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
The amendment filed 04/30/2024 has been entered. Claims 18-36 are pending in the application.
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 29 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites the element “the actuator” in lines 3 and 5. It is unclear if this is refereeing to the “electromechanical actuator” or the “actuator element” recited in claim 28. For the sake of examination, the limitation will be interpreted as reciting “the electromechanical actuator”.
Claim Rejections - 35 USC § 102
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 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.
Claims 18-21, 23-25, 27, 30-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlsson (US 2021/0038817).
Regarding Claim 18, Carlsson discloses a drug delivery device (10, Fig 1) comprising: a mechanism unit (1, Fig 1) comprising a housing element (11, Fig 3A), an interface feature (16, Fig 1) for forming a connection interface releasably connecting the mechanism unit with a drug reservoir unit (2, Fig 1) (Para 0060), and a locking mechanism (14, 17, Fig 1) with a first movable element (17, Fig 1) being movable relative to the housing element between a first position (position of locking element 17 seen in Fig 6D) and a second position (position of locking element 17 seen in Fig 6C); wherein the mechanism unit is configured to enable a dispense process for dispensing a drug dose (Para 0096); wherein the locking mechanism is switchable between a released state (Para 0082; See Fig 6D-6E) and a locked state (Para 0072; See Fig 6C); wherein when the first movable element is in the first position, the locking mechanism is in the released state (See Fig 6D) and, when the first movable element is offset from the first position, the locking mechanism is in the locked state (See Fig 6C), wherein when the locking mechanism is in the locked state, the locking mechanism prevents a release of the connection interface so that the drug reservoir unit connected to the mechanism unit cannot be separated from the mechanism unit (Para 0072), wherein when the locking mechanism is in the released state, the locking mechanism enables release of the connection interface for separating the drug reservoir unit from the mechanism unit (Para 0082).
Regarding Claim 19, Carlsson discloses the locking mechanism (14, 17, Fig 1) comprises a coupling element (14, Fig 1) that is movable between a lock position (position of element 14’ relative to ledge 29 in Fig 6C) and a release position (position of element 14’ relative to ledge 29 in Fig 6E); wherein the coupling element is configured to engage the drug reservoir unit in the lock position (See Fig 6C) and to disengage from the drug reservoir unit in the release position (See Fig 6E); wherein when the locking mechanism is in the locked state, the coupling element is in the lock position (See Fig 6C); and wherein when the locking mechanism is in the released state, the coupling element is in the release position (See Fig 6E).
Regarding Claim 20, Carlsson discloses a movement of the first movable element (17, Fig 1) into the first position forces the coupling element (14, Fig 1), via mechanical interaction (the first movable element releases mechanical force that allows the ledge 29 to move into the release position), to move from the lock position into the release position (Para 0082).
Regarding Claim 21, Carlsson discloses when the first movable element (17, Fig 1) is moved into the first position (position seen in Fig 6D-6E), the coupling element is moved into the release position via a leverage effect (Para 0082; “The extensions 29 are able to leave the groove 14′ due to flexing of the parts 25 inwardly and this enable a disconnection of the connecting ends 13 and 23 and the units 1 and 2 accordingly”).
Regarding Claim 23, Carlsson discloses when the first movable element (17, Fig 1) is moved out of the first position, the coupling element automatically moves into the lock position (Para 0072).
Regarding Claim 24, Carlsson discloses the coupling element (14, Fig 1) is an elongated element which, in at least one of the lock position or the release position, is substantially orientated in an axial direction (Para 0056; the inner surface 14 forms an elongate member substantially oriented in an axial direction).
Regarding Claim 25, Carlsson discloses the dispense process is associated with a movement of the first movable element in a direction from the second position to the first position; and wherein when completely dispensing a drug dose, the first movable element is moved into the first position (Para 0082).
Regarding Claim 27, Carlsson discloses during a dispense process, the first movable element hits against the coupling element (See Fig 6C; the first movable element 17 at least indirectly hits the coupling element 14 through the ledge 29).
Regarding Claim 30, Carlsson discloses a drug reservoir unit comprising at least one of a drug reservoir (4, Fig 1) or a drug reservoir holder (21, Fig 1); wherein the drug reservoir unit is connected to the mechanism unit via the connection interface (Para 0054).
Regarding Claim 31, Carlsson discloses the drug reservoir is filled with a drug (“medicament”, Para 0096)
Regarding Claim 32, Carlsson discloses the drug delivery device is at least one of an injection device or a variable dose device or a fixed dose device or a pen type device (Para 0002).
