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 .
Election/Restrictions
Applicant's election with traverse of restriction requirement and election of Group I, claims 1-2, 6, and 15-16, drawn to a method for diagnosing autism spectrum disorder in a subject, in the reply filed on 01/28/2026 is acknowledged. The traversal is on the ground that Groups I-V are linked by a single general inventive concept and share the same corresponding special technical feature. This is not found persuasive because the restriction was found to have meet the requirements of 37 CFR 1.475 as the groups are found to have a common technical feature of determining or monitoring autism spectrum disorder, by providing a sample from the subject; and measuring at least one metabolic marker selected from the group consisting of ribitol, erythritol, and urate in said samples.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 20213627, filed on 12/11/2020.
Claim Objections
Claim 2 is objected to. The term “higher level” and “lower level” in claim 2 are not clearly defined within the claims, but is defined within the specifications as “Higher means an increase of at least 15 percent, while lower means a decrease of at least 15 percent.” It is recommended that these terms are defined within the claims to make terms clearer when reading the claims.
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 1-2, 6, and 15-16 rejected under 35 U.S.C. 101 because it constitutes abstract ideas.
Regarding independent claim 1, a two-step analysis is performed:
Step 1: Does the claim fall within a statutory category?
Yes, it is a method/process.
Step 2A, Prong 1: Identify the law of nature/natural phenomenon/abstract ideas.
A method for diagnosing ASD in a subject, comprising a) providing a sample from the subject; b) measuring the level of at least one metabolic marker selected from the group consisting of ribitol, lyxonate, erythritol, ribose and urate in said sample; and c) diagnosing ASD if the level of the at least one metabolic marker measured in step b) is specifically different in comparison to a typically developing control.
Measuring the level of a metabolic marker to be used for comparison with a control to determine if the subject can be diagnosed with ASD is considered a mental process, where it is evaluated based on one’s observation, evaluation, judgment and opinion using data as
comparison, making this an abstract idea (see MPEP 2106.04(III)(A), In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)).
Step 2A Prong 2: Has the abstract idea been integrated into a particular practical application?
The claim as a whole does not integrate the abstract idea into a practical application. Other than the abstract idea, claim 1 recites the additional elements: a sample from a subject, a metabolic marker, and measuring the level of at least one biomarker. With respect to mentioned additional elements, they represent insignificant extra solution activity (e.g., mere data gathering). Thus, there is no application of the abstract idea, much less a particular practical application.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claim 1 does not provide an inventive concept (significantly more than the abstract idea). A sample from a subject, a metabolic marker, and measuring the level of at least one biomarker are considered insignificant extra solution activity (e.g., mere data gathering). Furthermore, the additional elements above, alone and in combination within claim 1 as a whole, are well understood, routine, and conventional activities within the prior art (see 35 USC § 102 & 103 rejections).
Dependent claims 2, 6, and 15-16 do not resolve any of the issues discussed above because they involve limitations with more insignificant extra-solution activity (e.g., the sample being a blood/plasma sample) and/or abstract ideas in the form of mental process.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mussap et al. ("The Urine Metabolome of Young Autistic Children Correlates with Their Clinical Profile Severity").
Regarding claim 1, Mussap et al. teaches a method for diagnosing autism spectrum disorder in a subject (see 1. Introduction, disclosing investigating the most relevant metabolic perturbations in autism spectrum disorder (ASD), and to determining whether the severity of ASD core symptoms may be associated with urine metabolic altercations)., comprising a) providing a sample from the subject (see 4.3. Sample Collection, Storage, and Preparation, disclosing first-morning urine samples were collected by parents at home within sterile bags and delivered to the Children Psychiatric Unit of the University Hospital of Tor Vergata before the end of that morning.); b) measuring the level of at least one metabolic marker selected from the group consisting of ribitol, lyxonate, erythritol, ribose and urate in said sample (see Table 3., Table 4., 2.1. Urine Metabolic Profile in ASD Children and NT Children, disclosing univariate and multivariate statistical analysis identifying 13 metabolites as those best discriminating ASD from neurotypical (NT) children. Of the metabolites analyzed, uric acid (also known as urate) is used as shown in Table 3., and Table 4. shows ribitol analyzed as well in a similar comparison of ASD children with NT children.); and c) diagnosing autism spectrum disorder if the level of the at least one metabolic marker measured in step b) is specifically different in comparison to a typically developing control (see Table 3., Table 4., disclosing a comparison between ASD children's metabolites with NT children (i.e., the control), where uric acid was found to have a percent difference of -50%, and ribitol was found to have a percent difference of +156%.).
