DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 adding significantly more.
When considering subject matter eligibility under 35 U.S.C. 101, it must be determined whether the claim is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter. If the claim does fall within one of the statutory categories, it must then be determined whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea), and if so, it must additionally be determined whether the claim is a patent-eligible application of the exception. If an abstract idea is present in the claim, any element or combination of elements in the claim must be sufficient to ensure that the claim amounts to either a practical application of the abstract idea or significantly more than the abstract idea itself. Groupings of abstract ideas include: Mathematical Concepts, Mental Processes and Certain Methods of Organizing Human Activity.
Certain Methods of Organizing Human Activity include:
Fundamental economic principles or practices,
Commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations), and
Managing personal behavior or relationships or interaction between people (including social activities, teaching and following rules or instructions).
Mathematical Concepts
Mathematical relationships
Mathematical formulas
Mathematical calculations
Mental Processes
Concepts performed in the human mind (including an observation, evaluation, judgement, opinion)
Step 1
In the instant case, claim 1 is directed to a process. Analysis of claim 1 applies to analysis of claims 2-20.
Step 2A Revised (First Prong)
Determine whether claim 1 is directed to a judicial exception. Elements of an abstract idea are underlined. See Analysis.
Step 2A Revised (Second Prong)
Determine whether claim 1 has additional elements (in italics) integrated into a practical application:
a) requires an additional element or a combination of elements in the claim to apply, rely on, or use the judicial exception in a manger that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception; and
b) uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
See Analysis.
Step 2B (Revised)
In Step 2B, evaluate whether claim 1 recites additional elements that amount to an inventive concept that adds significantly more than the recited judicial exception. See Analysis.
Analysis
In Claim 1:
A system to manage usage of laboratory items in a laboratory, the system comprising:
a reader to scan tags on the laboratory items, the tags storing information associated with respective ones of the laboratory items, the laboratory items being a same type of laboratory item; and
memory including instructions to cause programmable circuitry to:
identify, based a scan of a first tag by the scanner, a selection of a first one of the laboratory items to be used in a laboratory instrument;
determine an expiration date of the first one of the laboratory items is later than a second one of the laboratory items; and
generate a recommendation to select the second one of the laboratory items to be used in the laboratory instrument in place of the first one of the laboratory items.
Claim 1 executes methods that are directed to abstract ideas comprising processes that can be executed by a human while following a procedure that organizes human activity related to managing interactions using conventional computing elements. Please note: Laboratory equipment procedures are developed by one or more persons. The laboratory person is following instructions created by one or more persons.
No evidence of an improvement to the functioning of a computer, or to any other technology or technical field.
No evidence exists in the instant specification or claims of a particular machine.
No evidence exists of a transformation or reduction of a particular article to a different state or thing.
The claim does not go beyond generally linking the use of the judicial exception to a particular technological environment, e.g. processor, device.
Claim 1 does not recite additional elements that amount to inventive concepts that are “significantly more” than the recited judicial exception. Courts have routinely found conventional computer processing functions (e.g. sending/receiving data, formatting data, storing data, retrieving data, manipulating data, calculating, searching data, displaying data, organizing data) insignificant to transform an abstract idea into a patent-eligible invention. See Alice, 134 S. Ct. at 2360. As such, the claims amount to nothing significantly more than an instruction to implement the abstract idea across a generic computer network which is not enough to transform an abstract idea into a patent-eligible invention.
The elements of the instant process, when taken in combination, together do not offer substantially more than the sum of the functions of the steps when each is taken alone. That is, the steps involved in the recited process undertake their roles in performance of their activities according to their generic functionalities which are well-understood, routine and conventional. The elements together execute in routinely and conventionally accepted coordinated manners and interact with their partner elements to achieve an overall outcome which, similarly, is merely the combined and coordinated execution of generic computer functionalities which are well-understood, routine and conventional activities previously known to the industry.
Conclusion
Accordingly, the examiner concludes there are no meaningful limitations in claims 1-20 that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception itself.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-3, 5, 9-13, 15, 19 and 20 are rejected under 35 USC 103(a) as being unpatentable over Fritchie et al., US 2009/0117620 “Fritchie,” in view of Asahara et al., US 2010/0248289 “Asahara.”
