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 .
Response to Amendment
The Amendment filed 05/28/2025 in which claims 1-4 were amended, and claims 9 and 10 were canceled, has been entered. Claims 5-8 were previously withdrawn.
Claims 1-4 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 05/28/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 03/12/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 05/28/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 03/12/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, maintained) Applicant’s amendments to the Specification submitted on 05/28/2025 have not overcome the objection previously set forth in the Non-Final Office Action mailed 03/12/2025. The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is still missing.
Claim Objections
(Previous objections, withdrawn as to claims 1, 2 and 4). Applicant’s amendments to claims 1, 2, and 4 have overcome previous objections to those claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Previous rejection, maintained as necessitated by amendment to claims 1-4, withdrawn as to claims 9 and 10) Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The previous rejections of claims 9 and 10 is moot in view of Applicant’s cancelation of these claims.
See claims 1-4 as submitted on 05/28/2025.
Regarding amended claim 1, the recitation of “based on a receptor binding domain (RBD) region” remains unclear because it is not indicated what the term ‘based on’ means. For example, it is unclear whether the targeted exosome of claim 1 bears any sequence identity or any structural identity to an RBD of SARS-CoV-2. Further, it is not clear if the term ‘based on’ encompasses specific modifications to a targeted exosome. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claim 1 was interpreted herein a targeted exosome derived from an RBD of SARS-CoV-2.
The rejection is maintained for reasons of record.
(New rejection, necessitated by amendment to claims 1-4) Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1-4 as submitted on 05/28/2025.
Amended claim 1 recites “and the targeted exosome is enriched in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours”. It is unclear what the term “enriched” means. For instance, it is unclear if the term “enriched” encompasses a process by which additional structural features are imparted on a targeted exosome. Instant Specification (page 6 lines 1-7) refers to enrichment of the targeted exosome “in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours” after the targeted exosome was injected into humanized ACE2 mice. Such explanation simply indicates internal localization of the targeted exosome to lung, heart, and kidney tissue after injection into mice, it does not seemingly refer to any process by which additional structural modifications were imparted onto the targeted exosome. There are no other mentions of enrichment in instant Specification and therefore it is unclear what the term encompasses. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claim 1 was interpreted herein consistent with the Specification to refer to a targeted exosome wherein upon injection into humanized ACE2 mice, it localizes predominantly in lung, heart and kidney tissue for a period of not less than 96 hours wherein such localization does not impart any additional structural features to the targeted exosome. Accordingly, any prior art targeted exosome having all of the structural limitations as recited in claim 1 was herein understood as a targeted exosome wherein upon injection into humanized ACE2 mice, it localizes predominantly in lung, heart and kidney tissue for a period of not less than 96 hours. See MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 1-4, withdrawn as to claims 9 and 10) Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Coley et al. Prior art of record.
The previous rejections of claims 9 and 10 is moot in view of Applicant’s cancelation of these claims.
See claims 1-4 as submitted on 05/28/2025.
Regarding amended claim 1, it is noted that the amendment to claim 1 recites “and the targeted exosome is enriched in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours”. Such recitation, being interpreted herein, does not impart any additional structural features to the targeted exosome of claim 1, therefore this recitation is considered to flow from the features already present in the targeted exosome as recited in claim 1. See MPEP 2111.02. Further, given that instant claims are directed to a targeted exosome and not to a method of using the same, the recitations with respect to the manner in which the claimed targeted exosome is used do not differentiate the claimed targeted exosome from any prior art targeted exosomes that meet the structural limitations as recited in claim 1.
As previously explained, Coley et al. disclose extracellular vesicles (EVs), including exosomes as anti-viral therapeutic agents and methods for preparing the same (Abstract). Coley et al. further disclose constructing a SARS-CoV-2 RBD-VSVG fusion protein which is expressed on the surface of targeted exosomes wherein the transmembrane domain of the S protein of SARS-CoV-2 were replaced by those of the vesicular stomatitis virus glycoprotein (VSV-G) (pages 37, 38). Coley et al. further disclose a construct comprising the transmembrane and cytoplasmic domains of VSV-G fused to the S1 domain of SARS-CoV-2 which includes the receptor binding domain (RBD) (pages 37-39). As indicated above, any prior art targeted exosome having all of the structural limitations as recited in claim 1 was herein understood as a targeted exosome wherein upon injection into humanized ACE2 mice, it localizes predominantly in lung, heart and kidney tissue for a period of not less than 96 hours. See MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES. Accordingly, Coley et al. anticipate the limitations of claim 1.
Regarding amended claim 2, it is noted that the amendment was made to overcome the previous objection set forth in the Non-Final Office Action mailed on 03/12/2025. No new limitations were introduced in the amendment filed on 05/28/2025. Accordingly, the rejection under 35 U.S.C. 102 set forth in the previous Non-Final Office still applies to amended claim 2. As previously explained, Coley et al. further disclose a fusion protein comprising the SARS-CoV-2 RBD-VSVG regions. The sequence of Coley et al.’s sequence shares 100% identity with instant SEQ ID NO: 1. Alignment of record.
