DETAILED ACTION
Status
This communication is in response to the application filed on 24 April 2025. Claims 1-29 have been canceled, no claims have been amended, and new claims 30-56 have been added; therefore, claims 30-56 are pending and presented for examination.
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 .
Priority
This application is a 371 National Stage Entry of PCT/IB2023/000624, filed 24 October 2024, Applicant’s claim for the benefit, via the PCT, under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/418,734, filed on 24 October 2022, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 August 2025 was filed after the mailing date of the application on 24 April 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner’s Note
The Examiner notes that recitations to Applicant's specification, as below, are in reference to the “clean” version of Applicant’s specification submitted 13 June 2025.
Claim Objections
Claim 39 is objected to because of the following informalities: claim 39 recites “to initiate a call be opening a phone application”, where this should be “to initiate a call by opening a phone application”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 30-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method (claims 30-46), one or more non-transitory computer-readable storage media (claims 47-50), and a device (claims 561-56), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 30 recites a computer-implemented method comprising: executing a program for managing a plurality of medical conditions being treated by a first medicament; providing a first user interface allowing a user to specify a first medical condition being treated by the first medicament; providing a second user interface allowing the user to specify a second medical condition being treated by the first medicament; providing treatment access information related to the first medicament; providing at least one of information relating to the first medical condition, a journal facilitating input of symptoms related to the first medical condition, or a notification relating to the first medical condition; and providing at least one of information relating to the second medical condition, a journal facilitating input of symptoms related to the second medical condition, or a notification relating to the second medical condition.
Independent claims 47 and 51 are analyzed in the same manner as claim 30 above since claim 47 is directed to one or more non-transitory computer-readable storage media storing instructions that, when executed by at least one computer, cause the at least one computer to perform the same or similar activities as at claim 30 above, and claim 51 is directed to a user device comprising one or more processors and one or more storage devices storing instructions that, when executed by the one or more processors, cause the one or more processors to perform the same or similar activities as at claim 30 above.
The dependent claims (claims 31-46, 48-50, and 51-56) appear to be encompassed by the abstract idea of the independent claims since they merely indicate the first and second interfaces being the same (claims 31 and 48), what the conditions are (i.e., Atopic Dermatitis and Asthma) (claim 32), the interface being able to specify further medicaments (claim 33), pairing the program with one or more external devices, receiving user specific data from the external device(s), and receiving and displaying environmental information (claims 34, 48, and 52), what the user data is (i.e., physiological data or activity data) (claims 35 and 53), determining authorization for customized information is required and presenting an authorization interface (claims 36 and 49), the authorization being for user location (claims 37 and 50), providing a dose support screen to initiate a call with a healthcare professional (claim 38) with instructions to prepare or administer the medicament, and opening a phone application when initiating a call (claim 39), providing a post-call screen indicating a locations for an injection (claim 40), providing a reminder system to allow reminder parameters and generate and provide a reminder (claim 41), providing a prescription management system for medicament collection or deliver details and status updates, with push notifications (claim 42), providing a third user interface for insurance or financial information for accessing the first medicament, sending that information to a third party, and displaying notifications (claim 43), scanning a code to check the expiration of a medicament and warning when expired, including by using a camera (claims 44, 54), scanning a code for injection device(s), including by using a camera, launching the program and determining the user is registered, and displaying a confirmation interface (claims 45 and 55), and/or providing a refill reminder reset (claims 46 and 56).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of searching for, or looking up, medicament and/or condition information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Certain methods of organizing human activity (e.g. … commercial or legal interactions such as … advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions); and
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion).
The Examiner notes that the claims appear primarily directed to managing the personal behavior of persons dealing with diseases or conditions, and/or the relationships of between people regarding how to access and/or administer a medicine (i.e., medicament); therefore, the certain methods of organizing human activity grouping is listed, and considered, as primary. But many of the activities or decisions regarding the medicine, how to access and/or administer it, etc. appear also to be evaluations, judgments, and/or opinions that can be performed mentally (e.g., asking a doctor or prescriber about how to access treatment and providing information regarding a medicine – the “interface” being person-to-person, face-to-face, or in writing).
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that the method is a computer-implemented method comprising executing a program for performing the activities (at claim 30), using a phone application (at claim 39), a non-transitory computer-readable storage media storing instructions that, when executed by at least one computer, cause the at least one computer to perform the activities (at claim 47), and a user device comprising one or more processors and one or more storage devices storing instructions that, when executed by the one or more processors, cause the one or more processors to perform the activities (at claim 51).
. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant p. 33, line 24 to p. 35, line 7 and Fig. 21 appear to be the most thorough explanation or description of the computer(s) claimed and/or used (both the user device and the “host computer (not shown)” – citing Applicant p. 33, line 34), but only describe generic or general-purpose computers.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore, the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
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 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.
Claim Rejections - 35 USC § 102
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.
Claims 30-33, 47, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drugs.com as evidenced by screenshots of Drugs.com downloaded via Archive.org WayBack Machine, dated 3 July 2022 (hereinafter, Drugs.com homepage), and the Dupixent link at the 3 July 2022 Drugs.com homepage which resolves to the Dupixent page downloaded via the Archive.org WayBack Machine, also dated 3 July 2022 (hereinafter Dupixent page).
Claim 30: Drugs.com discloses a computer-implemented method comprising:
executing a program for managing a plurality of medical conditions being treated by a first medicament (see Drugs.com homepage at least at p. 1, search bar to “Enter a drug name, condition, pill imprint, etc.”);
providing a first user interface allowing a user to specify a first medical condition being treated by the first medicament (see Drugs.com homepage at least at p. 1, search bar to “Enter a drug name, condition, pill imprint, etc.”);
providing a second user interface allowing the user to specify a second medical condition being treated by the first medicament (see Drugs.com homepage at least at p. 1, search bar to “Enter a drug name, condition, pill imprint, etc.”);
providing treatment access information related to the first medicament (Dupixent page, Dupixent is a prescription medicine that works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, …”, at p. 1, “Use Dupixent exactly ads prescribed by your doctor” at p. 3);
providing at least one of information relating to the first medical condition, a journal facilitating input of symptoms related to the first medical condition, or a notification relating to the first medical condition (Dupixent page, “Dupixent is a prescription medicine that works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, …”, at p. 1); and
providing at least one of information relating to the second medical condition, a journal facilitating input of symptoms related to the second medical condition, or a notification relating to the second medical condition (Dupixent page, “Dupixent is a prescription medicine that works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, …”, at p. 1).
Claim 31: Drugs.com discloses the computer-implemented method according to claim 30, wherein the first user interface is the same as the second user interface (see Drugs.com homepage at least at p. 1, search bar to “Enter a drug name, condition, pill imprint, etc.”).
Claim 32: Drugs.comdiscloses the computer-implemented method according to claim 30, wherein the first medical condition is Atopic Dermatitis and the second medical condition is Asthma (Dupixent page, “Dupixent is a prescription medicine that works by blocking two proteins that contribute to a type of inflammation that plays a major role in atopic dermatitis, asthma, …”, at p. 1).
Claim 33: Drugs.com discloses the computer-implemented method according to claim 30, wherein at least one of the first user interface or the second user interface allows a user to specify further medicaments being used to treat the first medical condition, second medical condition or a further medical condition (see Drugs.com homepage at least at p. 1, search bar to “Enter a drug name, condition, pill imprint, etc.”).
Claims 47 and 51 are rejected on the same basis as claim 30 above since Drugs.com necessarily includes one or more non-transitory computer-readable storage media storing instructions that, when executed by at least one computer, cause the at least one computer to: execute a program for the same or similar activities (for claim 47), and a user device comprising one or more processors and one or more storage devices storing instructions that, when executed by the one or more processors, cause the one or more processors to perform the same or similar activities (for claim 51) as at claim 30 above.
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 of this title, 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 34-35, 48, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Hussain (U.S. Patent Application Publication No. 2016/0100817).
