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 .
Priority
This application was filed on 09/21/2021 and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2020/024056 filed 03/20/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 77, 79-87, 89-111 are pending. Claims 77, 79, 86, 94 are amended. Claims 77, 79-87, 89-111 are being examined on the merits in this office action.
Drawings -Withdrawn
The objection to drawings is withdrawn in view of the amended Drawings.
Claim Rejections - Withdrawn
The rejection of claims 77, 79-87, 89-111 under 35 U.S.C. 103 as being unpatentable over Bowman et al. (WO2017087589A2 – hereinafter “Bowman”) in view of Sidhu et al. (WO2012078313A2 – hereinafter “Sidhu”) is withdrawn in view of the amendments and arguments.
The provisional rejection of claims 77, 79-87, 89-111 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-13, 16-26, 31, 35, 41-43, 53-54, 60-61 of copending Application No. 18/732,500 is withdrawn because the copending application is abandoned.
The provisional rejection of claims 77, 79-87, 89-111 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-13, 16-27, 31, 35, 41-43, 53-54, 60-61 of copending Application No. 18/490,707 is withdrawn because the copending application is abandoned.
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 89 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 89-90 are dependent on cancelled claim 88 and are therefore indefinite since the metes and bounds are unknowable.
For examination purposes, claims 89-90 are construed to depend on claim 77.
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.
Claims 103, and 106-111 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sidhu et al. (WO2014071234A1 – hereinafter “Sidhu”).
Regarding claim 103, Sidhu teaches peptidic compounds including D-peptidic compounds that specifically bind to a target molecule, that the compound may include protein domains of up to 50 residues (Abstract; claims 12-15). Sidhu teaches that the compound is bi-specific and that the compound has a specific binding to a target as well as a second target (Abstract; Page 27, line 1-13). Sidhu teaches that the compound has specific binding properties for two target molecules, that the compound may include two potential binding surfaces for the same target molecule, that the compound may include a first potential binding surface for a first target molecule and a second binding surface that recruits a second target molecule (Page 38, 2nd paragraph, lines 1-12). Sidhu teaches that the compound binds to a target protein such as VEGF protein and that the compound is VEGF antagonist (Page 61, line 1-2; Page 74, last paragraph, line 1-4) in cell-based display techniques (Page 48, 3rd paragraph, line 1-4). Sidhu further teaches that the compound may inhibit at least one activity of its target (Page 51, 1st paragraph, line 1), that the protocols may be cellular assays (Page 51, 2nd paragraph, line 1-4).
Regarding claim 106, Sidhu teaches that the compound may have 54 or more residues, such as 55 or more, 56 or more, 57 or more, 58 or more, 59 or more or 60 residues or more (Page 26, line 1-2).
Regarding claim 107-109, Sidhu teaches the compound may be a monomer that is capable of being multimerized (Page 13, 4th paragraph last sentence; page 20, line 5), that the compound may be dimeric, multimeric, or tetrameric (Page 14, 2nd paragraph, line 8-10), a homodimer or heterodimer (Page 13, 3rd paragraph, last sentence).
Regarding claim 110, Sidhu teaches that the compound has specific binding properties for two target molecules, that the compound may include two potential binding surfaces for the same target molecule, that the compound may include a first potential binding surface for a first target molecule and a second binding surface that recruits a second target molecule (Page 38, 2nd paragraph, lines 1-12). Sidhu teaches that the compound has a binding affinity for target, non-specific binding, or bi-specific binding properties (Page 8, last paragraph, line 1-5).
Regarding claim 111, Sidhu teaches compounds may exhibit an affinity for a target protein of 1 uM or less, such as 300nM or less, lO0nM or less, 30nM or less, 10nM or less, 5 nM or less, 2 nM or less, 1 nM or less, 600pM or less, 300pM or less, or even les s(Page 38, 3rd paragraph, lines 1-9).
Claim Rejections - 35 USC § 103 - New
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.
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 77, 79-87, 89-111 are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu et al. (WO2014071234A1 – hereinafter “Sidhu”) in view of Johansson et al. (FEBS Letters 374 (1995) 257 261).
