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 preliminary amendment filed on February 7, 2025. As directed by the amendment: claims 4-6, 8-11, 13-20, 22, 26-27, 29-32, and 34 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-36 are presently pending in this application.
Drawings
3. The drawings are objected to because:
Figure 1 includes reference numerals that are not plain and legible, it is recommended to replace the existing reference numerals with reference numerals in the same format as the reference numerals presented in figure 6. See 37 CFR 1.84(p).
Figure 6 includes reference numerals "15" and "17" which are both pointing to the same structure labelled as a loading device by “15” and as an application device by “17”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
4. The abstract of the disclosure is objected to because “(Fig. 6)” is unclear in its purpose and is recommended to be removed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: the specification does not include sections for the following: referencing related applications, background of the invention, brief summary of the invention, brief description of the several views of the drawing, or a detailed description of the invention. See 37 CFR 1.77(b).
Appropriate correction is required.
Claim Interpretation
5. 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.
6. 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.
7. 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 and 10, claim 19 lines 6-7, claim 20 line 10, claim 28 line 3, claim 30 line 18, claim 32 line 5, claim 33 line 3, claim 34 line 5, and claim 35 lines 3-4 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 15, claim 3 line 2, claim 10 line 2, and claim 12 lines 2-3 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 3 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.
“mechanism” in claim 8 line 3 and claim 13 line 3 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 10 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 19 line 3, claim 20 lines 7-8, claim 27 line 4, claim 28 line 2, claim 32 line 4, claim 33 line 2, and claim 34 line 4 is interpreted as an electronic component or the like according to PGPUB paragraph [0605].
“feedback device” in claim 27 lines 3 and 5 and claim 28 line 7 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
8. 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.
9. Claims 1-36 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 claims 1, 24-25, 28-30, and 32-35, the limitation “in particular” in line 2 of claim 1, line 5 of claim 24, line 4 of claim 25, lines 10, 12, 17-18, 20, and 27 of claim 28, line 6 of claim 29, lines 12, 14-15, 22, 30, 34, and 39 of claim 30, line 9 of claim 32, lines 7 and 19 of claim 33, line 17 of claim 34, and lines 8 and 19 of claim 35 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claims 5, 15, 27-28, 33, and 35, the limitation “preferably” in line 3 of claim 5, line 6 of claim 15, line 5 of claim 27, lines 6, 11, 13, 22, and 23 of claim 28, lines 12 and 15 of claim 33, and lines 13 and 15 of claim 35 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 5 recites the limitation "the loading device" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the loading device" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the dose chamber" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the loading device" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the loading device" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the limitation “during a re-begin of locking period” in lines 3-4 is unclear because “re-begin” implies a locking period was previously started and stopped, but there is not a previous mention of a locking period. This limitation is being interpreted as –a beginning of a locking period--.
Claim 20 recites the limitation "the detection device" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the data storage" in lines 4 and 13-14. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the locking device" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, the limitation “the further steps of claim 22” in line 3 is unclear as to which steps are considered “further”. This limitation is being interpreted as --storing the amount and/or a concentration in the data storage, and temporarily locking the dispenser--.
Regarding claim 24, the limitation “e.g.” in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 27 recites the limitation "the detection device" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation “the control device” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the data storage" in line 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the locking period" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the control device” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the data storage” in lines 15-16. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the estimated target concentration” in lines 10 and 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the calculated target concentration” in lines 26, 32, and 35-36. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation “the control device” in lines 2 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation “the target concentration” in lines 7 and 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the evaluation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the detection device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the control device" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the target concentration" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the locking period" in lines 6 and 11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 33, the limitation “considering both at least one” in line 12 is unclear if the following limitations are both included or only one of actuation points that occur within the locking period or after the locking period.
Claim 34 recites the limitation "the evaluation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the detection device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the control device" in lines 8 and 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the target concentration" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the locking period" in lines 6 and 10-11. There is insufficient antecedent basis for this limitation in the claim.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 102
10. 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.
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claim(s) 1, 11, 16, 18-19, and 36 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Bruna (US 2004/0231669).
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), in particular an analgesic ([0002] states that medication can be provided, an analgesic in fluid or powder form can be similarly used), 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); and
- 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).
