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 .
Priority
This application a 371 of PCT/KR2021/003583 and claims priority to 03/23/2021.
The examiner and art unit assigned to this application has change to Supervisory Patent Examiner Gary Benzion of Art Unit 1681.
Status of the claims
Claims 1 and 2 are newly amended. Claims 3, 4 6, 8, 9 and 15 have been canceled. Claims 5, 7, 10-13, 17-21 have been withdrawn from consideration. Claims 1, 2, 14, and 16 are currently pending.
All rejections or objection not reiterated in this Office Action have been withdrawn.
Claim interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. In regard to the term “cosmetic composition,” the specification does not set forth a limiting definition. A comprehensive, but not limiting definition, is noted at page 13, which states:
When the composition of the present invention is prepared as the cosmetic composition, the composition may be prepared even in any formulation commonly prepared in the art, and may be formulated by, for example, a solution, a suspension, an emulsion, a paste, a gel, a cream, a lotion, a powder, soap, a surfactant-containing cleansing, oil, a powder foundation, an emulsion foundation, a wax foundation, a spray, and the like, but is not limited thereto. More specifically, the composition of the present invention may be prepared in formulations of softener, nourishing toner, nourishing cream, massage cream, essence, eye cream, cleansing cream, cleansing foam, cleansing water, pack, spray or powder.
Therefore, the accepted definition of “cosmetic composition” refers to a mixture or compound suitable for topical application on mammalian skin and or other keratinous tissues. Accordingly, naturally occurring products are encompassed within this definition.
The term “concentrate” is not defined in the specification. In biology, a "concentrate" refers to increasing the amount of a substance in a solution or the intensity of a solution, making it less dilute and more potent. It is not seen how this term, as used in claim 1, “a concentrate of the culture of mesenchymal stem cells” set forth the metes and bounds of the subject matter claimed. Does the term concentrate refer to the dilution of the MSC cells or the properties of the culture medium itself? The specification is silent and thus unhelpful to understand what applicants intended.
New Matter
The amendment filed 9/23/2022 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claim 1 recited the limitation of “a concentrate of the culture of mesenchymal stem cells, first entered in the claims as claim 17 (filed 9/23/2022), and lacking support in the original claims and the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
35 USC 112(b)
Claims 1, 2, 14 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 recites:
A composition comprising mesenchymal stem cells, a culture of mesenchymal stem cells, a concentrate of the culture of mesenchymal stem cells, or an extract of the culture of mesenchymal stem cells, wherein the mesenchymal stem cells are subcultured in the presence of an added culture medium comprising 0.1 to 20% fetal bovine serum (FBS) and one or more mycoplasma inhibitors.
As currently claimed, it is unclear if the composition comprises, in the alternative or as a mixture of some or all of the following components, comprising:
mesenchymal stem cells
a culture of mesenchymal stem cells
a concentrate of the culture of mesenchymal stem cells,
or
an extract of the culture of mesenchymal stem cells
This is confusing as the preamble recites “A composition comprising” but it is indefinite as to what distinguished mesenchymal stem cells from a culture of mesenchymal stem cells or a concentration of the culture of mesenchymal stem cells, as they all comprise mesenchymal stem cells. How does a culture or a concentration differ from mesenchymal stem cells. Further, it is indefinite as to what the metes and bounds of an extract of the culture of mesenchymal stem cells. As claims 2, 14 and 16 depend from claim 1, but do not clarify the metes and bounds of the invention as all refer to the composition of claim 1, and thus are also indefinite. Accordingly, the invention as claimed fails to set forth 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.
35USC 112(a)
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.
Claims 1, 2, 14 and 16 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1, newly amended, recites the limitation of “a concentrate of the culture of mesenchymal stem cells” lack literal support in the specification as originally filed. A search of the specification for the term “concentrate” provides 8 hits, all of which refer to the concentration of the culture media and not a concentration of the culture of mesenchymal stem cells. For example, at page 10 the following recitations is noted:
The active ingredient of the composition for ciliogenesis of the present invention is a mesenchymal stem cell, a culture medium of mesenchymal stem cell or a concentrate thereof, and an extract of the active ingredient, but is not limited.
