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 .
Status of Claims
Claims 1-15 are pending. Claims 3-6 and 12 are currently amended.
Response to Amendment
The Response of 03/26/2026 is entered. In addition to the amendments to claims 3-6 and 12, the drawings and specification have also been amended.
Response to Arguments
Applicant asserts that the 35 USC 112(f) interpretation should not be maintained, Response bottom pf pg 7 – pg 16. Applicant argues that the term “indicator” when read in light of the Specification connotes sufficiently definite structure, such that the limitation should not be interpretated under 112(f).
On review, Examiner agrees that the Specification discloses structures referred to by the limitation “indicator”, but disagrees that this means the interpretation under 35 USC 112(f) is not appropriate. In the claim, indicator is associated with a function of indicating inhalation volume information, but no structure is provided in the claim. Without referring to the Specification, the structures that may qualify as meeting this limitation are not apparent. Currently, the claim language is considered the equivalent of an indicator means for indicating inhalation volume information. The interpretation of “indicator” under 35 USC 112(f) is maintained. Because there is support for “indicator” as claimed, there is no further issue with the interpretation. If the Applicant wishes to avoid a 35 USC 112(f) interpretation of this term, the Applicant may amend the claim to include sufficient structure from the Specification to meet the claimed function of the limitation.
On review, Examiner disagrees that the amendments to the Specification are supported by the Application as filed, and thus the amendments that attempt to support the claimed limitation are considered new matter that must be cancelled. Applicant argues that the interpretation of “modifying mechanism” is not appropriate under 35 USC 112(f). In the claim, “modifying mechanism” is associated with a function of “resetting or otherwise modifying the inhalation volume information” and is configured such that “wherein the modifying mechanism is operable by one or both of engaging the article with the holder and disengaging the inhalation article from the holder”, but no structure is provided in the claim for providing the function or associated with this configuration. Currently, the claim language is considered the equivalent of a modifying mechanism means for modifying inhalation volume information and having the claimed configuration. The interpretation of “modifying mechanism” under 35 USC 112(f) is maintained.
Examiner disagrees that the Specification discloses sufficient structures to support the limitation of a “modifying mechanism coupled to the indicator for resetting or otherwise modifying the inhalation volume information” and “wherein the modifying mechanism is operable by one or both of engaging the article with the holder and disengaging the inhalation article from the holder.” Applicant relies on new matter to support the claimed limitation, see the objection to the Specification below. This is not persuasive. Thus, the previous rejections under 35 USC 112(a) and 35 USC 112(b) are also maintained.
Specification
The amendment filed 03/26/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
A structure and reference character 370 were added to Fig 1. Additionally, the Specification was amended to add description regarding a modifying mechanism 370 coupled to the indicator for resetting or otherwise modifying the inhalation volume information.
The modifying mechanism appears to be a button. There is no direct support for a button at this location. There is no drawing depicting how the button is coupled to the indicator. Applicant appears to be relying on the ordinary skill in the art to support the amendment.
The original specification did not recite sufficient structure for this limitation as claimed. The Specification asserts that the structures would be apparent to one of ordinary skill in the art after reading the disclosure. Yet, the modifying mechanism operable by one or both of engaging the inhaler article with the holder and disengaging the inhaler article from the holder is only described by function. Examiner is not able to reasonably determine what structures are disclosed that meet the claimed limitation based on the Specification and Drawings as originally.
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the modifying mechanism must be shown as “coupled to the indicator” or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: Because the features are not believed to be supported by the application as filed, it is believed that adding the required drawing changes and support to the Specification would be new matter.
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.
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: “indicator” and modifying mechanism in claims 1- 15 (present in all the claims by virtue of the claim dependencies).
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 limitation “indicator” is required to be coupled to the turbine, and as such is being interpreted to cover the corresponding structures comprising a pointer, a scale, an indication surface, a reference window, where at least part of the indicator (such as the pointer) is coupled to the turbine mechanically by a series of gears (Specification [pg 2 lines 16-34]).
The limitation “modifying mechanism” is required to be “operable by one or both of engaging the inhaler article with the holder and disengaging the inhaler article from the holder” and to be “coupled to the indicator for resetting or otherwise modifying the inhalation volume information”. The disclosure indicates that a “sensor could be used to detect the motion of the sleeve downwards to reset the inhalation count”, (Specification [pg 18 lines 9-10]), but also that a mechanical inhalation counter and mechanical inhalation count indicator may be used, to avoid the use of a battery or electrical components in the device, (Specification [pg 18 lines 10-12]). There is no direct disclosure regarding what the further modifying mechanism structures are required to operate as claimed.
