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 .
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) filed 1/26/26. Claims 21, 27, 32, and 37 have been amended. Claims 1-20, 25, 31, 36, and 40 are canceled. Claims 21-24, 26-30, 32-35, 37-39, 41, and 42 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/25 has been entered.
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.
Claims 21-24, 26-30, 32-35, 37-39, 41, and 42 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.
The newly added recitation of “the default values comprising predetermined values being determined prior to storage in the data table” within claims 21 and 32 appear to constitute new matter.
In particular, Applicant does not point to, nor was the Examiner able to find support for this newly added language within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed specification and claims.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 21 and 32 are objected to because of the following informalities: change “the default values” to “the one or more default values” and “the data table” to “the at least one data table”. Appropriate correction is required.
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) 21-24, 26-30, 32-35, 37-39, 41, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2015/0142457 A1) in view of Hickle et al. (US 2003/0135087 A1), and further in view of Souter (US 2009/0137956 A1).
(A) Referring to claim 21, Marshall discloses a system, comprising (abstract of Marshall):
a display, the display further configured to present at least one patient parameter of one or more patient parameters (para. 20 & 29-33 and Fig. 3 of Marshall);
a data storage in communication with the display, wherein the data storage comprises at least one data table comprising one or more default values corresponding to each value or range of values entered for each patient parameter of the one or more patient parameters (Fig. 3, para. 128-130 & 36-38 of Marshall; any of the data entry boxes 66 may comprise a drop-down list or a drop-down table, and to enter data the user may select a value from the drop-down list or table. For example, the user may select a value from a drop-down list or table by clicking with a mouse on data entry box 66 to open the drop-down list or table and then clicking on the line of the drop-down list or the section of the drop-down table that represents the value that the user wishes to enter. In further embodiments, one or more of the data entry boxes 66 on the data entry screen 60 as first displayed at stage 30 contains a default value. For example, in one embodiment in an obstetrics clinic the value for patient gender defaults to female. In another embodiment, the patient height defaults to a height that was previously measured for the same patient. When a data entry box 66 displays a default value, the user may choose to accept the default value, for example by pressing the Enter key when the cursor 68 is in the relevant data entry box 66.), the default values comprising predetermined values being determined prior to storage in the data table (para. 38 & 68 of Marshall; If the user wishes to change one or more of the values, he or she repeats stage 32 by re-entering at least one value. In the present embodiment, the user overwrites the value that was originally entered by typing a new value in the data entry box 66 using the keyboard 18. In alternative embodiments, the user selects a new value from a drop-down list or drop-down table, or uses any suitable input method. The user may accept one or more of the previously entered values and overwrite other values. In the present embodiment, the user overwrites any value that he or she wishes to correct, and then clicks on the button 70 using the mouse 18.);
at least one data processor (para. 20 of Marshall); and
at least one memory storing instructions which, when executed by the at least one data processor, result in operations comprising (para. 20-23 & 65 of Marshall):
receiving, via a user interface of the display, a first entry, the first entry including a first value for a first patient parameter among the at least one patient parameter (para. 30-36 of Marshall; data entry screen 60 requests entries for four required data entry fields 64. The required data entry fields 64 are patient height, patient weight, patient age and patient gender.);
retrieving, based on the first entry, a default value for a second patient parameter from among the at least one patient parameter, from the data storage based on the received first parameter (para. 36-38, 40, 85-87, 92-94, & 105-107 of Marshall; once the user has entered a value for patient height and a value for patient weight, the likelihood unit 24 calculates the most likely value for patient age given the entered values for patient height and patient weight and sets the most likely value for patient age as a default value for patient age. After the value for patient gender is entered, the likelihood unit 24 recalculates the displayed likelihoods given the value for patient gender, and calculates the likelihood of the patient gender given the currently-displayed values for patient height, patient weight and patient age… one or more of the data entry boxes 66 comprises a drop-down list or drop-down table, and the ordering of which possible values are displayed in the drop-down list or drop-down table is dependent on the likelihoods of the possible values. When a data entry box 66 displays a default value, the user may choose to accept the default value, for example by pressing the Enter key when the cursor 68 is in the relevant data entry box 66. Alternatively, the user may choose to overwrite the default value with a new value. For example, the user may click on the data entry box 66 for the patient height and overwrite a default value for the patient height with a newly-measured value for the patient height.); and
presenting, on the display, the retrieved default value of the second patient parameter (para. 38 & 105-107 of Marshall; The default value is displayed in the data entry box 66 corresponding to patient age.).