In Fritchie see at least (underlined text is for emphasis):
Regarding claim 1: A system to manage usage of laboratory items in a laboratory, the system comprising:
a reader to scan tags on the laboratory items, the tags storing information associated with respective ones of the laboratory items, …
[Fritchie: 0013] The method described herein includes a method of reading information from labels. According to this method, radio frequency identification tags, conforming to the guidelines of ISO 14443 or ISO 15693 and ISO 18000, are positioned on the items of interest, such as, for example, reagent containers, sample containers, and micro-well plates. These tags can be read by and written to by either a moving antenna of a radio frequency identification reader or a stationary antenna of a radio frequency identification reader. Reading of radio frequency identification tags and writing to radio frequency identification tags are controlled by software. The use of radio frequency identification technology provides faster and more reliable readings than do barcodes, and further eliminates the hazards associated with laser scanning devices. The system described herein enables tracking of micro-well plates from the initial dispensing of samples and reagents to the final reading of results from the plates.
[Fritchie: 0097] … Information of the type shown in TABLE 1 can be updated on the radio frequency identification tags by the radio frequency identification reader.
[Fritchie: TABLE-US-00001] TABLE 1 Class of data Specific data Tag identifier Unique identifier for container Manufacturing data (a) Revision number(s) of reagent(s) (b) Serial number(s) of reagent(s) (d) Component identifier(s) I Lot number(s) of reagent(s) (f) Stability/expiration data for reagent(s) (g) Times/dates of manufacture of reagent(s) (h) Configuration(s) of assay(s) (e.g., number of reagent containers needed) (i) Number of tests in container(s) (j) Associated components of assay(s) (k) Calibration data for assay(s) Shipping and storage (a) Temperature(s) of reagent during shipping data (b) Times/dates of shipping movements and storage periods (c) Locations and dates of storage periods Analyzer and usage data (a) Times/dates of opening(s) of reagent container(s) (b) Number of aspirations from reagent container(s) (c) Carryover and potential contamination or dilution of reagent(s) or sample(s) (d) Encryption algorithms for protection of data I Other algorithms to ensure integrity of data (f) Chain of custody for operations performed on micro-well plates, reagent containers and sample containers; for micro-well plates, dispensing of samples, reagents(s), incubation temperature, processing, and readings; for reagent containers, date of manufacture, date of shipping, date of loading in reagent inventory management system, date of opening, date of loading into analyzer, aliquots removed and remaining, cumulative carryover, expiration date; for sample containers, draw date, patient, doctor, technicians, test orders, centrifugation, decapping, aliquots removed, cumulative carryover, resealing, entry into storage
… the laboratory items being a same type of laboratory item; and
[Fritchie: 0078] … The reagent containers 30 can be loaded by the operator into the refrigerator, when the reagent containers 30 are received in a shipping carton from a shipping department. This loading process may require removing the top of the shipping carton. The radio frequency identification tags 36 affixed to the reagent containers 30 can be read by a radio frequency identification reader (not shown) associated with the refrigerator and the inventory is recorded.
memory including instructions to cause programmable circuitry to:
identify, based on a scan of a first tag by the scanner, a selection of a first one of the laboratory items to be used in a laboratory instrument;
[Fritchie: 0078] … The radio frequency identification tags 36 affixed to the reagent containers 30 can be read by a radio frequency identification reader (not shown) associated with the refrigerator and the inventory is recorded. When an analysis section of the laboratory automation system 10 connected to the system for managing the inventory of reagents requests a reagent container(s) 30, the system for managing the inventory of reagents typically removes the oldest reagent(s) of the type requested from a shipping carton in the refrigerator, i.e., in a first-in, first-out manner, prepares the reagent container(s) 30 for processing (e.g., caps are removed, septa are installed, etc.) and places the reagent container(s) 30 into reagent container carrier(s) 34.
determine an expiration date of the first one of the laboratory items is later than a second one of the laboratory items; and generate a recommendation to select the second one of the laboratory items to be used in the laboratory instrument in place of the first one of the laboratory items.
Rejection is based in part upon the teachings applied to claim 1 by Fritchie and further upon the combination of Fritchie-Asahara. Although Fritchie relies upon a “first-in first-out” (FIFO) procedure whereby the oldest reagents are removed, Fritchie does not expressly mention comparing expiration dates. Asahara on the other hand would have taught Fritchie such techniques.
In Asahara see at least:
[Asahara: 0136] The expiration date monitor processing operation is executed when the reagent preparing device 4 first performs the preparing operation after change of date. First, in step S61, the CPU 49a determines whether or not the reagent in the supply chamber 47 is within the expiration date based on the supply chamber information table 496. Specifically, the CPU 49a selects the oldest expiration date of the pre-opening expiration date information and the post-opening expiration date information of the information on three reagents recorded in the supply chamber information table 496, and determines whether the selected oldest expiration date is older than the current date. In other words, the CPU 49a determines whether the expiration date of the reagent having the oldest expiration date is no longer valid of the reagents having a possibility of being stored in the supply chamber 47. Whether or not supply of reagent to the measurement section 2 is possible is then determined. If the expiration date of the reagent in the supply chamber 47 is still valid, the expiration date monitor processing operation is terminated as is.
