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 .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 6/30/2026. As directed by the amendment: claim(s) 15, 28, 32, and 34 are amended. Thus, claims 15-24 and 27-34 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the preceding 112a rejection on page 7:
Applicant's present amendment resolves the preceding office actions stated 112a rejection of the claims.
Regarding applicant’s argument regarding the independent claims on page 7-9:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device"
Applicant particularly argues that the diffuser aperture 1111 cannot be considered a lens system configured to align with the camera of the user device because it is a diffuser which is not capable of guiding light, which is allegedly required by the amended claims. However, not only do applicant's arguments confuse their own amendment to the claims, as the claims do not recite the lens system as guiding light, they also are confused to the structures of the prior art which were relied upon for teaching/disclosing functional capabilities of aligning the camera of the user and aligning a flash light of the user device.
Applicant argues that a diffuser is allegedly not capable of guiding light because it supposedly spreads light. However, examiner notes that in the prior art relied upon for the claimed light guide, the diffuser aperture 1111 and diffuser 4000 of Wang is provided to ensure that light travelling from a flash light of a user device is directed sufficiently to illuminate a device to be imaged, see paragraph 48 of Wang. Thus as light which travels through aperture 1111 and diffuser 4000 must be directed - or guided -to the device to be imaged in order to achieve an adequate image, those structures may be considered a light guide configured in the claimed manner.
See examiner's rejection as necessitated by the amendment, below, detailing the manner that Wang’s lens aperture 1112 is considered a lens system configured in the claimed manner.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the light guide/diffuser of the prior art of Wang focusing the camera onto a position that is closer than the camera’s focusing capability) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In the case of Gyory in view of Wang, it is well known in the art as well as from paragraph 8-9 of Wang that medical articles such as test strips and autoinjectors should avoid cross-contamination with user devices such as smarthpones, such that when imaging the medical article having a housing which distances such elements in a controlled manner is advantageous. Further, Wang’s smartphone housing had advantageous features such as additional light sources and light guiding/diffusing mechanisms which improve imaging of a device to be imaged, see paragraph 14+53-54 of Wang. In the case of Hopper’s teachings applied to Gyory in view of Wang, it is provided in paragraph 34-35 of Hopper that tracking plunger position of an autoinjector with a camera is advantageous feature for tracking a patient’s compliance with a treatment regiment having a certain dose rate. In the case of Claes teachings applied to Gyory in view of Wang, it is knowledge generally available to a person of ordinary skill in the art in view of Claes that a lid covering a slot holding a medical article with a sharp element – such as an autoinjector or syringe – is desirable for preventing needle prick injuries by obscuring user access to a medical article within the slot via the lid covering the slot.
Accordingly, in view of the above discussion of applicant’s remarks, and examiner's rejection as necessitated by the amendment below, the rejection of the claims in view of the prior art of record stands.
Regarding applicant’s argument regarding dependent claims on page 9:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the case comprises a lid, and wherein the slot is provided on the lid” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
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 15-20, 23-26, 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200043589 A1, henceforth written as Gyory, in view of US 20170023542 A1, henceforth written as Wang.
Regarding Claim 15,
Gyory discloses:
A system comprising:
(the claimed system at least comprising smartphone 10 and syringe 38; fig 4)
a drug delivery device;
(syringe 38; fig 4+6)
a user device comprising a camera; and --
(paragraph 34; smartphone 10 includes an image-capturing device 11; fig 1+4 )
--wherein the drug delivery device is a pen-type injection device,
(fig 4 demonstrates syringe 38 as a capped syringe, and therein may be considered a pen-type injection device as its cap resembles a pen cap over the puncturing end of syringe 38)
-- the user device [is configured] such that the camera can capture images of at least one feature of the drug delivery device
(paragraph 30-31+33-43; the app on smartphone 10 analyzes the image captured by image capturing device 11 to determine such features of syringe 38 as a dosage being delivered, indicia 36 44, and/or plunger location 40; fig 4)
Gyory discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a case for the user device, the case comprising: a slot adapted to receive the drug delivery device, and a first wall, a second wall, and two side walls defining a space therebetween that is configured to receive the user device, wherein, when the user device and the drug delivery device are inserted into the case, the case is configured to align the drug delivery device and the camera of the user device such that the camera can capture images of at least one feature of the drug delivery device from one or both of a predefined distance and a predefined orientation.
