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 .
This office action is in response to an amendment filed 6/8/2026. New claims 8-13 have been added. Therefore, claims 1-13 are pending.
Claim 1 has been amended without margins to change “A method” to “The method”. Amendments must be accompanied by strike through for deletions and underlining” under 37 CFR 1.121. In lieu of a non-compliant memo, the claims will be examined herein.
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 5/16/2022.
Information Disclosure Statement
An IDS filed 6/8/2026 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action.
Response to Amendments
The objections to the disclosure are overcome by applicants’ amendments.
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: it is newly noted that abbreviations found in claim 6 should be spelled out. Although claims are allowed abbreviations, if an abbreviation is not spelled out upon first use in a claim, MPEP §2429 states that Applicant only use abbreviations that are specifically defined in "WIPO Standard ST.25 (1998)" or that are well known and would be clear to someone who had not read the invention description.
Appropriate correction is required.
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 and 8-13 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. These are new rejections necessitated by applicants’ amendment.
Claim 1 recites the limitation "The method for isolating and culturing dermal papilla cells" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the scalp” in line 3. There is insufficient antecedent basis for this limitation in the claim. The dependent claims are included in the rejection because they fail to address or clarify the basis of the rejection as discussed in detail for the independent claims.
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 1-7 and 12 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. This rejection is maintained for reasons of record wherein newly added claim 12 is included for reasons below.
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 preamble recites a method to isolating and culturing the cells but no step related to isolation is provided only culturing. 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.
New claim 12 is rejected because the claim simply refers to physical properties of the immunocompatible dermal papilla cells (that they inhibit the expression of any one or more mRNAs selected from the group consisting of HLA-A, HLA-B, CD55, IL-1RA and CCL2). This is a limitation claimed as a functional property wherein the only mention made appears to indicate this is an inherent property (see e.g. ¶0015).
(MPEP 2163.03(v)While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.”Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
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.
Response to Arguments
Applicants argue in the reply filed 6/8/2026 that the method of claim 1 does not require a step of isolating but that the cells are already isolated from the scalp as a starting point. Applicants argue that the cells are isolated from the scalp as a product by process. This argument is not persuasive. The claim as recited is,
(ORIGINAL) The method for isolating and culturing dermal papilla cells, comprising culturing dermal papilla tissue isolated from the scalp under hypoxic conditions and attaching the dermal papilla cells to a culture plate.
Now, without the requirement in the preamble and due to the lack of steps, the cells can be considered for analysis as product by process. However, the claims require a step of isolating that is currently required of the claims that is not present in the claim. As to the teaching in the disclosure, the teachings are that donor scalp is collected and plated so that hair follicles could be 8isoatedl and dermal papilla tissue cut out. It is noted that the methods require isolating dermal papilla cells and while the claims can be read in light of the disclosure but this does not allow for limitations to be read into the claims especially critical elements such as how the required step of isolating is to be accomplished.
The second issue is that the cells are cultured under hypoxic conditions. Applicants argue that the specification defines hypoxic conditions. However, the specification as provided by applicants identifies some potential hypoxic conditions (may have, preferably may have). The disclosure does not define the term but provides a very narrow potential representative of the hypoxic condition. Again, while life can be breathed into the claims, limitations from the disclosure cannot be read into the claims. The definition online for hypoxic is: characterized by reduced levels of dissolved oxygen. Under 112a, the specification must reasonably convey that the inventor was in possession of the full, generic scope recited in the claims at the time of filing, and it must enable a person skilled in the art to practice the entire claimed scope without undue experimentation.
Finally, the claims recite “attaching” the dermal papilla cells to a culture plate. Applicants argue that the disclosure supports this step. Literal support for the words in the claims does not in and of itself make the claim sufficiently supported. The step in the claims is “and attaching the dermal papilla cells to a culture plate”. This literally means the practitioner is attaching the cells. However, the steps required of this even as applicants provide documentary support is –culturing the cells such that the dermal papilla cells attach to the culture plate--. There is no physical attaching by the person culturing the cells, it is a consequence of a step performed by the practitioner but is not in itself performed by the practitioner. The means otherwise is not disclosed in the specification.
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 and 13 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 from 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, page 1). Hence, its upregulation will lead to reduction of IL-1Ra which means based on the disclosure the cells are defined as immunocompatible i.e. reduced IL11 and this meets the limitations of claims 5 and 6.
Therefore, the cells of KR20190127553 are those of claim 7 and 13.
Response to Arguments
Applicants argue in the reply filed 6/8/2026, that KR20190127553 teaches that the cells are not dermal papilla tissue isolated from the scalp but cells previously isolated and established. Applicants allege that the attachment step, therefore, has already occurred before the hypoxic culturing begins. As to claim 6, applicants argue that the relationship between IL-1RA and VEGF in cancer cells cannot be expected to be the same in the dermal papilla cells and furthermore that this is but one of the listed molecules. This argument is extended to the immunocompatible cells of claim 7 which would then require the characteristics of claim 6. Furthermore, applicants argue that the cells of claim 7 are not produced by the method of claim 1.
Beginning with the argument based on the nature of the starting cells, the instant claims as applicants have stated above in response to the rejection based upon 112a are drawn to a product by process set of cells. As recited in the claims, the dermal papilla tissue isolated from scalp is the starting point of the cells of KR20190127553. The promocells are primary cells and are isolated form scalps. Applicants argue that the cells are by being pre-cultured already attach. However, this is not apparent from the KR20190127553 teachings and furthermore not disallowed of the cells. The claims simply recite isolating dermal papilla cells form tissue, culturing under hypoxic conditions and attaching the cells to the plate. These components are all met by these teachings
Human dermal papilla cells (hDPC) derived from PromoCell were grown on Follicle Dermal Papilla cell growth media (Promocell, Heidelberg, 1%) containing 1% Antibiotic and Antimycotic Hyclone sv30079.91. Germany) was inoculated in the medium and cultured in a 5% carbon dioxide incubator at 37 ℃ prepared cells. HDPC prepared in 6-well was inoculated in Follicle Dermal Papilla cell Growth media at 1Х10 4 / well concentration, and further incubated for 3 days under low oxygen conditions with 1-5% oxygen partial pressure.
These results are shown in Figure 1 which demonstrates attachment.
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If applicants reading of the cells is to be followed, the claims are not limited to a single attachment step.
As to claims drawn to claim 6 and hence claim 7 and 13, it is first noted that the claims only require a single mRNA expression level be evaluated. To this end, applicant allege but provide no evidence that this mechanism would only function in cancer cells. “The arguments of counsel cannot take the place of evidence in the record.” (MPEP 716.01(c)). Evidence has been put forth and needs to be proven incorrect and not just asserted. Given that the claimed steps are the same one would expect the product to also be the same. As to the immunocompatible state of the cells, the cells are evaluated based upon the product made. The immunocompatible nature is a property applicants assert of the cells to have a reduced immune response. The method of making starts with dermal papilla cells and involves hypoxic culturing. There are not other steps and hence one would expect the product to have the same properties absent a step that appears to lead to different imunocompatible properties.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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