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. Claim 1, 3, 5-6, 11 and 15 have been amended. Claims 3 and 15 remain withdrawn as drawn to non-elected inventions. Claim 7 has been cancelled. Claims 1-2, 4-6, 8-14 and 17 have been examined.
Information Disclosure Statements
The Information Disclosure Statements filed 03/03/2023 and 05/01/2024 have been considered by the Examiner.
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, 4-6, 8-14 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 is confusing because it states that the prediction model is created using training data comprising data on the reaction between the antibody and the probes other than the first test data and data on the type of the antibody bound other than the second test data but earlier in the claim the only data that has been mentioned is the first and second test data and thus it is unclear what other data is present that is being used for creating the prediction model.
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) 1, 4, 6, 8-12 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).
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 each 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 at least one of the probes and an antibody contained in the biological sample; a step of identifying the type of antibody that reacted with the at least one probe for each reaction detected (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 first test data on the reaction with the antibody for each of the two or more probes and second test 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 training data comprising data on the reaction between the antibody and the probes other than the first test data and data on the type of the antibody bound other than the second test data (page 1081, right column, Statistical analysis; page 1086, Figure 3 and caption); wherein the data on the reaction with the antibody comprises an intensity of reaction with the antibody (page 1081, right column, Peanut epitope-specific IgE and IgG4 section).
While Suprun teaches that the statistical method used for creating the model is the Random Forest method, the reference fails to teach that the statistical method used is a CART method or a MARS method. Boniface teaches throughout the publication determining biomarkers for pregnancy analysis. More specifically, Boniface teaches that learning models for desired biomarkers can be used including learning algorithms well-known in the art such as CART, random forest, MART, among others (paragraphs 0177 and 0282).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the random forest statistical method of Suprun, a CART or MARS method as taught by Boniface because one having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent statistical analysis method and since the same expected learning models would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired analytics for the training model.
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 each of the two or more probes is solid-phase immobilized (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 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(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 at least one of the two or more probes 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.
Response to Arguments
Applicant’s arguments filed 04/13/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. Applicant merely states that Claim 1 has been amended to recite the prediction model is created using a CART or MARS method and since Suprun doesn’t teach this statistical method, that the rejection cannot be sustained and the claims are in condition for allowance.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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
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