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 06/09/26 is acknowledged and has been entered. Claims 1, 3-4, 7, 11, 14 and 21 have been amended. Claims 2, 18-19, 21, 23 and 27-28 have been canceled. Claims 15-17, 22, 24-26 and 29 were previously canceled. Accordingly, claims 1, 3-14 and 21 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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, 3-14 and 21 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 claims are directed to a naturally occurring correlation between the levels of CD38+ peripheral blood mononuclear cells a subject at risk of developing or suspected of having Alzheimer’s disease compared to a reference. Also, claim 12 is directed to an abstract idea of calculating the proportion of cells.
Step 2A, Prong 2
The additional elements of measuring in a blood sample the recited biomarkers and making a comparison to a reference does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “wherein an increased level of at least one of CD38+ PBMCs as compared to a respective reference as compared to a respective reference, indicates that the subjects is likely developing, or is affected by AD”. The “wherein” 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 recited biomarkers being correlated with neurodegenerative disease, disorder or condition. No active method steps are invoked or clearly required; the “wherein” statements do 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 Burns et al (Int. J. Mol. Sci., February 2021, 22, pages 1-19) it is well known, routine and conventional to measure CD38 PBMC and compare to that of a control (e.g. abstract).
With respect to the “administering an immune checkpoint modulator to the subject which is likely developing or is affected by AD, thereby treating the subject” as recited in claim 1. Although the claim invokes administering an immune checkpoint modulator to the subject the claim as currently recited does not provide a step of positively identifying the subject as having AD and thus given its broadest reasonable interpretation allows for a determination of an equal or decreased amount in the subject and thus the subject would not be diagnosed with AD and therefore the treatment step would not be performed. Therefore, the current claims allow for an embodiment wherein no treatment is administered. Therefore, this scenario does not recite something significantly more than the judicial exception.
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 06/09/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that claim 1 has been amended to recite a method for treating Alzheimer's disease. Therefore, the claim is not directed to a natural phenomena, as it includes a treatment step of administering an immune checkpoint modulator to the subject. Claims 3-14 and 21 depend directly or indirectly from claim 1, and therefore also qualify as eligible subject matter under 35 USC 101.
This argument is not found persuasive because although the claim invokes administering an immune checkpoint modulator to the subject the claim as currently recited does not provide a step of positively identifying the subject as having AD and thus given its broadest reasonable interpretation allows for a determination of an equal or decreased amount in the subject and thus the subject would not be diagnosed with AD and therefore the treatment step would not be performed. Therefore, the current claims allow for an embodiment wherein no treatment is administered. Therefore, this scenario does not recite something significantly more than 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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