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 .
Detailed Action
The amendment filed April 2, 2026, is acknowledged and has been entered. Claims 28-30 have been canceled. Claim 27 has been amended.
Claims 27 and 31-51 are pending. Claims 34, 37-38 and 46 are withdrawn from further consideration, as being drawn to non-elected species of invention. Claims 27, 31-33, 35-36, 39-45 and 47-51 are under consideration.
Claim Rejections Maintained
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 27, 31, 35-36, 39-45 and 47-51 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Goodman et al (WO 2019/051380 A1).
With respect to claims 27-29, 44-45 and 47-48, Goodman et al disclose methods for treating cancer comprising administering an effective amount of a composition comprising Gram negative bacterial extracellular vesicles from Escherichia genus and an immune checkpoint inhibitor which is the PD1 antagonist antibody nivolumab as an active ingredient to a subject in need thereof simultaneously (see pages 97, 114-116, 138, 210, 224, 238 and claims). With respect to claim 49, the cancer to be treated is lung cancer (see page 138). With respect to claims 50-51, the subjects include humans and the composition is administered intravenously (see pages 9, 20, 113, 116, 130 and 132). With respect to claim 31, the bacteria are transformed bacteria (see pages 21-22). With respect to claims 35-36, the bacteria are cultured in M9 medium (see page 152). With respect to claims 39-42, the bacteria extracellular vesicles can be chemically modified or otherwise modified to comprise targeting materials, cyclodextrin or polyethylene glycol (see pages 16, 97-98, 236 and 244 and claims). With respect to claim 43, the bacterial extracellular vesicles are isolated by ultracentrifugation (see pages 99-100).
Therefore, the methods of Goodman et al are deemed to anticipate the claimed methods absent a showing otherwise.
In the response, Applicant traverses the rejection and argues that the “findings demonstrate that anticancer efficacy is unexpectedly and significantly enhanced when Escherichia-derived EVs are administered in combination with an immune checkpoint inhibitor. This synergistic effect is clearly distinguishable from, and not readily derivable in view of the teachings of the applied prior art.
Accordingly, for at least these reasons, it is respectfully submitted that amended independent claim 27 recites patentable subject matter, and the combination of the applied art does not anticipate or render obvious the recitations of amended independent claim 27.”
In response, this argument is not found persuasive as this is a 35 U.S.C. 102 rejection and as set forth in MPEP § 2131.04. “Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).”
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 27, 31-33, 35-36, 39-45 and 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al (WO 2019/051380 A1) and Kim et al (Nature Communications, 8:626, pages 1-9, IDS).
Goodman et al is discussed above. Goodman et al does not teach modifying endotoxin to attenuate toxicity of the extracellular vesicles for use in methods of treating cancer.
Kim et al disclose methods for treating cancer comprising administering a composition comprising Gram negative bacterial extracellular vesicles from Escherichia genus which have modified endotoxin to attenuate toxicity which has the advantage of increasing safety by avoiding possible adverse effects of the endotoxin (see page 3 and 7). Kim et al disclose in the future testing the modified endotoxin bacterial extracellular vesicles in combination with PD-1 antibodies (see page 7).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to use the modified endotoxin bacterial extracellular vesicles of Kim et al in the methods Goodman et al because such modified endotoxin bacterial extracellular vesicles (EVs) would have the advantage of increasing safety by avoiding possible adverse effects of the endotoxin that would be present in the EVs of Goodman. In this case, using modified endotoxin bacterial extracellular vesicles of Kim et al in the methods Goodman et al would be seen as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results. Furthermore, one of ordinary skill in the art would have expected success in practicing such methods as genetic engineering techniques were commonly used in the art which could be used to make the modified endotoxin bacterial extracellular vesicles and these EVs were known to treat cancer.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In the response, Applicant traverses the rejection and argues that the “findings demonstrate that anticancer efficacy is unexpectedly and significantly enhanced when Escherichia-derived EVs are administered in combination with an immune checkpoint inhibitor. This synergistic effect is clearly distinguishable from, and not readily derivable in view of the teachings of the applied prior art.
Accordingly, for at least these reasons, it is respectfully submitted that amended independent claim 27 recites patentable subject matter, and the combination of the applied art does not anticipate or render obvious the recitations of amended independent claim 27.”
In response, this argument is not found persuasive as it states that the combination of the applied art does not anticipate or render obvious the recitations of amended independent claim 27, and claim 27 is rejected under 35 U.S.C. 102, with the difference in the 35 U.S.C. 103 rejection being the subject matter of claims 32-33 , neither of which are argued in the traversal. Notably, as set forth in MPEP § 716.01(b), “evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations”. In this case, the nexus of the evidence is directed to the broader subject matter of claim 27 which was found in the prior art, and therefore the evidence does not have a nexus to the limited subject matter of claims 32-33. As further set forth in MPEP § 716.01(b), "there must be a nexus to some aspect of the claim not already in the prior art." In re Kao, 639 F.3d 1057, 1068-69, 98 USPQ2d 1799, 1808 (Fed. Cir. 2011).
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRAD DUFFY whose telephone number is (571)272-9935. The examiner can normally be reached Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
June 9, 2026
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