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 Objections
Claim(s) 1 and 9 is/are objected due to the following informalities:
In claim 1, line 10 and line 18, “the programmed dose” should be corrected to “the programmed dose volume” for claim language consistency.
In claim 1, line 13, the term “the” in the phrase “the patient” should be replaced with the term “a”, since this is the first time this phrase was introduced.
In claim 1, line 17, the term “the” in the phrase “the difference” should be replaced with the term “a”, since this is the first time this phrase was introduced.
In claim 1, lines 18-19, “the volume of the fluid dispensed” should be corrected to “the volume of the fluid actually dispensed” for claim language consistency.
In claim 9, line 11, the term “the” in the phrase “the difference” should be replaced with the term “a”, since this is the first time this phrase was introduced.
In claim 9, line 12, “the programmed dose” should be corrected to “the programmed dose volume” for claim language consistency.
In claim 9, line 12, “the volume actually dispensed” should be corrected to “a volume actually dispensed” since this is the first time this phrase was introduced.
In claim 9, line 16, “a history log” should be corrected to “the history log” since this phrase was previously introduced.
In claim 9, line 17, the term “volume” should be inserted after the phrase “the programmed dose” for claim language consistency.
In claim 9, line 17, the term “and” should be inserted between “the programmed dose” and “the volume of fluid actually dispensed” for grammatical correctness.
In claim 9, line 17, “the volume of fluid actually dispensed” should be corrected to “the volume actually dispensed” for claim language consistency.
In claim 17, line 3, the term “pump” should instead be “pumping mechanism” for claim language consistency.
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(s) 1-20 is/ are 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 1, line 12 recites “repeat” but does not specify what step or action is being repeated, and therefore claim 1 is indefinite. For the sake of examination, the term “repeat” is being interpreted to refer to repeating the dispensing step of lines 6-7 of claim 1. Applicant is suggested to amend claim 1 to overcome this rejection.
Claim(s) 2-8 is/are rejected by virtue of their dependency on claim 1.
Claim 5, lines 2-3 recites the term “a subsequent request from the patient”. Claim 5 is dependent on claim 1, and claim 1 also introduces a term “a subsequent request from the patient”. It is unclear if the Applicant intended to introduce a new “subsequent request” in claim or refer to the “subsequent request” of claim 1. For the sake of examination, the term “a subsequent request from the patient” in this claim is being interpreted to refer to that of claim 1. Therefore, Applicant is suggested to amend claim 5 to overcome this rejection.
Claim 8, line 2 recites “another fluid supply containing the same fluid”. Claim 8 is dependent on claim 1, but claim 1 introduces “a subsequent fluid supply”. It is unclear if the Applicant intended for the “another fluid supply containing the same fluid” of claim 8 to refer to the “subsequent fluid supply” of claim 1 or if claim 8 is introducing a third “fluid supply”. For the sake of examination, “another fluid supply” is being interpreted as being intended to refer to “the subsequent fluid supply” of claim 1.
Claim 9, lines 13 and 23 each recite “repeat” but does not specify what step or action is being repeated, and therefore makes claim 9 indefinite. For the sake of examination, the term “repeat” is being interpreted to refer to repeating the dispensing step of line 10 of claim 9. Applicant is therefore suggested to amend 9 to overcome this rejection.
Claim(s) 10-20 is rejected by virtue of their dependency on claim 9.
Claim 10, line 2 recites the term “the same fluid”. Claim 10 is dependent on claim 9, however claim 9 only introduces “fluid” from the “subsequent fluid supply” and fails to introduce “a fluid” from “a fluid supply”, and therefore there is insufficient antecedent basis for this limitation in the claim. Applicant is therefore suggested to amend claim 10 to overcome this rejection.
Allowable Subject Matter
Claims 1 would be allowable if rewritten or amended to overcome the rejection of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) and objections set forth in this Office Action. Claims 2-4 and 6-7 depend from claim 1 and would be allowable if claim 1 is amended to overcome the objection and rejection set forth above. Claim(s) 5 and 8 depend from claim 1 and would be allowable if rewritten to overcome the rejection of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, and if claim 1 were amended to overcome the 112(b) rejection and objection set forth above.
The following is an examiner’s statement of reasons for allowance: Upon consideration of the prior of record, the limitations recited in independent claim 1 are not taught or suggested by prior art and therefore define allowable subject matter.
