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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Response to Amendment
The amendment filed 02/17/2026 has been entered. Claims 1, 7-13, 15-26 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is no support for the limitation “prompt the user via the display to confirm that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the units of measurement of the patient weight value have been properly selected”. While paragraph 0014 of the instant specification mentions that errors in patient weight entry can result from using the incorrect units, there is no mention of a confirmation or check separate from confirming the accuracy of the patient weight value for the units. Therefore, these limitations appear to be new matter.
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.
Claims 1, 7, 11, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen (US 2014/0180711) in view of Woo (US 2009/0062727).
Regarding claim 1, an infusion pump (Device of Fig 208 which is an infusion pump 145, Para 0443), comprising: a display (3404, Fig 208) configured to display a keypad (3428, Fig 223) and to receive input from a user via the keypad (Para 1229); a processor in communication with the display; and a memory in communication with the processor (Para 0086) and configured to store instructions that when executed by the processor cause the execution of a patient weight check configured to: receive via the keypad and, prior to initiating an infusion therapy, a patient weight value corresponding to a current weight of a medical patient (Para 1229), wherein the infusion pump is configured to provide the infusion therapy according to one or more treatment parameters (Para 1244); receive, prior to initiating the infusion therapy, an estimated current weight value (“Confirm Patient Weight”) of the medical patient; determine that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current weight value violates a threshold condition (Para 1231); provide an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition (Para 1231); prompt the user via the display to confirm that the patient weight value is an accurate value of the current weight of the medical patient and that units of measurement of the patient weight value have been properly selected (Para 1231; The display shows kg and lbs. to ensure appropriate units); receive a confirmation associated with the patient weight value, wherein the confirmation indicates that the patient weight value is accurate and that the units of measurement of the patient weight value have been properly selected; determine the one or more treatment parameters using the patient weight value; and provide the infusion therapy to the patient according to the one or more treatment parameters (Para 1244).
Kamen is silent regarding the estimated current weight is received from a patient weight measurement device or from an electronic medical record.
Woo teaches an analogous infusion pump wherein an estimated current weight value is received from a patient weight measurement device (103, Fig 1-a) (Para 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to receive a patient weight value and an estimated current weight value from a patient weight measurement device as taught by Woo in order to more accurately control infusion based on body weight (Para 0019 and 0021).
Regarding Claim 7, the modified invention of Kamen and Woo discloses the patient weight measurement device (103, Fig 1-a -Woo) comprises a scale (“electric scale”, Para 0060 -Woo), a device that estimates a weight from an image of at least a portion of the patient, or a laser scanning device configured to scan at least a portion of the patient.
Regarding Claim 11, the modified invention of Kamen and Woo discloses the indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition comprises highlighting or identifying a user- selectable input region of a message for presentation on the display (Para 1231 -Kamen; Violating the threshold condition results in requiring re-entry of the value which, as seen in Fig 223, highlights or identifies the user-selectable input region with a dotted line).
Regarding Claim 12, the modified invention of Kamen and Woo discloses the one or more treatment parameters comprises one or more of a dose, an infusion rate, a volume to be infused, an infusion duration, or a patient weight (Para 1246; See Fig 230 -Kamen).
Claims 1, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Rosinko (US 2018/0021514) and further in view of Estes (US 2014/0249500) and further in view of Kamen (US 2014/0180711).
Hand discloses an infusion pump (100 and 106, Fig 1), comprising: a display (112, Fig 1) and a keypad (114, Fig 1) configured to receive input from a user via the keypad (Para 0021, 0026); a processor (106A, Fig 1) in communication with the display (Para 0026); and a memory (106B, Fig 1) in communication with the processor (Para 0024-0025) and configured to store instructions that when executed by the processor cause the execution of a patient weight check configured to: determine, prior to initiating an infusion therapy, a patient weight value corresponding to a current weight of a medical patient, wherein the infusion pump is configured to provide infusion therapy according to one or more treatment parameters (Para 0051); receive a confirmation associated with the patient weight value, wherein the confirmation indicates that the patient weight value is accurate (Step 222, Fig 4); determine the one or more treatment parameters using the patient weight value; and provide the infusion therapy to the patient according to the one or more treatment parameters (Para 0053; See Fig 4, steps 218, 222, 220, 224).
