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 with traverse of Group I, claims 3, 4, 11, 15, 17, 18, 20, 24-27, 65, 67, and 68, drawn to a contiguous polypeptide, an isolated polypeptide, as well as an isolated nucleic acid encoding and a host cell comprising said contiguous polypeptide, in the reply filed on 11/21/2025 is acknowledged. The traversal is on the ground(s) that Groups I-VI share a special technical feature and, therefore, a search and evaluation of each of Groups I-VI would cover a unified special technical feature. This is not found persuasive. As stated in the Requirement for Restriction/Election, 37 CRF 1.475(b) limits unity of invention to a single product and process of use, but the instant application claims multiple products and processes of use. This means unity of invention is lacking.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of the species SEQ ID NO: 136, which encompasses SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 184, and SEQ ID NO: 117, in the reply filed on 11/21/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
Claims 3, 4, 11, 18, 20, 25, 26, 28, 29, 65, 67, 68, 70, 72, 79, 83, and 85-90 are pending. Claims 28, 29, 70, 72, 79, and 83 are withdrawn as non-elected inventions. Claims 3, 4, 11,18, 20, 25, 26, 28, 65, 67, 70, 72, 79, and 83 are currently amended. Claim 29 was previously presented. Claims 85-90 are new. Claims 1, 2, 5-10, 12-17, 19, 21-24, 27, 30-64, 66, 69, 71, 73-78, 80-82, and 84 have been cancelled by the Applicant.
Priority
The instant application is the 371 national stage entry of PCT/US2021/028679, filed 4/22/2021, which claims priority to the provisional applications 63/014,573, filed 4/23/2020, and 63/014,090, filed 4/22/2020. The priority date of 4/22/2020 is acknowledged.
Information Disclosure Statement
The IDS’s submitted on 10/19/2022, 11/28/2023, 10/16/2024, 5/7/2025, 6/18/2025, and 11/21/2025 are under consideration.
Drawings
The drawings are objected to because 1) for Figures 4-8, it is unclear a) what the units of concentration and time are and b) which concentrations correspond to which lines in the time graphs because the concentrations are all similar shades of gray; and 2) for Figures 9 and 11, it is unclear which lines in the right most panel correspond to the lines in the left and middle panels because the lines are all similar shades of gray. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the "Sequence Listing" part of the disclosure submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is not the same as the CRF of the "Sequence Listing" as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide:
A replacement "Sequence Listing" as described above in items 1) c) or d) in accordance with 37 CFR 1.825(b)(1)(ii) or (iii); as well as
An amendment specifically directing its entry into the application as required by 37 CFR 1.825(b)(2)(ii);
A statement that identified the locations of any deletions, replacements or additions to the “Sequence Listing” as required by 37 CFR 1.825(b)(3);
A statement that the "Sequence Listing" added by amendment includes no new matter as required by 37 CFR 1.825(b)(5);
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4); and
A statement that the content of the previously-filed CRF is identical to the "Sequence Listing" part of the disclosure added by amendment as required by 37 CFR 1.825(b)(7), where provided under item 1) c) or d) (note that where a "Sequence Listing" part of the disclosure is provided under item 1) a) or b), the text file will also serve as the CRF, and the statement of identity is not required);
OR
A CRF as required by 37 CFR 1.821(e)(1) or 1.821(e)(2); and
A statement that the content of the CRF is identical to the "Sequence Listing" part of the disclosure previously submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Specifically, it is noted that the Sequence Listing contains 183 sequences but the CRFE only contains SEQ ID NO: 1.
Claim Interpretation
It is noted that claim 90 depends from claim 1, which is cancelled. For purposes of examination, claim 90 is being interpreted as depending from claim 3, which is currently pending, instead of claim 1.
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 3, 4, 11, 18, 20, 25, 26, 66, 67, 86-87, and 90 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 3 recites the limitation that the “FP is a fusion partner, optionally an IgG Fc polypeptide”. The instant specification defines a fusion partner as “an additional component of an IL13R/ILR4 contiguous polypeptide” and then provides examples of polypeptides or other proteins or fragments thereof ([0070]). This definition renders the scope of the claim indefinite because it is unclear whether the fusion partner is limited to polypeptides or can comprise other attachments or molecules in addition to polypeptides. Further, by virtue of their dependency on claim 3, claims 4, 11, 18, 20, 25, 26, 66, 67, and 86-87 are hereby rejected for this same reasoning.
For purposes of examination, a fusion partner is being interpreted as a polypeptide or other protein-based molecule.
Regarding claim 4, the phrase "such as" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the claim is being interpreted such that the IgG Fc variant has increased affinity relative to the wild-type Fc.
