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 .
Status of the Claims
Claims 1-8 are examined.
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 1-8 is 11/18/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/16/2022, 11/13/2023, and 09/24/2024 were considered by the examiner.
Specification Objections
The specification is objected to because pg. 12 [0037] contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim objections
Claims 1 and 7 are objected to because of the following informalities. Appropriate correction is required.
The following issues are objected to:
Claim
Recitation
Comment
1
…(c) a step of determining …; (d) a step of predicting ..
Missing the conjunction “and” between step (c) and step (d).
7
…measured using …
Should read “measured by using” for proper grammar.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 3 and 7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention.
The following issues cause the respective claims to be rejected under 112(b) as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
(d)... a risk of occurrence of anaphylaxis in the infant or the child
The relationship is unclear between this instance and that in the preamble. Possibly "the risk..." here.
3
an IgE antibody against an allergen
The relationships are unclear between these instances and those of claim 1. Possibly here "the" should be recited.
3
…wherein the avidity of an IgE antibody against an allergen is numerically converted as 1/IC50.
The relationships are unclear between the recited "avidity" and "1/IC50."
7
DCP
The abbreviation must be defined in the claim, it not being clearly well-known as for example "ROC" in claim 1 and not clearly defined in the specification, e.g. [6].
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 1-8 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), 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)).
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
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 1-8), which falls within one of the categories of statutory subject matter. [Step 1: claims 1-8 – 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
Mathematical concepts recited in instant claims 1-3, and 5, include the terms:
• “calculating avidity of an IgE antibody against an allergen in the sample”;
• “cutoff value by ROC analysis”,
• “numerically converted as”;
Said terms are being identified as mathematical concepts. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one having ordinary skill in the art. Thus, the recited terms corresponds 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).
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:
• "predicting a risk of occurrence of anaphylaxis in the infant or the child by using the cutoff value as a criterion" (claim 1);
Under the BRI, the recited limitations are mental processes because a human mind is sufficiently capable of evaluate a measurement value based on a cutoff to predict a risk.
Dependent claims 2, 5 and 7 recite further details about obtaining the cutoff value determined by ROC analysis; dependent claims 3-4, and 6 recite details about obtaining the avidity value of an IgE antibody; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: claims 1-8 – 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 claims 1 and 8 recite additional elements that are not abstract ideas:
• “a step of collecting a sample from an infant or a child” (claim 1).
Dependent claim 8 recites further details about the sample. The recited claim reads on data gathering activities or the type of data being gathered; not amounting to a practical application. The type of data doesn’t change that it is mere data gathering to be used for subsequent mathematical calculations; reading on insignificant extra-solution activity.
Hence, these are mere instructions to apply the abstract idea 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)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information.
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.
At this point in examination it is not yet the case that any of the Step 2A, Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [0123], esp. p. 36, lines 7-12; also [1 and 6]; )
[Step 2A Prong Two: claims 1-8- No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of the 35 USC § 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
As explained above, the steps of collecting a sample from an infant or a child 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)).
It is known in the art that the use of blood samples to test for allergic reactions in children is well-understood, routine and conventional (Sicherer et. al. "Allergy testing in childhood: using allergen-specific IgE tests." Pediatrics 129(1):193-197 (2012) – pg. 194 col. 1 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). [Step 2B: claims 1-8 - No]
Conclusion: Instant claims are directed to non-statutory subject matter
For these reasons, 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. Hence, the claimed invention does not constitute significantly more than the abstract idea, so instant claims 1-8 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kotaniemi "Allergen-specific immunoglobulin E antibodies in wheezing infants: the risk for asthma in later childhood." Pediatrics 111(3):e255-e261 (2003) in view of Simons "Risk assessment in anaphylaxis: current and future approaches." Journal of allergy and clinical immunology 120(1):S2-S24 (2007) as cited on the attached Form PTO-892.
Independent claim 1 recites:
(a) a step of collecting a sample from an infant or a child;
(b) a step of calculating avidity of an IgE antibody against an allergen in the sample;
(c) a step of determining a cutoff value by ROC analysis based on the avidity of an IgE antibody against an allergen;
which Kotaniemi teaches as the measurement of specific immunoglobulin E (IgE) antibodies to food and/or inhalant allergens in infants to predict the risk for asthma (pg. 1 para. 1); wherein the analysis of inhalant allergen-specific IgE concentrations in relation to later risk of childhood asthma was displayed as a ROC curve (Figs. 1-2 pg. e258); the receiver operating characteristic (ROC) curves to evaluate the optimal cutoff concentrations for specific IgE antibodies (i.e. reading on determining a cutoff value by ROC analysis) (pg. e256 col. 2 para. 2).
