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 .
Claim Objections
Claim(s) 2 is/are objected to because of the following informalities:
Claim 2, Ln. 5-6 recites “the second portion of the temporary increase” which should read “the second portion of the temporary decrease” following after Ln. 3
Appropriate correction is required.
Claim 14 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only (the claim currently recites dependence on both claims 13 and 8). See MPEP § 608.01(n). Accordingly, the claim 14 not been further treated on the merits.
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.
Claim(s) 4, 8-9 and 14 is/are 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 pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation “the conversion mechanism is configured to resist the departing movement of the actuator” in Ln. 3-4 which deems the claim indefinite. Claim 3 has recited the conversion mechanism as comprising the actuator but the claim has not recited any other structure for the conversion mechanism. The present limitation is thus unclear as it appears to imply that some other portion of the conversion mechanism which is not yet claimed is operating to resist the departing movement of the actuator. The claim should be amended to include that resistance performing structure (which appears to be one of the disclose “resistance components”). For the purposes of examination the conversion mechanism will be interpreted as further including a resistance component to perform the claimed function of resist the departing movement of the actuator. (Note is made that the language “resistance component” will invoke 35 U.S.C. 112(f).)
Claim 8 recites the limitation “for resetting or otherwise modifying the information relating to the inhalation count” in Ln. 2-3 which deems the claim indefinite. The language “or otherwise modifying” is indefinite as it fails to clearly establish the metes and bounds of the claim. One of ordinary skill in the art would be left to question how many possible other modifications beyond resetting are encompassed by the claim? Applicant is requested to either amend the claim to specify specific other modifications possible to the information relating to the inhalation count or to delete the overly broad portion of the limitation.
Claim 14 recites the limitation “the combined modifying and energising mechanism” in Ln. 3. There is insufficient antecedent basis for this limitation in the claim. Note that claim 14 as an improper multiple dependent claim (see above claim objection) as it recites dependence on two different claims without doing so in the alternative as required by 37 CFR 1.75(c). The claim cannot be properly examined until the claim dependency is corrected.
Claim Interpretation - 35 USC § 112(f)
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”) (“biasing means” in claim 1 and “indication means” in claim 7) 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: “a conversion mechanism which, in use, is configured to perform a first action in response to a temporary increase in fluid flow rate through the fluid flow passage” in claim 1, “rotatable component” in claim 5, “flexible component” in claim 6, “modifying mechanism” in claim 8, “energising mechanism” in claim 10 and “combined modifying and energising mechanism” in claim 11.
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.
The corresponding structure for the biasing means is best understood from the specification as at least: biasing means 354 in the form of a spiral spring (Figs. 2 & 4) or biasing means 454 in the form of a helical spring (Fig. 3).
The corresponding structure for the conversion mechanism is best understood from the specification as at least: actuator 358 in the form of a piston and resistance component 360 in the form of a helical spring (Fig. 2) or actuator 458 in the form of a flexible membrane (Fig. 3) or actuator 558 in the form of a rotatable flap and resistance component 560 in the form of a torsional spring (Fig. 4).
The corresponding structure for the rotatable component is best understood from the specification as at least: actuator 558 in the form of a rotatable flap (Fig. 4).
The corresponding structure for the flexible component is best understood from the specification as at least: actuator 458 in the form of a flexible membrane (Fig. 3).
The corresponding structure for the indication means is best understood from the specification as at least: indication means 364 in the form of a pointer 366 and a substantially circular scale 368 (Fig. 2) or indication means 464 in the form of a pointer 466 and a substantially linear scale 468 (Fig. 3).
The corresponding structure for the modifying mechanism is best understood from the specification as at least: freewheel clutch 370 (Fig. 2) or freewheel clutch 470 (Fig. 3).
The corresponding structure for the energising mechanism is best understood from the specification as at least: freewheel clutch 370 (Fig. 2) or freewheel clutch 470 (Fig. 3).
The corresponding structure for the combined modifying and energising mechanism is best understood from the specification as at least: freewheel clutch 370 (Fig. 2) or freewheel clutch 470 (Fig. 3).
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
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.
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.
Claim(s) 1-3, 5, 7, 10, 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tampieri et al. (U.S. Pub. 2015/00374937).