Hand is silent regarding a display configured to display a keypad and the processor configured to: receive via the keypad a patient weight value; receive, prior to initiating the infusion therapy, from a patient weight measurement device or from an electronic medical record, an estimate an estimated current weight value of the medical patient; determine that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current eight value violates a threshold condition; provide an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompt the user via the display to confirm that the patient weight value is an accurate value of the current weight of the medical patient and that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the patient weight value is accurate and that the units of measurement of the patient weight value have been properly selected.
Rosinko teaches an analogous device comprising a display configured to display a keypad (120, Fig 4B) through a touchscreen (Para 0004, 00026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the display and the keypad disclosed by Hand to be a touchscreen display as taught by Rosinko in order to reduce the likelihood of users confirming pump parameters that have been mistakenly programmed (Para 0007).
The modified invention of Hand and Rosinko discloses all of the elements of the invention as discussed above, however, is silent regarding the processor configured to: receive via the keypad a patient weight value; receive, prior to initiating the infusion therapy, from a patient weight measurement device or from an electronic medical record, an estimate an estimated current weight value of the medical patient; determine that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current eight value violates a threshold condition; provide an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompt the user via the display to confirm that the patient weight value is an accurate value of the current weight of the medical patient and that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the patient weight value is accurate and that the units of measurement of the patient weight value have been properly selected.
Estes teaches an analogous infusion pump (10, Fig 1) comprising a processor (241, Fig 5) configured to receive, prior to initiating the infusion therapy, from an electronic medical record, an estimated current weight value (“previously stored value”) of the medical patient (“proactive safety checks” Para 0129); determine that the patient weight value (“newly input value”) may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current weight value violates a threshold condition; provide an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompt the user via the display to confirm (“accept” or “reject”) that the patient weight value is an accurate value of the current weight of the medical patient (Para 0014, Para 0083, Para 0089-0090).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed by Hand to be configured to estimate an estimated current weight value of the medical patient prior to initiating the infusion therapy; determine that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current eight value violates a threshold condition; provide an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompt the user to confirm that the patient weight value is an accurate value of the current weight of the medical patient as taught by Estes in order to ensure proper dose amounts and that a newly inputted weight value is a correct value (Para 0014).
The modified invention of Hand, Rosinko, and Estes discloses all of the elements of the invention as discussed above, however, is silent regarding prompt the user via the display to confirm that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the units of measurement of the patient weight value have been properly selected.
Kamen teaches an analogous system comprising a processor that causes the execution of a patient weight check configured to prompt the user via the display to confirm that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the units of measurement of the patient weight value have been properly selected (Para 1229-1231).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor to confirm the units of measurements of the patient’s weight as taught by Kamen in order to ensure the correctness of the patient’s weight and its units.
Regarding claim 10, the modified invention of Hand, Rosinko, Estes, and Kamen discloses the threshold condition may be configured by an operator (“the level of imbalance tolerated can be adjustable, for example, in response to user input from a clinician or the user”; Para 0016, Para 0083 -Estes).
Regarding claim 12, the modified invention of Hand, Rosinko, and Estes discloses the one or more treatment parameters comprises one or more of a dose, an infusion rate, a volume to be infused, an infusion duration, or a patient weight (Para 0014 -Estes).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kamen (US 2014/0180711) in view of Woo (US 2009/0062727) and further in view of Abdel-Rahman (US 2012/0085277).
Regarding claim 8, the modified invention of Kamen and Woo discloses all of the elements of the invention as discussed above, however, is silent regarding the patient weight measurement device comprises a mid-arm circumference measurement accessory.
Abdel-Rahman teaches the use of a patient weight measurement device (1, Fig 3) comprises a mid-arm circumference measurement accessory (See Figs 4a-4c, Para 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient weight measurement device disclosed by Woo to be a mid-arm circumference measurement accessory as taught by Abdel-Rahman in order to be able to acquire an estimated weight of a patient even when obtaining an accurate weight from a scale is impaired by the presence of external hoses, tubing and other medical equipment (Para 0002).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Rosinko (US 2018/0021514) and further in view of Estes (US 2014/0249500) and further in view of Kamen (US 2014/0180711) and further in view of Gupta (US 2018/03226146).
