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 .
Specification
The disclosure is objected to because of the following informalities: in paragraph [0068], “Response device 55B” should be corrected to “Response device 55b” to match Fig. 4.
Appropriate correction is required.
Claim Objections
Claims 51-65 are objected to because of the following informalities:
Regarding claim 51, “in the closed position” should be corrected to “in the closed condition”, “allow medication” should be corrected to “allow the medication”, “the body” should be corrected to “a body”, “its closed position” should be corrected to “the closed position” or similarly for claim language consistency.
Regarding claim 54, “its open” should be corrected to “the open” for claim language consistency.
Regarding claim 56, “one or more data signal” should be corrected to “one or more data signals” for correctness.
Regarding claim 59, “to output audible” should be corrected to “to output the audible”, “the location” should be corrected to “a location”, “the Auto” should be corrected to “the medication Auto”, all recitations of “said instructions” should be corrected to “said audible and/or visible instructions”, all recitations of “a user” should be corrected to “the user”, all recitations of “the device” should be corrected to “the first remote device” for claim language consistency.
Regarding claim 60, the second recitation of “an order for a new” should be corrected to “the order for the new” for claim language consistency.
Regarding claim 62, “the opportunity” should be corrected to “an opportunity” for claim language consistency.
Regarding claim 64, “the location” should be corrected to “a location” for claim language consistency.
All preambles of all dependent claims should be corrected to “The cap for the medication Auto-Injector…” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 58-64 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards
Claim 58 recites the limitation "the medication container" in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the medication container is being interpreted as in reference to the medication Autoinjector or to any part of the medication Autoinjector, including the cap. The Examiner notes that the specification discloses that “The Adrenaline Auto-Injector (AAI) 1 of Figure 1 serves as both a medication container and medication dispenser.” ([0039]).
The Examiner notes that claims 60 and 63-64 include reference to “the medication container”.
Regarding claim 59, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 51-58 and 60-65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grasso (WO 2019200074 A1).
Regarding claims 51 and 65, Grasso discloses a cap for a medication Auto-Injector (second component 140 for autoinjector 50, [0076]-[0077] & Fig. 1-3), the auto-injector comprising a main body having a compartment to hold medication (autoinjector 50, [0075]-[0076] & Fig. 1-2; “The autoinjector may be designed to deliver one or more doses of a drug in a manner that facilitates self-administration of the drug via a syringe”, [0010]; also see [0005] for discussion of the autoinjector containing adrenaline; also see [0063]-[0064]), wherein: the cap is movable between a closed condition and an open condition on the medication auto-injector (second component 140 is movable between a closed condition and an open condition on autoinjector 50, [0077] & Fig. 1-3; component 140 is positioned in contact with and in close proximity to autoinjector 50 in the closed condition, Fig. 3; “both the autoinjector 50 and the communication and sensor module 175 may be received within… the second component 140.”, [0081]), in which: in the closed position the medication cannot be accessed (“the second component 140 may be coupled to the first component 120 to seal the autoinjector 50 within the communication enabled device 100”, [0077] & Fig. 3), and in the open condition the medication can be accessed to allow medication from the compartment to be injected into the body of a user (“the first and second components 120, 140 may be removably coupled to each other. For example, during use, as required, the first and second components 120, 140 can be decoupled from each other so that the autoinjector 50 can be accessed as needed.”, [0077] & Fig. 1-2), and
wherein the cap incorporates electronic components that are arranged to generate an alert signal when the cap is moved out of its closed condition (“the first and second components 120, 140 may be adapted and configured to receive a communication and sensor module 175 therein. In one embodiment, the second component 140 may include an outer body 142 and an interior cavity 146 having an opening 144 at one end thereof so that in use, the communication and sensor module 175 can be inserted into the interior cavity 146 through the opening 144 formed in the second component 140 of the device 100.”, [0081] & Fig. 2; “the communication and sensor module 175 may be operatively associated with the communication enabled device so that upon opening the device 100, 200, 300 (e.g., decoupling of the first and second components, removal of the protective coating (e.g., protective wrap and/or sleeve), or the like), the communication and sensor module 175 may transmit a notification (e.g., an alert) to one or more remote entities.”, [0099]; also see trigger mechanism 150, [0079]), the electronic components affording communication with one or more remote devices (“a communication and sensor module 175. The communication and sensor circuity may include wireless communication components 180 for enabling the communication enabled device 100, 200, 300 to communicate (e.g., send and/or receive messages including notifications, information, data, or the like) using any of a variety of communication technologies… the communication enabled device 100, 200, 300 can communicate with external devices via a wireless communication protocol.”, [0096] & Fig. 8; “the communication and sensor module 175, wirelessly communicate with one or more remote devices such as, for example, a user’s mobile device (e.g., smartphone) 202.”, [0108] & Fig. 9).
