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 .
Response to Amendment
The amendment filed 05/19/2025 has been entered. Claims 13-24 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and 112(b) rejections previously set forth in the Non-Final Office Action mailed 12/18/2024.
Response to Arguments
Applicant's arguments filed 06/16/2025 (“Remarks”) have been fully considered but they are not persuasive.
Regarding the claim objections and 112(b) rejections, the amendments to the claims have rendered these moot, and have been withdrawn.
Regarding the argument on page 6 of “Remarks” that the drawing objections should be withdrawn since the rotary actuation mechanism having a driving component and the mutually interfering slots or ribs are shown in fig. 3A, the explanation of the driving component assists with understanding which components comprise the rotary actuation mechanism. However, it is not clearly shown in the drawings or described in the specification what the cage component is in the structure. It is suggested to amend the drawings and specification to include reference numbers indicating the driving component, cage structure, slot, etc. Regarding the argument that the slot is shown, the examiner appreciates the highlighted area of the annotated figure included on page 6. It is suggested to indicate the slot with a reference number. However, it is not clear what the rib is, and it appears that either a slot or a rib is described and claimed. It is not apparent how the slot or rib would be considered mutually interfering from the provided drawings and specification.
Regarding the argument that the 112(f) interpretation is rendered moot by the cancellation of claim 22, it appears that claim 22 is still pending in the current claim set. Thus, the 112(f) interpretation of “a driving component” has been maintained.
Regarding the argument on page 8 that neither Johnson nor Ouyang disclose a chassis, these arguments have been considered, but are not persuasive. Applicant states that the chassis identified in the Johnson reference does not support the third and fourth set of teeth, and identifies Johnson’s third set of teeth as “f”, and Johnson’s fourth set of teeth as “f3”. However, the office action identifies “f6” as the third set and the lower set of teeth “f7” as the third and fourth sets of teeth, respectively. These two sets of teeth are supported by framework, or chassis, “f2” as seen in Johnson fig. 1.
The argument that Ouyang does not disclose a chassis supporting the third and fourth sets of teeth has been carefully considered but is not persuasive. The chassis as claimed by the applicant has a described on page 10 as a body of the inhaler. It is noted that the features upon which applicant relies (i.e., the chassis of the inhaler having the third and fourth sets of teeth arranged on an inner wall of the chassis, as described on page 11 of the original specification) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The chassis identified in Ouyang meets the criteria of being a portion of a body of an inhaler, and supports the third and fourth sets of teeth.
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).
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.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. It appears that the abstract has been submitted as the first page of the WIPO publication associated with this application rather than in the correct format.
Claim Interpretation
Applicant defines “ratchet ring” on page 9 lines 15-19 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” 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 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 is: “a driving component” in claim 22.
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.
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 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
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 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.
Claims 13 and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (US 0685282), hereafter Johnson.
Regarding Claim 13, Johnson discloses a ratchet mechanism comprising: a ratchet ring (fig. 1, ratchet-toothed ring b, page 1 lines 55-56) rotatable about an axis relative to a chassis (fig. 1, chassis is axially projecting stud f², page 1 line 68), with a general direction of rotation determined by teeth of the ratchet mechanism (fig. 1, ratchet teeth are angled to permit one-way rotation, page 1 lines 59-61), wherein the ratchet ring comprises a first set of teeth arranged regularly around the ratchet ring (top set of teeth on ratchet ring b) and protruding in a first axial direction from the ratchet ring (first set of teeth extend upwardly in an axial direction) and a second set of teeth arranged regularly around the ratchet ring (fig. 1, second set are bottom teeth on ratchet ring b) and protruding in a second opposite axial direction from the ratchet ring (second set of teeth extend downward in the axial direction); and the chassis comprising a third set of teeth (fig. 1, f6, page 1 line 77) arranged regularly and protruding in the second axial direction (fig. 1 teeth f6 extend downward) and generally opposed to the first set of teeth (fig. 1, teeth f7 oppose the direction of first set of teeth on b in order to engage together, page 1 lines 78-80), and a fourth set of teeth arranged regularly and protruding in the first axial direction (fig. 1, fourth set of teeth are f which protrude upward axially) and generally opposed to the second set of teeth (f7 oppose the bottom teeth on b, page 1 lines 78-80), wherein: each tooth protruding in the first axial direction or the second axial direction comprises a leading edge and a trailing edge (see annotated fig. 1) with respect to the general direction of rotation of the ratchet ring (page 1 lines 85-93), 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. 1, the trailing edge is vertical 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 fig. 1), 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 fig. 1, the leading edge on the third and fourth set of teeth are vertical in the axial direction) 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 (the trailing edges of the third and fourth set of teeth are angled; page 1 lines 85-101).
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Regarding Claim 17, Johnson 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 greater than an axial depth of the ratchet ring (fig. 1, there is a greater distance between the third set of teeth and the fourth set of teeth than the axial length of the ratchet ring b so as to avoid engaging both sets of teeth at the same time).
Regarding Claim 18, Johnson 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. 1, the first and second set of teeth protrude in opposite directions of the ratchet ring).
Regarding Claim 19, Johnson 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 (there are the same number of teeth in the first set and third set of teeth, thus related by an integer multiple, i.e., 1).
Regarding Claim 20, Johnson 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 (there are the same number of teeth in the second and fourth sets of teeth, thus related by an integer multiple, i.e. 1).
Regarding Claim 21, Johnson 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. 1, there are the same number of teeth in the first and second sets of teeth).
Claims 13, 14, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by 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), 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, as best understood based on the 112(b) rejection above, 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 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)).
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. WO 2004026380 A2 discloses and inhaler with a rotary drive indicator (fig. 3 in particular).
THIS ACTION IS MADE FINAL. 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 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 /VICTORIA MURPHY/Supervisory Patent Examiner, Art Unit 4100
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