Marshall does not expressly disclose that the display is a display of an infusion device, the infusion device configured to deliver an analgesic substance to a patient; wherein the infusion device includes a fluid channel to receive a tube and a pump configured to deliver the analgesic substance to the patient via the tube coupled to a fluid supply and received by the fluid channel; presenting, on the display of the infusion device, one or more adjustments to the retrieved default value of the second patient parameter; determining a value for the second patient parameter based on the retrieved default value of the second patient parameter and a selection by a user via the user interface of at least one of the one or more adjustments; determining, based on at least one or more values corresponding to the at least one patient parameter, a dose of the analgesic substance to be delivered to the patient; and causing, based on at least the determined dose, delivery of the analgesic substance to the patient via the tube and from the fluid supply.
Hickle discloses a display of an infusion device, the infusion device configured to deliver an analgesic substance to a patient (para. 82, 138 & 129 of Hickle; FIG. 24 shows an example display of stat mode dosage display 150. User 3 may also initiate a provision of propofol at a rate that will allow a targeted ESC or dosage to be reached as quickly as possible by activating the stat mode key 49 in the propofol portion 46 of the membrane keypad 34 (an overshoot of the targeted ESC is possible with this administration mode). Upon activation of this key, stat mode dosage display 150 is presented to user 3. Within this display, the current ESC, infusion rate or dose of propofol chosen or being currently administered is shown in a touch entry data box.); and determining, based on at least one or more values corresponding to the at least one patient parameter, a dose of the analgesic substance to be delivered to the patient (para. 129, 131, 138, and 141 of Hickle; Delivery system 2 recognizes certain ranges of values for user entered levels, doses, infusion rates or effect-site concentrations for which it may require additional confirmation by the user before targeting. These values are represented in a safety-data set stored within the system's memory. For example, if the user-entered ESC is less than a particular value in the safety data set proportionate to the patient's age (e.g., 4.0 .quadrature.g/cc for patients younger than 70 or 3.0 .quadrature.g/cc for patients 70 or older), delivery system 2 will proceed with the initiation process for propofol administration, i.e., it will change the current level administered or it will display the systems initiation screen (described below) at the beginning of a new procedure. For example, if the user-entered ESC exceeds that particular value, but is less than a second value (e.g., 15 .quadrature.g/cc), UI 1 will display drug warning screen for sedation and analgesia 180 to user 3, which cautions user 3 that the value he entered exceeds the maximum recommended propofol limit for sedation and analgesia.).
