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 .
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 8/20/2025 are acknowledged. No claims are amended; claims 2-13, 15-25, 27-37, 39, 41, 43-48, 51-58, 60-66, 68-85, 87-156, 158-174, 177-183, 187 and 189-204 are canceled; claims 1, 14, 26, 38, 40, 42, 49-50, 59, 67, 86, 157, 175-176, 184-186, 188 and 205 are pending; claims 26, 38, 40, 42, 49-50, 59, 86, 157, 175-176, 184-186 and 188 are withdrawn; claims 1, 14, 67 and 205 have been examined on the merits.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 14, 67 and 205 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al., WO2017/136764 (Foreign Patent Document cite 018, IDS, 11/15/2023; herein “Maguire”) in view of Nordin et al., WO2018/153581 (cite N, PTO-892, 5/20/2025; herein “Nordin”).
Maguire teaches an extracellular vesicle (EV) comprising an adeno-associated virus (AAV) and a scaffold protein (EVs inherently comprise scaffold proteins), wherein the AAV is in the lumen of the EV (Fig. 1A); wherein the AAV in the EV has higher transduction of inner ear hair cells (p. 2, “Summary”, ¶1; Figs. 1A-E, 2A-D, 3A-C), i.e., wherein the AAV in the EV has altered properties as compared to the AAV alone.
Maguire does not teach that the EV comprises a scaffold protein linked to an affinity agent that specifically binds the AAV; however, a person of ordinary skill in the art at the time of filing would have found it obvious for the EV to comprise a scaffold protein linked to an affinity agent that specifically binds the AAV in view of the disclosure of Nordin.
Nordin teaches methods of improving loading of EVs using fusion proteins (Abst.) wherein the fusion protein can comprise an exosomal sorting domain, a multimerization domain and a protein of interest (p. 2d, “Summary of the invention”, ¶1) wherein the exosomal sorting domain can be the protein Lamp2b (p. 9, first full ¶; Lamp2b is a type I transmembrane scaffold protein according to the instant disclosure at [0055]) and the protein of interest can be an antibody or single chain variable fragment (p. 3, ¶2; p. 15, ¶3 – p. 17, ¶1).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to have the EV producing cells of Maguire express a fusion protein comprising Lamp2b, a multimerization domain and an antibody, or any functional fragment thereof, directed against AAV because such a fusion protein would improve the loading of AAV into the EVs of Maguire thereby enhancing the transduction efficiency of the AAV in the EV; therefore, claims 1, 14 and 67 are prima facie obvious.
Regarding claim 205, a person of ordinary skill in the art at the time of filing would have found it obvious for the antibody, or any functional fragment thereof, directed against AAV to be linked to the C-terminus of Lamp2b, i.e., the scaffold protein, because Lamp2b is a type I transmembrane protein, which, by definition, has its N-terminus outside the EV and its C-terminus in the lumen of the EV and the AAV is to be loaded into the lumen of the EV; therefore, claim 205 is prima facie obvious.
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive. Regarding the rejection of claims 1, 14, 67 and 205 under 35 U.S.C. 103 over Maguire in view of Nordin, Applicant argues (pp. 7-8) that in Nordin the antibody is the cargo, whereas in the instant invention the AAV is the cargo; therefore, a person of ordinary skill in the art at the time of filing would have found it non-obvious to use a fusion protein comprising Lamp2b, a multimerization domain, and an antibody, or any functional fragment thereof, directed against AAV, to improve the loading of AAV into EVs. This is unpersuasive because a person of ordinary skill in the art is not a thoughtless automaton but can use common sense and ordinary creativity to employ the teachings of the prior art - “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.” MPEP 2141.03(I). Hence, a person of ordinary skill in the art would readily see that Maguire’s compositions of AAV within EVs which enhance the transduction efficiency of the AAV could be improved by increasing the efficiency of loading of the AAV into the EV by providing the EV with a fusion protein encompassed by the teachings of Nordin comprising an EV scaffold protein (Lamp2b) fused to a multimerization domain and an antibody which binds to AAV because the fusion protein would recruit and maintain AAV within the EV. Thus, Applicant’s arguments are unpersuasive and the rejection is maintained.
Regarding claim 205, Applicant admits that Nordin teaches internally facing proteins, but argues that all examples are focused on displaying proteins on the external face of the exosomes. A person of ordinary skill in the art is capable of discerning whether they want the antibody moiety of the fusion protein to sequester the AAV to the EV internally or externally and have the antibody moiety on the external portion of Lamp2b or the internal portion of Lamp2b, especially because Nordin discloses that the protein of interest can be internally facing or externally facing, and design the fusion protein accordingly. Thus, Applicant’s arguments are unpersuasive and the rejection is maintained.
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 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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651