Regarding claim 52, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the main body of the medication auto-injector has an outer profile and the cap has an outer profile that matches that of the main body (as seen in Fig. 1-3, autoinjector 50 has a cylindrical outer profile and outer body 142 of component 140 has a matching cylindrical profile, [0081] & Fig. 2-3).
Regarding claim 53, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the cap is secured to a cover of the main body (first component 120 secured to second component 140, [0077] & Fig. 1-3; component 120 covering autoinjector 50, [0076]-[0077 & Fig. 1-3), and wherein said cover has an outer profile that matches those of the cap and the main body (first component 120, second component 140, and autoinjector 50 having cylindrical outer profiles, see Fig. 1-3).
Regarding claim 54, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the cap is arranged to be twisted to move between its open and closed conditions (“The first and second components 120, 140 can be removably coupled to each other by any suitable means now known or hereafter developed including, for example, a press-fit connection, a snap-fit connection, a latching mechanism, a hook and recess-type connection, etc.”, [0078] & Fig. 1-3; component 140, when configured to be press-fit to first component 120, can be twisted to facilitate disconnection).
Regarding claim 55, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the electronic components are arranged to output one or more data signals (“the communication enabled device 100, 200, 300 may communicate or transmit wireless signals, including data, information, or information elements including indications of operating conditions to one or more remote entities 401.”, [0109] & Fig. 9; “The method 900 begins with step 905 where first information is received from a communication enabled device, such as the communication enabled devices shown in and described with respect to FIGS. 1-13.”, [0176]; “The method 1300 begins with step 1305 where various data related to the medical device is received by the electronic device. The data may be some or all of the data shown and listed in step 1305 of FIG. 26, and/or any other information described herein… the communication enabled devices described herein may transmit the data, or information related to the data, to the electronic device.”, [0215] & Fig. 26) that indicate one or more of:
a. an identity of the medication (“the first information may be related to information on type of medical device”, [0176] & Fig. 22);
b. a dispense date of the medication (see 1305 of Fig. 26);
c. an expiry date of the medication (“the communication enabled device 100, 200, 300 may transmit a notification (e.g., an alert) to one or more remote entities 401 upon expiration of the autoinjector, or shortly therebefore… the communication enabled device 100, 200, 300 may include memory for storing, for example, the expiration date of the medication contained in the autoinjector.”, [0109] & Fig. 9);
f. a present ambient temperature (see claim 21 and 25 and [0197] and [0228]).
Regarding claim 56, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the electronic components are arranged to establish communication with the one or more remote devices in order to transmit said alert signal and/or one or more data signal to the one or more remote devices (“”The communication and sensor circuity may include wireless communication components 180 for enabling the communication enabled device 100, 200, 300 to communicate (e.g., send and/or receive messages including notifications, information, data, or the like) using any of a variety of communication technologies”, [0096] & Fig. 8; “the communication and sensor module 175 may be operatively associated with the trigger mechanism 150 so that upon activation of the trigger mechanism 150, the communication and sensor module 175 may detect activation of the trigger mechanism 150 and transmit a notification (e.g., an alert) to one or more remote entities.”, [0099] & Fig. 1-3 and 8-9).
Regarding claim 57, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein said electronic components provide a GPS or other location functionality ([0024], [0112], [0125], [0154]; “The method 1300 begins with step 1305 where various data related to the medical device is received by the electronic device. The data may be some or all of the data shown and listed in step 1305 of FIG. 26, and/or any other information described herein… the communication enabled devices described herein may transmit the data, or information related to the data, to the electronic device.”, [0215] & Fig. 26; location being part of the data transmitted to the remote device, see Fig. 26; also see [0128] & Fig. 17B).
Regarding claim 58, Grasso discloses all the limitations of claim 51. Grasso further discloses the cap for a medication Auto-Injector wherein the medication auto-injector is in combination with a first remote device of the one or more remote devices that is arranged to communicate with said electronic components for the exchange of data with said electronic components (“a communication and sensor module 175. The communication and sensor circuity may include wireless communication components 180 for enabling the communication enabled device 100, 200, 300 to communicate (e.g., send and/or receive messages including notifications, information, data, or the like) using any of a variety of communication technologies… the communication enabled device 100, 200, 300 can communicate with external devices via a wireless communication protocol.”, [0096] & Fig. 8; “the communication and sensor module 175, wirelessly communicate with one or more remote devices such as, for example, a user’s mobile device (e.g., smartphone) 202… the communication enabled device 100, 200, 300 may communicate or transmit wireless signals, including data, information, or information elements including indications of operating conditions to one or more remote entities 401”, [0108]-[0109] & Fig. 8-9; also see step 905 of method 900, [0176] & Fig. 22), wherein
the first remote device stores and/or processes data relating to the medication container (“FIG. 26 is a flow chart showing an embodiment of a method 1300 performed by one or more electronic devices for managing a medical device, such as an autoinjector. The method 1300 may be performed by an application on a mobile device… The method 1300 then moves to step 1310 where the data is analyzed to determine the adequacy of the medical device. Step 1310 may include analysis of the various data listed in step 1310 of FIG. 26.”, [0214]-[0216] & Fig. 26; also see step 910 of method 900, [0177] & Fig. 22), and wherein the first remote device stores and is arranged to output audible and/or visible instructions for use of the medication container (“In step 1315, an alert may be provided related to a change in the drug health or potency, or other attributes of the medical device. The mobile device may output an alert or push notification for display on the screen and/or audible alert”, [0217] & Fig. 26; “The third information may be analysis related to information on contemporarily available medical devices… instructions for use, methods of use… any and all drug-related information… The results may be shown on the screen of the mobile device for viewing by a user. The results may be electronically communicated to a user, for example to a user’s email, by text message, or other means. The results may be communicated visually, audibly, and/or using tactile means such as vibrations,”, [0179]-[0181] & Fig. 9; also see [0069]).