Instead, the disclosure regarding the modifying mechanism provides “the modifying mechanism is operated by movement of the sleeve downwards towards the piercing element. The mechanism is not shown in the Figures, but several options for this mechanism would be apparent to one skilled in the art after reading the disclosure”, (Specification [pg 17 lines 28-34]). In other sections, the disclosure suggests that the reset can be done using hands or a tool, (Specification [pg7-8 lines 32-5]), that movement of the sleeve relative to the housing may be used to operate the modifying mechanism, (Specification [pg 9 lines 18-21]), and that engaging the article with the holder operates the modifying mechanism, (Specification [pg 10 lines 3-22]).
While the disclosure does provide structure for the modifying mechanism related to user initiated reset of the inhalation volume information, (Specification [pg 20 lines 7-18] a button and a winding mechanism), this structure is related to allowing manual reset of the indicator component rather than reset by one or both of engaging/disengaging the inhaler article with the holder.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
While the disclosure does provide structure for the modifying mechanism related to user initiated reset of the inhalation volume information, (Specification [pg 20 lines 7-18] a button and a winding mechanism, this structure is related to allowing manual reset of the indicator component rather than reset by one or both of engaging/disengaging the inhaler article with the holder). Thus, claim 1 is rejected under 35 USC 112(a) for failing to recite a combination of element as required by 35 USC 112(f), and thus cannot rely on the Specification to provide the necessary structure.
Regarding claims 2-15, these claims depend on claim 1, requiring that the function of the modifying mechanism perform as claimed in claim 1. None of the claims add the necessary structure to overcome the 35 USC 112(a) rejection as it pertains to claim 1. Note: the additional configuration of claim 12 is supported by the specification as noted in the preceding paragraph, but because claim 12 still requires the functionality of claim 1 related to the modifying mechanism (which is not disclosed), and thus claim 12 is also properly rejected under 35 USC 112(a).
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 limitation “modifying mechanism” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As described above: The disclosure only provides structure for the modifying mechanism related to user initiated reset of the inhalation volume information, (Specification [pg 20 lines 7-18] a button and a winding mechanism, this structure is related to allowing manual reset of the indicator component rather than reset by one or both of engaging/disengaging the inhaler article with the holder).
As recited in claim 1 the limitation “modifying mechanism” is required to be “operable by one or both of engaging the inhaler article with the holder and disengaging the inhaler article from the holder” and to be “coupled to the indicator for resetting or otherwise modifying the inhalation volume information”. The disclosure indicates that a “sensor could be used to detect the motion of the sleeve downwards to reset the inhalation count”, (Specification [pg 18 lines 9-10]), but also that a mechanical inhalation counter and mechanical inhalation count indicator may be used, to avoid the use of a battery or electrical components in the device, (Specification [pg 18 lines 10-12]). There is no direct disclosure regarding what the modifying mechanism structures are when configured to operate as claimed.
Instead, the disclosure regarding the modifying mechanism provides “the modifying mechanism is operated by movement of the sleeve downwards towards the piercing element. The mechanism is not shown in the Figures, but several options for this mechanism would be apparent to one skilled in the art after reading the disclosure”, Specification [pg 17 lines 28-34]). In other sections, the disclosure suggests that the reset can be done using hands or a tool, (Specification [pg7-8 lines 32-5]), that movement of the sleeve relative to the housing may be used to operate the modifying mechanism, (Specification [pg 9 lines 18-21]), and that engaging the article with the holder operates the modifying mechanism, (Specification [pg 10 lines 3-22]). A statement that one of ordinary skill in the art would be capable of supplying the necessary structure is insufficient to disclose the necessary structure in the Specification.
While the disclosure does provide structure for the modifying mechanism related to user initiated reset of the inhalation volume information, (Specification [pg 20 lines 7-18] a button and a winding mechanism, this structure is related to allowing manual reset of the indicator component rather than reset by one or both of engaging/disengaging the inhaler article with the holder]).
Therefore, the claim 1 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 2-15 are rejected as indefinite under 35 USC 112(b) by virtue of their dependency on an indefinite base claim.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Conclusion
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 DANIEL E VAKILI whose telephone number is (571)272-5171. The examiner can normally be reached Monday - Friday 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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