Regarding claim 3, it is noted that the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 03/12/2025. No new limitations were introduced in the amendment filed on 05/28/2025. Accordingly, the rejection under 35 U.S.C. 102 set forth in the previous Non-Final Office still applies to amended claim 3. As previously explained, Coley et al. further disclose incorporating a signal sequence wherein the signal sequence is derived from the targeting molecule or the transmembrane protein (page 38).
Regarding claim 4, it is noted that the amendments were made to overcome the previous and an objection and a rejection under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 03/12/2025. No new limitations were introduced in the amendment filed on 05/28/2025. Accordingly, the rejection under 35 U.S.C. 102 set forth in the previous Non-Final Office still applies to amended claim 4. As previously explained, Coley et al. further disclose a signal sequence which shares 100% identity with instant SEQ ID NO: 2. Alignment of record.
Accordingly, claims 1-4 were anticipated by Coley et al. before the effective filing date especially in the absence of evidence to the contrary.
The rejection is maintained for reasons of record.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claim 1) Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kuate et al. in view of Wu et al. Prior art of record.
See claims 1 as submitted on 05/28/2025.
As indicated above, the amendment to claim 1 recites “and the targeted exosome is enriched in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours”. As indicated above, such recitation, as is being interpreted herein, does not impart any additional structural features to the targeted exosome of claim 1. Therefore this recitation is considered to flow from the features already present in the targeted exosome as recited in claim 1. See MPEP 2111.02. Further, given that instant claims are directed to a targeted exosome and not to a method of producing the same, the recitations with respect to the manner in which the claimed targeted exosome is enriched do not differentiate the claimed targeted exosome from any prior art targeted exosomes that meet the structural limitations as recited in claim 1.
As previously explained, Kuate et al. teach an exosome-based vaccine containing exosomes comprising the spike (S) protein of SARS-CoV (Abstract, page 1). Kuate et al. further teach constructing a SARS-Co-V RBD-VSVG fusion protein which is expressed on the surface of targeted exosomes wherein the transmembrane and cytoplasmic domains of the S protein of SARS-CoV were replaced by those of the vesicular stomatitis virus glycoprotein (VSV-G) (Abstract, pages 1-2). Kuate et al. further teach a chimeric vector comprising the transmembrane and cytoplasmic domains of VSV-G fused to the ectodomain of SARS-CoV which includes the S1 and S2 domains, and within S1 domain lies the receptor binding domain (RBD) (Fig. 1).
Kuate et al. does not explicitly teach the RBD region of SARS-CoV-2 S protein.
However, Wu et al. teach the full genomic sequence of SARS-CoV-2 including the RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267).
In view of the teachings of Kuate et al. and Wu et al., one of ordinary skill in the art would have been motivated to incorporate the sequence encoding the RBD region of SARS-CoV-2 S protein into the exosomes as taught by Kuate et al. for the benefit of targeting SARS-CoV-2 with an exosome-based vaccine formulation. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in formulating an exosome-based vaccine comprising exosomes wherein the exosomes comprise an RBD-VSVG fusion protein given that the methods of vector cloning and exosome expression are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Thus, such an embodiment, a targeted exosome based on the RBD region of SARS-CoV-2 S protein, wherein a RBD-VSVG fusion protein is expressed on the targeted exosome, which is obtained by replacing the extracellular region of VSVG with the RBD of the SARS-CoV-2 S protein, is an obvious construct in view of the teachings of Kuate et al. and Wu et al.
Accordingly, the limitations of claim 1 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
The rejection is maintained for reasons of record.
Response to Arguments
Applicant's arguments filed 05/28/2025 have been fully considered but they are not persuasive.
Applicant contends on page 8 of the Remarks: Amended claim 1 recites, "the targeted exosome is enriched in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours." Coley fails to teach at least these elements of claim 1. Accordingly, claim 1 is allowable over Coley. Dependent claims 2-4 are also allowable for at least the same reasons as claim 1. The combined teaching of Kuate and Wu fails to teach at least these elements of claim 1.
In response: As indicated above the new recitation in claim 1 of "the targeted exosome is enriched in mouse lung tissue, heart and kidney tissue for a period of not less than 96 hours" fails to particularly point out and distinctly claim the subject matter which the inventors regard as the invention. Specifically, it is unclear what the term “enriched” refers to and/or if it encompasses a process by which additional structural features are imparted on a targeted exosome. This recitation was interpreted herein as referring to a process by which no additional structural features are imparted on a targeted exosome. Additionally as indicated above, any prior art targeted exosome having all of the structural limitations as recited in claim 1 was herein understood as a targeted exosome wherein upon injection into humanized ACE2 mice, it localizes predominantly in lung, heart and kidney tissue for a period of not less than 96 hours. See MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES. Therefore as explained in detail above the disclosure of Coley et al. anticipates claims 1-4, and the teachings of Kuate et al. and Wu et al. in combination render claim 1 prima facie obvious.
Conclusion
No claims are allowed.
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 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 MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1671
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1671
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