DETAILED ACTION
This communication is a Non-Final Office Action on the merits in response to communications received on 10/23/2025. Claims 1, 4-8, 15, and 17 have been amended. Therefore, claims 1-20 are pending and have been addressed below. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
4. Under Step 1 of the two-part analysis from Alice Corp, claims 1, 8, 17 recite a process (i.e., a series of acts or steps). Thus, each of the claims fall within one of the four statutory categories.
5. Under Step 2A – [Prong One] of the two-part analysis from Alice Corp, the claimed invention recites an abstract idea.
Claim 1 which is representative of claims 8 and 17 recite:
“a user having access to the first consumable;”, “providing access information regarding the class of consumables;”, “receiving a first query to identify the safety status of the first consumable, the query comprising the unique identifier;”, “wherein the safety status of the first consumable is valid before receiving the first query;”, “marking the safety status of the first consumable as invalid upon receipt of the first query;” and “sending a notice that the safety status of the first consumable was valid before the first query received.”
Under the broadest reasonable interpretation, the limitations recite processes for allowing a user to invalidate a consumable and receive preexisting/updated authenticity information related to the consumable which encompasses fundamental economic practices (i.e., mitigating risks), commercial interaction, (i.e., marketing or sales activities, business relations) and managing personal behavior or interactions (i.e., following rules or instructions), that fall within the certain methods of organizing human activity grouping of abstract ideas. See MPEP 2106.04
The Applicant’s Specification at [0007] emphasizes authentication of products or items to combat sale or distribution of counterfeit or fraudulent goods have been attempted. However, in spite of this mistakeable goods that are easy to imitate flood the marketplace with at times disastrous effects. The opiate epidemic in the United States is fueled by deadly fentanyl based drugs that are mistakeable for less harmful opiate pharmaceuticals. [0008]Rather than focusing on proving that a pill or item is authentic, there remains a need for methods, devices, databases, and systems to invalidate the authenticity of the item and safeguard the public.
Consistent with the disclosure, the limitations recite fundamental economic practices, i.e., mitigating risks, or commercial/legal interactions, i.e., legal obligations, business relations, and/or managing personal behavior because they cover steps for allowing a user to perform when invalidating a consumable, i.e., medication, with a unique identifier. The series of steps organize information related to the consumable using the unique identifier for regulatory or legal purposes and serve to protect other users against the risk of using the consumable if it has been reported as counterfeit. Accordingly, the claim recites an abstract idea.
6. Under Step 2A – Prong Two of the two-part analysis from Alice Corp, this judicial exception is not integrated into a practical application because the additional elements of: “a safety database”, “the safety database” – see claims 1, 8, and 17 is/are recited at a high-level of generality in light of the specification. Thus, because the specification describes the computer components in general terms without describing the particulars the additional elements may be broadly but reasonably construed as reciting a generic computer component being used to perform the judicial exception. Therefore, the additional elements recited in the claim add the words “apply it” with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely use the database as a tool to perform the abstract idea as discussed in MPEP 2106.05 (f).
The other additional elements of “a method of marking a safety status of a first consumable as invalid, wherein the first consumable has a unique identifier and the first consumable is associated with a class of consumables, comprising:” is merely an attempt to limit the claimed invention to a particular field of use or technological environment, as discussed in MPEP 2106.05 (h).
Thus, the additional claim elements are not indicative of integration into a practical application, because the claims do not involve improvements to the functioning of a computer, or to any other technology or technical field (MPEP 2106.05(a)), the claims do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition (Vanda Memo), the claims do not apply the abstract idea with, or by use of, a particular machine (MPEP 2106.05(b)), the claims do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and the claims do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (MPEP 2106.05(e) and Vanda Memo). Therefore, the claims do not, for example, purport to improve the functioning of a computer. Nor do they effect an improvement in any other technology or technical field. Accordingly, the additional elements do not impose any meaningful limits on practicing the abstract idea and the claims are directed to an abstract idea.
7. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, the additional element(s) of: “a safety database”, “the safety database” – see claims 1, 8, and 17 at best amounts to nothing more than mere instructions in which to apply the judicial exception and cannot provide an inventive concept.
8. Claims 2-7, 9-16, and 18-20 are dependents of claims 1, 8, and 17.
Claim 2 recites “wherein the class of consumables comprises a weight management treatment, a GLP-1 receptor agonist, a semaglutide, a liraglutide, a tirzepatide, a dulaglutide, an exenatide, an albiglutide, a lixisenatide, or a retatrutide” which further describes the data/information recited in the abstract idea, but does not make the claim any less abstract. Claims 3 and 11 recite “wherein the first consumable is a pill, and (i) not an approved member of the class of consumables, (ii) comprises a component hazardous to human health, (iii) comprises an analog of one of semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide, or (iv) comprises semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide.” which further describes the data/information of the abstract idea and narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claims 4 and 12 recite “wherein a user has anonymous access to the safety database or verified access to the safety database, wherein verified access is as a verified distributor of the class of consumables.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claim 5 recites “wherein the first query marks the safety status of the unique identifier as invalid in the safety database.” which further describes the data/information recited in the abstract idea, but does not make the claim any less abstract. Claims 6 and 14 recites “wherein a user has anonymous access to the safety database.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claims 7 and 15 recites “wherein a user has verified access to the safety database, the first consumable has a pre-query safety status in the safety database, and wherein verified access by the first user returns the safety status of the first consumable to the pre-query safety status.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claim 9 recites “wherein the safety status is one of valid or invalid.” which further describes the data/information recited in the abstract idea, but does not make the claim any less abstract. Claim 10 recites “wherein the class of items is one of a consumable, a pharmaceutical, a generic pharmaceutical, a brand name pharmaceutical, a weight management pharmaceutical, a nutraceutical, or a dietary supplement” which further describes the data/information recited in the abstract idea, but does not make the claim any less abstract. Claim 13 recites “wherein the data invalidates the safety status of the first item in the safety database.” which further describes the data/information recited in the abstract idea, but does not make the claim any less abstract. Claim 16 recites “wherein a user has physical access to the first item.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claim 18 recites “further comprising a user submitting a credential to the safety database, wherein submitting the credential returns the safety status of the first item from invalid to the pre-query safety status.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claim 19 recites “further comprising a time limit for a user to submit the credential, wherein expiration of the time limit prevents any subsequent modification of the safety status of the first item” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. Claim 20 recites “wherein the first item is an opiate pharmaceutical, and the response comprises a warning that if the pre-query safety status is invalid, ingestion of the opiate pharmaceutical is deadly.” which further narrows how the abstract idea may be performed, but does not make the claim any less abstract. The additional elements recited in the dependent claims when considered individually and in combination with the judicial exception do not integrate the judicial exception into a practical application or provide an inventive concept.
Claim Rejections - 35 USC § 102
9. 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.
