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 .
Claims 1, 3, 8-12, 15, 17, 25-26, 32-33, 43-44, 46-48, 61, and 71 are pending as amended 7/26/25 and are considered herein.
Formalities:
The specification as amended 10/25/24 is entered.
The drawings of 10/25/24 are entered.
The IDS statements of 10/25/24 and 1/1/25 and references cited therein have been considered. A signed copy of each IDS is provided herewith.
Applicant’s priority is noted to be:
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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.
Claims 26, 43-44, 46-48 and 61 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.
Claim 26: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation at least 50%, and the claim also recites at least 70/80/85/09% which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 43 is self dependent. Thus, the scope cannot be determined. However, in the interest of compact prosecution, the claim will be considered to depend from Claim 32, allowing for the widest scope of composition.
Claims 44, 46-48 and 61 all depend from Claim 43, and so, are necessarily lacking a clear scope. Fixing Claim 43 will fix these rejections.
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.
Claim(s) 1, 3, 8, 9, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung, et al. (2019) “PLGA Microspheres Coated with Cancer Cell-Derived Vesicles for Improved Internalization into Antigen-Presenting Cells and Immune Stimulation”, Bioconjugate Chemistry, 30(6): 1690-1701 (Applicant’s citation, IDS of 10/25/24, reference no. 2) and Lee, et al. (2018) Facile Metabolic Glycan Labeling Strategy for Exosome Tracking”, Biochimica et Biophysica Acta., 1862(5): 1091-1100 (Applicant’s citation, IDS of 1/1/25, reference no. 17).
Claim 1: Jung discloses cancer cell derived vesicles (which are extracellular vesicles), on the surface of PLGA micrspheres (which are hydrogel microparticles) (e.g., ABSTRACT).
While Jung uses click chemistry with VE-azide and MS-alkyne to make the VE functionalized MS (p. 1698, col. 2, paragraphs 4-5), Jung fails to disclose the azido sugar and strained alkyne with the triazole linkage between.
On the other hand, the Artisan, interested in linking methods for exosomes to other entities, would be aware of Lee. Lee discloses labeling of exosomes with an azido sugar into a glucan and strain-promoted azide-alkyne click reaction (e.g., ABSTRACT). Scheme 1 demonstrates the attached sugar-azide, and binding to a dye molecule containing the strained alkyne to develop the triazole linkage between them. One reason for using this is stated to be optimizing exosome based therapeutic approaches (e.g., ABSTRACT).
Thus, at the time of invention, it would have been obvious to modify the click chemistry of Jung to use that of Lee to join the microspheres to the extracellular vesicle. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claim 3: Lee teaches the triazole linkage (e.g., p. 1092, col. 1, paragraph 2).
Claim 8: Lee teaches, e.g., N-azidoacetylmannosamine, tetraacylated (p. 1092, col. 2, paragraph 2).
Claim 9: Lee teaches ADIBO (p. 1092, col. 1, paragraph 2).
Claim 32: Jung discloses the compositions in a buffer and water, which meet the carrier requirement. E.g., p. 1699, col. 2, paragraph 2.
Claims Free of the Art of Record
Claims 10-12, 15, 17, 25, and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 71 is free of the art. To wit, while the broad aspect of decorating a hydrogel microparticle with EVs is obvious, the choice of the specific astrocyte population, and particular linkages with azido sugar and strained alkyne is not obvious given the extremely large choices of EV and linkage types.
Conclusion
Claims 1, 3, 8, 26, 32, 43-44, 46-48, and 61 are rejected.
Claims 10-12, 15, 17, and 33 are objected to.
Claim 71 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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