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:
Claim 10 was canceled.
Claims 1, 9, and 11-17 were amended.
Claim 21 was added.
Claims 1-9 and 11-21 are pending.
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; determining a source national drug code (NDC) associated with the medication using 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 including the time and the date of the use of the medication, wherein the generated medication diary includes a dosage summary compris[ing] an amount of the one or more active ingredients consumed over a period of time from all sources including 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, displaying… a dosage warning, 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.
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. 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.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 9, 11-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fotsch et al. (U.S. 2011/0145018) in view of Lawrence et al. (U.S. 10496793), Ghanbari et al. (U.S. 2013/0085771), referred to hereinafter as Fotsch, Lawrence, and Ghanbari, respectively, and Maughan (U.S. 2008/0015549).
REGARDING CLAIM 1
Fotsch teaches the claimed device comprising:
a processor configured to: [Para. 0086 teaches a processor.]
determine label information for a medication; [Para. 0089 teaches acquiring a label for a drug.]
determine a source national drug code (NDC) associated with the medication using the label information; [Para. 0189 teaches mapping a national drug code associated with the drug.]
determine a brand name associated with the medication using the product NDC; [Para. 0189 teaches mapping a brand associated with the drug.]
determine one or more active ingredients associated with the brand name using the normalized identifier; [Para. 0189 teaches mapping an active ingredient associated with the drug.]
Fotsch may not explicitly teach
a user interface; and
send a first message to a first server, wherein the first message indicates a request for a validation of the source NDC;
receive 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;
However, Lawrence teaches the following:
a user interface; and [Col. 9, Line 16 teaches a user interface.]
send a first message to a first server, wherein the first message indicates a request for a validation of the source NDC; [Col. 4, Line 41-42 teaches providing a healthcare transaction to a validation engine. Col. 4, Line 36-38 teaches the healthcare transaction includes a medication identifier (e.g., an NDC).]
receive 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; [The normalized identifier may be an RxNorm concept unique identifier. Col. 9, Line 7-9 teaches receiving a response to an eligibility verification request and/or a healthcare transaction. Col. 26, Line 41-43 teaches a validation engine conducting the identification of the medication/product identifier (e.g., NDC or RxNorm code) in the eligibility verification request. Col. 27, Line 6-11 teaches transmitting data in the eligibility verification request.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch to send and receive messages as taught by Lawrence, with the motivation of reducing the potential for errors (see Lawrence at Col. 3, Line 36).
Fotsch in view of Lawrence may not explicitly teach
determine a drug display name using the brand name and the one or more active ingredients;
determine 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; display, on the user interface, the drug display name and the determined active ingredient information to a user;
However, Ghanbari teaches the following:
determine a drug display name using the brand name and the one or more active ingredients; [Para. 0130 teaches a list including the chemical name (active ingredient) and the trade (brand) name of the medication.]
determine 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; and display on the user interface, the drug display name and the determined active ingredient information to a user. [Para. 0130 teaches displaying a list including the chemical name, the trade name (drug display name), and the dosage (for example, dose = 400, dose unit/unit type = mg). The Examiner notes that dose unit and unit type are not defined in the claim. Given the broadest reasonable interpretation, the dosage of Ghanbari is interpreted to include a dose unit/unit type. Para. 0129 teaches a user interface.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence to determine and display a drug display name and active ingredient information as taught by Ghanbari, with the motivation of improving practices meant to protect patient rights (see Ghanbari at Para. 0026).
Fotsch in view of Lawrence and Ghanbari may not explicitly teach
control to receive, on the user interface, an input identifying a time and a date of a use of the medication;
generate a medication diary including the time and the date of the use of the medication, wherein the generated medication diary includes a dosage summary comprises an amount of the one or more active ingredients consumed over a period of time from all sources including 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, display, on the user interface, a dosage warning.
However, Maughan teaches the following:
control to receive, on the user interface, an input identifying a time and a date of a use of the medication; [Para. 0013 teaches receiving signals from input devices to manipulate a user interface display image. Para. 0024 teaches a user interface display image presents a history of medication administrations, specifically, administration time and date.]
generate a medication diary including the time and the date of the use of the medication, wherein the generated medication diary includes a dosage summary comprises an amount of the one or more active ingredients consumed over a period of time from all sources including the medication; and [Para. 0019 teaches identifying medication administrations for medications and associated ingredients for the lifetime of a patient. Para. 0024 teaches a user interface display image presents running cumulative dosages and a history of medication administrations, specifically, administration time and date.]
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, display, on the user interface, a dosage warning. [Para. 0028 teaches identifying cumulative ingredient dosage limits. Para. 0012, 0029 teaches generating an alert message in response to determining the cumulative dosage, including the medication, is approaching or exceeding the cumulative dosage limit. The alert message is displayed.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence and Ghanbari to receive input, generate a summary, and display a dosage warning as taught by Maughan, with the motivation of improving patient safety and quality of care (see Maughan at Para. 0011).
REGARDING CLAIM 2
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Lawrence further teaches
wherein the normalized identifier is a RxNorm concept unique identifier (RxCUI). [Col. 4, Line 38 teaches the identifier is an RxNorm code.]