Claim 34: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising at least one of the following: pairing the program for managing a plurality of medical conditions being treated by a first medicament with one or more external devices and receiving user specific data from the one or more external devices, or receiving environmental information and displaying the environmental information. Drugs.com, however, being able to “Manage your Meds” and use “Mobile Apps” in conjunction with the site (see Drugs.com homepage at least at p. 3, at “Browse by Site Selection”). Hussain, though, teaches “the systems, devices, and methods for capturing and outputting data regarding a bodily characteristic can include capturing data, processing the same, and delivering output representative of body sounds. The systems, devices, and methods can include a stethoscope configured to pair to other devices to thus allow the sharing of immersive three-dimensional feedback experiences with one or more users in addition to a user of the stethoscope” (Hussain at 0136), where “The signals can be processed so that a diagnosis may be presented” (Hussain at 0142), “A baseline of the patient's breathing can be established over time can be established using data gathered from a stethoscope so as to allow comparison of data thereto in the event of anomalies subject conditions such as asthma attacks or pneumonia” (Hussain at 0219), and “The second hardware device 111 can be remote from the first hardware device 101 since the pairing is electronic and can be remote via network connection. The first hardware device 101 can transmit at least one of the heart sound representative raw data signals and the lung sound representative raw data signals or other body sound signals via Bluetooth 105 to the first mobile device 107 linked to the first hardware device 101. The raw data signals can further include at least one of ECG signal, gyroscope signals, temperature signals, infrared signals and ultrasound signals and others as included. For example, accelerometer signals can provide patient positional information gained from the gyroscope signals” (Hussain at 0232). Therefore, the Examiner understands and finds that to pair a device to get signal data such as physiological data is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to process the data remotely for diagnosis.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the device data of Hussain in order to pair a device to get signal data such as physiological data so as to be able to process the data remotely for diagnosis.
The rationale for combining in this manner is that to pair a device to get signal data such as physiological data is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to process the data remotely for diagnosis as explained above.
Claim 35: Drugs.com in view of Hussain discloses the computer-implemented method according to claim 34, wherein the user specific data is physiological data and/or activity data (Hussain at 0136, 0142, 0219, 0232, as combined above and using the rationale as at the combination above).
Claim 48 is rejected on the same basis as claims 30-31 and 34 above since incorporating the same or similar limitations as at claims 30-31 and 34 above.
Claims 52-53 are rejected on the same basis as claims 30-31 and 34-35 above since incorporating the same or similar limitations as at claims 30-31 and 34-35 above.
Claims 36-37 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Margolis et al. (U.S. Patent Application Publication No. 2017/0293923, hereinafter Margolis).
Claim 36 and 49: Drugs.com discloses the computer-implemented method and media according to claims 30 and 47, but does not appear to explicitly disclose further comprising: determining that an authorization is required to customize the information related to the first medical condition and/or the information related to the second medical condition; and presenting a user interface to obtain the authorization. Drugs.com, however, being able to “Manage your Meds” and use “Mobile Apps” in conjunction with the site (see Drugs.com homepage at least at p. 3, at “Browse by Site Selection”). Margolis, though, teaches to “gather information directly from a user using a questionnaire, series of questions, or other method that are presented to a user on a computing device. Such information may include common metrics about an individual, including the user's height, weight, age, existing medical conditions (e.g., heart disease, diabetes, depression), wellness goals, or other user characteristics. The discovery engine 172 may also retrieve information about a user from outside services. To access outside services, the discovery engine 172 can utilize various application program interfaces (APIs) to access data stored in other sources” (Margolis at 0025), where “In addition to data received directly from the user or data received from other services, the discovery engine 172 may also receive information from devices associated with the user that may be used to characterize the state of the user. If the user grants permission, the discovery engine 172 can determine the location of the user by accessing or receiving location information from the user's computing device 100. For example, the discovery engine 172 may receive GPS information transmitted from the user's smartphone or smart watch. Using the location information, the discovery engine 172 can estimate weather conditions near the user using a local weather service” (Margolis at 0027). Therefore, the Examiner understands and finds that to permissibly authorize information such as the user or patient location is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to characterize the state and/or environment of the user/patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the external data of Margolis in order to permissibly authorize information such as the user or patient location so as to be able to characterize the state and/or environment of the user/patient.
The rationale for combining in this manner is that to permissibly authorize information such as the user or patient location is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to characterize the state and/or environment of the user/patient as explained above.
Claim 37 and 50: Drugs.com in view of Margolis discloses the computer-implemented method and media according to claim 36 and 49, wherein the authorization is to access a location of the user (Margolis at 0025 and 0027, as combined above and using the rationale as at the combination above).
Claims 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Sayiner et al. (U.S. Patent Application Publication No. 2024/0274256, hereinafter Sayiner) in further view of Robertson et al. (U.S. Patent Application Publication No. 2015/0205919, hereinafter Robertson).
