DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7 are pending.
This application is a 371 filing of PCT/KR2022/006996 filed 5/16/2022 which claims priority to foreign applications KR10-2021-0063593 filed 5/17/2021 and KR10-2021-0135996 filed 10/13/2021. None of the foreign documents are in English. Therefore, applicant cannot rely upon the foreign priority papers to overcome this rejection until a translation of said papers has been made of record in accordance with 37 CFR 1.55. See MPEP § 201.15. Therefore, the effective filing date is 5/16/2021.
Information Disclosure Statement
An IDS filed 11/17/2023 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. In the case that only an English abstract was identified, these references have been considered only on the basis of the provided English abstracts.
Specification
The disclosure is objected to because of the following informalities: on page 2, ¶3, the statement “First of all, it is difficult to dermal papilla cells isolate from the scalp, the culture conditions are strict, and it is difficult to culture a sufficient amount of cells” is grammatically incorrect. This should be corrected to “First of all, it is difficult to isolate dermal papilla cells from the scalp, the culture conditions are strict, and it is difficult to culture a sufficient amount of cells”. As well, on page 10, ¶ 3, mRNA is misspelled in the last sentence.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 1-6 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.
The claims are drawn to a genus of methods. The method is drawn to taking isolated scalp dermal papilla cells and culturing the cells under “hypoxic” conditions and “attaching” the cells to a culture plate. As a first issue, the method is drawn to isolating the cells but no step exists for this step. The second issue is that the cells are cultured under hypoxic conditions. Finally, the claims recite “attaching” the dermal papilla cells to a culture plate. But, this appears to be consequence of simply culturing the cells wherein the practitioner does not attach the cells.
The written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
Dermal papilla cells are mesenchymal stem cell derived (see page 1, ¶ 2). Applicants demonstrate (see figure 2) improved attachment rates of dermal cells when culturing occurs in hypoxic vs normoxic conditions. The disclosure teaches that “ it is difficult to isolate dermal papilla cells from the scalp, the culture conditions are strict, and it is difficult to culture a sufficient amount of cells’”. Applicants advance the art by developing means to increase attachment thus shortening the period of establishing dermal papilla cells in culture. This method starts with isolation of scalp tissue in a Petri dish and hair follicles isolated (example 1 and 2). Cells were separated from the tissue and cultured was incubated under normoxic conditions (5 % CO₂: 21 % O₂) and hypoxic conditions (5 % CO₂: 2% O₂) at 37 °C. The period for attachment for cells under normoxic cells was 12 days and for hypoxic cells 5 days less (hence 7 days). The immune response appears reduced by demonstration of recured expression of HLA-A, HLA-B, CD55, IL-1RA and CCL2 which would promote enhanced allogeneic transplantation.
Hence, the method as disclosed more specifically teaches plating a hair follicle to form dermal papilla tissue in vitro which was cultured thereafter in follicle dermal papilla cell growth media at 5 % CO₂: 2% O₂ at 37 °C for 7 days wherein the cells attached to the cell culture plate.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR20190127553 as evidenced by Papilla Cells (Promocell, downloaded 2/4/2026) and evidenced by Chen et al (J Clin Lab Anal. 2019, pages 1-7).
KR20190127553 teaches culturing of hair dermal papilla cells. The instant claims recite the cells are isolated from scalp. The reference teaches that the dermal papilla cells are from Promocell which as evidenced by Promocell are isolated form the scalp (see ¶1 of page 1). The cells are cultured under hypoxic conditions (see page 2, first line under Description).
As recited in claim 2 and 3, this is 2% (see page 5, ¶3).
As to claim 4, Figure 9 (reproduced below) demonstrates that at 6 days, the hypoxic cells have attached and formed a spheroid but the normoxic grown cells do not indicating that at least 5 days or more shortening period for attachment.
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These genes are differentially regulated.
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The art teaches that VEGFA inversely regulates IL-1RA (Chen, 2019, pages 1). Hence, its upregulation will lead to reduction of IL-1RA which means the cells are immunocompatible as recited in claims 5 and 6.
Therefore the cells of KR20190127553 are those of claim 7.
Conclusion
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/MARIA MARVICH/Primary Examiner, Art Unit 1634