10. Claim(s) 1-2, 4-10, 12-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banks (US 2020/0098460 A1).
With respect to claim 1, Banks discloses
a method of marking a safety status of a first consumable as invalid in a safety database (¶ 0009, 0018, 0035, 0049: discloses database 203 may store information associated with medication such that the information described may be provided in response to a query containing the unique identifier. If the unique medication identifier has been assigned, but does not match the type of medication then it is counterfeit.),
wherein the first consumable has a unique identifier (¶ 0018-0019, 0030, 0035, 0050, 0063: discloses manufacturer 210 may manufacture a medication 100 and place a unique medication identifier 110 on the medication. The unique medication identifier may uniquely identify a single dose of medication, i.e., individual pill, tablet, capsule, or other form of single dose medication) and
the first consumable is associated with a class of consumables (¶ 0004, 0009, 0034: discloses narcotic medications, i.e., opiates, opioids, and benzodiazepines, other controlled prescription medications.), comprising:
a user having access to the first consumable (¶ 0018, 0026-0027, 0040: discloses to access the information associated with the medication a scanning device may, i.e., scan, read, photograph, etc., the medication to read the unique medication identifier.);
providing access to the safety database (¶ 0026, 0034, 0039-0040: discloses users having an interest in the medication may access the database via the network. The database may be accessed by the manufacturer or another party.),
the safety database having information regarding the class of consumables (¶ 0004, 0009, 0026-0027: discloses the database may be populated such that all the information presently known about the medication may be associated with the unique identifier for the medication. The medication may correspond to prescription medication, over the counter medication, a vitamin or a nutritional supplement.);
receiving, at the safety database, a first query to the safety database to identify the safety status of the first consumable (¶ 0027, 0036, 0038, 0040, 0050, 0052, 0063, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication.), the query comprising the unique identifier (¶ 0027, 0035-0036, 0063), and wherein the safety status of the first consumable is valid in the safety database before receiving the first query (¶ 0026, 0034, 0053, 0063, 0065: discloses a manufacturer computer sends data about the medication the server which is stored in the database. At this point a database may be populated such that all of the information that is presently known about the medication may be associated with the unique identifier for the medication. The information associated with the medication may include the authenticity of the medication.);
marking the safety status of the first consumable as invalid in the safety database upon receipt of the first query (¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication. Drug and associated drug information can be populated into the database by any user. User device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc.); and
sending, from the safety database, a notice that the safety status of the first consumable was valid before the first query was received at the safety database. (¶ 0034, 0050, 0057, 0062, 0065, 0067: discloses database 203 may store the information associated with medication such that the information may be provided in response to a query containing the unique medication identifier. Database may include a medication profile which includes the unique identifier for the medication 100 as well as all information associated with the medication 100. The information associated with the medication 100 may be scanned and queried from the database may include whether the medication is subject to recall, is authentic or counterfeit, is weaponized, etc. Medication may be scanned and queried by law enforcement to determine whether medication 100 is authentic or counterfeit. The information stored in the database may be used to make a number of decisions.)
With respect to claim 2, Banks discloses the method of claim 1,
wherein the class of consumables comprises a weight management treatment (¶ 0009: discloses the medication may correspond to a vitamin or nutritional supplement), a GLP-1 receptor agonist, a semaglutide, a liraglutide, a tirzepatide, a dulaglutide, an exenatide, an albiglutide, a lixisenatide, or a retatrutide.
With respect to claim 4, Banks discloses the method of claim 1,
wherein a user has anonymous access to the safety database or verified access to the safety database (¶ 0062: discloses if a device is associated with an unknown individual or an individual associated with a profile for which limited access is granted then the information associated with the medication provided in response to the query may be limited.),
wherein verified access is as a verified distributor of the class of consumables. (¶ 0026, 0063: discloses manufacturers, distributors, supply chain managers, and others having an interest in the medication may access the databases. Furthermore, only devices associated with manufacturers and certain others may upload information associated with medication.)
With respect to claim 5, Banks discloses the method of claim 1,
wherein the first query marks the safety status of the unique identifier as invalid in the safety database. (¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication. Drug and associated drug information can be populated into the database by any user. User device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc.)
With respect to claim 6, Banks discloses the method of claim 1,
wherein a user has anonymous access to the safety database. (¶ 0061-0062: discloses the user device 240 may be associated with any person or entity having access to database 203. If the user device is associated with an unknown individual, then the information associated with medication provided in response to the query may be limited.)
With respect to claim 7, Banks discloses the method of claim 1,
wherein a user has verified access to the safety database (¶ 0062: discloses an individual associated with a profile for which access is granted.), the first consumable has a pre-query safety status in the safety database (¶ 0039, 0058: discloses database 203 includes existing information associated with the medication 100), and
wherein verified access by the first user returns the safety status of the first consumable to the pre-query safety status. (¶ 0026, 0028, 0062, 0065: discloses verified users access the database using verified credentials. The database maintains information on each medication status, i.e., valid, counterfeit, recalled, prior to a query. When a verified user queries the database, the receive pre-existing information.)