Souter discloses wherein the infusion device includes a fluid channel to receive a tube and a pump configured to deliver the analgesic substance to the patient via the tube coupled to a fluid supply and received by the fluid channel (para. 23, 24, 54, 61, 10, and 68 of Souter; The system includes at least one delivery tube configured to transport medication from the one or more ampoules received in the system to a patient. The emergency medication pump system may include a key or other input interface for executing an injection sequence. For example, the input may comprise an inject key, button, or other interface. When the key is pressed, the injection sequence is executed, the pump or pumps are activated, and the medication is delivered to the patient through the delivery tube.); presenting, on the display of the infusion device, one or more adjustments to the retrieved default value of the second patient parameter; determining a value for the second patient parameter based on the retrieved default value of the second patient parameter and a selection by a user via the user interface of at least one of the one or more adjustments (para. 48-50 of Souter; The system 10 is typically programmed with default concentrations for the plurality of medications in the ampoules 38 received in the plurality of medication ports 13. If, however, the concentration in at least one of ampoules 38a-38f is different than at least one of the default values, the concentration adjustment keys 16 allow an emergency medical provider or other user to override the default concentration value and enter a new concentration value. Additionally, the system 10 includes a plurality of concentration readout displays 18 that readily allow an emergency medical provider or other user to see the concentration value that is input into the system 10 as either a default value or as a manually entered override value. The system 10 may include a plurality of weight adjustment keys 26 and 28 configured to allow an emergency medical provider to enter a patient's weight or adjust up or down from a default setting (e.g., 70 kg). Typically, the dosage amount (i.e., the volume of medication solution administered to a patient) for each of the plurality of medications received in the system 10 is a function of the concentration of the medication (e.g., measured in mg/ml), the dosage rate of the medication (e.g., measured in mg/kg), and the patient's weight (e.g., measured in kg). The system 10 may advantageously be programmed with default values for the concentrations and dosage rates for each of the plurality of medications received in the system.); and causing, based on at least the determined dose, delivery of the analgesic substance to the patient via the tube and from the fluid supply (abstract, para. 26, 36, 68, 69, and 54 of Souter; the emergency medical provider can administer one or more medications to the patient in rapid sequence by selecting at least one medication, entering the patient's weight and/or the patient's Broselow color (and/or length), and pressing the inject key. The medication(s) is then carried to the patient's IV line 66 via delivery tube 36; the IV line 66 then carries the medication into the patient's circulatory system along with the IV fluid.).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Hickle and Souter within Marshall. The motivation for doing so would have been to prevent drug overdose (para. 8 & 9 of Hickle) and to automatically calculate dosages and administer selected medications to a patient based on minimal input (e.g., the patient's weight) (para. 2 of Souter).
(B) Referring to claim 22, Marshall discloses wherein the operations further comprise: receiving, via the user interface, a second entry, the second entry including a second value of the second patient parameter, the second value being an adjustment of the default value of the second patient parameter that is an accurate representation of the second patient parameter (para. 38 of Marshall).
(C) Referring to claim 23, Marshall discloses wherein the operations further comprise: receiving, via the user interface, a confirmation for the presented retrieved default value of the second patient parameter (para. 38, 105, 108, and 109 of Marshall).
(D) Referring to claim 24, Marshall discloses wherein the operations further comprise: presenting, on the user interface of the display, at least one of the at least one patient parameter (Fig. 3 and para. 81-86 of Marshall).
(E) Referring to claims 26 and 27, Marshall does not disclose wherein the infusion device comprises at least one of a target controlled infusion pump, a syringe pump, an anesthesia delivery pump, or a patient- controlled analgesic pump and wherein the analgesic substance comprises at least one of a fluid, or a medication.
Hickle discloses wherein the infusion device comprises at least one of a target controlled infusion pump, a syringe pump, an anesthesia delivery pump, or a patient- controlled analgesic pump and wherein the analgesic substance comprises at least one of a fluid, or a medication (para. 16, 8, 5, and 62 of Hickle).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Hickle within Marshall. The motivation for doing so would have been to check that certain requisite predecessor conditions for the safety of sedation and analgesia have been satisfied before the system will administer drugs to a patient (para. 14 of Hickle).
(F) Referring to claim 28, Marshall discloses wherein at least one patient parameter comprises a value corresponding to at least one of a patient age, patient height, patient weight, patient gender, patient laboratory results, patient body mass index (BMI), or patient opiate usage (para. 33 of Marshall).
(G) Referring to claim 29, Marshall discloses wherein the first patient parameter and the second patient parameter are displayed simultaneously (Fig. 3 and para. 38 & 81-87 of Marshall).
(H) Referring to claim 30, Marshall discloses wherein the first patient parameter and the second patient parameter are displayed sequentially (para. 38 & 81-87 of Marshall).
