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 .
In view of the appeal brief filed on 04/20/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Response to Arguments
The arguments presented in the Appeal Brief filed 04/20/2026 have been carefully considered and are partially persuasive.
Regarding argument (1. a.) on pages 4-6, applicant argues that the interpretation of “chassis” is improper as the interpretation stretches the claim language beyond its broadest reasonable scope consistent with the specification. The examiner respectfully disagrees that the chassis must be a single, integrated structure with the third and fourth sets of teeth based on the characterization in the original specification, page 10, that the chassis may be one or more parts fixed together. However, page 10 lines 20-21 state that “chassis” refers to the body of a portable inhaler; thus, “chassis” does not apply to Johnson, since a ratchet wrench does not meet this description set forth in the specification.
Regarding argument (1. .b.) Johnson’s third and fourth sets of teeth are not part of the chassis, since the claim requires “the chassis comprising a third set of teeth … and a fourth set of teeth” (emphasis added), this argument is persuasive. In addition, the “chassis” claim interpretation as shown in the specification has rendered the rejection over Johnson moot. The rejection over Johnson has been withdrawn.
Regarding argument (2.a.) that Ouyang’s chassis does not have a third and fourth set of teeth, since identified components cap 269 and support 246 show a third set of teeth on 246, but not a fourth set of teeth. This argument is persuasive. Please see below for the updated rejection clarifying the components of the chassis.
Regarding argument (2.b.) that combining features of Ouyang to define a chassis is not proper, since combined components is contrary to “chassis”. Even if the combination of 269, 246, and 241 is combined as a chassis to include the fourth set of teeth, the wheel 241 has a separate function and does not act as a supporting frame. This argument is not fully persuasive, since the specification states that the chassis may be one or more parts (page 10, lines 21-23; emphasis added). Further, page 11 line 24 states that “Optionally, the fourth set of teeth may be arranged on a counter mechanism”. Additionally, “the chassis comprising” (emphasis added), where “comprising” is interpreted broadly according to MPEP 2111.03(I), does not imply that the third and fourth sets of teeth cannot be separate components that, when assembled, form a chassis.
It is suggested by the examiner to further define the claims to establish the relationship between the chassis and the third and fourth sets of teeth as described in the specification and the figures. For example, it is suggested to amend the claim to state that the chassis comprises a third and fourth sets of teeth extending from the inner wall of the chassis (as supported by page 11 of the specification and fig. 6); or alternatively, it is suggested to amend the claim to state that the chassis comprises a third and fourth set of teeth, fixed to the chassis. The applicant is invited to discuss alternative proposed amendments via interview with the examiner.
Claim Interpretation
Claim 13 term “chassis” has been interpreted according to the specification to mean “a body of the portable inhaler” (see page 10, lines 20-21).
Claim 13 “ratchet ring” (line 2) is interpreted as detailed on page 9 lines 15-19 of the original specification as “an annular ring having an axial depth, and having two peripheral surfaces (namely, a first peripheral surface and a second peripheral surface) spaced apart by the axial depth of the ratchet ring”.
The “axial depth of the ratchet ring” (claim 17) is interpreted according to the specification immediately following the above definition as “The axial depth may be defined as the distance between the first peripheral surface and the second peripheral surface of the ratchet ring”. This axial distance appears to exclude the axial depth of the teeth on the ratchet ring.
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: “driving component” in claim 22.
“A driving component” in claim 22 has been interpreted under 35 U.S.C. 112(f). Original specification page 4 “Optionally, the ratchet ring and a driving component of the rotary actuation mechanism have mutually interfering ribs or slots such that the ratchet ring and the driving component, e.g. a cage component, are rotationally coupled.” Page 8 states that the “driving component and a first part of the inhaler housing which is rotatable relative to another part of the housing are mutually coupled to provide actuation for release of dosage”. Pages 20 and 23 explain the operation of the driving component. The “driving component” is interpreted to be a mechanism as described by the specification which actuates the release of a dosage, such that it translated axially as the ratchet ring is rotated (page 20), and equivalents thereof.
