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.
The amendment received August 19, 2026 amended claims 124 and 129; canceled claims 126, 130; and added new claim 131.
Claims 124, 125, 127-129, and 131 are currently pending.
Claims 124, 125, and 129 are currently under consideration.
Election/Restrictions
Applicant elected, without traverse, Group III (claims 124-128; now claims 124-130) in the reply filed on December 23, 2025.
Applicant elected, without traverse, an IL-1R antagonist and Ne-(4-(4-iodophenyl)butanoyl)lysine as the species in the reply filed on December 23, 2025. 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Claims 127, 128, and 131 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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is a CON of 17/540,316 filed December 2, 2021 (now U.S. Patent 11,939,617) because the restriction requirement was withdrawn in the Notice of Allowance mailed November 14, 2023 (see page 2).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 August 19, 2026 is being considered by the examiner.
Specification
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.
Withdrawn Objection
The objection to the disclosure regarding 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) is withdrawn in view of the amendment received August 19, 2026.
New Objections Necessitated by Amendment
Claim Objections
Claim 124 is objected to because of the following informalities: “comprising Ne-(4-(4-iodophenyl)butanethioyl)lysine” should read “wherein at least one of the one or more non-natural amino acids is Ne-(4-(4-iodophenyl)butanethioyl)lysine”. Appropriate correction is required.
Claim 129 is objected to because of the following informalities: a conjunction is missing in the Markush group. Appropriate correction is required.
Withdrawn Rejections
The rejection of claim 130 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 is withdrawn in view of the amendment received August 19, 2026.
The rejection of claims 124, 125, 129, and 130 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 is withdrawn in view of the amendment received August 19, 2026.
The rejection of claims 124-126, 129, and/or 130 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,214,820 alone or in combination with Holt et al. is withdrawn in view of the TD filed and approved on August 19, 2026.
The rejection of claims 124-126, 129, and 130 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 is withdrawn in view of the TD filed and approved on August 19, 2026.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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, and 129 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, 125, and 129, Neri et al. teach polypeptides including interferons, interleukins, antibody fragments, growth factors, blood enzymes, etc. 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Neri et al. for claims 124, 125, and 129 were considered but are not persuasive for the following reasons.
Applicants contend that Neri et al. do not teach Ne-(4-(4-iodophenyl)butanoyl lysine.
Applicants’ arguments are not convincing since the teachings of Neri et al. anticipate the composition of the instant claims. Neir et al. teach Ne-(4-(4-iodophenyl)butanoyl lysine (please refer to the entire specification particularly paragraphs 30-71; claims).
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, 125, and 129 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, 125, and 129, 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, 125, and 129, Neri et al. teach polypeptides including interferons, interleukins, antibody fragments, growth factors, blood enzymes, etc. 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Dennis et al. and Neri et al. for claims 124, 125, and 129 were considered but are not persuasive for the following reasons.
Applicants contend that Dennis et al. and Neri et al. do not teach Ne-(4-(4-iodophenyl)butanoyl lysine.
Applicants’ arguments are not convincing since the teachings of Dennis et al. and Neri et al. render the composition of the instant claims prima facie obvious. Neir et al. teach Ne-(4-(4-iodophenyl)butanoyl lysine (please refer to the entire specification particularly paragraphs 30-71; claims).
Claims 124, 125, and 129 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, 125, and 129, 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, 125, and 129, 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Holt et al. and Dumelin et al. for claims 124, 125, and 129 were considered but are not persuasive for the following reasons.
Applicants contend that Holt et al. and Dumelin et al. do not teach Ne-(4-(4-iodophenyl)butanoyl lysine.
Applicants’ arguments are not convincing since the teachings of Holt et al. and Dumelin et al. render the composition of the instant claims prima facie obvious. 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). See Brandt et al., 2022, “Clickable” Albumin Binders for Modulating the Tumor Uptake of Targeted Radiopharmaceutical, Journal of Medicinal Chemistry, 65: 710-733 (reference 31 is Dumelin et al.; page 711, right column, lines 10 and 11; Ne-(4-(4-iodophenyl)butanoyl lysine (Lys(IPB))-derived albumin binders as described originally by Dumelin et al.31).
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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