DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of group I, claims 1-3, 5-6, 8, 12-13, 15, 27, 36, and 51-52, in the reply filed on 8/4/26 is acknowledged. Applicant has further elected a mutant IL-1alpha, wherein the only mutation is deletion of amino acids 1-6 and a VHH targeting moiety directed against a tumor cell. Upon reconsideration, the species election requirement between linker and Fc region is withdrawn. Claims 42-44, 46, 63, 86, and 92 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 2-3, 5-6, and 52 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species.
Claims 1, 8, 12-13, 15, 27, 36, and 51 are being acted upon.
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 13, 15 and 36 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 13 is unclear since it recites an “or” separating some of the elements in line 3, but also recites and “and/or” separating in the next line, and further recites an “or” after the “and/or”. The scope of the claims is unclear and indefinite due to the numerous or and and/or separating the options to which the targeting moiety binds to.
Regarding claim 15, the recitation of "e.g. cysteine knot protein, knottin” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 36 recites that the chimeric protein complex is a heterodimer and has a trans orientation/configuration. The scope of the claimed structures is unclear. For example, one embodiment recites that the trans configuration relates to any targeting moiety and IL-1a, relative to each other. The claim depends from claim 1, which is directed to a chimeric protein complex comprising a mutant IL-1alpha, and one or more targeting moieties, with a connector such as an Fc domain. If the IL-1 and the targeting moiety are on different sides of the Fc domain, does this meet the limitation that the IL-1 and targeting moiety are in trans configuration relative to each other? Does the trans configuration actually require two different targeting moiety/IL-1 containing polypeptides, and the limitation refers to how they are arranged with respect to each other? The other embodiments in claim 36 are also indefinite for similar reasons. For example, the claim recites trans configuration as relates to “any targeting moieties relative to each other”, but depends from claim 1, which encompass one targeting moiety. Although claim 36 is directed to a heterodimer, it does not specify that each heterodimer has a targeting moiety and/or IL-1. For example, a chimeric complex comprising a chimeric protein having one targeting moiety, IL-1, and an Fc protein linked to chimeric protein comprising an IL-2-Fc protein, would be a chimeric protein complex that is a heterodimer. Or does the recitation of targeting moiety/IL-1 “relative to each other” mean that a second heterodimer needs to comprise a second targeting moiety and a IL-1 mutant? The scope of the claim is unclear and indefinite.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 8 and 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20110091411 (of record).
The ‘411 publication teaches a chimeric protein complex comprising an IL-1alpha protein consisting of SEQ ID NO: 63, which is a mutant IL-1alpha that represents a deletion of amino acids 1-6 from SEQ ID NO: 3 of the instant claims (See attached alignment). The ‘411 publication teaches that the chimeric protein further comprises a flexible linker and a virus like particle (i.e. a targeting moiety that comprises recognition domains that binds to receptors, see paragraphs 59-60 and Example 16, in particular. The ’411 publication teaches a vaccine composition comprising said chimeric protein, and since a virus like particle would comprise numerous antigens that induce an immune response, it also meets the limitations of claim 51.
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.
Claim 1, 8, 12-13, 15, 27, 36, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/191519 (of record), in view of US 20110091411 (of record), and AU 5379590.
WO 2019/191519 teaches a chimeric protein and complexes of said chimeric proteins, wherein the chimeric protein comprises a signaling agent and a targeting moiety with an Fc domain between them (see page 2 and drawings in particular). WO 2019/191519 teaches that the targeting moiety can be a VHH and can target an antigen or receptor expressed on a tumor cell, and can contain any of the signaling agents described here (see page 57 and 126-127, in particular). WO 2019/191519 teaches that the signaling agent can be IL-1, such as IL-1a and that the signaling agent can be wild-type or mutant, and can have an N-terminal truncation (See page 26 and 47, in particular). WO 2019/191519 teaches that the Fc domain can have one or more mutations that promote Fc pairing, stability, or reduce effector function (see page 11, in particular). WO 2019/191519 teaches that the complexes can be heterodimeric and have a trans orientation/configuration (see page 19 and the drawings in particular).
The reference differs from the claimed invention in that it does not explicitly teach a mutant IL-1a wherein the mutation is a deletion of amino acids 1-6 of SEQ ID NO: 3.
AU 5379590 teaches IL-1 linked to an antibody can be used to treat cancer by delivering it to the tumor, wherein the IL-1 acts as a biological response modifier (see page 9 and claims 1,4, in particular). AU 5379590 teaches that doing so is advantageous since it targets the biological response modifier directly to the tumor wherein it can increase host defense mediated processes (see page 11, in particular). AU 5379590 teaches that the antibodies/biological response modifiers can be administered in combination with an interferon (see page 18, in particular).
The ‘411 publication teaches a chimeric protein complex comprising an IL-1alpha protein consisting of SEQ ID NO: 63, which is a mutant IL-1alpha that represents a deletion of amino acids 1-6 from SEQ ID NO: 3 of the instant claims (See attached alignement0. The ‘411 publication teaches said IL-1a is biologically active (see example 16).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the IL-1a having residues 1-6 deleted of the ‘411 publication, as the IL-1a in the chimeric proteins of WO 2019/191519. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘411 publication teaches that it is suitable for use in chimeric proteins and is biologically active. Furthermore, the ordinary artisan would be particularly motivated to select a construct comprising both IL-1a and a tumor targeting VHH, as the combination of elements, since AU 5379590 teaches IL-1 linked to an antibody can be used to treat cancer by delivery to the tumor, which is advantageous since it targets it directly to the tumor wherein it can increase host defense mediated processes.
Regarding claim 51, it would be obvious to include a different cytokine such as an interferon, as suggested by WO 2019/191519 or the ‘411 publication, which would be within the scope of an “antigen” which can induce an immune response. This would render obvious all the components of the claimed “vaccine” composition.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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