DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the amendment filed on 07/27/26. As directed by the amendment: claims 1, 5-6, 8, 10, 12-13, 15-16, 21-22, and 24-36 have been amended, claims 11 and 18-20 have been cancelled, and claim 37 has been added. Thus, claims 1-10, 12-17, and 21-37 are presently pending in this application.
Claim Interpretation
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
4. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
5. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“requesting device” in claim 1 lines 7, 10, 15, and 27, claim 28 line 3, claim 30 line 16, claim 32 lines 3-4, claim 33 line 3, claim 34 lines 3-4, and claim 35 lines 3 is interpreted as an end-sided push button or the like according to the PGPUB of the application (US 2024/0024594) paragraph [0381].
“application device” in claim 1 line 37, claim 3 line 2, claim 10 lines 1-2, and claim 12 line 2 is interpreted as a piston or the like according to the PGPUB paragraph [0414]. The limitation is not interpreted under 112f for claims 4-6 due to the introduction of sufficient structure.
“loading device” in claim 2 line 5, and claim 10 line 2 is interpreted as a piston or the like according to the PGPUB paragraph [0059]. The limitation is not interpreted under 112f for claims 4-6 and 14-15 due to the introduction of sufficient structure. Examiner notes that the “loading device” is being interpreted as an “application device” according to the PGPUB paragraph [0705], paragraph 1 of page 20 of “remarks,” and figure 6 of the application.
“mechanism” in claim 8 line 3 and claim 13 line 2 is interpreted as a part of the dispenser according to the PGPUB paragraph [0065] or a knob or the like according to PGPUB paragraph [0362].
“locking device” in claim 16 line 3 and claim 22 line 9 is interpreted as an electronic component or the like according to the PGPUB paragraph [0605].
“dose-detection device” in claim 17 line 3 is interpreted as a sensor or the like according to the PGPUB paragraph [0213].
“detection device” in claim 1 lines 12 and 21, claim 27 line 3, claim 28 line 2, claim 32 line 3, claim 33 line 2, and claim 34 line 3 is interpreted as an electronic component or the like according to PGPUB paragraph [0605].
“feedback device” in claim 27 lines 2 and 3-4 and claim 28 line 6 is interpreted as a switch or the like according to PGPUB paragraph [0149].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-10, 12-17, and 21-37 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.
Regarding claim 1, the limitation “the electronic control device (9) is further programmed to” in lines 18-19 is indefinite because the term “further” implies the control device is already programmed to perform some functions, however, these are not present in the claims so it is unclear what the control device is already programmed to perform. The limitation is being interpreted as –the electronic control device (9) is programmed to--.
Regarding claims 5, 15, 24-25, 27-30, and 32-35, the limitation “optionally” in claim 5 line 3, claim 15 line 5, claim 24 lines 3-4, claim 25 line 4, claim 27 line 4, claim 28 lines 5, 9-12, 16, 18, 20-22, and 25, claim 29 line 5, claim 30 lines 11, 13, 20, 28, 31, and 36, claim 32 line 7, claim 33 lines 7, 12, 14, and 18, claim 34 line 14, and claim 35 lines 7, 12, 14, and 18 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 13 recites the limitation "the dose chamber" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "a locking period" in lines 3-4. It is unclear if this is in reference to the locking period introduced in claim 1 line 25 or if this is a new, distinct locking period. The claim is being interpreted as “the locking period.”
Claims 32 and 34 recites the limitation "an evaluation of the actuation behavior" in line 2 respectively. However, it is unclear if this in in reference to the function of the control device introduced in claim 1 line 21 “evaluate the user’s actuation behavior” or if this is referring to a newly introduced evaluation step. The limitation is being interpreted as –the control device is further programmed so that the evaluation of the actuation behavior--.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claim(s) 1, 16, 21, 26, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna (US 2004/0231669) in view of Eberhart et al. (US 9,033,939).
Regarding claim 1, Bruna discloses a nasal applicator (fig. 1) for the nasal administering of at least one medical substance ([0002] the fluid or powder is medication), said nasal applicator (fig. 1) comprising a housing (fig. 1, body 10) which respectively comprises, or is connected to,
- a substance reservoir (fig. 1, fluid or powder reservoir 20) for comprising a quantity of the substance ([0018] states that reservoir 20 contains one or more doses of fluid or powder);
- a requesting device (fig. 1, manual actuator element 40) to be actuated by the user with the aim of requesting a next application dose of the substance ([0018] states that when pressed, the actuator element 40 actuates the dispenser means 30);
- a dispenser (fig. 1, dispenser means 30) for dispensing application doses upon actuation of the requesting device at a respective dispensing point of time ([0005] states that when the manual actuator element actuates a dispenser to dispense doses of fluid or powder),
- a nasal attachment or a nasal piece (see annotated fig. 1 below);
- a detection device ([0022] states control unit 60 performs the functions below including [0033] where data can be transmitted to the doctor regarding the history of the dose-taking) at least for detecting an activation behavior of the user at an actuation point of time ([0033] states the transmitted data can determine the history of dose-taking inherently meaning the doses are recorded) relating to the requesting device (fig. 1, manual actuator element 40 delivers doses, see [0018]) with the aim of applying a next or further application dose ([0022] states control unit 60 can additionally [0027] provide a timer until a next dose);
- a data storage ( [0027] states that the control unit includes a memory) for storing at least the dispensing points of time ( [0027] additionally stores time between doses for display) of one or more already dispensed application doses ( [0033] states that the transmitted data can provide history of the dose-taking);
- an electronic control device (fig. 1, control unit 60), wherein the electronic control device is programmed to
read data stored in the data storage ([0027] states that remaining doses and time until the next dose can be stored in memory and displayed);
evaluate the user’s actuation behavior detected by the detection device ([0026] states that the control unit can signal to the patient when to take a dose, [0030] states that the control unit adjust the authorized actuation period based on patient lack of actuation, [0031] states that the control unit can lock the device in response to actuation, and [0033] states that the control unit can communicate dose history information to a doctor);
- an application device (fig. 1, dispenser means 30 can be a pump which includes a piston, see [0008]) for applying an application dose of the substance ([0005] the dispenser means dispenses doses of fluid or powder) through the nasal applicator ([0001] states that the device is a nasal spray device which inherently means the drug is dispensed to the nose which is outside of the applicator device).