However, Wang teaches a phone case for imaging a sample:
a case for the user device,
(housing (not enumerated) of test reader 1000; fig 1-12)
the case comprising: a slot adapted to receive the [device to be imaged], and
(port 1120 receives cartridge 3000; fig 1+9+11-12)
a first wall, a second wall, and two side walls defining a space therebetween that is configured to receive the user device, wherein,
(see examiner’s annotation of Wang’s fig 9b and 12, below, denoting the claimed walls of Wang’s case and the space receiving the user device)
when the user device and the [device to be imaged] are inserted into the case, the case is configured to align the [device to be imaged] and the camera of the user device such that the camera can capture images of at least one feature of the [device to be imaged] from one or both of a predefined distance and a predefined orientation.
(paragraph 14+48-54; smartphone 2000 captures an image of features of cartridge 3000 with its camera from a position and orientation which is predefined by the shape the housing (not enumerated) of reader 1000 is manufactured in, a shape which holds a static position between deck 1121 receiving cartridge 3000 from port 1120 and the diffuser aperture 1111 and lens aperture 1112 guiding the imaging capturing means of the smartphone 2000 in the docking station 1110; fig 1-12)
wherein the first wall of the case is adapted to allow the user to see and/or operate a screen of the user device,
(see examiner’s annotation of Wang’s fig 9b+12, below, demonstrating the manner by which the first wall is considered adapted to allow the user to see/operate a screen of the user device)
and wherein the second wall comprises a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device.
(paragraph 48-51; see examiner’s annotation of Wang’s fig 9b+12, below, demonstrating the manner by which the second wall is considered to comprise an orifice for lens port 1112, which couples -and therein aligns- with a camera lens of device 2000 and thus is a lens system, and another orifice for diffuser aperture 1111, which couples with a flashlight 2100 of device 2000 such that light from flashlight 2100 is diffused by diffuser 4000 in order to produce an image of the device to be imaged, therein the aperture 1111 and diffuser 4000 guide light from flashlight 2100 to adequately illuminate the device to be imaged)
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Wang’s teachings of providing a smartphone housing for imaging a biological sample test cartridge to the Gyory’s disclosure system of using a smartphone to track a patient’s compliance with a medication regiment, by substituting the smartphone 2000 and cartridge 3000 of Wang with the device 10 and syringe 38 of Gyory, such that Wang’s reader 1000 provides a docking station for receiving Gyory’s device 10 to image Gyory’s syringe 38 in Wang’s port 1120, in order to advantageously arrive at an invention which can track a patient’s compliance with an injection procedure and reduce risks associated with cross-contamination of user device’s and sensitive equipment like test strips or drug delivery devices and further improves imaging capabilities by both providing an external light source and guiding light from the smartphone, see paragraph 14+53-54 of Wang.
Regarding claim 16, the modified device of Gyory in view of Wang discloses:
The system of claim 15, wherein the case further comprises a lens system that is positioned between the camera and the drug delivery device when the user device and the drug delivery device are inserted into the case.
Wang: (paragraph 49-51; lens aperture 1112, therein a lens system; fig 1-8)
Examiner notes in light of the combination made in claim 15 above, lens aperture 1112 is disposed between Gyory's device 10 and Gyory's syringe 38, when device 10 is in Wang's docking station 1110.
Regarding claim 17, the modified device of Gyory in view of Wang discloses:
The system of claim 15, wherein the user device further comprises a flash light and
Gyory: (flash/light producing structure (not enumerated) of smartphone 10)
the case further comprises a light guide, the light guide being configured to guide a light from the flash light towards the drug delivery device.
Wang: (paragraph 49-51; diffuser aperture 1111 guides light from smartphone 2000 toward cartridge 3000; fig 1-8)
Examiner notes in light of the combination made in claim 15 above, diffuser aperture 1111 guide's light from Gyory's smartphone 10 and Gyory's syringe 38, when smartphone 10 is in Wang's docking station 1110.
