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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claim 7) in the reply filed on 05/22/2026 is acknowledged.
Claim 7 has been amended.
Claims 9-12 have been newly added and no claims have been newly canceled.
Claims 1-6 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/22/2026.
The restriction requirement is made Final.
Claims 7 and 9-12 have been examined on their merits.
Claim Objections
Claim 7 is objected to because of the following informalities:
There should be the letter “a” in line one of claim 7 before the term “tonsillar organoid”.
Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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.
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.
Claim(s) 7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Clevers et al (US 2014/0243227-previously cited) in view of Singh et al (US 10,317,395) and Poggel et al (US 2017/0145369).
Regarding claims 7, 9 and 12, Clevers disclose methods of expanding and differentiating populations of stem cells for obtaining organoids with culture medium that contains a p38 inhibitor such as SB202190 (abstract, page 1 para 9). The stem cells are preferably human epithelial stem cells from human epithelial tissue origin (page 21, para 246). The culture media may comprise one or more mitogenic growth factor such as basic fibroblast growth factor (bFGF, also known as FGF2) and hepatocyte growth factor (HGF) (page 9 para 97-98). An additional media supplement that is advantageous to include is an activator of prostaglandin signaling pathway, PGE2, (page 11 para 111). When the p38 inhibitor is present the cell culture medium allows the survival and proliferation of the cells of the organoid and when the p38 inhibitor is initially present in a cell culture medium but is then removed from the medium (e.g. by failing to add it when the medium is refreshed), allow the survival and differentiation of the cells or organoid (page 20 para 234-235). A suitable concentration for HGF is indicated to be 50 ng/ml (page 17 para 177) and 25-50 ng/ml (page 18 para 197). HGF was indicated as essential for long term culture for several passages (subcultures of at least a second generation) (pages 17-18 para 185).
Clevers do not specifically disclose wherein the epithelial cells are isolated from tonsil epithelial tissue.
Singh teach that ex vivo engineered organoids from tissue such as tonsils could offer the benefit of a new approach for studying physiology, pathology of cell origins as well as screening of therapeutics including immunotherapeutics and that there is a need for alternative secondary immune organs that can be created and used in an ex vivo context (column 1 line 42- column 2 line 4).
Poggel disclose a process and device for isolating cells from biological tissue (Title, abstract) to release target cells with good yield and viability of the target cells (page 1 para 15). The target cells include epithelial cells and tissue stem cells and the biological tissue includes tonsil (page 4 para 62-63).
One of ordinary skill in the art would have been motivated to use epithelial stem cells from tonsil tissue in their methods of producing organoids because Singh teach and suggest that ex vivo engineered organoids from tissue such as tonsils could offer the benefit of a new approach for studying physiology, pathology of cell origins as well as screening of therapeutics including immunotherapeutics and that there is a need for alternative secondary immune organs that can be created and used in an ex vivo context (column 1 line 42- column 2 line 4). One of ordinary skill in the art would have had a reasonable expectation of success because Poggel disclose a process and device for isolating cells from biological tissue (Title, abstract) to release target cells with good yield and viability of the target cells (page 1 para 15) and wherein the target cells include epithelial cells and tissue stem cells and the biological tissue includes tonsil (page 4 para 62-63).
Regarding claims 10-11, while Clevers, Singh and Poggel are silent with regard to the gene expression of tonsillar organoids, Applicant’s disclosure indicates that when the claimed culture medium is used that the organoids will express genes of CD44, nerve growth factor receptor, cytokeratin 5, cytokeratin 13, Integrin alpha 6 and epithelial cell adhesion molecule (Applicant’s Specification page 4 last paragraph). Therefore, the expression of the claimed genes is deemed to be inherently present when the epithelial cells are obtained from tonsil tissue and the claimed culture medium ingredients are used.
Regarding the issue of inherency, see Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020). (see MPEP 2112 (IV)).
Therefore, the combined teachings of Clevers et al, Singh et al and Poggel et al render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim et al., “Separation Culture and Identifying Method of Human Tonsil Epithelial Cell”, CN 105936888 A, 2016, machine translation, pp. 1-8.
Describes using tonsillar tissue for the production of organoids.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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