Regarding Claim 33, Carlsson discloses a drug delivery device (10, Fig 1) comprising: a mechanism unit (1, Fig 1) comprising: a dispense mechanism for dispensing a drug dose, the dispense mechanism comprising a plunger rod (5, Fig1); a housing element (11, Fig 3A); an interface feature (16, Fig 1) for forming a connection interface releasably connecting the mechanism unit with a drug reservoir unit (2, Fig 1) (Para 0060); and a locking mechanism (14, 17, Fig 1) with a first movable element (17, Fig 1) being movable relative to the housing element between a first position (position of locking element 17 seen in Fig 6D) and a second position (position of locking element 17 seen in Fig 6C), and a coupling element (14, Fig 1) that mechanically interacts with the first movable element (Para 0072); wherein the mechanism unit is configured to enable a dispense process for dispensing a drug dose (Para 0096); wherein the locking mechanism is switchable between a released state (Para 0082; See Fig 6D-6E) and a locked state (Para 0072; See Fig 6C); wherein when the first movable element is in the first position, the locking mechanism is in the released state (See Fig 6D) and, when the first movable element is offset from the first position, the locking mechanism is in the locked state (See Fig 6C), wherein when the locking mechanism is in the locked state, the locking mechanism prevents a release of the connection interface so that the drug reservoir unit connected to the mechanism unit cannot be separated from the mechanism unit (Para 0072), wherein when the locking mechanism is in the released state, the locking mechanism enables release of the connection interface for separating the drug reservoir unit from the mechanism unit (Para 0082)
Regarding Claim 34, Carlsson discloses the coupling element is movable between a lock position (position of element 14’ relative to ledge 29 in Fig 6C) and a release position (position of element 14’ relative to ledge 29 in Fig 6E); wherein the coupling element is configured to engage the drug reservoir unit in the lock position (See Fig 6C) and to be disengaged from the drug reservoir unit in the release position (See Fig 6E); wherein when the locking mechanism is in the locked state, the coupling element is in the lock position (See Fig 6C); and wherein when the locking mechanism is in the released state, the coupling element is in the release position (See Fig 6E).
Regarding Claim 35, Carlsson discloses a drug reservoir unit (2, Fig 1) for a drug delivery device (10, Fig 1), the drug reservoir unit comprising: at least one of a drug reservoir (4, Fig 1) or a drug reservoir holder (21, Fig 1); a coupling feature (29, Fig 1) configured to releasably engage with a coupling element (14’, Fig 1) of a locking mechanism (14’, 17, Fig 1) of a drug delivery device; wherein the locking mechanism is configured to prevent a release of the coupling feature from the coupling element so that the drug reservoir unit cannot be separated from the drug delivery device, and to enable the release of the coupling feature from the coupling element for separating the drug reservoir unit from the mechanism unit (Para 0072, 0082).
Regarding Claim 36, Carlsson discloses a method of delivering a medicament from a drug delivery device (Para 0096), the method comprising: providing a drug delivery device with a mechanism unit (1, Fig 1) comprising an interface feature (14’) and a dispense mechanism (5, Fig 1); releasably coupling the interface feature of the drug delivery device with a drug reservoir unit (2, Fig 1) to form a connection interface (Para 0072, 0082), the drug reservoir unit comprising a drug reservoir filled with a drug; dispensing a drug dose by moving at least one element of the dispense mechanism relative to another element of the dispense mechanism (Para 0096).
Claims 18-19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlsson (US 2021/0038817). *Alternative interpretation of Carlsson to read on claim 22
Regarding Claim 18, Carlsson discloses a drug delivery device (Device of Fig 19) comprising: a mechanism unit (1, Fig 19) comprising a housing element (11, Fig 19), an interface feature (34, Fig 1) for forming a connection interface releasably connecting the mechanism unit with a drug reservoir unit (2, Fig 19) (Para 0112), and a locking mechanism (17, 35', Fig 23A) with a first movable element (17, Fig 23A) being movable relative to the housing element between a first position (position of locking element 17 closer to the distal closed end 12 as described in Para 0117) and a second position (position of locking element 17 closer to proximal end 13 seen in Fig 23C); wherein the mechanism unit is configured to enable a dispense process for dispensing a drug dose (Para 0096); wherein the locking mechanism is switchable between a released state (Para 0117) and a locked state (Para 0116); wherein when the first movable element is in the first position, the locking mechanism is in the released state (Para 0117) and, when the first movable element is offset from the first position, the locking mechanism is in the locked state (Para 0116), wherein when the locking mechanism is in the locked state, the locking mechanism prevents a release of the connection interface so that the drug reservoir unit connected to the mechanism unit cannot be separated from the mechanism unit (Para 0116), wherein when the locking mechanism is in the released state, the locking mechanism enables release of the connection interface for separating the drug reservoir unit from the mechanism unit (Para 0117).
