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 .
Applicant’s response filed 3/16/2026 has been received and entered into the case. Claims 1, 2, 4, 7, 9-13, 16-19, 22, 23, 27, 28, 31, 32, 34, 39, 40, 41, 44, 47 are pending. Claims 17, 22, 23, 27, 28, 39-41, 44 are withdrawn. Claims 1, 2, 4, 7, 9-13, 16, 18, 19, 31, 32, 34, 47 have been considered on the merits. All arguments and amendments have been considered.
All previous rejections of record are withdrawn in light of applicants claim amendments.
New rejection of record necessitated by amendment
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, 2, 4, 7, 9-13, 16, 18, 19, 31, 32, 34, 47 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.
Applicant’s claims have been amended to include the limitation “wherein the at least 40% ciliated cells comprise ciliated cells that are beating synchronously”. The claims are drawn to a method of generating proximal differentiated airway organoids from adult lung cells comprising culturing the airway organoids in a proximal differentiation medium, wherein the medium comprises at least a Notch inhibitor, EGF, insulin, transferrin, hydrocortisone, triiodothyronine and epinephrine, wherein the proximal differentiation medium comprises one or more additional components as set out in Table 2, optionally at the concentrations shown in Table 2, wherein at least 40% ciliated cells are obtained at about 14-16 days in culture, wherein the at least 40% ciliated cells comprise ciliated cells that are beating synchronously. When looking to applicants Table 2, the PD medium is disclosed to be contain EGF, insulin, transferrin, hydrocortisone, triiodothyronine and epinephrine (required by instant claim 1) and additionally contains Basal medium, BSA, bovine pituitary extract, and antibiotics with all components disclosed at in specific concentrations. The specification also discloses that “In some embodiments, the PD medium is serum free and/or BPE (bovine pituitary extract)-free. An example of a suitable PD medium is the commercially available PneumaCult-ALI medium (StemCell Technologies). PneumaCult™- ALI Medium is a serum- and BPE-free medium for the culture of human airway epithelial cells at the air-liquid interface (ALI). Airway epithelial cells cultured in PneumaCult-ALI Medium undergo extensive mucociliary differentiation to form a pseudostratified epithelium that exhibits morphological and functional characteristics similar to those of the human airway in vivo. PneumaCult-ALI Medium supports the generation of differentiated airway organoids in a 2D or 3D culture system. The current claimed method 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 the invention, i.e. to make the airway organoid having at least 40% ciliated cells which comprise ciliated cells that are beating synchronously using the claimed medium.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. Regarding undue experimentation, In re Wands, 8 USPQ2d 1400, at 1404 (Fed. Cir. 1988) states:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims (Citations omitted).
Regarding the unpredictability in the art, it is noted that the specification is limited to the disclosed PD medium with an added Notch inhibitor. However, the art (previously relied upon) Barkauskas, Tan, and Konishi, for example, teach generating airway organoid in the claimed medium with a Notch inhibitor which generates at least 40% ciliated cells; however, the while beating cilia having metachronal wave-like beating are observed, a lack of synchroneity of ciliary beating for generating a unidirectional flow was found (Konishi) and Barauskas teach that although the ciliated cells are motile, there is no evidence of coordination between cells, thus a lack of synchroneity. Therefore, there is an unpredictability in the art and thus, it is clear that undue experimentation would be required to determine which medium components (not included in the claims but in Table 2) and optional concentrations would enable one to make the claimed organoid having at least 40% ciliated cells which comprise ciliated cells that are beating synchronously using the current claimed medium.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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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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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
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