DETAILED ACTION
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 .
Claims 1-15 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-5) in the reply filed on 08/10/2026 is acknowledged. Claims 6-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/10/2026.
Claims 1-5 were examined on their merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The preamble of Claim 1 recites, “an in vitro method of generating hair follicle stem cells”, this has been construed as a statement of purpose or intended use and has been evaluated to determine whether the recited purpose or intended use results in a manipulative difference between the claimed invention and the prior art. See the MPEP at 2111.02, II.
For purposes of examination the claim limitation has been construed as being met by any in vitro (lacking a definition in the disclosure, the term has been given its’ broadest, reasonable interpretation of occurring outside the living body) culturing of any epithelial cells with atRA and any PKC inhibitor.
Claim 4 contains an optional limitation. The broadest, reasonable interpretation of an optional limitation is that it is not required and the claim has been construed thusly.
Claim Rejections - 35 USC § 112
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 1-5 are rejected under 35 U.S.C. § 112, 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(s), at the time the application was filed, had possession of the claimed invention. The claim encompasses a method comprising culturing epithelial cells in a cell culture medium comprising all-trans-retinoic acid (atRA) and a calcium-dependent protein kinase C inhibitor (PKCi). The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See the MPEP at § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe the subgenus. In re Gostelli, F.2d at 1012, USPQ2d at 1618.
As stated supra, the MPEP states that the written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable, that Claim 1 is broadly generic, with respect to all possible epithelial cells and PKC inhibitors.
The variations as generically disclosed in the specification are limitless, and examples reflecting the variety of possible species in the genus are not provided.
For example, epithelial cells are found in such diverse tissues as: lung alveoli, kidney, stomach, bladder, esophagus, sweat gland, skin, salivary duct, trachea and the intestine. The disclosure only refers to “epithelial cells” in a generic manner, see the published disclosure at Paragraphs [0008] and [0039], and there is no indication in the disclosure that treatment of any particular specific type of epithelial cell (such as stomach epithelium) with atRA and a PKC inhibitor will necessarily result in generation of hair follicle stem cells. Further, the disclosure refers to a generic PKC inhibitor at Paragraphs [0008], [0039], [0067] but only discloses two PCK inhibitors (Gö6976 and Gö6983) at Pg. 10, Table A and Paragraph [0112] and there is no indication in the disclosure that treatment of any particular specific type of epithelial cell (such as stomach epithelium) with atRA and any PKC inhibitor will result in generation of hair follicle stem cells. The Examiner notes that Ding et al. (2011) at Pg. 163, Table I discloses 26 known PKC inhibitors of which only Gö6976 is disclosed in the instant Specification. Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonable convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Claims 2-5 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the lack of written description thereof.
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 1-5 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. Claim 1 is drawn to a method of generating hair follicle stem cells (HFSC) by culturing epithelial cells in a culture medium comprising all-trans retinoic acid (atRA) and a protein kinase C (PKC) inhibitor. However, the disclosure appears to require the epithelial cells be keratinocytes, which are initially cultured in FBS media comprising many other components (including a steroid, buffers and growth factors) in specific amounts, as well as specific amounts of atRA and the PKCi Go-6976 for 7 days before replacement with serum-free medium supplement B-27 containing specific amounts of other components (Pg. 11, Table B and Paragraph [0112]). Only under these specific conditions do the differentiated epithelial cells (keratinocytes) appear to take on an HFSC aspect. However, as discussed above, the claims are much broader than what is disclosed and therefore it cannot be determined how Applicant intends to limit the method by the addition of the functional result, “to thereby…” as claimed.
Since, it is improper to import into a claim specification limitations which are not part of the claim, see the MPEP at 2111.01, II., and having no understanding how Applicant means to limit the claim by indicating the result of the broadly recited method steps, the claims have been construed as being met by any culturing of any epithelial cells in a culture medium comprising all-trans retinoic acid (atRA) and a protein kinase C (PKC) inhibitor. Claims 2-5 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
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.
Claims 1-5 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Berardi et al. (2021), of record, as evidenced by Yamamoto et al. (2017).
Berardi et al. teaches culturing epithelial cells (LM38-LP composed of subpopulations of luminal epithelial and myoepithelial cells) and HCC38 (comprising epithelial cells, see Yamamoto et al., Pg. 1210, Abstract) (Pg. 2, Materials, 2nd paragraph) with a serum-free DMEM-F12 medium supplemented with B27 without Vitamin A, atRA and Gö6976, and reading on Claims 1, 2, 3, 4 and 5.
With regard to Claim 1, the preamble was evaluated to determine whether the recited purpose or intended use results in a manipulative difference between the claimed invention and the prior art. As the prior art anticipates the recited method step, no manipulative difference between the claimed invention and the prior art.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 08/25/2026
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