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
This office action is responsive to the amendment filed on 03/12/2026. As directed by the amendment: claims 1-2, 20, and 22-23 have been amended, claim 10 has been cancelled, and no claims have been added. Thus, claims 1-9 and 11-32 are presently pending in this application, with claims 16-18 and 25-32 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Office Action mailed on 12/16/2025. The 112(f) interpretation is maintained.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a component” in claim 1,
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a component” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (component), (ii) it is coupled with functional language (associated with an injection operation of the injection device), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0067 discloses “component 122 may include a plunger stopper, a plunger rod, a needle shield of injection device 102, and/or a mobile trigger or component that initiates or triggers the injection operation (e.g., a button, a trigger, and/or the like that moves or is displaced to initiate and/or perform the injection operation to deliver a dose of a medicament to a user, etc.).” Examiner is interpreting the limitations as these structures and equivalents thereof.
U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7-9, 12, 14, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al. (U.S Patent Pub. No. 20180280607 A1, “Richards”) in view of Schabbach et al. (U.S Patent Pub. No. 20200164154 A1, “Schabbach”).
Regarding claim 1, Richards discloses (Claim 1) a sensor assembly (150 in Fig. 10) for an injection device (102 in Fig. 1) comprising:
a housing (106, see Fig. 7 and 10) including:
a sensor (128 in Fig. 10) configured to detect a movement of a component (“stopper” in para. 0076) of the injection device (102) associated with an injection operation of the injection device (102, examiner notes the component is interpreted under 112(f) as including a plunger stopper, a plunger rod, a needle shield of injection device, a mobile trigger or component such a button, trigger, or the like that initiates or triggers the injection operation, and/or any combination or equivalents thereof, see Fig. 7 and para. 0076 – sensor array 128 detects movement of stopper within container 104 of injection housing 102); and
a communication device configured to communicate, to a computing device, information (see para. 0067 – module 150 may comprise communication capabilities to transmit device data to an external device such as a smartphone); and
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a mechanical interface (see Fig. 7 and 10) configured to attach the housing to an exterior surface (exterior of 102 in Fig. 7) of the injection device (102, see Fig. 7 and para. 0067 – mechanical interface is interpreted as the mechanical features of cover 106 and injection housing 102 that allow cover 106 to removably connect to the exterior surface of injection housing 102), wherein the mechanical interface is configured to position the sensor (128) in a predetermined location relative to a drug inspection window of the injection device (102, see annotated Richards drawing 1 below and para. 0067 – injection housing 102 has a window that allows for viewing the container 104 interpreted as the drug inspection window, cover 106 is configured to attached to the injection housing 102 at a predetermined location such that the sensor array 128 is in a predetermined location relative to said window),
wherein the mechanical interface includes a cutout or opening (108 in Fig. 4) corresponding to a portion of the drug inspection window (see annotated Richards drawing 1 above for window, see para. 0069 – cover 106 includes a cutout or opening 108 in a location that mechanically interfaces with the injection housing 102 and corresponding to a portion of the window annotated above),
and wherein the cutout or opening (108) is sized and configured to leave a portion of the drug inspection window visible to a user when the housing is attached to the injection device (102) via the mechanical interface (see Fig. 3-4 and para. 0069 – cutout or opening 108 leaves a portion of annotated window above visible to user upon attaching cover 106 to injection housing 102).
However, Richards fails to disclose (Claim 1) a wireless communication device configured to communicate, to a computing device, information associated with the movement of the component of the injection device, wherein the sensor is calibrated according to the predetermined location of the sensor relative to the drug inspection window.
