DETAILED ACTION
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. Claims 1-11, 16, 18-21, 26, 29-33, 39, 43, 49, 57 and 61 are pending upon entry of amendment filed on 8/28/25.
In light of Applicant’s response filed on 8/28/25, the restriction requirement mailed on 7/2/25 has been withdrawn.
Claims 1-11, 16, 18-21, 26, 29-33, 39, 43, 49, 57 and 61 are under consideration in the instant application.
3. Applicant’s IDS filed on 8/15/25, 5/1/25 and 5/21/25 (two entries) have been acknowledged.
4. The oath filed on 8/15/22 has been entered.
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-11, 16, 18-21, 26, 29-33, 39, 43, 49, 57 and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that Applicant was in possession of the claimed genus of matrix bound vesicles derived from extracellular matrix.
The guidelines of the Examination of Patent Applications Under the 35 U.S.C. 112, §1 “Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see specially page 1106 column 3).
The instant claims are drawn to a huge genus of structurally distinct matrix derived from the various organs or tissues ([0013-0014]). The matrix has wide ranges of molecular weight and forms. This would encompass powder, liquid, nebulized molecules, as well as vesicles of different ranges of enzymatic profiles and characteristics. Thus, claims would encompass structurally unrelated vesicles derived from extracellular matrix. There is no art recognized correlation between structure and function of such classes of the molecules exhibiting the claimed specific functions. Other than the specification discloses MBV comprises miRNA defined by the SEQ ID NO:1-3 in p. 33), no MBV that may be used in treatment of ARDS as required by the invention. The instant specification does not disclose a correlation between structure of the MBV with the various functions claimed. Further, the disclosed species are not sufficiently representative of the huge genus encompassed by the present claims. Thus, one of skilled in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus of the claimed pharmaceutical compositions. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398.
7. Claims 1-11, 16, 18-21, 26, 29-33, 39, 43, 49, 57 and 61 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating ARDS comprising UBM or MBV derived from BMDM of examples 16-19 of the instant application, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use matrix bound vesicles (MBV) from extracellular matrix in treatment and prevention of ARDS. The currently amended claims are readable upon MBV of any sources and administering the MBV even in treatment of ARDS.
Although Examples 10-15 of the instant specification discloses therapeutic efficacy of MBV derived from urinary bladder matrix, no examples disclose prevention of ARDS from MBV of any other sources. As such, one MBV from urinary bladder matrix in treatment of ARDS cannot be extrapolated treatment or prevention of ARDS by MBV of any source or dose ranges encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. The specification discloses one exemplary MBV from urinary bladder matrix (p. 88-90) but the MBV encompassed by the claims have not been tested for therapeutic efficacy for ARDS. It is unpredictable to develop MBV from any extracellular matrix of any organs in treatment and prevention of ARDS and one exemplary species of MBV disclosed in the example cannot be extrapolated to various formulations encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
8. Claim 33 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “MBV are administered in an amount of 1x106 to 1x10 20 MBV per kg of body weight” or “MBV are administered in an amount of 1x109 to 1x10 14 MBV per kg of body weight” as in items a and c of claim 33. Applicants has not pointed out where the support comes from. At most, the range of 1x106 to 1x10 12 MBV per kg is disclosed in [0016] in the instant application. The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
9. 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 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.
10. 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.
11. Claim(s) 1, 18-21, 29-33, 39, 43, 49, 57 and 61 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by U.S. Pub. 2019/0117837.
The ‘837 publication teaches pharmaceutical compositions comprising matrix bound vesicles (MBV) derived from extracellular matrix (ECM). The MBV is derived from various mammal including human and the human organs include urinary bladder, esophageal tissue and small intestine and the MBV do not express CD63, CD81 markers (claims, p. 7). The In addition, the ‘837 publication teaches administration of infusion, intranasal, intravenous or pulmonary inhalation ([169], p.18). Further, [0161] discloses AIDS associated population group, claim 43 reciting viral infection is included in this rejection.
Although the molecular weight of MBV may vary, the number of MBV particles will be within the ranges of ng/kg to g/kg disclosed in p.15 ([0141-0142]), claim 33 is included in this rejection.
As evidenced by the instant application in Example 2 of the instant application, the MBV of the claimed invention and the MBV of the prior art are produced identically, the molecular weight or characteristics are identical, the administration would result in treatment of ARDS and meets the claimed invention. The reference teachings anticipate the claimed invention.
12. 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 of this title, 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.
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.
13. Claims 1-4, 6-11, 16, 18-21, 26, 29-33, 39, 43, 49, 57 and 61 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub 2018/0125874 in view of U.S. Pub. 2019/0117837 and WO2019/213482 (IDS reference).
The ‘874 publication teaches treatment of ARDS with IL-4 and/or DNA methyltransferase inhibitor including mRNAs (p. 1). IN addition, the patients of ARDS have lung injuries and inflammations, infections including viral infection (p. 2, 7). The treatment of inflammation reduces ARDS. Further, the tissue macrophage including M2 tied with TGF-b result in a diminution of pathological inflammation (p. 17)
The disclosure of the ‘874 publication differs from the instant claimed invention in that it does not teach the use of MBV in treatment of ARDS as in claim 1 of the instant application.
The teachings of the ‘837 publication have been discussed, supra.
The ‘482 publication teaches use of MBV in treatment of inflammation and various other regimen in reduction of inflammation (p.4-7). The ‘482 publication teaches the use of MBV in treatment to toxin (p. 12), viral associated disease and graft-versus host disease (p. 11) and inflammations including pulmonary disease (p. 12). The patient population group overlaps with ARDS and inflammation as in ‘874 and ‘482 publications. Claims 3, 5 and 7 are included in this rejection as the patient populations included viral infections and would be obvious to extend to other virus groups.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize MBVs taught by the ‘837 and ‘482 publications into the treatment of ARDS taught by the ‘874 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of MBV reduces inflammation and the reduction of inflammation is key regimen in treatment of the ARDS.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. No claims are allowable.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
September 25, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641