DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendments and remarks filed 05/22/2026 are acknowledged. Claim 26 is cancelled. Claims 22-25 are amended. Claims 22-25 are pending and under examination.
Withdrawn Rejections
3. The rejection of claims 22-25 under 35 U.S.C 102(a)(2) for being unpatentable over Bu, et al. (“Exosome-mediated delivery of inflammation-responsive Il-10 mRNA for controlled
atherosclerosis treatment.” Theranostics vol. 11,20 9988-10000. 25 Oct. 2021,
doi:10.7150/thno.64229), is withdrawn in light of Applicant’s amendments thereto. See pages 3-5 of the previous office action.
Maintained Rejection
4. Claims 22-25 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Tang,
et al. (“Extracellular vesicle-encapsulated IL-10 as novel nanotherapeutics against ischemic
AKI.” Science advances vol. 6,33 eaaz0748. 12 Aug. 2020, doi:10.1126/sciadv.aaz0748)
This rejection is maintained for reasons of record (pp. 5-7, Office action mailed
23 February 2026) and for the reasons discussed below. For convenience, the rejection
is repeated herein, modified to adhere to the amendments:
The instant claims are directed to an exosome comprising a nucleic acid that expresses IL-10, wherein the exosomes are isolated for size and loading of the nucleic acid that expresses IL-10.
Tang, et al. teach RAW 264.7 macrophages were transfected with a plasmid coding for murine IL-10 and loaded into exosomes, that were isolated based on size. Tang, et al. anticipated instant claim 22. The recitation of “in an amount sufficient to treat a pregnant female subject at risk of preterm birth”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding the limitation in claim 22 with routes of administration, Tang teaches intravenous administration (IL-10 EVs protect against renal I/R injury in mice), which meets the limitation of the Markush group of various routes of administration.
Instant claim 23 recites the exosomes are isolated from a media by at least one of: ultracentrifugation, purification, or size exclusion chromatography. Tang, et al. teach the extracellular vesicles, including exosomes, were isolated with ultracentrifugation at 200,000g for 2 hours (preparation of IL-10 EV’s section). Tang, et al. anticipate instant claim 23.
Instant claim 24 recites the exosome have a particle size ranging between 40 nm-110nm. Tang, et al. teach EVs had diameters ranging from 10 to 500 nm, with a mean diameter of 134 nm. Tang, et al. further teach the morphology appeared heterogeneous under a transmission electron microscope (TEM), with a mixture of both small exosome-like and large microvesicle-like particles. Although Tang, et al. do not directly teach the particle size between 40 nm-110, the range of 10-500 nm taught by Tang, et al. encompasses the range taught by the Applicant.
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Regarding the limitations wherein the nucleic acid that expresses IL-10 are loaded into the exosomes by one or more electroporation steps (instant claim 25), these limitations refer to the process by which the composition is made. MPEP 2113 states that “[E]ven though product- by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. At 1370 ( "a product in the prior art made by a different process can anticipate a product -by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim." ). Thus, the product of Tang et al. anticipate the product of the instant claims, even if made by a different process.
Tang, et al. anticipate the claimed invention.
Applicant Argument’s
A) Applicant argues Tang fails to anticipate the present invention as IL-10 production was stimulated by treating cells with Dexamethasone. Applicant argues the use of dexamethasone would cause negative consequences early child developmental stages to treat pre-term birth.
B) Applicant argues Tang teaches exosomes as delivery vehicle for the drug against Ischemic AKI, not preterm pregnancy.
Response to Argument’s
A) Applicant’s contention that Tang uses dexamethasone to induce and maximize IL-10 production and that dexamethasone is contraindicated in the prenatal setting, is not persuasive. Applicant is claiming a product which is a composition comprising an exosome comprising IL-10. The claims contain no limitation excluding dexamethasone and no limitation directed to the process of manufacture. The manner in which Tang’s cells are stimulated to express IL-10 is a process of making, resulting in the product, which is an exosome comprising IL-10 protein. Whether dexamethasone may be contraindicated for a particular therapeutic does not alter the structure of Tang’s exosome.
B) Applicant’s contention that Tang is directed to Ischemic AKI rather than preterm birth is not persuasive as the intended use and patent population do not distinguish a composition claim. The recitation of “in an amount sufficient to treat a pregnant female subject at risk of preterm birth”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The recitation does not set forth a specific dose and has not been shown to impart any structural different over Tang’s IL-10 loaded exosome, which is capable of the recited use. As such, the rejection is maintained.
