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 amendment filed October 9, 2025 has been received and entered. Claims 3-4 have been canceled. Accordingly, claims 1-2, and 5-21 remain pending in the instant application, of which claims 14-21 have been withdrawn from further consideration as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
1. The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being vague and indefinite in the recitation of “not typically pathogenic” is withdrawn in view of Applicants amendment.
Claim Rejections - 35 USC § 101
2. The rejection of claims 1-13 as not directed to patent eligible subject matter is withdrawn in view of Applicants amendment.
Claim Rejections - 35 USC § 102
3. The rejection of claim(s) 1-3 and 5-13 under 35 U.S.C. 102(a)(1) as being anticipated by Grifantini et al is withdrawn in view of Applicants amendment.
Claim Rejections - 35 USC § 103
4. The rejection of claim(s) 1-13 under 35 U.S.C. 103 as being unpatentable over Grifantini et al in view of Cleary et al is withdrawn in view of Applicants amendment.
The following new grounds of rejection are applied to the amended claims:
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.
5. Claim(s) 1-2 and 5-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al.
NOTE: Applicants assert that the cancellation of claim 4 and incorporation into claim 1 renders the claims novel over Grifantini et al. However, Applicants will hopefully appreciate that claim 3 was rejected over Grifantini et al for the genus of Escherichia. Applicants amendment to claim 1 did involve deleting the genus of Escherichia for several recited Escherichia species, however it also included several distinct genus members, (e.g., Bacteroides from original claim 3) that remain anticipated by the prior art.
The claims are drawn to a therapeutic composition comprising a commensal bacterial outer membrane vesicle (OMV) loaded with a therapeutic moiety that is exogenous to the OMV, wherein the commensal bacteria OMV is from a bacterial genera selected from Akkermansia, Bacteroides, Enterococcus, Klebsiella, Parabacteroides, Prevotella, Pseudomonas, Staphylococcus, or Veillonella or an Escherichia coli bacterial species selected from DH5-alpha, 541-15, 568-2, T75, LF82, 79, 88 117, 128, 132, 142, 143, 147, 149, UM-146, HM427, HM428, HM452, HM454, HM455, HM456, HM463, HM484, HM484, HM488, HM489, HM615, 4F, 13I, 30A, 150F, NRG857c.
Lu et al (US Publication 2017/0145061) disclose of human gut commensals of Bacteroides species to secrete heterologous therapeutic proteins via outer membrane vesicles. (See abstract; claims). Lu et al further disclose the OMVs to have a diameter ranging from 20 to 250 nm. (See paragraph 0033). Lu et al further disclose the therapeutic protein to be an antibody, cytokine or growth factor. (See claim 12). Lu et al further disclose of administering the OMVs comprising a therapeutic protein via oral administration. (See paragraph 0059).
Accordingly, Lu et al disclose of each and every limitation of the instantly filed claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 December 22, 2025
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