DETAILED ACTION
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 . Claims 1-20 are pending.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "the user having access to the database, the database having information regarding the class of items" (emphasis ours) in the second paragraph of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
The rest of the dependent claims are rejected by virtue of their dependence. Accordingly, claims 17-20 are rejected.
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 1-20 are rejected under 35 USC § 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (The Statutory Categories): Is the claim to a process, machine, manufacture or composition of matter? MPEP 2106.03.
Per Step 1, claims 1, 8, and 17 are directed to a method (i.e., a process). Thus, the claims are directed to statutory categories of invention. However, the claims are rejected under 35 U.S.C. 101 because they are directed to an abstract idea, a judicial exception, without reciting additional elements that integrate the judicial exception into a practical application.
The analysis proceeds to Step 2A Prong One.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon? MPEP 2106.04.
The abstract idea of claim 1 is:
a user having access to the first consumable;
the database having information regarding members of the class of items;
the user submitting the unique identifier as a query;
in response to the query, recording a status of the first consumable as unsafe; and
the user receiving a response that the first consumable was a safe or unsafe member of the class of consumables before the user submitted the query, thereby protecting the user from harm due to consumption of the first consumable.
The abstract idea of claim 8 is:
the user having access to information regarding the class of items;
the user submitting the identifier as a query;
in response to the query, adding a datum regarding the safety of the identifier; and
the user receiving a response regarding a safety status of the first item as a member of the class of items, thereby protecting the user from harm from the first item.
The abstract idea of claim 17 is:
the user having access to information regarding the class of items;
the user submitting the unique identifier as a query;
in response to the query, marking a safety status of the first item as unsafe, wherein the first item has a pre-query safety status;
the user receiving a response comprising the pre-query safety status of the first item, wherein the pre-query status is as a safe or unsafe member of the class of items, thereby warning the user of harm from the first item.
The abstract idea steps italicized above encompasses managing product status in a database, with steps involving a user accessing data, submitting a query, and receiving a result, which constitutes a process that, under its broadest reasonable interpretation (BRI), covers commercial activity. This is further supported by paragraphs [0008] and [0009] of applicant’s specification as filed. If a claim limitation, under its BRI, covers commercial interactions, including contracts, legal obligations, advertising, marketing, sales activities or behaviors, and/or business relations, then it falls within the Certain Methods of Organizing Human Activity – Commercial or Legal Interactions grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Additionally and alternatively, the claim is directed to determining product status and associating them with a class, which are steps that could be performed mentally, including pen and paper. This is further supported by paragraphs [0008] and [0009] of applicant’s specification as filed. If a claim limitation, under its BRI, covers performance of the limitation in the mind, including observations, evaluations, judgements, and/or opinions, then it falls within the Mental Processes – Concepts Performed in the Human Mind grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? MPEP §2106.04.
This judicial exception is not integrated into a practical application because the additional elements are merely instructions to apply the abstract idea to a computer, as described in MPEP §2106.05(f).
Claims 1, 8, and 17 recite the following additional elements: database.
These elements are merely instructions to apply the abstract idea to a computer, per MPEP §2106.05(f). Applicant has only described generic computing elements in their specification, as seen in paragraph [0014] of applicant’s specification as filed, for example. Further, the combination of these elements is nothing more than a generic computing system.
Accordingly, these additional elements, alone and in combination, do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
Step 2B (The Inventive Concept): Does the claim recite additional elements that amount to significantly more than the judicial exception? MPEP §2106.05.
Step 2B involves evaluating the additional elements to determine whether they amount to significantly more than the judicial exception itself.
The examination process involves carrying over identification of the additional element(s) in the claim from Step 2A Prong Two and carrying over conclusions from Step 2A Prong Two on the considerations discussed in MPEP §2106.05(f).
The additional elements and their analysis are therefore carried over: applicant has merely recited elements that facilitates the tasks of the abstract idea, as described in MPEP §2106.05(f).
Further, the combination of these elements is nothing more than a generic computing system. When the claim elements above are considered, alone and in combination, they do not amount to significantly more.
Therefore, per Step 2B, the additional elements, alone and in combination, are not significantly more. The claims are not patent eligible.
Further, the analysis takes into consideration all dependent claims as well:
Regarding claims 2-7, 9-16, and 18-20, applicant further narrows the abstract idea with additional step(s). There are no further additional elements to consider, beyond those highlighted above. This further narrowing of the abstract idea, similar to above, is also not patent eligible. See MPEP §2106.05(f).
