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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-10, in the reply filed on 12/12/2025 is acknowledged.
Claims 11-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Status of Claims
Claims 1-32 remain pending in the application, with claims 1-10 being examined and claims 11-32 being withdrawn pursuant to the election filed 12/12/2025.
Claim Objections
Claims 1, 3 are objected to because of the following informalities:
Claim 1 line 18 recites “analyze the secondary values associate with a particular one of the lot values” where it is suggested to change “associate” to “associated” to help the claim read more smoothly.
Claim 3 recites “wherein the authentication code is stored on the storage unit as one or more of: a 1D barcode, a 2D barcode, a QR code, and a numeric string.” This is an improper Markush grouping.
In particular, please note alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C", see MPEP 2117.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1-10 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 1 recites “store authentication codes” on line 12 and “analyze authentication codes” on line 14, where it is unclear if the authentication codes are the same or different from the one recited on line 3.
For examination it will be interpreted that they are the same.
It is suggested to amend claim 1 to recite:
“store the authentication codes” on line 12 and “analyze the authentication codes” on line 14.
Line 14 recites “from multiple consumables” on line 14, where it is unclear if these multiple consumables are the same or different from the multiple consumables recited on line 12, additionally it is unclear if the multiple consumables are the same or different from the plurality of consumables recited on line 2.
For examination it will be interpreted that they are the same.
It is suggested to amend both lines 12 and 14 to recite “from multiple of the plurality of consumables” or similar.
Line 18 recites “analyze the secondary values associate with a particular one of the lot values” where this is unclear because on lines 3-5 describes that each consumable has a secondary value related to the lot value by a predetermined function. It is unclear how now there are multiple secondary values associated with a single lot value.
For examination, it will be interpreted that the processor will analyze the secondary value with the lot value for each of the consumables to determine if it conforms with the predetermined function.
Claims 2-10 are rejected by virtue of being dependent on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7-10 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuo (US-2010/0094564-A1) in view of Linder (US-2011/0256551-A1).
Regarding claim 1, Kuo teaches an authentication system, comprising:
a plurality of consumables (analytical strip 20), each of the consumables (20) having a storage unit (optically readable pattern 22) and an authentication code (identification information) stored by the storage unit (22), the authentication code (identification information) having a lot value (type of analytical strip) and a secondary value (lot number) related to the lot value (type of analytical strip) by a predetermined function (reaction signal data) assigned to the lot value (type of analytical strip) ([0027], [0033] see database sub-module 34 stores reaction signal data of analytical strips of various types where therefore there will be a plurality of analytical strips beyond just those shown in Figures 2A-B, Figures 1, 2A-B);
an analyzer (analytical strip reading apparatus 10) comprising ([0027], Figure 1A):
a reader (optical reader 400) operable to read the authentication code (identification information) from respective consumables (20) ([0029], Figure 1A);
a controller (control module 6) including a processor (processing sub-module 36), an output device (monitor 200), and a non-transitory computer readable medium (database sub-module 34)) storing instructions that, when executed by the processor (36), cause the processor (36) to ([0027], [0033], Figure 1A):
store authentication codes (identification information) from multiple consumables (20) in the non-transitory computer readable medium (34) ([0033] see processing sub-module 36 reads, according to the type of analytical strip 20, the reaction signal data stored in the database sub-module 34 corresponding to the type of analytical strip and reagent calibration data corresponding to the lot number, comparing the reaction signal emitted from the strip 20 against data and information read to come to an analysis result);
analyze authentication codes (identification information) from multiple consumables (20) to determine the lot value (type of analytical strip) and the secondary value (lot number) in the authentication code (identification information) of each of the consumables (20); correlate the lot value (type of analytical strip) with the predetermined function (reaction signal data) ([0033]);
However, Kuo does not specifically teach where there is analysis for the lot number with a particular one of the type of analytical strips to determine if the lot number conforms with the reaction signal data, nor to perform a predetermined action when the lot number does not conform with the reaction signal data.
In the same problem solving area of identifiers associated with a cassette, Linder teaches an identification reader integrated with a control system where the control system is programmed to recognize a specific identifier (Linder; [0161], [0164]).
