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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s arguments and amendments dated 7/20/26 have been received and entered in the application.
Claims 1, 4, 6-10 are currently pending and examined on the merits.
Claims 1, 6, 8-10 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
Claim Interpretation
With respect to claim 10, the wherein clauses recites the intended result of the method rather than requiring an additional, active method step be performed. MPEP § 2111.04 states “[c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that such a clause "in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”. Therefore, since this claim only recite the results of the actively recited method steps (protein content of ECM), art reading on the method of claim 1, necessarily results in the same expression profile in the absence of evidence to the contrary.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-14 is/are rejected under 35 U.S.C. 103 as being obvious over Cho et al., PCT Publication No. WO 2022/114937 (hereinafter Cho) in view of Zhou et al., US Publication No. 2025/0123274 (hereinafter Zhou).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 1, 10, 12-13, Cho discloses extracellular matrices scaffolds for culture of organoids, and methods of making and using thereof (Abstract). Cho discloses combining dECM with alveolar type 2 cells (p2 ¶ 8-10). The combination is dispensed into a Transwell plate and cultured until fused spheroids form (3D organoid culture, Fig. 4). The spheroids are then transferred to a second culture media, and further cultured (3D organoid culture).
Cho does not explicitly disclose that the cell culture is subject to gelation. However, the present specification indicates that gelation of the dECM occurs via incubation at 37 °C (See p20 ¶ 1). As Cho discloses that the combination of alveolar type 2 cells and dECM are cultured (i.e., at 37 °C) until spheroids are formed, it is implicit that the culture of Cho would likewise induce gelation.
Regarding claim 2, Cho discloses that the disclosed methods are compared to culture in Matrigel as a control (3D organoid culture, Example 2). Organoids cultured according to the disclosed methods demonstrates better expression of alveolar specific markers as compared to cells cultured in Matrigel (Example 4, Figs. 5-6).
Regarding claim 4, Cho discloses culturing the dECM and alveolar cells in a small airway epithelial cell growth media until spheroids form (p4, 3D Organoid Culture).
Regarding claim 5, Cho discloses culturing the spheroids in an alveolar differentiation media (3D Organoid Culture).
Regarding claim 6, Cho discloses that the alveolar differentiation media contains B-27 supplement, dexamethasone, 3-isobutyl-1-methylxanthine (IBMX), HEPES, CaCl 2 , ITS premix, 8-Br-CAMP, KGF, bovine serum albumin (BSA), FGF7, and penicillin/streptomycin in Ham's F12 medium. (p2 ¶21, 3D Organoid Culture).
Regarding claim 7, Cho discloses preparing the dECM by cutting isolated lung tissue into approximately 1 mm slices, washing the slices, decellularizing, removing fat from the tissue, treating with DNase, lyophilizing, enzymatically digesting with pepsin, and neutralizing the enzymatically digested dECM (p2 ¶ 12, Preparation of dECM (decellularized extracellular matrix) from lung tissue).
Regarding claim 8, Cho discloses that the decellularization is performed by treating with sodium dodecyl sulfate, followed by Triton X-100, and washing (p2 ¶ 12, Preparation of dECM (decellularized extracellular matrix) from lung tissue).
Regarding claim 9, Cho discloses that the neutralized dECM is incubated at 37°C to induce gelation (p2 ¶ 16, Preparation of dECM (decellularized extracellular matrix) from lung tissue).
Regarding claim 10, Cho does not explicitly disclose that the dECM comprises certain proteins. However, the specification at Table 2 indicates the listed proteins are inherently present in dECM. Therefore, it is inherent that the dECM of Cho would likewise inherently contain the listed proteins.
Regarding claim 11, Cho discloses that the dECM is included at concentration of 0.01 to 10% w/v, or more particularly 0.5%, dECM (p3 ¶ 23, 3D organoid culture).
Regarding claim 14, Cho discloses that the lung organoid may be used to treat a respiratory disease in a subject in need thereof (p4 ¶ 18- p5 ¶ 2).
Cho does not disclose that the spheroids are formed using a hanging drop culture plate.
Zhou discloses methods of making alveolar organoids (Abstract). Zhou discloses isolating primary lung cells and culturing in an expansion media for two to six weeks to form 3D organoids, and subsequently culturing in adherent free conditions in a differentiation medium ([0032], [0079]). In some embodiments, the cells are cultured using known methods for scaffold-free generation of cell spheroids, such as hanging, forced floating (e.g., Transwell), agitation-based approaches, or in suspension culture plates ([0033], [0079]). In a preferred embodiment, the cells are combined with Matrigel and cultured on suspension culture plates ([0033], [0079]).
As both Cho and Zhou are directed to methods of making alveolar organoids, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the Transwell-based method of Cho could be exchanged with the hanging drop method disclosed by Zhou as a simple substitution of one known method of suspension culture for another with a reasonable expectation that alveolar organoids would successfully produced.
Response to Arguments
Applicant's arguments dated 7/20/26 have been fully considered but are moot due to the new grounds of rejection necessitated by applicant’s amendments.
Conclusion
No claims are 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