`With respect to claim 8, Banks discloses
a method of invalidating a safety status of a first item having a unique identifier (¶ 0009, 0018, 0035, 0049: discloses database 203 may store information associated with medication such that the information described may be provided in response to a query containing the unique identifier. If the unique medication identifier has been assigned, but does not match the type of medication then it is counterfeit.),
wherein the first item is one of a plurality of items associated with a class of items (¶ 0004, 0034: discloses narcotic medications, i.e., opiates, opioids, and benzodiazepines, other controlled prescription medications.), and
wherein the safety status of the first item is valid (¶ 0026, 0034, 0053, 0063, 0065: discloses a manufacturer computer sends data about the medication the server which is stored in the database. At this point a database may be populated such that all of the information that is presently known about the medication may be associated with the unique identifier for the medication. The information associated with the medication may include the authenticity of the medication.), comprising:
providing access to a safety database having information regarding the class of items (¶ 0026, 0034, 0039-0040: discloses users having an interest in the medication may access the database via the network. The database may be accessed by the manufacturer or another party.);
receiving, at the safety database, a query comprising the unique identifier (¶ 0027, 0036, 0038, 0040, 0050, 0052, 0063, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication.);
upon receipt of the query at the safety database (¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069), adding a data regarding the unique identifier to the safety database to invalidate the safety status of the first item in the safety database (¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication. Drug and associated drug information can be populated into the database by any user. User device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc.); and
sending, from the safety database, a notice including the safety status of the first item before the query. (¶ 0034, 0050, 0057, 0062, 0065, 0067: discloses database 203 may store the information associated with medication such that the information may be provided in response to a query containing the unique medication identifier. Database may include a medication profile which includes the unique identifier for the medication 100 as well as all information associated with the medication 100. The information associated with the medication 100 may be scanned and queried from the database may include whether the medication is subject to recall, is authentic or counterfeit, is weaponized, etc. Medication may be scanned and queried by law enforcement to determine whether medication 100 is authentic or counterfeit. The information stored in the database may be used to make a number of decisions.)
With respect to claim 9, Banks discloses the method of claim 8,
wherein the safety status is one of valid or invalid. (¶ 0034, 0050, 0057, 0062, 0065, 0067: discloses the information associated with the medication 100 may be scanned and queried from the database may include whether the medication is subject to recall, is authentic or counterfeit, is weaponized, etc. Medication may be scanned and queried by law enforcement to determine whether medication 100 is authentic or counterfeit. The information stored in the database may be used to make a number of decisions.)
With respect to claim 10, Banks discloses the method of claim 8,
wherein the class of items is one of a consumable (¶ 0042), a pharmaceutical (¶ 0042: discloses prescription medication), a generic pharmaceutical (¶ 0042: discloses over the counter medication), a brand name pharmaceutical (¶ 0034: discloses detailed information on the medication may be stored in the database including the brand name.), a weight management pharmaceutical (¶ 0042), a nutraceutical (¶ 0042), or a dietary supplement. (¶ 0042: discloses nutritional supplements, vitamins, etc.)
With respect to claim 12, Banks discloses the method of claim 8,
wherein a user has anonymous access to the safety database or verified access to the database (¶ 0062: discloses if a device is associated with an unknown individual or an individual associated with a profile for which limited access is granted then the information associated with the medication provided in response to the query may be limited.), wherein verified access is as a verified distributor of the class of items. (¶ 0026, 0063: discloses manufacturers, distributors, supply chain managers, and others having an interest in the medication may access the databases. Furthermore, only devices associated with manufacturers and certain others may upload information associated with medication.)
With respect to claim 13, Banks discloses the method of claim 8,
wherein the data invalidates the safety status of the first item in the safety database. (¶ 0056, 0061: discloses the user device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, etc.)
With respect to claim 14, Banks discloses the method of claim 13,
wherein a user has anonymous access to the safety database. (¶ 0061-0062: discloses the user device 240 may be associated with any person or entity having access to database 203. If the user device is associated with an unknown individual, then the information associated with medication provided in response to the query may be limited.)
