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 .
Election/Restrictions
Claims 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 July 2026.
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: “electronic control unit”, “user proximity detection unit” and “electrical signaling unit” in claim 1. The examiner draws the reader’s attention to applicant’s drawing Figures 4A-4C and the attendant discussion regarding structure.
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.
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
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) 21-36 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Pre-Grant Publication 2020/0114087 to Bauer et al. (Bauer hereinafter).
Regarding claim 20, Bauer teaches an electronic system for a drug delivery device, the electronic system comprising: at least one user interface member (600) configured to be manipulated by a user for performing a dose operation, an electronic control unit (610) configured to control operation of the electronic system, the electronic system having a first state (sleep, see paragraph 147) and a second state (powered on, same paragraph), wherein the electronic system has an increased electrical power consumption in the second state as compared to the first state, wherein the user interface member comprises an exterior operation surface (510) which is arranged to interact with the user for the dose operation, wherein the user interface member comprises a user proximity detection unit (600) configured to generate an electrical signal in response to detecting that the user is close to the exterior operation surface (i.e. activates 626) or touches the exterior operation surface, wherein the user proximity detection unit comprises a movable member (626) arranged to be moved by the user away from an initial (proximal) position relative to the exterior operation surface towards a (distal) operation position before the user reaches the exterior operation surface, wherein the user proximity detection unit further comprises an electrical signaling (620) unit, wherein the user proximity detection unit is configured to provide the electrical signal when the movable member has been moved away from the initial position, and wherein the electronic system is configured such that the electronic control unit switches the electronic system from the first state into the second state in response to the electrical signal (paragraph 143).
Regarding claim 21, Bauer teaches a member interface body (520) having a portion (519) extending into an opening (547) of the exterior operation surface.
Regarding claim 22, Bauer further teaches multiple openings (631) through which the movable body passes, the portions (646) of the movable member extending from a central common main body (638 and/or surrounding ring) which is provided in an interior of the user interface member body.
Regarding claim 23, Bauer teaches a force transfer path (i.e. along 627) which bypasses (i.e. does not pass through) the control unit.
Regarding claim 24, Bauer teaches that a user contact region (upper central surface) of the movable member (626) is elevated relative to the exterior operation surface (see e.g. Fig. 26) and sub-flush in the operation position (in order to contact the switch 620).
Regarding claim 25, Bauer teaches that the electrical signal is generated in response to movement of the movable member relative to the electrical signaling unit, and/or wherein the electrical signaling unit comprises an electrical switch, wherein the electrical switch is arranged to be triggered during the movement from the initial position to the operation position (paragraph 145).
Regarding claim 26, Bauer teaches that a biasing member may be provided (paragraph 144, “a member that is biased proximally such as by springs (not shown)”).
Regarding claim 27, Bauer teaches a delivery surface (510 for interacting with the user for performing a dose delivery operation (paragraph 131).
Regarding claim 28, Bauer teaches that the user interface member (600) is connected to a mechanism member (519, see paragraph 139).
Regarding claim 29, Bauer teaches a first member (510, 547) and a second member (519, 520) which are movable relative to each other to set the dose (paragraph 139).
Regarding claim 30, Bauer teaches a shuttle member (608) and a biasing system (672).
Regarding claim 31, Bauer teaches that the electronic system is configured such that the user interface member (600) is operatively connectable to a mechanism member (510) via a dose operation interface (520) to drive movement of the mechanism member during the dose operation and wherein the electronic system is configured such that, in order to establish the dose operation interface, the exterior operation surface has to be displaced from a first position relative to the mechanism member to a second position relative to the mechanism member, and wherein the shuttle member biasing system is configured to be biased during the movement from the first position to the second position.
Regarding claim 32, Bauer teaches that the electronic system is configured as an add-on module for a drug delivery device.
Regarding claim 33, for a sufficiently small arbitrarily selected area, Bauer teaches the claimed ratio.
Regarding claim 34, Bauer teaches that the movable member is configured to be moved further away from the initial position.
Regarding claim 35, Bauer teaches securement of the signaling unit (620) via the board (610).
Regarding claim 36, Bauer teaches that the movable member (626) is configured and arranged such that before the user touches the exterior surface, at least in order to set a dose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 17 September 2026
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