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 .
Claim Status
Claims 1 – 11 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10 – 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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 2 – 3 and 10 – 11 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.
Regarding claims 10 – 11, Attempts to claim a process without setting forth any steps involved in the progress renders the claim indefinite. The word “use” in line 1 renders the claims indefinite.
Claims 2 – 3 contain the trademark/trade name 1) StemSpan-XF and 2) ImmunoCult-ACF. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe 1) serum free medium for the in vivo culture/expansion of human hematopoietic cells 2) medium for culturing immune cells and, accordingly, the identification/description is indefinite.
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.
Claims 1 – 5 and 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Balan et al. (Large-Scale Human Dendritic Cell Differentiation Revealing Notch-Dependent Lineage Bifurcation and Heterogeneity, Cell Reports 24, 1902 – 1915 (2018); cited on IDS, hereinafter Balan) in view of Thordardottir et al. (The Aryl Hydrocarbon Receptor Antagonist StemRegenin 1 promotes Human Plasmacytoid and Myeloid Dendritic Cell Development from CD34+ Hematopoietic Progenitor Cells, Stem Cells and Development, Vol. 23, No. 9, (2014); hereinafter Thordardottir), Inoue et al. (C.A. Patent application Publication No. 2687534; cited on IDS, hereinafter Inoue), Strobl et al. (U.S. Patent No. 6,498,034; hereinafter Strobl), and Foster et al. (Ex-Vivo Uses and Applications of Cytokines for Adoptive Immunotherapy in Cancer, Current Pharmaceutical Design, 10, 1207 – 1220, (2004); hereinafter Foster).
Regarding claims 1 – 3, Balan discloses a method for preparing conventional type 1 dendritic cells (cDC1s) in vitro, wherein purified CD34+ human cord blood (CB) cells are expanded (p. e5, Expansion and differentiation…) with FLT-3L, TPO, SCF, and IL-3 (as a stimulant). Balan further discloses differentiation conditions that include a second medium with FLT-3L, IL-7, TPO, and GM-CSF. Balan does not disclose IL-6, SR1, or TGF-β as cytokines for the expansion and/or differentiation of DCs.
However, Thordardottir discloses/provides motivation with a method for generating dendritic cells from hematopoietic stem cells, in which the inhibition of aryl hydrocarbon receptor with its antagonist StemRegenin 1 (SR1) leads to the generation of clinical scale numbers of DCs (Abstract).
Inoue discloses methods for the production of dendritic cells, in which they report a marked increase in DC progenitor proliferation when a medium that includes IL-6 (p.2 line 5 – 25), SCF, FLT-3 and IL-3 was used for culturing the cells.
Strobl discloses a method for producing dendritic cells from human hematopoietic progenitor cells with TGF-β1. Strobl further discloses (col. 1, line 35 – 50) that TGF-β plays a critical role in the in vitro generation/development of high numbers of dendritic cells from hematopoietic progenitor cells (col. 4, line 55 – 67 ).
Foster discloses ex vivo uses and applications of cytokines for adoptive immunotherapy in cancer, in which the in vitro generation/maturation of dendritic cells has been mapped to the cytokines (2nd cytokine composition – “differentiation”) of table 3 (p. 1213) including: Flt-3L, GM-CSF, IL-3, and TGF-β.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medium composition/protocol of Balan with the SR1 of Thordardottir, the IL-6 of Inoue, and the TGF-β of Strobl. Further, It would be obvious to use/optimize the knowledge from Foster for generating an in vitro DC differentiation cocktail to substitute Balan’s second cytokine ingredients. Doing so would enhance an expansion/differentiation protocol for generating DCs and increase the DC yield at the conclusion in vitro.
Regarding claims 4 – 5 and 8, Balan discloses concentrations (p. e5, Expansion and differentiation… and Cell stimulants…) for the starting mononuclear cells, TPO (2.5 ng/ml), SCF (2.5 ng/ml), FLT-3L (15 ng/ml) and GM-CSF (1 ng/ml; Fig. 6). Thordardottir discloses SR1 at 1 µM (p. 958, Results, 1st sect., 1st para.)
Inoue discloses concentrations (p. 3, line 5 – line 9) for GM-CSF (10 to 100 ng/ml), SCF (5 to 50 ng/ml), FLT-3L ( 5 to 35 ng/ml; p. 20, line 5), IL-3, and IL-6 (5 to 15 ng/ml; p. 20, line 5 – 10).
Strobl discloses TGF-β as an optimized concentration at 0.5 ng/ml (col. 3, line 55 – 67) along with SCF and GM-CSF.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and optimize 1) the amount of mononuclear cells to inoculate and 2) each cytokine used by Balan, Thordardottir, Inoue, Strobl, and Foster to expand and then differentiate DCs from blood mononuclear cells. Doing so would enhance/increase the number of obtainable cDC1s that a dendritic cell expansion/differentiation protocol can generate in vitro.
Regarding claim 9, Balan discloses expanding the cells for 7 days and differentiating the cells for 14 – 21 days (e5, Expansion and differentiation…).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the expansion time in order to maximize the DC yield at the conclusion of the protocol.
Claims 6 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Balan, Thordardottir, Inoue, Strobl, and Foster as applied to claims 1 – 5 and 8 – 9 above, and further in view of Bell (W.O. Patent Application Publication No. 99/25812; hereinafter Bell).
Regarding claims 6 – 7, Balan, Thordardottir, Inoue, Strobl, and Foster teach all of the elements of the current invention as stated above except the addition of plasma at 5 v/v% to the culture. Strobl discloses that plasma (10%) supplementation of the culture medium is required for the efficient in vitro development of DCs (col. 4, line 35 – 55). However, Bell discloses a method for the production and use of dendritic cells, in which plasma at 5 and 20 v/v% are used (Fig. 3; p. 9 line 10 – 15) for culturing the dendritic cells. Bell further discloses plasma as a T-cell growth suppressive compound (p. 7, line 10 – 19).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the T-cell growth suppressive compound of Bell (plasma) in the in vitro cDC1 generating protocol of Balan, Thordardottir, Inoue, Strobl, and Foster. Doing so would suppress T-cell growth in vitro as T cells can also be differentiated from blood mononuclear cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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