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 .
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.
DETAILED ACTION
Claims 1-17 are pending in this application. This application is a national stage entry of PCT/KR2020/010496, filled on 08/07/2020, which claims foreign priority to KR 10-2019-0095934, filed on 08/07/2019 in Korea.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
Claims 1 and 5-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riordan, I (US 2018/0036348 A1).
Riordan, I meets all of the limitations of claims 1, 5, and 14-16. Riordan, I discloses stem cells from skeletal muscle tissue in form of exosomes (vesicle) (abstract, paragraph 5, and claims 1 and 3). With the stem cells from skeletal muscle tissue disclosed by Riordan, I being the same as claimed, the stem cells from skeletal muscle tissue disclosed by Riordan, I would have the same markers as claimed in the instant claim 5.
With respect to the instant rejection, it is noted that the reference does not teach that the composition can be used in the manner instantly claimed, [cosmetic and for antioxidation or improvement of skin condition … selected from a group consisting of skin aging delay, wound healing, scar reduction and skin whitening in claim 1, pharmaceutical and for preventing or treating a hyperpigmentation disease in claim 14, pharmaceutical and for healing skin wound or reducing scar in claim 15, and pharmaceutical and for inhibiting skin aging in claim 16]; however, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Riordan, I meets all of the limitations of claims 9-13. The instant claim is a product-by-process claim. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. Stem cells from skeletal muscle tissue in form of exosomes (vesicle) disclosed by Riordan, I and extracellular vesicles isolated from skeletal muscle-derived stem cells recited in the instant claim both comprise the same component, thus the product disclosed by Riordan, I would necessarily be the same as the product recited in the instant claim. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed extracellular vesicles isolated from skeletal muscle-derived stem cells resulted from the said process is different from that of stem cells from skeletal muscle tissue in form of exosomes (vesicle) disclosed in the prior art. See MPEP 2113.
Riordan, I meets all of the limitations of claims 6-8. Though Riordan, I does not expressly teach the properties of recited in claims 6-8, as a result of the composition having the same components as claimed, the composition would necessarily have the claimed properties, whether expressly recognized by Riordan, I or not. Please refer to MPEP 2112.01 II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 1 and 5-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rudnicki et al. (US 2014/0221466 A1).
Rudnicki et al. meet all of the limitations of claims 1 and 14-16. Rudnicki et al. disclose a commotion comprising 0.05-99% by weight of satellite cells (stem cells from skeletal muscle) in form of vesicle (paragraph 5, 140, and 142 and claim 17 and 18).
With the stem cells from skeletal muscle tissue disclosed by Rudnicki et al. being the same as claimed, the stem cells from skeletal muscle tissue disclosed by Rudnicki et al. would have the same markers as claimed in the instant claim 5.
With respect to the instant rejection, it is noted that the reference does not teach that the composition can be used in the manner instantly claimed, [cosmetic and for antioxidation or improvement of skin condition … selected from a group consisting of skin aging delay, wound healing, scar reduction and skin whitening in claim 1, pharmaceutical and for preventing or treating a hyperpigmentation disease in claim 14, pharmaceutical and for healing skin wound or reducing scar in claim 15, and pharmaceutical and for inhibiting skin aging in claim 16]; however, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Rudnicki et al. meet all of the limitations of claims 9-13. The instant claim is a product-by-process claim. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. Stem cells from skeletal muscle in form of vesicle disclosed by Rudnicki et al. and extracellular vesicles isolated from skeletal muscle-derived stem cells recited in the instant claim both comprise the same component, thus the product disclosed by Rudnicki et al. would necessarily be the same as the product recited in the instant claim. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed extracellular vesicles isolated from skeletal muscle-derived stem cells resulted from the said process is different from that of stem cells from skeletal muscle tissue in form of vesicle disclosed in the prior art. See MPEP 2113.
Rudnicki et al. meet all of the limitations of claims 6-8. Though Rudnicki et al. do not expressly teach the properties of recited in claims 6-8, as a result of the composition having the same components as claimed, the composition would necessarily have the claimed properties, whether expressly recognized by Rudnicki et al. or not. Please refer to MPEP 2112.01 II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
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, 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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, 2, and 5-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Riordan, I (US 2018/0036348 A1) in view of Carmeliet et al. (US 7,105,168 B1).
The teachings of Riordan, I are discussed above and applied in the same manner.
Riordan, I does not specify the skeletal muscle including orbicularis oculi muscle in the instant claims 2 and 17.
This deficiency is cured by Carmeliet et al. who teach skeletal muscle including orbicularis oculi muscle (the paragraph bridges column 8 and 9).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Riordan, I and Carmeliet et al. to specify skeletal muscle taught by Riordan, I including orbicularis oculi muscle. Skeletal muscle including orbicularis oculi muscle was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1, 3, and 5-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Riordan, I (US 2018/0036348 A1) in view of Rohde et al. (Manufacturing and characterization of extracellular vesicles from umbilical cord derived mesenchymal stromal cells for clinical testing, Cytotherapy, June 2019; 21: 581 592).
The teachings of Riordan, I are discussed above and applied in the same manner.
Riordan, I does not specify the size of exosomes (vesicle) in the instant claim 3.
This deficiency is cured by Rohde et al. who teach extracellular vesicles having particle size of about 50-150 nm (the paragraph under “Introduction”).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Riordan, I and Rohde et al. to specify size of exosomes taught by Riordan, I being about 50-150 nm. Extracellular vesicles having particle size of about 50-150 nm was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1 and 4-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rudnicki et al. (US 2014/0221466 A1).
The teachings of Rudnicki et al. are discussed above and applied in the same manner.
Rudnicki et al. do not specify the same concentration of satellite cells (stem cells from skeletal muscle) in form of vesicle (0.05-99% by weight → about 0.5-990 µg/mL vs the claimed 5-100 µg/mL in the instant claim 4).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of concentration of stem cells from skeletal muscle is 5-100 µg/mL and the range of concentration of satellite cells taught in the prior art is about 0.5-990 µg/mL and therefor, includes the claimed range.
Claims 1, 2, and 4-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rudnicki et al. (US 2014/0221466 A1) in view of Carmeliet et al. (US 7,105,168 B1).
The teachings of Rudnicki et al. are discussed above and applied in the same manner.
Rudnicki et al. do not specify the skeletal muscle including orbicularis oculi muscle in the instant claims 2 and 17.
This deficiency is cured by Carmeliet et al. who teach skeletal muscle including orbicularis oculi muscle (the paragraph bridges column 8 and 9).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Rudnicki et al. and Carmeliet et al. to specify skeletal muscle taught by Rudnicki et al. including orbicularis oculi muscle. Skeletal muscle including orbicularis oculi muscle was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1 and 3-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rudnicki et al. (US 2014/0221466 A1) in view of Rohde et al. (Manufacturing and characterization of extracellular vesicles from umbilical cord derived mesenchymal stromal cells for clinical testing, Cytotherapy, 2019; 21: 581 592).
The teachings of Rudnicki et al. are discussed above and applied in the same manner.
Rudnicki et al. do not specify the size of vesicle in the instant claim 3.
This deficiency is cured by Rohde et al. who teach extracellular vesicles having particle size of about 50-150 nm (the paragraph under “Introduction”).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Rudnicki et al.and Rohde et al. to specify size of vesicle taught by Rudnicki et al. being about 50-150 nm. Extracellular vesicles having particle size of about 50-150 nm was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614