Claim 38: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising providing a dose support screen having a call-scheduling element configured to initiate a call booking process with a healthcare professional when selected. Drugs.com, however, being able to “Manage your Meds” and use “Mobile Apps” in conjunction with the site (see Drugs.com homepage at least at p. 3, at “Browse by Site Selection”). Sayiner, however, teaches “a series of screen images of interfaces for instructing a patient on making an injection of medication” as at Fig. 7 of Sayiner (Sayiner at 0029), with notifications via phone call (Sayiner at 0067) and “The coach 113 may be in synchronous or asynchronous contact with the patient such as through telephone calls, texts, video calls” (Sayiner at 0129), the interfaces at Fig. 7A and 7B providing instructions and “a graphic of different body locations for the injection” (Sayiner at 0165-0166, quoting 0165), so as to “walk[ the patient] through the steps of injection” (Sayiner at 0151). Therefore, the Examiner understands and finds that to provide a dose support screen interface, including images for injection locations, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to walk the patient through performing an injection.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the injection instructing of Sayiner in order to provide a dose support screen interface, including images for injection locations, so as to be able to walk the patient through performing an injection.
The rationale for combining in this manner is that to provide a dose support screen interface, including images for injection locations, is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to walk the patient through performing an injection as explained above.
Drugs.com in view of Sayiner, however, does not appear to explicitly disclose a call-scheduling element configured to initiate a call booking process with a healthcare professional when selected. Robertson, though teaches “how to provide current information regarding a patient to treating medical persons and to facilitate proper care of the patient” (Robertson at 0020), including a patient webpage where “If a dynamic webpage was used, the webpage code could include logic to check the current time of day and automatically set the correct contact information (for a hospital or clinic or on-call doctor) for the contact information or for a `click to call us` link” (Roberson at 0094). Therefore, the Examiner understands and finds that to include a call element for selection is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to facilitate proper and more complete care of a patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com in view of Sayiner with the click to call link of Robertson in order to include a call element for selection so as to be able to facilitate proper and more complete care of a patient.
The rationale for combining in this manner is that to include a call element for selection is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to facilitate proper and more complete care of a patient as explained above.
Claim 39: Drugs.com in view of Sayiner in further view of Robertson discloses the computer-implemented method according to claim 38, further comprising providing a pre-call instruction screen containing: instructions for preparing and/or administering the first medicament; and a call-initiating element configured to initiate a call be opening a phone application when selected (Drugs.com as cited above for the instructions; Robertson at 0094 for the calling, as combined above and using the rationale as at the combination above – the screen necessarily being a “pre-call instruction screen” since the combination would have the click to call button at/with the instructions provided by Drugs.com).
Claim 40: Drugs.com in view of Sayiner in further view of Robertson discloses the computer-implemented method according to claim 39, further comprising providing a screen containing a body representation with multiple predefined areas for indicating a location of an injection (Sayiner at 0165-0166, as combined above and using the rationale as at the combination above). Drugs.com in view of Sayiner in further view of Robertson, however, does not appear to explicitly disclose that the image representation screen is post-call. However, there are literally only three options available – that the screen is pre-call, mid-call, or post-call. Each option has its advantages and disadvantages for use (e.g., pre-call may instruct the patient before the patient attempts an injection whereas post-call the person may not remember as well where to make the injection, whereas post-call may allow the patient to be better prepared overall for the injection), but each would also have the same reasonable expectation of success. Therefore, the Examiner understands and finds that to present the image representation screen post-call would be obvious to try since choosing from a finite number of identified, predictable solutions with a reasonable expectation of success so as to be able to walk the patient through performing an injection.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com in view of Sayiner in further view of Robertson with the finite number of available options in order to present the image representation screen post-call so as to be able to walk the patient through performing an injection.
The rationale for combining in this manner is that to present the image representation screen post-call would be obvious to try since choosing from a finite number of identified, predictable solutions with a reasonable expectation of success so as to be able to walk the patient through performing an injection as explained above.
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of O’Connor et al. (U.S. Patent Application Publication No. 2022/0203023, hereinafter O’Connor).
Claim 41: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising providing a reminder system configured to: allow input of medication administration reminder parameters; and generate a reminder for display on a graphical user interface provided by the program for managing a plurality of medical conditions being treated by a first medicament or for display as a push notification on a locked screen of a user device. O’Connor, though, teaches “systems and methods for delivering a medication to a user” (O’Connor at 0036), where for “diabetes therapy management … [this is] to manage a user's blood glucose levels and for controlling the delivery of the drug, medication, or therapeutic agent to the user” (O’Connor at 0039), and “The user may enable/disable and/or set the parameters …. A tap on slider 3004 will cause the state to switch between “on” and “off”. The exemplary screen shows the three reminders being enabled. FIG. 30b shows an example of a screen that may be used to set the parameters of one of the reminders” (O’Connor at 0152). Therefore, the Examiner understands and finds that to allow setting of reminder parameters via an interface screen is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the reminders of O’Connor in order to allow setting of reminder parameters via an interface screen so as to be able to enable the user to better control the delivery of a drug.
