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 .
Reassignment of Application
Please note that this application has been reassigned to Examiner Ibrahim Bori, in Art Unit 1629. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change.
Preliminary matter:
The Examiner contacted the Applicant's representative (Jongwon Kim, 703-263-9390), to request authorization for an Examiner's amendment to the claims, however, Applicant elects to receive an Office action and discuss the claim amendments later (see attached interview summary).
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed 05/20/2026, 12/01/2025 and 10/01/2025 have been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
Lined-through references fail to comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609 because they are not in English and, despite checking the box indicating an English language translation is attached, there is no indication of the patent number and publication date on each of the translated abstract.
As such, the documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 C.F.R. §1.97(e). MPEP §609.05(a).
Status of the Claims
Claims 1-10 and 13-14 are pending.
Applicant’s arguments, filed on 12/01/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicant’s amendments filed on 12/01/2025, have been entered into the record. Applicant has amended claims 10 and 14. Applicant has cancelled claims 11-12 and 15. Claims 1-9 and 13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Therefore, claims 10 and 14 are subject of the Office action below.
Withdrawn Rejections
The rejection of claims 10, 12 and 14-15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is overcome by the Applicant’s amendments and is hereby withdrawn. For example, Applicant has amended claims 10 and 14 so that claims 10 and 14 no longer recite the limitation “extracellular vesicle”. Applicant has cancelled claims 12 and 15.
The rejection of claims 10 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by:
1) Tang et al of record (Int. J. Molecular Medicine, 2017); and
2) Liang et al of record (Int. J. Nanomedicine, 2018),
is overcome by the Applicant’s amendments and is hereby withdrawn. For example, Applicant has amended claim 10 so that claim 10 no longer recite the limitation “extracellular vesicle”. Applicant has cancelled claims 12.
Maintained Rejections
Claim Rejections - 35 USC § 101
Maintained/New Grounds of Rejection Necessitated by Applicants’ Amendments
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Making reference to the Interim Guidance for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc. 566U.S._132 S.Ct. 1289, 101 USPQ2d 1961 (2012), the Supreme Court made clear that claims that do nothing significantly more than simply describing natural relations are not patentable. For instance, the Supreme Court stated:
“If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction "apply the law." Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float…
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”
In the instant case, the claims are held to be directed to a law of nature, a natural phenomenon, or naturally occurring relation or correlation without significantly more, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101. The rationale for this finding is explained below:
The claim(s) recite(s) a composition comprising exosomes derived from skin fibroblast cells, in which the level of microRNA-26a (miR-26a), is increased.
Based upon an analysis with respect to the claims as a whole, claim 1 is determined to be directed to a law of nature/natural principle. The rationale for this determination is explained below.
1) Is the claimed invention directed to at least one of the four statutory categories (process, machine, manufacture or composition of matter)?
Claim 10 is directed to a composition, specifically a composition comprising exosomes derived from skin fibroblast cells, in which the level of miR-26a is increased. As such, the condition for the first inquiry is met.
2A) Does the claim recite or involve a judicial exception (Abstract Ideas, Laws of Nature/Natural Principles, Natural Phenomena or Natural Products)?
Claim 1 recites naturally occurring exosomes derived from skin fibroblast cells, in which the level of miR-26a is increased. For example, Zhang et al (FASEB J., 2019, 33, 13590-13601), teaches naturally occurring exosomes derived from KEK293 cells, in which the level of miR-26a is increased (see, e.g., “MATERIALS AND METHODS” section on page 13591, page 13594 last ¶ left column through 1st ¶ right column and Figure 4A). As such, the condition for the second inquiry is met.
2B) Does the claim include additional elements/steps or a combination of elements/step that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?).
No. This is because the claimed exosomes naturally produced by skin fibroblast cells are not markedly different from their naturally occurring counterparts, i.e., the exosomes naturally produced by, for example, HEK293 cells. There is no indication on the record that the exosomes naturally produced by skin fibroblast cells have any characteristics that are different from the exosomes naturally produced by HEK293 cells. This judicial exception is not integrated into a practical application because the claims do not apply the claimed composition to any application.
For the reasons of record set forth above, claim 10 is not eligible.
Claim Rejections - 35 USC § 102
New Grounds of Rejection Necessitated by Applicants’ Amendments
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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (hereinafter “Zhang”, FASEB J., 2019, 33, 13590-13601).
By way of a background, Applicant’s invention (see, e.g., pages 1-10 of the specification), is drawn to a method for using miR-26a as a therapeutic option for suppressing muscle loss or promoting myogenesis, and a method for producing exosomes in which the level of miR-26a is increased, by treating skin fibroblasts with a material selected from the group consisting of betaine, a camellia japonica flower extract, camelliaside A, myricetin, naringenin, nobiletin, kojyl carboxy dipeptide-23, L-carnosine and copper tripeptide, or a combination thereof
Claim 10 is directed to a product by process claim, specifically, a composition comprising as an active agent, skin fibroblast-derived exosomes in which the level of miR-26a is increased.
Regarding claim 10, Zhang teaches exosomes in which the level of miR-26a is increased (see, e.g., “MATERIALS AND METHODS” section on page 13591, page 13594 last ¶ left column through 1st ¶ right column and Figure 4A). Similar to the Applicant’s invention (see discussions above), Zhang discloses exosomal miR-26a as a therapeutic option for suppressing muscle wasting and renal fibrosis in obstructive kidney disease (see abstract).
"[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). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) See MPEP 2113.
In the instant case, Zhang teaches exosomes in which the level of miR-26a is increased (see discussions above). Therefore, claim 10 is anticipated by Zhang.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (hereinafter “Wang”, J. Experimental & Clinical Cancer Research, 2019, 38(201), 1-15).
Regarding claim 10, Wang teaches exosomes in which the level of microRNA-26a is increased (see page 6, 3rd ¶ on right column and Figure 3a-b). Similar to the Applicant’s invention (see discussions above), Wang discloses exosomal miR-26a as a therapeutic option for promoting angiogenesis of microvessel endothelial cells in glioma (see abstract).
"[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). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) See MPEP 2113.
In the instant case, Wang teaches exosomes in which the level of miR-26a is increased (see discussions above). Therefore, claim 10 is anticipated by Wang.
Conclusion
Claim 14 claim is allowable.
Claim 10 is rejected
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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