The device of Bruna further discloses that the control device can deliver an application dose at a next dispensing point in the event that the user actuates the requesting device outside a locking period ([0031] states the control unit only allows actuation at set times) and that a doctor can modify dosage ([0034]), but does not expressly disclose that the control unit predetermines the amount of the next application dose, at a predetermination point of time which lies at or after the actuation point of time, based on the data in the storage comprising: the dispensed time, elapsed time, and the next dispensing time or the amount of previous dispensed doses, and/or the amount of one or of several of the already dispensed application doses.
However, Eberhart discloses a nasal applicator that is configured to predetermine a dischargeable maximum amount based on a maximum amount per time, the difficulty of the drug to metabolize, and potentially the patient’s opioid habits (col. 2, lines 58-67 and col. 3, lines 1-8).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the locking schedule program of Bruna with the predetermined maximum amount and locking schedule program of Eberhart to better tailor doses of a prescribed drug to the individual patient (col. 1, lines 63-67 and col. 2, lines 1-5).
The modified device of Bruna reads on the control device being programmed to: predetermine (Eberhart col. 2, lines 58-67 state that a predetermined maximum amount is provided as a maximum amount per time, and Bruna [0022], [0027], and [0033] states that a history of the dose-taking is transmitted to a doctor/patient and therefore recorded), at a predetermination point of time (Based on the maximum amount per time, Eberhart col. 2, lines 58-67, and the previously discharged doses, see Bruna [0022], [0027], and [0033], at any given actuation time, a predetermination point of time can be defined at the same time where a remaining amount that can currently be administered is accessed), the amount of the next or the further application dose which may be delivered to the user at a next dispensing point of time (Based on the maximum amount per time, Eberhart col. 2, lines 58-67, and the previously discharged doses, see Bruna [0022], [0027], and [0033], at any given actuation time, a predetermination amount of substance can be found) in the event that the user actuates the requesting device outside a locking period (a locking period is set by Bruna [0031] states the control unit only allows actuation at set times), wherein the predetermination point of time lies at or after the actuation point of time (Based on the maximum amount per time, Eberhart col. 2, lines 58-67, at any point in time an admissible amount can be found, therefore, when the device is actuated, a current admissible amount is inherently accessed based on the max amount per time where the time between doses is used to calculate a new maximum amount , therefore the time in which the user actuates the device is defined as a predetermination point of time because the elapsed time until that point is used in calculating an allowed dose), and wherein the predetermination takes place considering the data read from the data storage (Eberhart col. 2, lines 58-67, the maximum amount per time is referenced when determining admissible active substance maximum amounts), wherein this data encompasses at least a) the dispensing point of time of one or several of the already dispensed application doses or the elapsing time period between the one or the several dispensing point of time(s) of the already dispensed application doses (Bruna [0027] states that the amount of remaining doses and time between doses is displayed to the user which inherently means the data regarding previous doses and the overall treatment is stored) and the dispensing point of time lying after the next actuation point of time (Eberhart col. 2, lines 58-67, the maximum dosage per time would require the previous dosage, the elapsed time, and the current time to make a calculation on an admissible active substance maximum amount), on the one hand and/or b) the amount of one or of several of the already dispensed application doses on the other hand (Bruna [0027] states that previous doses and time between doses is displayed and is therefore recorded).
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Regarding claim 16, the modified device of Bruna reads on claim 1 and further reads on a locking device (Bruna fig. 2, securing system 50) for temporarily locking the dispenser (Bruna [0019] states that the securing means can control if the manual actuator can communicate with dispenser means 30) during a locking period (Bruna [0031] states that the system is locked between doses to prevent over dosage) that begins again at or after the respective dispensing application dose, the locking period begins (Bruna [0031] a locked period between doses inherently means the locking period begins after a dose is delivered).
Regarding claim 21, the modified device of Bruna reads on claim 1 and further reads on the data storage encompasses data associated with the substance (Eberhart col. 9, lines 35-41 describe a patient specific maximum dose) wherein the electronic control device is further programmed for additional reading of data stored in the data storage concerning the data associated with the substance (Eberhart col. 9, lines 35-41 state that a respective patient dosage can be written into the memory) and wherein predetermining the next application dose of the substance takes place with additional consideration of the additionally read data (Eberhart col. 2, lines 58-67 and col. 3, lines 1-8 the provided dose is dependent on the data regarding maximum dosage).
