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 .
Election/Restrictions
Claims 11-13, 16, 21, 23, 25, 31, 34, 40, 42, 44, 45, 52 and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/14/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim provides for “PIK3 kinase inhibitor;” this appears to be a typographical error for “PI3 kinase inhibitor” or “PI3K inhibitor.” Appropriate correction is required.
Claims 1and 7 are objected to because of the following informalities: dorsomorphin is not a proper noun and does not need to be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 5, and 9 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The instant invention is drawn to a method of generating cells that are positive for Nkx2.1 and negative for Tuj1 and Pax8. The instant claims state that this process occurs when human foregut endoderm cells are exposed to a Wnt agonist, a PI3 kinase inhibitor, a BMP antagonist, and a drug.
When looking at the method of the invention in the instant specification, it seems reasonably clear that when human foregut endoderm cells are exposed to Wnt agonists, PI3 kinase inhibitors, and BMP agonists, the cells become positive for Nkx2.1 and negative for Tuj1 and Pax8, and possess the claimed lung lineage. However, the instantly claimed method does not use a BMP agonist, the instant method claims a BMP antagonist, which in claim 7 is explicitly claimed as dorsomorphin. When looking at the instant specification, it is explicitly stated that dorsomorphin abrogates the expression of Nkx2.1 in human foregut endoderm cells. Based upon this, it appears that the instant specification suggests that dorsomorphin, and BMP antagonists in general, would do the opposite of what is claimed and could not be enabled for the claimed method.
When looking at the applied data provided in the instant specification, there is no evidence to suggest that dorsomorphin or BMP antagonists are capable of generating Nkx2.1 positive lung progenitor cells, wherein the only use of dorsomorphin is to generative human foregut endoderm cells from induced pluripotent stem cells; these cells are objectively different than the claimed lung cells. Furthermore, there is no evidence to suggest that the claimed “drug” would provide for any increased expression of Nkx2.1 that would overcome the abrogation provided by dorsomorphin/BMP antagonist. Since the instant specification admits that one of the claimed ingredients is not enabled for the claimed method, and performs an action that runs directly contrary to the claimed increase of Nkx2.1 expression, it does not appear if the method is enabled.
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, and 9 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 provides for a PI3 kinase inhibitor and a “drug” that can include PIK-75. Since PIK-75 is a PI3 kinase inhibitor, it is unclear if the artisan can choose the drug PIK-75 and have it fulfill the claim limitation for both the PI3 kinase inhibitor as well as the “drug.” This uncertainty is further underscored when viewing claim 5, which requires the inclusion of PIK-75. It is unclear if the artisan must also choose a “drug” that is independent the claimed PIK-75. Based upon the instant specification, it appears as though the “drug” and the PI3 kinase inhibitor can be viewed as the same, and as such, if prior art includes PIK-75, it will be considered to fulfill both claim limitations.
Claim 9 recites the limitation "the growth factor" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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