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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-5 in the reply filed on 2/5/2026 is acknowledged.
Claims 6-20 have been canceled.
Priority
This application is a 371 of PCT/US2022/027897 (5/5/2022) which claims benefit of 63/184,654 (5/5/2021).
Information Disclosure Statement
The information disclosure statement (IDS) filed on 5/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, abstract idea, without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. The claim is directed to a process.
Step (2A):
Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Yes. The claim recites an abstract idea, diagnosing the subject. Diagnosing the subject is a mental process, as this step encompasses looking at a result (mast cell tryptase levels) and deciding if a person has CP/CPPS or not. This action is performed mentally, and therefore this claim is directed to a judicial exception.
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. The claim does not recite any additional elements other than the mental step of diagnosing.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. Claim 2 does not recite additional elements to amount to significantly more than the exception. Claim 2 only recites diagnosing a patient as having CP or CPPS if mast cell tryptase is elevated. Additionally, such a process is routine and conventional in the art (see rejection under 35 U.S.C. § 102, Thumbikat col. 13 lines 55-67).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thumbikat et al., US 8,586,044 B2.
Regarding claim 1, Thumbikat teaches methods for detection, diagnosis, and treatment of chronic prostatitis/chronic pelvic pain syndrome (CPPS) (“Abstract”; col. 1 lines 30-35). Thumbikat teaches obtaining samples of expressed prostatic secretion (EPS) and testing the sample to quantify levels of mast cell tryptase (col. 13 lines 46-65).
Regarding claim 2, Thumbikat teaches detection or measurement of mast cell tryptase as an indicator of CPPS in a subject, and teaches diagnosis of CPPS based on detection of mast cell tryptase above a threshold level, i.e. above a control (col. 13 lines 55-67).
Regarding claim 3, Thumbikat teaches treating subjects with CPPS, i.e., subjects that have higher tryptase levels than control (col. 13 lines 55-67; col 14 lines 1-5).
Regarding claim 4, Thumbikat teaches that the treatment comprises inhibitors of the CPPS biomarker mast cell tryptase, or mast cell inhibitor therapy (col. 18 lines 15-20).
Regarding claim 5, Thumbikat teaches administering cromolyn sodium and/or cetirizine (col. 17 lines 60-65).
Conclusion
Claims 1-5 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights