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
This office action is responsive to the amendment filed 06 May 2026. As directed by the amendment claims 1-4, 6, 8-11, 14-18, 26-28, and 30-32 are pending in this application. The amendment to claim 15 has overcome the previous 35 USC 112 rejection.
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 06 May 2026, with respect to the rejection(s) of claim(s) rejection of claims 1-4, 6, 8-11, 14-18, 26-28, and 30-32 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-4, 6, 8, 9-11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the computer directed infusion pump" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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) 1, 2, 9-11, 14, 26-27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436).
Regarding claim 1, Dumont and Kuchimanchi teach a method for steady state infusion of a drug (abstract, ¶[0092]) comprising:
calculating the rate constants of a patient for transport of a drug from an infusion site to an active site (¶[0041], where the rate constant of a patient is determined by said patient and thus why variability occurs);
creating a computer deliverable program that calculates the rate constants of the patient suited to control an infusion pump (¶[0033], where an MPC is designed for use in calculating rate constants, ¶[0048], where the rate constant of a patient is determined by said patient and thus why variability occurs);
providing an infusion pump (Fig. 1, 13) controllable by the computer deliverable program (¶[0048], where the pump 13 is controlled by controller 12 for the delivery process); and
delivering the drug to the patient via the computer directed infusion pump at a desired flow rate or flow constant (k) (¶[0048], where the controller 12 takes the constants calculated and directs the infusion pump 13 to deliver to the patient 14).
Dumont does not specifically teach delivering at a desired flow rate or flow constant as determined by said patient’s own rate constants identified in (i). Kuchimanchi teaches a system (Fig. 31, 102, 108, 112) including a processor (Fig. 31, 3104) with a visual display (Fig. 1, 3116). The device calculates the rate constants of a patient (¶[0061] & ¶[0143]). The processor is configured to update said constants for intravenous fluid delivery based on the individualized data from the patient in order to reach optimal rates (¶[0061]). The device of Kuchimanchi teaches that a patient’s individual flow rates are used in a calculation for a delivery of intravenous fluid at a desired flow rate or flow constant, therefore, modifying the device of Dumont to use individualized rates would improve the device by tailoring the flow rate constants to an individual to provide the most optimized delivery possible and also prevents excess fluid delivery (¶[0083]-[0086] from Kuchimanchi). Kuchimanchi also teaches that the model accounts for and allows for steady state functions (¶[0074]). Steady state infusion is well-known in the art and would be obvious to implement into the device of Dumont.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to include have a processor that allows a device to deliver fluid at a desired flow rate or flow constant based on a patient’s own rate constants (¶[0061], [0083]-[0086], [0143] from Kuchimanchi).
Regarding claim 2, Dumont and Kuchimanchi teach the method of claim 1, Dumont further teaches wherein the delivery, via a needle, is intravenous or intramuscular (¶[0039], where the delivery methods include intravenous and intramuscular delivery).
Regarding claim 9, Dumont and Kuchimanchi teach discloses the method of claim 1, Dumont further teaches wherein an initial bolus of the drug is delivered providing kinetics for its steady state delivery (¶[0094], where an initial bolus reaches a steady state at a point after delivery).
Regarding claim 10, Dumont and Kuchimanchi teach the method of claim 1, Dumont further teaches wherein the computer deliverable program comprises a two-compartment model (¶[0036], where the MPC controller utilizes a PKPD model which is a multi-compartment model, which can include a two-compartment model).
Regarding claim 11, Dumont and Kuchimanchi teach the method of claim 1, Dumont further teaches wherein the computer deliverable program comprises a multi-compartment model (¶[0036], where the MPC controller utilizes a PKPD model which is a multi-compartment model).
Regarding claim 14, Dumont and Kuchimanchi teach the method of claim 2, Dumont further teaches wherein intramuscular means within the pectoralis, the gluteus, the calf, the rectus abdominus, the quadriceps or other muscle capable of accepting an intramuscular needle (¶[0039], where the intramuscular delivery method disclosed would include any muscle capable of accepting an intramuscular needle).
Regarding claim 26, Dumont and Kuchimanchi teach an apparatus for administering a steady-state infusion of a drug to a patient comprising:
a computer assisted infusion device (¶[0048], where the infusion pump 13 is controlled by an MPC controller);
a computer program designed to drive the infusion device (¶[0048]);
wherein the computer program calculates the rate constants of said patient from a first bolus(¶[0041]);
wherein the infusion device delivers a steady-state infusion of drug to said patient in proceeding bolus’ using said rate constants derived from said first bolus (¶[0094], where an initial bolus reaches a steady state at a point after delivery).
Dumont does not specifically teach wherein the computer program calculates the rate constants of said patient from a first bolus or wherein the infusion device delivers a steady-state infusion of drug to said patient in proceeding bolus’ using said rate constants derived from said first bolus.