Regarding claim 26, the modified device of Bruna reads on claim 1 and further reads on the evaluating step encompasses determining the actuation point of time for requesting the next application dose (Bruna [0026] states that the control unit can signal to the patient when to take a dose based on a previous dose), and the predetermining step encompasses considering the determined next actuation point of time (Eberhart col. 2, lines 60-64 states that a maximum amount of substance is predetermined based on a maximum amount per time which means the subsequent activations take into account the maximum amount that can be delivered).
Regarding claim 36, the modified device of Bruna reads on claim 1 and further reads on the device being part of a treatment system (Bruna fig. 3) which includes one or more peripheral devices (Bruna fig. 3, a personal computer), wherein the nasal applicator is in signal communication with the peripheral device (Bruna [0022] states that the control unit 60 of the device in fig. 1 is able to transmit and receives data with a computer so that parameters of the control unit can be modified and, see [0033], a history of the doses taken can be sent to the doctor).
Regarding claim 37, the modified device of Bruna reads on claim 1 and further reads on wherein the at least one medical substance is an analgesic (Bruna [0002] states that medication can be provided, an analgesic in fluid or powder form can be similarly used).
11. Claim(s) 2-5, 8, 10, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Weston et al. (US 5,497,944).
Regarding claim 2, the modified device of Bruna discloses the limitations of claim 1 and further discloses that the dispenser means 30 can be a pump with a piston (Bruna [0008]), but does not expressly disclose a dose chamber and a loading device for loading the dose chamber.
However, Weston teaches of a metered dose inhaler (fig. 1) that provides liquid (fig. 1, collapsible bag 10 stores liquid) through an inlet passage (fig. 1, 11) to a pressure chamber (fig. 1, 4) during a suction stroke (col. 7, lines 10-12) of a piston (fig. 1, 3) for dispensing to an atomizing head (fig. 1, 22) during compression of the piston causing pressure buildup (col. 9, lines 9-19).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the dispenser means of Bruna with the pump apparatus as taught by Weston as a simple substitution of one known element for another to obtain a predictable result of pumping medication from a reservoir to the patient.
The modified device of Bruna reads on a dose chamber (Weston fig. 1, pressure chamber 4) for temporarily receiving the application dose of the substance (Weston col. 9, lines 1-4 state that the pressure chamber receives and holds the liquid) held in the substance reservoir (Bruna fig. 1, reservoir 20); and a loading device (Weston fig. 1, piston 3 acts as a loading device by sucking in the fluid, see col. 7, lines 10-12, and acts as an application device when pushing up thereby increasing the pressure in the pressure chamber, see col. 9, lines 9-19) for loading the dose chamber with the application dose of the substance from the substance reservoir (Weston col. 7, lines 10-12 state that during a suction stroke fluid is able to flow into the pressure chamber from the reservoir).
Regarding claim 3, the modified device of Bruna reads on the limitations of claim 2 and further reads on the application device (Weston fig. 1, piston 3) is arranged for applying the application dose of the substance present in the dose chamber (Weston fig. 1, pressure chamber 4) out of the nasal applicator (Bruna abstract states the fluid is to be dispensed).
Regarding claim 4, the modified device of Bruna reads on the limitations of claim 2 and further reads on the application device (Weston fig. 1, piston 3) and/or the loading device (Weston fig. 1, piston 3) comprises an energy storage (Weston fig. 1, spring 6) for spring energy.
Regarding claim 5, the modified device of Bruna reads on the limitations of claim 2 and further discloses that the dispenser means 30 can be a pump with a piston ([0008]), but does not disclose the application device and/or the loading device comprises a motor.
However, Weston teaches of a metered dose inhaler (fig. 1) that pumps fluid using a piston (col. 7, lines 10-12) that can draw on an energy storage means which can be a motor (col. 5, lines 13-21)
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the dispenser means of Bruna with the pump apparatus as taught by Weston as a simple substitution of one known element for another to obtain a predictable result of pumping medication from a reservoir to the patient.
Regarding claim 8, the modified device of Bruna reads on the limitations of claim 2 and further reads on a mechanism (Weston fig. 1, reduced diameter portion 5 of piston 3 which sealingly engages within pressure chamber 4, see col. 8, lines 31-33) for changing the capacity volume of the dose chamber (Weston fig. 1, the volume of pressure chamber 4 is dependent on how far back the piston is pulled during a suction stroke) for the application dose of the substance (Weston col. 9, lines 12-19 state that when the piston is released the pressure builds and ejects the fluid in the pressure chamber 4).
Regarding claim 10, the device of Bruna reads on the limitations of claim 2, and further reads on the application device and the loading device comprise or consist of identical components (Weston fig. 1 and col. 7, lines 10-12 state that the piston pulls in liquid during a suction stroke, and col. 9, lines 9-19 state the piston ejects the medication during a forward motion therefore acting as an application and loading device, also see claim interpretation regarding the loading device being interpreted as an application device above).
Regarding claim 13, the device of Bruna reads on the limitations of claim 1 and further discloses that the dispenser means 30 can be a pump with a piston ([0008]), but does not disclose the application device and/or the loading device comprises a motor.
