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 reply to the Restriction Requirement, dated June 22, 2026, has been received. By way of this submission, Applicant has elected, without traverse, the species of one disease-associated protein, alpha-synuclein and Parkinson's disease (PD).
Claims 1-10 and 15-24 are pending in the application. Claims 15-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Claims 1-10 are under examination before the Office.
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.
Claims 1-10 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 1 recites the term "preferably". Examples and preferences create confusion over the intended scope of a claim. It is not readily apparent if the preferred species recited are intended as limitations that narrow the scope of the claims. Description of examples or preferences is properly set forth in the specification rather than the claims. MPEP 2173.05(d).
For the purpose of claim construction, any limitation that is described as "preferably" in the claims is being considered optional.
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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jara (US20160077112A1, cited in IDS).
Jara teaches a method of detecting misfolded protein in a sample, comprising contacting the sample with a monomer of the protein, incubating the mixture under conditions to cause misfolding and/or aggregation of the monomeric protein in the presence of the soluble, misfolded protein, and determining the presence of a misfolded aggregate (para. 0005).
Jara further teaches that 40 μL of sample may be combined with 100 μL of alpha-synuclein reaction mixture (i.e., a 1:2.5 ratio of sample:dilutent) (para. 0139), which is pertinent to claim 2.
Jara further teaches that the reaction may take place in a multiwell plate (i.e., separate confined volumes) (para. 0095, 0111, and 0147), which is pertinent to claim 3.
Jara further teaches that the reaction may be incubated at a temperature of between 4 degrees and 60 degrees Celsius (para. 0073), which is pertinent to claim 4.
Jara further teaches the use of antibodies that bind misfolded protein, which are coupled to beads (para. 0095-0096), which is pertinent to claims 5-6.
Jara further teaches contacting the sample with Thioflavin T (i.e., a detection reagent), and determining the presence of the soluble, misfolded protein in the sample by detecting a fluorescence (i.e., a detection reagent signal) of the Thioflavin T corresponding to soluble, misfolded protein (para. 0006), which is pertinent to claims 7-8 and 20.
Jara further teaches that the sample may be plasma or cerebrospinal fluid (para. 0083), which is pertinent to claim 9.
Jara further teaches that the method is useful for diagnosing a synucleinopathy such as PD (para. 0078), and alpha-synuclein may be associated with PD (para. 0051), and that cerebrospinal fluid from patients with PD significantly accelerates alpha-synuclein aggregation (para. 0144), which is pertinent to claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Crowther (US20160011208A1) teaches methods of detecting aggregates of alpha-synuclein (para. 0048). Crowther further teaches that such methods may be performed in microfluidic droplets with volumes measured in picoliters (para. 0045: "Classically, assays for protein aggregation are carried out in microwell plates, the standard format for pharmaceutical and biochemical experimentation. However, recently assays have been reported that have been scaled down to nano- or even pico-litre volumes.").
Bargar (Acta Neuropathol Commun. 2021 Apr 7;9(1):62) teaches methods of detecting aggregates of alpha-synuclein in volumes as small as microliters (page 5, right column: " In summary, our streamlined RT-QuIC assay enabled ultrasensitive detection of αSynD in PD and DLB cases using only nanoliters of CSF.").
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1642
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