Sidhu teaches peptidic compounds including D-peptidic compounds that specifically bind to a target molecule, that the compound may include protein domains of up to 50 residues, that the compound can be multimers that include two or more GB1 peptidic compounds connected via a branching moiety, that these compounds have specific binding to target molecules, that compounds can be linked via a linker (Abstract; claims 12-15). Sidhu teaches that the compound is bi-specific and that the compound has a specific binding to a target as well as a second target (Abstract; Page 27, line 1-13). Sidhu teaches that the compound has specific binding properties for two target molecules, that the compound may include two potential binding surfaces for the same target molecule, that the compound may include a first potential binding surface for a first target molecule and a second binding surface that recruits a second target molecule (Page 38, 2nd paragraph, lines 1-12). Sidhu teaches compounds may exhibit an affinity for a target protein of 1 uM or less, such as 300nM or less, lO0nM or less, 30nM or less, 10nM or less, 5 nM or less, 2 nM or less, 1 nM or less, 600pM or less, 300pM or less, or even les s(Page 38, 3rd paragraph, lines 1-9). Sidhu teaches that the compounds have high thermal stability with a melting temperature of 50°C or more, such as 60°C or more, 70°C or more, 80°C or more, or even 90°C or more (Page 39, line 1-3). Sidhu teaches that the compounds have low immunogenicity, e.g., are nonimmunogenic (Page 39, 3rd paragraph, line 1-2).
Sidhu teaches that the domain comprises a helix motif, but does not teach that the D-domain is a three-helix domain.
Johansson teaches a GA module albumin binding domain that is composed of a three-helix bundle (Abstract). Johansson teaches that module is remarkably stable with respect to both pH and temperature (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the D-protein compound of Sidhu and use a different protein such as the albumin binding domain taught by Johansson given its temperature stability (Abstract). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the teachings of Sidhu to use another stable protein such as the one taught by Johansson since Johansson teaches that module is remarkably stable with respect to both pH and temperature (Abstract). Regarding the limitation “wherein the compound is bivalent and has a target protein binding affinity that is at least 10- fold stronger than the target protein binding affinity of a monovalent first D-domain”, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the compound of claim 77 and is given little patentable weight. The disclosures render obvious claim 77.
Regarding claim 79, Sidhu teaches compounds may exhibit an affinity for a target protein of 1 uM or less, such as 300nM or less, 100nM or less, 30nM or less, 10nM or less, 5 nM or less, 2 nM or less, 1 nM or less, 600pM or less, 300pM or less, or even less (Page 38, 3rd paragraph, lines 1-9).
Regarding claim 80, Sidhu teaches that the compound binds to a target protein such as VEGF protein and that the compound is VEGF antagonist (Page 61, line 1-2; Page 74, last paragraph, line 1-4).
Regarding claims 81-82, Sidhu teaches that the compound may be dimeric or tetrameric (Page 14, 2nd paragraph, line 8-10). Sidhu teaches that the compound may comprises a first, second and third segment (Page 50, 3rd paragraph, line 3-5).
Regarding claims 83-84, Sidhu teaches that the compound has a binding affinity for target, non-specific binding, or bi-specific binding properties (Page 8, last paragraph, line 1-5).
Regarding claims 85-86, Sidhu teaches that the compound comprises variable scaffold domain Page 5, 1st paragraph, line 1-4). Sidhu further teaches that scaffold domains may have the same structural motif (Page 23, 2nd paragraph, line 1-3).
Regarding claim 87, Sidhu teaches that the compound may have 54 or more residues, such as 55 or more, 56 or more, 57 or more, 58 or more, 59 or more or 60 residues or more (Page 26, line 1-2).
Regarding claim 89, Johansson teaches a GA module albumin binding domain that is composed of a three-helix bundle. It would have been obvious to modify Sidhu with the protein of Johansson.
Regarding claim 90, Sidhu teaches that compound further comprises a linker between the at least one N-terminal peptidic extension and C-terminal peptidic extension and the GB 1 motif (Page 18, 3rd paragraph, line 1-2) and that the structural motif of GB l is characterized by a motif that includes an arrangement of four β-strands and one α-helix (Page 23, 3rd paragraph, line 1-4).
Regarding claims 91-92, Sidhu teaches that the compound comprises a variable domain variable domain that is defined by a discontinuous sequence of residues may include contiguous variant amino acids at positions that are arranged close in space relative to each other in the structure of the compound, that the variable domain may form a potential binding interface of the subject compound (Page 37, 3rd paragraph, line 1-8), that the compound includes 3 or more different non-core mutations, such as, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more , 10 or more, 11 or more, or 12 or more different non-core mutations in a region outside of the β1-β2 region (Page 29, 4th paragraph, line 1-3).
