DETAILED ACTION
Notice of 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 .
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 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.
Withdrawal of Objections and Rejections
Applicant's response, filed 04/13/2026, has been fully considered.
In view of the amendment and remarks from 04/13/2026, the objection to the specification, the objection to the claims and the rejection of the following claims are withdrawn:
claims 1, 3 and 7 under 35 USC § 112(b);
claims 2-3 and 5-6 under 35 U.S.C. § 101 and
claims 1, 5-6 and 8 under 35 U.S.C. § 103.
The following rejections and/or objections are either maintained or newly applied for claims 1, 4 and 7-8. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 12/12/2025.
Status of the Claims
Claims 2-3 and 5-6 are canceled.
Claims 1, 4 and 7-8 are pending.
Claim 7 is objected to.
Claims 1, 4 and 7-8 are rejected.
Priority
This US Application 17/777,183 (05/16/2022) is a 371 of PCT/JP2020/042862 ( 11/17/2020) and claims priority from Foreign Application No. JP2019-208045 (11/18/2019) as reflected in the filing receipt mailed on 09/12/2022. The claims to the benefit of priority are acknowledged; and the effective filing date of claims 1, 4 and 7-8 is 11/18/2019.
Claim objections
Claim 7 is objected to because of the following informality: the recited "by using 1) … 3) …" presents incorrect numbering of the recited steps. Appropriate correction is required.
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, 4 and 7-8 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). Any newly recited portions are necessitated by claim amendment.
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1, 4 and 7-8) which falls within one of the categories of statutory subject matter.
[Step 1: claims 1, 4 and 7-8: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mathematical concepts (in particular mathematical relationships and formulas) and mental processes (in particular procedures for observing, analyzing and organizing information) as well as a law of nature or a natural phenomenon are as follows.
Mathematical concepts (in particular mathematical relationships and formulas) include:
• "(d)_a step of determining a cutoff value of the results of conducting ROC analysis as to test subjects diagnosed as anaphylaxis cases and test subjects diagnosed as non-anaphylaxis cases by using as a parameter, a numerical value obtained by multiplying the value of the avidity of the IgE antibody against the allergen by the antibody titer of the IgE antibody" (independent claim 1).
The claims identified above read on math. The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation and determined each element performed either in the mind and/or by mathematical operation. Without further detail as to the methodology involved in "calculating/quantitatively measuring an antibody titer", under the BRI, one may simply, for example, use pen and paper to perform mathematical steps to arrive at the described steps. Further support for the mathematical techniques used in the claims is provided in the specification at [0029] which discloses a method for calculating the antibody titer. Thus, the recited terms correspond to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). MPEP 2106.04(a)(2) pertains.
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
• "(c) a step of obtaining 1/IC50 of the IgE antibody which is a value of avidity of the IgE antibody against the allergen, wherein the IC50 is a value that indicates a concentration of an allergen at which antigen-antibody binding reaction is inhibited by 50%" (independent claim 1);
• "(e) a step of predicting that the risk of occurrence of anaphylaxis is high for the infant or the child when a value obtained for the infant or the child exceeds the cutoff value" (independent claim 1) and
• "(f) a step of providing a dietary instruction to the infant or the child who is predicted to have a high risk of occurrence of anaphylaxis" (independent claim 1).
Dependent claim 4 recites further details about the IC50 value obtained.
Under the BRI, the recited limitations are mental processes because a human mind is also sufficiently capable of evaluating data to obtain an IC50 value, evaluate a risk based on a value in comparison to a cutoff, and providing dietary instructions.
Furthermore, the instant claims recite a natural correlation by correlating the measurement of an antibody titer of an IgE antibody against an allergen with the risk of occurrence of anaphylaxis. (see MPEP 2106.04(b).I).
