DETAILED ACTION
The amendment filed April 8, 2026 has been entered. Claims 70, 72-77, 79-82, 84-88, and 90-93 remain pending.
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 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.
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. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 103
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.
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.
Claims 70, 80, 85-86 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2013/0197693 to Kamen et al. (Kamen) in view of US Patent 4,953,545 to McCarty (McCarty).
Regarding claims 70, 80 and 85, Kamen discloses a system and method comprising: a single dose medication chamber (cup 24); a dispensing apparatus (35); and a controller (control system 32), configured to: detect presence of the single dose of medication received by the dispensing apparatus (via cameras 26 and 27); and to prevent access to the to the single dose chamber while the dispenser is actuated (in the embodiment having a door restricting access to the medication until after dispensing). Kamen does not disclose the dispensing apparatus includes an aerosol generator and the medication being an aerosol, wherein in response to detecting presence of the single dose aerosol chamber received by the aerosol dispensing apparatus, actuate the aerosol generator to deliver an aerosol dose into the single dose aerosol chamber. McCarty teaches a device for dispensing single doses of an aerosol to a single-use aerosol chamber (10) and having an aerosol dispenser including an aerosol generator (20, 22) to dispense single doses of the aerosol to the single-use chamber. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of McCarty with the system and method of Kamen such that single doses of an aerosol can be dispensed to a single-use aerosol chamber to aid a user in inhaling the aerosol and to remove the need for cleaning the aerosol chamber, as taught by McCarty. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the cameras of Kamen to detect the presence of the aerosol chamber in dispensing apparatus prior to dispensing the aerosol, as any aerosol product dispensed without the aerosol chamber in place would be wasted. Therefore, to eliminate waste and ensure the aerosol product is delivered to the patient, the controller would be programmed to only actuate the aerosol generator when it has been verified that the aerosol chamber is properly positioned.
Regarding claim 86, McCarty further teaches generating a Coanda effect within the single dose aerosol chamber (the shape of the chamber produces the effect and would be present in the combination as set forth above).
Regarding claim 90, Kamen as modified by McCarty does not disclose a proximity sensor, wherein the controller is configured to detect presence of the single dose aerosol chamber received by the aerosol dispensing apparatus via the proximity sensor. As set forth above, the aerosol chamber is detected by a camera. However, proximity sensors are well known for detecting the presence of an object. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a proximity sensor instead of a camera for detecting the aerosol chamber, as such a change requires only the substitution of one known element with another known element for performing the same function.
Claims 72-73, 77, 79, 81-82, 84 and 87-88 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of McCarty as applied to claims 70, 80 and 85 above, and further in view of US Patent Application Publication 2004/0065321 to Stenzler (Stenzler).
Regarding claims 72-73, 84, and 87-88, Kamen as modified by McCarty discloses the system of claim 70, controller of claim 80 and method of claim 85, but does not disclose wherein the aerosol dispensing apparatus further includes a container containing a liquid and a pump linked to the container, wherein the aerosol generator includes a reservoir, and wherein the controller is further configured to cause the pump to deliver a quantity of the liquid from the container to the reservoir before the aerosol generator is actuated, wherein the controller is further configured to detect end of dose of the quantity of the liquid and end actuation of the aerosol generator in response to detecting end of dose of the quantity of the liquid. Stenzler teaches an aerosol delivery device which includes a container (container 74 contains the drug in liquid form) containing a liquid and a pump (92) linked to the container (the pump is fluidly connected to the container), wherein the aerosol generator (100) includes a reservoir (conduit 94 can be considered a reservoir for the liquid fed from the pump to the nebulizer 100), and wherein the controller (4) is further configured to cause the pump to deliver a quantity of the liquid from the container to the reservoir before the aerosol generator is actuated (liquid is first delivered and then the aerosol generator is actuated), wherein the controller is further configured to detect end of dose of the quantity of the liquid and end actuation of the aerosol generator in response to detecting end of dose of the quantity of the liquid (the controller operates both the pump and aerosol generator and is configured to end operations thereof when the desired dose has been delivered). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Kamen as modified by McCarty to include liquid storage and a pump and to program the controller to supply the liquid to an aerosol generator and to stop the dispensing when the desired dose is reached as taught by Stenzler to ensure that the proper dose is administered ([0005] and [0008] of Stenzler).
Regarding claims 77, 79 and 81-82, Kamen as modified by McCarty discloses the system of claim 70, controller of claim 80 and method of claim 85 and Kamen further discloses the aerosol dispensing apparatus further includes a user interface (touchscreen 15 and speaker 29) wherein the user interface includes a display screen or a speaker. Kamen as modified by McCarty does not disclose the controller is further configured to generate instructions for inhalation of the aerosol dose from the single dose aerosol chamber and provide the instructions through the user interface, wherein the instructions for inhalation include a period of time or a number of inhalations. Stenzler further teaches a user interface (see Fig. 1) and the controller is further configured to generate instructions for inhalation of the aerosol dose from the single dose aerosol chamber and provide the instructions through the user interface, wherein the instructions for inhalation include a period of time or a number of inhalations (see [0028], [0038], [0040], [0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Kamen to include providing instructions to the user via the interface from the controller as taught by Stenzler to aid the user in properly using the system and in administering the medication.
Response to Arguments
Applicant's arguments filed April 8, 2026 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues that the camera of Kamen only detects the pills and not the receiving cup. However, the camera is capable of detecting the cup and the examiner has provided rationale as why one of ordinary skill in the art would use the camera to detect the aerosol chamber when combined with the teachings of McCarthy such that the product being dispensed is an aerosol rather than a pill. “Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the cameras of Kamen to detect the presence of the aerosol chamber in dispensing apparatus prior to dispensing the aerosol, as any aerosol product dispensed without the aerosol chamber in place would be wasted. Therefore, to eliminate waste and ensure the aerosol product is delivered to the patient, the controller would be programmed to only actuate the aerosol generator when it has been verified that the aerosol chamber is properly positioned.” Applicant has given no reasoning why the combination of the references along with the general knowledge of one of ordinary skill in the art as set forth by the examiner fails to render obvious the claimed invention.
Allowable Subject Matter
Claims 74-76 and 91-93 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 NICOLAS A ARNETT whose telephone number is (571)270-5062. The examiner can normally be reached M- F, 8AM - 3PM.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 June 9, 2026
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