(J) Referring to claim 32, Marshall discloses A computer-implemented method comprising (para. 18 & 19 of Marshall):
receiving, via a user interface of a display, a first entry, the first entry including a first value for a first patient parameter among at least one patient parameter of one or more patient parameters (para. 30-36 of Marshall; data entry screen 60 requests entries for four required data entry fields 64. The required data entry fields 64 are patient height, patient weight, patient age and patient gender.);
retrieving, based on the first entry, a default value for a second patient parameter from among the at least one patient parameter from a data storage, wherein the data storage is in communication with the display and comprises at least one data table comprising one or more default values corresponding to each value or range of values entered for each patient parameter of the one or more patient parameters (Fig. 3, para. 36-38, 40, 85-87, 92-94, 128-130, 105-107 of Marshall; once the user has entered a value for patient height and a value for patient weight, the likelihood unit 24 calculates the most likely value for patient age given the entered values for patient height and patient weight and sets the most likely value for patient age as a default value for patient age. Likelihood unit 24 calculates two likelihoods using the probabilistic data model: the likelihood of the entered value for patient height given the entered value for patient weight, and the likelihood of the entered value for patient weight given the entered value for patient height. Any of the data entry boxes 66 may comprise a drop-down list or a drop-down table, and to enter data the user may select a value from the drop-down list or table. For example, the user may select a value from a drop-down list or table by clicking with a mouse on data entry box 66 to open the drop-down list or table and then clicking on the line of the drop-down list or the section of the drop-down table that represents the value that the user wishes to enter. In further embodiments, one or more of the data entry boxes 66 on the data entry screen 60 as first displayed at stage 30 contains a default value. For example, in one embodiment in an obstetrics clinic the value for patient gender defaults to female. In another embodiment, the patient height defaults to a height that was previously measured for the same patient. When a data entry box 66 displays a default value, the user may choose to accept the default value, for example by pressing the Enter key when the cursor 68 is in the relevant data entry box 66. After the value for patient gender is entered, the likelihood unit 24 recalculates the displayed likelihoods given the value for patient gender, and calculates the likelihood of the patient gender given the currently-displayed values for patient height, patient weight and patient age.); the default values comprising predetermined values being determined prior to storage in the data table (para. 38 & 68 of Marshall; If the user wishes to change one or more of the values, he or she repeats stage 32 by re-entering at least one value. In the present embodiment, the user overwrites the value that was originally entered by typing a new value in the data entry box 66 using the keyboard 18. In alternative embodiments, the user selects a new value from a drop-down list or drop-down table, or uses any suitable input method. The user may accept one or more of the previously entered values and overwrite other values. In the present embodiment, the user overwrites any value that he or she wishes to correct, and then clicks on the button 70 using the mouse 18.); and
presenting, on the display of the device, the retrieved default value of the second patient parameter (para. 38 & 105-107 of Marshall; The default value is displayed in the data entry box 66 corresponding to patient age.).
Marshall does not expressly disclose that the display is a display of an infusion device configured to deliver an analgesic substance to a patient; wherein the infusion device includes a fluid channel to receive a tube and a pump configured to deliver the analgesic substance to the patient via the tube coupled to a fluid supply and received by the fluid channel; presenting, on the display of the infusion device, one or more adjustments to the retrieved default value of the second patient parameter; determining a value for the second patient parameter based on the retrieved default value of the second patient parameter and a selection by a user via the user interface of at least one of the one or more adjustments; determining, based on at least one or more values corresponding to the at least one patient parameter, a dose of the analgesic substance to be delivered to the patient; and causing, based on at least the determined dose, delivery of the analgesic substance to the patient via the tube and from the fluid supply.
Hickle discloses a display of an infusion device configured to deliver an analgesic substance to a patient (para. 82, 129, and 138 of Hickle; FIG. 24 shows an example display of stat mode dosage display 150. User 3 may also initiate a provision of propofol at a rate that will allow a targeted ESC or dosage to be reached as quickly as possible by activating the stat mode key 49 in the propofol portion 46 of the membrane keypad 34 (an overshoot of the targeted ESC is possible with this administration mode). Upon activation of this key, stat mode dosage display 150 is presented to user 3. Within this display, the current ESC, infusion rate or dose of propofol chosen or being currently administered is shown in a touch entry data box.); and determining, based on at least one or more values corresponding to the at least one patient parameter, a dose of the analgesic substance to be delivered to the patient (para. 129, 131, 138, and 141 of Hickle; Delivery system 2 recognizes certain ranges of values for user entered levels, doses, infusion rates or effect-site concentrations for which it may require additional confirmation by the user before targeting. These values are represented in a safety-data set stored within the system's memory. For example, if the user-entered ESC is less than a particular value in the safety data set proportionate to the patient's age (e.g., 4.0 .quadrature.g/cc for patients younger than 70 or 3.0 .quadrature.g/cc for patients 70 or older), delivery system 2 will proceed with the initiation process for propofol administration, i.e., it will change the current level administered or it will display the systems initiation screen (described below) at the beginning of a new procedure. For example, if the user-entered ESC exceeds that particular value, but is less than a second value (e.g., 15 .quadrature.g/cc), UI 1 will display drug warning screen for sedation and analgesia 180 to user 3, which cautions user 3 that the value he entered exceeds the maximum recommended propofol limit for sedation and analgesia.).
