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 .
Formal Matters
Applicant's response, filed 23 January 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 13-15, 17-22, 33, and 45-51 are currently pending and have been examined.
Claims 13-15, 17-22, 33, and 45-51 have been rejected.
Priority
The instant application claims the benefit of priority under 35 U.S.C 119(e) or under 35 U.S.C. § 120, 121, or 365(c). Accordingly, the effective filing date for the instant application is 28 August 2020 claiming benefit to Provisional Application 63/071,794.
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.
Claims 13-15, 17-20, 22, 33, 45-49, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Fryman (US 2020/0335195)[hereinafter Fryman], in view of Anderson (AU 2014/271345)[hereinafter Anderson], further in view of Dutta et al. (US 10751259)[hereinafter Dutta].
As per Claim 13, Fryman teaches the following:
a first clinical supply pack (Abstract, paragraphs 6-8, is met by the met by the medical containers containing medical fluid that comprise the infusion device unit)
comprising: packaging (Abstract, paragraphs 6, is met by medication containers housing medication)
a supply of clinical product stored in at least one storage container, the at least one storage container being sealed within the packaging for distribution (Abstract, paragraphs 6-8 and 113, is met by the medication containers housing the medication or therapeutic material in a pre-filled or pre-packaged environment)
a processor in communication with the electronic label (paragraphs 31 and 67, is met by the processors associated with the infusion system and pharmacy filing system)
wireless communication circuitry in communication with the processor (paragraphs 40 and 50, is met by wireless communication with the medicine containers, infusion devices, and the communication interfaces)
a memory in communication with the processor; and computer-executable instructions stored in the memory (paragraphs 88 and 90, is met by the memory that stores instructions relating to the infusion system)
which, when executed by the processor, cause the first clinical supply pack to: establish a wireless communications link with a communication device (paragraphs 45 and 96-97, fig. 11, is met by the user device communicating wirelessly with the infusion devices)
receive, from the communication device via the wireless communications link while the first clinical supply pack is sealed for distribution, labeling information (paragraphs 37-38, is met by the pharmacy filling system and the constituent electronic components supplying information to the electronic medical label)
comprising information regarding a first patient, a dosing regimen, and safety information (paragraph 31, is met by the label information including the patient name for whom the medication is intended to be administered, the parameters of administration, disposal instructions, and container integrity information)
visually display the labeling information on the electronic display of electronic label (paragraphs 103-104, is met by an affixed label that displays the machine-readable clinical information of the medicine container)
receive, from the communication device via the wireless communications link while the first clinical supply pack is sealed for distribution, a set of labeling rules comprising an expiration date of the supply of clinical product (paragraphs 31 and 96, is met by the labeling information including the expiration date of the administered fluid)
and further receive a serialization of the first clinical supply pack (paragraph 48-49, is met by a barcode with a unique infusion order and identification on the seal medication package)
adjust the labeling information displayed on the electronic display in accordance with the labeling rules (paragraphs 31 and 45, is met by the ability of physicians or providers to modify any information on the medicine label, which includes the expiration date)
receive, from the communication device via the wireless communications link, labeling status information comprising a product state (paragraphs 8 and 51, is met by updates to the labels based on sensor data from the medicine container being used to update the container label information)
and adjust the labeling information displayed on the electronic display in accordance with the product state (paragraphs 8 and 51, is met by updates to the labels based on sensor data from the medicine container being used to update the container label information).
Fryman fails to specifically teach the following limitation(s), which is/are taught by Anderson:
the dosing regimen and the safety information being provided in a first language according to regulatory requirements for a region in which the first patient receives treatment (pg. 6, is met by the data presented by the information system being in English as well as other languages and having to comply with the labeling requirements and any other regulatory requirements of the law applicable in the user’s country).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the manner in which the labeling information of the affixed medical tags of Fryman are communicated to be in a language that adheres to a specific labeling requirements of the patient’s location, as taught by Anderson, with the motivation of catering to users and physicians residing in various countries (see: Anderson, pg. 6).
Fryman and Anderson fail to specifically teach the following limitation(s), which is/are taught by Dutta:
an electronic label disposed on the packaging and having an electronic display that selectively displays images and/or text for viewing and comprehension by a user (col 11 lines 1-31, col 22 lines 9-35, FIG. 2A, and Fig. 15A and is met by an electronic label that receives and displays medication related data to a patient on a medication package).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the electronic readable label of Fryman to display the corresponding medical information readable to a user directly on the label via a digital display of Dutta with the motivation of “more reliable dispensing of medication, less missed doses and overall better patient health” (see: Dutta, col 2 lines 13-15).
