DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Regarding the rejection of claims under Double Patenting, this rejection has been updated in view of the current amendments.
Regarding the arguments against the rejection of claims under 35 USC 103, the Examiner respectfully disagrees. Applicant argues that Despa does not describe the mobile device configured to adapt at least one overlay depending on the injection-related information. Examiner asserts that these limitations are taught by Burkholz. Applicant further argues that a person of ordinary skill in the art would have no motivation to modify Burkholz with the teaching of Despa because doing so would have no apparent benefit or success. Examiner further asserts that Burkholz teaches of the display of the information, and the camera alone would not be able to sense environmental conditions such as temperature. As noted in the rejection, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have used environmental conditions as context of application of an injection device as in Despa in the system of Burkholz with the motivation of providing more pertinent information for a more accurate determination of compliance with a medication injection plan as taught by Despa over that of Burkholz.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”) as follows:
Regarding claim 1:
A system for supporting a use of an injection device, the system comprising: …; a display; (Claim 1 of 11631487 teaches “A system for supporting a use of an injection device, the system comprising: a display”)
a processor being configured to determine the injection device, to obtain data on the use of the determined injection device, …, (Claim 1 of 11631487 teaches “a processor being configured to determine the injection device, to obtain data on the use of the determined injection device, and to add at least one overlay on the display,”)
wherein the at least one overlay is generated depending on the obtained data of the use of the determined injection device, (Claim 1 of 11631487 teaches “wherein the at least one overlay is generated depending on the obtained data of the use of the determined injection device,”)
wherein the processor is configured to adapt the at least one overlay depending on a context of application of the injection device, the context of application of the injection device comprising one or more environmental conditions including at least one of the following: ambient light, time, date and temperature; and (Claim 1 of 11631487 teaches “wherein the processor is configured to adapt the at least one overlay depending on a context of application of the injection device, the context of application of the injection device comprising at least one of the following: ambient light, time; date, temperature, use history of the injection device, drug, injection site, and dosage, and”, where the ambient light, time, date and temperature are interpreted as the environmental conditions)
11631487 however does not teach:
an image capturing components configure to capture an image of the injection device;
… and to display the captured image of the injection device on the display together with at least one overlay
wherein adapting of the at least one overlay depending on the context of application of the injection device comprises at least one of the following: displaying the overlay in different colors, altering a size of the overlay, and selecting a position of the overlay on the display.
Burkholz however teaches before the effective filing date of the current invention the following: [0054]- use of use of camera to capture image of position markers from the fluid delivery apparatus (interpreted as an image capturing component configured to capture an image of the injection device). [0061]- image capture device can capture images of the fluid delivery procedure. [0063]- when the device is used in a procedure, an overlay of a virtual layer is shown to the user on top of the reality layer (interpreted as displaying the captured image of the injection device on the display together with the least one overlay). [0043]- wearable electronic device described with a display for a user (the device is interpreted as the system for supporting a use of an injection device). [0063]- when an injection procedure is occurring, the virtual, projected layer of the display of the device has an interface showing a heading with information when the injector is in use as further illustrated in Figure 2 (interpreted as the overlay being generated dependent on the obtained used data of the injection device). [0089]- as seen in Figure 8, in the projected layer in the field of view of the user, different colors can be used to show different vein traces or different vein sizes (interpreted as adapting the overlay depending on the context by displaying the overlay in different colors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have modified the system recited in claim 1 of 11631487 to include the image capture components capturing images of the injector, display the captured image of the injection device on the display together with at least one overlay, and adapting of overlay depending on context of application of the injection device comprising displaying the overlay in different colors with the virtual layer as taught by Burkholz in order to provide improved visualization to improve an injection procedure as described in [0096] of Burkholz.
Claims 2, 3, 4, 5, 6, 7, and 8 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 17, 4, 5, 6, and 7 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”), respectively.