The rationale for combining in this manner is that to allow setting of reminder parameters via an interface screen is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug as explained above.
Claim 42: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising providing a prescription management system configured to: allow input of collection or delivery details for the first medicament; display status updates relating to collection or delivery details of the first medicament; and generate one or more push notifications relating to collection or delivery details of the first medicament. O’Connor, though, teaches “systems and methods for delivering a medication to a user” (O’Connor at 0036), where for “diabetes therapy management … [this is] to manage a user's blood glucose levels and for controlling the delivery of the drug, medication, or therapeutic agent to the user” (O’Connor at 0039), and “The user may enable/disable and/or set the parameters …. A tap on slider 3004 will cause the state to switch between “on” and “off”. The exemplary screen shows the three reminders being enabled. FIG. 30b shows an example of a screen that may be used to set the parameters of one of the reminders” (O’Connor at 0152). Therefore, the Examiner understands and finds that to allow input of collection or delivery details, display status, and generate push notifications is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the reminders of O’Connor in order to allow input of collection or delivery details, display status, and generate push notifications so as to be able to enable the user to better control the delivery of a drug.
The rationale for combining in this manner is that to allow input of collection or delivery details, display status, and generate push notifications is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug as explained above.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Rosenblum (U.S. Patent Application Publication No. 2005/0049746).
Claim 43: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising: providing a third user interface facilitating the input of insurance and/or financial information related to accessing the first medicament; sending the insurance and/or financial information to a third party; and displaying an insurance and/or financial status notification related to accessing the first medicament. Rosenblum, though, teaches “The present invention concerns dispensing systems, such as vending machines, particularly dispensing systems for prescription drugs” (Rosenblum at 0002), where “the patient's insurance plan can be uploaded to the computer along with other patient information, each drug viewed will usually indicate whether the drug is on the patient's insurer's formulary along with its approval status and whether the drug is in the remote dispenser” (Rosenblum at 0105), with an “automatic dispensing machine 9400 located in a pharmacy 9402…. [that] includes a user interface screen 9412 and a financial transaction portion 9414, such as a cash, credit card, debit card, or check reader, and a change return 9416, and a medication retrieval portion 9418” (Rosenblum at 0228). Therefore, the Examiner understands and finds that to provide an insurance or financial interface with a status indication is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide accurate and approved delivery of a medication.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the insurance information of Rosenblum in order to provide an insurance or financial interface with a status indication so as to provide accurate and approved delivery of a medication.
The rationale for combining in this manner is that to provide an insurance or financial interface with a status indication is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide accurate and approved delivery of a medication as explained above.
Claims 44-45 and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Kietzmann (U.S. Patent Application Publication No. 2023/0420125, hereinafter Kietzmann).
Claim 44: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising: scanning a code on an injection device in order to check an expiry date of medicament within the injection device; and in response to a determination that the medicament within the injection device is expired, outputting a warning via the program. Kietzmann, though, teaches “a user device configured to track use of an injection device,” (Kietzmann at 0007), where “The injection device 10 may be scanned or otherwise read by the user device 400 before an injection takes place, after an injection takes place or before each injection device 10 is placed into the storage device 100. These and various other ways of tagging injection device 10 with information are contemplated. Various types of information may be included in the label. These can include the type of medicament or injection device, manufacturing source, expiration date, dose, country of origin, etc.” (Kietzmann at 0073), and “The wireless communication module may transmit an alert to the user device 400 if one of the injection devices 10 has expired.” (Kietzmann at 0087) in order to “increase patient adherence with their prescribed medicament regimen” (Kietzmann at 0052). Therefore, the Examiner understands and finds that to scan an injection device for expiration and warn if expired is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase patient adherence with their prescribed medicament regimen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the expiration scanning of Kietzmann in order to scan an injection device for expiration and warn if expired so as to increase patient adherence with their prescribed medicament regimen.
The rationale for combining in this manner is that to scan an injection device for expiration and warn if expired is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase patient adherence with their prescribed medicament regimen as explained above.
Claim 45: Drugs.com discloses the computer-implemented method according to claim 30, but does not appear to explicitly disclose further comprising: scanning a code associated with a new injection device or a new batch of injection devices; launching the program and determining that the user is a registered user of the program; and displaying a user interface asking the user to confirm that they have received a new injection device or batch of injection devices. Kietzmann, though, teaches “a user device configured to track use of an injection device,” (Kietzmann at 0007), where “The injection device 10 may be scanned or otherwise read by the user device 400 before an injection takes place, after an injection takes place or before each injection device 10 is placed into the storage device 100. These and various other ways of tagging injection device 10 with information are contemplated. Various types of information may be included in the label. These can include the type of medicament or injection device, manufacturing source, expiration date, dose, country of origin, etc.” (Kietzmann at 0073), and “The wireless communication module may transmit an alert to the user device 400 if one of the injection devices 10 has expired.” (Kietzmann at 0087), “The user device 400 may display an interface asking the user to confirm that the scanned injection device 10 has been used” (Kietzmann at 0113, noting that the device had to be received in order to be used), “A package received by a patient can include one or more autoinjectors/injection devices 10. For example, a package could include six injection devices 10 representing 3 or 6 months supply. A single package of injection devices 10 could also include one or more autoinjectors containing different dosages of medicament” (Kietzmann at 0166), in order to “increase patient adherence with their prescribed medicament regimen” (Kietzmann at 0052). Therefore, the Examiner understands and finds that to scan a new injection device or batch of injection devices for and confirm receiving is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase patient adherence with their prescribed medicament regimen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com with the scanning of Kietzmann in order to scan a new injection device or batch of injection devices for and confirm receiving so as to increase patient adherence with their prescribed medicament regimen.
The rationale for combining in this manner is that to scan a new injection device or batch of injection devices for and confirm receiving is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase patient adherence with their prescribed medicament regimen as explained above.
Claims 54-55 is rejected on the same basis as claims 44-45 above since incorporating the same or similar limitations as at claim 44-45 above.
Claims 46 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Drugs.com (as above) in view of Kietzmann in further view of Dubey et al. (U.S. Patent Application Publication No. 2016/0292456, hereinafter Dubey).
Claim 46: Drugs.com in view of Kietzmann discloses the computer-implemented method according to claim 45, but does not appear to explicitly disclose further comprising: in response to receiving a user input confirming that they have received the new injection device or batch of injection devices, causing a refill reminder in the program to be reset. Dubey, though, teaches “the patient may use the patient application to order a prescription refill, set refill or delivery reminders, and/or view prescriber and/or pharmacy information. In some embodiments, the patient application activates a barcode scanner coupled to the computing device executing the patient application and scans a barcode on a received shipment of the medication. The patient application then transmits confirmation of receipt of the medication to a server computer, based on the scanned barcode” (Dubey at 0195), where setting the refill reminders would include resetting the refill reminder that had been set originally. Therefore, the Examiner understands and finds that to reset refill reminders is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the information input of Drugs.com in view of Kietzmann with the refill reminders of Dubey in order to reset refill reminders so as to be able to enable the user to better control the delivery of a drug.
The rationale for combining in this manner is that to reset refill reminders is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to enable the user to better control the delivery of a drug as explained above.
Claim 56 is rejected on the same basis as claim 46 above since incorporating the same or similar limitations as at claim 46 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boguniewicz et al., Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13. PMID: 33453450. Downloaded from https://pubmed.ncbi.nlm.nih.gov/33453450/ on 14 September 2026, indicating “Dupilumab has demonstrated efficacy with acceptable safety in clinical trials in patients with moderate to severe atopic dermatitis (AD)” (at Background), “To assess dupilumab's impact on asthma and sinonasal conditions in adult patients with moderate to severe AD in four randomized, double-blinded, placebo-controlled trials” (at Objective), and “In this first analysis of patients with comorbid moderate to severe AD, asthma, and/or chronic sinonasal conditions, dupilumab improved all three diseases in a clinically meaningful and statistically significant manner (vs placebo), based on validated outcome measures” (at Conclusions).
Kobylevsky et al. (U.S. Patent Application Publication No. 2002/0052762, hereinafter Kobylevsky) indicates scheduling calls based on clicking an Outbound Calls button (Kobylevsky at 0076).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT D GARTLAND whose telephone number is (571)270-5501. The examiner can normally be reached M-F 8:30 AM - 5 PM.
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, Kambiz Abdi can be reached at 571-272-6702. 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.
/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
