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 .
Status of the Claims
Claims 1-128 were originally filed February 13, 2024.
The amendment received May 22, 2024 canceled claims 1-33, 35-37, 40, 42-64, and 66-123.
The amendment received December 23, 2025 canceled claims 34, 38, 39, 41, and 65 and added new claims 129 and 130.
Claims 124-130 are currently pending.
Claims 124-126, 129, and 130 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 124-128; now claims 124-130) in the reply filed on December 23, 2025 is acknowledged.
Applicant’s election of an IL-1R antagonist and Ne-(4-(4-iodophenyl)butanoyl)lysine as the species in the reply filed on December 23, 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)).
Claims 127 and 128 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 23, 2025.
Priority
The present application claims status as a DIV of 17/540,316 filed December 2, 2021 (now U.S. Patent 11,939,617) which claims status as a DIV of 15/695,831 filed September 5, 2017 (now U.S. Patent 11,214,820) which claims the benefit of 62/383,382 filed September 2, 2016.
The present application is a CON of 17/540,316 filed December 2, 2021 (now U.S. Patent 11,939,617) because the restriction requirement was withdrawn in the Notice of Allowance mailed November 14, 2023 (see page 2). In addition, the claims were not rejoined because a method was elected and the particulars of the method were not present in the canceled claims (see page 3 of the Notice of Allowance received November 14, 2023).
Application 15/695,831 is also a CON because the claims were canceled, not in response to a Restriction Requirement, but in response to a Non-Final Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 10, 2025 is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See Table 1.
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.
Specification
The disclosure is objected to because of the following informalities: the first line of the specification should be updated to include 17/540,316 filed December 2, 2021 (now U.S. Patent 11,939,617) and 15/695,831 filed September 5, 2017 (now U.S. Patent 11,214,820).
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 130 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how an engineered protein scaffold is necessarily a therapeutic polypeptide or how an Fc fusion is necessarily a therapeutic polypeptide.
Claim Rejections - 35 USC § 102
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.
Claims 124, 125, 129, and 130 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dennis et al., 2002, Albumin Binding as a General Strategy for Improving the Pharmacokinetics of Proteins, The Journal of Biological Chemistry, 277(38): 35035-35043.
For present claims 124, 125, 129, and 130, Dennis et al. teach polypeptides which bind albumin comprising an acetylated amino acid and/or an amidated amino acid (i.e. non-natural) conjugated to Fab (i.e. antigen-binding polypeptide) (please refer to the entire reference particularly the abstract; page 35036, left column, first paragraph; “Construction, Expression, and Purification of D3H44-L and D3H44-Ls-D3H44 Fab”; Tables I-III).
Therefore, the teachings of Dennis et al. anticipate the presently claimed composition.
Claims 124-126, 129, and 130 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neri et al. U.S. Patent Application Publication 2010/0172844 published July 8, 2010.
For present claims 124-126, 129, and 130, Neri et al. teach polypeptides comprising modified lysines which bind albumin (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) conjugated to therapeutic agents including proteins, peptides, antibodies and antibody fragments (i.e. antigen-binding polypeptide; Fc fusion) (please refer to the entire specification particularly the abstract; Figures 1, 2, 7-10; paragraphs 1, 3-7, 9, 17, 19-24, 30-101, 119-121, 126, 127; claims).
Therefore, the teachings of Neri et al. anticipate the presently claimed composition.
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.
Claims 124-126, 129, and 130 are rejected under 35 U.S.C. 103 as being unpatentable over Dennis et al., 2002, Albumin Binding as a General Strategy for Improving the Pharmacokinetics of Proteins, The Journal of Biological Chemistry, 277(38): 35035-35043 and Neri et al. U.S. Patent Application Publication 2010/0172844 published July 8, 2010.
For present claims 124-126, 129, and 130, Dennis et al. teach polypeptides which bind albumin comprising an acetylated amino acid and/or an amidated amino acid (i.e. non-natural) conjugated to Fab (i.e. antigen-binding polypeptide) (please refer to the entire reference particularly the abstract; page 35036, left column, first paragraph; “Construction, Expression, and Purification of D3H44-L and D3H44-Ls-D3H44 Fab”; Tables I-III).
However, Dennis et al. does not teach Ne-(4-(4-iodophenyl)butanoyl lysine.
For present claims 124-126, 129, and 130, Neri et al. teach polypeptides comprising modified lysines which bind albumin (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) conjugated to therapeutic agents including proteins, peptides, antibodies and antibody fragments (i.e. antigen-binding polypeptide; Fc fusion) (please refer to the entire specification particularly the abstract; Figures 1, 2, 7-10; paragraphs 1, 3-7, 9, 17, 19-24, 30-101, 119-121, 126, 127; claims).