Regarding claim 2, Mussap et al. teaches the method according to claim 1, wherein specifically different means a higher level in case of ribitol, lyxonate, erythritol or ribose (see Table 4., disclosing a univariate and multivariate statical analysis of metabolites, discriminating ASD children with NT children, citing a +156% increase of ribitol in ASD children compared to NT children.) and a lower level in case of urate (see Table 3., disclosing a -50% decrease of uric acid in ASD children compared to NT children.).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mussap et al. as applied to claim 1 above, in view of Durham (US PG-Pub 20200325519 A1).
Regarding claim 6, Mussap et al. teaches a correlation between the clinical phenotype of autistic children and their urine metabolome (see Mussap et al., Abstract).
Mussap et al. fails to teach where the diagnosis in step c) is autism spectrum disorder phenotype 1.
However, in the analogous art of biomarker assay for use in monitoring autism, Durham teaches using a protein kinase A (PKA) biomarker for use in diagnosing autism spectrum disorder (ASD), in particular ASD phenotype 1 (see Durham, Abstract, [0001]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the autism spectrum disorder phenotype viewed in the metabolite analysis of Mussap et al. to incorporate the diagnosis of autism spectrum disorder phenotype 1 (as taught by Durham), for the benefit of being able use markers to identify and/or diagnose ASD phenotype 1 in patients without using slower and time consuming processes such as looking for characteristics, clinical signs and symptoms known in ASD phenotype 1 patients that would otherwise only hint at a potential diagnosis (see Durham, [0031]).
Regarding claim 15, Mussap et al. teaches urine being the primary sample used, where metabolomes were analyzed from the urine to see how it discriminates severe from mild-to moderate, restricted, repetitive, and stereotyped behaviors. Mussap et al. additional brings up a separate study finding significant uric acid in the plasma of autistic children (see Mussap et al., Abstract. 3.1. The Metabolic Profile of Autistic Children).
Mussap et al. fails to teach wherein the sample is a blood sample, preferably a plasma sample.
However, Durham teaches that the sample used for assaying the PKA biomarker may be any sample of a body fluid from a patient. This is selected from blood sample, serum sample, plasma sample, saliva sample, or urine sample (see Durham, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the samples used in Mussap et al. to incorporate a blood sample and a plasma sample (as taught by Durham et al.), for the benefit of being able to monitor the state of the ASD phenotype 1 in a patient, such as the severity of it, and the efficacy of ASD treatment in a ASD phenotype 1 patient (see Durham, [0013]-[0022]).
Regarding claim 16, Mussap et al. teaches urine being the primary sample used, where metabolomes were analyzed from the urine to see how it discriminates severe from mild-to moderate, restricted, repetitive, and stereotyped behaviors. Mussap et al. additional brings up a separate study finding significant uric acid in the plasma of autistic children (see Mussap et al., Abstract. 3.1. The Metabolic Profile of Autistic Children).
Mussap et al. fails to teach wherein the sample is a plasma sample.
However, Durham teaches that the sample used for assaying the PKA biomarker may be any sample of a body fluid from a patient. This is selected from blood sample, serum sample, plasma sample, saliva sample, or urine sample (see Durham, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the samples used in Mussap et al. to incorporate a plasma sample (as taught by Durham et al.), for the benefit of being able to monitor the state of the ASD phenotype 1 in a patient, such as the severity of it, and the efficacy of ASD treatment in a ASD phenotype 1 patient (see Durham, [0013]-[0022]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY CHING-TIAN COLENA/ Examiner, Art Unit 1797
/LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797