5. Claim(s) 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tang, et al. (“Extracellular vesicle-encapsulated IL-10 as novel nanotherapeutics against ischemic AKI.” Science advances vol. 6,33 eaaz0748. 12 Aug. 2020, doi:10.1126/sciadv.aaz0748) in view of Luan, et al. (“Engineering exosomes as refined biological nanoplatforms for drug delivery. Acta Pharmacol Sin. 2017 Jun;38(6):754-763. doi: 10.1038/aps.2017.12. Epub 2017 Apr 10. PMID: 28392567; PMCID: PMC5520184.”)
This rejection is maintained for reasons of record (pp. 7-10, Office action mailed
23 February 2026) and for the reasons discussed below. For convenience, the rejection
is repeated herein, modified to adhere to the amendments:
The instant claims are directed to an exosome comprising a nucleic acid that expresses IL-10, wherein the exosomes are isolated for size and loading of the nucleic acid that expresses IL-10.
Tang, et al. teach RAW 264.7 macrophages were transfected with a plasmid coding for murine IL-10 and loaded into exosomes, that were isolated based on size. Tang, et al. anticipated instant claim 22. The recitation of “in an amount sufficient to treat a pregnant female subject at risk of preterm birth”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding the limitation in claim 22 with routes of administration, Tang teaches intravenous administration (IL-10 EVs protect against renal I/R injury in mice), which meets the limitation of the Markush group of various routes of administration.
Instant claim 23 recites the exosomes are isolated from a media by at least one of: ultracentrifugation, purification, or size exclusion chromatography. Tang, et al. teach the extracellular vesicles, including exosomes, were isolated with ultracentrifugation at 200,000g for 2 hours (preparation of IL-10 EV’s section). Tang, et al. anticipate instant claim 23. Instant claim 24 recites the exosome have a particle size ranging between 40 nm-110nm. Tang, et al. teach EVs had diameters ranging from 10 to 500 nm, with a mean diameter of 134 nm. Tang, et al. further teach the morphology appeared heterogeneous under a transmission electron microscope (TEM), with a mixture of both small exosome-like and large microvesicle-like particles. Although Tang, et al. do not directly teach the particle size between 40 nm-110, the range of 10-500 nm taught by Tang, et al. encompasses the range taught by the applicant.
Tang, et al. does not teach the IL-10 are loaded into exosomes by one or more electroporation steps.
Although the claims limitations is a product by process limitation, Luan, et al. teach electroporation leads to superior loadings of siRNA over chemical transfection as used by Tang, et al. Luan, et al. further teach that electroporation not only enhances RNA loading into exosomes but also increase hydrophilic small molecule loading into exosome. Luan, et al. also teach that electroporation is the most common technique used to incorporated siRNA or miRNA into exosomes because this method destabilizes the vesicle membrane and allows siRNA or miRNA to penetrate vesicles.
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exosome of Tang, et al by loading the IL-10 by electroporation as taught by Luan, et al. because Luan, et al. teach that electroporation is also a technique for loading nucleic acids in exosomes, and teaches that electroporation provides superior loading into exosomes over chemical transfection. Thus, it would be obvious to one of ordinary skill in the art to substitute the method of transfection for the method of electroporation when loading the IL-10 in the exosome, because one of ordinary skill in the art would have been able to carry out such a substitution, and the results would have yielded the predictable result of enhanced loading of the IL-10 in the exosome. The Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the prior art contained a product which differed from the claimed product by the substitution of some component with another component, where both components are known in the art, and one of ordinary skill in the art could have substituted one known element for another to yield predictable results, the substitution of one known element for another would have been obvious.
Applicant Argument’s
A) Applicant argues Tang fails to anticipate the present invention as IL-10 production was stimulated by treating cells with Dexamethasone. Applicant argues the use of dexamethasone would cause negative consequences early child developmental stages to treat pre-term birth.
Response to Argument’s
A) Applicant’s contention that Tang uses dexamethasone to induce and maximize IL-10 production and that dexamethasone is contraindicated in the prenatal setting, is not persuasive. Applicant is claiming a product which is a composition comprising an exosome comprising IL-10. The claims contain no limitation excluding dexamethasone and no limitation directed to the process of manufacture. The manner in which Tang’s cells are stimulated to express IL-10 is a process of making, resulting in the product, which is an exosome comprising IL-10 protein. Whether dexamethasone may be contraindicated for a particular therapeutic does not alter the structure of Tang’s exosome. As such, the rejection is maintained.
New Rejection Necessitated by Applicant’s Amendments
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.
6. Claim 1 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 term “in an amount sufficient to treat” in claim 1 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Conclusion
7. No claims are allowed
8. 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 Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J. ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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