Regarding claim 18, Gyory discloses:
The system of claim 15, wherein the drug delivery device comprises a container for containing a medicament, and wherein
(syringe 38 has barrel (not enumerated) containing medicament (not enumerated) ; fig 4)
the container comprises a bung for displacing the medicament.
(plunger 40; fig 4)
Regarding claim 19, the modified device of Gyory in view of Wang discloses:
The system of claim 18, wherein the case is configured to align the camera and the container such that the camera is positioned to capture an image of the bung.
Examiner notes in light of the combination made in claim 15 above, Wang's housing (not enumerated) of reader 1000 aligns Gyory's imaging device 11 of Gyory's smartphone 10 such that imaging device 11 is positioned to capture an image of Gyory's plunger 40.
Regarding claim 20, Gyory discloses:
The system of claim 19, wherein the user device is configured to: capture a first image of the container using the camera; and determine a first position of the bung from the first image using a processor, the first position corresponding to a reference position of the bung before a dose of the medicament has been administered.
(paragraph 39; app on device 10 utilizes machine vision, therein utilizing an electronic processor (not enumerated/illustrated) of deice 10, to analyze an image of a plunger location 40 before dose delivery; fig 4)
Regarding Claim 23,
The system of claim 15, wherein the camera comprises a back camera.
Examiner notes that the claim term “back” is a relative term and further the claim does not recite nor define what a front or back of the device is, such that Gyory’s image capturing device 11 on smartphone 10 may be considered a front or back camera.
Regarding claim 24, the modified device of Gyory in view of Wang discloses:
The system of claim 23, wherein the case is configured to align the back camera and the drug delivery device such that the back camera can capture the images of the at least one feature of the drug delivery device from one or both of the predefined distance and the predefined orientation.
Examiner notes in light of the combination made in claim 15+23 above, Wang’s lens aperture 1112 is configured to align the back camera of Gyory’s smartphone 10 to image Gyory’s syringe 38 in the aforementioned predefined manner.
Regarding Claim 28,
Gyory discloses:
a user device
(device 10)
a drug delivery device, wherein the drug delivery device is a pen-type injection device,
(fig 4 demonstrates syringe 38 as a capped syringe, and therein may be considered a pen-type injection device as its cap resembles a pen cap over the puncturing end of syringe 38)
a camera of the user device
(paragraph 34; smartphone 10 includes an image-capturing device 11; fig 1+4 )
such that the camera can capture images of at least one feature of the drug delivery device
(paragraph 30-31+33-43; the app on smartphone 10 analyzes the image captured by image capturing device 11 to determine such features of syringe 38 as a dosage being delivered, indicia 36 44, and/or plunger location 40; fig 4)
Gyory discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
A case for a user device, the case comprising: a first wall, a second wall, and two side walls defining
a space therebetween that is configured to receive a user device; and
a slot adapted to receive a drug delivery device, wherein the drug delivery device is a pen-type injection device,
wherein the case is adapted to align the drug delivery device and a camera of the user device when the user device and the drug delivery device are inserted into the case
such that the camera can capture images of at least one feature of the drug delivery device from one or both of a predefined distance and a redefined orientation, wherein the first wall of the case is adapted to allow the user to see and/or operate a screen of the user device, and wherein the second wall comprises a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device.
However Wang teaches:
A case for a user device,
(housing (not enumerated) of test reader 1000 for holding smartphone 2000; fig 1-12)
the case comprising: a first wall, a second wall, and two side walls defining a space therebetween that is configured to receive a user device; and
(see examiner’s annotation of Wang’s fig 9b and 12 denoting the claimed walls of Wang’s case and the space receiving the user device)
a slot adapted to receive a drug delivery device,
(port 1120 receives cartridge 3000, therein is functionally capable of receiving a drug delivery device of a compatible size; fig 1+9+11-12)
wherein the case is adapted to align the drug delivery device and a camera of the user device when the user device and the drug delivery device are inserted into the case such that the camera can capture images of at least one feature of the drug delivery device from one or both of a predefined distance and a predefined orientation.