Claim 90 depends from claim 1, which is cancelled. Thus, the scope of the claim is indefinite.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 90 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claim 90 recites the elected SEQ ID NO: 136, which exhibits the general formula, IL4R-L1-IL13R-L2-FP and does not correspond to any of formula III-VI recited in parent claim 3. Therefore, claim 90 does not recite all the limitations of its parent claim.
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.
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.
Claim 4 is 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.
Claim 4 recites the polypeptide comprises a variant IgG Fc polypeptide from a companion animal species capable of binding to neonatal Fc receptor (FcRn) with an increased affinity relative to the wild-type Fc polypeptide, such as at a low pH. The rejection stems from the fact that this limitation recites a feature (a variant IgG Fc polypeptide) by functional (an increased affinity for FcRn relative to the wild-type Fc polypeptide) rather than structural language. There is nothing further in the claim to indicate the structural feature(s) (i.e., an amino acid sequence(s)) required to meet this functional limitation, and describing an invention by function is insufficient to meet the written description requirement.
Per MPEP 2163(II)(3)(a), for some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, "(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 ("The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes" where the genes were novel combinations of known DNA segments.). However, the claimed invention itself must be adequately described in the written disclosure and/or the drawings. For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
Brondyk (US2024209096A1 ([0005-0075]) and US2024209062A1 ([0005-0135]), both published 6/27/2024 after Applicant’s effective filing date) teaches a variety of canine and feline IgG Fc polypeptides, respectively, that exhibit increased binding to their respective FcRn relative to their wildtype counterparts under acidic conditions. Both publications by Brondyk list hundreds of potential canine and feline IgG Fc variants. Based on the lack of structural limitations recited, any of these would meet the limitations of the instant claim 4. Importantly, the examples from Brondyk only recite IgG species from dogs and cats; however, the claim contemplates IgG Fc polypeptides from companion animals, which per the instant specification, encompasses any animal suitable to be a companion to humans ([0041]), wherein examples include but are not limited to dogs, cats, horses, rabbits, ferrets, guinea pigs, rodents. Thus, the claim effectively reads on any IgG Fc variant from an animal kept as a companion by a human so long as it exhibits increased binding to FcRn relative to its wildtype counterpart.
Applicants have disclosed IgG Fc variants with mutations relative to their wild-type counterparts such as those described in embodiments 61 and 62 (instant specification Pg 11-13) as well as SEQ ID NO: 116-129 in embodiment 63 (Pg 13), which collectively encompass substitutions of the naturally-occurring residue for Tyr, Phe, or His at a handful of positions in IgG Fc’s derived from dogs, cats, and horses. However, the claim listed above is written such that it contemplates or includes additional compounds that retain the same functional characteristics beyond these instant examples. Thus, the instant specification does not provide adequate written description to possess the broad genus described above.
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.
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 3, 11, 18, 20, 25, 26, 67, 68, and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over Zhan et al. (WO 2018195388 A1, published 10/25/2025, cited on IDS filed 11/28/2023), as evidenced by Chen et al. (Fusion protein linkers: property, design and functionality. Adv Drug Deliv Rev. 2013 Oct;65(10):1357-69.).
Zhan teaches IL13R/IL4R fusion polypeptides derived from companion animal species that bind to IL13 and/or IL4 (Abstract). Zhan teaches that both IL13 and IL4 play important roles in T-cell mediated immune responses associated with allergies; IL4 can form a signaling complex with either heterodimeric receptors IL4 receptor subunit alpha (IL4R) and γc or IL4R and IL13 receptor subunit alpha-1 (IL13R); and the extracellular domains of IL4Ra or IL13Ra1 bind to IL4 and/or IL13, thus reducing the concentration of free cytokines and reducing immune signs associated with allergies ([0003]). Zhan teaches fusion polypeptides that comprise two different formulas: formula I (IL13R-L1-IL4R-L2-FP) or II (IL4R-L1-IL13R-L2-FP), wherein IL13R is an extracellular domain of an IL13R polypeptide derived from the companion animal species, IL4R is an extracellular domain of an IL4 polypeptide derived from the companion animal species, L1 is a first optional linker, L2 is a second optional linker, and FP is a fusion partner ([0005-0006]).
Zhan does not teach the instant formulas III-VI as recited in claim 3.
However, it would have been prima facie obvious to try rearranging the order of the individual components - IL13R, IL4, and FP - connected by linkers. At the time of filing, the art recognized that connecting peptides or peptide domains to each other through flexible linkers allowed the fusion protein to retain the individual structure and functionalities of the peptides or peptide domains, as evidenced by Chen (see Introduction, Pg1; 3.1 Flexible linkers, Pg 4-5). Zhan teaches that a similar degree of flexibility exists within formulas I and II, as the relative positioning of IL4R, IL13R, and FP can be altered such that IL4R or IL13R can occupy the N-terminal region of the fusion polypeptide while still retaining the individual functionalities of each domain. One of ordinary skill in the art would recognize that a fusion peptide comprising three independent peptides/peptide domains connected by linkers could only be combined in six different ways; moreover, one would recognize that after trying the orientation taught by Zhan, wherein the FP is at the C-terminus and is preceded by IL4R and IL13R, there would only be four additional possible combinations, the instant formulas III-VI. Therefore, it would be obvious to try each possible combination of IL4R, IL13R, and FP, based upon the teachings of Zhan as evidenced by Chen, thus leading one to the instant formulas III-VI.
