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 .
Response to Amendment
The amendment filed 08/12/2025 has been entered. Claims 1-13, 15-26 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 02/12/2025.
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 1-5, 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).
Regarding claim 1, 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 to receive the infusion therapy from the infusion pump 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 an accurate value of the current weight of the medical patient; 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 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.
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 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.
Estes teaches an analogous infusion pump (10, Fig 1) comprising a processor (241, Fig 5) configured to estimate an estimated current weight value (“previously stored value”) of the medical patient prior to initiating an infusion therapy (“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 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).
Regarding claim 2, the modified invention of Hand, Rosinko, and Estes discloses the patient weight check is configured to determine the patient weight value from the input received from the user via the keypad (Para 0059, 0064 -Estes).
Regarding claim 3, the modified invention of Hand, Rosinko, and Estes discloses the patient weight check is configured to determine the patient weight value from data received over a network (Para 0026-0029 -Hand).
Regarding claim 4, the modified invention of Hand, Rosinko, and Estes discloses the data is received from an electronic medical record (Para 0029-0030 -Hand).
Regarding claim 5, the modified invention of Hand, Rosinko, and Estes discloses the patient weight check is configured to receive the patient weight value from a first source (user input) and receive the estimated current weight value from a second source (memory) different than the first source (Para 0058 -Estes).
Regarding claim 10, the modified invention of Hand, Rosinko, and Estes 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 11, the modified invention of Hand, Rosinko, and Estes 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 a message for presentation on the display (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).
Claims 6-7 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 Woo (US 2009/0062727).
Regarding claim 6, the modified invention of Hand, Rosinko, and Estes discloses all of the elements of the invention as discussed above, however, is silent regarding the estimated current weight value is determined from data received from a 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 device 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 7, the modified invention of Hand, Rosinko, Estes, 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 8 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 Woo (US 2009/0062727) and further in view of Abdel-Rahman (US 2012/0085277).
Regarding claim 8, the modified invention of Hand, Rosinko, 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 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 Gupta (US 2018/03226146).
Regarding claim 9, the modified invention of Hand, Rosinko, and Estes 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).
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 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
Estes teaches an analogous infusion pump (10, Fig 1) comprising a methods of estimating an estimated current weight value (“previously stored value”) of the medical patient prior to initiating an infusion therapy (“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 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).
Regarding claim 15, the modified invention of Hand and Estes discloses determining the patient weight value comprises determining 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 Hand and Estes discloses determining the patient weight value comprises determining the patient weight value from data received over a network (Para 0026-0029 -Hand).
Regarding claim 17, the modified invention of Hand and Estes discloses determining the patient weight value comprises determining the patient weight value from data received from an electronic medical record (Para 0029-0030 -Hand).
Regarding claim 18, the modified invention of Hand and Estes discloses determining the patient weight value comprises receiving the patient weight value from a first source (user input) and wherein determining 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 and Estes 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 and Estes 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).
Regarding claim 25, the modified invention of Hand and Estes discloses the medical device comprises an infusion pump (100, Fig 1; Para 0021 -Hand).
Regarding claim 26, the modified invention of Hand 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).
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 Woo (US 2009/0062727).
Regarding claim 19, the modified invention of Hand and Estes discloses all of the elements of the invention as discussed above, however, is silent regarding determining the estimated current weight value comprises receiving data from a patient weight measurement device and determining the estimated current weight value from the data received 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, 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 Rosinko (US 2018/0021514) and further in view of Estes (US 2014/0249500) and further in view of Gupta (US 2018/03226146).
Regarding claim 22, the modified invention of Hand and Estes 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 regarding the prior art of record failing to teach “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” have been fully considered but are not persuasive. As detailed in Para 0088-0090, the “proper” or estimated value (from a look-up table based on the previously stored values for at least one of the different user-specific settings) is compared to the inputted value. This comparison determines if the inputted value may be an incorrect value or not. Lastly, Estes states, in Para 0014, that the user-specific setting can be user weight. Thus, all of the elements of the claimed invention are taught by the prior art of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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 on 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.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783