DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 15 August, 2024.
Claims 1 – 6 are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because of the following informalities: The specification as filed includes two paragraphs at the bottom of Page 8:
“Referring to Figure 4, a flowchart of preferred methods of the present principles is illustrated. The method starts at 195, and at 198 accesses, or is given access to the unique identifier 80 or
SmartTag 70. The method then determines at step 200 whether a bill for the patient has been identified. If not, then the method then either returns to step 198 to search new unique identifiers or SmartTags, or to verify the input unique identifier , for a specific number of attempts as set by the system, or determines at 210 then no bill exists for the patient so identified and so stops at 220.”
However it appears that all of the above text should be in one paragraph as shown below:
“Referring to Figure 4, a flowchart of preferred methods of the present principles is illustrated. The method starts at 195, and at 198 accesses, or is given access to the unique identifier 80 or SmartTag 70. The method then determines at step 200 whether a bill for the patient has been identified. If not, then the method then either returns to step 198 to search new unique identifiers or SmartTags, or to verify the input unique identifier , for a specific number of attempts as set by the system, or determines at 210 then no bill exists for the patient so identified and so stops at 220.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 – 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Examiner cannot determine the metes and bounds of the claims. Claim 1 recites: creating an NFT to which digitized information will be applied; however the digitized information is applied “to a digital prescription insert” and not to the created NFT. A digital prescription insert is not an NFT.
The specification discloses that an “NFT” is a “non-fungible token” created by uploading a file. NFTs are known to those of ordinary skill in blockchain arts. An NFT may be used to identify digital items such as artwork, videos or music. (@ 0009 as published) The specification also refers to an NFT as a “SmartTag” used as a unique identifier for a patient.
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.
The following rejection is formatted in accordance with MPEP 2106.
Claim 1 is independent. Claim 1 recites:
A method to generate a digital prescription insert, comprising:
digitizing medication information and storing the digitized information in a file,
creating an NFT to embody a patient’s digital twin to which the digitized medication information will be applied;
determining whether a patient is permitted to be prescribed the medication; and
applying the digitized information to a digital prescription insert when the patient is permitted to be prescribed the medication.
Claims 1 - 6 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), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a method which is included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea including:
determining whether a patient is permitted to be prescribed the medication; and
applying the information to a prescription insert when the patient is permitted to be prescribed the medication.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The claims recite a process for digitizing, storing and providing medication information as a digital prescription insert when a patient is permitted to be prescribed the medication. The specification discloses that digitizing, storing and providing digital prescription inserts is old and well-known. In particular, the specification discloses that a patient may be permitted to be prescribed the medication if the medication is “permitted by the patient’s insurance company and coverage or other factors dictating whether the patient can take the drug.” (@ 0079). There are no technical details disclosed as to how the determination is made. Analyzing a medication against insurance rule for coverage, or against any other factor, to determine whether the medication is permitted to be prescribed, is a process that under the broadest reasonable interpretation, can be performed in the human mind. It is routine in medicine to determine whether a patient is permitted to be prescribed a medication using insurance rules and drug-to-drug contraindications.
Collecting information, including when limited to particular content, is within the realm of abstract ideas, and analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, are mental processes within the abstract idea category (Electric Power Group v. Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
commercial or legal interactions including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations;
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite digitizing, storing and applying digital medication information to a prescription package insert in a digital form, when the prescription is permitted. Providing prescription package inserts, including in digital form, is typical in medicine, even according to the present specification, and the claims recite a process that merely organizes this human activity. As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO and STEP 2B
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
digitizing medication information and storing the digitized information in a file,
creating an NFT to embody a patient’s digital twin to which the digitized medication information will be applied.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
Digitizing and storing medication information related to package inserts is an extra-solution data gathering step; and is purely conventional in accordance with the specification. Similarly, creating an NFT serves as an identifier for patient records and is an extra-solution activity; and is purely conventional in accordance with the specification. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular blockchain technological environment.
Nothing in the claim recites specific limitations directed to an improved computer system, processor, memory, network, database or Internet. The claims do not recite any of these elements at all. Similarly, the specification is silent with respect to these kinds of improvements. As such, the additional elements recited in the claim do not integrate the abstract prescription information process into a practical application of that process; and do not provide significantly more, or an inventive concept.
The dependent claims add additional features including:
those that recite additional abstract ideas such as:
implementing payment for the drug (Claim 6);
those that recite well-understood, routine and conventional activity or computer functions such as:
providing interactive features (Claims 2 - 4);
activating update using QR codes (Claim 5);
those that recite insignificant extra-solution activities or those that are an ancillary part of the abstract idea.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. These elements merely narrow the abstract idea, recite additional abstract ideas, or append conventional activity to the abstract process. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being obvious over Schaub: (US PGPUB 2015/0254423 A1) in view of Cordonnier et al.: (US PGPUB 2023/0268040 A1)
CLAIM 1
Schaub discloses a computer-based prescription system that includes the following limitations:
A method to generate a digital prescription insert; (Schaub 0008, 0019), comprising:
digitizing medication information and storing the digitized information in a file; (Schaub 0037, 0038, 0056, 0063, 0104);
determining whether a patient is permitted to be prescribed the medication; (Schaub 0038, 0108); and
applying the digitized information to a digital prescription insert when the patient is permitted to be prescribed the medication; (Schaub 0037, 0038, 0056, 0063, 0104).
Schaub discloses a method for generating digital prescription inserts including generating a digital “medication dataset” that includes a medication package insert for a medication that has been prescribed for a patient, in response to determining that the prescription is authorized (i.e. permitted to be prescribed) for the patient. Providing a digital prescription insert, as disclosed in Schaub, inherently includes digitizing and storing the medication information in a file.
Examiner notes that generating digital prescription inserts and providing them to a patient who has been prescribed a particular medication is known in the art in accordance with Applicant’s admission as to the state of the prior art in the specification (@ 0010 – 0012).
With respect to the following limitation:
creating an NFT to embody a patient’s digital twin to which the digitized medication information will be applied; (Cordonnier 0015, 0016, 0020, 0021, 0040, 0100 – 0102, 0113, 0114).
Schaub discloses exchanging data related to a prescription, including digital inserts, using the identification for a digital certificate, (@ 0027, 0053); but does not disclose the use of NFTs to identify (i.e. embody) a patient’s electronic record (i.e. a patient’s digital twin), as disclosed in the present specification (@ 0078). Cordonnier discloses linking patient data to an NFT, including medication information. The NFT is created using known techniques and all of the patient data is linked, referenced or otherwise stored on or with the NFT. Cordonnier does not expressly disclose linking a digital prescription insert to the NFT, nonetheless; applying digital prescription inserts information to an NFT merely applies established blockchain methods in a new data environment – i.e. patient records, and in particular, digital prescription inserts. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the prescription system of Schaub so as to have included NFTs to manage patient data, in accordance with the teaching of Cordonnier, in order to increase patient access to their own records.
Claims 2 - 4 are rejected under 35 U.S.C. 103 as being obvious over Schaub: (US PGPUB 2015/0254423 A1) in view of Cordonnier et al.: (US PGPUB 2023/0268040 A1) in view of Official Notice.
CLAIMS 2 - 4
The combination of Schaub/Cordonnier discloses the limitations above relative to Claim 1. With respect to the following limitations:
providing interactive features to the digital prescription insert; wherein the interactive features are members of group including a patient’s drug interactions, drug allergies and medical conditions wherein the interactive features are updatable to supplement the digital prescription insert.
Schaub/Cordonnier discloses providing a digital prescription insert, but does not expressly disclose the recited interactive features. The US Food & Drug Administration (FDA) provides on-line, digital package inserts for any medication. The inserts include interactive features for drug interactions, allergies and medical conditions. The FDA “Daily Med” landing page (see https://www.dailymed.nlm.nih.gov/dailymed/) provides options for search for a particular medication, and displaying the drug label information in response. The FDA provides drug label archives, indicating that the drug labels may be updated. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the prescription system of Schaub/Cordonnier so as to have included interactive package inserts, in accordance with the Official Notice taken, in order to increase patient access to medication label information.
Claim 5 is rejected under 35 U.S.C. 103 as being obvious over Schaub: (US PGPUB 2015/0254423 A1) in view of Cordonnier et al.: (US PGPUB 2023/0268040 A1) in view of Official Notice in view of Al-Jazaeri et al.: (US PGPUB 2022/0384026 A1).
CLAIM 5
The combination of Schaub/Cordonnier/Official Notice discloses the limitations above relative to Claim 4. With respect to the following limitations:
wherein the updatable features are activatable by a QR code; (Al-Jazaeri 0013 – 0016, 0018, 0019, 0024, 0033, 0080 – 0085, 0092).
Al-Jazaeri discloses a patient doctor information sharing system that used QR code to convey information including use instructions for medications (i.e. package insert). Information may be updated by updating the QR code. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the prescription system of Schaub/Cordonnier/Official Notice so as to have included using QR code to update information, in accordance with the teachings of Al-Jazaeri, in order to provide a convenient information update mechanism.
Claim 6 is rejected under 35 U.S.C. 103 as being obvious over Schaub: (US PGPUB 2015/0254423 A1) in view of Cordonnier et al.: (US PGPUB 2023/0268040 A1) in view of Official Notice in view of Al-Jazaeri et al.: (US PGPUB 2022/0384026 A1) in view of deWaide: (US PGPUB 2023/0028859 A1).
CLAIM 6
The combination of Schaub/Cordonnier/Official Notice/Al-Jazaeri discloses the limitations above relative to Claim 5. With respect to the following limitations:
wherein patient payment for the drug is implemented using the digital prescription insert; (deWaide 0029, 0039) .
DeWaide discloses an electronic payment system that includes generating a QR code containing an encoded link prompting a user for payment. The QR code is captured by the user’s smartphone and a payment application is launched. It would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the prescription system of Schaub/Cordonnier/Official Notice/Al-Jazaeri so as to have included an encoded payment link in the interactive package insert QR code, in accordance with the teachings of deWaide, in order to provide a convenient and secure payment process.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2007/0179957 A1 to Gibson et al. discloses a system and method for disseminating prescription drug package insert information in digital form.
US PGPUB 2020/0097606 A1 to Hamilton II et al. discloses a system and method for presenting prioritized information including medication package inserts.
US PGPUB 2020/0135331 A1 to Mohebbi et al. discloses a medication monitoring system that includes providing digital prescription drug inserts to a user.
US PGPUB 2021/0366029 A1 to Oller et al. discloses a pharmaceutical sales system that includes links to payment options.
“How NFTS could transform health information exchange: Can patients regain control over their health information?”; Kostick-Quenet et al.; 4 February, 2022; HHS Public Access; discloses using NFTs to point to digital data.
“Non-Fungible Tokens”; US GAO; June 2022 discloses using NFTs for health records.
“Patents and intellectual property assets as non-fungible tokens; key technologies and challenges”; Bamakan et al.; Nature.com; 9 February 2022
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
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/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 28 October, 2025