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 .
Response to Amendment
This office action is responsive to the amendment filed on 12/11/2025. As directed by the amendment: claims 1, 2, 5-7 and 10 have been amended. Claim 9 has been cancelled. Claims 16 and 17 have been added.
Thus, claims 1-8 & 10-17 are pending in this application.
Applicant’s amendments to the specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 09/25/2025.
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: “the holding mechanism” in claim 1.
Presumption is rebutted because no structure is recited that can perform the limiting function. The word “mechanism” is a generic placeholder that does not denote a sufficient structure to hold engagement between the add on module and the injection device.
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 for instance, the holding element 21c, 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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 18, “the holding surfaces” should read “the holding surface”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1).
Regarding claim 1, Graf et al disclose an injection system (figs 3-4), comprising: an injection device (10) having a longitudinal axis (L) and comprising a holding surface (3/3a) directed proximally (figs 1-2); and an add-on module (30) comprising a receiving region (11) adapted to a shape of a device housing of the injection device such that the receiving region is configured to be mounted on the injection device along the longitudinal axis (fig 3-4, para 0078), and a holding mechanism (20/21) configured to releasably secure the add-on module when mounted to the injection device against moving axially relative to the injection device (para 0070-71), wherein when the injection device (10) is inserted into the add-on module (30), a control element of the holding mechanism (20) moves under tension of a spring (24) such that a holding element (21) of the holding mechanism (20) is caused to engage with the holding surface (3a) and holds the injection device proximally against a separating movement (para 0070-72), wherein the add-on module (30) comprises a release element (22), which in a release movement for releasing the holding mechanism from the holding surfaces, is moved radially in a plane perpendicular to the longitudinal axis (para 0083 and 0087, pushing onto button 22 is radially moved perpendicular to the longitudinal axis L, see figs 3-4).
Graf et la fail to expressly teach said injection system comprising a discharge button arranged at a proximal end thereof, the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication from a container of the injection device; and said add-on module comprising a sensor unit and wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device.
Graf et al disclose that the delivery movement is likewise triggered by the user using a corresponding activating or actuating handle or structure to discharge a liquid medication from a container (2) of the injection device (see para 0026).
However, Helmer discloses an injection system (fig 2, para 0011) comprising an injection device (10) and a discharge button (13) arranged at a proximal end thereof (figs 1A-B), the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication (16) from a container (18) of the injection device (para 0088); and an add-on module (2) comprising a sensor unit (25, 23, 26) and a receiving region (20) wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device (see fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injection system of Graf et al to have said injection system comprising a discharge button arranged at a proximal end thereof, the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication from a container of the injection device; and said add-on module comprising a sensor unit and wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device as taught by Helmer. This would provide the benefit of having an actuator/ trigger coupled to a drive element which performs the delivery movement (para 0088) and having a sensor unit for detecting processes or states of the injection device (para 0035).
Regarding claim 2, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the radial release movement of the release element (22) further is a linear, non-tilting, non-rotatable release movement (para 0087, pressing button 22 is non rotatable).
Regarding claim 3, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the release element (22) is provided in a distal half of the add-on module (see fig 3).
Regarding claim 4, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the add-on module (30) comprises a handle (casing 11 is suitable for use as a handle for a user to grip), which is configured such that with one hand (module 30 can be used with one hand), a user can actuate the discharge button and at least partially cover the release element (22) when gripping the handle in a first grip position (see figs 3-4, an user can actuate the modified device of Graf et al when gripping handle 11).
Regarding claim 5, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the receiving region is configured to receive the injection device by inserting the injection device in the distal direction (para 0078, examiner notes: inserting said injection device in the distal direction is an intended use of the device).
Regarding claim 6, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the injection device comprises a distal carpule holder (1) for receiving the container (2), wherein the device housing is arranged proximal thereto (see fig 2) and configured for receiving a delivery mechanism for discharging the liquid medication from the container (para 0054-55), wherein the holding surface (3) is formed by a protrusion or a recess (3a) on the carpule holder (see figs 1-2 and 5a).
Regarding claim 7, Graf et al in view of Helmer disclose the injection system according to claim 1,
Graf et al further disclose wherein the release element assumes a stable release position at an end of the release movement (para 0083 and 0087).
Regarding claim 8, Graf et al in view of Helmer disclose the injection system according to claim 7,
Graf et al further disclose wherein by inserting the injection device into the add-on module, the release element executes a holding movement counter to the release movement (para 0083).
Regarding claim 11, Graf et al in view of Helmer disclose the injection system according to claim 5,
Graf et al further disclose wherein the injection device (10) comprises at least one of protrusions or recesses (3, figs 5a-b), and wherein the add-on module (30) comprises at least one of grooves in a lateral face of the receiving region, which correspond to the protrusions, or holding elements (21) for engagement in the recesses, which correspond to the recesses (para 0070), and further comprising a further injection device (fig 9), which differs from the injection device only by the at least one of the protrusions or recesses and a medical indication (para 0090, see figs 5a-b and 14).