Regarding claim 9, the modified invention of Hand, Rosinko, Estes, and Kamen discloses all of the elements of the invention as discussed above, however, is silent regarding the patient weight check is configured to determine that the difference between the patient weight value and the estimated current weight value violates a threshold condition by determining that the estimated current weight value is at least 20% different than the patient weight value.
Gupta teaches an analogous device wherein the patient weight check is configured to determine that the difference between the patient weight value (weight entered on the first channel) and the estimated current weight value (weight entered on the second channel) violates a threshold condition by determining that the estimated current weight value is at least 20% different than the patient weight value (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed by Hand, Rosinko, and Estes to have a 20% threshold condition as taught by Gupta in order to prevent patient weight entry errors that could result in serious over or under dosing (Para 0062).
Claims 13, 15-18, 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Estes (US 2014/0249500) and further in view of Kamen (US 2014/0180711).
Regarding claim 13, Hand discloses a method, comprising: determining, prior to initiating an infusion therapy, a patient weight value corresponding to a current weight of a medical patient to receive therapy from a medical device according to one or more treatment parameters (Para 0051); receiving a confirmation associated with the patient weight value, wherein the confirmation indicates that the patient weight value is an accurate value of the current weight of the medical patient; determining the one or more treatment parameters using the patient weight value; and providing the infusion therapy to the patient according to the one or more treatment parameters (Para 0053; See Fig 4, steps 218, 222, 220, 224).
Hand is silent regarding receiving, prior to initiating the infusion therapy, from a patient weight measurement device or from an electronic medical record, an estimated current weight value of the medical patient; determining that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current weight value violates a threshold condition; providing an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompting the user via the display to confirm that the patient weight value is an accurate value of the current weight of the medical patient and that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the patient weight value is accurate and that the units of measurement of the patient weight value have been properly selected.
Estes teaches an analogous infusion pump (10, Fig 1) comprising a processor (241, Fig 5) receiving, prior to initiating the infusion therapy, from an electronic medical record, an estimated current weight value (“previously stored value”) of the medical patient (“proactive safety checks” Para 0129); determining that the patient weight value (“newly input value”) may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current weight value violates a threshold condition; providing an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompting the user via the display to confirm (“accept” or “reject”) that the patient weight value is an accurate value of the current weight of the medical patient (Para 0014, Para 0083, Para 0089-0090).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Hand to include estimating, prior to initiating an infusion therapy, an estimated current weight value of the medical patient; determining that the patient weight value may be an incorrect value of the current weight of the medical patient by determining that a difference between the patient weight value and the estimated current weight value violates a threshold condition; providing an indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition; prompting the user to confirm that the patient weight value is an accurate value of the current weight of the medical patient as taught by Estes in order to ensure proper dose amounts and that a newly inputted weight value is a correct value (Para 0014).
The modified invention of Hand, Rosinko, and Estes discloses all of the elements of the invention as discussed above, however, is silent regarding prompt the user via the display to confirm that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the units of measurement of the patient weight value have been properly selected.
Kamen teaches an analogous system comprising a processor that causes the execution of a patient weight check configured to prompt the user via the display to confirm that the units of measurements of the patient weight value have been properly selected; and the confirmation indicates that the units of measurement of the patient weight value have been properly selected (Para 1229-1231).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor to confirm the units of measurements of the patient’s weight as taught by Kamen in order to ensure the correctness of the patient’s weight and its units.
Regarding claim 15, the modified invention of Hand, Estes, and Kamen discloses receiving the patient weight value comprises receiving the patient weight value from an input received at a keypad of the medical device (Para 0059, 0064 -Estes).
Regarding claim 16, the modified invention of the modified invention of Hand, Estes, and Kamen discloses receiving the patient weight value comprises receiving the patient weight value over a network (Para 0026-0029 -Hand).
Regarding claim 17, the modified invention of the modified invention of Hand, Estes, and Kamen discloses receiving the patient weight value comprises receiving the patient weight value from an electronic medical record (Para 0029-0030 -Hand).
Regarding claim 18, the modified invention of the modified invention of Hand, Estes, and Kamen discloses receiving the patient weight value comprises receiving the patient weight value from a first source (user input) and wherein receiving the estimated current weight value comprises receiving the estimated current weight value from a second source (memory) different than the first source. (Para 0058 -Estes)
Regarding claim 23, the modified invention of Hand, Estes, and Kamen discloses the threshold condition may be configured by an operator (“the level of imbalance tolerated can be adjustable, for example, in response to user input from a clinician or the user”; Para 0016, Para 0083 -Estes).