With respect to claim 15, Banks discloses the method of claim 8,
wherein a user has verified access to the safety database. (¶ 0039, 0061-0062: discloses the user device 240 may be associated with any person or entity having access to database 203. If the user device is associated with an individual associated with profile for which limited access is granted, then the information associated with medication provided in response to the query may be limited. Permissions associated with read/write access to the database…may restrict the ability of many devices to upload information associated with medication to the database.)
With respect to claim 16, Banks discloses the method of claim 8,
wherein a user has physical access to the first item. (¶ 0027, 0035, 0040: discloses to access the information associated with medication, a user operating scanning device may interrogate, i.e., scan, read, photograph, the medication to read the unique identifier.)
With respect to claim 17, Banks discloses
a method of invalidating a safety status of a first item in a safety database (¶ 0009, 0018, 0035, 0049: discloses database 203 may store information associated with medication such that the information described may be provided in response to a query containing the unique identifier. If the unique medication identifier has been assigned, but does not match the type of medication then it is counterfeit.),
wherein the first item has a unique identifier (¶ 0018-0019, 0030, 0035, 0050, 0063: discloses manufacturer 210 may manufacture a medication 100 and place a unique medication identifier 110 on the medication. The unique medication identifier may uniquely identify a single dose of medication, i.e., individual pill, tablet, capsule, or other form of single dose medication) and
the first item is associated with a class of items (¶ 0004, 0009, 0034: discloses narcotic medications, i.e., opiates, opioids, and benzodiazepines, other controlled prescription medications.), comprising:
providing access to the safety database (¶ 0026, 0034, 0039-0040: discloses users having an interest in the medication may access the database via the network. The database may be accessed by the manufacturer or another party.), the safety database having information regarding the class of items (¶ 0004, 0009, 0026-0027: discloses the database may be populated such that all the information presently known about the medication may be associated with the unique identifier for the medication. The medication may correspond to prescription medication, over the counter medication, a vitamin or a nutritional supplement.);
receiving, at the safety database, a query to the safety database (¶ 0027, 0036, 0038, 0040, 0050, 0052, 0063, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication.), the query comprising the unique identifier (¶ 0027, 0035-0036, 0063);
marking the safety status of the first item as invalid in the safety database upon receipt of the first query (¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069: discloses the party scanning the unique medication identifier may update the database to provide additional information associated with the medication. Drug and associated drug information can be populated into the database by any user. User device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc.), wherein the first item had a pre-query safety status of valid in the safety database (¶ 0026, 0034, 0053, 0063, 0065: discloses a manufacturer computer sends data about the medication the server which is stored in the database. At this point a database may be populated such that all of the information that is presently known about the medication may be associated with the unique identifier for the medication. The information associated with the medication may include the authenticity of the medication.); and
sending, from the safety database, a notice of the pre-query safety status of the first item. (¶ 0034, 0050, 0057, 0062, 0065, 0067: discloses database 203 may store the information associated with medication such that the information may be provided in response to a query containing the unique medication identifier. Database may include a medication profile which includes the unique identifier for the medication 100 as well as all information associated with the medication 100. The information associated with the medication 100 may be scanned and queried from the database may include whether the medication is subject to recall, is authentic or counterfeit, is weaponized, etc. Medication may be scanned and queried by law enforcement to determine whether medication 100 is authentic or counterfeit. The information stored in the database may be used to make a number of decisions.)
With respect to claim 18, Banks discloses the method of claim 17,
further comprising a user submitting a credential to the safety database (¶ 0028-0029, 0033: discloses if a user is a medical professional, law enforcement agent, or first responder, they can input their government registration and identification into their profile which is verified using a database.),
wherein submitting the credential returns the safety status of the first item from invalid to the pre-query safety status. (¶ 0028-0029, 0033, 0062: discloses the information associated with medication that is provided in response to the query may vary depending upon what information has been populated in the database as permissions of the user associated with query.)
