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 .
DETAILED ACTION
Response to Amendment
In the Amendment dated 05 August 2025, the following occurred:
Claims 1, 6, 9, 14, and 15 were amended.
Claims 1-9 and 11-21 are pending.
Subject Matter Free of Art
Claims 1-9 and 11-21 include subject matter that is free of prior art. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claims 1, 9, and 15. In particular, the cited prior art fails to expressly teach or suggest the combination of:
determining label information for the medication, the label information received from an image of a label containing the label information, wherein determining the label information for the medication comprises:
determining a source national drug code (NDC) associated with the medication based on the label information;
sending a first message to a first server, wherein the first message indicates a request for a validation of the source NDC;
receiving a second message from the first server, wherein the second message indicates the source NDC is valid, indicates a product NDC, and indicates a normalized identifier;
determining a brand name associated with the medication using the product NDC;
determining one or more active ingredients associated with the brand name using the normalized identifier;
determining a drug display name using the brand name and the one or more active ingredients;
determining active ingredient information for the one or more active ingredients, the determined active ingredient information comprising, for each active ingredient of the one or more active ingredients, a dose associated with the active ingredient, a dose unit associated with the active ingredient, and a unit type associated with the medication;
displaying, on an interface, the drug display name and the determined active ingredient information to a user; receiving an input identifying a time and a date of a use of the medication;
generating a medication diary;
retroactively populating, via an application programming interface (API), the generated medication diary with the time and the date of consumption of the medication, wherein the generated medication diary includes a dosage summary comprising an amount of the one or more active ingredients consumed over a period of time from all sources including the medication;
upon a new consumption of the medication being logged, updating the medication diary with the time and date of the new consumption of the medication; and
based on determining the amount of the one or more active ingredients consumed over the period of time is nearing or has reached a threshold from active ingredient consumption data, displaying, on the interface, a dosage warning, the displayed dosage warning including instructions for at least one immediate action.
The closest prior art Fotsch et al. (U.S. 2011/0145018) teaches acquiring a label for a drug, and mapping a national drug code, a brand, and an active ingredient associated with the drug. However, Fotsch fails to teach sending a first message, wherein the first message indicates a request for a validation of the source NDC, and receiving a second message, wherein the second message indicates the source NDC is valid, indicates a product NDC, and indicates a normalized identifier.
The prior art Lawrence et al. (U.S. 10496793) teaches providing a healthcare transaction, including a medication identifier (e.g., an NDC), to a validation engine, receiving a response to an eligibility verification request and/or a healthcare transaction, and transmitting data in the eligibility verification request. However, Lawrence fails to teach determining a drug display name using the brand name and the one or more active ingredients, determining active ingredient information for the one or more active ingredients, and displaying the drug display name and the determined active ingredient information to a user.
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 1-9 and 11-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 9, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a device and a method for capturing medications and medication usage, and therefore meet step 1.
Step 2A1
The limitations of (Claim 9 being representative) determining label information for the medication, the label information received from an image of a label containing the label information, wherein determining the label information for the medication comprises: determining a source national drug code (NDC) associated with the medication based on the label information; sending a first message…, wherein the first message indicates a request for a validation of the source NDC; receiving a second message…, wherein the second message indicates the source NDC is valid, indicates a product NDC, and indicates a normalized identifier; determining a brand name associated with the medication using the product NDC; determining one or more active ingredients associated with the brand name using the normalized identifier; determining a drug display name using the brand name and the one or more active ingredients; determining active ingredient information for the one or more active ingredients, the determined active ingredient information comprising, for each active ingredient of the one or more active ingredients, a dose associated with the active ingredient, a dose unit associated with the active ingredient, and a unit type associated with the medication; displaying… the drug display name and the determined active ingredient information to a user; receiving an input identifying a time and a date of a use of the medication; generating a medication diary; retroactively populating… the generated medication diary with the time and the date of consumption of the medication, wherein the generated medication diary includes a dosage summary comprising an amount of the one or more active ingredients consumed over a period of time from all sources including the medication; upon a new consumption of the medication being logged, updating the medication diary with the time and date of the new consumption of the medication; and based on determining the amount of the one or more active ingredients consumed over the period of time is nearing or has reached a threshold from active ingredient consumption data, displaying… a dosage warning, the displayed dosage warning including instructions for at least one immediate action, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
That is, other than reciting a device and a method implemented by processors (general-purpose computing devices), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a device/processor (claim 1, 9) and a non-transitory computer-readable medium (claim 15) that implement the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using generic computer components. See MPEP 2106.05(f). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, determining information and sending a message to a server is considered insignificant extra solution activity such as pre-solution activity e.g., data gathering (performed by receiving/transmitting/etc.) See MPEP 2106.05(g).
The claims recite the additional elements of a first server and a user interface that implement the identified abstract idea. The first server and the user interface merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claim further recites the additional element of an application programming interface (API). Populating the generated medication diary via an API equates to saying “apply it.” MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a device/processor or CRM to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a first server and a user interface were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of an API was determined to be “apply it.” This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Claims 2-8, 11-14, and 16-21 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claims 2 and 18 merely describe the normalized identifier, which further defines the abstract idea.
Claims 3, 11, and 19 merely describe the product NDC, which further defines the abstract idea.
Claims 4, 12, and 20 merely describe the source NDC, which further defines the abstract idea.
Claims 5 and 13 merely describe the product NDC and the source NDC, which further defines the abstract idea.
Claims 6 and 14 merely describe determining the label information, which further defines the abstract idea.
Claim 7 merely describes determining the brand name, which further defines the abstract idea.
Claim 7 further recites a second server, which is considered to “generally link” under both the practical application and significantly more analysis.
Claim 8 merely describes determining the one or more active ingredients, which further defines the abstract idea.
The database of claim 8 is interpreted to be part of the generic computer.
Claim 16 merely describes determining a prescribable synonym name and generating the drug display name, which further defines the abstract idea.
Claim 17 merely describes sending an active ingredient information request and receiving an active ingredient information response, which further defines the abstract idea.
Claim 17 further recites a third server, which is considered to “generally link” under both the practical application and significantly more analysis.
Claim 21 merely describes receiving, determining, updating, and displaying, which further defines the abstract idea.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-9 and 11-21, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
The Office Action alleges the claims are directed to the abstract idea of covering performance of limitations in the mind, including observation, evaluation, and opinion.
Regarding (a), the Examiner respectfully disagrees that the abstract idea was characterized as being directed to a mental process. The claimed invention was characterized as falling under Certain Methods of Organizing Human activity (see Non-Final Office Action dated 06/04/2025 at Pg. 4). As such, this argument cannot be persuasive.
Claim 9 does not merely recite personal behavior or interactions between people involving generic computer components but specific, non-generic computer components including an interface…
Regarding (b), the Examiner respectfully disagrees. The claimed invention recites an abstract idea that encompasses a series of rules or instruction for a person or persons to follow, with or without the aid of a computer, for capturing medications and/ or medication usage (see Spec. Para. 0003) in the manner described in the identified abstract idea (the bolded part in the rejection). This is a human activity. Applicant’s claims may be a certain way to perform this task, but the claim encompasses a series of rules or instruction for a person or persons to follow. Regarding the non-generic computer components, the Applicant has not pointed to any of the claimed components that are not generic computer components. In fact, Spec. Para. 0075, 0157, 0319 describes a generic computer. Finally, where the claims to actually require a non-generic computer or components thereof, it is highly likely that a written description issue would present itself, because no non-generic computer components are described in the Specification.
…the limitations of claim 9 provide a technical solution to the technical problem of electronically managing a complete and accurate record of medication usage that is recited in paragraph [0002] of the Specification. In particular, the Specification notes that a "complete and accurate record of patient medications may be important for the safe and effective use of medicines", but that "discrepancies may be common among both recorded and reported medications", which leads to errors.
Regarding (c), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the computer. The problem of healthcare providers making dosing errors was not a problem caused by the computer, is it a problem that existed and/or exists regardless of whether a computer is involved in the process. At best, Applicant’s identified problem is a healthcare problem. Applicant’s claimed invention may provide a technological solution, but the problem is not a technical one and thus this test is not met. Because no technological problem is present, the claims do not provide a practical application. Further, unlike Enfish, Applicant’s claims are not providing any improvement to the computer; Applicant is not claiming an improved database structure that results in improved performance of the computer. Applicant is using a computer as a tool with no improvement as to how the computer fundamentally operates.
The limitations of claim 9 improve the functioning of a computer by providing an interface that more accurately reduces medication discrepancies and errors in order to improve medication safety.
Regarding (d), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer. Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to run faster, more efficiently, or utilize less power. In fact, the computer may be caused to operate slower and less efficiently through the implementation of Applicant’s claimed invention; we do not know. Because there is no improvement to the function of the computer, a practical application is not present.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Gome et al. (U.S. 2013/0218596) which discloses a method and system for facilitating user navigation through a computerized medical information system.
Cauley et al. (U.S. 2008/0052113) which discloses a system and method for managing a health and human services regional network.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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, Robert W Morgan can be reached on 571-272-6773. 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.
/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
Prosecution Insights