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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/03/25 has been entered.
Detailed Action
This Office Action is in response to the Applicant’s reply received 11/03/25. Claims 1-13, and 15-20 are pending. Claims 1-12 are withdrawn. Claims 13, and 15-20 are considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C. 112 rejections are withdrawn:
Claims 13, and 15-20 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;
Claims 13, and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for lack of enablement;
The Applicant’s substantial amendments to the claims necessitated the above withdrawals. In particular replacing “predicting a prognosis” to “diagnosing” and “identifying” to “detecting”. All arguments drawn to these rejections are now considered moot.
New Rejections Necessitated by Amendment
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.
Claim 13, and 15-20 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.
Problem A) The claims are drawn to a method of diagnosing autism or autism spectrum disorder (ASD). They do not list sufficient criteria to determine when a subject would receive a positive or negative diagnosis for either disease. The last step in claim 13 and 20 indicates diagnosing the subject based on the detected microbial ecology change and the detected metabolite level change, but do not set for criteria for a positive or negative result, therefore the diagnosis is incomplete.
Problem B) The claims do not provide any active steps on how the diagnosing autism or ASD other than it is “based on” the a) detected microbial ecology change and b) detected metabolite level. It is unclear how the detection of a) and b) are configured or analyzed to reach a diagnosis. There are no steps to indicate how a) and b) are manipulated or otherwise arranged to reach a diagnosis.
Problem C) There are no limitations to the quantity of detecting the a) detected microbial ecology change and b) detected metabolite level other than it is based on a normal control sample. There are no limitations on the size of the change which reads on very slight alterations of little statistical significance can be used to make a diagnosis of autism or ASD.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988). These factors include, but are not limited to:
(A) The breadth of the claims;
The claims are to a method of diagnosing autism or ASD induce by microplastic exposure, the method comprising:
obtaining a feces sample and a brain tissue sample from the prefrontal cortex or hippocampus of a human or animal subject that has been exposed to microplastics;
detecting a microbial ecology change in the feces sample relative to a normal control sample from a subject not exposed to microplastics, wherein this change comprises an increase in at least one of Alistipes putredinis and Barnesiella intestinihominis and a decrease in Lactobacillus reuteri, and
detecting a metabolite level change in the brain tissue sample relative to a normal control sample; and
diagnosing autism or ASD induced by microplastic-induced brain disease for the subject based on the detected microbial ecology change and metabolite level change.
(B) The nature of the invention;
The claims are to a method of diagnosing autism or ASD based on the a) detected microbial ecology change in a feces sample and b) detected metabolite level change in a brain sample
(C) The state of the prior art; and (D) The level of one of ordinary skill; (E) The level of predictability in the art;
The references supplied by the Applicant shows some correlation between gut alterations from microplastic exposure with ASD (see Stein et al., De Thede et al. and Rosenfeld) but they do not provide any guidance on monitoring fecal samples and brain tissue as a predictor for autism or any other brain disease. Nor do they provide any guidance on diagnosing autism/ASD based on a change in microbial ecology in a feces sample or metabolite level change in a brain sample
(F) The amount of direction provided by the inventor; (G) The existence of working examples;
The Examples provided by the inventor also show correlation between people with autism/ASD and microplastic exposure. However they do not provide any steps to diagnosing autism or ASD based on a change in microbial ecology in a feces sample or metabolite level change in a brain sample. The Specification does not provide an analysis algorithm to diagnose based on the brain sample and feces sample. The Examples never combine the detection of a brain sample and feces sample into a diagnostic method. Examples 1 is drawn to only changes in the intestinal microbial ecology. Example 2 is drawn to changes in the metabolic processes in feces. Example 3 is to polyethylene penetration in brain tissue. Example 4 is to changes in brain tissue metabolism from polyethylene exposure. Example 5 is a mouse model of autism symptoms caused by polyethylene exposure. None of these examples combine both detecting a change in the microbial ecology in a feces sample with a metabolite change in brain tissue to diagnose autism or ASD. None of the examples provide a method of diagnosing autism or ASD based on a change in microbial ecology in a feces sample or metabolite level change in a brain sample.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In the instant case, one of ordinary skill would not have a suitable understanding on how to diagnose autism or ASD based on the detection of a change in the microbial ecology in a feces sample with a metabolite change in brain tissue as claimed. It would take extensive experimentation to determine a diagnostic algorithm using the two samples based on the Applicant’s disclosure.
In the instant case several of these factors are missing and do not provide assurance that the disclosure is enable and that undue experimentation would be needed to make and use this invention.
Request for Interview
This Application is presenting particularly difficult challenges involving 35 USC 112. The Examiner believes an interview may be useful in progressing this case. The Applicant is encourage to contact Thane Underdahl at (303) 297-4299 to discuss this application prior to replying to this Office Action.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699