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 .
Applicants' arguments, filed 08/11/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 101--Previous
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 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. This rejection also applies to newly added claims 23-27. 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.
Applicant has amended claim 1 to further recite “A pharmaceutical composition comprising” and “a pharmaceutically acceptable carrier”. However, since the body of the claim continues to qualify as a judicial exception, the addition of generic field-of-use labels like “pharmaceutical composition” and “pharmaceutically acceptable carrier” fail to amount to significantly more than the judicial exception. These are additions well-understood, routine, conventional activities engaged in by scientists in the field. The amendment is not considered a meaningful limitation insofar as it does not improve another technology, technical field, or improves the function of the exosomes comprising IL-27 and/or IL-35 (see MPEP 2106.07(b)). The carrier does not transition the claim into a specific practical application; it merely drafts a standard composition format. Accordingly, the rejection will be maintained.
Claim Rejections - 35 USC § 102/103—New by Amendment
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, 23-27 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 Zylberberg, (WO 2019/165447, cited in IDS).
Zylberberg teaches a method of “suppressing the autoimmune response in the subject” (p. 3, lines 1-3) by administering “one or more proteins associated with immune regulatory and/or tissue reparatory processes, comprise . . . Epstein-Barr Virus Induced 3 . . . “ (Id., lines 7-9); “the method further comprises administering one or more anti-inflammatory agents” (Id. lines 13-15).
Epstein-Barr Virus Induced 3 includes “two immunosuppressant/anti-inflammatory cytokines; IL-27 and IL35” (p. 27, lines 6-7).
The method for autoimmunity treatment and inflammatory disease treatment comprises “administering to the mammal extracellular vesicles”, “which comprises administering to the mammal exosomes” (p. 5, lines 17-20).
The method uses a “pharmaceutically acceptable carrier” for the administration of therapeutic agents (p. 13, line 29), wherein the route of administration is taught to be “through a convenient parenteral route, to the mammal in need” (p. 2, line 1). Parenteral route includes “e.g., intravenous, intradermal, subcutaneous, oral (e.g., inhalation, transdermal (topical), transmucosal, and rectal administration” (p. 49, lines 23-26).
The prior art is anticipatory insofar as it teaches pharmaceutical compositions comprising isolated exosomes comprising IL-27 and/or IL-35 or a combination and a pharmaceutically acceptable carrier, as per claims 1, 23-24, where administration includes parenteral administration, e.g., injection, which also means the prior art compositions are formulated for parenteral, intravenous, and retroorbital injection, as per claims 25-27.
Assuming, for the sake of argument, that the prior art lacks sufficient specificity to rise to the level of anticipation, it would have been obvious to provide a pharmaceutical product with isolated exosomes comprising IL-27, IL-35 or a combination, and a carrier, in view of Zylberberg.
Claim Rejections - 35 USC § 103—New by Amendment
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 1, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tomita et al., (American Journal of Transplantation, 2017, cited in IDS) in view of Zylberberg, (WO 2019/165447, 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 does not teach adding a pharmaceutically acceptable carrier.
Zylberberg teaches a method of “suppressing the autoimmune response in the subject” (p. 3, lines 1-3) by administering cytokines such as IL-27 and IL-35. (see p. 27, lines 6-7).
The method combines exosomes (p. 5, lines 17-20) with a “pharmaceutically acceptable carrier” for the administration of therapeutic agents (p. 13, line 29), wherein the route of administration is taught to be “through a convenient parenteral route, to the mammal in need” (p. 2, line 1), wherein parenteral route includes “e.g., intravenous, intradermal, subcutaneous, oral (e.g., inhalation, transdermal (topical), transmucosal, and rectal administration” (p. 49, lines 23-26).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the isolated exosomes comprising IL-35 of Tomita et al. with a pharmaceutically acceptable carrier, based on its suitability for its intended use in administering cytokines to patients for their immunosuppressant and anti-inflammatory effects, as taught by Zylberberg. The artisan would have been motivated to include IL-27, as per claim 23, for the same reasons.
2) Claim(s) 1, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al., (Cell Rep, January 2020) in view of Zylberberg, (WO 2019/165447, cited in IDS).
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.).
. The prior art does not teach adding a pharmaceutically acceptable carrier.
Zylberberg teaches a method of “suppressing the autoimmune response in the subject” (p. 3, lines 1-3) by administering cytokines such as IL-27 and IL-35. (see p. 27, lines 6-7).
The method combines exosomes (p. 5, lines 17-20) with a “pharmaceutically acceptable carrier” for the administration of therapeutic agents (p. 13, line 29), wherein the route of administration is taught to be “through a convenient parenteral route, to the mammal in need” (p. 2, line 1), wherein parenteral route includes “e.g., intravenous, intradermal, subcutaneous, oral (e.g., inhalation, transdermal (topical), transmucosal, and rectal administration” (p. 49, lines 23-26).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the isolated exosomes comprising IL-35 of Sullivan et al. with a pharmaceutically acceptable carrier, based on its suitability for its intended use in administering cytokines to patients for their immunosuppressant and anti-inflammatory effects, as taught by Zylberberg. The artisan would have been motivated to include IL-27 for the same reasons.
Technological Background
The prior art made of record and considered pertinent to applicant's disclosure Fu et al., (NanoImpact, 2020). Fu et al. is pertinent for teaching the use of exosomes for cargo loading and targeted delivery (p. 2, para. [0019]). Fu et al. teaches, “Exosomes, a class of small bilayer vesicles derived from virtually all eukaryotic cells, have been exploited as a promising natural delivery platform due to their low toxicity, excellent structural stability, nanoscale size, cargo loading ability, and editable surface structure”, where exosome cargo includes “drugs, nucleic acids, proteins, peptides, and nanomaterials” (Abstract). The reference also teaches administration of exosomes “through intravenous, intraperitoneal, or subcutaneous injection” (p. 11, sec. 4, 1st paragraph).
Response to Arguments
Applicant’s argument are moot in view of the new ground of rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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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