reservoir, wherein the infusion pump is further configured to back prime fluid from the cassette or cartridge into the first IV bag upon determining that the first IV bag is in a depletion zone, and wherein discontinuing drawing fluid from the first IV bag further comprises back priming fluid from the cassette or cartridge into the first IV bag, since a mere reversal of essential working parts of a device involves only routine skill within the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). The motivation being to allow the user to provide medical fluid from either of the fluid sources when a first source is depleted.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobson in view of Lopez et al. (US 11007119 B2, herein Lopez).
Regarding Claim 16, Jacobson discloses the infusion pump system of claim 15.
Jacobson does not expressly disclose wherein the determination of second IV bag fluid availability is based on a threshold weight of at least one of the first IV bag and the second IV bag.
Lopez teaches wherein the determination of second IV bag fluid availability is based on a threshold weight of at least one of the first IV bag and the second IV bag (Col. 36 Lines 13-31).
Therefore It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the infusion pump as disclosed by Jacobson wherein the determination of second IV bag fluid availability is based on a threshold weight of at least one of the first IV bag and the second IV bag as taught by Lopez so that users are able to determine if a proper amount of fluid has been delivered to the patient (Col. 36 Lines 24-31).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt Fri. off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783