Kuchimanchi teaches a system (Fig. 31, 102, 108, 112) including a processor (Fig. 31, 3104) with a visual display (Fig. 1, 3116). The device calculates the rate constants of a patient (¶[0061] & ¶[0143]). The processor is configured to update said constants for intravenous fluid delivery based on the individualized data from the patient in order to reach optimal rates (¶[0061]). The device of Kuchimanchi teaches that a patient’s individual flow rates are used in a calculation for a delivery of intravenous fluid at a desired flow rate or flow constant, therefore, modifying the device of Dumont to use individualized rates would improve the device by tailoring the flow rate constants to an individual to provide the most optimized delivery possible and also prevents excess fluid delivery (¶[0083]-[0086] from Kuchimanchi). Kuchimanchi also teaches that the model accounts for and allows for steady state functions (¶[0074]). Steady state infusion is well-known in the art and would be obvious to implement into the device of Dumont.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to include have a processor that allows a device to deliver fluid at a desired flow rate or flow constant based on a patient’s own rate constants (¶[0061], [0083]-[0086], [0143] from Kuchimanchi).
Regarding claim 27, Dumont and Kuchimanchi teach the apparatus of claim 26, Dumont further teaches wherein the infusion device delivers the drug intravenously or intramuscularly (¶[0039], where the delivery methods include intravenous and intramuscular delivery).
Regarding claim 32, Dumont and Kuchimanchi teach the apparatus of claim 26, Dumont further teaches wherein the computer assisted infusion device infuses the drug with kinetics of a two-compartment model or a multi-compartment model (¶[0036], where the MPC controller utilizes a PKPD model which is a multi-compartment model).
Claim(s) 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436) as applied to claim 1 above, and further in view of Morgan (US 2024/0197652).
Regarding claim 3, Dumont and Kuchimanchi teach the method of claim 1, however, Dumont does not specifically teach wherein the drug is a serotonergic drug.
Dumont teaches different types of drugs that are able to be used in the device such as hypnotics (the infusion device and the controller of Dumont have the capability to delivery other drugs including: analgesics, neuro-muscular blockers, hemodynamics and others, ¶[0011]). Morgan teaches a serotonergic agent that affects a serotonin receptor (¶[0326]). The device of Dumont already has a wide breadth of drugs that can be utilized in the device and by modifying the device of Dumont with the drugs used in Morgan, it would not only provide a wider array of drugs that can be infused, but because it is a serotonergic agent it would block or influence reactions at the receptors (¶[0326] from Morgan).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to use a serotonergic drug in an intramuscular injection (¶[0326] from Morgan).
Regarding claim 4, the combination of Dumont, Kuchimanchi and Morgan teaches he method of claim 3, Morgan further teaches wherein the serotonergic drug is a psychedelic drug (¶[0327]).
Claim(s) 6, 8, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436) as applied to claim 1 above, and further in view of in view of Haider et al. (US 2005/0245895).
Regarding claim 6, Dumont and Kuchimanchi teach the method of claim 2, however, Dumont does not specifically disclose wherein the needle comprises a number of side holes ranging from 1-100.
Haidar teaches a device for epidermal or intradermal delivery including a needle. Haidar teaches a needle shaft (Fig. 1b, 11) comprising side holes (Fig. 1b, 19). Modifying the device of Dumont to include a needle that includes side holes would allow for the delivery of a substance at various depths shallower than the length of the needle shaft (¶[0040] from Haidar).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to include a needle shaft (Fig. 1b, 11 from Haidar) that has side holes that range from 1-100 (Fig. 1b, 19 from Haidar).
Regarding claim 8, Dumont and Kuchimanchi teach the method of claim 2, Haidar further teaches wherein the needle comprises curve at the base of the needle ranging from 0 to 90 degrees (Fig. 1b, 11, where the angle of the curve would be considered 0 as the needle is straight).
Regarding claim 28, Dumont and Kuchimanchi teach the apparatus of claim 27, Haidar further teaches wherein intramuscular infusion comprises a modified needle.
Haidar teaches a device for epidermal or intradermal delivery including a needle. Haidar teaches a needle shaft (Fig. 1b, 11) comprising side holes (Fig. 1b, 19). This is a modification of a traditional needle. Modifying the device of Dumont to include a needle that includes side holes would allow for the delivery of a substance at various depths shallower than the length of the needle shaft (¶[0040] from Haidar).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to include a needle shaft (Fig. 1b, 11 from Haidar) that has side holes that range from 1-100 (Fig. 1b, 19 from Haidar) and have a modified needle.
Regarding claim 30, Dumont and Kuchimanchi teach the apparatus of claim 28, Haidar further teaches wherein the needle (Fig. 1b, 11) comprises a number of side holes ranging from 2-100 (Fig. 1b, 19).