Schabbach discloses an injection device (100 in Fig. 1) having an attachable electronic device (420 in Fig. 4B) with an emitter (402 in Fig. 4B) and receiver (404 in Fig. 4B) for optically sensing the position of the stopper (108 in Fig. 4B) within the drug cartridge (400 in Fig 4B, see para. 0042-0043), wherein Schabbach teaches (Claim 1) a wireless communication device (“wireless transceiver” in para. 0039) configured to communicate, to a computing device, information associated with the movement of the component (108) of the injection device (100, see para. 0038-0039 and 0043 – the electronic device 420 may comprise a microcontroller 450 which has the same capabilities of microcontroller 210 of the embodiment above thus incorporates a wireless transceiver for communicating the sensor data from receiver 404 wirelessly with an external database), wherein the sensor (402, 404) is calibrated according to the predetermined location of the sensor (402, 404) relative to the drug inspection window (see para. 0043-0044 – emitter 402 and receiver 404 must be calibrated upon attachment to cartridge housing 440 according to their predetermined location relative to the transparent cartridge housing 440 and stopper 108).
Since Richards discloses an attachable electronic device with communication module and a cutout or opening that positions the optical sensor in a predetermined location relative to a drug inspection window, and Schabbach discloses an attachable electronic device that calibrates the optical sensor according to its location relative to the drug cartridge and stopper, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly taught by Richards to incorporate a wireless communication module and calibration of the sensor relative to its predetermined location as taught by Schabbach. Schabbach teaches wireless communication allows for the electronic device to communicate data to an external database in an a known, wireless manner (see para. 0039), and that calibration of the optical emitter and receiver typically enables them to accurately determine the position of the stopper within the cartridge and ensures proper positioning upon attachment to the injection device (see para. 0043-0044).
Regarding claim 2, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 2) wherein the component (“stopper” in para. 0076) of the injection device (102) includes at least one of the following: a stopper of a plunger (see para. 0067 and 0079) and wherein the sensor (128) is configured to detect the movement of the at least one of the stopper (“stopper” in para. 0076) of the plunger (see para. 0067).
Regarding claim 3, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 3) wherein the information associated with the movement of the component (“stopper” in para. 0076) of the injection device (102) includes at least one of the following: a speed of the injection operation (see para. 0081 – sensor data which is the change in position of the stopper as a function of time can be used to calculate the rate of delivery of the drug).
Regarding claim 4, modified Richards discloses the sensor assembly of claim 1, as discussed above.
While Richards discloses that the sensor (128) may be in electronic communication with a controller for controlling the sensor (128) and processing sensor data, modified Richards fails to disclose (Claim 4) wherein the housing includes one or more processors programmed and/or configured to determine, based on sensor data received from the sensor, the information associated with the movement of the component of the injection device.
Schabbach teaches the sensor assembly (420in Fig. 4B) comprising the sensor (402, 404 in Fig. 4B) and a microcontroller (450 in Fig. 4A) having processing abilities for determining information based on the sensor data received from the sensor (402, 404) associated with the movement of the component (108) of the injection device (100, see para. 0038-0040 and 0043).
Since Richards discloses an attachable electronic device comprising the sensor which may be in electronic communication with a controller for controlling the sensor and processing sensor data, and Schabbach discloses an attachable electronic device having an onboard microcontroller for controlling the sensor, external communication, and processing sensor data, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly taught by modified Richards to incorporate the microcontroller as taught by Schabbach according to known methods to yield predictable results. One of ordinary skill in the art would have recognized that incorporating a microcontroller directly on board the sensor assembly of modified Richards as taught by Schabbach would yield results that were predictable.
Regarding claim 5, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 5) wherein the housing (106) includes a user feedback device (110 in Fig. 4), and wherein the user feedback device (110) includes at least one of the following: a light-emitting diode (LED) (see Fig. 4 and para. 0012 and 0069 – cover 106 includes an indicator 110 which may be a light-emitting diode providing feedback to the user).
Regarding claim 7, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Schabbach discloses (Claim 7) wherein the wireless communication device includes a short range wireless communication device (see para. 0039 – the wireless transceiver may use Bluetooth which is a short range wireless communication mechanism).
Regarding claim 8, modified Richards discloses the sensor assembly of claim 1, as discussed above.
However, modified Richards fails to disclose (Claim 8) wherein the housing includes a memory.
Schabbach discloses the microcontroller (450) within the sensor assembly (420) may comprise a memory storage medium (see para. 0043).
Since Richards discloses an attachable electronic device comprising the sensor which may be in electronic communication with a controller for controlling the sensor and processing sensor data, and Schabbach discloses an attachable electronic device having an onboard microcontroller for controlling the sensor, external communication, and processing sensor data, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly taught by modified Richards to incorporate the microcontroller with its memory storage medium as taught by Schabbach according to known methods to yield predictable results. One of ordinary skill in the art would have recognized that incorporating a microcontroller directly on board the sensor assembly of modified Richards as taught by Schabbach would yield results that were predictable.
Regarding claim 9, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 9) wherein the injection device (102) includes one of the following: a wearable injector (see Fig. 1 and para. 0066).
Regarding claim 12, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 12) wherein the housing (106) is integrated with the mechanical interface (see Fig. 10 and para. 0077 – the mechanical features at least on the cover 106 allowing for removable connection to the injection housing 102 are integrated with the cover 106).
Regarding claim 14, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 14) the sensor wherein the mechanical interface includes the exterior surface of the injection device (102, see Fig. 7 and 10 and para. 0067 – examiner is interpreting the mechanical interface as the combined structure of the mechanical features of both the cover 106 and injection housing 120, mechanical interface thus includes the exterior surface of injection housing 120 having the mechanical structure to interface with cover 106).
Regarding claim 19, modified Richards discloses the sensor assembly of claim 1, as discussed above. In modified Richards, Richards discloses (Claim 19) wherein the sensor (128) includes an optical sensor (see para. 0076).
Regarding claim 20, modified Richards discloses the sensor assembly of claim 19, as discussed above. In modified Richards, Richards discloses (Claim 20) wherein, when the housing is attached to the injection device (102) via the mechanical interface (106), the optical sensor is positioned to detect the movement of the component (“stopper” in para. 0076) of the injection device (102) through the drug inspection window of the injection device (102, see annotated Richards drawing 1 above for window, see para. 0079 – the emitters 130 and detectors 132 of sensor 128 are positioned to detect movement of the stopper of the injection housing 102 through the annotated window when cover 106 is attached to injection housing 102).
Regarding claim 21, modified Richards discloses the sensor assembly of claim 20, as discussed above. In modified Richards, Richards discloses (Claim 21) wherein the optical sensor includes an array of photodetector (132 in Fig. 10) and LED pairs (130 in Fig. 10, see para. 0077).
Regarding claim 23, modified Richards discloses the sensor assembly of claim 19, as discussed above. In modified Richards, Richards discloses (Claim 23) wherein, when the housing is attached to the injection device (102) via the mechanical interface (106), the housing partially overlaps the drug inspection window of the injection device (102, see Fig. 4 and 7 and para. 0079 – when cover 106 is attached to the injection housing 102, the emitters 130 and detectors 132 and thus their housing are at least partially overlapping the annotated window of the injection housing 102 to emit light into the container 104).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Schabbach as applied to claim 1 above, and further in view of Bitton et al. (U.S Patent Pub. No. 20180280624 A1, “Bitton”).
Regarding claim 6, modified Richards discloses the sensor assembly of claim 1, as discussed above.
However, modified Richards fails to disclose (Claim 6) wherein the housing includes a battery configured to power the sensor.
Bitton discloses an add-on device (102 in Fig. 1-3) comprising sensors (140 in Fig. 2) for sensing parameters in an injection device (106 in Fig. 1), wherein Bitton teaches (Claim 6) wherein the housing (134) includes a battery (234 in Fig. 2) to power the sensor (140, see para. 0067 and 0184).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor assembly of modified Richards to incorporate a battery as taught by Bitton as Bitton teaches the add-on device operates using any suitable power source for powering its electrical components, and a battery may either be easily replaced or recharged for reuse (see para. 0184).
Claim(s) 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Schabbach as applied to claim 1 above, and further in view of Keller et al. (U.S Patent Pub. No. 20190240411 A1, “Keller”).
Regarding claim 11, modified Richards discloses the sensor assembly of claim 1, as discussed above. However, modified Richards fails to disclose (Claim 11) wherein the housing is removably attached to the mechanical interface.
Keller discloses an auxiliary sensing unit (40 in Fig. 1) for use with an injection pen (10, see para. 0020 and 0046), wherein the auxiliary sensing unit (40) comprises a mechanical interface interpreted as the mechanical features of the auxiliary sensing unit (40) and injection device (10) allowing for their removable connection. Keller discloses said mechanical interface including a base plate (30 in Fig. 2-3) mounted on the exterior surface of the injection device (10) such that the housing (housing of 40) of the auxiliary sensing unit (40) is removably attached to said base plate (30, see para. 0046). Thus Keller teaches (Claim 13) wherein the housing (housing of 40) is removably attached to the mechanical interface (see para. 0046 – housing of unit 40 removably attaches to mount 30 which is a part of the mechanical interface).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical interface of modified Richards to incorporate a base plate configured to be attached to the exterior surface of the injection device as taught by Keller. Incorporating a mount as part of the mechanical interface allows any injection device to have the mount attached thereon and thus use of an auxiliary sensing unit. Keller teaches that incorporating a mount into the mechanical interface of the auxiliary unit and the injection device ensures the auxiliary unit is robustly and accurately positioned in relation to the injection device (see para. 0046), and it further allows for a keyed attachment mechanism ensuring the correct auxiliary unit is attached to the intended injection device (see para. 0055). In combination, the injection housing (102) of Richards would incorporate a mount for removable attachment of the cover (106) to the injection housing (102).
Regarding claim 13, modified Richards discloses the sensor assembly of claim 1, as discussed above. However, modified Richards fails to disclose (Claim 13) wherein the mechanical interface includes a base plate configured to be attached to the exterior surface of the injection device.
Keller teaches (Claim 13) wherein the mechanical interface includes a base plate (30 in Fig. 2-3) configured to be attached to the exterior surface (exterior of 20) of the injection device (10, see Fig. 2A-2D and para. 0046 – mount 30 is interpreted as a base plate as it is a plate-like structure used as a base for the mounting of the sensor assembly 40 to the injection pen 10, base plate 30 is fixedly attached to the outer surface of housing 20 of injection pen 10).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical interface of modified Richards to incorporate a base plate configured to be attached to the exterior surface of the injection device as taught by Keller. Incorporating a mount as part of the mechanical interface allows any injection device to have the mount attached thereon and thus use of an auxiliary sensing unit. Keller teaches that incorporating a mount into the mechanical interface of the auxiliary unit and the injection device ensures the auxiliary unit is robustly and accurately positioned in relation to the injection device (see para. 0046), and it further allows for a keyed attachment mechanism ensuring the correct auxiliary unit is attached to the intended injection device (see para. 0055). In combination, the injection housing (102) of Richards would incorporate a mount for removable attachment of the cover (106) to the injection housing (102).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Schabbach as applied to claim 1 above, and further in view of Kuhn et al. (U.S Patent Pub. No. 20160235925 A1, “Kuhn”).
Regarding claim 15, modified Richards discloses the sensor assembly of claim 1, as discussed above. While Richards discloses the sensor assembly (150) is removably attached to the injection housing (102, see para. 0067), modified Richards fails to disclose (Claim 15) wherein the mechanical interface includes an adhesive.
Kuhn discloses a supplemental sensor assembly (200 in Fig. 2-3) for an injection device (100), wherein Kuhn teaches (Claim 15) wherein the mechanical interface includes an adhesive (see Fig. 3 and para. 0065 – the mechanical interface between sensor assembly 200 and injection device 100 may comprise an adhesive coupling).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the mechanical interface of modified Richards with an adhesive coupling as taught by Kuhn. Kuhn teaches that the sensor assembly may have a mechanical interface configured for removable or permanent attachment to an injection device, and thus provides that the releasable attachment is substitutable with a permanent attachment such as an adhesive coupling (see para. 0065). One of ordinary skill could have substituted the mechanical interface of modified Richards for the adhesive coupling of Kuhn with the results being predictable.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Schabbach as applied to claim 19 above, and further in view of Samosky et al. (U.S Patent Pub. No. 20150379900 A1, “Samosky”).
Regarding claim 22, modified Richards discloses the sensor assembly of claim 20, as discussed above.
However, modified Richards fails to disclose (Claim 22) wherein the optical sensor includes a single pair consisting of a photodetector and LED, and wherein the component of the injection device includes a printed or gradated pattern visible through the drug inspection window of the injection device.
Samosky further teaches (Claim 22) wherein the optical sensor (60, 62) includes a single pair consisting of a photodetector (62 in Fig. 3A) and LED (60 in Fig. 3A, see para. 0054), and wherein the component (14 in Fig. 6-7A) of the injection device (10) includes a printed or gradated pattern (100) visible through the drug inspection window (12) of the injection device (10, see Fig. 7A and para. 0057-0058 – plunger 14 comprises a gradient pattern visible through the transparent barrel 12 of the injection device 10).
Since modified Richards discloses an optical sensor array configured to detect the position of the stopper, and Samosky discloses an optical sensor configured to detect the position of the plunger using the gradated pattern, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor array of modified Ricahrds to have a single photodetector and LED pair and for the stopper to have a gradient pattern as taught by Samosky. Samosky teaches a simpler optical sensor requiring only a singular photodetector and LED that sense different light transmissions due to the gradient pattern on the plunger and use the signals to calculate several injection parameters (see para. 0058 and 0061).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Schabbach as applied to claim 19 above, and further in view of Shekalim (U.S Patent Pub. No. 20180200451 A1, “Shekalim”).
Regarding claim 24, modified Richards discloses the sensor assembly of claim 19, as discussed above. In modified Richards, Richards discloses the limitations (Claim 24) wherein the injection device (102) includes a drug inspection window (see annotated Richards drawing 1 above), and wherein, when the housing (106) is attached to the injection device (102) via the mechanical interface (see Fig. 7 and para. 0067 – mechanical interface is interpreted as the mechanical features of cover 106 and injection housing 102 that allow cover 106 to removably connect to the exterior surface of injection housing 102), the housing (106) fully overlaps the drug inspection window (see Fig. 4 and 7 and para. 0079 – when cover 106 is attached to the injection housing 102, the cover 106 fully overlaps with the annotated window of the injection housing 102).
However, modified Richards fails to disclose the limitations (Claim 24) wherein the injection device includes a plurality of drug inspection windows, the housing fully overlaps one of the plurality of drug inspection windows.
Shekalim discloses a smart cap (100 in Fig. 2A-3B) for an injection pen (200) wherein the smart cap (100) comprises an optical sensor (110 in Fig. 3A-3B) for sensing the position of the plunger (220) of the injection pen (200, see para. 0050). Shekalim teaches (Claim 24) wherein the injection device (200) includes a plurality of drug inspection windows (see Fig. 5A-5B and para. 0058), the housing (housing of 100) fully overlaps one of the plurality of drug inspection windows (see Fig. 3B, para. 0049 and 0059 – housing of assembly 100 in its engaged position seen in Fig. 3B would fully overlap at least one of the plurality of windows formed by ribs 213 subdividing the window 211).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug inspection window of modified Richards to incorporate bridging ribs to subdivide the window into a plurality of drug inspection windows as taught by Shekalim according to known methods to yield predictable results. One of ordinary skill could have modified the singular drug inspection window of modified Richards to be subdivided into a plurality of drug inspection windows as each individual element performs the same function separately as providing a transparent window for optical sensing of the stopper. Further, Shekalim discloses that the subdivided drug inspection window is a known feature in commercially available pen injectors (see para. 0058), and thus one of ordinary skill in the art would have recognized that such a modification would be predictable. In combination, the housing (106) of Richards would fully overlap at least one of the modified plurality of drug inspection windows.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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