Claim 23 is not interpreted under 35 U.S.C. 112(f) since the claim recites additional structure further defining the driving component.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 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 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 being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the “rotary actuation mechanism having a driving component” of claim 22 and the “mutually interfering ribs or slots” of claim 23 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). The response filed 10/08/2025 shows an annotated drawing of fig. 3B pointing out the slot; however, it remains unclear what structure is shown in the annotated indication of the “rib”. It is suggested to submit a substitute drawing of fig. 3 including a reference number pointing to the slot (and including an amendment to the specification including the reference number and a brief description). One of ordinary skill in the art would be able to understand the a rib would be an alternative structure to a slot, where the rib would be a radially outwardly projecting rib, where the slot in an internally projecting recess, as indicated in the annotated fig. 3B.
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.
Claims 13, 14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Ouyang et al. (US 2004/0149773), hereafter Ouyang.
The closest prior art of record is Ouyang et al. (US 2004/0149773), hereafter Ouyang.
Regarding Claim 13, Ouyang discloses a ratchet mechanism comprising: a ratchet ring (fig. 2, first indicator wheel 241, [0017] lines 5-6) rotatable about an axis ([0029]) relative to a chassis (fig. 2, chassis includes 269, 246, 241), with a general direction of rotation determined by teeth of the ratchet mechanism (fig. 2, teeth are angled to prevent reverse movement [0030]), wherein the ratchet ring comprises a first set of teeth arranged regularly around the ratchet ring (see annotated fig. 2, upper set of teeth 251, [0019])) and protruding in a first axial direction from the ratchet ring (teeth extend in an axial direction upward from the ratchet ring) and a second set of teeth arranged regularly around the ratchet ring (see annotated fig. 2, teeth 270 [0019]) and protruding in a second opposite axial direction from the ratchet ring (teeth 270 extend axially downward from the ratchet ring in the opposite direction); and the chassis comprising a third set of teeth arranged regularly (see annotated fig. 2, teeth 264 [0020]) and protruding in the second axial direction (teeth extend downward axially) and generally opposed to the first set of teeth (the third set of teeth 264 oppose teeth 251, fig 2), and a fourth set of teeth arranged regularly (fig. 2, fourth set of teeth 248 [0018]) and protruding in the first axial direction (teeth 248 extend upward axially) and generally opposed to the second set of teeth (teeth 248 oppose teeth 270), wherein: each tooth protruding in the first axial direction or the second axial direction comprises a leading edge and a trailing edge with respect to the general direction of rotation of the ratchet ring (see annotated fig. 2), the trailing edge on each tooth of the first set of the teeth and the second set of teeth is oriented in the axial direction of protrusion (see annotated fig., the trailing edges of the teeth on the first and second sets of teeth are shown as vertical, i.e., extending in the axial direction) and the leading edge on each tooth of the first set of teeth and the second set of teeth is angled towards the trailing direction with respect to the axial direction of protrusion (see annotated fig., the leading edges of the first and second sets of teeth are the angled edges of the teeth), and the leading edge on each tooth of the third set of teeth and the fourth set of teeth is oriented in the axial direction of protrusion (see annotated fig., the orientation of the third and fourth sets of teeth are oriented in the opposing direction as the first and second in order to prevent reverse movement of the indicator wheel, [0030]) and the trailing edge on each tooth of the third set of teeth and the fourth set of teeth is angled towards the leading direction with respect to the axial direction of protrusion (see annotated fig., the third and fourth sets of teeth have angled trailing edges).
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Regarding Claim 14, Ouyang discloses a ratchet mechanism as in claim 13, wherein the teeth from the first set of teeth and the third set of teeth are arranged to align with each other at a different relative position of the ratchet ring and the chassis to those at which teeth from the second set of teeth and the fourth set of teeth are arranged to align (the first and third set of teeth are designed to align differently than the second and fourth set of teeth so that the ‘tens’ indicia are incremented only once for every ten increments of the ‘units’ indicia, [0029]).
Regarding Claim 16, Ouyang discloses a ratchet mechanism as in claim 13, wherein the vertical spacing between distal ends of the third set of teeth and the fourth set of teeth is less than the spacing between distal ends of the first set of teeth and second set of teeth (fig. 2, when assembled, the distance between the tips of the third set and teeth and the fourth set of teeth is less than the distance between the first and second sets of teeth in order to engage both sides of the ratchet ring 241, otherwise, the ratchet ring 241 would slip between the third and fourth sets of teeth).
