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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/10/2023 and 7/29/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 9 and 18 are objected to because of the following informalities:
On line 1 of claim 9, “any one of claim 7” should read “claim 7” to correct a minor typographical error.
On line 1 of claim 18, “the system” should read “the electronic system” to provide proper antecedent basis.
Appropriate correction is required.
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:
Electrical signaling unit in claim 1
Connection feature in claims 5-7
Biasing mechanism in claim 14
Electrical motion sensing unit in claim 19
Communication unit in claim 19
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.
See par. [0047] and par. [0136] of the pg-publication for the electrical signaling unit
See par. [0029]-[0032] of the pg-publication for the connection feature
See par. [0048] of the pg-publication for the biasing mechanism
See par. [0071] of the pg-publication for the motion sensing unit
See par. [0059] of the pg-publication for the communication unit
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.
Claim(s) 1-15 and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Novo Nordisk (EP 3448470; hereafter Novo).
In regard to claim 1, Novo discloses an electronic system (102) for a drug delivery device (100), the electronic system comprising: a user interface member (122 and “inner sleeve of data capture unit 102”; see par. [0068]) configured to be manipulated by a user for performing a dose operation, the user interface member comprising a first portion (122) and a second portion (“inner sleeve”), the first portion being movable relative to the second portion from a rest position to a signaling position (see par. [0065]-[0070]; the sleeve 122 functions as described outer sleeve 22 and the inner sleeve functions as described inner sleeve 21; see par. [0049]- there is relative movement before simultaneous movement of both elements); an electronic control unit (“electronic data acquisition unit”; see par. [0047]) configured to control operation of the electronic system, the electronic system having a first state (“non-use state”; see par. [0047]) and a second state (“wake-up” state; see par. [0047]), wherein the electronic system has an increased electrical power consumption in the second state as compared to the first state (see par. [0047]- the device transitions from the dormant non-use to the activated wake-up state); an electrical signaling unit (“switch arrangement 25”; see par. [0066]) configured to provide an electrical signal indicative that the user interface member is being manipulated; wherein the electronic control unit is configured to switch the electronic system from the first state into the second state in response to the electrical signal (see par. [0047]-[0060]); and wherein the electrical signaling unit is configured to provide the electrical signal in response to a movement of the first portion (122) relative to the second portion (inner sleeve) from the rest position into the signaling position (see par. [0047]-[0060]).
In regard to claim 2, Novo discloses wherein the movement of the first portion (122) from the rest position to the signaling position involves rotational movement of the first portion relative to the second portion (see par. [0049] and [0068]).
In regard to claim 3, Novo discloses wherein the electronic control unit is connected to the second portion (see par. [0047], [0049] and Fig. 4- connected via the switch arrangement 25).
In regard to claim 4, Novo discloses wherein the first portion (122) and the second portion (inner sleeve) are permanently directly mechanically interconnected during the dose operation by a mechanical interconnection (see par. [0068]-[0069]; see also Figs 3-4; the internal surface of the first portion is directly connected to the external surface of the second portion).
In regard to claim 5, Novo discloses wherein the mechanical interconnection comprises a connection feature that is integrally formed with the first portion and the second portion (see par. [0068]-[0069]; see also Figs 3-4; the internal surface of the first portion is directly connected to the external surface of the second portion).
In regard to claim 10, Novo discloses wherein the second portion is configured to abut a stop feature (22) when the first portion is moved from the rest position towards the signaling position (see par. [0049]).
In regard to claim 11, Novo discloses wherein the rest position is a no dose set position (see par. [0047]; the initial dose can be the original rest position).
In regard to claim 12, Novo discloses wherein the signaling unit (25) comprises an electrical switch mechanism that is configured to be triggered to provide the electrical signal when the first portion (122) is moves relative to the second portion(inner sleeve) from the rest position to the signaling position (see par. [0049] and Figs. 3-4).
In regard to claim 13, Novo discloses wherein the electronic system is configured such that the electronic system is switched only from the first state into the second state when the first portion (122) of the user interface member is held away from the rest position for a time exceeding a predetermined time (the time it takes for the stop 22 to move to hit the stops 21a, 21b).
In regard to claim 14, Novo discloses wherein, when the first portion (122) is in the signaling position, the first portion is biased towards the rest position by a biasing mechanism (“spring arrangement”; see par. [0051]) of the user interface member.
In regard to claim 15, Novo discloses wherein the electronic system is configured as an add-on module for a drug delivery device unit (see par. [0048], [0068]).
In regard to claim 17, wherein the first portion (122) and the second portion (inner sleeve) are coupled via a force-sensitive coupling (see Fig. 3-4; concentric rotational coupling is force sensitive in that it can be forced apart).
In regard to claim 18, Novo discloses wherein the system is configured such that the first portion (122) is connected to the second portion (inner sleeve) in a torque-proof and/or force-proof way after the relative movement has been completed in the direction away from the rest position (the system is configured to withstand torque and/or force after movement from the rest position).
In regard to claim 19, Novo discloses wherein the electronic system comprises one or more of an electrical motion sensing unit; a communication unit (see par. [0034]); a memory unit.
In regard to claim 20, Novo discloses, wherein when in the rest position, the first portion (122) is movable relative to the second portion (inner sleeve) in two different directions (see par. [0060]; resetting the device is possible and therefore the outer sleeve is rotatable in either direction).
In regard to claim 21, Novo discloses a drug delivery device (100) comprising: an electronic system (102) having a first state (“non-use state”; see par. [0047]) and a second state (“wake-up” state; see par. [0047]), wherein the electronic system has an increased electrical power consumption in the second state as compared to the first state; the electronic system comprising: a user interface member (122 and “inner sleeve of data capture unit 102”; see par. [0068]) configured to perform a dose setting operation to set a dose of drug to be delivered by the drug delivery device and/or a dose delivery operation for delivering a set dose, the user interface member comprises a first portion (122) and a second portion (“inner sleeve”), wherein the first portion is movable relative to the second portion from a rest position of the first portion to a signaling position of the first portion (see par. [0065]-[0070]; the sleeve 122 functions as described outer sleeve 22 and the inner sleeve functions as described inner sleeve 21; see par. [0049]- there is relative movement before simultaneous movement of both elements); an electrical signaling unit (“switch arrangement 25”; see par. [0066]) configured to provide an electrical signal indicative that the user interface member is being manipulated; and an electronic control unit (“electronic data acquisition unit”; see par. [0047]) configured to control operation of the electronic system and to switch the electronic system from the first state into the second state in response to the electrical signal, wherein the electrical signaling unit is configured to provide the electrical signal in response to the movement of the first portion relative to the second portion from the rest position into the signaling position (see par. [0047]-[0060]); and a reservoir with a drug (see par. [0063]-[0064] and Fig. 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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