Accordingly, claims 1-20 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. § 102(a)1 and (a)(2) as being anticipated by Banks (US 20200098460).
Claim 1
Regarding claim 1, Banks discloses:
A method of protecting a user from harm due to consumption of a first consumable, wherein the first consumable has a unique identifier and the first consumable is associated with a class of consumables, comprising: {Systems and methods designed to prevent harm to a user by identifying unsafe medications such as counterfeit, weaponized, recalled, expired, or otherwise unsafe medications prior to consumption prevents patient harm and improves public safety is used (paragraph 0040). Each individual medication unit (i.e., consumable) has a “unique medication identifier” that is stored in a database along with information about the medication (e.g., its association with broader categories such as type, lot, batch, or packaging). The system can determine that a medication is counterfeit, stolen, or otherwise invalid and flag it in the database accordingly (paragraphs 0010, 0020, 0030-0032, 0035).}
a user having access to the first consumable {A patient, guardian, caregiver, pharmacist, or authorized official can physically receive and thus have access to a uniquely identified medication unit. Access is controlled by linking the unit’s unique identifier to the user’s profile and verifying identity at pickup (paragraphs 0029-0030).}
providing a database accessible to the user, the database having information regarding members of the class of consumables {The system includes a database accessible by multiple users that stores information about medications as member of broader classes, including medication type, lot, batch, controlled status, and authenticity (paragraphs 0026, 0034).}
the user submitting the unique identifier as a query to the database {A user scans a medication to read its unique medication identifier and submits that identifier to the database as a query via a scanning device or user device (paragraph 0027).}
in response to the query to the database recording a status of the first consumable as unsafe {Upon evaluating the submitted unique identifier, the database records the medication as counterfeit or weaponized when the identifier is unassigned, duplicated, or mismatched (i.e., recording unsafe status for the consumable) (paragraph 0035).}
the user receiving a response from the database that the first consumable was a safe or unsafe member of the class of consumables before the user submitted the query, thereby protecting the user from harm due to consumption of the first consumable {The database already contains status information about the medication prior to the query. Querying returns an indication of whether the medication is authentic, counterfeit, recalled, expired, or otherwise unsafe, based on pre-existing database records (paragraphs (0040), (0065)). Identifying counterfeit, weaponized, recalled, expired, or otherwise unsafe medications prior to consumption prevents patient harm and improves public safety (paragraphs 0034, 0040).}
Claim 2
Regarding claim 2, Banks discloses:
wherein the class of consumables comprises a Schedule I-V substance, an analog of a Schedule I-V substance, or an opiate {The system is applicable to controlled substances, including narcotics such as opioids (i.e., Schedule I-IV classifications). The database stores legal control information for each medication class and restricts access to such substances (paragraphs 0034, 0038-0039, 0061).}
Claims 3 and 11
Regarding claims 3 and 11, Banks discloses:
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 a fentanyl analog, or (iv) comprises fentanyl {Each medication unit, including pills, can be determined to be counterfeit, weaponized, or otherwise unsafe, and controlled substances such as opioids (e.g., fentanyl) are tracked. The database can flag pills containing hazardous or unapproved components (paragraphs 0034-0035, 0038, 0042, 0061).}
Claims 4 and 12
Regarding claims 4 and 12, Banks discloses:
wherein the user has anonymous access to the database or verified access to the database, wherein verified access is as a verified distributor of the class of consumables {Access to the database can be restricted by permissions, with some users (e.g., the public) receiving only limited information, while verified users (e.g., distributors) have full access. Verified distributors of controlled substances (i.e., class of consumables) are authenticated via credentials or biometric identification before being allowed database access (paragraphs 0026, 0028, 0062).}
Claim 5
Regarding claim 5 , Banks discloses:
wherein the query marks the status of the unique identifier as unsafe in the database {When a user submits a query containing a unique identifier, the database can determine from existing records that the identifier is improper, the system then marks it as weaponized or counterfeit (i.e., making the unique identifier’s status as unsafe) (paragraph 0035).}
Claims 6 and 14
Regarding claim 6 and 14, Banks discloses:
wherein the user has anonymous access to the database. {Database access permissions can allow certain users (e.g., unknown individuals or those with limited profiles) to receive only restricted information without full identification (i.e., anonymous access) (paragraph 0062).}
Claim 7
Regarding claim 7, Banks discloses:
wherein the user has verified access to the database, the first consumable has a pre-query status in the database, and wherein verified access by the first user returns the status of the first consumable to the pre-query status. {Verified users (e.g., distributors, pharmacists) access the database using verified credentials. The database maintains information on each consumable’s status (e.g., valid, counterfeit, recalled) prior to any given query. When a verified user queries the database, they receive the existing status without altering it (i.e., returning the status to its pre-query state) (paragraphs 0026, 0028, 0062, 0065).}
Claim 8
Regarding claim 8, Banks discloses:
A method of protecting a user from harm from a first item having a unique identifier, wherein the first item is one of a plurality of items associated with a class of items, comprising {Systems and methods designed to prevent harm to a user by identifying unsafe medications such as counterfeit, weaponized, recalled, expired, or otherwise unsafe medications prior to consumption prevents patient harm and improves public safety is used (paragraph 0040). Each individual medication unit (i.e., consumable) has a “unique medication identifier” that is stored in a database along with information about the medication (e.g., its association with broader categories such as type, lot, batch, or packaging). The system can determine that a medication is counterfeit, stolen, or otherwise invalid and flag it in the database accordingly (paragraphs 0010, 0020, 0030-0032, 0035).}
the user having access to a database, the database having information regarding the class of items {A patient, guardian, caregiver, pharmacist, or authorized official can physically may access a database which stores information about medication units and their associated class. Access is controlled by linking the unit’s unique identifier to the user’s profile and verifying identity at pickup (paragraphs 0029-0032.}
the user submitting the identifier as a query to the database {A user scans the unique medication identifier with a scanning device or user device, which sends that identifier to the database as part of a query to retrieve associated information (paragraph 0027).}
in response to the query, the database adding a datum regarding safety of the identifier to the database {When a unique medication identifier is submitted in a query, the database can be updated with new information associated with that identifier, including information indicating whether the medication is counterfeit, weaponized, recalled, stolen, or otherwise unsafe. This information is stored as additional data associated with the identifier (paragraphs 0027, 0035).}
the user receiving a response from the database regarding a safety status of the first item as a member of the class of items, thereby protecting the user from harm from the first item {When a user queries the database with a unique medication identifier, the system returns information indicating the medication’s (i.e., first item) status (e.g., recalled, expired), i.e., safety status, based on its membership in a particular class (e.g., type, lot, batch) (paragraphs 0039-0040, 0065).}
Claim 9
Regarding claim 9, Banks discloses:
wherein the safety status is one of a {The database can indicate whether an item (e.g., medication unit) is a safe member of its class (e.g., authentic, properly assigned) or an unsafe member (e.g., counterfeit) (paragraphs 0035, 0065).}
Claim 10
Regarding claim 10, Banks discloses:
wherein the class of items is one of a consumable, a pharmaceutical, a generic pharmaceutical, a brand name pharmaceutical, an opiate pharmaceutical, a nutraceutical, or a dietary supplement {The system applies to various types of consumables items, including pharmaceuticals, controlled substances such as opioids, and other ingestible products such as nutritional supplements and vitamins (paragraphs 0034, 0038, 0042),}
Claim 13
Regarding claim 13, Banks discloses:
wherein the datum identifies the first item as unsafe in the database {When information associated with a unique identifier indicates a problem (e.g., unassigned identifier, duplication, or mismatch to medication type), the database records a flag identifying the medication unit as counterfeit or weaponized. This recorded flag constitutes a datum in the database that identifies the first item as unsafe (paragraph 0035).}
Claim 15
Regarding claim 15, Banks discloses:
wherein the user has verified access to the database, and the datum does not identify the first item as unsafe in the database {Verified users (e.g., distributors, pharmacists) access the database using verified credentials to add or retrieve information. In many cases, the information they add does not change the validity status of the medication unit in the database (e.g., adding prescription details, shipment info) (paragraphs 0026, 0028, 0057).}
Claim 16
Regarding claim 16, Banks discloses:
wherein the user has physical access to the first item {An authorized person can physically receive or handle an individual medication unit (i.e., the first item) once it has been assigned to them or is in their possession (paragraphs 0029-0030).}
Claim 17
Regarding claim 17, Banks discloses:
A method of warning a user of harm from a first item, wherein the first item has a unique identifier and the first item is associated with a class of items, comprising {Systems and methods warns users about potential harm from consuming or possessing a medication unit by using a unique medication identifier associated with a broader class (e.g., medication type, controlled status). By scanning the identifier and querying a database, the system can determine whether the item is counterfeit, weaponized, recalled, expired, or otherwise unsafe, and can notify the user accordingly (paragraphs 0018, 0020, 0037, 0040).}
the user having access to the database, the database having information regarding the class of items {Authorized users can access the database by scanning a medication’s unique identifier through a device or application. The database stores information not only about the specific unit but also about its class (e.g., type of medication, lot number, batch, container, pallet) (paragraphs 0026, 0030-0032).}
the user submitting the unique identifier as a query to the database {A user scans the unique medication identifier with a scanning device or user device, which sends that identifier to the database as part of a query to retrieve associated information (paragraph 0027).}
in response to the query, the database marking a safety status of the first item as unsafe in the database, wherein the first item has a pre-query safety status in the database {Before a query is made, the database holds information about the item’s status (e.g., safe assigned). When a query containing the unique identifier is submitted and the database determines that the identifier is unassigned or duplicated, it flags the item as counterfeit or weaponized (i.e., changing its status from the pre-query status to unsafe) (paragraphs 0035, 0065).}
the user receiving a response from the database comprising the pre-query safety status of the first item, wherein the pre-query status is as a safe or unsafe member of the class of items, thereby warning the user of harm from the first item {Upon scanning a medication’s unique identifier and querying the database, the user receives a response indicating whether the medication is authentic (i.e., safe) or counterfeit (i.e., unsafe), including cases where the database already had information about its status from earlier records (e.g., recall). This determination is made using existing database entries before the current query (i.e., pre-query status) (paragraphs 0033, 0035, 0065).}
Claim 18
Regarding claim 18, Banks discloses:
further comprising the user submitting a credential to the database, wherein submitting the credential returns the safety status of the first item from unsafe to the pre-query status {Verified users (e.g., distributors, pharmacists) can submit credentials to the database. Verified access allows these users to correct or update database records, such as fixing a mistaken counterfeit flag (i.e., restoring the item’s status to its original (pre-query) state) (paragraphs 0026, 0028, 0062).}
Claim 19
Regarding claim 19, Banks discloses:
further comprising a time limit for the user to submit the credential, wherein expiration of the time limit prevents subsequent modification of the safety status of the first item {Certain actions (e.g., verifying receipt of a prescription, confirming a patient’s authorization) must occur within a certain time frame after an event (e.g., delivery, pickup). If verification is not completed in time, the system can prevent further changes to the record (i.e., locking the status) (paragraph 0074).}
Claim 20
Regarding claim 20, Banks discloses:
wherein the first item is an opiate pharmaceutical, and the response comprises a warning that if the pre-query status is unsafe, ingestion of the opiate pharmaceutical is deadly {The system applies to controlled substances (e.g., opiate pharmaceuticals) and the database can return information and alerts indicating dangerous conditions (e.g., weaponized medication) that could cause serious harm or death if consumed (paragraphs 0034-0035, 0037-0038).}
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-10, 12-14, and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-10, 12-14, and 16-20 of copending Application No. 18/952,056. (Claims 4-7, 9-10, 12-14, 16, and 18-20 of instant Application No. 18/586,077 are virtually identical to claims 4-7, 9-10, 12-14, 16, and 18-20 of copending Application No. 18/952,056. Their mapping has been omitted for purposes of brevity.)
18/586,077
18/952,056
Claim 1
A method of protecting a user from harm due to consumption of a first consumable, wherein the first consumable has a unique identifier and the first consumable is associated with a class of consumables, comprising:
(Examiner notes that protecting a user from harm due to consumable is not recited explicitly in the copending application. The copending application includes maintaining a status of a consumable, which Examiner notes that these are equivalent.)
a user having access to the first consumable;
providing a database accessible to the user, the database having information regarding members of the class of consumables;
the user submitting the unique identifier as a query to the database;
in response to the query, the database recording a status of the first consumable as unsafe; and
the user receiving a response from the database that the first consumable was a safe or. (Examiner notes that the notice’s timing (pre-query) inherently covers a user receiving a safe or unsafe classification before the user’s query was submitted, as the information was already validated and communicated in advance.)