However, Weston teaches of a metered dose inhaler (fig. 1) that pumps fluid using a piston (col. 7, lines 10-12) into a pressure chamber (fig. 1, 4).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the dispenser means of Bruna with the pump apparatus as taught by Weston as a simple substitution of one known element for another to obtain a predictable result of pumping medication from a reservoir to the patient.
The modified device of Bruna reads on the limitations that the electronic device (Bruna fig. 1, control unit 60) is programmed to act on the mechanism (Weston fig. 1, piston 3) for changing the capacity volume of the dose chamber (Bruna [0031] states the control unit controls actuation of the device, actuating the device meaning Weston fig. 1, pressure chamber 4 is compressed so that medicament can be expelled).
Regarding claim 14, the modified device of Bruna reads on the limitations of claim 2 and further reads on the loading device (Weston fig. 1, piston 3) for loading the dose chamber (col. 7, lines 10-12 state that the piston pulls in liquid during a suction stroke) with the application dose of the substance (Weston fig. 1, the dose within pressure chamber 4) comprises at least one first one-way valve (Weston fig. 1, non-return valve 13), wherein the dose chamber (Weston fig. 1, pressure chamber 4) is limited by at least one first one-way valve (Weston col. 9, lines 20-23 state that non-return valve 13 prevents the dose within pressure chamber 4 from returning to the bag which is considered the reservoir).
Regarding claim 15, the modified device of Bruna reads on the limitations of claim 2 and further reads on the loading device (Weston fig. 1, piston 3) for loading the dose chamber (Weston fig. 1, pressure chamber 4) with the application dose of the substance (Weston fig. 1, the dose within pressure chamber 4) comprises at least one second one-way valve (Weston fig. 1, non-return valve 23), wherein the dose chamber (Weston fig. 1, pressure chamber 4) is limited by at least one second one-way valve (Weston col. 9, lines 33-35 states the non-return valve 23 prevents air from being sucked into the pressure chamber 4), wherein the second check valve (Weston fig. 1, non-return valve 23) optionally comprises an opening direction being, with respect to the dose chamber (Weston fig. 1, pressure chamber 4), opposite to that of the first check valve (Weston col. 9, lines 20-23 states non-return valve 13 prevents the dose from exiting the pressure chamber, and col. 9, lines 33-35 states the non-return valve 23 prevents air from being sucked into the pressure chamber).
12. Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Weston and van der Linden et al. (US 5,950,619).
Regarding claim 6, the modified device of Bruna reads on the limitations of claim 2 and further reads on an application and loading device (Weston fig. 1, piston 3 acts as a loading device by sucking in the fluid, see col. 7, lines 10-12, and acts as an application device when pushing up thereby increasing the pressure in the pressure chamber, see col. 9, lines 9-19), but does not expressly disclose the application device and/or the loading device comprises a motor.
However, Weston teaches of a metered dose inhaler (fig. 1) that pumps fluid using a piston (col. 7, lines 10-12) that can draw on an energy storage means which can be a motor (col. 5, lines 13-21).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the dispenser means of Bruna with the pump apparatus as taught by Weston as a simple substitution of one known element for another to obtain a predictable result of pumping medication from a reservoir to the patient.
The modified device of Bruna further reads on a rod connected to the piston (Weston fig. 1, rod 31), but does not expressly disclose a spindle.
However, Linden teaches of an ultrasonic atomizer device (fig. 1A, 2) that uses a motor (col. 10, lines 58-62) to rotate a spindle (fig. 4, 72) to push a plunger (fig. 4, 66).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the motor of the modified device of Bruna with the motor and spindle apparatus as taught by Linden as a simple substitution of one known element for another to obtain a predictable result of allowing the piston to load and apply medication.
Regarding claim 7, the modified device of Bruna reads on the limitations of claim 6 and further reads on the motor is connected to the spindle (Linden col. 10, lines 58-62 states that the motor rotates to drive propelling gear 56 which rotates a coupling socket 34 and connection rod 80 and thereby the spindle 72. Therefore, the spindle is connected to the motor via the propelling gear, coupling socket, and connection rod).
13. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Lanzkowsky (US 2018/0110939).
Regarding claim 9, the device of Bruna reads on the limitations of claim 1, but does not disclose a second fluid chamber comprising a substance neutralizing agent.
However, Lanzkowsky teaches of an apparatus for administering pain medicaments that includes a tamper resistant container (fig. 4) with an antidote substance (fig. 4, 403) to prevent abuse of the substance ([0018]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Bruna with the tamper resistant container of Lanzkowsky to control the substance and prevent abuse by breaking the device (Lanzkowsky [0018]).
14. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Linden.
Regarding claim 12, the modified device of Bruna reads on the limitations of claim 1 and further discloses that the dispenser means 30 can be a pump with a piston (Bruna [0008]), but does not disclose the application device and/or the loading device comprises a motor.
However, Linden teaches of a motor (fig. 2, 10) that includes a motor sensor which communicates to the controller to control the motor speed (col. 16, lines 1-14) to precisely expel medicament at a controlled flow rate (col. 15, lines 25-29).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the pump of Bruna with the motor and dosating unit of Linden as a simple substitution of one known element for another to obtain a predictable result of pumping medication from a reservoir to the patient.