Regarding claim 24, the modified invention of Hand, Estes, and Kamen discloses providing the indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition comprises displaying a message on a display of the medical device (Para 0016, Para 0083 -Estes), however, is silent regarding highlighting or identifying a user- selectable input region of a display.
Kamen further teaches indication to the user that the difference between the patient weight value and the estimated current weight value violates the threshold condition comprises highlighting or identifying a user- selectable input region of a message for presentation on the display (Para 1231 -Kamen; Violating the threshold condition results in requiring re-entry of the value which, as seen in Fig 223, highlights or identifies the user-selectable input region with a dotted line).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to include highlighting or identifying a user- selectable input region of a display when the difference between the patient weight value and the estimated current weight value violates the threshold condition as taught by Kamen in order to provide a clear and easy interface to correct the weight value (Para 1231).
Regarding claim 25, the modified invention of Hand, Estes, and Kamen discloses the medical device comprises an infusion pump (100, Fig 1; Para 0021 -Hand).
Regarding claim 26, the modified invention of Hand, Estes, and Kamen discloses the one or more treatment parameters comprises one or more of a dose, an infusion rate, a volume to be infused, an infusion duration, or a patient weight (Para 0014 -Estes).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Estes (US 2014/0249500) and further in view of Kamen (US 2014/0180711) and further in view of Woo (US 2009/0062727).
Regarding claim 19, the modified invention of Hand, Estes, and Kamen discloses all of the elements of the invention as discussed above, however, is silent regarding receiving the estimated current weight value comprises receiving the estimated current weight value from the patient weight measurement device.
Woo teaches an analogous infusion pump wherein an estimated current weight value is determined from data received from a patient weight measurement device (103, Fig 1-a) (Para 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to receive an estimated current weight value from a patient weight measurement device as taught by Woo in order to more accurately control infusion based on body weight (Para 0019 and 0021).
Regarding claim 20, the modified invention of Hand, Estes, Kamen, and Woo discloses the patient weight measurement device (103, Fig 1-a -Woo) comprises a scale (“electric scale”, Para 0060), a device that estimates a weight from an image of at least a portion of the patient, or a laser scanning device configured to scan at least a portion of the patient.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Estes (US 2014/0249500) and further in view of Woo (US 2009/0062727) and further in view of Abdel-Rahman (US 2012/0085277).
Regarding claim 21, the modified invention of Hand, Estes, and Woo discloses all of the elements of the invention as discussed above, however, is silent regarding the patient weight measurement device comprises a mid-arm circumference measurement accessory.
Abdel-Rahman teaches the use of a patient weight measurement device (1, Fig 3) comprises a mid-arm circumference measurement accessory (See Figs 4a-4c, Para 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient weight measurement device disclosed by Woo to be a mid-arm circumference measurement accessory as taught by Abdel-Rahman in order to be able to acquire an estimated weight of a patient even when obtaining an accurate weight from a scale is impaired by the presence of external hoses, tubing and other medical equipment (Para 0002).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hand (US 2020/0353163) in view of Estes (US 2014/0249500) and further in view of Kamen (US 2014/0180711) and further in view of Gupta (US 2018/03226146).
Regarding claim 22, the modified invention of Hand, Estes, and Kamen discloses all of the elements of the invention as discussed above, however, is silent regarding determining that the difference between the patient weight value and the estimated current weight value violates a threshold condition by determining that the estimated current weight value is at least 20% different than the patient weight value.
Gupta teaches an analogous device wherein the patient weight check is configured to determine that the difference between the patient weight value (weight entered on the first channel) and the estimated current weight value (weight entered on the second channel) violates a threshold condition by determining that the estimated current weight value is at least 20% different than the patient weight value (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method disclosed by Hand and Estes to have a 20% threshold condition as taught by Gupta in order to prevent patient weight entry errors that could result in serious over or under dosing (Para 0062).
Response to Arguments
Applicant’s argument filed 02/17/2026, on pages 7-9, regarding none of the applied art, alone or combined, teaches or suggests the features of the amended independent claims have been fully considered, but are moot in view of the current rejection that relies on Kamen to teach the new limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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