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 field 8/6/2026.
Claims 1-5 are pending.
This application has no priority document. Therefore, the effective filing date is 3/21/2024.
Response to Amendments
Applicants arguments are sufficient to overcome the rejection under 35 USC 112, second. The rejection under 35 USC 112, first paragraph has been maintained in part as set forth below.
The Declaration under 37 CFR 1.130(a) filed on 8/6/2026 is sufficient to overcome the rejection of claims 1-5 based on Nizuma et al.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 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(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.
Due to applicants' amendment, the main issues that lead to a rejection under 35 USC 112, first paragraph for lack of enablement have been overcome. The remaining issue cited here is more properly a rejection under 35 USC 112, first paragraph for lack of written description. The previous inclusion in the enablement rejection was due to a number inoperable embodiments that made the ability to perform the invention unpredictable. Applicants' amendment has not overcome the basis of this rejection and their arguments have not addressed this issue.
That the claims are drawn to the cells produced by a particular method does not narrow the end product.
The instant claims are drawn to regenerative therapy in which cells are used to treat hair damage which is further claimed to be gray hair, hair loss and thinning hair. The claims recite that the cell therapy requires “an effective amount of an SSEA-3+ pluripotent stem cells. However, the disclosure only teaches CL2020 which are clinical grade product of Muse cells Muse cells are Multilineage-differentiating Stress-Enduring Cells which are naturally obtained from bone marrow aspirates, adipose tissues, dermal connective tissues, and are also broadly present in tissues and connective tissues in organs. Muse cells were first reported in 2010 by at Tohoku University, Japan.` MUSE cells are a rare subpopulation of adult stem cells found in bone marrow, adipose tissue, skin, and peripheral blood. They are characterized by: (i) SSEA-3-positive; (ii) CD105-positive; (iii) having low or no telomerase activity; (iv) capable of differentiating into any of tridermic cells; (v) showing no neoplastic proliferation; and (vi) having self-renewal capacities (see Alanazi, Cells, 2023, abstract and Part 2 and 3, page 2-3). The art teaches that Muse cells hone to the site of injury to mediate repair by methods of differentiation and immunomodulation (see Alanazi, part 3.4, page 4).
These cells in the disclosure were administered to patient with cerebral infarction and administered intravenously. However, 7/25 of the subjects experienced blackening of hair, hair growth and improvement in hair glow, amount of hair and skin blemishes. Hence, in a process of treating cardiac disorder, applicants have discovered a secondary use of the cells. However, the only cells provided for by applicants is CL2020 which are allogeneic MUSE cells. Muse cells inherently comprise the properties of claims 4 and 5. This is a limited descriptive element wherein the claims broadly and incompletely claim the inventive elements. Hence, the claims are directed to subject matter that is claimed in generic terms wherein the disclosure is limited. The disclosure of the single type of cells CL2020 and claims of any SSEA3+ PSC cell is linked only with properties that indicate that the cell is CL2020.
Secondly, MUSE cells inherently comprise the properties of claims 4 and 5. This is a limited descriptive element wherein the claims broadly and incompletely claim the inventive elements. Hence, the claims are directed to subject matter that is claimed in generic terms wherein the disclosure is limited. The disclosure of the single type of cells CL2020 and claims of any SSEA3+ PSC cell is linked only with properties that indicate that the cell is CL2020. The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description of a biomolecule requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the molecule itself. It is not sufficient to define molecules solely by its principal biological property, because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any cell with that biological property. Naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. When one is unable to envision the detailed constitution of a complex chemical compound having a particular function so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the cell has been isolated. Thus, claiming all SSEA3+ cells that achieve a result without defining what means will do so is not in compliance with the description requirement. Rather, it is an attempt to preempt the future before it has arrived. Also, where a claim purports to cover all nucleic acids that encode a specific protein and the specification discloses but a single cell type known to do so, the situation is analogous to a single means claim and does not meet the enablement requirement under para. 1 ' of§112.
It is noted that the claims should indicate that the administration to the subject.
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, 2, 4 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshimura et al (WO 201611035419) as evidenced by Alanzi (Cell, 2023, pages 1-15). This rejection is maintained for reasons of record but is updated based upon applicants’ amendment.
Yoshimura et al teach regeneration methods using Muse cells which are SSEA-03 PSC isolated from, mesenchymal tissue and administered to a subject (see abstract and page 7, ¶2). The subject by virtue of lacking normal skin inherently have hair loss. Furthermore, Yoshimura explicitly states that hair is regenerated upon Muse administration. Regeneration is a step of replacement or regrowth. The administration is intravenous (see page 5, ¶5).
MUSE cells are a rare subpopulation of adult stem cells found in bone marrow, adipose tissue, skin, and peripheral blood. They are characterized by: (i) SSEA-3-positive; (ii) CD105-positive; (iii) having low or no telomerase activity; (iv) capable of differentiating into any of tridermic cells; (v) showing no neoplastic proliferation; and (vi) having self-renewal capacities (see Alanazi, Cells, 2023, abstract and Part 2 and 3, page 2-3). Hence, the properties recited in claims 4 and 5 are inherent.
Response to Arguments
Applicants argue as regards Yoshimura et al, the claims are drawn to treating hair damage and not skin ulcers. To this end, applicants argue that the ulcer would return to its natural state naturally. This deficiency is argued not to be remedied by Alanazi et al. This does not embrace the claims as recited which are simply drawn to treating hair damage by intravenous administration of MUSE cells. The prior art teaches just that, that hair is regenerated upon administration of SSEA-3+ MUSE cells.
(Abstract) The purpose of the present invention is to provide a novel medicinal use in regeneration medicine, said medicinal use comprising pluripotent stem cells (Muse cells). Provided is a cell preparation for treating skin ulcer, said cell preparation comprising SSEA-3 positive pluripotent stem cells isolated from a mesenchymal tissue of a living organism or cultured mesenchymal cells. The cell preparation according to the present invention is based on such mechanism of skin tissue regeneration that, when the Muse cells are administered to a skin ulcer site of a subject suffering from the aforesaid disease, the Muse cells differentiate into skin-constituting cells.
(Page 7) In an embodiment of the present invention, the cell preparation of the present invention can treat a patient's skin ulcer and reconstruct normal skin. Here, “reconstruct normal skin” means a state in which an affected part having a skin ulcer has been wound-healed and completely cured. The reconstructed skin state is preferably a state in which the entire surface is covered with epithelial keratinocytes, and epithelialization is completed. Furthermore, it is preferable that a dermis having a sufficient thickness is constructed under the epithelium. More preferably, skin appendages such as sweat glands and / or hair follicles are being regenerated.
These passages by indicating that hair is regenerated, there was hair damage i.e. loss wherein the hair is regenerated and thus treated. That the source of the damage is an ulcer is not occluded by the claims. As well, there is direct indication in the above passage that the cell preparation treated the ulcer to reconstruct normal skin that included glands and hair.
Conclusion
No claims allowed.
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.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA MARVICH/ Primary Examiner, Art Unit 1634
