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 .
Status of Claims
The following is in response to the amendments and arguments filed 12/1/2025 and entered with the RCE filed 12/12/2025. Claims 1-17 are pending. Claims 16 and 17 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Election/Restrictions
Claims 16 and 17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/1/2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation (see 37 CFR 1.75 (i)).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Applicant’s arguments and amendments have overcome the prior 35 USC 112 (a) rejections and as such, the rejections are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (WO 2019/096875), hereinafter Wendland, in view of Burkholz (US 2015/209114), hereinafter Burkholz.
As per Claim 1, Wendland teaches a computer implemented method for supporting an operation of a drug delivery device for injection or infusion (see: Wendland, Abstract; pg. 1, lines 25-35, is met by a system containing a processor and display to support the use of an injection device), the method comprising the steps of: using a camera of a mobile device to capture a marker arranged on the drug delivery device representative of a position of the drug delivery device (see: Wendland, pg. 2, lines 9-13; pg. 6, lines 11-19; Claim 3, is met by the processor determining an injection device depended on the detected form, color, tag, and/or label); and using the mobile device to display, in a real-time camera preview on a display screen of the mobile device, the provided drug delivery device data, the marker and the drug delivery device (see: Wendland, pg. 7, lines 31-37; pg. 8, lines 1-10 figs. 1-2; Claim 5, is met by the display of injection device data, including the ID and instructions, the label/tag, and the injection device in the camera overlay; p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), wherein the display of the provided drug delivery device data is dynamically arranged with respect to the display of the marker and the drug delivery device in the real time camera preview such that a movement of the marker in the real time camera preview causes a dynamic rearrangement and movement of the display of the provided drug delivery device data with respect to a positions of the drug delivery device and the marker in the real time camera preview (see: Wendland, pg. 2, lines 25-37, lines 21-26; pg. 3, lines 31-38; fig. 1, is met by the display overlay moving synchronously with the camera such that the augmented reality is always within camera view, as well as the altering of the location of the display based on ambient light, injection site and p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), and wherein the drug delivery device data in the real time camera preview comprises device- specific text instructions and an arrow pointing to or a sign indicating where on the drug delivery device a user is to carry out the device-specific text instructions (see: Wendland, pg. 3, lines 8-10; pg. 5, lines 5-6; fig. 1, is met by the displaying of usage instructions regarding the injection device and arrows indicating relevant portions of the injection device in the camera overlay).
Wendland fails to specifically teach the following limitation(s), which is/are taught by Burkholz: using the mobile device to transmit camera data of the camera relating to the captured marker to a provider (see: Burkholz, paragraphs 62 and 74; fig.1, is met by the transmission of electronic record data of a patient captured by the camera to the remote technician, wherein the patient ID that's tagged to the medical device is included in said data); using the mobile device to receive drug delivery device data transmitted from the provider in response to the transmitted camera data (see: Burkholz, paragraphs 39 and 67, is met by instructions for performing a fluid delivery procedure being provided by a technician in response to the transmitted camera data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the operations of Wendland to include the communication of camera data retrieved by the mobile device to a provider and the receiving of drug delivery device data from a provider, as taught by Burkholz, with the motivation of reducing the risk of medication error at the point of administration (see: Burkholz, paragraph 39).
As per Claim 3, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches wherein the instructions comprise one or more of: operation information about adjusting settings of the drug delivery device, preparing the drug delivery device for an injection or an infusion, exchanging a cartridge in the drug delivery device, mounting a needle, correcting a set dose, administering a set dose or disposal of the drug delivery device (see: Wendland, pg. 3, lines 8-10; pg. 5, lines 5-6; fig. 1, is met by the displayed instructions including directions as to the administration of the injection device by the user).
As per Claim 4, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches wherein the display of the drug delivery device data in the real time camera preview is implemented through a website displayed on the display screen by a web browser of the mobile device (see: Wendland, pg. 3, lines 1-3; fig. 1, is met by the camera overlay being provided on a webserver of a mobile device).
As per Claim 5, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches wherein the drug delivery device is configured as a pen shaped injector or a patch injector (see: Wendland, fig. 1, is met by the injection device being a syringe/pen-shaped device).