Souter discloses wherein the infusion device includes a fluid channel to receive a tube and a pump configured to deliver the analgesic substance to the patient via the tube coupled to a fluid supply and received by the fluid channel (para. 23, 24, 54, 61, 10, and 68 of Souter; The system includes at least one delivery tube configured to transport medication from the one or more ampoules received in the system to a patient. The emergency medication pump system may include a key or other input interface for executing an injection sequence. For example, the input may comprise an inject key, button, or other interface. When the key is pressed, the injection sequence is executed, the pump or pumps are activated, and the medication is delivered to the patient through the delivery tube.); presenting, on the display of the infusion device, one or more adjustments to the retrieved default value of the second patient parameter; determining a value for the second patient parameter based on the retrieved default value of the second patient parameter and a selection by a user via the user interface of at least one of the one or more adjustments (para. 48-50 of Souter; The system 10 is typically programmed with default concentrations for the plurality of medications in the ampoules 38 received in the plurality of medication ports 13. If, however, the concentration in at least one of ampoules 38a-38f is different than at least one of the default values, the concentration adjustment keys 16 allow an emergency medical provider or other user to override the default concentration value and enter a new concentration value. Additionally, the system 10 includes a plurality of concentration readout displays 18 that readily allow an emergency medical provider or other user to see the concentration value that is input into the system 10 as either a default value or as a manually entered override value. The system 10 may include a plurality of weight adjustment keys 26 and 28 configured to allow an emergency medical provider to enter a patient's weight or adjust up or down from a default setting (e.g., 70 kg). Typically, the dosage amount (i.e., the volume of medication solution administered to a patient) for each of the plurality of medications received in the system 10 is a function of the concentration of the medication (e.g., measured in mg/ml), the dosage rate of the medication (e.g., measured in mg/kg), and the patient's weight (e.g., measured in kg). The system 10 may advantageously be programmed with default values for the concentrations and dosage rates for each of the plurality of medications received in the system.); and causing, based on at least the determined dose, delivery of the analgesic substance to the patient via the tube and from the fluid supply (abstract, para. 26, 36, 68, 69, and 54 of Souter; the emergency medical provider can administer one or more medications to the patient in rapid sequence by selecting at least one medication, entering the patient's weight and/or the patient's Broselow color (and/or length), and pressing the inject key. The medication(s) is then carried to the patient's IV line 66 via delivery tube 36; the IV line 66 then carries the medication into the patient's circulatory system along with the IV fluid.).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Hickle and Souter within Marshall. The motivation for doing so would have been to prevent drug overdose (para. 8 & 9 of Hickle) and to automatically calculate dosages and administer selected medications to a patient based on minimal input (e.g., the patient's weight) (para. 2 of Souter).
(K) Referring to claim 33, Marshall discloses further comprising: receiving, via the user interface, a second entry, the second entry including a second value of the second patient parameter, the second value being an adjustment of the default value of the second patient parameter that is an accurate representation of the second patient parameter (para. 38 of Marshall).
(L) Referring to claim 34, Marshall discloses further comprising: receiving, via the user interface, a confirmation for the displayed retrieved default value of the second patient parameter (para. 38, 105, 108, and 109 of Marshall).
