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 .
DETAILED ACTION
Status of Claims
Claims 1-15 and 17 are pending. Claims 3 and 15 are withdrawn as drawn to non-elected inventions. Claims 1-2, 4-14 and 17 have been examined.
Election/Restriction
Applicant's election with traverse of Group I, claims 1-2, 4-14 and 17, in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that there is a technical relationship that involves the same special technical feature. This is not found persuasive because while there is a common technical feature present between Groups I-III, the common technical feature is not a special technical feature as it does not make a contribution over the prior art in view of the teachings of Suprun et al. (08/2020), as described in the rejections below.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application, Serial No. 18/043,999 (PGPub: US2023/0324405) was filed 03/03/2023. This application is a 371 of PCT/JP2021/032730 filed 09/06/2021.
This application claims priority to foreign priority to Japan 2020-150142 filed 09/06/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)- (d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statements
The Information Disclosure Statements filed 03/03/2023 and 05/01/2024 have been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 at line 6 states “a step of identifying type of the antibody” and would be clearer to recite “a step of identifying the type of antibody”.
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 1-2, 4-14 and 17 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 at lines 4 and 6 recite “…a reaction between the probe and an antibody…” and “type of antibody that reacted with the probe”, respectively, and given that two or more probes are claimed to be in contact with the sample, it is unclear which probe reaction is intending to be detected.
Claim 1 at lines 12-13 recites “…created using at least training data on the reaction with the antibody for the probes and training data on the type of the antibody bound” and there is no antecedent basis for “training data” because it is unclear if this is additional training data provided or if it is intending to be the data input on the reaction and the type of antibody.
Claim 5 is indefinite because it recites “the probe” and it is unclear which of the claimed two or more probes are being limited.
Claim 6 is indefinite because it recites “the probe” and it is unclear which of the claimed two or more probes are being limited.
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.
Claim(s) 1, 4 and 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suprun et al. (“Early epitope-specific IgE antibodies are predictive of childhood peanut allergy”, Food allergy and gastrointestinal disease, pages 1080-1088, Available online Aug 11 2020, IDS).
Regarding claim 1, Suprun teaches throughout the publication a method of determining an allergic disease (abstract), comprising: a step of allowing two or more probes selected from an allergen and a fragment thereof to come into contact with a biological sample collected from a subject; a step of detecting a reaction between the probe and an antibody contained in the biological sample; a step of identifying type of the antibody that reacted with the probe (page 1081, first two paragraphs of Methods section, concentrations of total IgE, PN-sIgG4 and sIgE to peanut Ara h 1, Ara h 2 and Ara h 3 were measured from plasma using ImmunoCAP system); a step of inputting data on the reaction with the antibody for each of the two or more probes and data on the type of the antibody bound into a prediction model so as to obtain a prediction result (page 1082, Machine learning section); and a step of determining an allergic disease based on the prediction result (page 1083-1085, Results section and page 1087, right column last paragraph), wherein the prediction model is a model with two or more explanatory variables and two or more terms, which is created using at least training data on the reaction with the antibody for the probes and training data on the type of the antibody bound (page 1081, right column, Statistical analysis; page 1086, Figure 3 and caption).
Regarding claim 4, Suprun teaches the method wherein the type of the antibody is selected from IgE and IgG4 (methods section of abstract).
Regarding claim 6, Suprun teaches the method wherein the probe is solid-phase immobilized (page 1081, right column, Peanut epitope-specific IgE and IgG4 section).
Regarding claim 7, Suprun teaches the method wherein the data on the reaction with the antibody are of intensity of reaction with the antibody (page 1081, right column, Peanut epitope-specific IgE and IgG4 section).
Regarding claim 8, Suprun teaches the method wherein additional training data are used for creating the prediction model (page 1082, Machine learning section).
Regarding claim 9, Suprun teaches the method wherein the allergen is selected from a food allergen (Objective section of abstract).
Regarding claim 10, Suprun teaches the method wherein the food allergen is globulin (abstract, for example, IgE).
Regarding claim 11, Suprun teaches the method which is used in a monitoring of the allergic disease, wherein the biological sample collected from the subject comprises two or more biological samples collected at different times, and wherein the step of determining an allergic disease comprises comparing prediction results obtained for the two or more biological samples with each other (Method and Results section of abstract).
