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 .
The amendments of 11/21/2025 have been entered in full. Claims 14, 17, 20, 23, 25, 26, 35, 41, 42, 44, and 52-55 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 11/21/2025.
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 14, 17, 20, 23, and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
First, it is noted that the claims meet step 1 of the analysis for subject matter eligibility (MPEP 2106) since the claims are directed to one of the statutory categories of invention (i.e. are directed to a process). The claims meet prong one of step 2A, since the claims recite a natural phenomenon, the negative correlation between expression level of GDF-11 and mood and/or anxiety disorder.
A claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception, which is addressed in prong two of step 2A. The claims do not meet prong two of step 2A since the claims do not recite additional elements that integrate the judicial exception into a practical application. The claims recite the single step of determining comparing the level of GDF-11 in a sample from a subject to healthy reference levels. The recited methods of quantitating GDF-11 levels merely constitute data gathering necessary to apply the judicial exemption. The claims do not comprise an additional element that applies or uses a judicial exception to effect a particular treatment, but instead recite the generalized instruction to apply the law of nature by performing a mental process of prognosing the subject to suffer from, or diagnosing subject to have, a mood and/or anxiety disorder.
Likewise, the claims are ineligible in view of step 2B of the analysis, because the claims to not recite any additional elements that amount to significantly more than the judicial exception.
Conclusion
Claims 14, 17, 20, 23, and 52 are rejected.
Claims 25, 26, 35, 41, 42, 44, and 53-55 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C GAMETT/Primary Examiner
Art Unit 1647
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