Regarding claim 1, Gylland (US 11246985 B2, herein Gylland) disclosed a computer-implemented method (method to infuse fluids with an infusion pump system [Col 1, lines 52-53]), comprising:
storing, in a memory of a pump, a programmed dose volume of a fluid from a fluid supply to be administered in response to a request from an operator (The infusion pump 230 includes a memory 233 operable to store programming code [Col 7, line 7-8]; wherein the first volume is stored in a memory; wherein the instructions for the delivery are received from an input via a user interface; [Col 3, lines 14-15]; it can be interpreted that the volume stored in memory is a programming code); and
when the request to dispense the programmed dose volume is received in a controller of the pump, instructing, via the controller, the pump to (The flow controller 235 is operable to execute the programming code and provide the control signal 231 to the fluid driver 232 in response to the programming code [Col 7, lines 12-15]):
begin dispensing the programmed dose volume of the fluid from the fluid supply (The fluid driver 232 is responsive to the control signal 231 to infuse the first fluid at a first rate along a first flow path 211 including the first reservoir [Col 7, line 15-17]).
Gylland however fails to explicitly disclose:
receive an indication that the pump has stopped pumping,
determine a partial dose volume equal to a difference in volume between the programmed dose and a volume of the fluid actually dispensed from the fluid supply,
when the partial dose volume equals zero, repeat in response to a subsequent request from the patient when a programmed lockout period has elapsed,
when the partial dose volume equals a value greater than zero, generate an alarm that the fluid supply is depleted and record, in a history log stored in the memory, the difference in volume between the programmed dose and the volume of the fluid dispensed from the fluid supply,
in response to the alarm that the fluid supply is depleted, provide a prompt to exchange the depleted fluid supply with a subsequent fluid supply,
after receiving an indication that the subsequent fluid supply is fluidly coupled to the pump, dispense, from the subsequent fluid supply, the partial dose volume, and
prevent any subsequent dispensing of fluid from the subsequent fluid supply for the programed lockout period.
Lanier Jr. et al. (US 11964126 B2, herein Lanier Jr.) teaches if the target volume exceeds the measured volume by a specified amount, which indicates under-delivery, the delivery controller, may post a pump fault and switch the pump system 2902 to a failsafe mode [Col 133, lines 17-21].
Lanier Jr. further teaches the term failsafe may refer to a state of non-delivery in response to a determined failure, following alerting the user/patient that the system is entering a failsafe mode [Col 129, lines 45-48].
Lanier Jr. further teaches the empty reservoir detection algorithm, may, evaluate the ability of the pump plunger 2902 to deliver fluid from the reservoir 2918 to the volume measurement chamber 2920. The pump system 2902, may use two parameters for this evaluation, which may include, but is not limited to, the pumping error and the total trajectory error. The pumping error may be the difference between the target and actual pumped volumes. An internal “empty reservoir indicator”, which may be set if the pump is under-delivering [Col 136, lines 27-36].
While Lanier Jr. discusses indicating an empty reservoir or indicating that a dose is “under-delivered”, it fails to teach delivering an amount to compensate for the under-delivery (i.e. a “partial dose volume”). Lanier instead teaches adjusting the delivery profile in order to reduce delivered volume (delivery controller may dynamically decrease the maximum target volume, this may allow the pump system 2900 to continue administering fluid/therapy by delivering smaller deliveries more frequently. [Col 136, lines 60-65]).
Therefore, modifying the device of Gylland with Lanier Jr. would render the device of Gylland inoperable as it is required to compensate for partial delivery from first fluid supply by delivering from the subsequent fluid supply a “partial dose volume”, that is different from what is taught by Lanier Jr.
Simmons (US 20150352284 A1, herein Simmons) teaches a dose and lockout interval programmed into the pump prior to delivery. The lockout interval is used to prevent a patient drug overdose resulting from giving himself or herself another bolus before the previous bolus has had a chance to take effect. [0005]. Simmons further teaches the continuous infusion is adjusted to provide the minimum amount of drug needed by a patient over time [0006]. Simmons therefore fails to teach delivering an amount to compensate for the under-delivery (i.e. a “partial dose volume”), wherein Simmons instead teaches adjusting the delivery rate in order to provide a minimum volume.
Claims 9 would be allowable if rewritten or amended to overcome the rejection of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) and the objections set forth in this Office Action. Claims 11-20 depend from claim 9 and would be allowable if claim 9 is amended to overcome the objection and rejection set forth above. Claim 10 depend from claim 9 and would be allowable if rewritten to overcome the rejection of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, and if claim 9 were amended to overcome the 112(b) rejection and objection set forth above. Claim 17 depend from claim 9 and would be allowable if rewritten to overcome the objection set forth in this Office action, and if claim 9 were amended to overcome the 112(b) rejection and objection set forth above.