With respect to claim 20, Banks discloses the method of claim 17,
wherein the first item is an opiate pharmaceutical (¶ 0004, 0009, 0038, 0050 0061: discloses the medication may correspond to prescription medication, over the counter medication. The database includes information associated with medication, i.e., opioids), and the response comprises a warning that if the pre-query safety status is invalid, ingestion of the opiate pharmaceutical is deadly. (¶ 0034-0035, 0037-0038: discloses the database can return information and alerts indicating dangerous conditions, i.e., weaponized medication, that could cause serious harm or death if consumed.)
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claim(s) 3 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banks in further view of Altschul (US 2015/0343144 A1).
With respect to claim 3, Banks discloses the method of claim 1,
wherein the first consumable is a pill (¶ 0009, 0042: discloses medication 100 may be any type of single dose of medication like a pill.), and (i) not an approved member of the class of consumables (¶ 0034: discloses the authenticity of the medication), (ii) comprises a component hazardous to human health (¶ 0034: discloses a narcotic or other restricted pharmaceutical product.),
The Banks reference does not explicitly disclose the following limitations.
In the same field of endeavor, the Altschul reference is related to providing a smart pill system. The smart pill system comprises several technologies (e.g., silicon, sensors, peer wireless communication), different devices (e.g., pill itself, enabling terminals), and an encrypted network for communication and data storage. The system is able to ensure reasonable anti-counterfeit and origin traceback, with a multilayered security system, and good overdose protection. (¶ 0018) and teaches:
(iii) comprises an analog of one of semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide, or (iv) comprises semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide.
The difference between the prior art and the claimed invention is that Banks does not explicitly recite agonists (e.g., liraglutide). Accordingly, the prior art references teach that opioids and agonists are elements known in the art for describing drugs/medicines.
Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to have substituted the opioids taught by Banks for the agonists of Altschul because both elements were known equivalents for describing drugs/medicines within the medication industry. The substitution would have resulted in the predictable result of adding specific types of drugs/medicines to the database. KSR International Co. v. Teleflex Inc., 127 S. Ct 1727, 1739 (2007).
With respect to claim 11, Banks discloses the method of claim 8,
wherein the first item is (i) not an approved member of the class of items (¶ 0034: discloses the authenticity of the medication), (ii) comprises a component hazardous to human health (¶ 0034: discloses a narcotic or other restricted pharmaceutical product.),
The Banks reference does not explicitly disclose the following limitations. In the same field of endeavor, the Altschul reference is related to providing a smart pill system. The smart pill system comprises several technologies (e.g., silicon, sensors, peer wireless communication), different devices (e.g., pill itself, enabling terminals), and an encrypted network for communication and data storage. The system is able to ensure reasonable anti-counterfeit and origin traceback, with a multilayered security system, and good overdose protection. (¶ 0018) and teaches:
(iii) comprises an analog of one of semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide, or (iv) comprises semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide, albiglutide, lixisenatide, or retatrutide. (¶ 0284: discloses examples of medicaments used for treatment of obesity include, but are not limited to, lipase inhibitors (e.g., orlistat), appetite suppressants (e.g., sibutramine, rimonabant, phendimetrazine, diethylpropion, phentermine, bupropio, topiramate, zonisamide), agents that delay gastric emptying (e.g., hormones and their analogs such as exenatide and pramlintide), and metformin. Examples of medicaments used for the treatment of diabetes include, but are not limited to, insulin, sulfonylurea secretagogues (e.g., tolbutamide, acetohexamide, tolazamide, chlorporpamide, glipizide, glyburide, glimepiride, gliclazide), meglitinide secretagogues (e.g., repaglinide, nateglinide), biguanide insulin sensitizers (e.g., metformin), thiazolidinediones (e.g., rosiglitazone, pioglitazone), alpha-glucosidase inhibitors (e.g., miglitol, acarbose), glucagon-like peptide analogs and agonists (e.g., liraglutide), dipeptidyl peptidase-4 inhibitors (e.g., vildagliptin, sitagliptin, saxagliptin), and amylin analogues (e.g., pramlintide).
