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 .
Status of the claims
Claims 1, 6, 17, 19-24 are pending and under exam. Claims 19-24 are withdrawn due to being directed to nonelected invention. Claims 1, 6 and 17 are under examination.
WITHDRAWN REJECTIONS
Drawings and Specification
The objection to the drawings and specification are withdrawn following Applicant amendments to cancel language to color figures.
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 5 and 18 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The rejection is withdrawn following cancellation of the claims.
Claim 1-3, 5-6, and 17-18 were 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The rejection is withdrawn for claims 2-5, and 7-16 following cancellation of the claims. New rejections for the amended claims are set forth below.
NEW REJECTION NECESSITATED BY CLAIM AMENDMENTS
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.
Claim 1, 6, and 17 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1: Applicant’s arguments have been fully considered. Applicant amended claim 1 to recite induction of differentiation of an iPSC to a definitive endoderm cell using Activin A in combination with about 10µM gentamicin, about 1µM minocycline or about 1µM methacycline. Applicant asserts that the amendments overcome the written description rejection because the recited compounds and concentrations are disclosed in the specification.
However, the amendments do not overcome the outstanding written description deficiency. While the specification discloses testing of gentamicin, minocycline and methacycline in certain experimental settings, the specification does not reasonably convey possession of the full scope of the presently claimed invention at the time of filing.
The claims encompass a method of inducing differentiation of an iPSC into a definitive endoderm cell using the recited compounds without limitation as to the identity or differentiation characteristics of the iPSCs across full scope of the claim. Accordingly, the claims read broadly on full genus of iPSCs.
Although the specification reports endoderm differentiation protocols and reports successful differentiation across multiple cell lines using a doxycycline based ML1 protocol, the disclosure does not provide commensurate representative support demonstrating that gentamicin, minocycline, or methacycline at the claimed concentrations achieve definitive endoderm induction across the scope of iPSC diversity encompassed by the claims.
Rather the specification does not provide representative disclosure demonstrating that each of the recited compounds is effective for inducing definitive endoderm differentiation across a representative scope of iPSC variability. While the specification acknowledges variability in iPSC behavior, such variability is not dispositive. However, in view of the breadth of the claims and limited compound-specific disclosure for the claimed compounds, the specification does not reasonably convey that Applicant was in possession of the full scope of the claimed methods. As such the specification did not provide sufficient representative species evidence for each of the three recited antibiotic embodiments to support possession of the claimed genus of methods across iPSC diversity.
Accordingly, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the presently claimed method throughout its full scope at the time of filing.
Claims 6 and 17 are rejected for their dependency.
Conclusion
No claim is 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 JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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, Christopher M. Babic can be reached at 571-272-8507. 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.
/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
Prosecution Insights