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 Group 1, claim 1, in the reply filed on 04/10/2026 is acknowledged.
Claims 4, 5, 7-11, 13, 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) isolated exosomes comprising interleukin-27 and/or interleukin-35. Exosomes are endogenous nanovesicles secreted by living cells, designed for intercellular communication. This judicial exception is not integrated into a practical application because merely isolating the product of nature does not add a meaningful limitation as it is a nominal aspect of the claims. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature") (see MPEP 2105.4(b)(II)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is nothing recited to distinguish the claimed vesicles from those found in mammals or any other creature producing exosomes.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tomita et al., (American Journal of Transplantation, 2017, cited in IDS).
Tomita et al. teaches, “Exosomes Containing IL35 Are Secreted by Donor-Specific Regulatory T Cells and Cause Linked-Suppression” (Ti.).
A population of the exosomes containing IL-35 were isolated as claimed insofar as the prior art teaches, “In order to investigate functions of IL35 containing exosome purified from tolerated mice, we used a novel flow-cytometry assay for sEbi3 expression by Treg cells, ELISA and tv-DTH linked-suppression assay” (see Methods). The reference also stated, “CD81 was enriched in the exosomes isolated by ultracentrifugation” (Results).
The prior art is anticipatory insofar as it teaches isolated exosomes comprising IL-35.
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
1) Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kang et al., (Frontiers in Immunology, 2020, cited in IDS).
Kang et al. teaches the use of “ex-vivo generated IL-35-producing regulatory B-cells (i35-Bregs)” for suppressing neuroinflammation (Abstract). The “i35-Bregs release exosomes that contain IL-35 (i35-Exosomes)” (Abstract).
The exosomes are taught to be isolated insofar as Kang et al. teaches, “Exosome-enriched extracellular vesicles (EV) were isolated from the cell supernatant using ExoQuick exosome precipitation solution” (p. 4, left column).
Kang et al. is anticipatory insofar as it teaches isolated exosomes comprising IL-35.
Assuming, for the sake of argument, that the prior art teaching is not specific enough to give rise to anticipation, it would have been obvious to provide an isolated population of exosomes comprising interleukin -35, in view of Kang et al. for the purpose of treating uveitis.
2) Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sullivan et al., (Cell Rep, January 2020).
Sullivan et al. teaches, “Treg-Cell-Derived IL-35-Coated Extracellular Vesicles Promote Infectious Tolerance” (Ti.).
Sullivan et al. further teaches, “IL-35 producers, although rate, secrete Ebi3 and p35 on extracellular vesicles (EVs) targeting a 25- to 100-fold higher number of T and B lymphocytes, causing them to acquire surface IL-35” (p. 2, 1st paragraph).
“To explain both the low frequency of IL-35 producers and the wide dissemination of exogenous IL-35 expression on non-Treg cells, we isolated EVs by ultracentrifugation from culture supernatants after 24-h in vitro restimulation of CBA-tolerized (day 35) B6 mouse splenocytes with either DBA (third party), CBA antigen, or media control” (p. 8, 2nd paragraph). Further, “Using nanoparticle tracking analysis (NTA), the particles released after restimulation predominantly showed a mean particle size range between 50 and 200 nm” (Id.)
Since the EV’s are nanosized they would therefore qualify as exosomes. It is further noted that “EV/exome free fractions” did not demonstrate evidence of p35 (Id.).
Sullivan et al. is anticipatory insofar as it teaches isolated exosomes comprising IL-35.
Assuming, for the sake of argument, that the prior art teaching is not specific enough to give rise to anticipation, it would have been obvious to provide an isolated population of exosomes comprising interleukin -35, in view of Sullivan et al. for the purpose of promoting infectious tolerance.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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