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 .
DETAILED ACTION
Response to Amendment
1. Claim 33 has been amended, claim 36 canceled and claims 45 and 46 added as requested in the amendment filed on March 30, 2026. Following the amendment, claims 21-35 and 37-46 are pending in the instant application.
2. Claims 21-35 and 37-46 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on March 30, 2026 have been fully considered but found to be not persuasive for reasons set forth below.
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.
5. Claim(s) 21, 23 and 25-29 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Groveman et al., 2018, for reasons of record in section 3 of Paper mailed on December 29, 2025.
Applicant argues at p. 1 of the Response that reference of Groveman does not teach Si3N4 beads as in current claims. Applicant’s argument has been fully considered but found to be not persuasive for the following reasons. The instant specification at [0092-93] recites various beads suitable to practice the invention, and clearly indicates that there is no preference of bead selection, thus making silicon nitride and borosilicate beads obvious variants of each other. Note that the instant rejection is made under anticipation or, in the alternative, obviousness. The Examiner maintains that the claims reciting silicon nitride beads having diameter of 1 mm stand anticipated or, in the alternative, obvious over the publication of Groveman.
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.
6. Claims 21, 31 and 32 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more for reasons of record in section 4 of Paper mailed on December 29, 2025.
Applicant is advised that because claims 21, 31 and 32 encompass a judicial exception—diagnostic method for detecting a protein misfolding disorder—and do not recite a novel assay to add significantly more to the exception, the claims stand rejected under 35 U.S.C. 101.
Conclusion
7. Claims 33-35 and 37-46 are allowed. Claims 21, 23, 25-29, 31 and 32 are rejected. Claims 22, 24 and 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
May 5, 2026
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