[Asahara: 0148] Furthermore, in the first embodiment, the reagents prepared at different times are simultaneously stored in the supply chamber 47 and the expiration date information for three reagents are recorded in the supply chamber information table 496 of the storage portion 49f, and the CPU 49a is configured to select the oldest expiration date of the pre-opening expiration date information and the post-opening expiration date information of the expiration date information for three reagents and determine whether or not the prepared reagent stored in the supply chamber 47 can be supplied to the measurement section 2 based on the selected oldest expiration date, and hence whether or not the prepared reagent stored in the supply chamber 47 can be supplied to the measurement section 2 can be supplied to the measurement section 2 can be determined based on the oldest expiration date information of the reagent in the supply chamber 47 even if the reagents prepared at different times are stored in the supply chamber 47, and the prepared reagent that is not suited for analysis in terms of expiration date is accurately prevented from being supplied to the measurement section 2 even when the reagents prepared at different times are stored in the supply chamber 47. Please note: Determining the oldest expiration date among two or more items and choosing the oldest qualifies as a recommendation.
One of ordinary skill in at the time the invention was made would have recognized that applying the known techniques of Asahara, which recommend the oldest reagent based upon expiration date determination among two or more reagents, would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the techniques of Asahara to the teachings of Fritchie would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such data processing features into similar systems. Obviousness under 35 USC 103 in view of the Supreme Court decision KSR International Co. vs. Teleflex Inc.
Regarding claim 2: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara pertaining to reading barcoded tags:
[Asahara: 0019] FIG. 8 is a view describing a barcode reader of the reagent preparing device according to the first embodiment of the present invention.
[Asahara: 0093] As shown in FIG. 1, the barcode reader 50 is a handy type and is configured to read a barcode 50b (see FIG. 8) of a label 50a attached to the high concentration reagent tank 5. The barcode 50b contains information unique to each high concentration reagent such as the lot number and the pre-opening expiration date of the high concentration reagent.
Regarding claim 3: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara pertaining to reading RFID tags:
[Frtchie: 0013] The method described herein includes a method of reading information from labels. According to this method, radio frequency identification tags, conforming to the guidelines of ISO 14443 or ISO 15693 and ISO 18000, are positioned on the items of interest, such as, for example, reagent containers, sample containers, and micro-well plates. These tags can be read by and written to by either a moving antenna of a radio frequency identification reader or a stationary antenna of a radio frequency identification reader. Reading of radio frequency identification tags and writing to radio frequency identification tags are controlled by software. The use of radio frequency identification technology provides faster and more reliable readings than do barcodes, and further eliminates the hazards associated with laser scanning devices. The system described herein enables tracking of micro-well plates from the initial dispensing of samples and reagents to the final reading of results from the plates.
[Asahara: Fig. 1 (50); 0058] … and a barcode reader 50 (see FIG. 1). Please note: Barcode reader is a handheld reader requiring a laboratory person to operate.
Given that Fritchie-Asahara teach the use of both RFID and barcode readers, wherein the barcode reader is a handheld reader used to scan laboratory item tages, and the RFID reader can have a moving antenna, it would have been obvious to one of ordinary skill in the art at time the invention was made to scan RFID tags by a laboratory item with a handheld device.
Regarding claim 5: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara pertaining to reading RFID tags:
[Fritchie: 0030] As used herein, the expression "radio frequency identification", or RFID, is a generic term for technologies that use radio waves to automatically identify objects, such as, for example, containers for biological samples and containers for reagents for analyzing biological samples. The most common method of identification is to store a serial number that identifies the object, and perhaps other information relating to the object or contents thereof, on a microchip that is attached to an antenna. The microchip and the antenna together are called an RFID transponder or an RFID tag. The antenna enables the microchip to transmit the identification information and other information to a RFID reader. The RFID reader converts the radio waves reflected back from the RFID tag into digital information that can then be passed on to computers that can make use of it.
[Fritchie: 0031] As used herein, the expression "radio frequency identification system", or RFID system, comprises a RFID tag made up of a microchip with an antenna, and a RFID interrogator or RFID reader with an antenna. The RFID reader sends out electromagnetic waves. The tag antenna is tuned to receive these waves. A passive RFID tag draws power from the field created by the reader and uses it to power the circuits of the microchip. The microchip then modulates the waves that the passive RFID tag sends back to the RFID reader, which converts the waves received by the RFID reader into digital data.