(paragraph 14+48-54; smartphone 2000 captures an image of features of cartridge 3000 with its camera from a position and orientation which is predefined by the shape the housing (not enumerated) of reader 1000 is manufactured in, a shape which holds a static position between deck 1121 receiving cartridge 3000 from port 1120 and the diffuser aperture 1111 and lens aperture 1112 guiding the imaging capturing means of the smartphone 2000 in the docking station 1110; fig 1-12; accordingly the disposition of apertures 1111 1112 renders the camera of smartphone 2000 functionally capable of capturing images of features of a drug delivery device)
wherein the first wall of the case is adapted to allow the user to see and/or operate a screen of the user device,
(see examiner’s annotation of Wang’s fig 9b+12, above, demonstrating the manner by which the first wall is considered adapted to allow the user to see/operate a screen of the user device)
and wherein the second wall comprises a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device.
(paragraph 48-51; see examiner’s annotation of Wang’s fig 9b+12, below, demonstrating the manner by which the second wall is considered to comprise an orifice for lens port 1112, which couples -and therein aligns- with a camera lens of device 2000 and thus is a lens system, and another orifice for diffuser aperture 1111, which couples with a flashlight 2100 of device 2000 such that light from flashlight 2100 is diffused by diffuser 4000 in order to produce an image of the device to be imaged, therein the aperture 1111 and diffuser 4000 guide light from flashlight 2100 to adequately illuminate the device to be imaged)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Wang’s teachings of providing a smartphone housing for imaging a sample to the Gyory’s disclosure system of using a smartphone to track a patient’s compliance with a medication regiment, by substituting the smartphone 2000 and cartridge 3000 of Wang with the device 10 and syringe 38 of Gyory, such that Wang’s reader 1000 provides a docking station for receiving Gyory’s device 10 to image Gyory’s syringe 38 in Wang’s port 1120, in order to advantageously arrive at an invention which can track a patient’s compliance with an injection procedure and reduce risks associated with cross-contamination of user device’s and sensitive equipment like test strips or drug delivery devices and further improves imaging capabilities by both providing an external light source and guiding light from the smartphone, see paragraph 14+53-54 of Wang.
Regarding claim 29, the modified invention of Gyory in view of Wang teaches:
The case of claim 28, wherein the case further comprises a lens system that is positioned between the camera and the drug delivery device when the user device and the drug delivery device are inserted into the case.
Wang: (paragraph 49-51; lens aperture 1112, therein a lens system, positioned between smartphone 2000's camera and a device to imaged, represented by cartridge 3000; fig 1-8)
Regarding claim 30, the modified invention of Gyory in view of Wang teaches:
The case of claim 28, wherein the case further comprises a light guide that is configured to guide a light from a flash light of the user device towards the drug delivery device when the user device and the drug delivery device are inserted into the case.
Wang: (paragraph 49-51; diffuser aperture 1111 guides light from smartphone 2000 toward a device to be imaged, represented by cartridge 3000, therein is functionally capable of guiding a light from the user device toward a drug delivery device; fig 1-8)
Regarding claim 31, the modified invention of Gyory in view of Wang teaches:
The case of claim 28, wherein the case is configured to align the camera and a container for containing a medicament such that the camera is positioned to capture an image of a bung configured to displace the medicament.