Claim 9 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”) as follows:
Regarding claim 9:
A method comprising; … determining an injection device, (Claim 13 of 11631487 recites A method comprising determining an injection device,)
obtaining data on a use of the determined injection device, and (Claim 13 of 11631487 recites obtaining data on a use of the determined injection device, and)
… wherein the at least one overlay is generated depending on the obtained data of the use of the determined injection device, and (Claim 13 of 11631487 recites adding at least one overlay on a display, wherein the at least one overlay is generated depending on the obtained data of the use of the determined injection device)
adapted depending on a context of application of the injection device, the context of application of the injection device comprising one or more environmental conditions including at least one of the following: ambient light, time, date, and temperature; and (Claim 13 of 11631487 recites adapted depending on a context of application of the injection device, the context of application of the injection device comprising at least one of the following: ambient light, time, date, temperature, use history of the injection device, drug, injection site, and dosage, and where the ambient light, time, date and temperature are interpreted as the environmental conditions)
11631487 however does not teach:
capturing an image of an injection device using an image capturing component,
displaying the captured image of the injection device on a display tighter with at least one overlay
wherein adapting of the at least one overlay depending on the context of application of the injection device comprises at least one of the following: displaying the overlay in different colors, altering a size of the overlay, and selecting a position of the overlay on the display.
Burkholz however teaches before the effective filing date of the current invention the following: [0054]- use of use of camera to capture image of position markers from the fluid delivery apparatus (interpreted as an image capturing component configured to capture an image of the injection device). [0061]- image capture device can capture images of the fluid delivery procedure. [0063]- when the device is used in a procedure, an overlay of a virtual layer is shown to the user on top of the reality layer (interpreted as displaying the captured image of the injection device on the display together with the least one overlay). [0043]- wearable electronic device described with a display for a user (the device is interpreted as the system for supporting a use of an injection device). [0063]- when an injection procedure is occurring, the virtual, projected layer of the display of the device has an interface showing a heading with information when the injector is in use as further illustrated in Figure 2 (interpreted as the overlay being generated dependent on the obtained used data of the injection device). [0089]- as seen in Figure 8, in the projected layer in the field of view of the user, different colors can be used to show different vein traces or different vein sizes (interpreted as adapting the overlay depending on the context by displaying the overlay in different colors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have modified the system recited in claim 1 of 11631487 to include the image capture components capturing images of the injector, display the captured image of the injection device on the display together with at least one overlay, and the adapting of overlay depending on context of application of the injection device comprising displaying the overlay in different colors with the virtual layer as taught by Burkholz in order to provide improved visualization to improve an injection procedure as described in [0096] of Burkholz.
Claims 10, 11, and 12 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, and 17 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”), respectively.
Claim 13 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”) as follows:
Regarding claim 13:
A device comprising: a processor, a memory, a display, a camera, and software stored in a non-volatile part of the memory, (Claim 17 of 11631487 teaches “A device comprising: a processor, a memory, a display, a camera, and software stored in a non-volatile part of the memory,”)
wherein the software configures the processor of the device to capture one or more images of an injection device with the camera, to show a captured image of the injection device on the display, to determine the injection device, to obtain data on use of the determined injection device and to add at least one overlay on the display, (Claim 17 of 11631487 teaches “wherein the software configures the processor of the device to capture one or more images of an injection device with the camera, to show a captured image of the injection device on the display, to determine the injection device, to obtain data on use of the determined injection device and to add at least one overlay on the display,”)
wherein the at least one overlay is generated depending on the obtained data on use of the determined injection device and adapted depending on a context of application of the injection device, the context of application of the injection device comprising one or more environmental conditions including at least one of the following: ambient light, time, date, and temperature; and (Claim 17 of 11631487 teaches “wherein the at least one overlay is generated depending on the obtained data on use of the determined injection device and adapted depending on a context of application of the injection device, the context of application of the injection device comprising at least one of the following: ambient light, time, date, temperature, use history of the injection device, drug, injection site, and dosage, and” where the ambient light, time, date and temperature are interpreted as the environmental conditions)
11631487 however does not teach:
wherein adapting of the at least one overlay depending on the context of application of the injection device comprises at least one of the following: displaying the overlay in different colors, altering a size of the overlay, and selecting a position of the overlay on the display.
Burkholz however teaches before the effective filing date of the current invention the following: [0043]- wearable electronic device described with a display for a user (the device is interpreted as the system for supporting a use of an injection device). [0063]- when an injection procedure is occurring, the virtual, projected layer of the display of the device has an interface showing a heading with information when the injector is in use as further illustrated in Figure 2 (interpreted as the overlay being generated dependent on the obtained used data of the injection device). [0089]- as seen in Figure 8, in the projected layer in the field of view of the user, different colors can be used to show different vein traces or different vein sizes (interpreted as adapting the overlay depending on the context by displaying the overlay in different colors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have modified the device recited in claim 17 of 11631487 to include the adapting of overlay depending on context of application of the injection device comprising altering display content with the virtual layer as taught by Burkholz in order to provide improved insertion success for a procedure as described in [0096] of Burkholz.