The difference between the prior art and the claimed invention is that Banks does not explicitly recite agonists (e.g., liraglutide). Accordingly, the prior art references teach that opioids and agonists are element known in the art for describing drugs/medicines.
Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to have substituted the opioids taught by Banks for the agonists of Altschul because both elements were known equivalents for describing drugs/medicines within the medication industry. The substitution would have resulted in the predictable result of adding specific types of drugs/medicines to the database. KSR International Co. v. Teleflex Inc., 127 S. Ct 1727, 1739 (2007).
14. Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banks in further view of Bobkov (WO 2023107236 A1).
With respect to claim 19, Banks discloses the method of claim 18, further comprising the credential (¶ 0028-0029, 0033: discloses if a user is a medical professional, law enforcement agent, or first responder, they can input their government registration and identification into their profile which is verified using a database.),
The Banks reference does not explicitly disclose the following limitations.
In the same field of endeavor, the Bobkov reference a system and method for communicating medical data by using medical identifiers. (¶ 0001)
a time limit for a user to submit, wherein expiration of the time limit prevents any subsequent modification of the safety status of the first item. (¶ 00100-00105, 00112, 00132: discloses the user is authorized based on the log-in credentials. The data access module automatically logs off the user according to preset period of time and therefore terminates the electronic session between the user device and the database.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods to Banks to include a time limit for the user to submit, wherein expiration of the time limit prevents subsequent modification of the status of the first item, as disclosed by Bobkov to achieve the claimed invention. As disclosed by Bobkov, the motivation for the combination would have been to allow the user to be in compliance with national standards for electronic health information. (¶ 00105)
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive.
With Respect to Rejections Under 35 USC 101
Applicant argues “As a basis for Step 2A – Prong One analysis, the MPEP requires the claims set forth or describe the judicial exception, and cautions “Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis).” MPEP 2106.04(II)(A)(1).”
“With respect to reciting commercial/legal interactions, it should be noted there are two primary components of the claimed methods: (i) providing access to safety status of an item/consumable in a database and (ii) for any item/consumable queried, defaulting the post-query safety status of the item/consumable to invalid in the database. The Office previously noted “the limitations recite processes for allowing a user to query and receive information regarding the authenticity status of a consumable”, which the Office viewed as certain methods of human activity.”
“However, the claims as amended herein do not recite or require users querying or receiving information. Rather, the amended claims provide access to a safety database, receive queries at the safety database regarding items/consumable having a valid safety status, marking the safety status as invalid upon receipt of the query, and sending a notice of the pre-query status of the item/consumable. In short, the amended claims recite the mechanisms of defaulting a safety status of an item in a safety database to invalid upon receipt of an query, and sending notice of pre-query status. As the amended claims simply do not recite, set forth, or describe commercial/legal interactions, the amended claims are not directed to an abstract idea and are eligible under Step 2A – Prong One.” The Examiner respectfully disagrees.
Contrary to the remarks, the claims remain ineligible under Step 2A Prong One of the analysis. The Examiner asserts the previous rejection was proper as the limitations that recite an abstract idea were identified and the previous rejection explains why the limitations fall with the certain methods of organizing human activity groupings. In response the remarks above, the step of “receiving” in the context of the claim may be performed by a user interacting with the safety database to add or update information associated with a medication. It is important for applicant to note certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the "certain methods of organizing human activity" grouping. See MPEP 2106.04(a)(2)(II)
Next, the additional element recited - a safety database - is used in its ordinary or normal capacity to store and/or retrieve data. The type of information/data provided by the user and/or sent to the user in response to the query does not make the claim any less abstract. Thus, when viewed as a whole the steps being carried out by the user and the safety database are merely used to perform the judicial exception and remain insufficient to integrate the judicial exception into a practical application or provide an inventive concept. For these reasons, the rejections under 101 are being maintained.