(M) Referring to claim 35, Marshall discloses further comprising: presenting, on the user interface of the display, at least one of the at least one patient parameter (Fig. 3 and para. 81-86 of Marshall).
(N) Referring to claim 37, Marshall does not disclose wherein the infusion device comprises at least one of a target controlled infusion pump, a syringe pump, an anesthesia delivery pump, or a patient-controlled analgesic pump, and the analgesic substance comprises at least one of a fluid, or a medication.
Hickle discloses wherein the infusion device comprises at least one of a target controlled infusion pump, a syringe pump, an anesthesia delivery pump, or a patient-controlled analgesic pump, and the analgesic substance comprises at least one of a fluid, or a medication (para. 16, 8, 5, and 62 of Hickle).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Hickle within Marshall. The motivation for doing so would have been to check that certain requisite predecessor conditions for the safety of sedation and analgesia have been satisfied before the system will administer drugs to a patient (para. 14 of Hickle).
(O) Referring to claim 38, Marshall discloses wherein at least one patient parameter comprises a value corresponding to at least one of a patient age, patient height, patient weight, patient gender, patient laboratory results, patient body mass index (BMI), or patient opiate usage (para. 33 of Marshall).
(P) Referring to claim 39, Marshall discloses wherein the first patient parameter and the second patient parameter are displayed simultaneously or sequentially (Fig. 3 and para. 38 & 81-87 of Marshall).
(R) Referring to claim 41, Marshall and Hickle do not expressly disclose wherein the one or more adjustments to the retrieved default value of the second patient parameter are presented by displaying one or more generated graphical elements to increment or decrement a value.
Souter discloses wherein the one or more adjustments to the retrieved default value of the second patient parameter are presented by displaying one or more generated graphical elements to increment or decrement a value (para. 48-50 & 26 of Souter).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Souter within Marshall and Hickle. The motivation for doing so would have been to conveniently provide keys that allow a provider to adjust up or down from a default setting (para. 50 of Souter).
(S) Referring to claim 42, Marshall and Hickle do not expressly disclose wherein presenting the one or more adjustments to the retrieved default value of the second patient parameter further comprises displaying one or more generated graphical elements to increment or decrement a value.
Souter discloses wherein presenting the one or more adjustments to the retrieved default value of the second patient parameter further comprises displaying one or more generated graphical elements to increment or decrement a value (para. 48-50 & 26 of Souter).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Souter within Marshall and Hickle. The motivation for doing so would have been to conveniently provide keys that allow a provider to adjust up or down from a default setting (para. 50 of Souter).
Response to Arguments
Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 12/16/25.
(1) Applicant respectfully requests the withdrawal of all rejections under 35 U.S.C. 103.
(A) As per the first argument, Examiner respectfully submits that the Examiner relied upon Souter to teach “determining a value for the second patient parameter based on the retrieved default value of the second patient parameter and a selection by a user via the user interface of at least one of the one or more adjustments” (see para. 48-50 of Souter; The system 10 is typically programmed with default concentrations for the plurality of medications in the ampoules 38 received in the plurality of medication ports 13. If, however, the concentration in at least one of ampoules 38a-38f is different than at least one of the default values, the concentration adjustment keys 16 allow an emergency medical provider or other user to override the default concentration value and enter a new concentration value. Additionally, the system 10 includes a plurality of concentration readout displays 18 that readily allow an emergency medical provider or other user to see the concentration value that is input into the system 10 as either a default value or as a manually entered override value. The system 10 may include a plurality of weight adjustment keys 26 and 28 configured to allow an emergency medical provider to enter a patient's weight or adjust up or down from a default setting (e.g., 70 kg). Typically, the dosage amount (i.e., the volume of medication solution administered to a patient) for each of the plurality of medications received in the system 10 is a function of the concentration of the medication (e.g., measured in mg/ml), the dosage rate of the medication (e.g., measured in mg/kg), and the patient's weight (e.g., measured in kg). The system 10 may advantageously be programmed with default values for the concentrations and dosage rates for each of the plurality of medications received in the system.); and causing, based on at least the determined dose, delivery of the analgesic substance to the patient via the tube and from the fluid supply (abstract, para. 26, 36, 68, 69, and 54 of Souter; the emergency medical provider