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 .
Specification
The amendment filed 06 Feb 2024 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: the incorporation by reference of the international patent application PCT/EP2022/071837 and of the foreign patent application EP 21199678.0 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 03 Aug 2022, see MPEP 1893.03(b). Therefore the specification amendment of 06 Feb 2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim(s) 16-30 is/are objected to because of the following informalities:
Claim 16, Ln. 5 recites “a channel an inlet end of which” which should read “a channel, an inlet end of the channel” for clarity (adding a comma and replacing the “which”)
Claim 21, Ln. 1-2 recites “the locking member of the loading button and the mating locking member of the main body is configured” which should read “the locking member of the loading button and the mating locking member of the main body are configured”
Claim 23, Ln. 2 recites “a user press” which should read “the user presses” following after claim 16
Claim 25, Ln. 2 recites “piston rod (4)” where the numeral should be removed as no other claims use numerals
Claim 25, Ln. 2 recites “an inlet end of the channel” which should read “the inlet end of the channel” following after claim 16
Claim 26, Ln. 2 recites “an outlet end of the metering chamber” which should read “the outlet end of the metering chamber” following after claim 16
Claim 29, Ln. 2 recites “an outlet end of the metering chamber” which should read “the outlet end of the metering chamber” following after claim 16
Appropriate correction is required.
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) 16-30 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 16 recites the limitation “the medical delivery member” in Ln. 23. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “the medicament delivery member”.
Claim 22 recites the limitation “the audible and/or tactile indication” in Ln. 4-5. There is insufficient antecedent basis for this limitation in the claim. The claim is dependent on claim 20 which has not introduced a tactile indication. Either the claim language needs to be amended or the claim dependency revised.
Claim 30 recites the limitation “the medicament indicator” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “a medicament indicator”.
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”) 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: “medicament delivery member” in claim 16.
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 “medicament delivery member” is best understood from the specification as at least: medicament delivery member 10 in the form of a mouthpiece (¶0038).
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.
Allowable Subject Matter
Claims 16-30 would be allowable if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 16, the prior art fails to teach or suggest a medicament delivery device including all elements and functionality recited by the instant claim. The claim defines a particular set of components and then recites a loading button as operable in a certain manner to cause actuation of medicament from the medicament delivery device. Specifically, the loading button is recited as moved by a user toward a distal end of the device, i.e. opposite from an end through which delivery occurs, to flow medicament into the metering chamber. The loading button is then acted on by a user which causes release of the compressed spring such that the medicament leaves the metering chamber to flow out of the device to the user.
Prior art of particular note include: Gazeley et al. (U.S. Pub. 2017/0354785), Säll et al. (WO 2020/064372 A1) and Dasbach et al. (U.S. Pub. 2021/0196892).
Gazeley teaches a drug deliver system (e.g. Fig. 1) including an actuator button 26 (Fig. 1; ¶0145). However, the actuator button 26 is intended to be moved in a same direction as delivery from the system, i.e. rightward in Figs. 1-2, which would be understood as a “proximal” direction. Gazeley thus fails to teach or suggest movement of the actuator button 26 in a distal direction to perform the actions recited of the loading button in the instant claim. One of ordinary skill in the art would not have been motivated to have modified Gazeley in order to have read on instant claim 16 without improper hindsight reasoning.
Säll teaches an aerosol dispenser (Fig. 1) including an activation member 9 which is distally movable to transition from a non-triggered position to a triggered position (Pg. 17-18; Figs. 7a, 7d-7e & 11). However, the activation member 9 of Säll does not contact the pump sleeve 11 (e.g. Figs. 7a, 7d-7e & 11) which is the structure in Säll needed to be read as the piston rod of the instant claim. One of ordinary skill in the art would not have been motivated to have modified Säll in order to have read on instant claim 16 without improper hindsight reasoning.
Dasbach teaches a drug delivery device (e.g. Figs. 2A-2D) including a button 22 (¶0129). However, the button 22 of Dasbach is not moved toward a distal end of the device and does not perform the functionality recited of the loading button of the instant claim. One of ordinary skill in the art would not have been motivated to have modified Dasbach in order to have read on instant claim 16 without improper hindsight reasoning.
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 claim invention by way of without improper hindsight reasoning.
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.
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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.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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