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 Claims
Claims 1-2 are pending.
Priority
Claims 1-2 are a DIV of 17/662,656 ABN filed on May 9, 2022, which has priority to PRO 63/185,423 filed on May 7, 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on November 15, 2024, and on November 15, 2024, and on November 15, 2024, were filed before the mailing of the First Office Action on July 18, 2026. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Drawings
The drawings are objected to because of the following informalities: There is description of color in the Specification of Figure 1C, 1E, and 6C, and also paragraph [0109], and the various colors cannot be distinguished from each other since the figures are in black and white.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-2 are rejected under 35 U.S.C. §103 as being unpatentable over Tan et al. [Human airway organoid engineering as a step toward lung regeneration and disease modeling, Biomaterials, 2017], in view of Panek et al. [The formation of intestinal organoids in a hanging drop culture, Cytotechnology, 2018].
For claim 1, Tan et al. teaches airway organoids by combining human adult primary bronchial epithelial cells, lung fibroblasts, and lung microvascular endothelial cells in Matrigel® [Abstract, pg. 119 left column ¶ 2]. Although Tan et al. teaches the presence of extracellular matrix proteins such as laminin, collagen IV, and entactin, Tan et al. does not teach co-culturing in soluble, non-gelling concentrations of extracellular matrix proteins.
For the claim 1 limitation of co-culturing epithelial cells, fibroblasts, and endothelial cells in a soluble, non-gelling concentration, Paneck et al. teaches supplementing a medium with Matrigel® at a concentration that remains in solution rather than forming a three-dimensional gel [Results and discussion ¶ 6], and because Matrigel® is a basement membrane extract composes of extracellular matrix proteins to include laminin, collagen IV, and entactin, the diluted Matrigel® provides a soluble, non-gelling concentration of extracellular matrix proteins to the cultured cells that does not form a gel.
For claim 2 where an organoid is obtained by the method of claim 1, both Tan et al. and Paneck et al. teach the formation of organoids. Tan et al. specifically teaches organoids formed from co-culturing epithelial cells, fibroblasts, and endothelial cells, while Paneck et al. discloses organoids formed from culturing intestinal epithelium cells in a soluble, non-gelling concentration of extracellular matrix proteins.
Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Tan et al. that teaches the formation of an organoid through co-culturing epithelial cells, fibroblasts, and endothelial cells exposed to a basement membrane solution that contains extracellular matrix proteins with the teachings of Paneck et al. that further teaches the formation of an organoid by culturing intestinal epithelial cells in a soluble, non-gelling basement membrane medium that also contains extracellular matrix proteins such as laminin, collagen IV, and entactin. Based on this, a person of ordinary skill would have had a reasonable expectation of success to co-culture epithelial cells, fibroblasts, and endothelial cells of Tan et al. in a soluble, non-gelling solution that contained extracellular matrix proteins as taught by Paneck et al. in order to produce an organoid derived from the different cell types.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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