can administer one or more medications to the patient in rapid sequence by selecting at least one medication, entering the patient's weight and/or the patient's Broselow color (and/or length), and pressing the inject key. The medication(s) is then carried to the patient's IV line 66 via delivery tube 36; the IV line 66 then carries the medication into the patient's circulatory system along with the IV fluid.) and Hickle, not Souter, as argued, to teach “determining, based on at least one or more values corresponding to the at least one patient parameter, a dose of the analgesic substance to be delivered to the patient” (see para. 129, 131, 138, and 141 of Hickle; Delivery system 2 recognizes certain ranges of values for user entered levels, doses, infusion rates or effect-site concentrations for which it may require additional confirmation by the user before targeting. These values are represented in a safety-data set stored within the system's memory. For example, if the user-entered ESC is less than a particular value in the safety data set proportionate to the patient's age (e.g., 4.0 .quadrature.g/cc for patients younger than 70 or 3.0 .quadrature.g/cc for patients 70 or older), delivery system 2 will proceed with the initiation process for propofol administration, i.e., it will change the current level administered or it will display the systems initiation screen (described below) at the beginning of a new procedure. For example, if the user-entered ESC exceeds that particular value, but is less than a second value (e.g., 15 .quadrature.g/cc), UI 1 will display drug warning screen for sedation and analgesia 180 to user 3, which cautions user 3 that the value he entered exceeds the maximum recommended propofol limit for sedation and analgesia.).
In response to applicant's argument that Souter does not teach a process by which a second patient parameter is determined based at least on a first patient parameter and default values stored in a data table, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments are not persuasive because it is unclear how the language of the claim differs from the applied prior art. See modified 103 rejection above which explains that Marshall teaches the newly added limitation of “the default values comprising predetermined values being determined prior to storage in the data table.” See para. 38 & 68 of Marshall which discloses “If the user wishes to change one or more of the values, he or she repeats stage 32 by re-entering at least one value. In the present embodiment, the user overwrites the value that was originally entered by typing a new value in the data entry box 66 using the keyboard 18. In alternative embodiments, the user selects a new value from a drop-down list or drop-down table, or uses any suitable input method. The user may accept one or more of the previously entered values and overwrite other values. In the present embodiment, the user overwrites any value that he or she wishes to correct, and then clicks on the button 70 using the mouse 18.“ Furthermore, the broadest reasonable interpretation of “retrieving, based on the first entry, a default value for a second patient parameter from among the at least one patient parameter, from the data storage based on the received first parameter” would include “once the user has entered a value for patient height and a value for patient weight, the likelihood unit 24 calculates the most likely value for patient age given the entered values for patient height and patient weight and sets the most likely value for patient age as a default value for patient age.” (paragraph 106 of Marshall) and “After the value for patient gender is entered, the likelihood unit 24 recalculates the displayed likelihoods given the value for patient gender, and calculates the likelihood of the patient gender given the currently-displayed values for patient height, patient weight and patient age… one or more of the data entry boxes 66 comprises a drop-down list or drop-down table, and the ordering of which possible values are displayed in the drop-down list or drop-down table is dependent on the likelihoods of the possible values” (see paragraphs 92-94 of Marshall). Also, see paragraph 38 of Marshall which discloses “When a data entry box 66 displays a default value, the user may choose to accept the default value.” Furthermore, see at least paragraph 40 of Marshall which discloses that “the likelihood unit 24 receives the values that have been entered by the user in the data entry boxes 66 and inputs the values into a probabilistic data model that has been constructed for the four data entry fields of display screen 60. The probabilistic data model may be considered to be part of a server backend which conducts data validation.” In addition, the arguments are not persuasive because the claim does not specify when the retrieved default parameter was determined.
In response to applicant's argument that Hickle teaches away, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In response to applicant’s argument that Hickle cannot be combined with Marshall and/or Souter, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivations to combine came directly from the references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches a method and device to monitor patients with kidney disease (US 2012/0277546 A1).
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687