The modified device of Bruna reads on the electronic control device is programmed to make the application device move at a plurality of speeds (Linden col. 16, lines 1-14 states that the controller operates the motor speed).
15. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Fleming et al. (US 2007/0240712).
Regarding claim 17, the modified device of Bruna reads on the limitations of claim 1 and further reads on monitoring a time that an application dose is dispensed ([0030]-[0031] the control unit provides a locking period upon dispensing which inherently requires a recording of when the drug was dispensed) and further discloses being able to write instructions into the control unit regarding the treatment length and dosage among other parameters ([0023]), but does not expressly disclose a dose-detection device for detecting the amount of the application dose.
However, Fleming teaches of an inhaler (fig. 1, 10) that can dispense varying doses (abstract) which uses a sensor for monitoring quantity of delivered drug so as to not exceed the necessary amount needed ([0033])
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Bruna with the sensor as taught by Fleming so as to prevent the device from delivering excessive drug quantities to the patient (Fleming [0033]).
16. Claim(s) 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Hebrank et al. (US 2022/0080137)
Regarding claim 22, the modified device of Bruna reads on the limitations of claim 1 and further reads on the electronic control device is programmed to initiate the steps of: dispensing the next application dose in the predetermined amount at the corresponding dispensing point of time by the dispenser (Eberhart col. 9, lines 35-41 state that a maximum dose can be configured and dispensed); and temporarily locking the dispenser for a locking period, beginning from or after the dispensing point of time of the next application dose (Eberhart col. 2, lines 58-66 states that upon reaching the maximum amount the locking device is activated), the locking having a locking period begin (Eberhart col. 2, lines 64-66 states that after a maximum dose the locking device can be activated) and locking period end (Eberhart col. 2, lines 60-63 state that a maximum amount per time can be used which means that after time has elapsed, another dose can be delivered which inherently has a locking period end). The modified device of Bruna further discloses providing dose history to a doctor (Bruna [0033]), does not expressly disclose that an amount and/or concentration of the dose is stored in the data storage.
However, Hebrank teaches of an inhalation delivery system (fig. 1, 100) that records time, dose, and amount delivered for monitoring the user ([0090]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the dose history of the modified device of Bruna with a time stamp, dose, and amount delivered as taught by Hebrank in order to benefit users through the involvement of care givers (Hebrank [0090]) which are then reviewed by the doctors (Bruna [0033]).
The modified device of Bruna reads on the control device is further programmed to initiate the steps of storing the amount, and/or a concentration resulting thereof, of the application dose of the dispensed next application dose in the data storage (Hebrank [0090]).
Regarding claim 23, the modified device of Bruna reads on the limitations of claim 22 and further reads on the electronic control device is programmed to carry out the further steps of claim 22 (Hebrank [0090] states that time, dose, and amount are recorded, and Eberhart col. 2, lines 60-66 state that after the max dose is deliver the device is locked) also in connection with several deliveries of further application doses subsequent to the next application dose (Bruna [0033] states that between maximum doses the device can be locked).
Regarding claim 24, the modified device of Bruna reads on the limitations of claim 23 and further reads on the electronic control device is programmed to read from the data storage (Eberhart col. 9, lines 35-38 states that patient dosing is stored in the memory) data encompassing models, and which map a temporal course between concentration in the body, in particular blood, of the patient (Eberhart col. 2, lines 60-64 states that a maximum amount of drug may be delivered over time when considered how long it takes to metabolize the substance which is considered a model), and to calculate a next maximum of the concentration based thereon (Eberhart col. 2, lines 58-62 state that a maximum amount dischargeable is based on a maximum amount per time).
Regarding claim 25, the modified device of Bruna reads on the limitations of claim 24 and further reads on the electronic control device is programmed, upon predetermining the amount of the next application dose based on data stored in the data storage (Eberhart col. 2, lines 58-62 state that a maximum amount dischargeable is based on a maximum amount per time), in particular models (Eberhart col. 2, lines 61-62 states that amount per time can be stored as microgram/hour), and on a therapeutic maximum stored in the data storage (Eberhart col. 2, lines 58-62 state that a maximum amount dischargeable is individually configured), to determine the amount of the next application dose such that the next maximum will not exceed the specified maximum (Eberhart col. 2, lines 58-62 state that a maximum amount dischargeable is based on a maximum amount per time so as to not exceed to maximum amount of dischargeable substance).
17. Claim(s) 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart and Lanzkowsky as applied to claim 9 above, and further in view of Davidson et al. (US 2022/0223247).
Regarding claim 27, the modified device of Bruna reads on the limitations of claim 9 and further discloses an indicator means (Bruna fig. 1, 70) that can be an electronic display, but does not expressly disclose a feedback device to be actuated by the user; wherein the detection device is programmed for detecting actuation of the feedback device at least at one, optionally first, feedback point of time; wherein the control device is programmed for determining the concentration of the substance present in the body or in the blood of the user at the at least one feedback point of time, and for setting a target concentration or its maximum value to a value respectively below the determined concentration.
However, Davidson teaches of a method for generating a delivery regimen of an active substance to a user that uses a user interface to receive feedback regarding the effect of the substance ([0200]) thereby adjusting the delivery regimen according to user preference, feedback, induced effect, or imposed restrictions ([0198]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for adjusting the dosing regimen as taught by Davidson to provide the substance in a regimen more personalized to the individual (Davidson [0205] states that delivery regimens are saved for specific individuals).