Regarding claim 1, Tampieri discloses an inhalation counter (Figs. 1A-1C; ¶0041) for an inhalation system (Fig. 4; ¶0039), the inhalation system comprising a fluid flow passage (within the inhaler of Fig. 4) and the inhalation counter comprising: an escapement wheel (Fig. 1A #12; ¶0041); a biasing means (Fig. 1A #40’; ¶0041) for incrementing the escapement wheel; a conversion mechanism (Fig. 1A #18, see also Fig. 2; ¶¶0041-0043, 0048) which, in use, is configured to perform a first action in response to a temporary increase in fluid flow rate through the fluid flow passage (¶0054 – flap 20 pivots based on sufficiently high inhalation force); and an anchor (Fig. 1A #30; ¶0053), wherein the anchor is coupled to the conversion mechanism (Fig. 1A; ¶0054) and configured to interact with the escapement wheel (Fig. 1A; ¶¶0055, 0057) so as to allow the biasing means to increment the escapement wheel in response to the first action of the conversion mechanism (Fig. 1A; ¶¶0055, 0057). The structure of inhalation actuated mechanism 18 (as shown in Figs. 1A & 2) is read as at least a functional equivalent of the disclosed conversion mechanism as it is operated on by a user’s inhalation force, which causes the inhalation actuated mechanism 18 to move in such a manner as to cause coupling member 30 (read as the claimed anchor) to alter its positioning such that a spring force of resilient member 40’ can operate to advance units wheel 12 (Fig. 1A; ¶¶0054-0055). It is noted that claim is not understood to require the first action to directly include incrementing of the escapement wheel. Rather, the claim recites the conversion mechanism as “allow[ing] the biasing means to increment the escapement wheel in response to the first action of the conversion mechanism” which allows for a subsequent motion after the first action of the conversion mechanism to complete the incrementing of the escapement wheel.
Regarding claim 2, Tampieri discloses the temporary increase in fluid flow rate comprises a first portion in which the fluid flow rate increases (¶0054 – as inhalation rises to sufficient force), and a subsequent second portion in which the fluid flow rate decreases (as inhalation wanes), and wherein the conversion mechanism is configured to initiate the first action in response to the first portion of the temporary increase in fluid flow rate (¶0054 – as inhalation reaches to sufficient force) and complete the first action in response to the second portion of the temporary increase in fluid flow rate (¶0054 – time following sufficient force of inhalation). The claim does not require any particular structural/positional difference between the first portion and the second portion.
Regarding claim 3, Tampieri discloses the conversion mechanism comprises an actuator (Fig. 1A #20; ¶0054) and the first action comprises movement of the actuator (¶¶0054-0055). The instant claim does not invoke 35 U.S.C. 112(f) in relation to the conversion mechanism.
Regarding claim 5, Tampieri discloses the conversion mechanism comprises a rotatable component (Fig. 1A #20; ¶0054 – pivoted) and the first action comprises rotation of the rotatable component (¶0054 – pivoted).
Regarding claim 7, Tampieri discloses the inhalation counter comprises an indication means (Fig. 1 #13; ¶0041) for indicating to a user information relating to an inhalation count of the inhalation counter.
Regarding claim 10, Tampieri discloses an energising mechanism (Fig. 1A #5; ¶0054) for energising the biasing means. Metering member 5 is read as a functional equivalent of the disclosed energising mechanism as it operates to compress the spring of resilient member 40’ (¶0054).
Regarding claim 13, Tampieri discloses a holder (Fig. 4 #1; ¶0008) for use with an inhaler article (all of Fig. 4), the holder comprising an inhalation counter according to claim 1 (see above).
Regarding claim 15, Tampieri discloses an inhalation system comprising an inhaler article (all of Fig. 4) and a holder according to claim 13 (see above).
Allowable Subject Matter
Claim(s) 4 and 8-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 6 and 11-12 is/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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, Tampieri fails to teach or suggest the first action comprises a departing movement of the actuator from a first position to a second position, and a returning movement of the actuator from the second position to the first position, and the conversion mechanism is configured to resist the departing movement of the actuator. Specifically, Tampieri fails to teach the conversion mechanism as including a resistance component to perform the claimed function of resisting the departing movement of the actuator. Note is made of the above 35 U.S.C. 112(b) rejection of the claim and accompanying claim interpretation.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 6, Tampieri fails to teach or suggest the conversion mechanism comprises a flexible component and the first action comprises flexing of the flexible component. The cited conversion mechanism in Tampieri is inhalation actuated mechanism 18 which has no consideration of being a flexible component to be flexed.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 8, Tampieri fails to teach or suggest the inhalation counter comprises a modifying mechanism coupled to the indication means for resetting or otherwise modifying the information relating to the inhalation count. Tampieri fails to teach any possible modifying mechanism, note the above 35 U.S.C. 112(f) interpretation of the limitation, which would operate to reset the indication means of claim 7.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 11, Tampieri fails to teach or suggest a combined modifying and energising mechanism for modifying the information relating to the inhalation count and energising the biasing means. Tampieri fails to teach any possible combined modifying and energising mechanism, note the above 35 U.S.C. 112(f) interpretation of the limitation, which would operate to modify the information relating to the inhalation count and energize the biasing means of claim 7.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
It is noted that claim 12 does not invoke 35 U.S.C. 112(f) in relation to the combined modifying and energising mechanism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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, Kendra Carter can be reached at (571) 272-9034. 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.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785