CTNF 18/414,593 CTNF 81760 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This office action is in response to applicant’s communication of 1/17/2024. Currently claims 1-20 are pending and rejected below. Information Disclosure Statement The information disclosure statement (IDS) submitted on 7/3/2024 is being considered by the examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim(s) 1-8, and 11-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2018/0333543 A1 (Diaz et al.) . Diaz teaches a sensor assembly (see abstract), comprising: an image capture device (para [0100] and 160 for example) configured to capture one or more images; a user feedback device (para [0106] and computing device for example) configured to provide an audible and/or visual output to a user; a mechanical connector (150 for example) configured to connect the sensor assembly to a lumen and/or a syringe (112 for example) configured to be connected to the lumen; and a processor (para [0110]) coupled to a memory and configured to: obtain the one or more the images captured by the image capture device (para [0100]); determine, based on the one or more images, information associated with a medication delivery for a patient; and control (again para [0100]), based on the information, the user feedback device to provide the audible and/or visual output to the user (para [0110]). Concerning claim 2 and the image capture device is configured to automatically capture the one or more images in response to a connection of the mechanical connector to the lumen and/or the syringe (see para [0031-0032]). Concerning claim 3 and a housing (150) including the image capture device (152, 158, 160), the user feedback device, and the processor (172 for example), wherein the mechanical connector extends from a sidewall of the housing (see figure 7 for example), wherein a field-of-view of the image capture device (160 for example) is fixed relative to the housing and/or the mechanical connector, and wherein, with the mechanical connector connecting the sensor assembly to the lumen and/or the syringe connected to the lumen, a field-of-view of the image capture device includes the syringe (see figures 6-7, 10a-10f). Concerning claim 4 and the mechanical connector includes an opening in a sidewall extending from the housing, and wherein the opening is configured to receive the lumen and/or a barrel of the syringe (see opening 162). Concerning claim 5 and the image capture device is configured to automatically capture the one or more images in response to the lumen and/or the barrel of the syringe being received in the opening (see para [0031-0032]). Concerning claim 6 and the mechanical connector includes a rigid deformable clip (see para [0113] and opening 162). Concerning claim 7 and the mechanical connector includes butterfly-style clip (it is examiner’s position that this is a butter fly style clip 150/162 as the two wings form the opening 162 between them in a butterfly shape). Concerning claim 8 and the image capture device is configured to automatically capture the one or more images in response to an actuation of the butterfly-style clip (see para [0010] and [0114] and it is examiner’s position that this reading would occur whenever the device is attached or clipped to the syringe). Concerning claim 11 and the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: detecting, in the one or more images, a patient identifier element associated with the patient; and determining, based on the detected patient identifier element, patient information associated with the patient, wherein the patient information includes an indication of a type and/or a dosage of a medication to be delivered to the patient and/or a unique identifier of a medication delivery lumen to be used to deliver the medication to the patient (see para [0106]-[0107]). Concerning claim 11 and the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: detecting, in the one or more images, a syringe identifier element associated with the syringe; and determining, based on the detected syringe identifier element, syringe information associated with the syringe, wherein the syringe information includes a type and/or a dosage of a medication contained in the syringe (see para [0106]-[0107]). Concerning claim 13 and the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: determining, based on the patient information and the syringe information, whether the medication contained in the syringe is a correct type and/or a correct dosage of the medication to be delivered to the patient; and controlling, based on whether the medication contained in the syringe includes the correct type and/or the correct dosage of the medication to be delivered to the patient, the user feedback device to provide the audible and/or visual output to the user (again see para [0106]-[0107]). Concerning claim 14 and the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: detecting, in the one or more images, a lumen identifier element associated with the lumen; and determining, based on the detected lumen identifier element, lumen information associated with the lumen, wherein the lumen information includes a unique identifier of the lumen (see para [0106] and examiner is of the position that the syringe is a lumen and lumen type). Concerning claim 15 and the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: determining, based on the lumen information and the syringe information, whether the lumen is the medication delivery lumen to be used to deliver the medication to the patient; and controlling, based on whether the lumen includes the medication delivery lumen to be used to deliver the medication to the patient, the user feedback device to provide the audible and/or visual output to the user (again see para [0106] and examiner is of the position that the syringe is a lumen and lumen type and further the disclosure as discussed above concerning the feedback and audible/visual output to user). Concerning claim 16 and the one or more images include a series of images including the syringe during the medication delivery for the patient, and wherein the at least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: detecting, in the one or more images, a movement of a stopper and/or a plunger rod of the syringe; determining, based on the detected movement, at least one delivery parameter of the following delivery parameters: a patency of the lumen; an average rate of delivery of the medication; a current rate of the delivery of the medication; a steadiness index of the current rate of delivery of the medication; a volume of the medication delivered; a completion of the medication delivery