Further, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the indicator means of Bruna with the user interface as taught by Davidson (Davidson [0200]) as a simple substitution of one known element for another to obtain a predictable result of allowing data transfer between the device and the user.
The modified device of Bruna further reads on a feedback device to be actuated by the user (Davidson [0200] states that users can control the device by inputting responses via the user interface); wherein the detection device (Bruna fig. 1, electronic control unit 60 can be programmed [0022] and can detect various inputs such as a locking code [0037]) is programmed for detecting actuation of the feedback device (Davidson [0220] states questions from the user interface can be delivered periodically and Davidson [0205] states that the user interface can receive input from a person) at least at one, optionally first, feedback point of time (Davidson [0200] states that interrogation may be periodic such as before or after inhalation); wherein the control device (Bruna fig. 1, electronic control unit 60) is programmed for determining the concentration of the substance present in the body or in the blood of the user at the at least one feedback point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), and for setting a target concentration or its maximum value to a value respectively below the determined concentration (Davidson [0245] states that the regimen can be adjusted according to user experience which can include setting a maximum dose, and [0208] states that the maximal dose can be learned).
Regarding claim 28, the modified device of Bruna reads on the limitations of claim 27 and further reads on the detection device (Bruna fig. 1, electronic control unit 60) is further programmed for detecting at least one actuation of the requesting device made by the user at actuation points of time (Bruna [0031] states that the activation time is stored to determine the end of the locking period) after the locking period (Bruna [0031] states a locking period is between doses, so after a locking period ends another dose can be delivered); wherein the control device s further programmed - for determining both a concentration in the body, optionally in the blood, associated with the, optionally first, feedback point of time as well as a concentration in the body, optionally in the blood, associated with the, optionally first, actuation point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen); - for determining a temporal concentration course, or a concentration course over time, from a group of temporal concentration courses (Davidson [0205] states delivery regimens can be saved for a population of users), optionally models or PK curves, associated with the same dose, from a plurality of temporal concentration courses, optionally PK models or PK curves, associated with the same dose and stored in the data storage (Davidson [0041] states that multiple delivery regimens are stored in the memory regarding the active substance), while considering both the, optionally first, feedback point of time and a concentration associated with the, optionally first, actuation point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen); and - for considering the temporal individual concentration course determined in this way, optionally the determined individual PK curve, upon predetermining the amount of one or several of the subsequent application doses (Davidson [0205] states the regimen can be determined for an individual user).
Regarding claim 29, the modified device of Bruna reads on the limitations of claim 27 and further reads on the control device (Bruna fig. 1, electronic control unit 60) is further programmed - for considering, upon predetermining the amount of the next application dose (Davidson [0274] states that the next dose can be modified when accounting for feedback), the maximum value (Davidson [0274] states that the user can indicate a strong effect thereby limiting the next dose which inherently requires setting a new, lower dose).
Regarding claim 30, the modified device of Bruna reads on the limitations of claim 9, but does not expressly disclose the control device being used to determine a first actuation point and concentration, detecting the second actuation point of time, and determining a temporal concentration course.
However, Davidson teaches of a method for generating a delivery regimen of an active substance to a user that uses a user interface to receive feedback regarding the effect of the substance ([0200]) thereby adjusting the delivery regimen according to user preference, feedback, induced effect, or imposed restrictions ([0198]) and additionally stores saved delivery regimens and their associated effects ([0205]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for adjusting the dosing regimen as taught by Davidson to provide the substance in a regimen more personalized to the individual (Davidson [0205] states that delivery regimens are saved for specific individuals).
The modified device of Bruna reads on the limitations of claim 9 and further reads on the control device is further programmed - for determining, after the dispensing of an initial dose which was dispensed at a dispensing point of time at, respectively, a concentration associated with the first actuation point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), and for setting the concentrations determined in this way, respectively, as the estimated target concentration of the associated temporal concentration course, wherein said determining is for a group of temporal concentration courses, optionally models or PK curves which are associated with the same dose from a plurality of temporal concentration courses, optionally PK models or PK curves, which are stored in the data storage and are associated with the same dose (Davidson [0041] states that multiple delivery regimens are stored in the memory regarding the active substance); - for applying the first application dose following the initial dose in response to the actuation of the requesting device at the first actuation point of time (Bruna fig. 1, manual actuator 40 allows dispensing of doses between locking periods, see [0031]);- for determining, for the temporal concentration courses of the group, at which time after the application of the first application dose the concentration in the body, optionally in the blood, will, respectively, have dropped again to the estimated target concentration of the associated temporal concentration course (Davidson [0023] states that an expected blood plasma level can be estimated at various selected time during the delivery regimen), and for setting, respectively, for the temporal concentration courses of the group, the determined time as the calculated target concentration time (Davidson [0023] for the estimated blood plasma, time associated with the estimated concentrations is known); - for detecting or determining the second actuation point of time for requesting a second or subsequent application dose (Bruna [0031] can lock the device for a period of time before allowing subsequent doses thereby storing the point in time for the second actuation); - for determining a temporal concentration course from the group as an individual temporal concentration course, optionally as an individual PK curve (Davidson [0205] states delivery regimens can be saved for a population of users and an individual user), while considering the respective difference between the calculated target concentration time of each temporal concentration course from the group and the second actuation point of time (Davidson [0060] states that a regimen accounts for delivery times), optionally the temporal concentration course which has the smallest difference between its calculated target concentration time and the second actuation point of time (Davidson [0060] states that a regimen accounts for delivery times, amount, and an expected timeline of a blood plasma level of the substance which can be done while determining the regimen [0200]); and - for considering the determined temporal individual concentration course (Davidson [0205] states that the individual regimen is used, and [0098] states that blood plasma level of the substance can be estimated), optionally the determined individual PK curve, upon predetermining the amount of one or several of the subsequent application doses (Davidson [0002] states that the regimen determines the delivery of the active substance to the user thereby predetermining subsequent doses).