As per Claim 33, Fryman teaches the following:
a method, comprising: establishing, at a clinical supply pack (Abstract, paragraphs 6-8, is met by the met by the medical containers containing medical fluid that comprise the infusion device unit)
a wireless communications link with a communication device (paragraphs 40 and 50, is met by wireless communication with the medicine containers, infusion devices, and the communication interfaces)
the clinical supply pack comprising (i) packaging (Abstract, paragraphs 6-8 and 113, is met by the medication containers housing the medication or therapeutic material in a pre-filled or pre-packaged environment)
(ii) a supply of clinical product stored in at least one storage container, that at least one container being sealed within the packaging for distribution (Abstract, paragraphs 6-8 and 113, is met by the medication containers housing the medication or therapeutic material in a pre-filled or pre-packaged environment)
(iii) a processor (paragraphs 31 and 67, is met by the processors associated with the infusion system and pharmacy filing system)
and (iv) an electronic label disposed on the packaging and having an electronic display (paragraphs 6, is met by electronic labels affixed to the medicine containers)
receiving, from the communication device via the wireless communications link while the first clinical supply pack is sealed for distribution, labeling information (paragraphs 37-38, is met by the pharmacy filling system and the constituent electronic components supplying information to the electronic medical label)
comprising information regarding a first patient, a dosing regimen, and safety information (paragraph 31, is met by the label information including the patient name for whom the medication is intended to be administered, the parameters of administration, disposal instructions, and container integrity information)
receiving, from the communication device via the wireless communications link while the first clinical supply pack is sealed for distribution, a set of labeling rules comprising an expiration date of the supply of clinical product (paragraphs 31 and 96, is met by the labeling information including the expiration date of the administered fluid)
and further receive a serialization of the first clinical supply pack (paragraph 48-49, is met by a barcode with a unique infusion order and identification on the seal medication package)
adjusting the labeling information visually displayed on the electronic display in accordance with the labeling rules (paragraphs 31 and 45, is met by the ability of physicians or providers to modify any information on the medicine label, which includes the expiration date)
receiving, from the communication device via the wireless communications link, labeling status information comprising a product state (paragraphs 8 and 51, is met by updates to the labels based on sensor data from the medicine container being used to update the container label information)
and adjust the labeling information visually displayed on the electronic display in accordance with the product state (paragraphs 8 and 51, is met by updates to the labels based on sensor data from the medicine container being used to update the container label information).
Fryman fails to specifically teach the following limitation(s), which is/are taught by Anderson:
the dosing regimen and the safety information being provided in a first language according to regulatory requirements for a region in which the first patient receives treatment (pg. 6, is met by the data presented by the information system being in English as well as other languages and having to comply with the labeling requirements and any other regulatory requirements of the law applicable in the user’s country).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the manner in which the labeling information of the affixed medical tags of Fryman are communicated to be in a language that adheres to a specific labeling requirements of the patient’s location, as taught by Anderson, with the motivation of catering to users and physicians residing in various countries (see: Anderson, pg. 6).
Fryman and Anderson fail to specifically teach the following limitation(s), which is/are taught by Dutta:
visually displaying the labeling information on the electronic display of the electronic label in a form of images and/or text for viewing and comprehension by a user (col 11 lines 1-31, col 22 lines 9-35, FIG. 2A, and Fig. 15A and is met by an electronic label that receives and displays medication related data to a patient on a medication package).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the electronic readable label of Fryman to display the corresponding medical information readable to a user directly on the label via a digital display of Dutta with the motivation of “more reliable dispensing of medication, less missed doses and overall better patient health” (see: Dutta, col 2 lines 13-15).
As per Claims 15, Fryman, Anderson, and Dutta teach the limitations of Claim 13. Anderson further teaches:
wherein the instructions further cause the first clinical supply pack to receive, from the communication device via the wireless communications link, the dosing regimen and the safety information in a second language (pg. 16, is met by the ability of the user to select a language from a set of choices, with the web-based platform capable of interacting with the user in the selected language).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the communication of dosing and other medical information contained on the infusion device label(s) of Fryman to include multiple languages from which a user can select for presentation, as further taught by Anderson, with the motivation of catering to users and physicians residing in various countries and maximize the amount of data accessible to said users and physicians (see: Anderson, pg. 6).