Moreover, per MPEP 2144.04(VI)(C), rearrangement of parts is one legal precedent recognized by the courts as directed to common practices that normally require only ordinary skill in the art and are considered routine expedients: “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).” In the instant case, the parts at hand are IL13R, IL4R, and FP, which can easily be rearranged and connected through linkers L1 and L2 to arrive at the instant formulas III-VI; Zhan teaches as much by disclosing two different formulas (I and II) comprising IL13R, IL4R, and FP, each of which encompasses the same parts in a different order relative to the other formula.
Regarding claim 11, Zhan teaches that the extracellular domain of IL13R exhibits at least 95% sequence identity to SEQ ID NO: 22, which is identical to the elected SEQ ID NO: 22 ([0011]; Table 1, Pg 13).
Regarding claim 18, Zhan teaches SEQ ID NO: 22, which is 100% identical to the elected SEQ ID NO: 22 (Table 1, Pg 13).
Regarding claim 20, Zhan teaches that the extracellular domain of IL14R exhibits at least 95% sequence identity to SEQ ID NO: 23, which is identical to the elected SEQ ID NO: 22 ([0013]; Table 1, Pg 13-14).
Regarding claim 25, Zhan teaches SEQ ID NO: 23, which is 100% identical to the elected SEQ ID NO: 23 (Table 1, Pg 13-14).
Regarding claim 26, Zhan teaches L1 and L2 can each independently comprise an amino acid sequence selected from glycine-serine rich linkers ([0014]), such as GSGS, which corresponds to the elected SEQ ID NO: 151. The linker GGGSG is also taught and shown in SEQ ID No: 15 of Table 1 (Pg 10).
Regrading claim 67, Zhan claims an isolated nucleic acid encoding the polypeptide (claim 25).
Regarding claim 68, Zhan claims a host cell comprising the nucleic acid (claim 26).
Regarding claims 86 and 87, as stated above, Zhan teaches an IL13R polypeptide with 95-100% sequence identity to SEQ ID NO: 22 and an IL4R polypeptide with 95-100% sequence identity to SEQ ID NO: 23 ([0011, 0013]; Table 1, Pgs 13-14).
Claims 3, 4, 11, 18, 20, 25, 26, 65, 67, 68, and 85-90 are rejected under 35 U.S.C. 103 as being unpatentable over Zhan et al. (WO 2018195388 A1, published 10/25/2025, cited on IDS filed 11/28/2023), as evidenced by Chen et al. (Fusion protein linkers: property, design and functionality. Adv Drug Deliv Rev. 2013 Oct;65(10):1357-69.), as applied to claims 3, 11, 18, 20, 25, 26, 67, 68, 86, and 87, and further in view of Lu et al. (US 2018/0009869 A1, published 1/11/2018).
The teachings of Zhan have been set forth above. Additionally, Zhan teaches SEQ ID NO: 21, which comprises the instant SEQ ID NO: 136, which comprises SEQ ID NO: 23-L1-SEQ ID NO: 22-L2-SEQ ID NO: 117. The only difference between the two fusion proteins is that Zhan has a Leu at position 584 whereas the instant SEQ ID NO: 136 has a Tyr at the same position, which corresponds to residue 565 (which also corresponds to position 23 in SEQ ID NO: 117). Zhan also does not teach that the FP can be a variant IgG Fc polypeptide with increased affinity for FcRn relative to the wild-type Fc.
Lu teaches leptin fusion proteins comprising leptin and a second protein, either of which can be human, canine or feline (Abstract). Lu teaches that Fc-Leptin fusion proteins are believed to further increase the in vivo half-life of leptin through introduction of mutations to the Fc domain of the fusion protein and increase the binding affinity to FcRn. One particular fusion protein of the invention includes a Fc-leptin fusion protein to SEQ ID NO: 48 ([0019]). SEQ ID NO: 48 of possesses a Tyr residue instead of a Leu residue at the position equivalent to position 23 in SEQ ID NO: 117/position 565 in SEQ ID NO: 136.
