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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of anti-IL13Ra2 antibody W-ME107-117 in the reply filed on December 2, 2025 is acknowledged.
However, after further consideration, all species have been examined.
Claim Status
Applicant’s amendment filed October 12, 2022 was received and entered.
Claims 1-51 have been canceled.
Claims 52-91 have been added.
Claims 52-91 are pending and under consideration.
Priority
This application is a 371 of PCT/SE2021/050419 filed May 15, 2021, which claims priority to foreign application SWEDEN 2050572-3 filed May 15, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted on October 12, 2022 and April 30, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency 1 – This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The specification recites the amino acid sequence GFTFX1X2X3X4 on pg. 3 (line 18) and pg. 19 (lines 8 and 31). Sequences of 4 or more contiguous amino acids must be present in the sequences listing. However, the amino acid sequence GFTF or GFTFXXXX does not appear in the sequence listing.
Required response – Applicant must provide:
An amended "Sequence Listing" part of the disclosure;
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency 2 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). The specification recites the amino acid sequence GFTFX1X2X3X4 on pg. 3 (line 18) and pg. 19 (lines 8 and 31), which must include a sequence identifier.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 52 is objected to for the following informalities:
Claim 52 recites the amino acid sequence GFTFX1X2X3X4. As stated above, sequences comprising 4 or more contiguous amino acids require a sequence identifier (SEQ ID NO). Applicant must include a sequence identifier for GFTF or GFTFXXXX.
Claim 52 recites “wherein each Xn, n=1…4, is independently selected from” and “wherein each Bm, m=1…6”, is independently selected from”.
However, the claim should read “wherein each X1, X2, X3, and X4 is independently selected from…” and “wherein each B1, B2, B3, B4, B5, and B6 is independently selected from…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claims 60-72 are rejected under 35 U.S.C. 112(a), 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.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP § 2163.
Claims 60-61 are drawn to an antibody, or antigen binding fragment thereof, capable of binding to interleukin-13 receptor subunit alpha-2 (IL13Ra2), wherein the antibody has specificity for an epitope within a beta sheet area of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75, a second beta strand of amino acid numbers 101 to 109, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2.
The claims encompass a large genus of antibodies that bind to IL13Ra2, comprised of different combinations of heavy and light chain amino acid sequences, respectively, which represent structurally distinct polypeptides. The state of the art is such that antibody variable regions are composed of a heavy and light chain, each involved in providing for binding specificity. Variability in the antigen binding site is achieved by V(D)J recombination via heavy and light chain pairing, with the most diverse regions being the 6 CDR regions in the heavy and light chain. As taught by Janeway et al. (2001), the antibody repertoire in humans is at least 1011, with a large degree of diversity in both heavy and light chains. See also Rabia et al. (2018; pg. 4), which teaches that the maximal chemical diversity of antibody CDRs is unimaginably large and is extremely challenging to define the sequence determinant of antibody specificity.
Claims 62-70 further define the antibody one CDR at a time. However, the claims do not provide all 6 CDRs for the recited antibody.
Further, the claims encompass a broad genus of structurally different antibodies derived from both human and nonhuman species, that would have different VH and VL sequences with different affinities or pharmacokinetic properties.
The state of the art is such that antibody production is extremely complex and requires a deep understanding of protein-engineering techniques, mechanisms of action and resistance, and the interplay between the immune system. The development of candidate antibodies involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (Scott et al., 2012; pg. 278-279). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (Scott, pg. 278). Furthermore, antibodies can have various effector functions including receptor blockage, reducing signaling, or in vivo cell depletion, and that antibody isotype alone is not predictive of in vivo function (Chan et al., 2010, pg. 307).
The art recognizes that the function of binding antibodies is extremely complex and unpredictable. The in vivo impact of a therapeutic monoclonal antibody is determined by both its epitope specificity (e.g., blocking or non‐blocking of ligand interactions) and heavy‐chain constant region (Fc) effector function (e.g., depleting or non‐depleting). Varying the Fc properties of an antibody can significantly affect the biological impact in vivo, and mutations in the heavy chain constant region have been shown to have highly divergent Fc effector function, without changing antibody specificity (Huss et al., 2016, p. 276).
The specification discloses the structure (i.e., amino acid sequence) of 44 scFV clones that bind to IL13Ra2 [Table 9]. However, epitope mapping studies found only one scFV clone (W-ME107-117), having the epitopes recited in the instant claims. In fact, the instant specification discloses that W-ME107-117 has an epitope located on the opposite side of IL13Ra2 from where the epitopes of the W-ME107-10, W-ME107-27 and W-ME107-75 scFv clones were found [pt. 69]. Therefore, the instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description’ inquiry, whatever is now claimed." (See Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116).
