DETAILED ACTION
This action is in reply to papers filed 06/03/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/03/2026 has been entered.
Status of Claims
Claims 1-5, 7, 9-20, and 38-42 are examined on the merits herein.
Claim 1 is currently amended.
Claims 38-42 are new.
Claims 6, 8, and 36-37 are currently cancelled.
Claims 21-22, 24-26, and 28-35 are withdrawn from consideration as being drawn to an invention non-elected without traverse, in the reply filed 01/03/2025.
Status of Rejections
The cancellation of claims 6, 8, and 36-37 renders any rejections thereof moot.
The rejection of claims 1-5, 7, and 9-20 under 35 U.S.C. 103 over Takahashi et al (Human Cell (2017) 30: 60-71; of record-IDS submitted on 11/12/21), taken with Bonnamain et al (Frontiers in Physiology (2013)-of record), as evidenced by Gonmanee et al (The Anatomical Record (2020) of record), is withdrawn in light of the amendments to claim 1.
The rejection of claim 16 under 35 U.S.C. 103 over Takahashi et al (Human Cell (2017) 30: 60-71; of record-IDS submitted on 11/12/21), taken with Bonnamain et al (Frontiers in Physiology (2013)-of record), as evidenced by Gonmanee et al (The Anatomical Record (2020) of record), and further in view of Abe et al (Cell Biology International (2012)-of record), is withdrawn in light of the amendments to claim 1.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities: The tables in the specification are of poor quality and difficult to read. In particular, Tables 3-7 contain illegible characters.
Appropriate correction of Tables 3-7 is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
The phrase “for from 0.5 to 10 days” should be corrected to “
The phrase “a temperature at between 30°C and 40°C and a carbon dioxide concentration at between 1% and 10%” should be corrected to “a temperature .
Appropriate correction is required.
Claim Interpretation
Claim 1 recites the limitation “preparing an adherent cell culture container in which initially cultured cells derived from intraoral mesenchymal tissue are cultured in a neuron differentiation medium…wherein the initially cultured cells are cultured in the neuron differentiation medium without being cultured with a basic medium” (lines 3-4 and 7-8).
First, the specification defines “initially cultured cells derived from intraoral mesenchymal tissue” as including “both cells cultured in the neuron differentiation medium after being cultured with a basic medium and cells cultured in the neuron differentiation medium without being cultured with a basic medium” (p 11, para 29; emphasis added). Second, based on examples of “basic medium” in the specification (e.g., DMEM and F12 medium; p 9, para 23), the term “basic medium” is interpreted as referring to “basal medium,” which is the commonly used term in the art. Thus, based on the specification, “initially cultured cells derived from intraoral mesenchymal tissue” are interpreted as primary cells derived from intraoral mesenchymal tissue, and the phrase “are cultured in the neuron differentiation medium without being cultured with a basic medium” is interpreted to mean that the primary cells are cultured in neuron differentiation medium without prior culturing in a basal medium. Therefore, for the sake of compact prosecution, said limitation in claim 1 is interpreted as “providing intraoral mesenchymal tissue, isolating cells from the intraoral mesenchymal tissue, and culturing the cells from the intraoral mesenchymal tissue in neuron differentiation medium, wherein the cells from the intraoral mesenchymal tissue are not cultured in a basic medium prior to culturing in the neuron differentiation medium.”
It is noted that this interpretation specifically excludes explant cultures, which do not comprise initially cultured cells (as required by instant claim 1) or isolation of primary cells.
Claims 18-20 each recite an intended use for the neural cell-containing preparation of claim 1. These recitations of intended use do not impart further structural limitations to the composition beyond the limitations recited in claim and therefore do not further limit the composition. See MPEP 2111.02(II). Therefore, claims 18-20 are patentably indistinct from claim 1.
Duplicate Claim Warnings
Applicant is advised that should claim 1 be found allowable, claims 18-20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b)
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, 7, 9-20, and 38-42 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, and as being incomplete for omitting essential steps, such omission amounting to a gap between the steps.
