DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 20-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (WO 2017/118980 A1) in view of Veirtio-Oja (US 2002/0173729 A1) and in further view of Jensen et al. (WO 2017/012622 A1).
With regard to claim 20 and 30, Davidson discloses A system comprising: an electroencephalogram (EEG) unit (p. 29, lines 10-12 and p. 30, line 22, EEG is a biomarker that is measured and thus an EEG unit must be present to measure this biomarker) operable to measure an EEG marker value of user; a storage container (Fig. 34, element 1603) storing a psychoactive drug including at least one of tetrahydrocannabinol (THC)(abstract); a microdose control unit (1607) operable to: receive the EEG marker value from the EEG unit, and determine an initial microdose of the psychoactive drug based on the EEG marker value (p.70, line 1-9, p. 71, line 1-3, p. 33, lines 1-20, 27-31, p. 34, lines 1-5, dosage of drug is based on acquired pharmacodynamic feedback which includes the measurement of the biomarker which can be EEG); and a microdose interface unit (1609) operable with the storage container to dispense the initial microdose to the user (p. 70, lines 10-14).
However, Davidson does not disclose the microdose control unit communicatively coupled to the EEG unit for receiving the EEG marker value in real-time.
Viertio-Oja teaches having a control unit (Fig. 1, element 16) for use in dispensing a medication (14) to a patient and further teaches an EEG unit (26) that is connected to the patient to measure EEG marker values in real-time (via cable 24 forming a closed loop where the EEG is able to take readings directly from the patient and send the signal information to the control unit that then determines a dose delivery based on the EEG signals (see closed loop of Fig.1)). Because Davidson already teaches that the microdose inhaler that delivers THC can include the controller as well as the decision module (which is similar to the control unit and EEG determination unit of Viertio-Oja) which takes the inputted EEG information from a user to determine dosage instructions, the EEG information could be provided in real-time as taught by Viertio-Oja rather than from previous user input in order to provide the most accurate up-to-date information prior to delivering the medication ([0056] reducing response times).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davidson with the real-time monitoring of EEG marker values as taught by Viertio-Oja for the purpose of providing more accurate and up-to-date information prior to delivering medication ([0056], reducing response times).
However, Davidson/Viertio-Oja does not teach the EEG is used to determine an initial starting microdose.
Jensen teaches a drug delivery system that uses EEG measurements prior to determining a patient dose of anesthetic (p. 12, ln 14 to p. 13, ln 6) thus teaching the claim limitation of determining an initial starting microdose of the drug based on the EEG marker value (p. 12, line 14 to p. 13, line 6, EEg data is available before anesthesia is started then the patient can be classified into a particular age group based on this data to determine anesthesia delivery).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davidson/Viertio-Oja for the purpose of providing a safer approach for assessing effects of a drug on the patient prior to drug delivery (p. 12, line 14 to p. 13, line 6).
With regard to claim 21 and 31, Davidson discloses wherein the microdose control unit is further operable to determine one or more adjusted microdoses of the psychoactive drug based on a change in the EEG marker value (p. 33, lines 1-20, 27-31, p. 34, lines 1-5).
With regard to claim 22, Davidson discloses wherein the microdose control unit is further operable to: compare the change in the EEG marker value to one or more of a target value or a target range (p. 22, lines 25-end, pharmacodynamic parameters of which EEG is one, compares to a predetermined threshold); and determine one or more adjusted microdoses of the psychoactive drug to move an adjusted EEG maker value to one or more of: close to the target value or within the target range (p. 22, lines 25-end, p. 33, lines 1-20, 27-31, p. 34, lines 1-5 the automatic adjustment will alter the delivery in order to stay within the threshold).
With regard to claim 23, Davidson discloses wherein the microdose control unit is further operable to: determine the initial microdose of the psychoactive drug by determining one or more of: the psychoactive drug, a number of doses, a dosage strength, a dosage duration, a dosage interval, or combinations thereof (p. 33, lines 1-20, 27-31, p. 34, lines 1-5).
With regard to claim 24, Davidson discloses wherein the microdose interface unit is further operable to: dispense the psychoactive drug to the user without receiving input from a user interface (p. 33, lines 1-20, 27-31, p. 34, lines 1-5, the controller is used automatically and does not require additional user input).
With regard to claim 26, Davidson discloses further comprising an interface (1605) operable to provide an indication to administer the psychoactive drug to the user.
With regard to claim 27, Davidson discloses further comprising a user interface (1605) operable to receive dosage information for the user.
With regard to claim 28 and 33, Davidson discloses wherein the storage container (1603) is separate from the microdose interface unit (1609), and wherein the storage container is coupled to the microdose interface unit to facilitate dispensing the psychoactive drug to the user (p .70, line 1-9, p. 71, line 1-3, p. 33, lines 1-20, 27-31, p. 34, lines 1-5).
With regard to claim 25 and 32, Davidson discloses the claimed invention except for an electronic type interface unit.
Viertio-Oja teaches a similar dosing device that has a microdose interface unit that comprises an electronically controlled pump (14a) and an electronic nebulizer (14b).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interface of Davidson as taught by Viertio-Oja for the purpose of delivering medication in a controlled coordinated fashion ([0060]).
With regard to claim 29, Davidson discloses the claimed invention except for the specific EEG marker value.
Viertio-Oja teaches wherein the EEG marker value comprises one or more of: an intrinsic frequency of a predefined EEG band ([0048]), EEG readings are determined with a specific frequency range or band).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davidson with the specific EEG marker value as taught by Viertio-Oja for the purpose of delivering medication in a controlled coordinated fashion ([0060]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 20-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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