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 Arguments
Applicant's arguments filed 8/20/2026 have been fully considered but they are not persuasive.
Applicant argues that the office action maps Yu’s first LED and second LED to the claims two or more subregions, and further that this mapping conflates two different claim components. Applicant argues that the claims recite a light-emitting region comprising two or more sub regions, and separately at least two light-emitting elements the illuminate those subregions. The examiner finds that Yu teaches these elements. The regions illuminated by each LED forms the subregion, and the LEDs are the light-emitting elements that illuminate the subregions. A light necessarily illuminates a region surrounding the light.
Applicant further argues that the distinction is structural as well as functional in that the light emitting region may comprise transparent or translucent subregions optionally separated by opaque regions. This argument is not convincing as these element are not claimed.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16-19, 22-24, 28-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al (US 2016/0259913).
Regarding claim 16, Yu discloses a user interface member 80 for a drug delivery device 10 (fig. 3), comprising: a light-emitting region 56 comprising two or more subregions (page 6, para. 0071: first LED and second LED), the light-emitting region configured to be illuminated by at least two light-emitting elements to emit light from the light-emitting region and to visually indicate an operation state of the drug delivery device to a user (page 6, para. 0071); wherein the two or more subregions are illuminable independently of each other by the at least two light-emitting elements to present different illumination patterns to a user via the light- emitting region (page 6, para. 0071: changes in color, brightness, blinking are interpreted to be different patterns); and wherein the different illumination patterns indicate different operation states of the drug delivery device to the user (page 6, para. 0071).
Regarding claim 17, Yu discloses that the user interface 80 member comprises the at least two light-emitting elements (page 6, para. 0071); and wherein the user interface member is configured to operate the at least two light-emitting elements depending on the operation state of the drug delivery device to present different illumination patterns to a user via the light-emitting region (page 6, para. 0071).
Regarding claim 18, Yu discloses that the user interface member comprises at least two light-emitting elements, the at least two light-emitting elements emit light of the same color (page 6, para. 0071: blinking or changing brightness are alternatives to changing color).
Regarding claim 19, the LEDs of Yu are fixed on the interface and therefore each LED is assigned to one subregion of the light-emitting region.
Regarding claim 22, Yu discloses that the light-emitting region is ring-shaped (fig. 3: extending around the outer surface of the cylindrical cap 80).
Regarding claim 23, Yu discloses that the cap includes a translucent shell (page 6, para. 0070). Such a shell has an inner surface forming a light-entry side; an outer surface forming a light-exit side; and a light distribution element configured to receive light from the at least two light-emitting elements at the light-entry side and to transfer the light to the light-exit side assigned to the light- emitting region (the shell transmit light thereby performing this function).
Regarding claim 24, the translucent shell disclosed by Yu includes the light-exit side is formed by a surface of the light distribution element running obliquely to a main extension plane of the light distribution element.
Regarding claim 28, Yu discloses that the cap is translucent (page 6, para. 0069) and therefore the light distribution element is configured to guide light from the light-entry side to the light-exit side by refraction.
Regarding claim 29. Yu discloses that the user interface member 80 is a knob configured to be axially moved relative to a housing of the drug delivery device when operated by a user (page 6, para. 0070: cap 80 affixed to actuator 70, actuator 70 is pressed axially).
Regarding claim 30, Yu discloses that the user interface member is configured to be manually operated by a user to initiate different operation states of the drug delivery device (page 6, para. 0070), and to generate different electronic signals depending on how the user interface member is operated (page 6, para. 0070, 0071); wherein the different electronic signals are associated with different operation states of the drug delivery device (page 6, para. 0070, 0071); and wherein the different operation states are assigned to the different illumination patterns (page 6, para. 0071).
Regarding claim 31, Yu discloses that manual operation comprises touching or pressing the user interface member (page 6, para. 0070).
Regarding claim 32, Yu discloses a drug delivery device 10 comprising: a user interface member 80 comprising: a light-emitting region 56 comprising two or more subregions (page 6, para. 0071: first LED and second LED), the light-emitting region configured to be illuminated by at least two light-emitting elements to emit light from the light-emitting region and to visually indicate an operation state of the drug delivery device to a user (page 6, para. 0071); wherein the two or more subregions are illuminable independently of each other by the at least two light-emitting elements to present different illumination patterns to a user via the light-emitting region (page 6, para. 0071: changes in color, brightness, blinking are interpreted to be different patterns); and wherein the different illumination patterns indicate different operation states of the drug delivery device to the user (page 6, para. 0071); and a container holder 21 for holding a drug container 20 (page 4, para. 0063).
Regarding claim 33, Yu discloses that drug container filled with a drug (page 6, para. 0071).
Regarding claim 34, Yu discloses that the drug delivery device is an injection device (fig. 3).
Regarding claim 35, Yu discloses a method of delivering a drug from a drug delivery device, the method comprising using the drug delivery device of claim 33 (page 6, para. 0070; see claim 33 above).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu.
Claim 20 calls for the different illumination patterns comprise one or more of a first illumination pattern, a second illumination pattern, a third illumination pattern, and a fourth illumination pattern; wherein the first illumination pattern comprises light emitted simultaneously from the two or more subregions in a continuous mode or a flashing mode for a predetermined first pattern time; wherein the second illumination pattern comprises light emitted in an alternating manner from the two or more subregions for a predetermined second pattern time; wherein the third illumination pattern comprises light emitted from one subregion of the two or more subregions for a predetermined third pattern time in a continuous mode or flashing mode while another subregion of the two or more subregions does not emit light during the predetermined third pattern time; and wherein the fourth illumination pattern comprises light of different brightness emitted from the two or more subregions for a predetermined fourth pattern time. Yu does not specifically disclose the claimed patterns, however Yu discloses a number of conditions, including at least four, that can be indicated by illumination patterns including change in color, brightness, blinking, etc. (page 6, para. 0071). Applicant has not provided criticality to the specific patterns, but rather that they are distinguishable from each other. Therefore, it would have been a matter of obvious design choice to modify the illumination patterns of Yu to arrive at the claimed patterns because Yu teaches a multitude of distinguishable patterns to alert the user to various operating conditions of the injector.
Regarding claim 21, Yu discloses that the interface 80 has a cylindrical shape, a proximal end and an outer surface (fig. 3). Claim 21 further calls for the light-emitting region to extend circumferentially at the outer surface and have a linear shape; and wherein the light-emitting region is formed at the proximal end. The particular orientation of the light-emitting region is not shown in fig. 3, however in a different embodiment, shown in fig. 7B, Yu teaches that the light-emitting regions extend circumferentially in a line at the proximal end of the interface. 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 light-emitting regions of Yu as shown in fig. 3 to be arranged as shown in Yu fig. 7B to provide a light pattern that is easily viewed by the user regardless of the orientation that the user holds the device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Spiro (US 8,375,613).
Claim 25 differs from Yu in calling for the light distribution element comprises at least two subsections, wherein each subsection of the at least two subsections is assigned to one subregion of the two or more subregions of the light-emitting region, wherein the at least two subsections are optically decoupled. Spiro teaches a visual indicator including two subsections, wherein each subsection is assigned to a light-emitting region, and the subsections are optically decoupled (col. 8, lines 30-36) thereby allowing the individual light sections to be clearly distinguished by the user. 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 light distribution element of Yu to include subsections that are optically decoupled as taught by Spiro to ensure that the different light patterns are readily recognizable by the user.
Claim(s) 26, 27 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Ho (US 5,356,328).
Claim 26 differs from Yu in calling for a recess to be formed in the light distribution element, the recess is configured to receive the at least two light-emitting elements. Ho teaches a cover member for light-emitting elements where in the cover has recesses to receive the diodes and transmit the light out of the cover to be viewed by the user (figs. 1-3). 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 light distribution element of Yu to include recesses configured to receive the LEDs as taught by Ho so that the light from the LEDs is transmitted to the user for providing the desired indication to the user.
Regarding claim 27, Ho further teaches that the recess is a hole 80 (fig. 2). In the combination described above with regard to claim 26, the material of the cap of Yu extends between the recesses and therefore the light-entry side adjoins the recess.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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