Regarding claim 16, Graf et al disclose an injection system (figs 3-4), comprising: an injection device (10) having a longitudinal axis (L); and an add-on module (30) comprising a receiving region (11) adapted to a shape of a device housing of the injection device such that the receiving region is configured to be mounted on the injection device along the longitudinal axis (figs 3-4, para 0078), and a holding mechanism (20/21) configured to releasably secure the add-on module when mounted to the injection device against moving axially relative to the injection device (0070-71), wherein the receiving region (11) is configured to receive the injection device by inserting the injection device in the distal direction (figs 3-4), and wherein the injection device (10) comprises a holding surface (3/3a) directed proximally (figs 1-2), which engages behind a holding element (21) of the holding mechanism (20) and holds the injection device proximally against a separating movement (para 0070-72), wherein the add-on module comprises a release element (22), which in a release movement for releasing the holding mechanism, can be moved in a plane perpendicular to the longitudinal axis or in a direction at least approximately perpendicular to the longitudinal axis (para 0083 and 0087, pushing onto button 22 is radially moved perpendicular to the longitudinal axis L, see figs 3-4) such that the release element (22) assumes a stable release position at an end of the release movement, wherein by inserting the injection device into the add-on module, the release element executes a holding movement counter to the release movement (para 0083 and 0087), and wherein the holding mechanism comprises a control element (20), which is moved under tension of a control spring (24) when the injection device is inserted, thereby unblocking the holding movement of the release element (para 0083 and 0087).
Graf et la fail to expressly teach said injection system comprising a discharge button arranged at a proximal end thereof, the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication from a container of the injection device; and said add-on module comprising a sensor unit and wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device.
Graf et al disclose that the delivery movement is likewise triggered by the user using a corresponding activating or actuating handle or structure to discharge a liquid medication from a container (2) of the injection device (see para 0026).
However, Helmer discloses an injection system (fig 2, para 0011) comprising an injection device (10) and a discharge button (13) arranged at a proximal end thereof (figs 1A-B), the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication (16) from a container (18) of the injection device (para 0088); and an add-on module (2) comprising a sensor unit (25, 23, 26) and a receiving region (20) wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device (see fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injection system of Graf et al to have said injection system comprising a discharge button arranged at a proximal end thereof, the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication from a container of the injection device; and said add-on module comprising a sensor unit and wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device as taught by Helmer. This would provide the benefit of having an actuator/ trigger coupled to a drive element which performs the delivery movement (para 0088) and having a sensor unit for detecting processes or states of the injection device (para 0035).
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1) and further in view of Sams (US 6899698 B2).
Regarding claim 10, Graf et al in view of Helmer disclose the limitations of claims 1 and 8 but fail to disclose wherein the holding movement of the release element is driven by a return spring.
However, Sams teach an injection system (figs 11-12) comprising a release element (97) wherein the holding movement of the release element is driven by a return spring (100, col 9, lines 54-61).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the release element of Graf et al in view of Helmer to include a spring as taught by Sams. The modification would provide the benefit of ensuring said button is held in place against the action of a spring until it is depressed to ensure said injection is safely secured to the said module (see col 9, lines 54-61).
Regarding claim 17, Graf et al in view of Helmer disclose the limitations of claims 16 but fail to disclose wherein the holding movement of the release element is driven by a return spring.
However, Sams teach an injection system (figs 11-12) comprising a release element (97) wherein the holding movement of the release element is driven by a return spring (100, col 9, lines 54-61).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the release element of Graf et al in view of Helmer to include a spring as taught by Sams. The modification would provide the benefit of ensuring said button is held in place against the action of a spring until it is depressed to ensure said injection is safely secured to the said module (see col 9, lines 54-61).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1) and further in view of Byerly et al (US 20220096751 A1).
Regarding claim 12, Graf et al in view of Helmer disclose the limitations of claim 1 but fail to teach wherein the add-on module comprises a charging socket for connecting a charging cable configured for charging an energy store of the add-on module, wherein the charging socket is inaccessible when the injection device is inserted into the add-on module.
However, Byerly et al disclose an injection system (see fig 1, 100) comprising an add-on module (102) wherein the add-on module comprises a charging socket (186, see fig 3) for connecting a charging cable (260, see fig 2) configured for charging an energy store of the add-on module (para 0033), wherein the charging socket (186) is inaccessible when the injection device is being used with the add-on module (para 0029-31).
Therebefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the module of Graf et al in view of Helmer and incorporate the teachings of Byerly et al to have add-on module comprises a charging socket for connecting a charging cable configured for charging an energy store of the add-on module, wherein the charging socket is inaccessible when the injection device is inserted into the add-on module. This would provide the benefit of reducing electric shock by making the charging socket inaccessible and prevents a user from delivering medicine with such a device when it is plugged into an electrical cable (see para 0004 and 0034).
Regarding claim 13, Graf et al in view of Helmer and Byerly et al disclose the injection system according to claim 12,
Byerly et al further disclose the charging socket opens into the receiving region, and wherein the add-on module comprises a lateral opening (184) through which the charging cable can enter and be plugged into the charging socket (see figs 1-3).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1) and further view of Pryor et al (US 20200327973 A1) and further in view of Yang et al (US 20180318526 A1).
Regarding claim 14, Graf et al in view of Helmer disclose the limitations of claim 1 but fail to teach wherein the add-on module comprises a device cap detector for detecting a device cap when mounted on a carpule holder of the injection device, comprising a tilting element for converting a movement of a first leg end of the tilting element in a direction perpendicular to the longitudinal axis into a movement of a second leg end of the tilting element in an axial direction, and a switching element, which is actuated by an axial movement of the second leg end.
However, Pryor et al disclose an injection system (20) with a smart module (120, see fig 4) comprise a device cap detector for detecting a device cap when mounted on a carpule holder of the injection device (para 0008), comprising a switching element (122) which is actuated by an axial movement of a slider (see fig 10 and para 0054 and 0067).
Therebefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the module of Graf et al in view of Helmer and incorporate the teachings of Pryor et al to have said add-on module comprises a device cap detector for detecting a device cap when mounted on a carpule holder of the injection device, comprising a switching element which is actuated by an axial movement of a component. This would provide the benefit of having detection means of user interaction with the injection device indicating whether said module is mounted or removed from the injection device to ensure the detection is accurate (para 54).
Graf et al in view of Helmer and Pryor fail to teach a cap detector comprising a tilting element for converting a movement of a first leg end of the tilting element in a direction perpendicular to the longitudinal axis into a movement of a second leg end of the tilting element in an axial direction which actuated said switch.
However, Yang et al disclose an injector (10) with a switch (41) and a tilting element (42) wherein the tilting element is for converting a movement of a first leg end (43) of the tilting element in a direction perpendicular to the longitudinal axis (fig 10) into a movement of a second leg end (45) of the tilting element in an axial direction element to the switch (100).
Therebefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the module of Graf et al in view of Helmer and Pryor and incorporate the teachings of Yang et al et al to have said switch activated by movement of the second leg end of a tilting element such as lever spring as taught by Yang et al. This would provide the benefit of having a tilting element having a second component that have a switch engagement region and also may have a pretension force applied to urge the switch to the activated position indicating said module is mounted to said injection device (para 0011).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1) and further view of Anderson (US 20180036484 A1).
Regarding claim 15, Graf et al in view of Helmer disclose the limitations of claim 1 but fail to teach wherein the add-on module comprises an injection device detector configured detecting when the injection device is inserted into the add- on module, the injection device detector comprising a switching element configured to be actuated by the release element in at least one of a locking movement counter to the release movement or in a subsequently assumed holding position.
However, Anderson discloses an injector system (see fig 1A) comprising an injection device (200) and add on module (400) wherein the add-on module comprises an injection device detector (450, see fig 3B) configured detecting when the injection device is inserted into the add- on module (para 0047), the injection device detector comprising a switching element (450) configured to be actuated by the release element (460) in at least one of a locking movement counter to the release movement or in a subsequently assumed holding position (see fig 5A-C, para 0051-52).
Therebefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injection system of Graf et al in view of Helmer and incorporate the teachings of Anderson to have the add-on module comprises an injection device detector configured detecting when the injection device is inserted into the add- on module, the injection device detector comprising a switching element configured to be actuated by the release element in at least one of a locking movement counter to the release movement or in a subsequently assumed holding position. This would provide the benefit of having detection means of user interaction with the injection device indicating whether said add on module is properly mounted or removed from the injection device because it is important that the injection device and the add on module are arranged correctly in their specified position relative to each other to ensure proper and correct detection of dose amounts (para 0054).
Response to Arguments
Applicant’s arguments, see Remark, filed on 12/11/2025, with respect to the rejection(s) of claim(s) 1-8 and 10-17 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Graf et al (US 20040186441 A1) in view of Helmer (US 20220409815 A1).
Even though newly filed claim 16 is based on original claim 9 and recites the allowable subject matter of cancelled dependent claim 9 as well as intervening claims 5, 7 and 8, it is not allowable in view of the newly found prior art and thus this office action is being made non-final.
Conclusion
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/FATIMATA SAHRA DIOP/ /BHISMA MEHTA/Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783