Claims 14, 15 and 16 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 2, and 3 of US 11631487 B2 (“11631487”) in view of US 2015/0209113 A1 to Burkholz et al. (“Burkholz”), respectively.
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.
Claims 1-16 are rejected under 35 USC 103 as being unpatentable over US 2015/0209113 A1 to Burkholz et al. (“Burkholz”) in view of US 2017/0304540 A1 to Despa et al. (“Despa”):
Regarding claim 1:
Burkholz teaches a system for supporting a use of an injection device, the system comprising: an image capturing component configured to capture an image of the injection device; a display; ([0043]- wearable electronic device described with a display for a user (the device is interpreted as the system for supporting a use of an injection device). [0053]- system can be used for with a fluid delivery apparatus including an injector. [0054]- use of use of camera to capture image of position markers from the fluid delivery apparatus (interpreted as an image capturing component configured to capture an image of the injection device). [0061]- image capture device can capture images of the fluid delivery procedure.)
a processor being configured to determine the injection device, to obtain data on the use of the determined injection device, and to display the captured image of the injection device on the display together with at least one overlay, ([0014]- description of the wearable electronic device including a microprocessor and how it is used for managing the visual display and processing acquired images. [0053]- the fluid delivery apparatus, the injector is identified and recognized (interpreted as the processor being configured to determine the injection device). [0058]- the system can identify when fluid delivery has occurred (interpreted as obtaining data on the use of the determined device). [0061]- image capture device can capture images of the fluid delivery procedure. [0063]- when the device is used in a procedure, an overlay of a virtual layer is shown to the user on top of the reality layer (interpreted as displaying the captured image of the injection device on the display together with the least one overlay).)
wherein the at least one overlay is generated depending on the obtained data of the use of the determined injection device, ([0063]- when an injection procedure is occurring, the virtual, projected layer of the display of the device has an interface showing a heading with information when the injector is in use as further illustrated in Figure 2 (interpreted as the overlay being generated dependent on the obtained used data of the injection device).)
wherein the processor is configured to adapt the at least one overlay depending on a context of application of the injection device, …; and ([0063]- on the virtual layer, information changes depending on events of the injection procedure including an indication of end dose as an icon (indicates that a context of application such as an event of end dose makes the overlay adapt).)
wherein adapting of the at least one overlay depending on the context of application of the injection device comprises at least one of the following: displaying the overlay in different colors, altering a size of the overlay, and selecting a position of the overlay on the display. ([0097]- Figure 10 for example shows the area of the overlay where the alert is visible to the user near the injection site (indicates that a position of the overlay is selected on the display near the real-life image of the injection field for the user to easily see the alert information).)
Burkholz however does not teach:
the context of application of the injection device comprising one or more environmental conditions including at least one of the following: ambient light, time, date, and temperature
Despa however teaches before the effective filing date of the current invention of a computing device to be used with an injection device to provide compliance during an injection [0033]. Injection related information from sensors includes information such as injection site temperature (interpreted as the context of application of the injection device comprising environmental conditions) [0092]. The sensor data is used for determining compliance with the treatment and can send an indication to the user with the determination [0050].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have used environmental conditions as context of application of an injection device as in Despa in the system of Burkholz with the motivation of providing more pertinent information for a more accurate determination of compliance with a medication injection plan as taught by Despa over that of Burkholz.
Claim 9 is rejected in a similar manner as claim 1.
Regarding claim 2:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the at least one overlay comprises textual information, a video, and/or one or more images. ([0063]- virtual layer shows textual information such as icons and alerts.)
Claims 10 and 15 are rejected in a similar manner as claim 2.
Regarding claim 3:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the processor is configured to determine the injection device with image processing of a captured image of the injection device, wherein the image processing comprises detecting a form of, a color of, a code, a tag and/or a label on the injection device, and ([0054]- use of digital camera to capture the code for identification of the fluid delivery apparatus where the tag is a code as described in [0053].)
determining the injection device depending on the detected form, color, code, tag, and/or label. ([0053]- the fluid delivery apparatus, the injector is identified and recognized based on code.)
Claims 11 and 16 are rejected in a similar manner as claim 3.
Regarding claim 4:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the processor is configured to determine the injection device by receiving injection device identification data. ([0053, 0054]- identification data from the code is used to identify and recognize (determine) the delivery injector.)