Regarding Claim 19, Carlsson discloses the locking mechanism (17, 35', Fig 23A) comprises a coupling element (35', Fig 22B) that is movable between a lock position (position of 35' seen in Fig 23C) and a release position (position of 35' seen in Fig 23B); wherein the coupling element is configured to engage the drug reservoir unit in the lock position (See Fig 23C) and to disengage from the drug reservoir unit in the release position (See Fig 23B); wherein when the locking mechanism is in the locked state, the coupling element is in the lock position (See Fig 23B); and wherein when the locking mechanism is in the released state, the coupling element is in the release position (See Fig 23B) (Para 0116-0117).
Regarding Claim 22, Carlsson discloses the coupling element (35', Fig 22B) is pivotably suspended in the mechanism unit (See Figs 23A-23C); and wherein when the first movable element (17, Fig 23A) is moved into the first position, a torque is exerted on the coupling element thereby causing the coupling element to move into the release position (Para 0117).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (US 2021/0038817) in view of Kristensen (US 2008/0306449).
Regarding Claim 26, Carlsson discloses the drug delivery device is a single or multiple delivery device (Para 0051), however, is silent regarding the mechanism unit is configured to enable setting a drug dose to be dispensed; and wherein setting a drug dose is associated with a movement of the first movable element in a direction from the first position to the second position.
Kristensen teaches an analogous drug delivery device having a mechanism unit is configured to enable setting a drug dose to be dispensed (Para 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanism unit to be configured to set a dose as taught by Kristensen in order to be able to select a dosage size that is adequate for a specific user (Para 0049). Examiner notes that the combined invention of Carlsson and Kristensen would teach setting a drug dose is associated with a movement of the first movable element in a direction from the first position to the second position as Carlsson teaches that the first movable element moves from the first position to the second position during attachment of the mechanism unit and drug reservoir unit (Para 0065). This can be considered associated with setting a drug dose as they are all steps for operating the drug device. The claim does not specify exactly how they are associated.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (US 2021/0038817) in view of Munk (US 6,514,230).
Regarding Claim 28, Carlsson discloses all of the elements of the invention as discussed above, however, is silent regarding the mechanism unit comprises an electromechanical actuator; wherein when operated, the electromechanical actuator moves an actuator element between a first position and a second position; and wherein the mechanism unit is configured to prevent at least one of setting a drug dose or dispensing a drug dose when the actuator element is in the first position.
Munk teaches an analogous drug delivery device (Device of Fig 2) comprising an electromechanical actuator (13, Fig 2); wherein when operated, the electromechanical actuator moves an actuator element (17, Fig 2) between a first position and a second position (Col 5, lines 17-32; the first position is the position before the motor moves the button to the second position that corresponds to the set dose); and wherein the mechanism unit is configured to prevent at least one of setting a drug dose or dispensing a drug dose when the actuator element is in the first position (The button 17 cannot be pressed to deliver the dose in the first position as the raising of the button to the second position is what allow a dose to be deliver).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to comprise an electromechanical actuator and actuator element as taught by Munk in order to provide an injection device wherein repetitive air shots can be performed without adding extra operation buttons to the device and without information of the air-shots being stored as a part of the operation history of the device (Col 2, lines 3-7).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (US 2021/0038817) in view of Munk (US 6,514,230) and further in view of Stowe (US 6,277,099).
The modified invention of Carlsson and Munk discloses all of the elements of the invention as discussed above, however, is silent regarding the mechanism unit is configured such that, unless a selected drug reservoir unit is coupled with the mechanism unit, operation of the actuator is prevented; and wherein the mechanism unit is configured such that a coupling of the mechanism unit with a selected drug reservoir unit is a precondition for the operation of the actuator.
Stowe teaches an electronic detection of the presence or absence of a properly connected cartridge to prevent actuation of the injection button when the medication cartridge is not properly connected to the pen so that an overdose does not occur (Col 1, lines 33-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanism unit to include an electronic detection of the presence of a properly connected drug reservoir, such that operation of the actuator is prevented unless the drug reservoir is properly coupled as taught by Stowe in order to prevent incorrect delivery of the medicament (Col 1, lines 33-43).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights