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
Applicant’s election without traverse of Group I (claims 1-15, 18-20) in the reply filed on 02/04/26 is acknowledged.
Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (claims 16-17), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/04/26.
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 1-6, 11-14, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2016/0106923).
Regarding claims 1 & 2, Brereton discloses an arrangement for a drug delivery device (1000) comprising:
a housing element 2 (Fig. 1A),
a plunger rod 9 & 17 being arranged axially movable with respect to the housing element 2,
a feedback element 28 being arranged axially movable with respect to the housing element and with respect to the plunger rod 9 & 17,
a feedback energy member 29 configured to provide energy in order to induce a movement of the feedback element relative to the plunger rod in a first axial direction;
a radially displaceable stop feature 30 (Fig. 14) and an impact feature 13 (Fig. 1A), wherein the arrangement has an initial state,( in Figs. 1A & Fig. 14A, “initial state A” in para [0105]) in which:
the plunger rod 9 & 17 is in a proximal position, in Fig. 1A;
the feedback element 28 is arranged in a cavity of the plunger rod (e.g., an elongate portion 28.1 (is a portion of the feedback element 28) arranged within the distal plunger sleeve 17, see para [0104], also see Fig. 14A) ,
the feedback element 28 is limited in its movement relative to plunger rod in the first axial direction by the stop feature 30 being in a first radial position,
wherein the arrangement is configured to be switched from the initial state (Fig. 1A) into a released state (Fig. 7A, para [0105]), in which:
the plunger rod is moved in a distal direction at least until the plunger rod reaches a feedback position, in Fig. 14C & para [0105]),
the movement of the plunger rod into the feedback position results in the stop feature 30 being radially displaced to enable a movement of the feedback element 28 relative to the plunger rod 9 & 17 in the first axial direction beyond the stop feature 30, Fig. 14C & para [0105]),
the feedback element 28 moves relative to the plunger rod 9 & 17 in the first axial direction and beyond the stop feature 30 due to the energy provided by the feedback energy member until the feedback element 28 hits against the impact feature 13, thereby producing a tactile and/or audible feedback, (para [0105], the noise component 28 is accelerated in the distal direction D {backward direction, away from the needle} and the distal end plate 28.2 impacts on the inside of the trigger button 13 producing audible and tactile feedback to the user that the injection is about finished);
wherein the stop feature 30 is axially fixed to the plunger rod 9 & 17, see Fig. 14A.
Regarding claim 3, wherein the plunger rod 9 & 17 is hollow cylindrically-shaped, in the initial state, the feedback element 28 is completely arranged inside the plunger rod, para [0104-0105] & Fig. 14A.
Regarding claim 4, wherein the impact feature 13 is arranged moveable with respect to the housing element 2, - in the released state, the impact feature 13 moves with respect to the housing element 2, para [0095].
Regarding claim 5, wherein the stop feature 30 is axially and rotationally (up & down; wherein the stop feature being inserted into the plunger 9 & 17; the stop feature is being rotated in up & down directions, from Fig. 14C to Fig. 14A) fixed to the plunger rod 9 & 17; wherein in the initial state A, in para [0105], the stop feature 30 radially projects into the cavity of the plunger rod 9 & 17.
Regarding claim 6, further comprising: an energy member 8 configured to provide energy in order to induce an axial movement of the plunger rod 9 & 17 in the forward/distal direction,
wherein: in the initial state, in Fig. 1A, the plunger rod 9 is (indirectly) coupled to the housing element 2 via a lock interface (16 & 28.3 or surfaces in between 15 & 17 (in Fig. 15A) or lock interface in between element 7.8 & 9.1 in Fig. 17) which prevents an axial movement of the plunger rod induced by the energy member 8;
Wherein in the released state, the lock interface is released so that an axial movement of the plunger rod induced by the energy member 8 is enabled, and the plunger rod moves in forward/distal direction due to the energy provided by the energy member 8, see paras [0084,0087, 0100] & Figs. 15A-C & 17.
Regarding claim 11, wherein the feedback energy member 29 is a spring; wherein in the initial state, the feedback energy member 29 is arranged in the cavity of the plunger rod 7, see Fig. 10A, and biases the feedback element 28 in the first axial direction, and the feedback element 28 abuts against the stop feature 30 in the first axial direction, see Figs. 14A-C.
Regarding claim 12, wherein the stop feature 30 is a protrusion of a displaceable arm, see Figs. 14A-C; wherein the displaceable arm 30 is oriented axially; wherein the stop feature 30 is arranged in the region of a proximal end of the plunger rod, see Fig. 1A & 14A; wherein at least one of the stop feature 30 and the feedback element 28 comprises a slide feature against which the other element (at 288.3 & 30.1, in Figs.14A-C) can abut and along which the other element can slide for displacing the stop feature 30 in radial direction.
Regarding claim 13, wherein in the initial state, the displaceable stop feature 30 being in the first radial position is biased in a radial direction; wherein when the plunger rod 7 reaches the feedback position 28, the displaceable stop feature 30 automatically moves out of the first radial position into a second radial position, see Figs. 14A-14C, and para [0105].
Regarding claim 14, wherein in the released state, the distance the feedback element 28 moves in the first axial direction induced by the feedback energy member 9 is at least the distance between the proximal position and the feedback position of the plunger rod.
Regarding claim 18, wherein the impact feature 13 is part of a transfer member (from initial position to trigger position).
Regarding claim 19, wherein the impact feature 13 is formed by a surface at an axial end of the transfer member, and wherein the surface faces towards the feedback element 28 (when pressing a button 13).
Regarding claim 20, wherein the feedback 28 element comprises a piston.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Brereton et al. (US 2016/0106923).
Regarding claim 15, Brereton discloses the claimed invention. Brereton also discloses that the feedback element 28 hitting the impact feature 13 creates audible feedback (producing audible noise to the user, see abstract, paras [0030, 0105]). Brereton fails to disclose the noise level of audio feedback at least 20dB. However, Brereton discloses that the noise spring ensures that the generated feedback is sufficiently strong to be easily recognized by the user, see para [0030]. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain a noise level at least 20 dB, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (e.g., enough loud alert level for the user to be heard).
Allowable Subject Matter
Claims 7-10 are objected to as being dependent upon a rejected base claim but would be allowable if claim 7 is rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783