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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/11/2026 has been entered.
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 1-4 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a population of i27-Breg cells which express LAG-3, PD-1, and CXCR4 and secrete IL-27, which can be found in nature without outside manipulation needed in order for the population of B-1a regulatory cells to express the claimed factors. This judicial exception is not integrated into a practical application because the nature of the invention appears to be simply re-creating an inflammatory environment without additional manipulation to the claimed population. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no manipulation to the claimed cell population that could not be found as a naturally occurring phenomenon. Additionally, simply isolating a natural product, regardless of the concentration of said product when compared to the concentration it is found in nature, fails to place the claimed invention in a markedly different state from its natural form. Isolating and purifying said product further fails to render it markedly different from its natural state, nor does placing the cells in a pharmaceutically acceptable carrier, nor does culturing for expansion in a laboratory setting. So long as the characteristics of said i-27 Breg cells found in the pharmaceutical composition continue to be unchanged from what is found in nature, of which they appear not to be as i-27 Bregs inherently express PD-1, CXCR4, and produce IL-27, there is no markedly different feature making them unique from i-27 Bregs found in the body.
Response to Arguments
Applicant's arguments filed 09/11/2026 have been fully considered but they are not persuasive. Specifically, Applicant’s arguments pertaining to the 35 U.S.C. 101 rejection are not persuasive. Applicant argues that the claimed invention is now that of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and the i-27 Breg cells concentrated at 75% or higher. As stated previously, so long as the i-27 Breg cells have remained unmanipulated and unchanged from what they naturally express when found in nature, the concentration of said cells does not make them markedly different than a product of nature as fundamentally the cells remain unchanged. Merely expanding said cells in a laboratory setting does not change this. I-27 Breg cells naturally express LAG-3, CXCR4, and produce IL-27. As stated previously in the Final Rejection dated 05/12/2026, there are currently no examples in the Specification which concretely prove the cells of the claimed invention have been manipulated in a way which sets them apart from naturally occurring i-27 Breg cells. As it has been established that the concentration of said population of i-27 Bregs fails to make it markedly different from naturally occurring i-27 Bregs, the argument of being unable to merely concentrate i27-Bregs taken from a mammal is moot.
As such, the 35 U.S.C. 101 rejection regarding the invention being directed towards a product of nature is upheld.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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, Tracy Vivlemore, can be reached on (571) 272-2914. 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.
/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