Regarding claim 60, Grasso discloses all the limitations of claim 59. Grasso further discloses the cap for a medication Auto-injector, wherein the first remote device is configured to send a message to a supplier of the medication container in order to initiate an order for a new medication container (see step 1260/1265 of method 1200, [0207] and [0213] & Fig. 25; the mobile application of the remote device sends a message to a third party to fill the order for a new delivery system), upon receiving said alert signal and/or a data signal indicating approaching, actual or past expiry date of the medication (“In step 1315, an alert may be provided related to a change in the drug health or potency, or other attributes of the medical device. The mobile device may output an alert or push notification for display on the screen and/or audible alert. The alert may indicate a certain percentage change in the drug health/potency… The method then moves to step 1325 where an option to access choice or purchase methods is output to the user, such as respectively the method 1100 or the method 1200.”, [0217] & Fig. 24-26; a change in the drug health or potency may be a signal indicating an approaching, actual, or past expiry date of the medication), and
wherein a device at the supplier of the medication container is configured to receive said message in order to initiate an order for a new medication container (at step 1260 of method 1200 (Fig. 25), a third party pharmacy receives contact online to fill an order ([0213]), which necessarily requires the pharmacy to have a device capable of online connection; “Exemplary medical devices may provide features including… Predictive analytics: information such as device expiration and usage is tracked along with user location; inventory requirements are determined and distributors/pharmacies may be advised in real time as to what demand may be for the device; allows distributors to place products where they will be needed, especially during a shortage.”, [0028]).
Regarding claim 61, Grasso discloses all the limitations of claim 58. Grasso further discloses the cap for a medication Auto-Injector wherein the first remote device is configured to send a message to a third party (see step 1260/1265 of method 1200, [0207] and [0213] & Fig. 25; the mobile application of the remote device sends a message to a third party to fill the order for a new delivery system) upon receiving said alert signal and/or a data signal indicating approaching, actual or past expiry date of the medication (“In step 1315, an alert may be provided related to a change in the drug health or potency, or other attributes of the medical device. The mobile device may output an alert or push notification for display on the screen and/or audible alert. The alert may indicate a certain percentage change in the drug health/potency... The method then moves to step 1325 where an option to access choice or purchase methods is output to the user, such as respectively the method 1100 or the method 1200.”, [0217] & Fig. 24-26; a change in the drug health or potency may be a signal indicating an approaching, actual, or past expiry date of the medication; also see [0067] and [0111]-[0112]), and wherein the third party is a relative or a medical adviser of the user of the medication (the third party is a pharmacy or parent, see [0067] and [0213] & Fig. 25).
Regarding claim 62, Grasso discloses all the limitations of claim 58. Grasso further discloses the cap for a medication Auto-Injector wherein, upon receipt of said alert signal, the first remote device is configured to display a message that affords a user the opportunity to confirm or deny that the alert signal is in respect of a medical emergency (“activation of the trigger mechanism 150 and/or opening of the cover 100, 200, 300 may indicate the presence of an emergency condition.”, [0099]; “In the event that one of the users suffers a medical event requiring treatment by the medical device, the user may flag the medical event on their mobile device (e.g., by pressing an “emergency” button on the device lock screen, home screen, or in an application).”, [0129]; also see [0093]).
Regarding claim 63, Grasso discloses all the limitations of claim 58. Grasso further discloses the cap for a medication Auto-Injector wherein the first remote device and the medication container are arranged to interact in order to provide a warning signal when the medication container is further than a predetermined distance from the first remote device (“The medical device may support location-based device authentication. The medical device may work in conjunction with the user’s mobile device to provide two- part device location tracking. For example, in order to ensure that the user does not leave their medical device behind when they leave a given location, the system may send alerts based on… (b) detecting that the device is more than a predefined distance away from the mobile device.”, [0125]; also see [0024], [0112], [0154], and [0215]).
Regarding claim 64, Grasso discloses all the limitations of claim 58. Grasso further discloses the cap for a medication Auto-Injector wherein the first remote device and the medication container are arranged to interact in order to provide an indication of the location of the medication container ([0024], [0112], [0125], [0154]; “The method 1300 begins with step 1305 where various data related to the medical device is received by the electronic device. The data may be some or all of the data shown and listed in step 1305 of FIG. 26, and/or any other information described herein… the communication enabled devices described herein may transmit the data, or information related to the data, to the electronic device.”, [0215] & Fig. 26; location being part of the data transmitted to the remote device, see Fig. 26; “The medical device may support location-based device authentication. The medical device may work in conjunction with the user’s mobile device to provide two-part device location tracking. For example, in order to ensure that the user does not leave their medical device behind when they leave a given location, the system may send alerts…”, [0125]; also see [0128] & Fig. 17B).
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.
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grasso (WO 2019200074 A1) as applied to claim 58 above, and further in view of Kamath (US 20190132801 A1).
Regarding claim 59, Grasso discloses all the limitations of claim 58. Grasso further discloses the cap for a medication Auto-Injector wherein the first remote device is configured to output audible and/or visible instructions in a local language (“The mobile device may output an alert or push notification for display on the screen and/or audible alert”, [0217] & Fig. 26; examples of mobile device notifications seen in Figs 14-18 in a language; “The third information may be analysis related to information on contemporarily available medical devices… instructions for use, methods of use… any and all drug-related information… The results may be shown on the screen of the mobile device for viewing by a user. The results may be electronically communicated to a user, for example to a user’s email, by text message, or other means. The results may be communicated visually, audibly, and/or using tactile means such as vibrations,”, [0179]-[0181] & Fig. 9), the location being detected by the Auto-Injector and/or the first remote device ([0024], [0112], [0125], [0154]; “The method 1300 begins with step 1305 where various data related to the medical device is received by the electronic device. The data may be some or all of the data shown and listed in step 1305 of FIG. 26, and/or any other information described herein… the communication enabled devices described herein may transmit the data, or information related to the data, to the electronic device.”, [0215] & Fig. 26; location being part of the data transmitted to the remote device, see Fig. 26).
However, Grasso fails to explicitly disclose wherein the first remote device has a volume setting and is configured to output said instructions at a high or maximum volume, irrespective of any volume currently set by a user of the device, wherein the first remote device is configured to output said instructions, irrespective of whether the device has been switched to an 'off' condition by a user of the device, and wherein the first remote device is configured to output said instructions, irrespective of whether the device has been set to an 'aeroplane' mode or the like by a user of the device.
However, Kamath teaches a remote device (display device 910 including mobile phone 910a, [0344] & Fig. 9) for use in a medication delivery system (system 900 including insulin pen 915d, [0344] & Fig. 9A), wherein the first remote device has a volume setting and is configured to output said instructions at a high or maximum volume, irrespective of any volume currently set by a user of the device, wherein
the first remote device is configured to output said instructions, irrespective of whether the device has been switched to an 'off' condition by a user of the device, and wherein the first remote device is configured to output said instructions, irrespective of whether the device has been set to an 'aeroplane' mode or the like by a user of the device (“Yet another aspect of configuring a follower's access to analyte and/or medicament data and associated alerts may be related to the mode of the device used to follow the user. For example a follower's device may be on silent or airplane mode or do not disturb, but in case of an emergency, as reflected by the analyte and/or medicament data and/or the alert itself, the device setting may be overridden and the alert provided notwithstanding that for example the device is in airplane mode”, [0508]; also see [0231], [0238], and [0266]; the device may output an audible alert/alarm at a volume irrespective of the device being set to silent; the device may output an audible/visual alert/alarm irrespective of the device being set to do not disturb, which may be interpreted as an ‘off’ condition as other notifications and device alerts are “off”; the device may output a visual alert/alarm, indicative of, for example, whether the user should or should not administer medicaments, irrespective of the device being set to airplane mode).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first remote device of Grasso with Kamath to include the first remote device having a volume setting and is configured to output said instructions at a high or maximum volume, irrespective of any volume currently set by a user of the device, being configured to output said instructions, irrespective of whether the device has been switched to an 'off' condition by a user of the device, and being configured to output said instructions, irrespective of whether the device has been set to an 'aeroplane' mode or the like by a user of the device, since such a modification would allow for the remote device to alert the user or output emergency instructions regardless of remote device settings ([0508] of Kamath).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pryor (US-20200327973-A1), Wengreen (US-20160228328-A1), Whalley (US-9250111-B2), Edwards (WO-2007126851-A2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights