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 .
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, as further evidenced by the examples detailed in the specification as found below:
Example 1 details a time-dependent decrease of CXCR4-expressing B cells which correlate to a response to IL-27 stimulation. IL-27 is naturally found in vivo and correlates to inflammation. (0282-0285)
Example 2 uses an EAU animal model to study how the claimed cell population impacts uveitis, and paragraph 0289 states that a population of i27-Breg cells were purified from a WT donor, not made. (0289)
Example 3 discusses the detection of i27-Breg cells already existing in an animal model. (0292-0293)
Example 4 discusses “innate IL-27-producing B-1a cells” (0294)
Example 5 details the cross talk between IL-27 producing B-1a cells and lymphoid or myeloid cells in vivo. (0296)
Example 6 details the stimulation of the cell population with LPS, which is a mechanism for activating B cells found in nature and further details the isolation and separation of existing B-1a cells from the peritoneal cavity of a mouse. (0300)
Example 7 details that B-1a cells expressing PD-1, IL-27, and LAG3 are already found in humans and expand in response to inflammatory stimuli. (0302-0303)
Example 8 details that human i27-Breg cells aid in the treatment of disease. (0304-0305)
Example 9 highlights the unique developmental origin of i27-Breg cells, further emphasizing that they are a product of nature. (0307)
Example 10 specifies that i-27 Bregs may serve as natural Bregs in human cord blood, “poised for…response to inflammation” (0309) This further emphasizes that the claimed B-1a cell population is a product of nature.
Example 11 details that innate i27-Bregs suppress CNS autoimmune disease through a BCR-independent mechanism. (0310)
Response to Arguments
Applicant's arguments filed 08/01/2025 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. While it is true that i27-Breg cells encompass a very small percentage of B cell populations found in nature, the fact remains that claim 1 is directed towards a population of naturally existing cells that have been concentrated but otherwise unchanged. The claims as written are not directed towards a distinguishing feature that would render the cell population changed from what is found in nature such as a composition or gene modification, instead being directed towards a naturally occurring (albeit newly identified) rare cell population that is being characterized. Regarding the requirement of the isolated cell population being 75% or higher so as to cause a therapeutic effect, this still does not change the fact that the naturally occurring cell population has been concentrated, but unchanged. Furthermore, the claims as written fail to be directed towards a composition or other therapeutic approach, making the argument surrounding therapeutic levels irrelevant.
As such, the 35 U.S.C. 101 rejection regarding the invention being directed towards a product of nature is upheld.
Applicant’s amendments to the claimset directed towards a population of i27-Breg cells being distinct from other B regulatory cells is persuasive, as there is nothing in the art reading on a population of i27-Breg cells which express LAG-3, PD-1, and CXCR4.
As such, the 35 U.S.C. 103 rejection of claims 1-4 and 29 over Yenson et al (Purification and Immune Phenotyping of B-1 Cells from Body Cavities of Mice, Methods in Molecular Biology, 2014), Zhong et al., (US 2018/0369336 A1) and Thudium et al. (CA 2734335 A1) is overcome.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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