REGARDING CLAIM 3
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Fotsch further teaches
wherein the product NDC comprises a labeler code and a product code. [National drug codes are three-segment numbers which serve as a universal drug product identifier. The segments represent the labeler code, product code, and package code. Para. 0189 teaches the national drug code (NDC).]
REGARDING CLAIM 4
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Fotsch further teaches
wherein the source NDC is a package NDC, and wherein the package NDC comprises a labeler code, a product code, and a package code. [National drug codes are three-segment numbers which serve as a universal drug product identifier. The segments represent the labeler code, product code, and package code. Para. 0189 teaches the national drug code (NDC).]
REGARDING CLAIM 5
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Fotsch further teaches
wherein the source NDC comprises a labeler code, a product code, and a package code, and wherein the product NDC comprises the labeler code and the product code. [National drug codes are three-segment numbers which serve as a universal drug product identifier. The segments represent the labeler code, product code, and package code. Para. 0189 teaches the national drug code (NDC).]
REGARDING CLAIM 6
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Ghanbari further teaches
wherein the processor is configured to determine the label information for the medication by receiving data from a user, wherein the data includes at least one of the source NDC, an active ingredient, a brand name, an image, or a video. [Para. 0008 teaches receiving input from a user. Para. 0027 teaches receiving an image. Para. 0141 teaches labels based on input from a caregiver.]
REGARDING CLAIMS 9 AND 11-14
Claims 9 and 11-14 are analogous to Claims 1 and 3-6, thus Claims 9 and 11-14 are similarly analyzed and rejected in a manner consistent with the rejections of Claim 1 and 3-6.
REGARDING CLAIM 15
Claim 15 is analogous to Claim 1, thus Claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
REGARDING CLAIM 16
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed non-transitory computer-readable medium of claim 15.
Ghanbari further teaches
wherein, to determine the drug display name using the brand name and the one or more active ingredients, the instructions further cause the processor to: determine a prescribable synonym name for at least an active ingredient of the one or more active ingredients; and generate the drug display name by combining the brand name with the prescribable synonym name. [Para. 0130 teaches a list including the chemical name (prescribable synonym name) and the trade (brand) name of the medication.]
REGARDING CLAIMS 18-20
Claims 18-20 are analogous to Claims 2-4, thus Claims 18-20 are similarly analyzed and rejected in a manner consistent with the rejections of Claim 2-4.
REGARDING CLAIM 21
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the computer-implemented method of claim 9.
Maughan further teaches
receiving, on the interface, a second input identifying a second time and a second date for a use of a second medication, the second medication different than the medication; [Para. 0028 teaches determining whether the cumulative dosage of different medications, including the particular medication of the patient, exceeds a cumulative dosage limit over the multiple different time periods.]
determining the second medication includes the one or more determined active ingredients; [Para. 0028 teaches identifying medications and their ingredients and associated cumulative medication and ingredient dosage limits for different time periods.]
updating the generated medication diary to include the second time and the second date for the use of the second medication, the updated medication diary including an updated dosage summary of the amount of the one or more active ingredients consumed over the period of time; [Para. 0019 teaches data identifying an administration event is automatically stored in the Administration Events Database in response to data entry. The database holds data identifying medication administrations for medications and associated ingredients for the lifetime of a patient.]
based on the updated dosage summary, determining the amount of the one or more active ingredients consumed over the period of time is nearing or has reached the threshold; and [Para. 0012, 0028 teaches determining whether the cumulative dosage of different medications is approaching or exceeding a cumulative dosage limit over the multiple different time periods.]
displaying, on the user interface, an updated dosage warning based on determining the amount of the one or more active ingredients consumed over the period of time is nearing or has reached the threshold. [Para. 0012, 0029 teaches generating an alert message in response to determining the cumulative dosage, including the additional dosage of the particular ingredient, is approaching or exceeding the cumulative dosage limit. The alert message is displayed.]
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fotsch in view of Lawrence, Ghanbari, Maughan, Lauritzen et al. (U.S. 2023/0395223), and Whitney et al. (U.S. 2020/0320470), referred to hereinafter as Lauritzen and Whitney, respectively.
REGARDING CLAIM 7
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Fotsch in view of Lawrence, Ghanbari, and Maughan may not explicitly teach
wherein the processor is configured to determine the brand name using the product NDC by:
However, Lauritzen teaches the following:
wherein the processor is configured to determine the brand name using the product NDC by: [Para. 0011 teaches a computer program product comprising a processor. Para. 0245 teaches detecting an NDC from image data. The device detects a brand name.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence, Ghanbari, and Maughan to determine the brand name using the NDC as taught by Lauritzen, with the motivation of improving how medications are tracked (see Lauritzen at Para. 0066).
Fotsch in view of Lawrence, Ghanbari, Maughan, and Lauritzen may not explicitly teach
sending a brand name request message to a second server, wherein the brand name request message indicates a request for a brand name associated with the product NDC;
and receiving a brand name response message from the second server, wherein the brand name response message indicates the brand name.
However, Whitney teaches the following:
sending a brand name request message to a second server, wherein the brand name request message indicates a request for a brand name associated with the product NDC; [Para. 0052 teaches sending a query (request message) that indicates a request for a brand name of a medication. The query is interpreted to be sent to a 2nd server.]
and receiving a brand name response message from the second server, wherein the brand name response message indicates the brand name. [Para. 0052 teaches retrieving the brand name.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence, Ghanbari, Maughan, and Lauritzen to send a brand name query as taught by Whitney, with the motivation of reducing unnecessary costs (see Whitney at Para. 0004).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fotsch in view of Lawrence, Ghanbari, Maughan, Komirishetty et al. (U.S. 2020/0105391), referred to hereinafter as Komirishetty, and Yurkovich (U.S. 2012/0215554).
REGARDING CLAIM 8
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed device of claim 1.
Fotsch in view of Lawrence, Ghanbari, and Maughan may not explicitly teach
wherein the processor is configured to determine the one or more active ingredients associated with the brand name by: sending an ingredient request message to the first server, wherein the ingredient request message indicates a request for one or more active ingredients associated with the normalized identifier;
receive an ingredient response message from the first server, wherein the ingredient response message indicates the normalized identifier and indicates one or more active ingredients;
However, Komirishetty teaches the following:
wherein the processor is configured to determine the one or more active ingredients associated with the brand name by: sending an ingredient request message to the first server, wherein the ingredient request message indicates a request for one or more active ingredients associated with the normalized identifier; [Para. 0029 teaches entering in an RxCUI code (normalized identifier).]
receive an ingredient response message from the first server, wherein the ingredient response message indicates the normalized identifier and indicates one or more active ingredients; [Para. 0029 teaches pulling up ingredients.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence, Ghanbari, and Maughan to send an active ingredient query as taught by Komirishetty, with the motivation of improving efficiency of health care management (see Komirishetty at Para. 0014).
Fotsch in view of Lawrence, Ghanbari, Maughan, and Komirishetty may not explicitly teach
and store the one or more active ingredients within a database such that the one or more active ingredients are associated with the brand name.
However, Yurkovich teaches the following:
and store the one or more active ingredients within a database such that the one or more active ingredients are associated with the brand name. [Para. 0073 teaches storing the active ingredient within a database such that the active ingredient is associated with a trade (brand) name.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the device of Fotsch in view of Lawrence, Ghanbari, Maughan, and Komirishetty to store the active ingredient with a brand name in a database as taught by Yurkovich, with the motivation of giving better insights (see Yurkovich at Para. 0010).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fotsch in view of Lawrence, Ghanbari, Maughan, Komirishetty, and Hess et al. (U.S. 2024/0145071), referred to hereinafter as Hess.
REGARDING CLAIM 17
Fotsch in view of Lawrence, Ghanbari, and Maughan teaches the claimed non-transitory computer-readable medium of claim 15.
Fotsch in view of Lawrence, Ghanbari, and Maughan may not explicitly teach
wherein, to determine the drug display name using the brand name and the one or more active ingredients, the instructions further cause the processor to: send an active ingredient information request to a third server, wherein the active ingredient information request indicates at least one of a structured product labeling identification (SPL ID) or the normalized identifier; and
However, Komirishetty teaches the following:
wherein, to determine the drug display name using the brand name and the one or more active ingredients, the instructions further cause the processor to: send an active ingredient information request to a third server, wherein the active ingredient information request indicates at least one of a structured product labeling identification (SPL ID) or the normalized identifier; and [Para. 0029 teaches entering in an RxCUI code (normalized identifier).]
Motivation to combine the teaching of Komirishetty with the teachings of Fotsch, Lawrence, Ghanbari, and Maughan is the same as that used with respect to claim 8 and is therefore reiterated here.
Fotsch in view of Lawrence, Ghanbari, Maughan, and Komirishetty may not explicitly teach
receive an active ingredient information response, wherein the active ingredient information response indicates an active ingredient and indicates at least one of a warning, a direction regarding the active ingredient, or a usage direction, or a drug interaction warning.
However, Hess teaches the following:
receive an active ingredient information response, wherein the active ingredient information response indicates an active ingredient and indicates at least one of a warning, a direction regarding the active ingredient, or a usage direction, or a drug interaction warning. [Para. 0003 teaches a message indicating medical product data. Para. 0172 teaches medical product data includes active ingredients and warnings.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the non-transitory computer-readable medium of Fotsch in view of Lawrence, Ghanbari, Maughan, and Komirishetty to receive a message indicating active ingredients and warnings as taught by Hess, with the motivation of increasing product awareness (see Hess at Para. 0071).
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 cause 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.
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.
Rejections under 35 U.S.C. § 103
Regarding the rejection of Claims 1-9 and 11-21, the Examiner has considered Applicant’s arguments; however, the arguments are moot given the new grounds of rejection as necessitated by amendment.
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:
Gardner et al. (U.S. 2021/0210170) which discloses an apparatus and method for processing data inputs in computing devices.
Leyde (U.S. 2009/0030403) which discloses methods and systems for attenuating the tolerance response to a drug.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683