Regarding claim 1, 18/952,056 discloses in claim 1:
A method of marking a safety status of a first consumable as invalid in a safety database, wherein the first consumable has a unique identifier and the first consumable is associated with a class of consumables, comprising:
a user having access to the first consumable;
providing access to the safety database, the safety database having information regarding the class of consumables;
receiving, at the safety database a first query to the safety database to identify the safety status of the first consumable, the query comprising the unique identifier, and wherein the safety status of the first consumable is valid in the safety database before receiving the first query;
marking the safety status of the first consumable as invalid in the safety database upon receipt of the first query; 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.
Claim 8
A method of protecting a user from harm from a first item(Examiner notes that protecting a user from harm due to consumable is not recited explicitly in the copending application. The copending application includes maintaining a status of a consumable, which Examiner notes that these are equivalent.)
the user having access to a database, the database having information regarding the class of items;
the user submitting the identifier as a query to the database;
in response to the query, the database adding a datum regarding safety of the identifier to the database; and
the user receiving a response from the database regarding a safety status of the first item as a member of the class of items, thereby protecting the user from harm from the first item. (Examiner notes that the notice’s timing (pre-query) inherently covers a user receiving a safe or unsafe classification before the user’s query was submitted, as the information was already validated and communicated in advance.)
Regarding claim 8, 18/952,056 discloses in claim 8:
A method of invalidating a safety status of a first item having a unique identifier, wherein the first item is one of a plurality of items associated with a class of items, and wherein the safety status of the first item is valid, comprising:
providing access to a safety database having information regarding the class of items;
receiving, at the safety database, a query comprising the unique identifier;
upon receipt of the query at the safety database, adding a data regarding the unique identifier to the safety database to invalidate the safety status of the first item in the safety database; and
sending, from the safety database, notice including the safety status of the first item before the query.
Claim 17
A method of warning a user of harm from a first item, wherein the first item has a unique identifier and the first item is associated with a class of items, comprising: (Examiner notes that protecting a user from harm due to consumable is not recited explicitly in the copending application. The copending application includes maintaining a status of a consumable, which Examiner notes that these are equivalent.)
the user having access to the database, the database having information regarding the class of items;
the user submitting the unique identifier as a query to the database;
in response to the query, the database marking a safety status of the first item as unsafe in the database, wherein the first item has a pre-query safety status in the database; and
the user receiving a response from the database comprising the pre-query safety status of the first item, wherein the pre-query status is as a safe or unsafe member of the class of items, thereby warning the user of harm from the first item. (Examiner notes that the notice’s timing (pre-query) inherently covers a user receiving a safe or unsafe classification before the user’s query was submitted, as the information was already validated and communicated in advance.)
Regarding claim 17, 18/952,056 discloses in claim 17:
A method of invalidating a safety status of a first item in a safety database, wherein the first item has a unique identifier and the first item is associated with a class of items, comprising:
providing access to the safety database, the safety database having information regarding the class of items;
receiving, at the safety database, a query to the safety database, the query comprising the unique identifier;
marking the safety status of the first item as invalid in the safety database upon receipt of the first query, wherein the first item had a pre-query safety status of valid in the safety database; and
sending, from the safety database, a notice of the pre-query safety status of the first item.
Regarding claims 1 and 17, Examiner notes that “in response to the query, the database recording a status of the first consumable as unsafe” is functionally equivalent to “marking the safety status of the first consumable as invalid in the safety database upon receipt of the first query”.
Regarding claim 8, Examiner notes that “in response to the query, the database recording a status of the first consumable as unsafe” is functionally equivalent to “upon receipt of the query at the safety database, adding a data regarding the unique identifier to the safety database to invalidate the safety status of the first item in the safety database”.
Regarding claim 13, Examiner notes that “wherein the datum identifies the first item as unsafe in the database” is functionally equivalent to “wherein the data invalidates the safety status of the first item in the safety database”.
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/952,056, in further view of Banks (US 20200098460).
Claim 15
The method of claim 8, wherein the user has verified access to the database, and the datum does not identify the first item as unsafe in the database.
18/952,056 does not explicitly disclose: the datum does not identify the first item as unsafe in the database.
However, Banks, in a similar endeavor directed to uniquely identifying a medication unit, teaches:
the datum does not identify the first item as unsafe in the database {In many cases, the information they add does not change the validity status of the medication unit in the database (e.g., adding prescription details, shipment info) (paragraphs 0026, 0028, 0057).}
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the features of Banks to improve the security of sensitive information like medication safety data.