Thus, regarding claims 4, 65, and 90, Zhan teaches that the FP can be a companion animal IgG Fc, like the one encompassed in SEQ ID NO: 21 which is nearly identical to SEQ ID NO: 117 as described above. Lu teaches a canine IgG Fc with improved ability to bind FcRn that has a Leu to Tyr substitution at the position corresponding to position 23 of SEQ ID NO: 117. In light of these teachings, it would be prima facie obvious to substitute the Leu at position 23 in SEQ ID NO: 21 of Zhan for Tyr, thereby arriving at the instant SEQ ID NO: 117 and 136, in order to improve the ability of the IgG Fc to bind to FcRn. One skilled in the art would have a reasonable expectation of success as Lu demonstrated that this substitution in this sequence not only improves the binding of the fusion protein to FcRn but also increases the overall half-life of the fusion protein as well.
Regarding claim 85, as stated above, Zhan and Lu teach SEQ ID NO: 117.
Regarding claims 88 and 89, as stated above, Zhan and Lu teach a polypeptide wherein IL13R comprises a sequence with at least 95-100% sequence identity to SEQ ID NO: 22, IL4R comprises a sequence with at least 95-100% sequence identity to SEQ ID NO: 23, L1 and L2 comprise linkers, and FP comprises 100% sequence identity to SEQ ID NO: 117.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 4, 11, 18, 20, 25, 26, 65, and 85-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, 23, and 28 of U.S. Patent No. 11,970,526 (US ‘526). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘526 recites a polypeptide comprising an amino acid sequence at least 95% identical to a sequence selected from the group consisting of SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO 18, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 28, SEQ ID NO: 29, SEQ ID NO: 30, and SEQ ID NO: 31. SEQ ID NO: 21 exhibits >99% sequence identity to the instant SEQ ID NO: 136.
Dependent claims include those specifically drawn to SEQ ID NO: 21 (claims 14 and 23) and a pharmaceutical composition comprising thereof (claim 28).
Claims 3, 4, 11, 18, 20, 25, 65, and 86-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 14 of U.S. Patent No. 12,428,466 (US ‘466). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘466 recites a heterodimeric protein comprising: a) a first contiguous polypeptide comprising at least one IL13R extracellular domain (ECD) and a first Fc polypeptide, wherein the amino acid sequence of the at least one IL13R ECD is SEQ ID NO: 22, SEQ ID NO: 24, SEQ ID NO: 26, SEQ ID NO: 32, or SEQ ID NO: 34, SEQ ID NO: 36, and b) a second contiguous polypeptide comprising at least one IL4R ECD and a second Fc polypeptide,
wherein the amino acid sequence of the at least one IL4R ECD is SEQ ID NO: 23, SEQ ID NO: 25, SEQ ID NO: 27, SEQ ID NO: 33, SEQ ID NO: 35, or SEQ ID NO: 37, wherein the IL13R ECD and/or the IL4R ECD are derived from a companion animal species.
Dependent claims include dissociation constant characteristics of the polypeptide (claim 4), the companion animal species (claim 5), the companion animal IgG species (claim 6), and a pharmaceutical composition thereof (claim 14).
Claims 3, 4, 11, 18, 20, 25, 26, 65, and 85-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 12-13 of copending Application No. 18/617,972 (‘972 reference application; claim set filed 3/27/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 recites a method of treating a companion animal species having an IL13-induced condition and/or an IL-4-induced condition, the method comprising administering to the companion animal species a therapeutically effective amount of a polypeptide comprising an amino acid sequence at least 95% identical to a sequence selected from the group consisting of SEQ ID NO: 13-21 and 28-31. SEQ ID NO: 21 exhibits >99% sequence identity to the instant SEQ ID NO: 136. Moreover, the instant specification indicates that the instant polypeptides can be used to treat IL13- and/or IL-4-induced conditions in companion animal species ([0019]).
Dependent claims include the companion animal species (claim 2), the species of IL13 and/or IL4-induced condition (claims 3 and 4), and percent identity to SEQ ID NO: 21 (claims 12 and 13).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3, 4, 65, and 88-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, 20, 24, 26, 30, 31, 40-43 and 46 of copending Application No. 17/284,875 (‘875 reference application; claim set filed 7/3/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 recites a polypeptide comprising a variant IgG Fc polypeptide comprising an amino acid sequence with at least 95% sequence identity to SEQ ID NO: 14 wherein said variant IgG Fc polypeptide comprises a tyrosine at position 24. SEQ ID NO: 14 of copending Application No. ‘875 is identical to the instant SEQ ID NO: 117.
Dependent claims include variant Fc polypeptide has increased serum half-life (claim 2), the variant is canine (claim 6), the percent identity and affinity for FcRn of the variant (claims 7, 20, 31, 40-42 and 46), the variant is a fusion polypeptide (claim 24), the variant is an IgG Fc canine polypeptide (claim 26), the receptors the variant IgG Fc has altered affinity for (claim 30), the IgG subtype (claim 43).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658