As per Claims 45 and 46, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 33, respectively. Anderson further teaches:
wherein the instructions further cause the first clinical supply pack to receive, from the communication device via the wireless communications link, the dosing regimen and the safety information in a second language in response to an input device of the clinical supply pack (pg. 16, is met by the ability of the user to select a language from a set of choices, with the web-based platform capable of interacting with the user in the selected language).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the communication of dosing and other medical information contained on the infusion device label(s) of Fryman to include multiple languages from which a user can select for presentation, as further taught by Anderson, with the motivation of catering to users and physicians residing in various countries and maximize the amount of data accessible to said users and physicians (see: Anderson, pg. 6).
As per Claim 17, Fryman, Anderson, and Dutta teach the limitations of Claim 13. Fryman further teaches:
wherein the instructions further cause the first clinical supply pack to display a notice of expiration based on evaluation of a labeling rule (paragraph 31, is met by the display of an expiration date of the fluid contained in the medicine container).
As per Claims 18 and 47, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 33, respectively. Fryman further teaches:
wherein the instructions further cause the first clinical supply pack to receive, from the communication device via the wireless communications link, and to display, updated labeling status information received by the communication device from a central system, the labeling status information pertaining to a product recall or expiration (paragraphs 31 and 45, is met by the ability of physicians or providers to modify any information on the medicine label, which includes the expiration date).
As per Claims 19 and 48, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 33, respectively. Fryman further teaches:
wherein the instructions further cause the first clinical supply pack to display an updated dosing regimen received from a central system via the communication device over the wireless communications link (paragraph 45, is met by the modification of the fluid container contents through data input from a data-entry device – e.g., a laptop computer or other device).
As per Claims 20 and 49, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 33, respectively. Fryman further teaches:
wherein the instructions further cause the first clinical supply pack to provide, to a central system via the wireless communications link to the communication device, clinical supply usage or environmental information (paragraph 104, is met by the wireless scanning of the use medicine container label to transmit usage documentation across the interconnection service to the EHR).
As per Claims 22 and 51, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 33, respectively. Fryman further teaches:
wherein the instructions further cause the first clinical supply pack to report, to a central management system for a clinical trial via the communication device, clinical supply usage or environmental information (paragraph 104, is met by the wireless scanning of the use medicine container label to transmit usage documentation to the interconnection service, which stores the information in the EHR).
Claims 21 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Fryman (US 2020/0335195)[hereinafter Fryman], in view of Anderson (AU 2014/271345)[hereinafter Anderson], in further view of Dutta et al. (US 10751259)[hereinafter Dutta], in further view of Carter et al. (US 8165892)[hereinafter Carter].
As per Claims 21 and 50, Fryman, Anderson, and Dutta teach the limitations of Claims 13 and 50, respectively. Fryman, Anderson, and Dutta fail to teach the following; Carter teaches:
wherein the instructions further cause the first clinical supply pack to receive, from the communication device via the wireless communications link, and to display, clinical trial information comprising an identifier of an investigator, an identifier of a subject, and an identifier of a study protocol (Col. 9 lines 46-67, is met by the medicine container being equipped with a patient identifier, dosing regimen, and association with an investigator site confirmation).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the information provided to and displayed on the medicine container labels of Fryman, Anderson, and Dutta to include a patient identifier, dosing regimen, and information associated with an investigator site confirmation, as further taught by Carter, with the motivation of ensuring patients receive the correct medication at the outset of the clinical trial (see: Carter, Col. 9 lines 59-62).
Response to Arguments
Applicant's arguments filed 23 January 2026 with respect to 35 USC § 103 have been fully considered but they are not persuasive. Applicant asserts that Examiner has misinterpreted or misunderstood the basis for Applicant’s arguments. Applicant then reasserts that Fryman fails to teach on a storage container sealed within packaging wherein the packaging has an electronic display. Fryman teaches in ¶ 0113:
“By way of confirmation, any medication or therapeutic material or drug in any form or container, including pills, liquids, powders, topicals, injectables such as syringes, etc., can be electronically labeled/tagged, such as by use of RFID, either when prepared on site by the pharmacy or other user, or when pre-filled or pre-packaged, or in any other stage”
Examiner notes that the structure of a prepackaged syringe includes a package and an inner sealed barrel “container”. Examiner is not persuaded by Applicant’s assertion that these are patentable distinct inventions.
Applicant’s assertion that Dutta teaches on another packing embodiment is not persuasive as Dutta is merely relied upon for the electronic display contents.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN LYNN JACKSON whose telephone number is (571)272-5389. The examiner can normally be reached Monday-Friday 8:30AM-4:30PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen M Vazquez can be reached at (571) 272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JORDAN L JACKSON/Primary Examiner, Art Unit 2857