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 .
Status of the claims
The amendment filed 06/26/26 is acknowledged and has been entered. Claims 1-2, 5 and 8-11 have been amended. Claims 4 and 7 have been canceled. Claims 14-15 remain withdrawn as being directed to a non-elected invention. Accordingly, claims 1-3, 5-6 and 8-13 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 1 the recitation “in a subject” should be --in a human subject--. Appropriate correction is required.
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.
Claims 1-3, 5-6 and 8-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The is directed to a naturally occurring correlation between the levels of antibodies against Y-box binding protein-1 (YB-1) in a subject with Alzheimer’s disease compared to that of a control level.
Step 2A, Prong 2
The additional elements of detecting by immunoassay a level of antibodies against YB-1 in a blood, serum, plasma or CSF sample by contacting with YB-1 or an antigenic peptide fragment thereof and comparing to a control does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Further, given its broadest reasonable interpretation “comparing” reads on a mental step and thus is an abstract idea.
Also, with respect to the recitation “diagnosing the human subject as having Alzheimer’s disease when the detected level of antibodies in increased relative to the control”. The “diagnosing” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the level of YB-1 antibodies being correlated with Alzheimer’s disease. No active method steps are invoked or clearly required; the “diagnosing” statement does not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by both Morgenroth et al (Cancers 2020, 12, 3507, pages 1-17) and Woody (2024/0228623) it is well known, routine and conventional in the art to determine a level of YB-1 autoantibodies as compared to that of a control and to determine the antibodies via immunoassay by contacting with YB-1 or an antigenic fragment thereof (e.g. Morgenroth et al abstract, pgs. 5 & 11) (Woody, para’s 00174-00178, Fig 1).
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Response to Arguments
Applicant's arguments filed 06/26/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that claim 1 is most analogous to claim 3 of Example 29 “Diagnosing and Treating Julitis” and that claim 1recites a series of steps, including determining the level of antibodies against Y- box binding protein-1 (YB-1) in a blood, serum, plasma, or cerebrospinal fluid sample from the subject via immunoassay and comparing the detected level in the sample to a control level of YB-1 antibodies derived from a human subject without AD. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
This argument is not found persuasive because the additional elements of detecting antibodies against YB-1 in a blood, serum, plasma, or CSF sample by immunoassay by contacting the sample with YB-1 or an antigenic peptide fragment thereof is well known, routine and conventional and thus does not add more than the judicial exception. Further, claim 3, Example 29 is not on point with the currently recited claims because claim 3, Example 29 the use of porcine antibodies for the detection of human JUL-1 was not routine and conventional and the instant claims do not provide the use of a specific affinity reagent which is not well known routine and conventional in detecting the recited antibodies. Therefore, this argument is not germane to the instantly recited claim.
Applicant argues that the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The claim recites the elements of determining the levels of antibodies against Y-box binding protein-1 (YB-1) in a sample by immunoassay. When the additional elements are viewed as a combination, the claim elements amount to a claim as a whole that adds meaningful limits on the use of the exception. The combination of steps, which is not routine and conventional, ensures that patients with Alzheimer's Disease (AD) will be accurately diagnosed and properly treated, as opposed to lacking accurate monitoring of the treatment. See Diamond V. Diehr, 450 U.S. 175, 188 (1981) ("a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made"). Further, prior to the inventors' discovery, it was not routine or conventional to test for levels of endogenous antibodies against YB-1 (antiYB-1 auto-antibodies) which the inventors surprisingly discovered are associated with Alzheimer's Disease (AD). Thus, the claim elements, when considered as a combination with the other additional elements, yield a claim as a whole that amounts to significantly more than the exception itself.
This argument is not found persuasive because the additional elements of detecting antibodies against YB-1 in a blood, serum, plasma, or CSF sample by immunoassay by contacting the sample with YB-1 or an antigenic peptide fragment thereof is well known, routine and conventional and thus does not add more than the judicial exception (see for example the teachings of Morgenroth et al (Cancers 2020, 12, 3507, pages 1-17) and Woody (2024/0228623) supra. Thus, the additional elements which are well known, routine and conventional are considered to be insignificant extra-solution activity and are insignificant steps of data gathering.
The discovery of the antibodies being associated with Alzheimer’s Disease is the judicial exception.
Conclusion
No claims are allowed.
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 GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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