Dependent claim 8 recites a method according to claim 1, wherein the sample is plasma or serum which Kotaniemi teaches as frozen serum samples were obtained from 80 children for determination of food and inhalant allergen-specific serum IgE antibodies by fluoroenzyme-immunometric assay (pg. 1 para. 2).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 1, Kotaniemi does not teach a method for predicting a risk of occurrence of anaphylaxis in an infant or a child and a step of predicting a risk of occurrence of anaphylaxis in the infant or the child by using the cutoff value as a criterion. However, Simons teaches said recitation as a review of approaches to distinguish sensitized individuals at minimum or no risk from those at increased risk of developing anaphylaxis include measurement of the ratio of allergen-specific IgE to total IgE and determination of IgE directed at specific allergenic epitopes (pg. S2 col. 2 para. 1); wherein cutoff values may vary among different populations; for example, lower values for milk (>=5 kU/L) and egg (>=2 kU/L) have been identified in infants (pg. S19 col. 1 para. 3).
Regarding claim 1, Kotaniemi does not teach the avidity of an IgE antibody against an allergen which Gianetti teaches as the magnitude of an allergic response being influenced by the number and/or density of IgE epitopes to a particular allergen or the affinity/avidity of specific IgE antibodies (pg. 51 col. 1 para. 1)
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1 and 8, one of ordinary skill in the art would be motivated to apply the teachings by Simons and Gianetti to the method by Kotaniemi because Simons teaches the risk assessment of individuals with anaphylaxis in which the greater the number of IgE binding epitopes recognized (epitope diversity) by an individual, the more likely he or she is to experience a severe allergic reaction (pg. S4 col. 2 para. 3) pointing to IgE as being rigorously investigated in human beings for different immune and nonimmune mechanisms underlying anaphylaxis (pg. S4 col. 1 para. 4); and Gianetti teaches specific IgE antibodies as predictive values parameters to identify patients with the risk to develop anaphylaxis (pg. 49 para. 1). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the role of IgE antibodies in allergic reactions.
Claim 5-6 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kotaniemi, Simons and Gianetti as applied to claim 1 above further in view of Zhang “High Throughput Screening of Allergy” In: Tao, A., Raz, E. (eds) Allergy Bioinformatics. Translational Bioinformatics, vol 8. Springer, Dordrecht. Chapter 8 pp. 121-137 (2015) as evidenced by Syedbasha "An ELISA based binding and competition method to rapidly determine ligand-receptor interactions." Journal of visualized experiments: JoVE 109:53575 (2016) as cited on the attached Form PTO-892
Dependent claim 5 recites a method according to claim 1, wherein the cutoff value determined by ROC analysis based on avidity of an IgE antibody against an allergen which Kotaniemi, Simons and Gianetti teaches as described in the rejection applied to claim 1 above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 5, neither Kotaniemi nor Simons nor Gianetti teach a cutoff value determined by ROC analysis based on IC50 of the IgE antibody which Zhang teaches the use of receiver operating characteristic (ROC) curves for the detection of specific IgE against allergens by allergen peptide microarray (pg. 127 para. 2); wherein during the process involving said microarrays, comparisons were made of the results with cutoff values and the reference serums to determine which allergens the patients are sensitive to (pg. 129 para. 1); wherein competitive IgE-binding inhibition test (e.g., ELISA or RAST) are the most common allergen standardized method (pg. 132 para. 3); wherein ELISA assays are known for allowing for analytical steps to estimate half maximal inhibitory concentration (IC50) as evidenced by Syedbasha (pg. 1 para. 1).
Regarding claim 6, neither Kotaniemi nor Simons nor Gianetti teach a method according to claim 5, wherein the IC50 is a competitive binding inhibitory activity value which Zhang teaches competitive IgE-binding inhibition test (e.g., ELISA or RAST) as the most common allergen standardized method (pg. 132 para. 3); wherein ELISA assays are known for allowing for analytical steps to estimate half maximal inhibitory concentration (IC50) as evidenced by Syedbasha (pg. 1 para. 1).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 5-6, one of ordinary skill in the art would be motivated to apply the teachings by Zhang to the method by Kotaniemi, Simons and Gianetti because Zhang teaches allergen microarrays as a versatile platform for detecting specific IgE or other types of antibodies against thousands of allergens in a parallel and high throughput way and are currently used in diagnosis of allergy (pg. 1 para. 1); the use of ROC curve of the machine learning (SVM) method of analysis was best at predicting allergy (pg. 127 para. 2). One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the role of IgE antibodies in allergic reactions.
No prior art has been applied to the following claims
No prior art is applied to claims 2-4 and 7. The art described in the 103 rejections above does not teach the instant combination of particular steps/elements regarding “the cutoff value determined by ROC analysis based on the avidity of an IgE antibody against an allergen being a cutoff value determined by ROC analysis based on a numerical value obtained by multiplying the avidity of an IgE antibody against an allergen by an antibody titer of the IgE antibody against the allergen” (claim 2) and “the avidity of an IgE antibody against an allergen is numerically converted as 1/IC50” (claim 3) and it is not clear that any combination of art would have rendered the claims obvious. Therefore, the claims are interpreted as free of the prior art.
Conclusion
No claims are allowed.
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/F.F.L./Examiner, Art Unit 1685
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686