Regarding claim 12, Suprun teaches the method wherein the allergic disease is food allergy (abstract).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Suprun et al. (“Early epitope-specific IgE antibodies are predictive of childhood peanut allergy”, Food allergy and gastrointestinal disease, pages 1080-1088, Available online Aug 11 2020, IDS), as applied to claim 1 above, and further in view of Ito et al., (“Quantitative evaluation of the symptoms provoked during the oral food challenge using the Anaphylaxis Scoring Aichi (ASCA)”, Clinical and Translational Allergy, 3 (Suppl 3), page 105, 2013).
Regarding claim 2, Suprun teaches the method as described above but fails to teach that determining the allergic disease is selected from determining whether the allergic disease is mild or severe and predicting a total ASCA score.
Ito teaches throughout the publication an original symptom scoring sheet named the ASCA to be used during oral food challenge (Background). More specifically, Ito teaches that the ASCA can list and sort subjective and objective symptoms in accordance with severity to show the overall severity and threshold dose of the allergic reaction (background and methods).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the determination of allergic disease step of the method of Suprun, prediction of ASCA score and allergic disease severity as taught by Ito because it would have been desirable to enable a quantitative analysis of a food allergy as well as being provided with the overall severity of the allergic reaction (Ito, Conclusion).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Suprun et al. (“Early epitope-specific IgE antibodies are predictive of childhood peanut allergy”, Food allergy and gastrointestinal disease, pages 1080-1088, Available online Aug 11 2020, IDS), as applied to claim 1 above, and further in view of Suprun et al. (Allergy, Vol. 75, No. 10, June 1, 2020, pages 2633-2643, hereinafter “Suprun75”, IDS).
Regarding claim 5, Suprun teaches the method as described above but fails to teach that the probe comprises an overlapping fragment of the allergen.
Suprun75 teaches throughout the publication the analysis of epitope-specific antibodies in allergens in children (abstract). More specifically, Suprun75 teaches the use of an overlapping fragment of the allergen (page 2635, section 2.2).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the probes in the method of Suprun to include overlapping fragments of the allergen as taught by Suprun75 because it would have been no more than the simple substitution of one known probe composition for another type of probe composition comprising an overlapping fragment that is well-known in the art. One skilled in the art would have been motivated to choose the desired probe composition based on the type of probes desired and desired reaction configurations.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Suprun et al. (“Early epitope-specific IgE antibodies are predictive of childhood peanut allergy”, Food allergy and gastrointestinal disease, pages 1080-1088, Available online Aug 11 2020, IDS), as applied to claim 1 above, and further in view of Getts et al. (US 2019/0359660 Pub Date: 11/28/2019, IDS).
Regarding claim 13, Suprun teaches the method as described above but fails to teach that the probes are provided as a kit. Getts teaches throughout the publication biomarkers, methods and kits for diagnosis of peanut allergy (abstract). More specifically, Getts teaches that probes for the diagnosis of the peanut allergy such as, for example, Aha h1 allergen, can be included in a kit and packaged together with instructions for use (paragraph 0105). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate the probes in the method of Suprun within a kit as taught by Getts because it would have been desirable to include the probes in a ready to use manner along with instructions for the user to conduct the reactions.
Regarding claim 14, Suprun teaches the method as described above but fails to teach that the probes are immobilized on a substrate of a biochip. Getts teaches throughout the publication biomarkers, methods and kits for diagnosis of peanut allergy (abstract). More specifically, Getts teaches that the probes can be incorporated in a microarray immunoassay or lateral flow immunoassay format where each probe is immobilized in a discrete area on a porous or chromatographic support (paragraph 0057). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate the probes of Suprun to be immobilized on a substrate of a biochip as taught by Getts because it would have been desirable to allow for discrete measurement of individual probes for more thorough analysis of the peanut allergy.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Suprun et al. (“Early epitope-specific IgE antibodies are predictive of childhood peanut allergy”, Food allergy and gastrointestinal disease, pages 1080-1088, Available online Aug 11 2020, IDS), as applied to claim 1 above, and further in view of Kaur et al. (US 2019/0099122, Pub Date: 04/04/2019, hereinafter “Kaur”).
Regarding claim 17, Suprun teaches the method of claim 1 as described above utilizing machine learning to complete the allergen prediction. However the reference fails to explicitly teach a storage medium storing a program for causing a computer to execute the method according to claim 1.
Kaur teaches throughout the publication the detection of allergies using a wearable device to monitor the user. More specifically, Kaur teaches that machine readable instructions for implementing the allergy detection system comprise programs/processes for execution by a processor that may be stored on a computer readable storage medium (paragraph 0043).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate the method of Suprun on a storage medium that stores a program for causing a computer to execute the method as taught by Kaur because it would have been desirable to include the method in a format that can be readily executed by a computer and user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677