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Regarding claim 11, the device of Bruna reads on the limitations of claim 1 and further reads on the device having an electronic control device (fig. 1, control unit 60).
Regarding claim 16, the device of Bruna reads on the limitations of claim 1 and further reads on a locking device (fig. 2, securing system 50) for temporarily locking the dispenser ([0019] states that the securing means can control if the manual actuator can communicate with dispenser means 30) during a re-begin of locking period ([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 ([0031] a locked period between doses inherently means the locking period begins after a dose is delivered).
Regarding claim 18, the device of Bruna reads on the limitations of claim 1 and further reads on 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).
Regarding claim 19, the device of Bruna reads on the limitations of claim 1 and further reads on 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).
Regarding claim 36, the device of Bruna reads on the limitations of claim 1 or 11 and further reads on the device being part of a treatment system (fig. 3) which includes one or more peripheral devices (fig. 3, a personal computer), wherein the nasal applicator is in signal communication with the peripheral device ([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).
Claim Rejections - 35 USC § 103
13. 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.
14. 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 Weston et al. (US 5,497,944).
Regarding claim 2, the device of Bruna discloses the limitations of claim 1 and further discloses that the dispenser means 30 can be a pump with a piston ([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 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) 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 device of Bruna reads on the limitations of claim 1 and further discloses the use of a pump as a dispensing means ([0005]), but does not expressly disclose mechanisms for changing the capacity volume of the dose chamber.
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 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 1, and further discloses the use of a pump as a dispensing means ([0005]), but does not expressly disclose structures for the application device and loading device comprising or consisting of identical components.
However, Weston teaches of a metered dose inhaler (fig. 1) with a piston that acts as a loading device (col. 7, lines 10-12 state that the piston pulls in liquid during a suction stroke) and acts as an application device (col. 9, lines 9-19 state the piston ejects the medication during a forward motion).
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 13, the device of Bruna reads on the limitations of claim 11 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) preferably 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).
15. Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Weston and van der Linden et al. (US 5,950,619) hereinafter Linden.
Regarding claim 6, 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) 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).
16. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna 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]).
17. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Linden.
Regarding claim 12, the device of Bruna reads on the limitations of claim 11 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, 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.
18. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Fleming et al. (US 2007/0240712).
Regarding claim 17, the 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]).
19. Claim(s) 20-21 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Weston and Eberhart et al. (US 9,033,939).
Regarding claim 20, Bruna reads on the limitations of claim 11 and further reads on the electronic control device (fig. 1, control unit 60) 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)
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)
The device of Bruna further discloses that a doctor can modify dosage ([0034]), but does not expressly disclose that the control unit predetermines the amount of the next application dose 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.
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 highly effective opioid painkillers to the individual patient (col. 1, lines 63-67 and col. 2, lines 1-5)
Regarding claim 21, the modified device of Bruna reads on the limitations of claim 20 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 the limitations of claim 20 and further reads on the evaluating step encompasses determining the actuation point of time for requesting the next application dose ([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).
20. Claim(s) 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of Weston and Eberhart as applied to claim 20 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 20 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]).
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 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), 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).
21. Claim(s) 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna in view of 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 (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, preferably 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, preferably 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, in particular in the blood, associated with the, preferably first, feedback point of time as well as a concentration in the body, in particular in the blood, associated with the, preferably 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), in particular models or PK curves, associated with the same dose, from a plurality of temporal concentration courses, in particular 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, preferably first, feedback point of time and a concentration associated with the, preferably 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, in particular 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, in particular models or PK curves which are associated with the same dose from a plurality of temporal concentration courses, in particular 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, in particular 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, in particular 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), in particular 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), in particular 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).
22. Claim(s) 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruna 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, in particular 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, in particular 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, in particular 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, in particular 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, in particular 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, preferably 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, preferably 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, in particular 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).
Conclusion
23. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Haber et al. (US 5,524,613) discloses an inhaler that uses a desiccant to maintain a medicant powder in a dry condition. Marsot et al. (US 2018/0360110) discloses a vaporizer device that includes a piston and adjustable dosing.
24. 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