Regarding claim 9, Gylland et al. (US 11246985 B2, herein Gylland) discloses an infusion pump apparatus (infusion pump system 100 in Fig. 1A) comprising:
a pumping mechanism configured to dispense a programmed dose volume from a fluid supply (The fluid driver 232 is responsive to the control signal 231 to infuse the first fluid at a first rate along a first flow path 211 including the first reservoir [Col 7, line 15-17]);
a memory storing the programmed dose volume and configured to record a history log (The infusion pump 230 includes a memory 233 operable to store programming code [Col 7, line 7-8]; wherein the first volume is stored in a memory; wherein the instructions for the delivery are received from an input via a user interface; [Col 3, lines 14-15]; it can be interpreted that the volume stored in memory is a programming code);
a patient request device; and
a processor in communication with the pumping mechanism, the memory, and the patient request device (The flow controller 235 is operable to execute the programming code and provide the control signal 231 to the fluid driver 232 in response to the programming code [Col 7, lines 12-15]),
However, Gylland fails to explicitly disclose:a patient request device; and
the processor configured to:
when the patient has made a request, via the patient request device, dispense the programmed dose volume from the fluid supply,
determine a partial dose volume equal to the difference in volume between the programmed dose and the volume actually dispensed from the fluid supply,
when the partial dose volume equals zero, repeat in response to a subsequent request from the patient if a programmed lockout period has elapsed,
when the partial dose volume equals a value greater than zero, raise an alarm that the fluid supply is depleted and record, in a history log, the difference in volume between the programmed dose the volume of fluid actually dispensed,
in response to the raised alarm that the fluid supply is depleted, and after a clinician exchanged the depleted fluid supply with a subsequent fluid supply, dispense, from the subsequent fluid supply, the partial dose volume,
prevent any subsequent dispensing of fluid from the subsequent fluid supply for the programed lockout period, and
repeat in response to a subsequent request from the patient when the programmed lockout period has elapsed.
Lanier Jr. et al. (US 11964126 B2, herein Lanier Jr.) teaches if the target volume exceeds the measured volume by a specified amount, which indicates under-delivery, the delivery controller, may post a pump fault and switch the pump system 2902 to a failsafe mode [Col 133, lines 17-21].
Lanier Jr. further teaches the term failsafe may refer to a state of non-delivery in response to a determined failure, following alerting the user/patient that the system is entering a failsafe mode [Col 129, lines 45-48].
Lanier Jr. further teaches the empty reservoir detection algorithm, may, evaluate the ability of the pump plunger 2902 to deliver fluid from the reservoir 2918 to the volume measurement chamber 2920. The pump system 2902, may use two parameters for this evaluation, which may include, but is not limited to, the pumping error and the total trajectory error. The pumping error may be the difference between the target and actual pumped volumes. An internal “empty reservoir indicator”, which may be set if the pump is under-delivering [Col 136, lines 27-36].
While Lanier Jr. discusses indicating an empty reservoir or indicating that a dose is “under-delivered”, it fails to teach delivering an amount to compensate for the under-delivery (i.e. a “partial dose volume”). Lanier instead teaches adjusting the delivery profile in order to reduce delivered volume (delivery controller may dynamically decrease the maximum target volume, this may allow the pump system 2900 to continue administering fluid/therapy by delivering smaller deliveries more frequently. [Col 136, lines 60-65]).
Therefore, modifying the device of Gylland with Lanier Jr. would render the device of Gylland inoperable as it is required to compensate for partial delivery from first fluid supply by delivering from the subsequent fluid supply a “partial dose volume”, that is different from what is taught by Lanier Jr.
Simmons (US 20150352284 A1, herein Simmons) teaches a dose and lockout interval programmed into the pump prior to delivery. The lockout interval is used to prevent a patient drug overdose resulting from giving himself or herself another bolus before the previous bolus has had a chance to take effect. [0005].
Simmons further teaches pump 10 includes a PCA input device 100, which allows the patient to manually actuate the pump actuator to deliver a bolus of analgesic to the patient when desired and when proper. PCA input device 100 is connected via a cord 102, which is plugged into or otherwise connected to housing 12 of pump 10 [0049] Simmons however teaches the continuous infusion is adjusted to provide the minimum amount of drug needed by a patient over time [0006]. Simmons therefore fails to teach delivering an amount to compensate for the under-delivery (i.e. a “partial dose volume”), wherein Simmons instead teaches adjusting the delivery rate in order to provide a minimum volume.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent- center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights