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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 08/25/2026. As directed by the amendment: claim 1 has been amended, no claims have 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 Thus, claims 1-9 and 11-32 are presently pending in this application, with claims 16-18 and 25-32 being withdrawn from consideration. The 112(f) interpretation is maintained.
Response to Arguments
Applicant's arguments filed 08/25/2026 have been fully considered but they are not persuasive.
In response to applicant’s arguments on p.8-9 of “Remarks”, filed 08/25/2026, that Richards “does not appear to disclose any indications located on the exterior surface or the cutout or opening to provide information regarding position and orientation at which to attach the cover 106 to the injection housing”, the examiner respectfully disagrees. Examiner notes that regarding the cutout or opening (108 in Fig. 4) of the cover (106), said opening (108) is explicitly disclosed “for viewing the contents of the container 104” (see para. 0069). Thus, the cutout or opening (108) as seen in Fig. 3 is mounted to thus be overlaid on the window of injection device (102) for viewing the container (104). Therefore, Richards discloses the newly added claim limitation as the cutout or opening (108) provides an indication of the position and the orientation at which to attached the mechanical interfacing structures of the cover (106) to the injection device (102) relative to the window in injection device (102). Further, examiner notes that the injection device (102) discloses a button (115 in Fig. 7) which engages with a corresponding opening in cover (106) so as to provide an indication on how to position and orient the cover (106) relative to the injection device (102) and thus its viewing window (see Fig. 7).
Applicant further argues that as provided in their annotated Figure of Richards on p. 10 of said “Remarks” that Richards provides locating fasteners and mounting tabs making the claimed indications superfluous. Examiner notes that said fasteners and mounting tabs are not explicitly disclosed in the specification of Richards, and thus one cannot assume the function of said structures.
Further, applicant argues that the cover (106) of Richards only has a single, unique orientation for mounting to the injection device (102), and there would be no need to provide the user with position and orientation information. Examiner respectfully disagrees as the only reason the cover (106) of Richards appears to have said “single, unique orientation” is because said cover (106) and injection device (102) provide indications of this correct orientation and positioning through namely the cutout or opening (108), button (115) and its corresponding opening, as well as the complementary shaping and contour of the cover (106) and injection device (102).
Therefore, the rejection is maintained.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11-15, and 19-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “wherein at least one of the exterior surface… providing an indication” in lines 17-18 renders the claim indefinite because it is unclear. In line 1 of said claim, the injection device is functionally recited. Thus, this limitation creates ambiguity whether the injection device is intended to be functionally recited or positively recited through its exterior surface. Examiner is interpreting it as functionally recited and the sensor assembly must be capable of being configured for use with an injection device having an exterior surface providing an indication as claimed.
Regarding claims 1-9, 11-15, and 19-24, these claims are rejected due to their dependency upon a rejected base claim.
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
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),
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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),
wherein at least one of the exterior surface or the cutout or the opening (108) providing an indication of a position and/or orientation at which to attach the mechanical interface to the injection device (102) with respect to the drug inspection window (see annotated Richards drawing 1 above for window, see Fig. 3-4 and para. 0069 – the cutout or opening 108 in cover 106 is for viewing the contents of the container 104 and thus is attached as seen in Fig. 3 such that the opening 108 overlays the container 104 in order for viewing, thus the opening 108 provides an indication of the position and orientation at which to attach the mechanical features of cover 106 to injection device 102 with respect to the drug inspection window annotated above, further injection device 102 comprises a button 115 in Fig. 7 which engages with a corresponding opening in cover 106 so as to provide an indication on how to position and orient the cover 106 relative to the injection device 102 and thus its viewing window),
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 unknown, 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 Richards 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gregory et al. (U.S Patent Pub. No. 20200147312 A1, “Gregory”) – Gregory discloses a sensor assembly (42 in Fig. 1-6) for an injection device (20 in Fig. 1-4, see para. 0042), wherein the sensor assembly (42) comprises an opening (74 in Fig. 5) aligned with a drug viewing window (23 in Fig. 2) of the injection device (20, see para. 0049). Gregory further discloses that the sensor assembly (42) comprises accessory engagement features (44 in Fig. 6) that mate with housing engagement features (46 in Fig. 2) which may include alignment features (48 in Fig. 2) configured to align and guide the accessory engagement features (42) into engagement with the housing engagement feature (46) and thus correctly position and orient the sensor assembly (42) relative to the injection device (20) and its drug viewing window (23, see para. 0045).
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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