As per Claim 10, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches an electronic module integrated in or attachable to the drug delivery device, the electronic module adapted to monitor a drug delivery process executed by the drug delivery device, wherein the method further comprises the steps of: using the electronic module to record delivery data related to the drug delivery process (see: Wendland, pg. 2, lines 22-26; pg. 7, lines 22-24, is met by the device label or tag storing the drug delivery device information and the injection device comprising an electronic comprising a controller, a wireless transceiver, and a non-volatile memory); using the electronic module to transmit the delivery data to the mobile device (see: Wendland, pg. 2, lines 9-20; fig. 1, is met by the obtaining of drug delivery device information by scanning a device label or tag using the mobile device camera); and using the mobile device to display the delivery data in the real time camera preview (see: Wendland, pg. 2, lines 22-26; pg. 3, lines 12-14; fig. 1 and fig. 3, is met by the overlay comprising information such as proper use of injection, history of the usage of the injection device, and other helpful guidance in the administration of the device).
As per Claim 11, Wendland and Burkholz teach the limitations of Claim 10. Wendland further teaches wherein the delivery data related to the drug delivery process comprise at least one of: an amount of a last administered dose, an indication of time of a last dose, an amount of a next dose to be administered, an indication of time of a next dose to be administered, or a total amount of an administered dose (see: Wendland, pg. 3, lines 12-14, is met by the use history data – which can be displayed in the overlay – including time and date stamps of a usage of the injection device).
As per Claim 12, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches pairing the mobile device with a remote computing device (see: Wendland, pg. 6, lines 21-25, is met by the connection of a computer to the smartphone); and using the mobile device to transmit camera data captured by the camera of the mobile device to the remote computing device (see: Wendland, pg. 6, lines 21-25, is met by the captured image from the mobile device being processed by a computer coupled to the smartphone that has superior computing resources to that of the smartphone).
As per Claim 13, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches further comprising the step of using the mobile device to output an acoustic signal based on the drug delivery device data received from the provider (see: Wendland, pg. 10, lines 5-13, is met by usage feedback being communicated to users in the form of an audible alert).
As per Claim 14, Wendland teaches a system comprising a microprocessor with a computer program product stored thereon, the computer program product comprising instructions which, when the program is executed by a computing device (see: Wendland, Abstract; pg. 2, lines 9-37; pg. 3, lines 5-19; Claims 1, 3-6, and 10, is met by the processor executing the steps prescribed by the software), cause the computing device to carry out the steps of: receiving, from a mobile device, camera data of a camera of the mobile device, the camera data relating to a captured marker arranged on a drug delivery device, wherein the marker is representative of a position of the drug delivery device (see: Wendland, pg. 2, lines 9-13; pg. 6, lines 11-19; Claim 3, is met by the processor determining an injection device depended on the detected form, color, tag, and/or label); and causing the provided drug delivery device data, the marker and the drug delivery device to be displayed in a real time camera preview on a display screen of the mobile device (see: Wendland, pg. 7, lines 31-37; pg. 8, lines 1-10 figs. 1-2; Claim 5, is met by the display of injection device data, including the ID and instructions, the label/tag, and the injection device in the camera overlay; see p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), wherein the drug delivery device data is dynamically arranged with respect to the display of the marker and the drug delivery device in the real time camera preview such that a movement of the marker in the real time camera preview causes a dynamic rearrangement and movement of the display of the provided drug delivery device data in the real time camera preview (see: Wendland, pg. 2, lines 25-37, lines 21-26; pg. 3, lines 31-38; fig. 1, is met by the display overlay moving synchronously with the camera such that the augmented reality is always within camera view, as well as the altering of the location of the display based on ambient light, injection site; see p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), and wherein the drug delivery device data with respect to a position of the drug delivery device and the marker in the real time camera preview comprises device-specific text instructions and an arrow pointing to or a sign indicating where on the drug delivery device a user is to carry out the device-specific text instructions (see: Wendland, pg. 3, lines 8-10; pg. 5, lines 5-6; fig. 1, is met by the displaying of usage instructions regarding the injection device and arrows indicating relevant portions of the injection device in the real time camera overlay and p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly).
