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 species a) figures 1-3c, claims 1, 2, 6, 8, 11, 13, 14, 18-19, 23, 25, 28, and 30-31 in the reply filed on 12/23/2025 is acknowledged.
Claims 3, 9, 10, 15, 20, 26-27, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
In regards to applicant’s remarks that claims 1, 2, 8, 11, 18-19, 25, 28, and 31 are generic, the examiner agrees with Applicant.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6, 8, 11, 18-19, 23, 25, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kourtis et al (US 20210146052 A1).
Regarding claim 1, Kourtis discloses a drug delivery device assembly 20 comprising:
an injector housing having a body with a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and at least one window 110;
a needle assembly 22 at least partially disposed within the body, the needle assembly comprising a syringe barrel 30 containing a medicament, a plunger stopper 32 disposed in the syringe barrel, and a needle or a cannula 34;
a drive assembly 24 at least partially disposed within the body and operably coupled with the needle assembly to urge the medicament through the needle or cannula during an injection sequence; and
a dose feedback accessory 104, including:
an accessory body 125 configured to be selectively coupled with the injector housing; and
a feedback indicator ([0055, 0058, 0078]; figs 8, 12-17; abstract) configured to convey to a user information relating to an injection status event.
Regarding claim 2, Kourtis discloses the dose feedback accessory 104 further includes a sensor 28,104 configured to detect the injection status event (figs 8-16; [0005]).
Regarding claim 6, Kourtis discloses the accessory body 125 is configured to slide on to the injector housing and/or slide off of the injector housing (figs 8-9); [0086].
Regarding claim 8, Kourtis discloses the accessory body 125 includes an opening 128 configured to receive and selectively couple with at least a portion of the injector housing.
Regarding claim 11, Kourtis discloses the feedback indicator includes (a) at least one light source that signifies a movement or a position of the plunger stopper [0003,0052, 0054, 0076-0078].
Regarding claim 18, Kourtis discloses an accessory 104 for a drug delivery device 20, comprising:
an accessory body 125 configured to be selectively coupled with an injector; and
a feedback indicator ([0055, 0058, 0078]; figs 8, 12-17; abstract) configured to convey to a user information relating to an injection status event.
Regarding claim 19, Kourtis discloses the feedback indicator comprises a sensor 28,104 configured to detect an injection status event of the drug delivery device (figs 8-16; [0005]).
Regarding claim 23, Kourtis discloses the accessory body 125 is configured to slide on to the drug delivery device and/or off of the drug delivery device (figs 8-9; [0086]).
Regarding claim 25, Kourtis discloses the accessory body 125 includes an opening 128 configured to receive and selectively couple with at least a portion of the drug delivery device 20.
Regarding claim 28, Kourtis discloses the feedback indicator includes (a) at least one light source that signifies a movement or a position of a plunger stopper of the drug delivery device [0003,0052, 0054, 0076-0078].
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.
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.
Claims 13, 14, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kourtis et al. (US 20210146052 A1) in view of Cabiri et al (US 20190022323 A1/see US 11311674 B2 drawings).
Regarding claims 13, 14, 30 and 31, Kourtis discloses the invention substantially as claimed. Kourtis discloses in [0057, 0055, 0058, 0078] the feedback indicator can include a plurality of lights and detectors aligned with a window [0052,0059 and provide an injection completion countdown [0052, 0053, 0066, 0073, 0074]], but does not specifically state how the plurality of light sources that each signify a movement or a position of the plunger stopper of the drug delivery device and the plurality of light sources are generally aligned with the window 118.
Cabiri teaches a drug delivery device including a status indicator light 104 [0024, 0121- 0124, 0166] viewing of a plunger position [0161, 0166] along a window 162 and provide an injection completion countdown [0125, 0205].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kourtis’s plurality light sources in the feedback indicator with the teachings of Cabiri’s plurality of light sources where each signify a movement or a position of the plunger stopper since such modification would allow the user to have more information of the drug delivery device status.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783