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 .
DETAILED ACTION
This application is in response to the Appeal Brief filed on August 26, 2025. Claims 4-9 are currently pending as per claims filed on October 18, 2024, of which claims 1-3 have been cancelled, and claims 4 has been amended. No new claims have been added.
Applicant is advised that the prior Office Action mailed on December 31, 2024 is vacated in favor of a new office action. An Appeal Brief meeting was conducted on February 26, 2026 in which Examiner Michael Riga, Primary Examiner Maria Leavitt, and Primary Examiner Bennett Celsa discussed the current status of the instant application in view of the remarks/arguments set forth in the Appeal Brief by Applicant. The consensus was to re-open prosecution as described herein:
In view of the appeal brief filed on August 26, 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
Therefore, claims 4-9 are currently under examination to which the new grounds of rejection are applicable.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Republic of Korea Patent Application No. 10-2020-0011970 filed on January 31, 2020 and PCT Application No. PCT/KR2020/013108 filed on September 25, 2020. Receipt is acknowledged of untranslated certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application Thus, the earliest possible priority for the instant application is January 31, 2020.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment to the claims dated October 18, 2024, wherein claim 4 has been amended, the rejection to claims 4-6, and 8 rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. in view of Furno et al. Zhou et al., and Kwack et al, have been withdrawn.
In view of Applicants’ amendment to the claims dated October 18, 2024, wherein claim 4 has been amended, the rejection to claims 5, 7 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. in view of Furno et al. Zhou et al., and Kwack et al further in view of Leiros et al., have been withdrawn.
The withdrawn rejections are in view of the Appeal Brief filed August 26, 2025 in which the Applicant has argued in view of claim 4 that the starting cell types are not the same, the differentiation media are not disclosed or suggested in combination with the references, the claimed gene expression outcome is not taught or suggested by the prior art, unexpected results are provided in the instant application, and the advantages of using AD-MSC at the start of the method supports non-obviousness.
In view of Applicants’ amendment to the claims dated October 18, 2024, wherein claim 4 has been amended, the rejection to claims 5, 7, and 9 under 35 U.S.C. 103 as being unpatentable over Veraitch et al. in view of Furno et al., have been withdrawn.
Applicants' arguments are moot in view of the withdrawn rejections. A response to any argument pertaining to a new or maintained rejection can be found below
New Grounds of Rejection
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.
Claim 4 is newly 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 4 is indefinite based on the claim reciting “A method for inducing differentiation of human adipose-derived mesenchymal stem cells into dermal papilla cells,” yet, the claim does not recite a step or rather limitation that dermal papilla cells are obtained by the claimed process.
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 5-9 are newly rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
Claims 5-9 all consist of a composition comprising the dermal papilla cells differentiated from human adipose-derived stem cells by the method according to claim 4.
This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well-understood, routine and conventional in cell biology. Furthermore, the claimed dermal papilla cells (DP) differentiated from human adipose-derived stem cells are not structurally different from the DP found in nature despite claiming a process by which they are made. The process by which the composition is obtained does not weigh on the structure of the composition. In reference to claims that are directed to a method of treatment, the claims do not recite any steps other than administering the DPs to a subject in need thereof, and moreover additional elements of the composition that comprises DP than what is naturally occurring.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
Step 1:
With regard to claims 5-7 the claims are directed to cosmetic or pharmaceutical compositions that comprise the DP, which are considered the statutory category of a composition of matter. With regard to claims 8-9, the claims are directed to a method of treatment, which are considered the statutory category of a process. Accordingly, the requirements of Step 1 are met.
Step 2A, Prong One:
Regarding Step 2A Prong One, claims 5-7 are directed to a natural phenomena (product of nature) based on the lack of elements that would differentiate the “dermal papilla cells differentiated from human adipose-derived stem cells” from a non-natural product. Claims 8-9 are directed to a method of treatment with the DP; and based on the only step being “administer” without other additional elements these claims are also directed to a natural phenomena (product of nature) based on the composition being similar.
Step 2A, Prong Two:
The judicial exception is not integrated into a practical application based on claims 5-7 not reciting additional elements of the compositions that would integrate into a practical application. Furthermore, in view of claims 8-9 the step of administering is considered routine and well-known; and is currently recited broadly wherein in no particular method steps are recited to show otherwise.
Step 2B:
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated above (see Step 2A prong one above), there are no additional elements recited.
Judicial Exception – Conclusion
Therefore, the claims are directed to a natural product without significantly more that is not integrated into a practical application, does not include elements that amount to significantly more than the natural product, and does not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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.
(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 5-9 are newly rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by (Armani et al. (US 2011/0305671 A1).
Claims 5-7 are anticipated by Armani et al. based on the teaching of a composition that comprises dermal papilla cells (abstract), and the claims being limited to a composition comprising dermal papilla cells. The claims recite “the dermal papilla cells differentiated from human adipose-derived stem cells by the method according to claim 4”, yet the process of derivation has no weight on the structure of the obtained composition when the structure is the same as the prior art. In the instant case, the compositions recited in claims 5-7 only recite the dermal papilla cells, and these cells are expected to be structurally the same as the dermal papilla cells taught by Armani despite the process of derivation being different.
Claims 5-7 are considered product-by-process claims. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”; “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 111 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 8-9, Armani teaches the method comprising administering a composition for promoting hair growth or preventing hair loss, wherein the composition is administered to a skin of the subject (abstract, claim 1, par 0040).
Conclusion
Proposed Amendments:
The limitations recited in claim 4 should be integrated into claim 8, e.g. steps of differentiation steps, with additional steps related to administering the produced DP cells to overcome the 35 USC 101 & 102 rejections. Furthermore, the preamble to claim 4, should be amended to “A method of treatment,…” based on the present claim not currently reciting the end product as being dermal papilla cells, despite the present preamble stating as such; or , the claim should be amended to include such step as obtaining dermal papilla cells at the end of differentiation.
Claims 4-9 are rejected. No claims are allowed.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Prosecution Insights