DETAILED ACTION
This office action is in response to the amendment filed 7/23/2026. As directed by the amendment, no claims have been amended or newly added, and claim 19 has been cancelled. Thus, claims 1-18 are presently pending in this application, with claims 1-15 presented on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/23/2026 is acknowledged. Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/2026.
Claim Interpretation
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.
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:
“a sensor component configured to determine a metabolic state of a user” in claim 1, corresponding to a temperature sensor, a heart rate sensor, chemical sensor, respiration sensor, etc.
“a delivery component configured to deliver a metabolic modulator” in claim 1, corresponding to an aerosol delivery device such as an aerosol delivery device, vaping device, electronic nicotine delivery system (END), etc.
“a controller configured to receive information relating to the metabolic state of the user and to control delivery of the metabolic modulator in response thereto” in claim 1, corresponding to a controller configured to receive information or data relating to the metabolic state of the user from at least one sensor.
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 § 102
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.
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 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.
Claim(s) 1-5, 7-8, and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyden et al (2016/0045682).
Regarding claim 1, Boyden in figs 1-4 discloses a delivery system for a metabolic modulator comprising: a sensor component (116) (sensor) configured to determine a metabolic state of a user (sensor (116) can be used to used to accept one or more parameters of a subject, including a physiological parameter such as metabolism (para [0146]), wherein the sensor (116) can measure blood sugar levels (para [0095]) or a blood alcohol concentration from an ethanol sensor (136) (para [0110])); a delivery component configured to deliver a metabolic modulator (device can be configured as an inhaler which includes a reservoir (124) and an actuator (122)) (para [0056]); and a controller (110) (control unit) configured to receive information relating to the metabolic state of the user and to control delivery of the metabolic modulator in response thereto (as shown in fig 18, control unit (110) is configured to receive parameters associated with a subject, including metabolism in operation (1810) (para [0146]), creating an ethanol delivery regimen in operation (1820) (para [0147]) and controllable dispensing an inhalant from the inhaler from the ethanol delivery regimen in operation (1830) (para [0148])).
Regarding claim 2, Boyden discloses the controller (110) is configured to use the received information relating to the metabolic state of the user to perform a comparison to one or more comparison values, and to control delivery of the metabolic modulator based on the comparison (control unit (110) may compare one or more parameters to one or more threshold levels that are associated with the one or more parameters) (para [0107]).
Regarding claim 3, Boyden discloses the one or more comparison values comprise at least one value selected from the group comprising a baseline value, a target value, a threshold value, an upper range value, and a lower range value (one or more threshold values or ranges associated with the parameter values) (para [0107]).
Regarding claim 4, Boyden discloses the controller (110) is configured to establish a metabolic rate of the user based on the received information relating to the metabolic state of the user (sensors (116) can be used to accept parameters associated with a subject corresponding to physiological parameters such as metabolism) (para [0146]), wherein the comparison comprises comparing the established metabolic rate to the one or more comparison values (controller (110) may compare one or more parameters to one or more threshold levels that are associated with the one or more parameters) (para [0107]).
Regarding claim 5, Boyden discloses the controller (110) is configured to control delivery of the metabolic modulator by determining a delivery parameter for delivering the metabolic modulator, and wherein the delivery component is configured to deliver the metabolic modulator based on the determined delivery parameter (ethanol delivery regimen associated with the subject in response to the one or more parameters is created in operation (1820)) (para [0147]).
Regarding claim 7, Boyden in fig 19 discloses the delivery component is configured to deliver a replacement substance at least in part in place of the metabolic modulator, and wherein the controller (110) is configured to control delivery of the replacement substance in response to the information relating to the metabolic state of the user (controller (110) is configured to select a second agent (222) such as caffeine, nicotine, or tetrahydrocannabinol, in operation (1940) (para [0166]), and dispensing the second agent (222) in operation (1950) (para [0167])).
Regarding claim 8, Boyden discloses the replacement substance is a second metabolic modulator (agent (222) can be caffeine, nicotine, or tetrahydrocannabinol) (para [0166]).