for the patient; or any combination thereof; and controlling, based on the at least one delivery parameter, the user feedback device to provide the audible and/or visual output to the user (again see para [0106]-[0107]). Concerning claim 17 and the one or more images include a series of images including one or more flush syringes connected to the lumen during a flush procedure, and wherein the least one processor is configured to determine, based on the one or more images, the information associated with the medication delivery for the patient by: detecting, in the one or more images, a lumen identifier element associated with the lumen; determining, based on the detected lumen identifier element, lumen information associated with the lumen, wherein the lumen information includes a unique identifier of the lumen; detecting, in the one or more images, one or more flush syringe identifier elements associated with the one or more flush syringes; determining, based on the one or more detected flush syringe identifier elements, flush syringe information associated with the one or more flush syringes, wherein the flush syringe information includes a number of flush syringes used for the flush procedure; and determining, based on the lumen information and the flush syringe information, that the flush procedure has been performed for the lumen, a number of flush syringes used for the flush procedure, and/or a type of the flush procedure performed (see para [0106] and examiner is of the position that the drug type data and frequency would detect flush or priming procedures). Concerning clam 18 and wireless communications circuitry configured to wirelessly communicate with an external computing device, wherein the at least one processor is configured to control the wireless communication circuitry to wirelessly communicate the information associated with the medication delivery for the patient to the external computing device (see para [0031]-0032] and examiner is of the position that the device would teach wireless circuitry as claimed above). Concerning claim 19 and a system, comprising: an external computing device (para [0100]); and one or more sensor assemblies (152, 158, 160), each sensor assembly of the one or more sensor assemblies including: an image capture device configured to capture one or more images, a user feedback device (see para [0058 and output devices such as displays, speakers, and haptic feedback) configured to provide an audible and/or visual output to a user, and a mechanical connector (150) configured to connect the sensor assembly to a lumen and/or a syringe (112) configured to be connected to the lumen; and a wireless communication link (see para [0031]-0032] and examiner is of the position that the device would teach wireless circuitry as claimed above). configured to facilitate communication between the external computing device, wherein the external computing device includes a processor coupled to a memory and configured to, for each sensor assembly: receive the one or more the images captured by the image capture device; determine, based on the one or more images, information associated with a medication delivery for a patient; and control, based on the information, via the wireless communication link, the user feedback device of the sensor assembly to provide the audible and/or visual output to the user (see para [0100] and examiner is of the position that the device would teach as claimed above). Concerning claim 20 and a method, comprising: capturing, with an image capture device of a sensor assembly, one or more images (see para [0100]), wherein the sensor assembly includes a mechanical connector (150) connecting the sensor assembly to a lumen and/or a syringe (112) configured to be connected to the lumen; obtaining, with at least one processor (para [0110]) of the sensor assembly, the one or more the images captured by the image capture device; determining, with the at least one processor of the sensor assembly, based on the one or more images, information associated with a medication delivery for a patient; and controlling, with the at least one processor of the sensor assembly, based on the information, a user feedback device of the sensor assembly to provide an audible and/or visual output to the user (see para [0100]-[0103]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0333543 A1 (Diaz et al.) in view of US 2013/0306543 A1 (Beisser) . Concerning claim 9 Diaz discloses the claimed invention except for the arcuate jaws attachment structure. Beisser teaches the mechanical connector (as in figures 1-3) includes arcuate jaws (2/3) configured to be actuated by one or more buttons (edges of 2/3), each arcuate jaw connected at a first end to a hinge (near 11) and including an inwardly facing surface (interior surface of 2/3) configured to enclose around an exterior surface of the lumen and/or the syringe, the hinge configured to urge second ends of the arcuate jaws together (urging closed via spring 7), and the one or more buttons configured to cause the arcuate jaws to separate from each other in response to an actuation of the one or more buttons (see para [0035]) to provide and connect a sensor to a one time medical device such as a syringe in order to affix a sensor to the device for medical treatment and monitoring. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Diaz with the arcuate jaws attachment structure as taught by Beisser, since such a modification would provide the method with the arcuate jaws attachment structure to provide and connect a sensor to a one time medical device such as a syringe in order to affix a sensor to the device for medical treatment and monitoring Concerning claim 10 and the image capture device is configured to automatically capture the one or more images in response to the actuation of the one or more buttons (see para [0031-0032]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX). 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 at (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. PHILLIP A. GRAY Primary Examiner Art Unit 3783 /PHILLIP A GRAY/Primary Examiner, Art Unit 3783 Application/Control Number: 18/414,593 Page 2 Art Unit: 3783 Application/Control Number: 18/414,593 Page 3 Art Unit: 3783 Application/Control Number: 18/414,593 Page 4 Art Unit: 3783 Application/Control Number: 18/414,593 Page 5 Art Unit: 3783 Application/Control Number: 18/414,593 Page 6 Art Unit: 3783 Application/Control Number: 18/414,593 Page 7 Art Unit: 3783 Application/Control Number: 18/414,593 Page 8 Art Unit: 3783 Application/Control Number: 18/414,593 Page 9 Art Unit: 3783
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