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 in the reply filed on 12/18/2025 is acknowledged. Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim Status
Claims 1-8 are pending with claims 1-6 being examined and claims 7-8 are withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite an “automatic determination system comprising a storage unit configured to store result of detection image information, check an image included in the result of detection image information against a data table, the information storage unit configured to store analyte information, the result of detection image information is scantron information, and the information storage unit is configured to acquire either or both the analyte information and the test result of detection image information”, and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” or “mathematical concepts” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind. Mental operations and mathematical concepts in the instant claims are recited as: “an information unit configured to store results of detection image information, check an image included in the result of detection image information against a data table, store analyte information, store analyte information and acquire either or both the analyte information and the test result of detection image information, wherein the result of detection image information is scantron information”.
In summary, the claim(s) recite(s) an information unit configured to store results of detection image information, check an image included in the result of detection image information against a data table, store analyte information, store analyte information and acquire either or both the analyte information and the test result of detection image information, wherein the result of detection image information is scantron information which is a step that can be performed using a computer which uses mathematical algorithms/formulas as a form of an abstract idea.
Said recited judicial exception steps are directed to storing and analyzing information against a data table and producing results in scantron information, which under the BRI, cover performance of the limitations in the mind and mathematical concepts, as said steps under said interpretation would involve a making a mental comparison and mental correlation or mathematical correlation. Thus, if a claim, under its BRI, covers performance of the limitation in the mind, but for the recitation of generic computer elements, then it falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)).
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) The claims recite mathematical process (judicial exception) which are not integrated into a practical application because the system describes storing results of detection image information, check an image included in the result of detection image information against a data table, store analyte information, store analyte information and acquire either or both the analyte information and the test result of detection image information, wherein the result of detection image information is scantron information” In summary, the claim(s) recite(s) an information unit configured to store results of detection image information, check an image included in the result of detection image information against a data table, store analyte information, store analyte information and acquire either or both the analyte information and the test result of detection image information, wherein the result of detection image information is scantron, a mathematical process, but the automatic determination system does not describe a resultant action/step that is taken by applying the linked determination of the information stored, and therefore the method does not add a meaningful limitation to the abstract idea;
(b) Although the claims recite a storage unit configured to store the result of detection image, analyte information in association with the result of detection image information, the result of determination derived by the result of determination deriving unit in association with the analyte information and the result of detection image information, and acquire either or both of the analyte information and the result of detection image information, the claims do not apply the exception, as the claim does not transform the automatic determination system to a different state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) A storage unit (or memory) is recited at a high level of generality (as a generic and well-known structure) such that it is no more than mere instructions to apply the exception using a generic computer/diagnostic system (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(d));
(d) The claims include storing information in the memory, which is recited at a high level of generality (i.e., generic computer and processor performing generic computer functions) such that the recitations amount to no more than instructions to apply the judicial exceptions on said generic computer (See MPEP 2106.05(f)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than an automatic determination system that includes generic computer elements (memory), which do not provide an inventive concept as a generic diagnostic system with a computer is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the memory and automatic determination system are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements of determining and linking (compare results against a data table) information, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity because the activity of using an automatic determination system to link/store information is not inventive since all automated diagnostic systems have memory that are used to control the processing (See MPEP 2106.05(g)).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. Dependent claims 2-6 amount to no more than determining information, and linking information, which is an intangible abstract idea or mathematical concept, and similarly does not integrate the exception into a practical application or include additional elements that amount to significantly more. The instant claims do not include an inventive concept.
Thus, in light of the above considerations the claims remain non-statutory, and are thus not patent eligible under 35 U.S.C. 101.
Step 1: Claims 1-5 are directed towards an automatic determination system.
Step 2A, Prong One: Claim 1 recites the abstract idea, “information storage unit configured to store result of detection image information…”, check an image included in the result of detection image information against a data table…” Abstract human reasoning or a generic computer is required to store the results of detection image information, and check an image included in the result of detection image information against a data table.
Claim 2 recites the abstract idea, “information storage unit configured to store analyte information…” Abstract human reasoning or a generic computer is required to store analyte information.
Claim 3 recites the abstract idea “information storage unit configured to store analyte information…” Abstract human reasoning or a generic computer is required to store analyte information.
Claim 4 recites the abstract idea “the result of detection image information is scantron information…” Abstract human reasoning or a generic computer is required to provide results in scantron information.
Claim 5 recites the abstract idea “information storage unit configured to acquire either or both the analyte information and the result of detection image information…” Abstract human reasoning or a generic computer is required to store either or both the analyte information and the result of detection image information.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application because upon evaluating the automatic determination system comprising an information storage unit and a result of determination deriving unit, nothing further is performed with the abstract evaluation.
Step 2B: Claim 1 recites the elements “store results of detection image information…, check an image included in the result of detection image information against a data table…”
Claim 2 recites the element “store analyte information in association with result of detection image information…”
Claim 3 recites “store the result of determination derived by the result of determination deriving unit…”
Claim 4 recites “the result of detection image information is scantron information…”
Claim 5 recites “acquire either or both the analyte information and the result of detection image information …”
These elements are interpreted as extra-solution activity which are incidental to the primary process and are mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erikson (US 20160080548 A1; hereinafter “Erikson” already of record).
Regarding claim 1, Erikson teaches an automatic determination system (Erikson; [0018]), comprising:
an information storage unit (Erikson; fig. 8A. 2000) configured to store result-of-detection image information acquired from a chromatographic strip support tool carrying the result-of-detection image information (Erikson; [0082] “smartphone acquires an image of at least a portion of the test strip and stores the image), the result of detection image information representing transcribed information regarding expression information obtained on a chromatographic strip that has been through testing (Erikson; Abstract); and
a result-of-determination deriving unit configured to check an image included in the result-of-detection image information against a data table, and derive a result of determination included in the data table and corresponding to the image (Erikson; fig. 6 and [0112]-[0113]).
Regarding claim 2, Erikson teaches the automatic determination system according to claim 1 (see above), wherein the information storage unit is configured to store analyte information in association with the result-of-detection image information (Erikson; Abstract), the analyte information being acquired from the chromatographic strip support tool (Erikson; fig. 5A, and 8A. 1000) further carrying the analyte information, the analyte information being regarding an analyte supplied to the chromatographic strip (Erikson; Abstract).
Regarding claim 3, Erikson teaches the automatic determination system according to claim 2 (see above), wherein the information storage unit is configured to store the result of determination derived by the result-of-determination deriving unit in association with the analyte information and the result-of-detection image information (Erikson; [0019] “the smartphone is capable of running a program suited for executing the embodied functionality” such as storing results (Erikson; Abstract). Erikson also teaches a detector that displays the determined selected quantitative indicia of the analyte on the smartphone (Erikson; [0036]).
Regarding claim 4, Erikson teaches the automatic determination system according to claim 2 (see above),wherein the analyte information is code information, and the result-of- detection image information is scantron information (Erikson; [0137] teaches the smartphone collects the sample information and display results on the smartphone screen for immediate use).
It is known in the art that smartphones can read and display information in barcode and QR code formats and can also read and display scantron information.
Regarding claim 5, Erikson teaches the automatic determination system according to claim 2 (see above), further comprising: an information acquiring unit configured to acquire either or both of the analyte information and the result-of-detection image information (Erikson; [0173] “smartphone obtains analyte data”, and [0174] “Camera that interprets the results”).
Regarding claim 6, Erikson teaches the automatic determination system according to claim 5 (see above), wherein the information acquiring unit is an image capturing unit (Erikson; [0173] “camera”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798