Wendland fails to specifically teach the following limitation(s), which is/are taught by Burkholz: providing, in response to the received camera data, drug delivery device data to the mobile device (see: Burkholz, paragraphs 39 and 67, is met by instructions for performing a fluid delivery procedure being provided by a technician in response to the transmitted camera data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the operations of Wendland to include the receiving of drug delivery device data from a provider, as taught by Burkholz, with the motivation of reducing the risk of medication error at the point of administration (see: Burkholz, paragraph 39).
As per Claim 15, Wendland teaches a mobile device configured to perform the steps of (see: Wendland, pg. 1, lines 29-31; pg. 2, lines 22-26; pg. 2, lines 36-37; pg. 3, lines 1-3; fig. 1, is met by the system being embodied by a mobile computing device, such as a smartphone): receiving, from a camera of the mobile device, a captured image of a marker arranged on a drug delivery device and representative of a position of a drug delivery device (see: Wendland, pg. 2, lines 9-13; pg. 6, lines 11-19; Claim 3, is met by the processor determining an injection device depended on the detected form, color, tag, and/or label); and displaying, in a real time camera preview on a display screen of the mobile device, the provided drug delivery device data, the marker and the drug delivery device (see: Wendland, pg. 7, lines 31-37; pg. 8, lines 1-10 figs. 1-2; Claim 5, is met by the display of injection device data, including the ID and instructions, the label/tag, and the injection device in the camera overlay and p. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), wherein the display of the provided drug delivery device data is dynamically arranged with respect to the display of the marker and the drug delivery device in the real time camera preview such that a movement of the marker in the real time camera preview causes a dynamic rearrangement and movement of the display of the provided drug delivery device data respect to a position of the drug delivery device and the marker in the real time camera preview (see: Wendland, pg. 2, lines 25-37, lines 21-26; pg. 3, lines 31-38; fig. 1, is met by the display overlay moving synchronously with the camera such that the augmented reality is always within camera view, as well as the altering of the location of the display based on ambient light, injection site and pg. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly), and wherein the drug delivery device data in the real time camera preview comprises device-specific text instructions and an arrow pointing to or a sign indicating where on the drug delivery device a user is to carry out the device-specific text instructions (see: Wendland, pg. 3, lines 8-10; pg. 5, lines 5-6; fig. 1, is met by the displaying of usage instructions regarding the injection device and arrows indicating relevant portions of the injection device in the camera overlay and pg. 10 lines 7-13 provides for “real time” software controls the user actions and fives feedback, if user is using correctly, the training continues showing the next step, if wrong, an alert is given and training is not continues until the user is able to perform the correctly).
Wendland fails to specifically teach the following limitation(s), which is/are taught by Burkholz: causing the mobile device to transmit data relating to the captured image of the marker to a provider (see: Burkholz, paragraphs 62 and 74; fig.1, is met by the transmission of electronic record data of a patient captured by the camera to the remote technician, wherein the patient ID that's tagged to the medical device is included in said data); receiving, in response to the transmitted camera data, drug delivery device data from the provider (see: Burkholz, paragraphs 39 and 67, is met by instructions for performing a fluid delivery procedure being provided by a technician in response to the transmitted camera data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the operations of Wendland to include the communication of camera data retrieved by the mobile device to a provider and the receiving of drug delivery device data from a provider, as taught by Burkholz, with the motivation of reducing the risk of medication error at the point of administration (see: Burkholz, paragraph 39).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (WO 2019/096875), hereinafter Wendland, in view of Burkholz (US 2015/209114), hereinafter Burkholz, further in view of Flexman (WO 2018/134143), hereinafter Flexman.