Regarding claims 93-94, Sidhu teaches the use of a peptidic linker (Page 17, last paragraph, line 5; page 19, line 2-3), and further teaches non-peptidic linkers (Page 3, line 5; page 18, line 7).
Regarding claims 95-98, Sidhu teaches the compound comprises a linker between the at least one N-terminal peptidic extension and C-terminal peptidic extension and the GB 1 motif and includes amino acid residues (Page 18, 3rd paragraph, line 1-2; 4t and 5th paragraphs). Sidhu teaches L is an optional linking group wherein Lis attached to X at any convenient location (e.g., the N terminal, C-terminal or the sidechain of a surface residue not involved in binding to the target) (Page 18, line 1-5).
Regarding claims 99, Sidhu teaches that the linker may include one or more substituent groups, for example an alkyl, aryl or alkenyl group, oligo(ethylene glycol), ethers, thioethers, disulfide, amides, carbonates, carbamates, tertiary amines, alkyls, which may be straight or branched, e.g., methyl, ethyl, n-propyl, 1-methylethyl (iso-propyl), n-butyl, n-pentyl, 1, 1-dimethylethyl ( t-butyl), and the like (Page 6, 2nd paragraph, line 10-14).
Regarding claims 100, Sidhu teaches that the compounds have high thermal stability with a melting temperature of 50°C or more, such as 60°C or more, 70°C or more, 80°C or more, or even 90°C or more (Page 39, line 1-3).
Regarding claims 101, Sidhu teaches that the compound half-life can be measured in vitro or in vivo, in human blood or serum, that the compound has a half-life of 1 hour or longer, such as 2 hours or longer, 6 hours or longer, 12 hours or longer (Page 39, 2nd paragraph, line 12-16).
Regarding claim 102, Sidhu teaches that the compounds have low immunogenicity, e.g., are nonimmunogenic (Page 39, 3rd paragraph, line 1-2).
Regarding claim 103, Sidhu teaches that the compound binds to a target protein such as VEGF protein and that the compound is VEGF antagonist (Page 61, line 1-2; Page 74, last paragraph, line 1-4) in cell-based display techniques (Page 48, 3rd paragraph, line 1-4).
Regarding claims 104-105, Johansson teaches a GA module albumin binding domain that is composed of a three-helix bundle (Abstract).
Regarding claim 106, Sidhu teaches that the compound may have 54 or more residues, such as 55 or more, 56 or more, 57 or more, 58 or more, 59 or more or 60 residues or more (Page 26, line 1-2).
Regarding claim 107-109, Sidhu teaches the compound may be a monomer that is capable of being multimerized (Page 13, 4th paragraph last sentence; page 20, line 5), that the compound may be dimeric, multimeric, or tetrameric (Page 14, 2nd paragraph, line 8-10), a homodimer or heterodimer (Page 13, 3rd paragraph, last sentence).
Regarding claim 110, Sidhu teaches that the compound has specific binding properties for two target molecules, that the compound may include two potential binding surfaces for the same target molecule, that the compound may include a first potential binding surface for a first target molecule and a second binding surface that recruits a second target molecule (Page 38, 2nd paragraph, lines 1-12). Sidhu teaches that the compound has a binding affinity for target, non-specific binding, or bi-specific binding properties (Page 8, last paragraph, line 1-5).
Regarding claim 111, Sidhu teaches compounds may exhibit an affinity for a target protein of 1 uM or less, such as 300nM or less, lO0nM or less, 30nM or less, 10nM or less, 5 nM or less, 2 nM or less, 1 nM or less, 600pM or less, 300pM or less, or even les s(Page 38, 3rd paragraph, lines 1-9).
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 12/11/2014, with respect to the rejection(s) of claim(s) 77, 79-87, 89-111 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sidhu et al. and Johansson et al.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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, Lianko G. Garyu can be reached on (571)270-7367. 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.
/MERCY H SABILA/Examiner, Art Unit 1654
/ARADHANA SASAN/Primary Examiner, Art Unit 1615
Prosecution Insights