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 1-22 are pending in this application.
Election/Restrictions
Applicant’s election of Group I (Claims 1-3) in the reply filed on 09/01/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 4-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/01/2026.
Claims 1-3 were examined on their merits.
Drawings
The drawings are objected to because Figs. 8-9 contain Trademarked terminology. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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).
The use of the terms GLUTAMAX®, STEMPRO® (Figs. 8-9), TRYPLE® and ROOSTERBIO® which are trade names or marks used in commerce, has been noted in this application.
The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at Pg. 18, Paragraph [00106]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-3 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 recites, “culturing bESCs in a serum-free culture medium comprising an effective amount of a γ-secretase inhibitor on a matrix-coated culture vessel…”. It is unclear if the γ-secretase inhibitor is disposed on the matrix-coated culture vessel or if the γ-secretase inhibitor is contained within the medium. For purposes of examination, the Examiner has interpreted the claim as the γ-secretase inhibitor being contained within the medium. Claims 2-3 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 are rejected under 35 U.S.C. § 103 as being unpatentable over Soto et al. (2021), in view of Yu et al. (2008) and Supplemental Data, both cited in the IDS.
Soto et al. teaches culturing CTFR-bESC in a serum free culture medium (CTFR medium) in feeder-free conditions, on MATRIGEL® (comprising collagen IV) or vitronectin (Pg. 9, Lines 25-27 and Pg. 10, Lines 27-29 and 60-65), and
obtaining an expanded population of bESC expressing Oct4, Sox2 (Pg. 3, Fig. 1), and reading on Claims 1 and 3.
Soto et al. further teaches that the method allows culturing of bESC in commercially available culture medium base and expansion without the use of feeders (Pg. 2, Lines 10-13).
The teachings of Soto et al. were discussed above.
Soto et al. did not teach a method wherein the culture medium comprises an effective amount of a γ-secretase inhibitor, as required by Claim 1;
or wherein the γ-secretase inhibitor is DAPT, as required by Claim 2.
Yu et al. teaches that notch signaling is elevated in differentiated hESC and inhibition of Notch signaling enhances growth of undifferentiated hESC as a population (Fig. S7), wherein notch signaling was inhibited by culturing hESC in a medium containing an effective amount of γ-secretase inhibitor (GSI) DAPT or GSI-18 (Pg. 462, Column 1, Lines 27-45 and Fig. S3).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of culturing bESC under feeder-free conditions with the inclusion of an effective amount of a GSI such as DAPT in the medium as taught by Yu et al. in order to maintain undifferentiated status of the bESC during expansion. Those of ordinary skill in the art would have been motivated to make this modification because Yu et al. teaches that inhibition of Notch signaling enhances growth of undifferentiated hESC as a population and that Notch signaling can be inhibited by inclusion of GSI in ESC culture media. There would have been a reasonable expectation of success in making this modification because both methods are drawn to the same field of endeavor, that is, the culture and expansion of ESC.
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 09/11/2026
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