As per Claim 2, Wendland Burkholz teach the limitations of Claim 1. Wendland and Burkholz fail to specifically teach the following limitation(s), which is/are taught by Flexman: wherein the device-specific text instructions comprise operation information about setting a dose using the drug delivery device, and wherein the arrow or the sign show the user a direction a dose button or a dose sleeve of the drug delivery device should be rotated to set the dose (see: Flexman, pg. 4, lines 21-25; pg. 18, lines 5-15; figs. 3-4, is met by the virtual display indicating to a user which knobs of certain tools/devices to adjust and by how much).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the instructions of Wendland and Burkholz to include the visual instruction of which knobs to adjust and by how much, as taught by Flexman, with the motivation of providing guidance to a user (see: Flexman, pg. 2, lines 4-5).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (WO 2019/096875), hereinafter Wendland, in view of Burkholz (US 2015/209114), hereinafter Burkholz, further in view of Quintanilla (US 2015/0278467), hereinafter Quintanilla.
As per Claim 6, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches further comprising, prior to the step of using the camera of the mobile device to capture the marker, performing an authentication process, the authentication process comprising the steps of: using a sensor of the mobile device to recognize a machine-readable identification code and reading out information from the code, wherein the code is assigned to the drug delivery device (see: Wendland, pg. 6, lines 16-19 and lines 27-35, is met by the identification of the drug delivery device by the smartphone via an attached QR-tag, NFC and/or RFID tag).
Burkholz further teaches using the mobile device to automatically contact the provider based on the read out information (see: Burkholz, paragraph 60, is met by the confirmation icon displaying an alert if the associated medical device code indicates a device that should not be used for the prescribed procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Wendland and Burkholz to include the communication to a provider based on injection device alerts, as taught by Burkholz, with the motivation of preventing improper usage of medical devices (see: Burkholz, paragraph 60).
Wendland and Burkholz fail to specifically teach the following limitation(s), which is/are taught by Quintanilla: receiving a request to access camera data of the mobile device from the provider in response to contacting the provider (see: Quintanilla, paragraph 61; fig. 16, is met by the physician the photo button to send a request for access to the camera of a patient's mobile device); and receiving a manual confirmation by the user on the mobile device authorizing access to the camera data by the provider (see: Quintanilla, paragraph 61; fig. 16, is met by the permission request being approved by the user and consequently enabling camera access to the provider).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the authentication capabilities of Wendland and Burkholz to include a received for camera access from a physician and subsequent approval from a patient or user, as taught by Quintanilla, with the motivation of effectively recording image information of the patient (see: Quintanilla, paragraph 61).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendland (WO 2019/096875), hereinafter Wendland, in view of Burkholz (US 2015/209114), hereinafter Burkholz, further in view of DeSalvo (US 2017/03 12457), hereinafter DeSalvo.
As per Claim 7, Wendland and Burkholz teach the limitations of Claim 1. Wendland further teaches further comprising the steps of: using a sensor of the mobile device to recognize a machine-readable identification code and reading out information from the code, wherein the code is assigned to the drug delivery device (see: Wendland, pg. 6, lines 16-19 and lines 27-35, is met by the identification of the drug delivery device by the smartphone via an attached QR-tag, NFC and/or RFID tag).
Burkholz further teaches using the mobile device to transmit the read out information from the identification code to the provider (see: Burkholz, paragraph 67, is met by the operator “seeing” the injection apparatus and the wearable electronic device identifying the associated tags).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the operations of Wendland and Burkholz to include the communication of injector device information to a provider, as further taught by Burkholz, with the motivation of facilitating provider oversight of user administration (see: Burkholz, paragraph 67).
Wendland and Burkholz fail to specifically teach the following limitation(s), which is/are taught by DeSalvo: receiving, from the provider in response to the transmitted information, at least one of data relating to the drug delivery device and data relating to a medication contained in the drug delivery device (see: DeSalvo, paragraphs 55 and 58, is met by the computing system processing image data and providing said data to the provider, where the provider, in response, can communicate information regarding treatment modifications or adjustments assistance with proper use of autoinjector, information regarding product recalls, or combinations thereof); and using the mobile device to display, in the real time camera preview, the data received from the provider (see: DeSalvo, paragraph 55, is met by the data received from the doctor being communicated over a computer executable software application).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system functionalities of Wendland and Burkholz to include the features of a computing system processing image data and providing said data to the provider, where the provider, in response, can communicate information regarding treatment modifications or adjustments assistance with proper use of autoinjector, information regarding product recalls, or combinations thereof over a computer executable software application, as taught by DeSalvo, with the motivation of tracking patient compliance with a treatment plan and/or to determine efficacy of treatment (see: DeSalvo, paragraph 55).
