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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/22/2025 has been entered.
Claim Status
Claims 1-8 and 10-14 remain pending in the present application. Claims 1, 4-5, 8, 12, and 14 are currently amended. Claims 1-8 and 10-14 are all examined on the merits.
Response to Arguments
Applicant’s amendments filed 10/22/2025 have necessitated a new grounds of rejection. Said amendments remove the need for 112(f) interpretation. However, upon further search and consideration, a new grounds of rejection is made in view of Landau.
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 1-8 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landau (US 2006/0089594 A).
Regarding claim 1, Landau discloses a container adapter for a medical delivery device (Figs. 1-7; Abstract), said medical delivery device has a container seat (Figs. 19-20; vial adapter 282) for holding a container in a predefined position (vial 290; ¶s 80-82), a dosage chamber (chamber 132 and fluid chamber 298), a dosing mechanism comprising a dial unit (dosage knob 24) rotatable about a device axis relative to a body part of the medical delivery device to transfer a liquid from the container held in the container seat to the dosage chamber (¶s 52 and 69 describe how the knob is used to draw fluid), and a lock mechanism (trigger lock 76; Figs. 5-7) having a locked state and an unlocked state (¶ 57, 67 and 70), the lock mechanism comprising an axially displaceable portion defining an abutting face that is configured to be pushed (¶ 57, 67, and 70; trigger locks 76 are pushed and displaced along pivot 87, causing the axial displacement of the ends of the trigger locks i.e. at spring 84 and legs 80), the container adapter comprising:
an adapter container seat configured to hold a container (gripping section 310);
a joint structure (fingers 322) configured to be detachable positioned in the container seat (¶ 82), and
an unlock mechanism (detent pin 128), comprising an activation member having a container face and a lock mechanism face (nozzle 140; ¶s 62-64 and 80-81; Figs. 8A-11 also show how the nozzle 140 moves, and also how the nozzle has contact face contacting detent pin which allows locking/unlocking of cartridge 22).
Limitations of: the container face “configured to contact the container”, the lock mechanism “adapted to prevent operation of the dosing mechanism when no container is held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat”, the lock mechanism face “configured to contact the abutting face of the axially displaceable portion of the lock mechanism”, the joint structure configured to “connect the adapter container seat to the dosing mechanism of the medical delivery device when the joint structure is positioned in the container seat of the medical delivery device”, and the activation member is “moveable between a non-activating position and an activating position, wherein the activation member is configured to prevent actuation of the lock mechanism of the delivery device when the container is not properly held in the adapter container seat“ are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 2, limitations of: the activation member being “movable relative to the adapter container seat from a non-activating position in which the lock mechanism of the medical delivery device is not activated when the joint structure is positioned in the container seat of the medical delivery device to an activating position in which the lock mechanism of the medical delivery device is activated when the joint structure is positioned in the container seat of the medical delivery device to the activating position in which the lock mechanism of the medical delivery device is activated when the joint structure is positioned in the container seat of the medical device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 3, limitations of the unlock mechanism being “arranged to be moved by the container from the non-activating position to the activating position while the container is set into the adapter container seat” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 4, limitations of the unlock mechanism is configured such that “the container contacts the container face to move the activation member while the container is set into the adapter container seat” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 5, limitations of the unlock mechanism being “configured such that the lock mechanism face contacts the abutting face of the axially displaceable portion of the lock mechanism of the medical delivery device to activate the lock mechanism of the medical delivery device to activate the lock mechanism of the medical delivery device when the container is held into the adapter container seat and while the join structure is positioned in the container seat of the medical delivery device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 6, Landau further discloses the activation member having a stem portion extending from the adapter container seat to the joint structure (nozzle 140 is elongate and thus is interpreted as having a stem portion between ends, which also connects to the adapter container seat in vial adapter 282, via flange 342).
Regarding claim 7, Landau further discloses the container face is arranged at one longitudinal end of the stem portion and the lock mechanism face is arranged at an opposite longitudinal end of the stem portion (Figs. 6-7 and 19-20 show how the nozzle 140/282 is between the container face, i.e. at the flange end, and the lock mechanism would be on opposite sides of said nozzle).
Regarding claim 8, Landau further discloses the activation member of the unlock mechanism has ring configured to define a movement of the activation member to a predefined path (washer 106 and ram seat 112 ).
Further, limitations of the ring being “configured to define a movement of the activation member to a predefined path” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 10, Landau further discloses the unlock mechanism comprises a holding structure configured to hold the activation member in the non-activating position (internal threads 122; ¶ 62).
Regarding claim 11, limitations of: the unlock mechanism being “configured to be elastically deformed while the container is set into the adapter container seat such that the activation member is disengaged” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 12, Landau further discloses a container adapter according to claim 1 (see rejection of claim 1 above) and a medical delivery device (entirety of Fig. 1), wherein the medical delivery device comprises a container seat (gripping section 310) for holding a container in a predefined position (vial 290; ¶ 82), a dosage chamber (chamber 132 and fluid chamber 298), a dosing mechanism to transfer a liquid from the container held in the container seat (¶s 52 and 69 describe how the knob is used to draw fluid), and a lock mechanism (trigger lock 76; Figs. 5-7), the lock mechanism having a locked state and an unlocked state (¶ 57, 67, and 70), the lock mechanism including an axially displaceable portion defining an abutting face that is configured to be pushed (¶ 57, 67, and 70; trigger locks 76 are pushed and displaced along pivot 87, causing the axial displacement of the ends of the trigger locks i.e. at spring 84 and legs 80).
Limitations of: the abutting face “configured to be pushed by the activation member of the unlock mechanism”, and the lock mechanism “adapted to prevent operation of the dosing mechanism when no container is held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 13, Landau further discloses the container seat of the medical delivery device has a fixation structure (gripping section 310 comprises ridges that fit around a vial neck).
Further, limitations of: the fixation structure “adapted to irremovably hold the container in a predefined position”, and the joint structure of the container adapter is “arranged to prevent interaction with the fixation structure of the container seat of the medical delivery device when the container adapter is held in the container seat of the medical device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 14, limitations of: the axially displaceable portion of the lock mechanism and the activation member of the container being “configured to interact when container adapter is forwarded into the container seat of the medical delivery device such that the axially displaceable portion of the lock mechanism is axially displaced while the joint structure of the container adapter is positioned in the container seat of the medical delivery device and when the container is held in the adapter container seat of the container adapter” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Landau has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781 /GUY K TOWNSEND/Primary Examiner, Art Unit 3781