Regarding claim 31, the modified device of Bruna reads on the limitations of claim 9 but does not expressly disclose the control device as being programmed to determine concentration of the substance in the body a one time and setting this concentration as a target, and setting the amount of the dose so that the concentration of the substance in the blood decreases to the target only after a predetermined time period.
However, Davidson teaches of a method for generating a delivery regimen of an active substance to a user that uses a user interface to receive feedback regarding the effect of the substance ([0200]) thereby adjusting the delivery regimen according to user preference, feedback, induced effect, or imposed restrictions ([0198]), some of the restrictions including the amount of the substance in the blood ([0099]-[0100]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for adjusting the dosing regimen as taught by Davidson to provide the substance in a regimen more personalized to the individual (Davidson [0205] states that delivery regimens are saved for specific individuals).
The modified device of Bruna reads on the limitations of claim 9 and further reads on the control device is further programmed - for determining the concentration of the substance present in the body or blood of the user at least at one considered actuation point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), and for setting this concentration as the target concentration (Davidson [0099]-[0100] states that the regimen can include a specific substance level in the blood); and wherein the control device is further programmed - for setting, at the next predetermination point of time, the amount of the next application dose (Davidson [0002] states that delivery of the doses is based on the generated regimen) such that the concentration in the body or in the blood of the user decreases again to the target concentration only after a predetermined time period has elapsed, beginning from the dispensing point of time of the next application dose (Davidson [0100] states that a minimum blood plasma level of substance can be included as a restriction thereby only allowing the amount of substance in the blood to decrease to this amount before a subsequent dose is taken).
18. Claim(s) 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Eberhart as applied to claim 1 above, and further in view of Davidson and Davidson et al. (US 2019/0027240) hereinafter Davidson2.
Regarding claim 32, the device of Bruna reads on the limitations of claim 1, but does not expressly disclose that the control device is programmed for determining a concentration in the body associated with actuation points of time and setting the target concentration to a minimum value.
However, Davidson teaches of a method for generating a delivery regimen of an active substance to a user that uses a user interface to receive feedback regarding the effect of the substance ([0200]) thereby adjusting the delivery regimen according to user preference, feedback, induced effect, or imposed restrictions ([0198]), includes a lockout period which can be replaced by providing the patient with a placebo dose ([0206])
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for adjusting the dosing regimen as taught by Davidson to provide the substance in a regimen more personalized to the individual (Davidson [0205] states that delivery regimens are saved for specific individuals).
The modified device of Bruna reads on the limitations of claim 1 and further reads on the control device is further programmed for determining a concentration in the body, optionally in the blood, associated with the actuation points of time within one of the locking periods (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), respectively; - setting the target concentration or its minimum value to a value respectively above the associated concentration (Davidson [0100] states that a minimum level of the substance in the blood plasma can be set). However, the modified device of Bruna does not expressly disclose that the actuation behavior of the user encompasses actuations of the requesting device during locking periods.
However, Davidson2 teaches of a delivery system and method that uses a placebo dose and reports its use for calibration purposes ([0141]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for reporting placebo doses as taught by Davidson2 to calibrate the device for particular users (Davidson2 [0141]).
The modified device of Bruna reads on the limitations of claim 1 and further reads on the evaluation of the actuation behavior of the user detected by the detection device (Davidson2 [0141] states that placebo doses can be delivered upon quick requesting of an additional dose) encompasses detecting actuations of the requesting device (Bruna [0018] uses manual actuator element 40 which can be detected by control unit 60 if it is within a locking period [0031]) by the user at actuation points of time within one of the locking periods (Davidson2 [0141] states that request of a second dose too quickly may be within a lock-out time thereby delivering a placebo).
Regarding claim 33, the modified device of Bruna reads on the limitations of claim 32 and further reads on detecting at least one actuation of the requesting device (Davidson2 [0141] states that if a second dose is requested too quickly a placebo can be given) by the user at actuation points of time after the locking period (Davidson2 [0141] states that a lock-out can be used for users who are at risk of addiction or having another reason for it); wherein the control device is further programmed - for determining a concentration in the body, optionally in the blood, associated with the actuation point of time after the locking period (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), respectively; - for determining a temporal concentration course of the group while considering both at least one, actuation point of time within the locking period as well as at least one actuation point of time after the locking period (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen which includes a locking period or when placebos are provided, [0246]), - for considering the determined temporal individual concentration course, optionally the determined individual PK curve (Davidson [0198] states that various changes can be used to adjust the regimen included the induced effect on the patient), upon predetermining the amount of one or several of the subsequent application doses (Davidson [0002] states that delivery of the doses is based on the generated regimen).
Regarding claim 34, the device of Bruna reads on the limitations of claim 1 and further discloses the control device (fig. 1, control unit 60) is programmed for detecting a missed or changed timing of a activation for a dose to be delivered ([00030]), but does not expressly disclose the evaluation encompasses evaluation actuations of the requesting device within the locking periods, the control device is programmed to detect an increase in time intervals between actuation points within a locking period, detect an absence of further actuation points within a locking period, defining a point of time which the degree of increase or absence satisfies a predetermined criteria, determining a concentration of the substance in the blood, and setting a target concentration.
However, Davidson teaches of a method for generating a delivery regimen of an active substance to a user that uses a user interface to receive feedback regarding the effect of the substance ([0200]) thereby adjusting the delivery regimen according to user preference, feedback, induced effect, or imposed restrictions ([0198]), includes a lockout period which can be replaced by providing the patient with a placebo dose ([0206])
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for adjusting the dosing regimen as taught by Davidson to provide the substance in a regimen more personalized to the individual (Davidson [0205] states that delivery regimens are saved for specific individuals).
Further, Davidson2 teaches of a delivery system and method that uses a placebo dose and reports its use for calibration purposes ([0141]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Bruna with the program for reporting placebo doses as taught by Davidson2 to calibrate the device for particular users (Davidson2 [0141]).
The modified device of Bruna reads on the limitations of claim 1 and further reads on the evaluation of the actuation behavior of the user detected by the detection device encompasses evaluating the actuations of the requesting device by the user at actuation points of time within one of the locking periods (Davidson2 [0141] states that if a second dose is requested too quickly a placebo can be given during a lock-out);- the control device is further programmed for determining an absence of further actuation points of time within the locking period (Davidson [0206] detects activations during a locking period thereby delivering placebos, and no further activations indicates no further placebos being delivered), and for defining a point of time starting from the absence satisfies predetermined criteria (Davidson2 [0140] a placebo can substitute a dose and the device can terminate delivery of placebos after a regimen is stabilized meaning after some time after the placebo); - the control device is further programmed for determining a concentration in the body, optionally in the blood, associated with the defined set point of time (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen); - setting the target concentration or its minimum value to a value above the associated concentration (Davidson [0100] states that use restrictions can include a minimal blood plasma level of the substance).
Regarding claim 35, the modified device of Bruna reads on the limitations of claim 34 and further reads on the control device is further programmed - for evaluating at least one detected actuation of the requesting device by the user at actuation points of time after the locking period (Bruna [0031] states that a dose can be delivered after a locking period which inherently requires detecting and evaluating an activation of actuator 40); wherein the control device is further programmed - for determining a concentration in the body, optionally in the blood, associated with the actuation point of time after the locking period (Davidson [0098] states an expected blood plasma level of the substance can be estimated at various times during the regimen), respectively; - for determining a temporal concentration course of the group while considering both a, optionally the last, actuation point of time within the locking period (Davidson [0206] detects activations during a locking period thereby delivering placebos, and no further activations indicates no further placebos being delivered) as well as a, optionally the first, actuation point of time after the locking period (Bruna [0030]-[0031] detect actuations after the locking period when delivering a dose and subsequently initiated an associated locking period); and - for considering the determined temporal individual concentration course, optionally the determined individual PK curve, upon predetermining the amount of one or several of the subsequent application doses (Davidson [0002] states that delivery of the doses is based on the generated regimen which accounts for the estimated concentration).
Response to Arguments
19. Applicant's arguments filed 07/27/26 have been fully considered but they are not persuasive.
Applicant argues, see page 25 paragraph 2 through page 26 paragraph 3 of “remarks,” that claim 20 was not fully appreciated due to “determining” the amount of the next application dose requires the control device to set or arrive at the amount of the next or further dose at a predetermination period of time by calculating it after the actuation point in time. Paragraph 3 of page 26 of “remarks” states that Eberhart teaches patient-specific maximum-amount-per-time control, which is not the same as determining the amount after the user’s actuation point. However, Eberhart’s discloses maximum-amount-per-time control (Eberhart col. 2, lines 58-67 and col. 3, lines 1-8) is referenced because the control relates an allowed dose to an amount of time in the form of microgram/hour. Upon reaching the maximum amount the user is locked out. This can be considered determining an amount of the application dose at a predetermination point of time lying at or after the user’s actuation point because the allowed dose changes according to the prescribed microgram/hour where time elapsed between the previous dose and the user’s actuation point in time determines how much more of the drug is allowed to be dispensed, constituting a “determination”. See the rejection to claim 1 above where the claim language is mapped to a combination of Bruna and Eberhart.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, see page 26 paragraph 4 through page 27 paragraph 1 of “remarks,” 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, Eberhart references a dischargeable maximum amount per time before lockout which can be individually configured based on a patient’s weight and habits, therefore allowing a more individualized treatment. See the rejection to claim 1 above.
Conclusion
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rubsamen et al. (US 5,694,919) discloses a method of controlling access to a drug in an aerosol drug delivery device that records amounts and time of delivery and control a maximum amount of narcotic drug delivered within a given period of time.
21. 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. 22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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