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Given the claimed broad class of antibodies that bind the recited epitopes of IL13Ra2, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making antibodies with the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Claims 62-72 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim.
Claim Rejections - 35 USC § 112(b)
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.
Claims 52-59, 65-66, and 74-89 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 52, 56, and 65 recite the amino acid sequence for SEQ ID NO: 4 is GYSFPP. However, the amino acid sequence of SEQ ID NO: 4 is GYSFP. As such, it is unclear if the claims are referring to the sequence spelled out by letters, which has two prolines at the end, or the one in the sequence listing, which has only one proline.
Claims 53-55, 57-59, 66, and 74-89 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 52-56, 58-59, and 74-89 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 52 and 80 recite the term “preferably”, which renders the claims indefinite because one cannot ascertain the metes and bounds of what is and what is not allowed.
Claims 53-56, 58-59, 74-79, and 81-89 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 60-73 and 90-91 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 60 and 90 are drawn to an epitope within a beta sheet area of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75 in IL13Ra2, a second beta strand of amino acid numbers 101 to 109 in IL13Ra2, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2. However, it is unclear what amino acid sequence the specified positions are referring to, as there is no amino acid sequence recited for IL13Ra2.
Claims 61-73 and 91 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 60-73 and 90-91 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 60 and 90 are drawn to an epitope within a beta sheet area of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75 in IL13Ra2, a second beta strand of amino acid numbers 101 to 109 in IL13Ra2, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2. However, it is unclear what the epitope of IL13Ra2 is.
Specifically, claims 60 and 90 recite amino acid residues of the anti-IL13Ra2 binding epitopes, however, dependent claims 61 and 91 recite different amino acid residues. As such, one cannot determine when a peptide stops being part of an epitope that binds IL13Ra2. The instant specification discloses the epitope corresponds to the second and largest beta sheet in domain 1 of IL13Ra2. Domain 1 consists of a beta sandwich fold with two beta sheets on top of each other. The epitope is located in 3 of the 4 strands in the largest beta sheet and is in the area pointing away from the binding site of IL-13 to IL13Ra2 [pg. 11; Fig. 10]. However, the description makes it harder for one to envision the epitope as claimed.
Claims 61-73 and 91 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 61 and 91 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 61 and 91 recite the phrase “i.e.”. Phrases such as "i.e.” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 61 and 91 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 61 and 91 are drawn to an epitope of IL13Ra2 comprising at least one peptide selected from the group consisting of amino acid number 67 to 81, amino acid number 96 to 106, and amino acid number 123 to 128 in IL13Ra2.
However, claims 61 and 91 depend from claims 60 and 90 which recite the antibody has specificity for an epitope within a beta sheet of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75, a second beta strand of amino acid numbers 101 to 109, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2.
Therefore, the amino acid position numbers recited in claims 61 and 91 exceed the boundaries of the epitope binding site recited in claim 60. Specifically, positions 67, 76-81, 96-100, and 123 are outside of the claimed amino acid positions in IL13Ra2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 90-91 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The instant claims recite an epitope of interleukin-13 subunit alpha-2 (IL13Ra2). This judicial exception is not integrated into a practical application because the claims read on multiple counterparts to the nature-based product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The epitopes as claimed are naturally occurring peptides located in the IL13Ra2 receptor. The instant specification discloses that IL13Ra2 is over-expressed in a variety of cancers, particularly glioblastomas [pg. 1]. The claimed epitope corresponds to the second and largest beta sheet in domain 1 of IL13Ra2. Domain 1 consists of a beta sandwich fold with two beta sheets on top of each other. The epitope is located in 3 of the 4 strands in the largest beta sheet and is in the area pointing away from the binding site of IL-13 to IL13Ra2 [pg. 11; Fig. 10].
Without any evidence to the contrary, the protein functionality and structure would not be markedly different from the naturally occurring proteins. Because there is no difference in the characteristics (structural, functional, or otherwise) between the claimed and naturally occurring proteins, the claimed epitope peptides do not have markedly different characteristics from what exists in nature. See, e.g., MPEP 2106, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013); Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018).
Accordingly, the claims are directed to a judicial exception. Because the claim does not include any additional features that could add significantly more to the exception, the claim does not qualify as eligible subject matter under 35 U.S.C §101.
Claim Rejections - 35 USC § 102
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 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 90 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lupardus et al. (Structure, 2010; 18(3):332–342) (“Lupardus”).
The instant claims are drawn to an epitope of IL13Ra2, wherein the epitope is within a beta sheet area of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75, a loop following the first beta strand, a second beta strand of amino acid numbers 101 to 109, a loop preceding the second beta strand, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2.
The instant specification discloses the epitope corresponds to the second and largest beta sheet in domain 1 of IL13Ra2. Domain 1 consists of a beta sandwich fold with two beta sheets on top of each other. The epitope is located in 3 of the 4 strands in the largest beta sheet and is in the area pointing away from the binding site of IL-13 to IL13Ra2 [pg. 11; Fig. 10].
