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 .
Election/Restrictions
Applicant's election without traverse of Group 1 in the reply filed on 11/11/25 is acknowledged.
Claims 16- withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/11/25.
Response to Amendment
This office action is in response to the amendment filed 11/11/25. Claim(s) 2-7, 9-15, and 19 have been amended, no new claims have been added, and claims 21-25 have been cancelled. Thus, claims 1-20 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 5 "the active ingredient" should be changed to --the inhalable active ingredient-- for consistency. Appropriate correction is required.
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.
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: an electronic component in claim 1.
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
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.
Claims 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.
In claims 4-7 and 9-12, line 1 in each instance the limitation “any preceding claim 1” is unclear if the claim is dependent on claim 1 or any/all previous claims. For examination purposes, Examiner interprets as dependent on claim 1 in each instance.
In claim 5, line 4 the limitation “wherein data” is unclear if this is referring to the inhaler data in claim 1 or new data.
In claim 5, line 3 the limitation “optionally secured” is unclear if the cap is or is not secured. The term ‘optionally’ renders the claim indefinite.
In claim 5, line 4 the limitation “is optionally transferred” is unclear if the data and/or power is or is not transferred. The term ‘optionally’ renders the claim indefinite.
In claim 9, line 2 the limitation “the indicator component is optionally” is unclear if the component is or is not an indicator ring. The term ‘optionally’ renders the claim indefinite.
In claim 10, line 2 the limitation “the structure optionally or preferably” is unclear if the structure does or does not include channels. The term ‘optionally or preferably’ renders the claim indefinite.
In claims 13-15, line 1 (in each instance) the limitation “aHy preeediHg” is unclear what is attempting to be claimed.
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.
Claim(s) 1-7, 9-12, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kakade (9,216,259) in view of Mohammed (2020/0376209).
With respect to claim 1, Kakade discloses an inhaler device (100, fig 1) operable to deliver a dose of an inhalable active ingredient (see col. 6, lines 10-21), the inhaler device comprising a housing (115/120, fig 1) comprising a mouthpiece (125, fig 1); a removable flow regulator (130, fig 1) at least partly received within the housing (see fig 1), the flow regulator defining a cavity (space within 205, fig 2) operable to receive a vessel (pressurized canister; see col. 6, lines 14-16) comprising the active ingredient (medication); but is silent regarding an electronic component operable to monitor inhaler data and to transmit the inhaler data to a remote device.
However, Mohammed teaches an inhaler device (100, fig 2A) comprising an electronic component (132/154, fig 4B/5) operable to monitor inhaler data (see sensors of 132 in fig 5 and [0106]) and to transmit the inhaler data to a remote device (to device; 161, fig 9 and [0107]).
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 modified the device of Kakade to include an electronic component and required elements as taught by Mohammed so as to provide the user and/or healthcare provider with feedback and data to control and use the device.
With respect to claim 2, the modified Kakade shows the electronic component is located within the removable flow regulator such that together the removable flow regulator and the electronic component form a removable core (note after the modification by Mohammed the electronic components are part of the core and would thus be removable).
With respect to claim 3, the modified Kakade shows the electronic component comprises a power source (cell; 146, fig 3 of Mohammed).
With respect to claim 4, the modified Kakade shows the removable flow regulator is a removable filter (the flow regulator filters ambient air into the device as defined by Merriam-Webster Dictionary “something that selectively alters or removes like a filter (as by holding back elements or modifying the appearance of something)” where selective air is allowed in).
With respect to claim 5, the modified Kakade shows the inhaler further comprises a cap (cover; 112, fig 1 of Kakade) operable to cover the mouthpiece, wherein the cap is optionally secured to the housing (see fig 1 of Kakade).
With respect to claim 6, the modified Kakade shows the inhaler data comprises one or more of: usage data, location data and dosage data (see [0174] of Mohammed).
With respect to claim 7, the modified Kakade shows the inhaler comprises a dosage counter (see [0107 and 174] of Mohammed) operable to count a number of doses administered by the inhaler (note the modification would include a dosage counter since the electronic component provides such information in Mohammed).
With respect to claim 9, the modified Kakade shows an indicator component (note the modification would include a dosage counter since the electronic component provides such information in Mohammed).
With respect to claim 10, the modified Kakade shows the removable flow regulator comprises a structure (220/600, figs 5-6 of Kakade) operable to regulate a speed of a fluid flowing through the inhaler device (see col. 4, lines 39-56 of Kakade), wherein the structure optionally or preferably includes one or more channels, dimples or openings (see 510 in fig 5 and 610 in fig 6 of Kakade).
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Annotated fig 1 of Kakade.
With respect to claim 11, the modified Kakade shows the housing defines a body portion (see annotated fig 1 of Kakade) having a first longitudinal axis (see annotated fig 1 of Kakade) and a mouthpiece portion (see annotated fig 1 of Kakade) having a second longitudinal axis (see annotated fig 1 of Kakade) is oriented at an angle to the first longitudinal axis, wherein the angle is in the range 130-135 degrees (see angle between the axes in the annotated figure).
With respect to claim 12, the modified Kakade shows the housing comprises an opaque colored portion (see housing 120 and 115 in fig 1 where it is not translucent).
With respect to claim 13, the modified Kakade shows an outer surface of the flow regulator substantially abuts an inner wall of the housing (note 130 is inserted into 140 fig 1 of Kakade), such that when a vessel (pressurized container) is inserted into the cavity within the flow regulator the flow regulator substantially fills a space between the vessel and the inner wall of the housing (see col. 6, lines 10-24 of Kakade).
With respect to claim 14, the modified Kakade shows the inhaler device is a metered dose inhaler (see col. 4, lines 3-5 of Kakade).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kakade and Mohammed as applied to claim 7 above, and further in view of Morrison (2017/0290527).
With respect to claim 8, the modified Kakade shows all the elements as claimed above but lacks the electronic component is operable to transmit an alert when the number of doses administered exceeds a predefined threshold.
However, Morrison teaches an inhaler device (700, fig 7) comprising an electronic component (710, fig 7) operable to transmit an alert when the number of doses administered exceeds a predefined threshold (see [0159]).
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 modified the electronic component of the modified Kakade to provide an alert as taught by Morrison so as to monitor patient adherence and compliance and communicate such information (see [0158] of Morrison).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kakade and Mohammed as applied to claim 1 above, and further in view of Tunnell (WO2014/204511).
With respect to claim 15, the modified Kakade shows all the elements as claimed above but lacks the electronic component is provided within a waterproof compartment.
However, Tunnell teaches an inhaler (100, fig 3A) comprising an electronic component (temperature sensor) provided within a waterproof compartment (see [0253]).
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 modified the electronic component of the modified Kakade to include a waterproof compartment as taught by Tunnell so as to avoid damage from any liquid or humidity in the environment of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brand (2003/0183226), and Alston (2004/0206350) are cited to show additional inhalers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785
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