Regarding claim 10, Boyden discloses providing an ethanol-containing inhalant (214) (para [0108]) and an agent such as nicotine (para [0166]), and therefore the substances delivered to the user including a metabolic modulator comprising a metabolic stimulant (agent (222) including tobacco, which is a metabolic stimulant) and a second metabolic modulator comprising a metabolic suppressant (ethanol-containing inhalant (214) is a substance that would suppress metabolism) (para [0108]).
Regarding claim 11, Boyden discloses the delivery component comprises a reservoir (124) for the metabolic modulator (214) (para [0067]).
Regarding claim 12, Boyden discloses the delivery component is physically separate from the sensor component (116) (sensor component (116) can be a remote sensor) (para [0146])
Regarding claim 13, Boyden discloses the controller (110) is physically separate from the sensor component (as shown in fig 5, controller (110) is physically coupled to the delivery component, (para [0122]), and therefore would be physically separate from a sensor component (116) which is a remote sensor (para [0146]).
Regarding claim 14, Boyden discloses the sensor component (116) comprises one or more sensors selected from the group comprising a chemical sensor (sensor (116) can measure a blood sugar levels (para [0095]) or a blood alcohol concentration (para [0110]).
Regarding claim 15, Boyden discloses the delivery component is configured to deliver the metabolic modulator during a usage event based on an interaction with the user (subject may enter information corresponding to a usage event, such as nformation related to drugs used by the subject, information related to food ingested by the subject, information related to the time since food was last ingested, information related to blood sugar levels, or the like) (para [0099]).
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al (2016/0045682).
Regarding claim 6, Boyden discloses the delivery component is configured to deliver determine when the determined delivery parameter is a first delivery parameter and when the determined delivery parameter is a second delivery parameter (controller (110) may compare the one or more assessed values to one or more threshold levels that are associated with the one or more values (para [0107]), and to deliver a first amount of metabolic modulator when the determined delivery parameter is a first delivery parameter and to deliver a second amount of metabolic modulator when the determined delivery parameter is a second delivery parameter (controller (110) is configured to compare a threshold value to a determined value using an inhaler and then calculate a quantity of inhalant (214) to be released to achieve or exceed the threshold value (para [0108]).
Boyden does not specifically disclose that the first amount is greater than the second amount.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Boyden by configuring the control unit to deliver a first amount of metabolic modulator when the determined delivery parameter is a first delivery parameter and to deliver a second amount of metabolic modulator when the determined delivery parameter is a second delivery parameter, wherein first amount is greater than the second amount as taught by Boyden, as it has been held that optimization of ranges are held to be within the level of skill of one of ordinary skill in the art. Therefore, modifying the quantity of the metabolic modulator delivered based on the first and second delivery parameters by routine experimentation would have been an obvious modification to reach a selected blood-alcohol concentration in a subject (Boyden, para [0108]).
Regarding claim 9, Boyden discloses a controller (110) configured to deliver a first metabolic modulator and a second metabolic modulator, wherein the controller (110) is configured to select a quantity of the second metabolic modulator (222) to be delivered (para [0119]) and/or numerous types of the second metabolic modulator (222) (para [0191]), such as a pharmaceutical, caffeine, nicotine, and/or tetrahydrocannabinol (paras [0191]-[0192]).
Boyden does not disclose the second metabolic modulator is configured to cause a smaller change in the metabolic state of the user than the first metabolic modulator.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Boyden by configuring the controller to select a second metabolic modulator that is configured to cause a smaller change in the metabolic state of the user than the first metabolic modulator as taught by Boyden in order to allow the controller to deliver a selected amount of the second metabolic modulator (para [0119]) or the formulation of the second metabolic modulator to be delivered to achieved a desired therapeutic effect (para [0192]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Gerder et al (2021/0353892), Childers et al (2004/0084044), Baker, Jr (2009/0320836), and Segal et al (2025/0001106) disclose pharmaceutical inhaler delivery systems including a sensor component, a delivery component, and a controller configured to control delivery of pharmaceutical in response to information received by the sensor component.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS Y SUL whose telephone number is (571)270-5260. The examiner can normally be reached Monday-Friday 9 am-5:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DOUGLAS Y SUL/Examiner, Art Unit 3785
Prosecution Insights