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 1-6 are pending and under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/TR2023/050468, filed on 05/24/2023; which claims priority from Turkey Patent application TR2022/008499, filed on 05/25/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/08/2024 is being considered by the examiner.
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 1-4 and 6 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 1 appears reciting a process without citing any step involved in the process, and thus, it is not a proper process claim and indefinite. MPEP 2173.05(q).
Claims 2-4 and 6 are “use” claim without citing any step involved in the process, and thus, they are not proper process claim and are indefinite. MPEP 2173.05(q).
Claim Rejections - 35 USC § 101
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because Claim 1 reciting a process without citing any step involved in the process is not a proper process claim; thus, it is not one of useful process, machine, manufacture, or composition of matter. Claims 2-4 and 6 being “use” claim without citing any step involved in the process are not proper process claim, thus, are not one of useful process, machine, manufacture, or composition of matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). MPEP 2173.05(q).
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 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Camussi et al. (WO2020182938).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Camussi et al. teaches a composition comprising a population of plant-derived extracellular vesicles (EVs) having a diameter ranging from 10 to 500 nm and showing pro-angiogenic, and anti-bacterial activity, for use in therapeutic applications (abstract). Extracellular vesicles (EVs) are a heterogeneous population of particles released by virtually all living cells. They have been purified from nearly all mammalian cell types and body fluids, as well as from lower eukaryotes, prokaryotes and plants. They mainly include microvesicles, released through the budding of the plasma membrane, and exosomes, derived from the endosomal compartment. Extracellular vesicles are referred to as “particles”,“microparticles”,“nanovesicles”,“microvesicles” and “exosomes” (page 1, line 10-15). The plant-derived extracellular vesicles (EVs) are derived from Ginkgo biloba (claims 1 and 8-9). The isolation of extracellular vesicles (EVs) from plant is also recited (page 19, line 5-20). The composition may be formulated in the form of tablet (page11, line 10-15).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Camussi et al. is that Camussi 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.
Camussi et al. teaches Extracellular vesicles (exosomes) derived from Ginkgo biloba as well as steps to make exosomes from plants. The limitation of “used in the treatment of Alzheimer's disease, cognitive dysfunction, forgetfulness and poor concentration disorders” is intended use, not limiting.
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 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US20230096790).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kim et al. teaches A method for preventing, alleviating, or treating cognitive impairment, the method comprising a step of administering to a subject at least one selected from the group consisting of a neprilysin-overexpressing stem cell, a conditioned medium thereof, and an exosome isolated therefrom, wherein the cognitive impairment is dementia, Alzheimer's disease, senile dementia, pre-senile dementia, Parkinson's disease, Huntington's disease, mild cognitive impairment, cerebral amyloid angiopathy, Down syndrome, amyloid stroke, vascular stroke, systemic amyloid disease, Dutch type amyloidosis, Niemann-Pick disease, multiple sclerosis, Lewy body dementia, Creutzfeldt-Jacob disease or frontotemporal dementia (claims 1 and 6). The exosome isolated is derived from ginseng ([0016-0017, 0059-0060]). The pharmaceutical composition comprising exosome is in the form of tablet in one embodiment ([0041]).
Since US20230096790 claims priority from KR10-2021-0129385 (filed on 09-30-2021) which recites exosomes derived ginseng treating Alzheimer's disease, Kim et al. is properly relied on as prior art in the 103 rejection.
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 that 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.
Regarding claims 2-4, Kim et al. teaches a method of treating cognitive impairment, dementia and Alzheimer's disease by administration of a composition comprising exosomes derived from ginseng.
Regarding claim 6, Kim et al. teaches the composition in the form of tablet.
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 clim 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