As per Claim 8, Wendland, Burkholz, and DeSalvo teach the limitations of Claim 7. Wendland further teaches wherein the data relates to the medication contained in the drug delivery device and comprises at least one of: medication type, expiration of medication, or validity of medication (see: Wendland, pg. 8, lines 35-37, is met by the overlay informing the patient of the kind of drug and the drug itself).
As per Claim 9, Wendland, Burkholz, and DeSalvo teach the limitations of Claim 7. DeSalvo further teaches wherein the data relates to the medication contained in the drug delivery device, and wherein the provider compares the information about the medication with previously stored user-specific medication data (see: DeSalvo, paragraphs 55-56, is met by the doctor analyzing patient records to make recommendations with respect to the medication and the medication device), and the method further comprises the steps of: using the mobile device to receive from the provider a result of the comparison (see: DeSalvo, paragraphs 55-56, is met by the computer executable software application for communicating the above information and analyses to the patient device); and using the mobile device to display in the real time camera preview the result of the comparison (see: DeSalvo, paragraph 55, is met by the display of the interpreted data pertaining to a patient on a screen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the information communicated to and displayed on the interface of the wearable electronic device of Wendland, Burkholz, and DeSalvo to include a physician’s recommendation(s) with respect to the medication and the medication device, based on an analysis of patient medical records, as taught by DeSalvo, with the motivation of tracking patient compliance with a treatment plan and/or to determine efficacy of treatment (see: DeSalvo, paragraph 55).
Response to Arguments
Applicant's arguments filed 12/01/2025 (and entered 12/12/2025) have been fully considered but they are not persuasive.
In the Remarks, Applicant argues in substance that (1) the rejection of the claims under 35 U.S.C. § 103 should be withdrawn because the amended limitations are not rendered obvious by the combination of cited prior art. Specifically, Applicant argues “Wendland, at the very least, does not disclose Applicant's claim 1 recitation in which "the display of the provided frug delivery device data is dynamically arranged with respect to the display of the marker…such that a movement of the marker in the camera preview causes a dynamic rearrangement and movement of the display of the provided drug delivery device data”, or the similar recitations of amended claims 14 and 15.” (see remarks pages 8-9). Examiner respectfully disagrees. Wendland teaches the display overlay moving synchronously with the camera such that the augmented reality is always within camera view, as well as the altering of the location of the display based on ambient light (see pg. 2, lines 25-37, lines 21-26; pg. 3, lines 31-38; fig. 1). Further, the limitations to which applicant has argued are directed to intended results and not to positively recited limitations. The claim must distinguish in terms of structure not function. Recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
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 this case, modifying the operations of Wendland to include the communication of camera data retrieved by the mobile device to a provider and the receiving of drug delivery device data from a provider, as taught by Burkholz, because the risk of medication error at the point of administration is reduced (see: Burkholz, paragraph 39).
Further, the Manual of Patent Examining Procedure (MPEP) states that there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. The MPEP goes on to state several exemplary rationales that may support a conclusion of obviousness, which includes a motivation to combine the references provided with the prior art reference. Such a rationale has been recognized as providing support for the legal conclusion of obviousness (MPEP 2141). Therefore, Examiner finds Applicant’s argument non-persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Seiflein discloses a head mounted, wearable device for conveying information about the surrounding environment to a user and at least one imaging device configured to receive real-time images, and a feedback system configured to process the real-time images to obtain the information about the surrounding environment and to transmit the information.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kelly Campen whose telephone number is (571)272-6740. The examiner can normally be reached Monday-Thursday 6am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abhishek Vyas can be reached at 571-270-1836. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Kelly S. Campen
Primary Examiner
Art Unit 3691
/KELLY S. CAMPEN/Primary Examiner, Art Unit 3691