Wang: (fig 1-8 demonstrate that apertures 1111 and 1112 align a camera of smartphone 2000 with a device to be imaged, represented by cartridge 3000, such that the housing of reader 1000 is functionally capable of align the camera of smartphone 2000 with a container containing medication and a bung)
Regarding Claim 32,
Gyory discloses:
A method of recognizing a drug delivery device that comprises a distinctive feature, wherein the drug delivery device is a pen-type injection device, and wherein the method comprises: the user device [is configured] such that the camera can capture images of the drug delivery device --
(paragraph 30-31+33-43; the app on device 10 analyzes the image captured by image capturing device 11 to determine such features of syringe 38 as a dosage being delivered, indicia 36 44, and/or plunger location 40; fig 4+6; fig 4 demonstrates syringe 38 as a capped syringe, and therein may be considered a pen-type injection device as its cap resembles a pen cap over the puncturing end of syringe 38)
capturing an image of the drug delivery device using the camera of the user device; identifying the distinctive feature of the drug delivery device based on the image using a processor of the user device;
(paragraph 39; app on device 10 utilizes machine vision, therein utilizing an electronic processor (not enumerated/illustrated) of device 10, to analyze an image of a plunger location 40 before dose delivery; fig 4)
comparing the distinctive feature to a set of predefined distinctive features stored in a memory of the user device to generate a comparison; identifying the drug delivery device based on the comparison; and
(paragraph 37+39; the image containing indicia 44 is compared against stored information of medication delivery protocol or device)
outputting a result comprising an identity of the drug delivery device using the screen of the user device.
(paragraph 37-39; app on smartphone 10 communicates to user if a device or medication type is improper for the prescribed treatment regiment
Gyory discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
providing a case comprising a first wall, a second wall and at least two side walls, the walls defining a space therebetween, the space being configured to removably receive a user device within the case, wherein the first wall of the case is adapted to allow the user to see and/or operate a screen of the user device, wherein the second wall of the case comprises a slot adapted to removably receive the drug delivery device within the case and a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device: inserting the drug delivery device into the case; inserting the user device into the case, wherein the case is configured to align a camera of the user device and the drug delivery device such that the camera can capture images of the drug delivery device from one or both of a predefined distance and a predefined orientation;
However Wang teaches:
providing a case
(housing (not enumerated) of test reader 1000; fig 1-12)
comprising a first wall, a second wall and at least two side walls, the walls defining a space therebetween, the space being configured to removably receive a user device within the case,
(see examiner’s annotation of Wang’s fig 9b and 12 denoting the claimed walls of Wang’s case and the space receiving the user device 2000)
wherein the first wall of the case is adapted to allow the user to see and/or operate a screen of the user device,
(see examiner’s annotation of Wang’s fig 9b+12 demonstrating the manner by which the first wall is considered adapted to allow the user to see/operate a screen of the user device)
wherein the second wall of the case comprises a slot adapted to removably receive [device to be imaged] within the case and
(port 1120 receives cartridge 3000; fig 1+9+11-12)
and a lens system configured to align with the camera of the user device and a light guide configured to guide light from a flash light of the user device:
(paragraph 48-51; see examiner’s annotation of Wang’s fig 9b+12, below, demonstrating the manner by which the second wall is considered to comprise an orifice for lens port 1112, which couples -and therein aligns- with a camera lens of device 2000 and thus is a lens system, and another orifice for diffuser aperture 1111, which couples with a flashlight 2100 of device 2000 such that light from flashlight 2100 is diffused by diffuser 4000 in order to produce an image of the device to be imaged, therein the aperture 1111 and diffuser 4000 guide light from flashlight 2100 to adequately illuminate the device to be imaged)
inserting the [device to be imaged] into a case;
(port 1120 receives cartridge 3000; fig 1+9+11-12)
inserting a user device into the case,
(fig 1+8-10 illustrate a top wall, bottom wall, and two side walls which define docking station 1110 which receives smartphone 2000)
wherein the case is configured to align a camera of the user device and the [device to be imaged] such that the camera can capture images of the [device to be imaged] from one or both of a predefined distance and a predefined orientation;
(paragraph 14+48-54; smartphone 2000 captures an image of features of cartridge 3000 with its camera from a position and orientation which is predefined by the shape the housing (not enumerated) of reader 1000 is manufactured in, a shape which holds a static position between deck 1121 receiving cartridge 3000 from port 1120 and the diffuser aperture 1111 and lens aperture 1112 guiding the imaging capturing means of the smartphone 2000 in the docking station 1110; fig 1-12)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Wang’s teachings of providing a smartphone housing for imaging a sample to the Gyory’s disclosure system of using a smartphone to track a patient’s compliance with a medication regiment, by substituting the smartphone 2000 and cartridge 3000 of Wang with the device 10 and syringe 38 of Gyory, such that Wang’s reader 1000 provides a docking station for receiving Gyory’s device 10 to image Gyory’s syringe 38 in Wang’s port 1120, in order to advantageously arrive at an invention which can track a patient’s compliance with an injection procedure and reduce risks associated with cross-contamination of user device’s and sensitive equipment like test strips or drug delivery devices and further improves imaging capabilities by both providing an external light source and guiding light from the smartphone, see paragraph 14+53-54 of Wang.