Accordingly, the specification does not support the limitation and fails to support the written description requirement of 112(a).
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, 2, 14, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more , that is, it is directed to a non‑patentable natural product/phenomenon and lacking an inventive concept. Claim 1 recites, “a composition comprising mesenchymal stem cells, a culture of mesenchymal stem cells, a concentrate of the culture of mesenchymal stem cells, or an extract of the culture of mesenchymal stem cells” and further recites that “the mesenchymal stem cells are sub-cultured in the presence of an added culture medium comprising 0.1 to 20% fetal bovine serum (FBS) and one or more mycoplasma inhibitors.” Regarding claims 14 and 16, which depend from claim 1 and are drawn to the composition of claim 1, where it is a cosmetic composition, and claim 2, wherein the mesenchymal stem cells of claim 1 are derived from various natural naturally occurring sources, these limitations do not distinguish these materials from a product of nature.
This judicial exception is not integrated into a practical application because the claims are recited at a high level of generality without any specific guidance regarding their application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they contain the judicial exception and nothing more.
According to the Manual of Patent Examination Procedure (MPEP) sections 2103 through 2106.07(c), which now incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), October 2019 Patent Eligibility Guidance Update (October 2019 Update), and the Berkheimer Memo, an initial two step analysis is required for determining statutory eligibility. The Supreme Court and Federal Circuit decisions governing patent eligibility require a two‑step framework (Alice/Mayo). Under that framework, the examiner determines (1) whether the claim is directed to a judicial exception (natural phenomenon, natural product, or law of nature), and if so (2) whether the claim elements, considered individually and as an ordered combination, add enough to transform the judicial exception into patent‑eligible subject matter (an “inventive concept”) (see Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. 66 (2012); Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); and USPTO guidance). The following analysis applies that framework to the claims at issue.
Step 1 — Directed to a judicial exception. This step requires a determination of whether the claims are directed to a process, machine, manufacture, or a composition of matter. In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a product.
Claim 1 recites, “a composition comprising mesenchymal stem cells, a culture of mesenchymal stem cells, a concentrate of the culture of mesenchymal stem cells, or an extract of the culture of mesenchymal stem cells” and further recites that “the mesenchymal stem cells are sub cultured in the presence of an added culture medium comprising 0.1 to 20% fetal bovine serum (FBS) and one or more mycoplasma inhibitors.”
Claim 14 recites that the composition is a cosmetic composition. Claim 16 recites that the cosmetic composition is a hair formulation or a skin care formulation. Claim 2 further narrows the source/origin of the mesenchymal stem cells. These claims are directed to biological materials (cells and cell culture products). The claims encompass (i) isolated/removed mesenchymal stem cells and (ii) culture medium/culture products (secreted factors, conditioned medium/concentrates). The claims therefore encompass products that are, in essence, naturally occurring biological entities or naturally occurring secreted products (the MSCs as cellular entities and the secreted factors present in conditioned medium).
Claims directed to natural products or products of nature are judicial exceptions under 35USC § 101 unless the claimed subject matter exhibits marked differences from what exists in nature or otherwise includes an inventive concept that transforms the claim (see Assoc. for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (isolated genomic DNA is a product of nature and not patent eligible); see also In re Roslin Institute (cloned mammals), and Mayo/Alice and follow‑on cases). In Myriad, the Court held that merely isolating naturally occurring genetic material did not render it patent eligible because the isolated DNA retained the same informational content as in nature. Analogously, merely isolating mesenchymal stem cells from a subject, or collecting culture supernatant containing factors secreted by MSCs, are processes that produce biological material whose composition and function originate in nature.
Accordingly, the claimed subject matter is directed to a judicial exception (natural product / natural phenomenon) — namely, isolated MSCs and conditioned medium (products of isolated/cultured biological cells), and the natural phenomenon of ciliogenesis (primary cilium formation) which is a naturally occurring biological process that is observed in target cells.
Step 2— Inventive concept (whether the claims recite significantly more) is a 2-part analysis
Step 2A prong 1, requires a determination of whether the claims are directed towards a judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea, while Step 2A prong 2, requires an analysis of whether the judicial exception integrated into a practical application if the claim recites a judicial exception under Prong 1.
