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
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected kit, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/4/2026.
The Applicant’s election of species, although not fully compliant with the election request, is noted and rendered moot. The Applicant has amended the independent claim to change the scope of the claim. Given the broadest reasonable interpretation of the claimed method, it requires either one of items (i) or (ii), and any one of either (iii), (iv), and (v); the elected combination of (i)-(v) is not consistent with the current claim language.
Claim Objections
Claims 1, 8-14 and 25 are objected to because of the following informalities: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) See MPEP 2173.05(s). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 7-17, 21 and 25 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without a step that would lead to an increase of accuracy, sensitivity, or specificity of an autism spectrum condition biomarker in a sample, which is critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The claims are drawn to a method of increasing the accuracy, sensitivity, or specificity of autism-spectrum disorder protein biomarkers in a sample, wherein the artisan must determine elevated or reduced expression of certain biomarkers, and either phosphorylation, S-nitrosylation, or volatile organic compound (VOC) profiles of other compounds. However, there are no method steps that would provide the skilled artisan with direction on how to increase any one of accuracy, sensitivity, or specificity of autism-spectrum disorder protein biomarkers in a sample.
Given the broadest reasonable interpretation of the preamble, the claims are drawn to increasing accuracy, sensitivity, or specificity of biomarkers in a sample, wherein the sample may, or may not be from an individual who has been diagnosed with autism. See MPEP 2111.02. The claims then provide for method steps wherein the artisan is asked to determine if either markers from Table 2 are elevated, or markers from Table 3 are reduced; then the artisan must determine if there is phosphorylation of a marker from Table 4, S-nitrosylation from a marker in Table 5, or a VOC profile based on one of the Tables 1a-1e; the claim then concludes with a reiteration of the preamble: thereby increasing the accuracy, sensitivity, or specificity of autism-spectrum disorder protein biomarkers in a sample. When considering the broadest reasonable interpretation of the claimed method, in the context of the preamble, there are no steps that would reasonably lead to increasing the accuracy, sensitivity, or specificity of autism-spectrum disorder protein biomarkers in a sample, and as such, steps that would enable the skilled artisan to perform the claimed method are missing.
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, 15, 16, 17, 21 and 24 is 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 recites the limitation "the subject" in the fourth line. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "said subject" in the first and second lines. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the subject" in the second line. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the subject" in the second line. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the diagnosing" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the subject" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Castagnola, et al (PGPub 2011/0079076); Sherr, et al (PGPub 2018/0002410); Parker (WO 2019/165129).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
