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 .
Claim Status
Claims 1, 3-6, 9-19, 22-24, and 26-28 are pending.
Claims 3 and 14-16 are withdrawn.
Claims 1, 4-6, 9, 10-13, 17-19, 22-24 and 26-28 are under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5th, December, 2025 has been entered.
Species Rejoinder
The species election requirement between Culture Dimension, as set forth in the Lack of Unity mailed on 27th, October, 2023, has been reconsidered. Because claim 1 is allowable and free of the prior art, claims 10-11, drawn to the previously non-elected species of two-dimensional culture are no longer withdrawn from consideration.
In view of the above noted withdrawal of the species election requirement, applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a species election requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 recites “the second culture is performed in a differentiation-inducing medium comprising a serum replacement containing no insulin basal medium containing 100 ng/mL activin A,” which is missing a conjunction at the end of the list.
Claim 23 recites “the second culture is performed in a differentiation-inducing medium comprising a serum replacement containing no insulin basal medium, high glucose, L-alanyl L-glutamine, pyruvate medium containing 100ng/mL activin A,” which is missing a conjunction at the end of the list.
Appropriate correction is required.
Response to Declaration under 37 C.F.R. § 1.132
The Declaration under 37 CFR 1.132 filed 5th, December, 2025, is sufficient to overcome the scope of enablement rejection of claims 1, 4-6, 9, 12-13, and 17-19 and 22-24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Withdrawn Claim Rejections - 35 USC § 112a
Scope of Enablement
The scope of enablement rejection of claims 1, 4-6, 9, 12-13, 17-19 and 22-24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as set forth in the previous office action is withdrawn in view of Applicant’s declaration under 37 C.F.R. § 1.132 and in view of Applicant’s amendments.
The scope of enablement rejection of claims 20-21 and 25 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as set forth in the previous office action is withdrawn in view of the cancellation of these claims.
Withdrawn Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claims 4-6, 9, 12-13, and 17-19 and 22-24 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 as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 20-21 and 25 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 as set forth in the previous office action is withdrawn in view of the cancellation of this claim.
Withdrawn Claim Rejections - 35 USC § 112b
The rejection of claims 22-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claim 25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of the cancellation of this claim.
New Claim Rejections - 35 USC § 112b
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 4-6, 9-13 and 22-23 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.
Claims 4-6, 9 and 10-13 are dependent or ultimately dependent on withdrawn claim 3 in the alternative (e.g. “method according to claim 1 or claim 3”) which renders the claim and its dependents indefinite, since the claims depend on a non-elected claim, and, therefore, are incomplete.
By nature of its ultimate dependency on claim 10, claim 11 is also rejected because it does not clarify the issue.
Claims 22-23 each recite “CHIR99021,” which is a GSK3β inhibitor. However, claim 1, already recites the first culture in a differentiation-inducing medium comprising a GSK3β inhibitor. It is unclear whether the CHIR99021 recited in each of claim 22 and 23 is the GSK3β inhibitor recited in claim 1, upon which claims 22-23 depend, or whether it is an additional component in the composition.
Claim 22 recites “the first culture is performed in a differentiation-inducing medium comprising a serum replacement containing insulin, basal medium containing 100ng/mL activin A.” Because claim 1, upon which claim 22 depends, already recites the first culture medium comprises activin A, a serum replacement, and insulin, the scope of the claim is unclear because it is unclear whether additional components are required and it is unclear which components are required. Specifically, claim 22 requires “serum replacement containing insulin” while claim 1, requires a serum replacement and insulin as separate components.
Claim 22 recites “the second culture is performed in a differentiation-inducing medium comprising a serum replacement containing no insulin basal medium containing 100 ng/mL activin A.” Furthermore, Because claim 1, upon which claim 22 depends, already recites the second culture medium comprises activin A, a serum replacement, and no insulin, the scope of the claim is unclear because it is unclear whether additional components are required and it is unclear which components are required. Specifically, claim 22 requires “serum replacement containing no insulin” while claim 1, requires a serum replacement and no insulin as separate requirements.
Claim 23 recites “the first culture is performed in a differentiation-inducing medium comprising a serum replacement containing insulin, basal medium high glucose, L-alanyl L-glutamine, pyruvate medium containing 100ng/mL activin A.” Because claim 1, upon which claim 23 depends, already recites the first culture medium comprises activin A, a serum replacement, and insulin, the scope of the claim is unclear because it is unclear whether additional components are required and it is unclear which components are required. Specifically, claim 23 requires “serum replacement containing insulin” while claim 1, requires a serum replacement and insulin as separate requirements.
Claim 23 recites “the second culture is performed in a differentiation-inducing medium comprising a serum replacement containing no insulin basal medium, high glucose, L-alanyl L-glutamine, pyruvate medium containing 100ng/mL activin A.” Because claim 1, upon which claim 23 depends, already recites the second culture medium comprises activin A, a serum replacement, and no insulin, the scope of the claim is unclear because it is unclear whether additional components are required and it is unclear which components are required. Specifically, claim 23 requires “serum replacement containing no insulin” while claim 1, requires a serum replacement and no insulin as separate requirements.
Examiner’s Remark
Claims 1, 4-6, 9, 10-13, and 17-24 and 26-28 are free of the prior art, and claims 1, 17-19 and 26-28 are allowable.
Because claims have been indicated as allowable, claims drawn to unelected species have been considered for rejoinder.
Unelected claim 3, drawn to the unelected species of “the first culture is performed in a differentiation-inducing medium comprising insulin and comprising no insulin signaling inhibitor, and the second culture is performed in a differentiation-inducing medium comprising insulin and an insulin signaling inhibitor” is not eligible for rejoinder because it conflicts with independent claim 1, which now requires the elected alternative embodiment of “the first culture is performed in a differentiation-inducing medium comprising insulin, and the second culture is performed in a differentiation-inducing medium comprising no insulin.”
Unelected claims 14-16 are not eligible for rejoinder because they are drawn to distinct methods for producing insulin-producing cells, which are not commensurate in scope with the elected method for producing a cell population comprising definitive endoderm cells.
Conclusion
Claims 1, 17-19 and 26-28 are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632