Claim 1 comprises indefinite language regarding the limitation “initially cultured cells.” Claim 1 recites the limitation “preparing an adherent cell culture container in which initially cultured cells derived from intraoral mesenchymal tissue are cultured in a neuron differentiation medium…wherein the initially cultured cells are cultured in the neuron differentiation medium without being cultured with a basic medium” (lines 3-4 and 7-8). The phrase “initially cultured cells” implies that the cells derived from intraoral mesenchymal tissue are cultured prior to culturing in the neuron differentiation medium and conditions defined in lines 4-7 of claim 1. It is then unclear whether the limitation “wherein the initially cultured cells are cultured in the neuron differentiation medium without being cultured with a basic medium” of lines 7-8 refer to 1) culturing that takes place before the limitations of lines 4-7 (i.e., the wherein clause places a limitation on the initial culturing), or 2) the culturing step recited in lines 4-7 (i.e., the wherein clause places a limitation on the culturing step of lines 4-7, which comprises initially cultured cells, which may have been previously cultured in a basic medium). The first interpretation is used for the purpose of examination, as set forth in Claim Interpretation above.
Claim 1 recites the limitation "the neural cell population" in the penultimate line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the neural cell population” is interpreted as referring to “a cell population” of line 12.
Regarding the omission of essential steps, claim 1 recites the limitation “wherein the neural cell-containing preparation comprises the neural cell population, or spheroids or neural cells derived from the cell population” in the last two lines (emphasis added). The steps recited in the method of claim 1 may lead to a cell-containing preparation comprising a neural cell population, but does not result in spheroids derived from the cell population, as recited in claim 1. Indeed, the instant specification recites that “the method of the present disclosure further includes spheroid formation in which the cell population is cultured to form spheroids” (p 19, para 50), implying that further culturing of the cell population is necessary for the formation of spheroids. See MPEP § 2172.01.
Claims 2-5, 7, 9-20, and 38-42 are included in the rejection because they depend from claim 1.
Claim 3 recites the limitation “wherein the cells that do not adhere to the adherent cell culture container are… cells further adhering to cells that adhere to the adherent cell culture container” (emphasis added). It is unclear what limitation is imposed on “the cells that do not adhere to the adherent cell culture container” by the word “further”; that is, it is unclear what “the cells that do not adhere to the adherent cell culture container” are adhering to, in addition to cells that adhere to the cell culture container.
Claim 9 recites the limitation "the container containing the neuron differentiation medium" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “neural cells of which axons are elongated” in line 3. The specification does not define what is meant by “elongated axons,” and therefore, the metes and bounds of this limitation is unclear.
Claim 10 recites the limitation "the free cells" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the free cells” is interpreted as referring to “cells that do not adhere to the adherent cell culture container” in line 11 of claim 1.
Claim 11 recites the limitation “culturing the cell population to form spheroids” (line 2). It is unclear whether the spheroids are formed from the cell population as a whole, or whether spheroids are formed from cells within the cell population. Based on the specification (e.g., p 40, para 92), claim 11 is interpreted as “The method according to claim 1, further comprising culturing the cell population such that cells in the cell population form spheroids.” Claims 12-16 are included in the rejection because they depend from claim 11.
Claims 12-14 recite the phrase “culturing the cell population in the spheroid formation,” which is unclear (i.e., whether the cell population is being cultured to form spheroids, or whether the cell population is being cultured in spheroids). Furthermore, there is insufficient antecedent basis for the limitation “the spheroid formation.” This phrase is interpreted as “culturing the cell population such that cells in the cell population form spheroids.”
Claim 13 recites the limitation “neural cells of which axons are elongated” in line 3. The specification does not define what is meant by “elongated axons,” and therefore, the metes and bounds of this limitation is unclear.
Claim 15 recites the limitation "the cells" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation “culturing the initially cultured cells in the neuron differentiation medium for 0.5 to 3 days” (emphasis added). This limitation comprising “initially cultured cells” renders claim 38 indefinite for the same reason as set forth above for claim 1.
Relevant Prior Art
Claims 1-5, 7, 9-20, and 38-42 appear to be free of the prior art, according to the Claim Interpretation set forth above.
Takahashi et al (Human Cell (2017) 30: 60-71; of record, IDS submitted on 11/12/21) and Bonnamain et al (Frontiers in Physiology (2013) 4: 357; of record) constitute the closest prior art. However, neither Takahashi nor Bonnamain teaches culturing cells isolated from intraoral mesenchymal tissue immediately in neuron differentiation medium, as required by instant claim 1 (see Claim Interpretation above). Rather, Takahashi and Bonnamain both teach first culturing cells isolated from intraoral mesenchymal tissue in basal medium, before culturing the cells in differentiation medium.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 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, Peter Paras can be reached at (571) 272-4517. 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.
/RISA TAKENAKA/Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
Prosecution Insights