Having determined that the claims are directed to judicial exceptions, the next consideration is Step 2B, whether the claims recite additional elements or an ordered combination that amount to an “inventive concept” sufficient to transform the nature‑based claim into patent‑eligible subject matter (see Mayo/Alice). The claimed additional elements in claim 1 consist of routine culturing parameters (presence of fetal bovine serum and one or more mycoplasma inhibitors, and subculturing), and broadly recited “concentrates” or “extracts” of culture.
In regard to 2B, the specification and claim language indicate that the claimed cells are merely “subcultured” in media containing FBS and mycoplasma inhibitors. These are routine and conventional laboratory steps routinely used by persons skilled in the art for culturing MSCs. The recitation of such conventional procedures does not meaningfully alter the nature of the underlying natural product — the cells remain cellular entities of biological origin and the culture supernatant remains a mixture of naturally secreted biological factors. The claims do not recite structural alterations to the cells (e.g., genetic modification, immortalization, or other alteration that would render the cells “markedly different” from their natural counterparts), nor do they recite a specific, non‑conventional, and non‑routine processing step that meaningfully changes the composition or character of the conditioned medium. See Chakrabarty, 447 U.S. 303 (1980) (genetically modified microorganism that is markedly different from natural form is patent eligible); contrast Myriad and Roslin where products that are not meaningfully altered remain ineligible.
In addition, the claims do not recite a particular, unconventional formulation or a novel chemical entity isolated from the medium that is structurally distinct from natural components; instead, they recite broad categories (“concentrate,” “extract”) and broad FBS ranges (0.1 to 20% FBS) and generic culture additives (“one or more mycoplasma inhibitors”). There is no claim limitation that provides a particular physicochemical modification or otherwise demonstrates that the claimed material is markedly different from what exists in nature. The claims also lack objective, verifiable functional thresholds (for example, specific quantified increases in ciliogenesis metrics) that would tie the claim to a specific practical application beyond reciting the natural phenomenon itself.
As such, the additional elements are routine, conventional, and well‑understood laboratory practices that merely recite the use of natural products obtained by conventional techniques. These elements do not add an inventive concept sufficient to transform the claims into patent‑eligible subject matter (see Mayo; Ariosa/Sequenom, Federal Circuit application of Mayo to diagnostic claims detecting naturally occurring fetal DNA).
The step analysis above indicates that the claims fall within the group of naturally occurring products and that there is inventive concept in claims 1, 2, 14 and 16. Accordingly, the claims are rejected as being ineligible under 35 USC 101.
Prior Art
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 2 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jang Jae-deok et al. (KR 20160002490 A). (English translation provided for your convenience).
Jang Jae-deok et al. teach a composition comprising isolated and culture of stem cells derived from bone marrow, adipose tissue, or umbilical cord blood-derived mesenchymal stem cells, and a stem cell culture medium composition comprising a basal medium is M199 / F12 mixture, MEM- alpha medium, DMEM medium, MCDB 131 medium, IMEM medium, DMEM / F12 medium, the medium composition for stem cell culture is selected from the group consisting of PCM medium and MSC expansion medium. Included in this medium are antifungal agents include amphotericin B and mycoplasma inhibitor and fetal bovine serum (FBS) included in the medium.
Claims 1, 2, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated Kim Il-kwon et al. (KR 20160003512 A) (English translation provided for your convenience).
Kim Il-kwon et al. disclose a culture of mesenchymal stem cell that are derived from bone marrow, tissue, embryo, umbilical cord blood, blood or body fluids. They disclose that stem cells are known to inhibit aging of cells due to harmful environment by stimulating proliferation and secretion of various cell activating substances through continuous cell division during activation and that stem cell culture can be used as a cosmetic to the skin was obtained and the injured hair follicles can be replaced with new hair cells. They disclose that the culture includes FBS and mycoplasma inhibitors. Accordingly, KR 20160003512 anticipate the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gary Benzion whose telephone number is (571)272-0782. The examiner can normally be reached M-F, 8 am to 5pm.
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/GARY BENZION/ Ph.D.Supervisory Patent Examiner, Art Unit 1681