[Step 2A Prong One: claims 1, 4 and 7-8: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Instant claim 1 recites additional elements that are not abstract ideas:
• "(b) a step of quantitatively measuring an antibody titer of an IgE antibody against an allergen in the sample" (independent claim 1) and
• "(a) a step of collecting a sample from an infant or a child" (independent claim 1);
• "using 1) a chip obtained by providing a carbon layer on the surface of a silicon substrate by a diamond-like carbon treatment and introducing a chemical modifying group to the carbon layer; a chip obtained by providing an electrostatic layer treated with an amino group-containing compound or a polymer and/or a copolymer thereof on the surface of a glass slide, and further treating the resultant with dicarboxylic acid or polyvalent carboxylic acid, etc. followed by activation with N- hydroxysuccinimide and/or carbodiimides; or 3) a chip obtained by introducing a chemical modifying group in the surface of a carrier" (claim 7).
Dependent claim 8 recites further details about the sample collected.
Considerations under Step 2A, Prong Two
Further steps directed to additional non-abstract elements of a computing device/computer do not describe any specific computational steps by which the "computer parts" perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions.
The judicial exceptions in the claims are considered to perform the claimed abstract idea with a computer, which is not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and merely performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
The recited "collecting a sample" and "quantitatively measuring" steps reads on data gathering activities; not amounting to a practical application. The type of data doesn’t change that it is mere data gathering or conventional computer receiving means.
Regarding the use of a chip to measure the IgE antibody against the allergen (claims 7-8), these are limiting the chip being used in the measurement of the antibody titer and the sample, which reads on data gathering steps as above.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)).
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
[Step 2A Prong Two: claims 1, 4 and 7-8: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during examination that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art review to Sicherer ("Allergy testing in childhood: using allergen-specific IgE tests." Pediatrics 129(1):193-197 (2012)), cited in the 12/12/2025 PTO-892 form) discloses that using blood samples to quantitatively measure allergens in children is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, pg. 194 col. 1 para. 1. With respect to the instant claims, the prior art review to Fall "Detection of known allergen-specific IgE antibodies by immunological methods." Microchip Methods in Diagnostics 107-122 (2009), newly cited) discloses that identifying allergens by immobilizing a specific allergen on a chip surface is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, pg. 114 para. 1.
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h).
The instant claims constitute insignificant extra solution activity, and when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)). Hence, these elements, when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(d)).
[Step 2B: claims 1, 4 and 7-8: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 101
The Remarks of 04/13/2026 have been fully considered but are not persuasive for the reasons below:
Applicant asserts starting in pg. 8 para. 3-4:
(A) It has been clarified by the amendments proposed above that the present invention is a method for reducing a risk of occurrence of anaphylaxis in an infant or a child. Applicant submits that this amendment is to integrate the abstract idea into a practical application and to clarify that the use of the abstract idea is confined to a particular technology, and therefore, submits that the rejection under 35 USC§ 101 has been overcome. (B) The present specification describes at paragraph [0121] as" ... very high possibility of occurrence of anaphylaxis was predicted because the value thereof was higher than the cutoff value of8960.10 (BUe/mL)/(nM) regarding the presence or absence of anaphylaxis in OVM slgE/OVMs IgE IC50 in 1- to 6-year-old subjects. Thus, this child is regarded as having the possibility of future occurrence of anaphylaxis, though no allergic symptom has not yet been confirmed by the ingestion of chicken eggs, and is under follow-up by dietary instruction, particularly, for chicken eggs under the supervision of a doctor." Claim 1 as amended is supported by this specific example. As such, the claim as amended is directed to more than a judicial exception, and Applicants respectfully request reconsideration and withdrawal of the rejection
It is respectfully submitted that this is not persuasive because predicting a risk based on data values and providing dietary instructions based on said prediction constitutes mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)). The analysis at Step 2A, Prong 2, considers the claims as a whole, i.e., the additional elements in combination with the judicial exceptions (see MPEP 2106.05(a)), although the integration provided in the claim must flow from the additional elements and not the judicial exceptions to be considered persuasive. In this case, the identified additional elements do not provide sufficient evidence to ensure that the claim as a whole amounts to significantly more than the judicial exception itself.
No prior art has been applied to the following claims
Claims 1, 4 and 7-8 are free of the analogous art at least because close art, e.g. Kotaniemi and Simons as cited in the now withdrawn art rejections, either individually or in obvious combination, does not teach the recited combination of claim 1 step (d). Additionally, Applicant's 04/13/2026 remarks at pg. 9 para. 1 support withdrawal of the rejection.
Conclusion
No claims are allowed.
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 FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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