Regarding Claim 17, Ouyang discloses a ratchet mechanism as in claim 13, wherein the vertical spacing between the distal ends of the third set of teeth and the fourth set of teeth is greater than the axial depth of the ratchet ring (as interpreted above, the axial depth of the ratchet ring does not include the depth of the first and second sets of teeth; the distance between the distal ends of the third and fourth sets of teeth must be greater than the axial depth of the ratchet ring in order to permit movement of the rings; should the depth be equal, the parts may experience a tight friction fit).
Regarding Claim 18, Ouyang discloses a ratchet mechanism as in claim 13, wherein the first set of teeth and the second set of teeth protrude from opposite surfaces of the ratchet ring (see annotated fig. 2, the first set of teeth protrude upward from the ratchet ring and the second set of teeth protrude downward from the ratchet ring in opposite directions).
Regarding Claim 19, Ouyang discloses a ratchet mechanism as in claim 13, wherein the number of teeth in the first set of teeth and the number of teeth in the third set of teeth are related by an integer multiple (fig. 2, the number of teeth in the first set and third set matches, thus the number is related by an integer (1)).
Regarding Claim 20, Ouyang discloses a ratchet mechanism as in claim 13, wherein the number of teeth in the second set of teeth and the number of teeth in the fourth set of teeth are related by an integer multiple (fig. 2, there are 3 teeth shown in the second set and one can estimate from the drawing in fig. 2 that there are 3 sets of indicia 0-9 on indicator wheel 241, with a tooth for each indicia 247 [0017-0018]; thus the number of second teeth to fourth teeth is related by an integer (10)).
Regarding Claim 21, Ouyang discloses a ratchet mechanism as in claim 13, wherein the number of teeth in the first set of teeth is equal to the number of teeth in the second set of teeth (fig. 2, the number of teeth in the first set of teeth is depicted as equal to the number of teeth in the second set of teeth, as shown by the vertical ridges forming the teeth).
Allowable Subject Matter
Claims 15 and 22-24 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.
Regarding Claim 15, Ouyang discloses a ratchet mechanism as in claim 14, but is silent on wherein the teeth are arranged such that opposition of teeth from the first set of teeth and the third set of teeth occurs at primary positions of the ratchet ring and opposition of teeth from the second set of teeth and the fourth set of teeth occurs at secondary positions of the ratchet ring, such that the primary positions and the secondary positions alternate as the ratchet ring is rotated in the general direction of rotation. This limitation has been interpreted by the examiner according to the original specification pages 18-19 to mean that the alignment of the teeth alternate between the top set of teeth (first and third) contacting in opposition, followed by the bottom set of teeth (second and fourth) contacting in opposition as the ratchet ring is rotated around the chassis.
There does not appear to be any prior art of record that indicates a ratchet mechanism with all the limitations of claim 14 which also has the above limitations.
Thus, claim 15 would be allowed should it overcome the above objection.
Regarding Claim 22, Ouyang discloses a portable inhaler, comprising a ratchet mechanism as in claim 13, wherein the portable inhaler comprises a rotary actuation mechanism having a driving component (fig. 2, axial depression of the cap 269 causes lower ring 254 to compress toward upper ring 253, which due to the helical coil 243, is transferred into rotational movement to drive the ratchet and dispense medication [0026] and [0030]); however, Ouyang is silent on the driving component being coupled to rotary movement by a user of a first part of the portable inhaler relative to a second part of the portable inhaler (emphasis added).
While other inhalers disclose driving component coupled to rotary movement by a user (see for example US 2003/0209245), there appears to be no motivation to modify or teach rotary movement by a user into Ouyang’s without rendering the device inoperable.
Thus, claim 22 would be allowable if rewritten to overcome the above objection. Claims 23-24 would also be allowed as dependent upon claim 22.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6095136 fig. 2 depicts internal splines (fig. 2, 36) which engage with a ring (fig. 2, 28) to operate rotationally together (col. 4, line 57-68)
US 6336453 B1 discloses a plurality of teeth inwardly facing on an inhaler body (figs. 4 and 5, 66).
US 2007/0181120 A1 fig. 15 [0117]
US 2008/0135575 A1 fig. 8
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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, Brandy S. Lee can be reached on (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