Lupardus discloses specific residues important for binding of IL13Ra2 to IL-13 which will provide a framework for development of IL-13 antagonists [Abstract]. Lupardus discloses the cytokine-binding region of IL-13Rα2 consists of three domains: an N-terminal S-type Ig domain (D1) and two fibronectin III-like domains (D2 and D3) [pg. 3].
Figure 1 below shows the structure of IL13Ra2 including the D1 domain which comprises the same epitopes as presently shown in instant claim 10.
PNG
media_image1.png
448
692
media_image1.png
Greyscale
Therefore, absent a showing of any difference, the IL13Ra2 epitopes disclosed by the prior art are deemed to anticipate the claimed methods.
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.
Claims 90-91 are rejected under 35 U.S.C. 103 as being unpatentable over Chene et al. (US 2021/0106652) (“Chene”).
The instant claims are drawn to an epitope of IL13Ra2, wherein the epitope is within a beta sheet area of IL13Ra2 comprising a first beta strand of amino acid number 68 to 75, a loop following the first beta strand, a second beta strand of amino acid numbers 101 to 109, a loop preceding the second beta strand, and a third beta strand of amino acid numbers 124 to 128 in IL13Ra2, wherein the epitope comprises a peptide consisting of WAETTY (SEQ ID NO: 46).
Chene discloses polypeptides comprising an IL13RA2 epitope which can be used as a target for antibodies [0179]. Chene discloses several IL13RA epitopes that are known tumor associated antigens [0182]. Preferred examples of IL13RA2 epitopes are disclosed in Table 1, including SEQ ID NO: 259 (QSSWAETTY).
Chene discloses several preferred epitopes of ILRa2, including QSSWAETTY which is located within the beta sheet of domain 1 of IL13Ra2 as instantly claimed.
The instant claims differ from Chene, in that the epitope comprises an additional 3 amino acids at the N-terminus (QSS). However, claims 90-91 recite the open language “comprising,” which does not exclude additional unrecited amino acid residues.
Accordingly, the combination of art references provided a prima facie case of obviousness.
Allowable Subject Matter
Claim 57 is objected to as being dependent on a rejected independent claim, but would be allowable if rewritten in independent form including all the limitations of the base claim.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 57 is drawn to an anti-IL13Ra2 antibody or antigen-binding fragment comprising the following VH and VL domain CDR amino acid sequences:
A VH domain CDR1 consisting of the amino acid sequence of SEQ ID NO: 101, a VH CDR2 consisting of the amino acid sequence of SEQ ID NO: 53; a VH CDR3 consisting of the amino acid sequence of SEQ ID NO: 65, a VL CDR1 consisting of the amino acid sequence of SEQ ID NO: 12, a VL CDR2 consisting of the amino acid sequence of AAS and a VL CDR3 consisting of the amino acid sequence of SEQ ID NO: 76; or a VH domain CDR1 consisting of the amino acid sequence of SEQ ID NO: 102, a VH CDR2 consisting of the amino acid sequence of SEQ ID NO: 55; a VH CDR3 consisting of the amino acid sequence of SEQ ID NO: 68, a VL CDR1 consisting of the amino acid sequence of SEQ ID NO: 12, a VL CDR2 consisting of the amino acid sequence of AAS and a VL CDR3 consisting of the amino acid sequence of SEQ ID NO: 78; or a VH domain CDR1 consisting of the amino acid sequence of SEQ ID NO: 104, a VH CDR2 consisting of the amino acid sequence of SEQ ID NO: 54; a VH CDR3 consisting of the amino acid sequence of SEQ ID NO: 70, a VL CDR1 consisting of the amino acid sequence of SEQ ID NO: 12, a VL CDR2 consisting of the amino acid sequence of AAS and a VL CDR3 consisting of the amino acid sequence of SEQ ID NO: 81; or a VH domain CDR1 consisting of the amino acid sequence of SEQ ID NO: 105, a VH CDR2 consisting of the amino acid sequence of SEQ ID NO: 7; a VH CDR3 consisting of the amino acid sequence of SEQ ID NO: 10, a VL CDR1 consisting of the amino acid sequence of SEQ ID NO: 12, a VL CDR2 consisting of the amino acid sequence of AAS and a VL CDR3 consisting of the amino acid sequence of SEQ ID NO: 11.
The amino acid sequences for the claimed anti-IL13Ra2 antibody CDR regions are free of prior art. The closest prior art to the claimed amino acid sequences, WO 2020/123691, is directed towards anti-CD20 antibodies, however, does not teach or suggest the presently claimed anti-IL13Ra2 antibodies.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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, Daniel Kolker can be reached on (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644