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 16-24 are pending and under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/KR2023/000838, filed on 01/18/2023; which claims priority from Korean patent application KR10-2023-0006807, filed on 01/17/2023; and KR10-2022-0008554, filed on 01/20/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/2024 and 09/10/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 16-19, 21-24 is/are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Kim et al. (KR102337998B1).
The limitation of claims 16, 18-19, 21-22 and 24 are met by Kim et al. disclosing a method of treating inflammatory bowel disease disorder such as ulcerative colitis with administration of pharmaceutical composition comprising endoplasmic reticulum derived from Roseburia faecis strain or lysate (title; abstract, claims 1-7). According to applicant’s specification (page 15, 3rd paragraph), endoplasmic reticulum is equivalent to extracellular vesicle.
Regarding claim 17, the limitation is met by Kim et al. disclosing endoplasmic reticulum with size of about 20nm to 200nm (page 2, 2nd paragraph).
Regarding claim 23, this is considered as inherency of prior art composition. Since prior art disclosing the same claimed composition, this same composition must have the same properties.
Claim(s) 16-17, 20-24 is/are rejected under 35 U.S.C. 102 (a)(1) & (a)(2) as being anticipated by Kim et al. (Kim 2 thereafter, KR102296285B1).
The limitation of claims 16, 20-22 and 24 are met by Kim2 disclosing a method of treating inflammatory bowel disease disorder such as ulcerative colitis with administration of pharmaceutical composition comprising endoplasmic reticulum derived from Bifidobacterium breve strain or lysate (title; abstract, claims 1-7). According to applicant’s specification (page 15, 3rd paragraph), endoplasmic reticulum is equivalent to extracellular vesicle.
Regarding claim 17, the limitation is met by Kim2 disclosing endoplasmic reticulum with size of about 20nm to 200nm (page 2, 1st paragraph).
Regarding claim 23, this is considered as inherency of prior art composition. Since prior art disclosing the same claimed composition, this same composition must have the same properties.
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 16-19, 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR102337998B1).
In arguendo that Kim et al. does not anticipate, the claimed invention is still obvious.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kim et al. teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kim et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
The limitation of claims 16, 18-19, 21-22 and 24 are met by Kim et al. teaching a method of treating inflammatory bowel disease disorder such as ulcerative colitis with administration of pharmaceutical composition comprising endoplasmic reticulum derived from Roseburia faecis strain or lysate (title; abstract, claims 1-7). According to applicant’s specification (page 15, 3rd paragraph), endoplasmic reticulum is equivalent to extracellular vesicle.
Regarding claim 17, the limitation is met by Kim et al. teaching endoplasmic reticulum with size of about 20nm to 200nm (page 2, 2nd paragraph).
Regarding claim 23, this is considered as inherency of prior art composition. Since prior art disclosing the same claimed composition, this same composition must have the same properties.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 16-17, 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Kim 3 thereafter, WO2021242056).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kim3 teaches a method of treating inflammatory bowel disease disorder such as ulcerative colitis with administration of pharmaceutical composition comprising endoplasmic reticulum derived from Bifidobacterium breve strain or lysate (title; abstract, claims 1-20)
Regarding claim 17, the limitation is met by Kim3 teaches endoplasmic reticulum with size of about 20nm to 200nm (page 2, 7th-9th paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and xxx is that xxx do not expressly teach xxx. This deficiency in xxx is cured by the teachings of xxx.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
The limitation of claims 16, 20-22 and 24 are met by Kim3 disclosing a method of treating inflammatory bowel disease disorder such as ulcerative colitis with administration of pharmaceutical composition comprising endoplasmic reticulum derived from Bifidobacterium breve strain or lysate. According to applicant’s specification (page 15, 3rd paragraph), endoplasmic reticulum is equivalent to extracellular vesicle.
Regarding claim 17, the limitation is met by Kim3 disclosing endoplasmic reticulum with size of about 20nm to 200nm.
Regarding claim 23, this is considered as inherency of prior art composition. Since prior art disclosing the same claimed composition, this same composition must have the same properties.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613