Regarding claim 15, 18/952,056 discloses in claim 15:
The method of claim 8, wherein a user has verified access to the safety database.
Response to Arguments
Applicant’s arguments filed on 11/18/2025 have been carefully considered. The
headings and page numbers below correspond to those used by applicant.
Claim Rejections - 35 USC § 101
On pages 6-7, Applicant offer remarks regarding the rejections under 35 U.S.C. §101. While well taken, they are not persuasive.
Applicant offers on pages 6-7:
“The Office rejected claims 1-20 under 35 U.S.C. § 101 as directed to an abstract idea without significantly more. While Applicant respectfully disagrees, in the interest of advancing prosecution the claims are amended herein.
Under Step 2A - Prong One of the Alice analysis, the Office concluded claims 1, 8, and 17 (i) "encompass managing product status in a database," interpreted as commercial activity and (ii) are "directed to determining product status and associating them with a class." Applicant respectfully disagrees, especially in view of the amendments herein and points discussed below.
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 understood the recited method is for protecting or warning a user of the harm caused by consuming a consumable, which is accomplished by two primary components: (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 unsafe in the database. A goal of the inventive subject matter is the safety of a consumable for consumption by an end user, and preventing or dissuading the end user from consuming unsafe consumables. As described in the Specification, "a user may believe a specific pill is an authentic or valid pill of OxyContinTM, when it is actually a dangerous or deadly pill including fentanyl. A mistake between an authentic OxyContinTM pill and a pill appearing similar but having fentanyl can be deadly for the user." Para [0017].
The focus of the inventive subject matter is emphasized in the amended claims by requiring protecting a user from harm due to consumption of a first consumable and marking the status of a consumable as unsafe by default. The amended claims simply do not describe, set forth, or otherwise recite any commercial interaction, contract, legal obligations, advertising, marketing, sales activities, or business relations. Rather, they recite protecting or warning a user of harm. 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. Applicant respectfully requests the rejection be withdrawn.”
The amended claims are still directed to an abstract idea under Step 2A, Prong One. The claims focus on looking up information, assigning a safety status to a consumable, and reporting that status to a user. This is managing information, which is an abstract concept.
Saying the goal is to protect a user from harm does not change what the claims actually do. The claimed steps remain database queries and status updates. Classifying an item as safe or unsafe and communicating that classification is still abstract when performed using generic computer functions.
The specification’s example about dangerous pills explains why the invention may be useful, but the claims do not recite any technical process for detecting unsafe consumables or improving computer operation. Marking an item as “unsafe by default” is a data rule, not a technological improvement.
Accordingly, the rejections under 35 USC §101 are maintained.
Claim Rejections - 35 USC § 102
On page 7, Applicant offer remarks regarding the rejections under 35 U.S.C. §102. While well taken, they are not persuasive.
Applicant offers on page 7:
“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 as unsafe based simply on submission of the unique identifier as a query. Likewise, Banks does not appear to teach warning or protecting a user from harm from consuming an item/consumable as required by amended claims 1, 8, and 17.
Claims 1, 8, and 17 are amended herein to require marking the safety status of the first consumable as invalid simply based on submission of the unique identifier as a query, with support at paras [0010], [0020], and [0037]. Such a feature is emphasized in the Specification at para [0032], 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." Likewise, claims 1, 8, and 17 are amended to require warning or protecting the user from harm from an item/consumable. Such features, alone or combined, do not appear taught by Banks. Applicant respectfully requests the claims be allowed.”
Applicant’s arguments are not persuasive. Banks discloses that safety status information for a medication is stored in a database before a user later scans the medication and submits a query. Banks discloses that manufacturers, pharmacies, regulators, and law enforcement populate the database with information indicating whether a medication is counterfeit, weaponized, recalled, expired, or restricted. (See paragraphs 0026-0027, 0034-0036, and 0039-0040). When a user scans the medication’s unique identifier, the database returns this pre-existing status information in response to the query. (See paragraphs 0027, 0065-0067).
Accordingly, Banks discloses both maintaining a safety status for a consumable prior to a query, and providing that safety status to the user in response to the query (i.e., warning or protecting the user form consuming an unsafe medication. (See paragraphs 0037, 0040).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.F.M./Examiner, Art Unit 3629 /SARAH M MONFELDT/Supervisory Patent Examiner, Art Unit 3629