Regarding claim 33, Gyory discloses:
The method of claim 32, wherein the distinctive feature comprises an outer shape, a color, a diameter, a distance between two components, a number of components, a position of components, or a ratio of components.
(paragraph 30-31+33-43; the app on device 10 analyzes the image captured by image capturing device 11 to determine such features of syringe 38 as a dosage being delivered, indicia 36 44, and/or plunger location 40; fig 4)
Regarding claim 34, the modified invention of Gyory in view of Wang discloses:
The method of claim 32, wherein the case comprises a lens system that is positioned between the camera and the drug delivery device when the user device and the drug delivery device are inserted into the case.
Wang: (paragraph 49-51; lens aperture 1112, therein a lens system; fig 1-8)
Examiner notes in light of the combination made in claim 32 above, lens aperture 1112 is disposed between Gyory's device 10 and Gyory's syringe 38, when device 10 is in Wang's docking station 1110.
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gyory in view of Wang as applied to claim 20 above, and further in view of WO 2017147202 A1, henceforth written as Hopper.
Regarding Claim 21,
Gyory in view of Wang discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Gyory in view of Wang is silent regarding:
The system of claim 20, wherein the user device is further configured to: capture a second image of the container using the camera; and determine a second position of the bung from the second image using the processor, the second position corresponding to an adjusted position of the bung after the dose of the medicament has been administered.
However, Hopper teaches a system of tracking an injection has been completed:
wherein the user device is further configured to: capture a second image of the container using the camera; and determine a second position of the bung from the second image using the processor, the second position corresponding to an adjusted position of the bung after the dose of the medicament has been administered.
(Paragraph 34-35; shape of the drug delivery device and certain indicia, including but not limited to a change of plunger position from an initial drug loaded position to a final drug delivered position, are imaged, analyzed, and compared to confirm a set drug dose had been adequately delivered; fig 3-4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, incorporate Hopper’s teachings of detecting when an injection is completed based on a change in plunger position of an injector to the modified system of Gyory in view of Wang, by taking a subsequent image of a drug delivery device to determine if a plunger position has changed and an injection was completed in order to advantageously arrive at an invention which can confirm that a user actually delivered the medication they intended to, therein improving patient’s compliance with their therapeutic regiment.
Regarding claim 22, the modified device of Gyory in view of Wang and Hopper discloses:
The system of claim 21, wherein the user device is further configured to determine a size of the dose based on the first and second positions.
Examiner notes in light of the combination made in claim 21 above, the user device of Gyory determines that a whole dose, therein a size of a dose, had been administered after comparing the first position and second position.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gyory in view of Wang as applied to claim 15 above, and further in view of US 5566828 A, henceforth written as Claes.
Regarding Claim 27,
Gyory in view of Wang discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Gyory in view of Wang is silent regarding:
The system of claim 15, wherein the case comprises a lid, and wherein the slot is provided on the lid.
However, Claes teaches a slot for securing a syringe:
wherein the case comprises a lid, and wherein the slot is provided on the lid.
(syringe 48 is received in cavity 17 and secured in place by a closing of cover member 11 coupling to cover member 12; fig 2)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, the lid covering a slot teachings of Claes to the modified system of Gyory in view of Wang, by disposing a cover member taught by Claes to cover the port 1120 of Wang and secure the syringe 38 of Gyory in place, in order to advantageously arrive at an invention which can protect a user from risks associated with contaminated medical devices or needle-prick injuries.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly subject matter of the independent claim(s) pertaining to a user device holder having a light guide and lens system for imaging a device retained in a slot of the user device holder:
US 20140154152 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
