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 .
The preliminary amendments of 07/24/2023 have been entered in full. Claims 1-7, 9, 11-14, 16, 18-20, and 22-25 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/28/2023 and the IDS submitted on 03/31/2023 appear to be duplicates. The annotated documents will show that several references have been lined through because they appear to be unrelated to the subject matter of the instant application, and no explanation of their relevance has been received.
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 12-15, 16, and 18-20 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.
Claim 12 recites the limitations "CD48 agonist" and “CD48 antagonist” in claim 1. There is insufficient antecedent basis for these limitations in the claim. Furthermore, the expression “CD244 receptors” is unclear because CD244 is itself a receptor. Therefore, “CD244 receptors” might be a redundancy that means the same as “CD244” or it may refer to something else that binds CD244.
Claim 13 recites the limitation “the CD48 antagonist”. Here the antecedent is expected to be within claim 13, but it is not present. Claims 14, 16, and 18-20 are unclear as they depend from claim 13.
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 1-7, 9, 11-14, 16, 18-20, and 22-25 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-7, 9, 11, 12, and 22 are drawn to compositions comprising isolated hematopoietic progenitor cells (HPCs) expressing CD244 and CD48 and at least one of an exogenous CD48 ligand and a CD244 agonist. Claims 13, 14, 16, and 18-20 are drawn to a method of method for increasing in vitro production of ILC2 cells comprising providing to an isolated hematopoietic progenitor cell (HPC) population expressing CD48 and CD244, a composition comprising at least one of a CD48 ligand or a CD244 agonist. Claims 23-25 recite methods of treatment comprising administering cells produced by the method of claim 13.
The common elements in all the claims include “CD48 ligand” and “CD244 agonist”, which each denote a genus of molecules described by their function, with no structural limitation in claim 1. Dependent claim 11 recites that these genera may encompass any of several broad categories of structures and functions: “at least one of a small molecule, a peptide, a polynucleotide, a genetically modified cell expressing a CD244 agonist or CD48 ligand, an antibody, an antibody fragment capable of at least one of activating the CD244, inhibiting CD48/2B4 interaction, or a combination thereof.” The specification contemplates additional structures and functions including, agonist CD48 antibody, soluble CD244 or CD244 mimetic, CD244 fixed to a solid material such as a matrix or beads, chimeric antigen receptors binding CD244, cells capable of expressing agonist CD48 antibody, or any CD48 ligand or CD244 agonist known in the art ([0011] in publication US 20230355675).
Although the specification contemplates both CD48 agonists and CD48 antagonists, the only CD48 ligand that is reduced to practice is an anti-CD48 blocking antibody. This single species is, at most, exemplary of the subgenus of CD48 ligands that function as antagonists. This single example does not establish a structure-function relationship that would enable one of skill in the art to envision the structure of any other CD48 antagonist, let alone the entire genus of CD48 ligands.
The CD244 agonists described in the specification include a CD244 agonist cross-linking antibody and stroma expressing CD48. Thes two examples do not establish a structure-function relationship that would enable one of skill in the art to envision the structure of any other CD244 agonist.
Claims 13, 14, 16, 18-20, and 22-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for increasing in vitro production of ILC2 cells comprising providing to an isolated hematopoietic progenitor cell (HPC) population expressing CD48 and CD244, a composition comprising a CD244 agonist cross-linking antibody or stroma expressing CD48, does not reasonably provide enablement for compositions comprising or methods comprising the use of a CD48 ligand. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claims 13, 14, 16, and 18-20 are drawn to a method of method for increasing in vitro production of ILC2 cells comprising providing to an isolated hematopoietic progenitor cell (HPC) population expressing CD48 and CD244, a composition comprising at least one of a CD48 ligand or a CD244 agonist. Claims 23-25 recite methods of treatment comprising administering cells produced by the method of claim 13.
All claimed methods encompass an embodiment comprising contacting a HPC population expressing CD48 and CD244 with a CD48 ligand. Although the specification contemplates both CD48 agonists and CD48 antagonists, the only CD48 ligand that is reduced to practice is an anti-CD48 blocking antibody. The specification teaches that during development, the addition of anti-CD244 or anti-CD48 blocking antibody significantly abrogated ILC2 differentiation, while the proportion and absolute number of NK cells were increased (FIGS. 1D and 1E and FIGS. 2A and 2B). Thus, contacting HPC with the only disclosed CD48 ligand does not yield ILC2 cells. Therefore, embodiments comprising use of a CD48 ligand are not enabled to achieve the stated goal of the method of claims 13, 14, 16, and 18-20, and such embodiment would not produce the cells required for the method of claims 23-25.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647
Prosecution Insights