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. Claims 2, 11, 13 and 16 have been amended, claims 6, 14, 15 and 18 canceled and claims 19 and 20 added as requested in the amendment filed on May 07, 2026. Following the amendment, claims 1-5, 7-13, 16, 17, 19 and 20 are pending in the instant application.
2. Claims 1-5, 7-13, 16, 17, 19 and 20 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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. The Declaration of Ute Raffetseder under 37 CFR 1.132 filed May 07, 2026 is sufficient to overcome the rejection of claims 1-5, 7-9, 11-13, 16 and 17, 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
5. New grounds of rejection necessitated by Applicant’s amendment are set forth below.
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. New claim 19 is 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 as applied to claims 6 and 13 in section 14 of Paper mailed on January 08, 2026. Briefly, claim 19, directed to a method of diagnosis of lupus nephritis, sets forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors and the pathology itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
Briefly, based upon an analysis with respect to the claim as a whole, claim 19 is determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claim 19 is directed to a process (encompass a process, interpreting “use” as a process, not a product) (Step 1: Yes).
Next, claim 19 encompasses changes in the presence or levels of YB-1-G, guanidinylated form of YB-1-like cold-shock domain of YB-1 protein, during pathology of lupus nephritis, the process that is governed by a law of nature, and thus is a judicial exception. The guanidinylated YB-1 is a naturally occurring factor that is expressed differently during pathology of lupus nephritis apart from any human action. The relation between the levels of YB-1-G and pathology of lupus nephritis exists in principle and is a consequence of the ways this factor is metabolized by the body, entirely natural process, a natural phenomenon, and thus a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claim does not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure a naturally occurring factor during a naturally occurring pathology. (Step 2A/2: No). Finally, claim 19 does not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claim represent routine steps that are recited at a high level of generality and, thus, encompass well-understood and purely conventional routine techniques in the art. (Step 2B: No).
Thus, for reasons fully explained above, claim 19 does not satisfy the requirement of 35 U.S.C. 101 and is therefore rejected.
Conclusion
7. Claims 1-5, 7-13, 16 and 17 are allowed. Claim 19 is rejected. Claim 20 is 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. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
June 3, 2026
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