Applicant further argues “With respect to reciting managing personal behavior or interactions of the user, amended claims 1, 8, and 17 do not recite actions of a user. As noted above, the amended claims recite the mechanic actions of a safety database that default a safety status of an item in the database to invalid upon receipt of a query, and sending notice of pre-query status. The claims do not require or compel a user to take actions. As such, the claims do not recite, set forth, or describe managing the personal behavior or interactions of a user and are not directed to an abstract idea and is eligible under Step 2A – Prong One. The claims as amended are not directed to a judicial exception and are eligible under Step 2A – Prong One analysis. Applicant respectfully requests the rejection be withdrawn.” The Examiner respectfully disagrees.
Contrary to the remarks, the claims remain ineligible under Step 2A Prong One of the analysis – managing personal behavior or interactions between people. Turning to the Specification, [¶ 0010, 0020] emphasize that a user submits a query to the database but the Specification fails to discuss or provide details as to any device or computer not being operated by the user which is then used to access and provide information to the safety database. Thus, after considering the Specification, the broadest reasonable interpretation of the “receiving” step may encompass allowing a user to provide the first query which may be reasonably characterized as subject matter falling within the certain methods of organizing human activity grouping. For these reasons, the rejections under 101 are being maintained.
With Respect to Rejections Under 35 USC 102
Applicant argues “Banks appears to teach methods and systems for marking pills or medicines with unique identifiers to distinguish authentic pills or medicines from counterfeit, and to log authentic or counterfeit status of each unique identifier. While Banks appears to teach marking the status of a pill as counterfeit or weaponized in response to an invalid unique identifier, Banks does not teach marking a consumable or unique identifier with a valid safety status as invalid based simply on submission of a valid query. Claims 1, 8, and 17 are amended herein to require marking the safety status of the first consumable having a valid safety status as invalid simply based on submission of a valid query with support at paras [0010], [0020], and [0037]. Such a feature is emphasized in the Specification at para [0037], noting “[w]hile this may invalidate otherwise valid or authentic items or pills, it impedes a user from subsequently transferring such items or pills under the guise of being authentic as any subsequent query of authenticity will show the pill or item is invalid.” Such a distinction is not taught by Banks. Applicant respectfully requests the claims be allowed.” The Examiner respectfully disagrees.
In the instant case, the cited passages from Applicant’s Specification [¶ 0010, 0020, 0037] have been considered, however, the Examiner contends the passages from the Banks reference teach or suggest the limitations as claimed. For example, Banks expressly teaches in at least ¶ 0027, 0030, 0035, 0038, 0040, 0044, 0052, 0057, 0061, 0069: the party scanning the unique medication identifier may update the database to provide additional information associated with the medication. Drug and associated drug information can be populated into the database by any user. User device 240 populates the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc.
As best understood from the teachings of Banks, user device 240 may be operated by a user to access and/or update the database with information associated with the medication, i.e., the medication has been weaponized, banned, is subject to age verification when distributed, etc. The Bank reference discusses allowing a user to upload information to a database to indicate that a medication is counterfeit responsive to scanning the medication. The information added may be provided in response to future queries for information associated with the medication. Therefore, the passages from the Banks reference meet the limitations as claimed. For these reasons, the rejections under 102 are being maintained.
With Respect to Rejections Under 35 USC 103
Applicant argues “The Office rejected claims 3 and 11 under 35 U.S.C. § 103 as obvious over Banks in view of US 2015/0343144 to Altschul (“Altschul”). While Altschul appears to teach a pill tracking system associated with liraglutide, it fails to cure the defects of Banks noted above. As such, Applicant respectfully requests the claims be allowed.” The Examiner respectfully disagrees.
Applicant's arguments regarding Banks in further view of Altschul fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant further argues “The Office rejected claim 19 under 35 U.S.C. § 103 as obvious over Banks in view of WO 2023107236 to Bobkov (“Bobkov”). While Bobkov appears to teach a communicating medical data including verified access and a time limit to enter credentials, it fails to cure the defects of Banks noted above. As such, Applicant respectfully requests the claims be allowed.”
The Examiner respectfully disagrees.
Applicant's arguments regarding Banks in further view of Bobkov fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
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