Specifically, Linder teaches where the identifier on a cassette may include information such as cassette type, type of analysis/assay to be performed, lot number, information about whether the cassette has been used, and other information (Linder; [0163]). Linder further teaches that the identifier of a cassette is associated with predetermined or programmed information contained in a database regarding the use of the system or cassette for a particular purpose, where if an incorrect match is detected or an identifier has been deactivated, the process may be halted or the system may be rendered not operable until the user has been notified or upon acknowledgment by a user (Linder; [0165]). Additionally, Linder teaches where the analyzer reads and identifier information associated with the cassette, and then compares the information to data stored in the control system to ensure it has calibration information for the particular sample, where in the even that the analyzer does not have the proper calibration information the analyzer outputs a request to the user to upload the specific information needed (Linder; [0172]).
It would have been obvious to one skilled in the art to modify the apparatus of Kuo such that the identification information (including the lot number and type of analytical strip) are compared to the reaction signal data that is stored on the database sub-module because it is taught by Linder that it is effective for an analyzer to ensure that it has proper stored data related to a specific test such that the test can proceed (Linder; [0165], [0172]).
As described by [0172] of Linder, if the analyzer determines that it does not have the proper calibration information, it will output a request to the user to upload the specific information needed. Thus, the lot number (secondary value) associated with a particular one of the type of analytical strips (lot value) will be analyzed to determine if the lot number (secondary value) conforms with the reaction signal data stored on the database sub-module (predetermined function). Where if the lot number (secondary value) does not conform with the reaction signal data stored on the database sub-module (predetermined function) the apparatus will output a request for the user to upload the specific information needed.
Regarding claim 2, modified Kuo teaches the system of claim 1. Kuo further teaches wherein the plurality of consumables (20) is a plurality of reagent strips (Kuo; [0033] see where tests can be a blood glucose test, a total cholesterol test, uric acid test, and so on, [0038] which shows an analytical strip 20 with at least one reaction zone 21 for presenting a reaction signal).
Regarding claim 3, modified Kuo teaches the system of claim 1. Kuo further teaches wherein the authentication code (identification information) further comprises a unique identifier value (expiration date) (Kuo; [0027]).
Regarding claim 4, modified Kuo teaches the system of claim 1. Kuo further teaches wherein the authentication code is stored on the storage unit as one or more of: a 1 D barcode, a 2D barcode (Kuo; [0027]).
Regarding claim 7, modified Kuo teaches the system of claim 1. Kuo further teaches wherein the analyzer (10) is a reagent strip analyzer (Kuo; [0027]).
Regarding claim 8, Kuo teaches the system of claim 1. Kuo further teaches wherein the analyzer (10) further comprises an input device (input keyboard 800) (Kuo; [0037], Figure 1A).
Please note that a communication device is not required, due to recitation of “or a combination thereof.”
Regarding claim 9, modified Kuo teaches the system of claim 1. Kuo further teaches wherein the reader (400) is an imager (Kuo; [0029] see the optical reader 400 reads the optically readable pattern 22 where [0027] describes the optically readable pattern as being a one dimensional-barcode or a two-dimensional barcode, therefore the optical reader 400 is an imager).
Regarding claim 10, modified Kuo teaches the system of claim 1. Linder further teaches wherein the predetermined action causes the processor to output a notification to the output device (Linder; [0172]).
Please note that while not required due to recitation of “or a combination thereof.”, Linder further teaches that the predetermined action causes the processor to restrict further operation of the analyzer, as one skilled in the art would find it obvious that if the analyzer outputs a request for the user to upload the specific information needed, the analyzer would restrict further operation of the analyzer until that information is received.
Allowable Subject Matter
Claims 5-6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the closest prior art of record is Kuo (US-2010/0094564-A1) in view of Linder (US-2011/0256551-A1). However, Kuo does not teach where the reaction signal data of analytical strips of various types (predetermined function) determines an average assigned value based on an average of the secondary values. Additionally, it would not be obvious to one skilled in the art to take an average of the lot numbers (secondary values).
Regarding claim 6, the closest prior art of record is Kuo (US-2010/0094564-A1) in view of Linder (US-2011/0256551-A1). However, Kuo does not teach where the reaction signal data of analytical strips of various types (predetermined function) is a statistical distribution based on an expected assigned value of the secondary values.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Groll (US-2005/0016846-A1) teaches that a test meter compares lot ID of the calibration data stored within a ROM key currently inserted into the meter (or calibration data previously-loaded into the test meter internal memory) to the lot ID read from the test strip, and if they do not match the meter displays the lot ID of the currently loaded calibration data and a warning in order to give the user the chance to insert a correct test strip or to insert a different ROM key (Groll; [0067]).
Donohue (US-5311426-A) teaches an analyzer with a carousel that holds a plurality of reaction cartridges, where the apparatus provides assay calibration data for use in assaying biological samples (Donohue; abstract, column 5 lines 1-5).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759