Regarding claim 31, Dumont and Kuchimanchi teach he apparatus of claim 28, Haidar further teaches wherein the needle comprises a curve at the base of the needle ranging from 0 to 90 degrees (Fig. 1b, 11, where the angle of the curve would be considered 0 as the needle is straight).
Claim(s) 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436) as applied to claim 1 above, and further in view of in view of Russ et al. (US 2020/0147038).
Regarding claim 15, Dumont teaches a steady state concentration of a psychotropic compound as determined by each patient’s rate constant (¶[0011], where the drug is hypnotic and is therefore psychotropic, [0094], where an initial bolus reaches a steady state, and a patient’s rate constant will vary as shown by the data samples in Dumont making each rate constant substantially different based on that patient)
wherein the steady state concentration is maintained by a computer controlled infusion pump (where the controller 12 is an MPC controller that interacts with the pump 13 and maintains the desired amount of infused drug);
wherein the infusion pump maintains the steady state concentration according to two compartment or multi-compartment kinetics (¶[0036], where the MPC controller utilizes a PKPD model which is a multi-compartment model).
Kuchimanchi teaches a system (Fig. 31, 102, 108, 112) including a processor (Fig. 31, 3104) with a visual display (Fig. 1, 3116). The device calculates the rate constants of a patient (¶[0061] & ¶[0143]). The processor is configured to update said constants for intravenous fluid delivery based on the individualized data from the patient in order to reach optimal rates (¶[0061]). The device of Kuchimanchi teaches that a patient’s individual flow rates are used in a calculation for a delivery of intravenous fluid at a desired flow rate or flow constant, therefore, modifying the device of Dumont to use individualized rates would improve the device by tailoring the flow rate constants to an individual to provide the most optimized delivery possible and also prevents excess fluid delivery (¶[0083]-[0086] from Kuchimanchi). Kuchimanchi also teaches that the model accounts for and allows for steady state functions (¶[0074]). Steady state infusion is well-known in the art and would be obvious to implement into the device of Dumont.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dumont to include have a processor that allows a device to deliver fluid at a desired flow rate or flow constant based on a patient’s own rate constants (¶[0061], [0083]-[0086], [0143] from Kuchimanchi).
Dumont does not specifically disclose a method of treating a mental health complaint comprising administering to a patient in need thereof.
Russ teaches a method of treating a mental health complaint comprising administering to a patient in need thereof (¶[0003]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the device of Dumont to treat a mental health complaint comprising administering to a patient in need the device of Dumont would be improved by directly treating the complaint in a wide variety of areas such as anxiety, depression or addiction (¶[0003], [0146], [0156] from Russ).
Regarding claim 18, Dumont, Kuchimanchi and Russ teach the method of claim 15, Dumont further teaches wherein the psychotropic compound is administered intravenously or intramuscularly (¶[0011], where the hypnotic agent is psychotropic, ¶[0039], where the delivery methods include intravenous and intramuscular delivery from Dumont).
Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dumont et al. (US 2018/0296759) in view of Kuchimanchi (US 2020/0312436) as applied to claim 1 above, and further in view of in view of Russ et al. (US 2020/0147038), and further in view of Tsibulsky (“Real time computation of in vivo drug levels during drug self-administration experiments”, NIH Public Access, 2005 May).
Regarding claim 16, the combination of Dumont, Kuchimanchi and Russ teaches the method of claim 15, however, Dumont, Kuchimanchi and Russ do not specifically teach wherein the kinetics is first order.
Tsibulsky teaches an administration program utilizing self-administration and pharmacokinetic properties. In particular Tsibulsky teaches there is a choice between first or second-order processes and uses a two or three-compartment model similar to the device used in Dumont. The first or second order of kinetics used is known in the art to be used in devices that utilize controllers and have multi-compartment models as demonstrated by the article by Tsibulsky (abstract). Kuchimanchi teaches that the models used in the device are first-order and when combined with Dumont gives the device rate constants associated with patient’s.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to utilize first order kinetics in the device of Dumont based on known pharmacokinetics as evidenced by the abstract of Tsibulsky.
Regarding claim 17, the combination of Dumont, Kuchimanchi and Russ teaches he method of claim 15, however, Dumont, Kuchimanchi and Russ do not specifically teach wherein the kinetics is second order.
Tsibulsky teaches an administration program utilizing self-administration and pharmacokinetic properties. In particular Tsibulsky teaches there is a choice between first or second-order processes and uses a two or three-compartment model similar to the device used in Dumont. The first or second order of kinetics used is known in the art to be used in devices that utilize controllers and have multi-compartment models as demonstrated by the article by Tsibulsky (abstract).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to utilize second order kinetics in the device of Dumont based on known pharmacokinetics as evidenced by the abstract of Tsibulsky.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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