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 1/27/2026. As directed by the amendment: claim(s) 25-26 have been cancelled, and 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 1/27/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 7:
Applicant's present amendment resolves the preceding office actions stated 112b 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:
"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"
In this regard applicant alleges that the prior art of Wang, which was relied upon for such a teaching in the preceding office action, is silent regarding aligning the camera of its user device and the test strip or that such a configuration would be advantageous. Applicant argues that because Wang is silent in this regard there is no teaching, suggestion, or motivation for such a combination of the prior art presented in the preceding office action would rely upon impermissible hindsight.
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).
However, Wang is explicit in its description of its invention as "a smartphone, including diagnostic software and a camera, may be docked onto the reader so that the camera of the phone is coupled to a diffuser for imaging test strips or other test cartridges provided to the reader. Preferably, the diagnostic software is configured to interpret an image of the strip and provide diagnostic feedback via the interface of the phone". Accordingly, the lens aperture 1112 of docking station 1100 is coupled to camera lens 2200 of smart phone 2000, when smart phone 2000 has been docked in station 1100, and aligns the camera lens 2200 such that an image of the test cartridge 3000, see paragraph 53 of Wang. Examiner also provides detailed annotations of Wang's figures, below, demonstrating that the Wang's case receives a phone in a manner such that an element to imaged is within the field of view of the camera on the phone. Thus, Wang is explicit in that its case aligns the camera of a user device with an element to be imaged.
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In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Examiner detailed a multitude of reasons why a person of ordinary skill in the art in possession of the prior art would be motivated to combine them together. Such as reducing cross-contamination of an element to be imaged and a smart phone, see paragraph 14 of Wang. It is well understood to a person of ordinary skill in the art that test strips, test cartridges, and drug delivery devices may be contaminated with biological fluids, see paragraph 6 of Wang, during regular use and thus should be avoided from contacting certain other elements to avoid the propagation of certain pathogens. Likewise it is well understood by a person of ordinary skill in the art that introducing other contaminants, such as from a phone or external device, to devices which may contact a biological specimen after contamination, such as test strips and drug delivery devices, impose certain risks of then passing on those other contaminants to the biological specimen, possibly delivering a lethal pathogen. Further one would be motivated to make the combine the prior art in the noted manner, as Wang's invention provides an advantageous additional light source to cooperate with a Camera's light source to provide illuminate the target to be imaged, see paragraph 53-54 of Wang.
Applicant argues that a person of ordinary skill in the art would not have been motivated to combine any of the prior art relied upon in preceding office action for any of the claimed combinations of features. However, applicant has not applied nor provided detailed or sufficient arguments for examiner in what manner applicant considers the references and/or office action lacking with regard to these claim features.
Examiner's preceding and present office action are clear in their reasoning and motivation for why a person of ordinary skill in the art would arrive at the claimed invention when in possession of the prior art of record.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-24 and 27-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 15, 28, and 32,
The claims recite “wherein the second wall comprises an opening configured to align with the camera of the user device and a flash light of the user device”. However, applicant’s disclosure only states that second wall 504 comprises a lens system 508, such a lens system which is positioned to align with a camera of the user device and such a lens system which also comprises a light guide to lead light from the flash light of the user device to the drug delivery device, see page 10 line 21-27. Applicant’s fig 13 illustrating this lens system 508, relies upon a simple rectangular shape with a distinct lack of three-dimensional geometry so as to suggest that it comprises an opening in the second wall 504. There is no further disclosure describing any sort of opening, aperture, orifice, or chasm as performing the claimed alignment of a camera/flashlight.
Accordingly, applicant’s original disclosure does not reasonably convey to one skilled in the relevant art that the inventor(s) were in possession of the claimed invention at the time of filing.
Regarding claim 16-24, 27-31, and 33-34
The above claims are at least rejected for being dependent upon the rejected independent claim incorporating new subject matter.
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 an opening configured to align with the camera of the user device and a flash light 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 to have opening which algins with the camera and flashlight of the user device)
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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 an opening configured to align with the camera of the user device and 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 an opening configured to align with the camera of the user device and a flash light 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 to have opening which algins with the camera and flashlight of the user device)
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 an opening configured to align with the camera of the user device and 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)
an opening configured to align with the camera of the user device and a flash light of the user device:
(see examiner’s annotation of Wang’s fig 9b+12 demonstrating the manner by which the first wall is considered to have opening which algins with the camera and flashlight of the user device)
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
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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