All the claimed elements (i.e. albumin binding polypeptides conjugated to therapeutic polypeptides; Ne-(4-(4-iodophenyl)butanoyl lysine) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. albumin binding to provide increased half-life to therapeutic polypeptides) and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. one nonnatural amino acid) for another (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) would have yielded predictable results (i.e. albumin binding) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. inserting Ne-(4-(4-iodophenyl)butanoyl lysine for albumin binding) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 124-126, 129, and 130 are rejected under 35 U.S.C. 103 as being unpatentable over Holt et al. WO 2005/118642 published December 15, 2005 and Dumelin et al., 2008, A Portable Albumin Binder from a DNA-Encoded Chemical Library, Angew Chem Int Ed, 47: 3196-3201.
For present claims 124-126, 129, and 130, Holt et al. teach polypeptides comprising an antigen-binding fragment or antibody which binds albumin and a therapeutic agent including IL-1R antagonist, plasma proteins (i.e. blood factor), enzymes, antibodies (i.e. antigen-binding polypeptide), growth factors, interleukins, hormones, etc. and wherein radionuclides (i.e. I125, I126) can also be bound (please refer to the entire specification particularly the abstract; pages 1-4, 9-12, 15-17, 20, 22, 27, 31-34, 45-50).
However, Holt et al. does not teach Ne-(4-(4-iodophenyl)butanoyl lysine.
For present claims 124-126, 129, and 130, Dumelin et al. teach that 4-(p-iodophenyl)butyric acid lysine derivatives (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) bind albumin and can be utilized to increase the half-life of drugs (please refer to the entire reference particularly the pages 3196, 3197; Figures 1-3, 5).
All the claimed elements (i.e. albumin binding polypeptides conjugated to therapeutic polypeptides; Ne-(4-(4-iodophenyl)butanoyl lysine) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. albumin binding to provide increased half-life to therapeutic polypeptides) and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. one amino acid) for another (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) would have yielded predictable results (i.e. albumin binding) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. inserting Ne-(4-(4-iodophenyl)butanoyl lysine for albumin binding) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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 124-126 and 129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,214,820. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to the end product of the method as claimed in U.S. Patent No. 11,214,820 (i.e. polypeptides with an Ne-(4-(4-iodophenyl)butanoyl lysine).
Claims 124-126, 129, and 130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,214,820 in view of Holt et al. WO 2005/118642 published December 15, 2005.
U.S. Patent No. 11,214,820 claims methods of inserting Ne-(4-(4-iodophenyl)butanoyl lysine into polypeptides.
However, U.S. Patent No. 11,214,820 does not claim the therapeutic polypeptides of present claim 130.
Holt et al. teach polypeptides comprising an antigen-binding fragment or antibody which binds albumin and a therapeutic agent including IL-1R antagonist, plasma proteins (i.e. blood factor), enzymes, antibodies (i.e. antigen-binding polypeptide), growth factors, interleukins, hormones, etc. and wherein radionuclides (i.e. I125, I126) can also be bound (please refer to the entire specification particularly the abstract; pages 1-4, 9-12, 15-17, 20, 22, 27, 31-34, 45-50).
All the claimed elements (i.e. albumin binding polypeptides conjugated to therapeutic polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. albumin binding to provide increased half-life to therapeutic polypeptides) and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. genus of polypeptides) for another (i.e. subgenus of therapeutic polypeptides in present claim 130) would have yielded predictable results (i.e. albumin binding to increase half-life) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. inserting Ne-(4-(4-iodophenyl)butanoyl lysine for albumin binding into therapeutic polypeptides) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 124-126, 129, and 130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,939,617 in view of Holt et al. WO 2005/118642 published December 15, 2005.
U.S. Patent No. 11,939,617 claims Ne-(4-(4-iodophenyl)butanoyl lysine.
Holt et al. teach polypeptides comprising an antigen-binding fragment or antibody which binds albumin and a therapeutic agent including IL-1R antagonist, plasma proteins (i.e. blood factor), enzymes, antibodies (i.e. antigen-binding polypeptide), growth factors, interleukins, hormones, etc. and wherein radionuclides (i.e. I125, I126) can also be bound (please refer to the entire specification particularly the abstract; pages 1-4, 9-12, 15-17, 20, 22, 27, 31-34, 45-50).
All the claimed elements (i.e. albumin binding polypeptides conjugated to therapeutic polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. albumin binding to provide increased half-life to therapeutic polypeptides) and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine) for another (i.e. Ne-(4-(4-iodophenyl)butanoyl lysine inserted into therapeutic polypeptides) would have yielded predictable results (i.e. albumin binding to increase half-life) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. inserting Ne-(4-(4-iodophenyl)butanoyl lysine for albumin binding into therapeutic polypeptides) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brandt et al., 2022, “Clickable” Albumin Binders for Modulating the Tumor Uptake of Targeted Radiopharmaceuticals, Journal of Medicinal Chemistry, 65: 710-733.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2006/051288
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658