Regarding claim 9: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara regarding reagents as items.
Regarding claim 10: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara regarding information stored in the RFID:
[Fritchie: 0061] … The most common method of identification is to store a serial number that identifies the object, and perhaps other information relating to the object or contents thereof, on a microchip that is attached to an antenna.
Please note: See [Fritchie: TABLE-US-00001] for additional information stored in the RFID tag.
Regarding claim 11: Rejection is based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara. Fritichie-Asahara’s reagent RFID may store information pertaining to the reagent, for example serial number, lot number, expiration date. It would have been obvious to one of ordinary skill in the art at time the invention was made to ascertain selecting a reagent lot having two or more bottles of reagent that may have the same pre-open expiration date will result in a recommendation for a second reagent bottle from the same lot.
Regarding claims 12, 13, 15,19 and 20: Rejections are based upon the teachings and rationale applied to claims 1 and 11 by Fritchie-Asahara and further applied to dependents of claim 1 reciting similar subject matter.
Claims 4, 6-8, 14 and 16-18 are rejected under 35 USC 103(a) as being unpatentable over Fritchie, US 2009/0117620” and Asahara, US 2010/0248289, as applied to claim 3 further in view of O’Banion et al., US 2006/0199196 “O’Banion.”
Regarding claims 4, 6, 14 and 16: Rejections are based upon the teachings and rationale applied to claim 1 by Fritchie-Asahara and further upon the combination of Fritchie-Asahara-O’Banion. Although Fritchie-Asahara teach item storage in a refrigerated area and each item being tagged with an RFID, Fritchie-Asahara do not expressly mention using RFID signal strength to locate the item, e.g. bottle or container of reagent, within the area. O’Banion would have taught Fritchie-Asahara such techniques.
In O’Banion see at least:
[O’Banion: 0153] In certain aspects, the RFID-labeled biological research reagent product is stocked within a supply center. A supply center is a storage location at a customer facility, where a supplier stocks supplies such that the supplies are shipped and stored at the storage facility before they are ordered by the customer. In related aspects, provided herein is a Supply Center that includes on or more RFID readers. For example, a plurality of antennae can be included at various locations on the Supply Center to transmit information about each of the locations (e.g. shelves) to a reader.
[O’Banion: 0161] The invention also includes methods for identifying the location of one or more RFIDs. The location of an RFID in an area may be determined by any number of methods. One example of such a method is the signal strength of the RFID when read at one or more locations. As an example, differences in signal strength from an RFID, as detected by three separate receivers may be used to determine the location of the RFID by triangulation.
One of ordinary skill in the art before the effective filing date would have recognized that applying the known techniques of O’Banion, which use differences in signal strength from an RFID, as detected by three separate receivers, to determine the location of the RFID by triangulation, would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the techniques of O’Banion to the teachings of Fritchie-Asahara would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such data processing features into similar systems. Obviousness under 35 USC 103 in view of the Supreme Court decision KSR International Co. vs. Teleflex Inc.
Regarding claims 7, 8, 17 and 18: Given that the teachings and rationale applied to claims 6 and 16 by Fritchie-Asahara-O’Banion’s identify one or more antennas being placed within a supply center, storage area and/or refrigerated storage area (each having ceilings and walls and/or adjacent walls), it would have been obvious to try, by one of ordinary skill in the art at time the invention was made, to place antennas in various locations (ceilings, walls and/or adjacent walls) within the supply center, storage area and/or refrigerated storage, and incorporate it into the system of Fritchie-Asahara-O’Banion since there are a finite number of identified, predictable potential solutions to the recognized need and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Obviousness under 35 USC 103 in view of the Supreme Court decision KSR International Co. vs. Teleflex Inc.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chain Drug Review, PTO-892 Item U “Pharmacy Power via Technology,” discloses: RFID at the stock bottle level has the potential to impact multiple areas of retail pharmacy. Once at the pharmacy, RFID tags in both stock bottles and vials offer the potential to streamline prescription filling, especially when a pharmacy is using such pharmacy automation as an automated dispensing or work flow management system. I anticipate a pharmacy being able to scan bottles during the drug assignment, drug changeover and replenishment of automated dispensers and instantly populate the application with key information such as the drug's lot codes, expiration dates and authentication data. This would eliminate manual data entry of certain items, which definitely translates into labor savings.
Conclusion
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/ROBERT M POND/Primary Examiner, Art Unit 3688 January 21, 2026