Claim 12 is rejected in a similar manner as claim 4.
Regarding claim 5:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches comprising an image capturing component to capture an image of the injection device, wherein the processor is configured to display the captured image of the injection device on the display together with the at least one overlay. ([0054]- digital camera captures image of the identification tag of the fluid delivery apparatus (the injector) and further captures images of the injector including the syringe barrel and plunger as described in [0059]. [0063]- the system shows the injector in the reality layer through the display with a virtual layer on top of the reality image as further shown in Figure 2.)
Regarding claim 6:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the processor is configured to generate the at least one overlay by loading the data on the use of the determined injection device from an internal storage and/or from an external storage by a data connection. ([0065]- patient ID can be scanned by the system to retrieve their medical records, where the records store information such as amount of fluid injected during the procedure, and this information is provided to the wearer of the wearable electronic device via the display (indicates that retrieving the use data of the injector from storage can be used to generate the overlay).)
Regarding claim 7:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the processor is configured to detect a user action and to adapt the overlay depending on the detected user action. ([0063]- the action of injecting using the injector is detected by the system and an icon can be generated to indicate the end of dose (interpreted as detecting a user action and adapting the overlay accordingly).)
Regarding claim 8:
Burkholz/Despa teaches all of the limitations of claim 1. Burkholz further teaches wherein the processor is configured to store data regarding a use history of the injection device. ([0061]- fluid delivery procedure (the use history of the injection device being used in the procedure) can be stored in patient’s electronic record.)
Regarding claim 13:
Burkholz teaches a device comprising: a processor, a memory, a display, a camera, and software stored in a non-volatile part of the memory, ([0043]- wearable electronic device described with a display for a user (the device is interpreted as the system for supporting a use of an injection device). [0053]- system can be used for with a fluid delivery apparatus including an injector. [0054]- camera is part of the wearable electronic device.)
wherein the software configures the processor of the device to capture one or more images of an injection device with the camera, to show a captured image of the injection device on the display, to determine the injection device, to obtain data on use of the determined injection device and to add at least one overlay on the display, ([0054]- digital camera captures image of the identification tag of the fluid delivery apparatus (the injector) and further captures images of the injector including the syringe barrel and plunger as described in [0059]. [0063]- the system shows the injector in the reality layer through the display with a virtual layer on top of the reality image as further shown in Figure 2. [0014]- description of the wearable electronic device including a microprocessor and how it is used for managing the visual display and processing acquired images. [0053]- the fluid delivery apparatus, the injector is identified and recognized (interpreted as the processor being configured to determine the injection device). [0058]- the system can identify when fluid delivery has occurred (interpreted as obtaining data on the use of the determined device). [0063]- the virtual layer on the display is part of the wearable device for a user to see in the wearable electronic device (interpreted as the overlay on the display).)
wherein the at least one overlay is generated depending on the obtained data on use of the determined injection device and adapted depending on a context of application of the injection device,…; and ([0063]- on the virtual layer, information changes depending on events of the injection procedure including an indication of end dose as an icon (indicates that a context of application such as an event of end dose makes the overlay adapt).)
wherein adapting of the at least one overlay depending on the context of application of the injection device comprises at least one of the following: displaying the overlay in different colors, altering a size of the overlay, and selecting a position of the overlay on the display. ([0097]- Figure 10 for example shows the area of the overlay where the alert is visible to the user near the injection site (indicates that a position of the overlay is selected on the display near the real-life image of the injection field for the user to easily see the alert information).)
Burkholz however does not teach:
the context of application of the injection device comprising one or more environmental conditions including at least one of the following: ambient light, time, date, and temperature
Despa however teaches before the effective filing date of the current invention of a computing device to be used with an injection device to provide compliance during an injection [0033]. Injection related information from sensors includes information such as injection site temperature (interpreted as the context of application of the injection device comprising environmental conditions) [0092]. The sensor data is used for determining compliance with the treatment and can send an indication to the user with the determination [0050].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have used environmental conditions as context of application of an injection device as in Despa in the device of Burkholz with the motivation of providing more pertinent information for a more accurate determination of compliance with a medication injection plan as taught by Despa over that of Burkholz.
Regarding claim 14:
Burkholz/Despa teaches all of the limitations of claim 13. Burkholz further teaches wherein the device is a smartphone, a Personal Digital Assistant, a tablet or laptop computer, or a head-mounted display device. ([0043]- glasses is the head mounted display device)
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
Prosecution Insights