Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed June 25, 2026, is acknowledged and has been entered. Claims 1-3 and 10-11 have been amended.
The species election without traverse filed June 25, 2026, is acknowledged.
After further consideration of the prior art, the species elections have been withdrawn.
Claims 1-19 are pending in the application and are under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Diluzio et al (US 10,040,855 B2, IDS) and Hong et al (WO 2018/104893 A1, IDS).
The claims are drawn to products, such as kits, that comprise an aqueous formulation for intravenous (see claim 11) or subcutaneous (see claim 10) administration comprising at least 180 mg/ml (see claim 1) or an undefined amount of an α4β7 targeting molecule comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:1, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:3, which is substantially aggregate free (see claim 1) or does not have an amount of aggregate defined (see claim 18). The dependent claims recite that the formulation can comprise about 300 mg of the molecule about 600 mg of the molecule and the second formulation can comprise about 300 mg of the molecule. The formulations comprise polysorbate or poloxamer, histidine, arginine and EDTA. The other limitations in the claims recite intended uses of the formulations or properties of the formulation, but the claims are not drawn to methods of treatment and these limitations do not materially or structurally limit the claimed formulations.
Diluzio et al disclose aqueous formulations of subcutaneous or intravenous compositions comprising 300 mg, 540 mg or 900 mg of an α4β7 targeting molecule at a concentration of 180 mg/ml comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:2, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:4 (see alignments, columns 3, 4, 6 and 26) (this molecule is 100% identical to instant SEQ ID NO:3 and differs from the instant SEQ ID NO:1 at 3 positions). Diluzio et al disclose that the formulations can comprise polysorbate or poloxamer, histidine, arginine and EDTA and be in vials, syringes or in a manufacture (kit) further comprising instructions (see columns 3, 11, 17-18 and 40).
RESULT 2
US-14-114-835-2
(NOTE: this sequence has 13 duplicates in the database searched.
See complete list at the end of this report)
Sequence 2, US/14114835
Patent No. 10040855
GENERAL INFORMATION
APPLICANT: MILLENNIUM PHARMACEUTICALS, INC.
TITLE OF INVENTION: FORMULATION FOR ANTI-ALPHA-4-BETA-7 ANTIBODY
FILE REFERENCE: 079259-0603
CURRENT APPLICATION NUMBER: US/14/114,835
CURRENT FILING DATE: 2013-10-30
PRIOR APPLICATION NUMBER: 61/544,054
PRIOR FILING DATE: 2011-10-06
PRIOR APPLICATION NUMBER: 61/481,522
PRIOR FILING DATE: 2011-05-02
NUMBER OF SEQ ID NOS: 15
SEQ ID NO 2
LENGTH: 470
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
NAME/KEY: source
OTHER INFORMATION: /note="Description of Artificial Sequence: Synthetic
polypeptide"
Query Match 99.3%; Score 2395; Length 470;
Best Local Similarity 99.3%;
Matches 447; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 79
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 139
Qy 121 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 140 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 199
Qy 181 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 200 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAG 259
Qy 241 APSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY 300
||||||||||||||| |:| ||||||||||||||||||||||||||||||||||||||||
Db 260 APSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY 319
Qy 301 NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 320 NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD 379
Qy 361 ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 380 ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR 439
Qy 421 WQQGNVFSCSVMHEALHNHYTQKSLSLSPG 450
||||||||||||||||||||||||||||||
Db 440 WQQGNVFSCSVMHEALHNHYTQKSLSLSPG 469
RESULT 2
US-14-114-835-4
(NOTE: this sequence has 13 duplicates in the database searched.
See complete list at the end of this report)
Sequence 4, US/14114835
Patent No. 10040855
GENERAL INFORMATION
APPLICANT: MILLENNIUM PHARMACEUTICALS, INC.
TITLE OF INVENTION: FORMULATION FOR ANTI-ALPHA-4-BETA-7 ANTIBODY
FILE REFERENCE: 079259-0603
CURRENT APPLICATION NUMBER: US/14/114,835
CURRENT FILING DATE: 2013-10-30
PRIOR APPLICATION NUMBER: 61/544,054
PRIOR FILING DATE: 2011-10-06
PRIOR APPLICATION NUMBER: 61/481,522
PRIOR FILING DATE: 2011-05-02
NUMBER OF SEQ ID NOS: 15
SEQ ID NO 4
LENGTH: 238
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
NAME/KEY: source
OTHER INFORMATION: /note="Description of Artificial Sequence: Synthetic
polypeptide"
Query Match 100.0%; Score 1141; Length 238;
Best Local Similarity 100.0%;
Matches 219; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 79
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSV 139
Qy 121 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 140 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 199
Qy 181 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
|||||||||||||||||||||||||||||||||||||||
Db 200 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 238
Diluzio et al does not disclose the YTE mutations in instant SEQ ID NO:1.
Hong et al disclose making YTE mutations in an α4β7 targeting molecule such that it comprises the instant SEQ ID NO:1 and SEQ ID NO:3 which improves half-life between 2-10 fold (see alignment, page 11, 31, 55 and 57-59).
RESULT 1
BFJ43875
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BFJ43875 standard; protein; 451 AA.
XX
AC BFJ43875;
XX
DT 26-JUL-2018 (first entry)
XX
DE Humanized anti-LPAM-1 IgG1 mAb heavy chain (YTE) mutant SEQ: 14.
XX
KW Immunoglobulin G1; Integrin alpha-4; LPAM-1 protein;
KW alpha4-beta7 integrin receptor; anti-hiv; antibody production;
KW antibody therapy; beta-7; heavy chain; hiv infection; humanized antibody;
KW monoclonal antibody; mutein; therapeutic; vedolizumab.
XX
OS Mus sp.
OS Homo sapiens.
OS Chimeric.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Misc-difference 256
FT /note= "Wild-type Met is replaced with Tyr"
FT Misc-difference 258
FT /note= "Wild-type Ser is replaced with Thr"
FT Misc-difference 260
FT /note= "Wild-type Thr is replaced with Glu"
XX
CC PN WO2018104893-A1.
XX
CC PD 14-JUN-2018.
XX
CC PF 06-DEC-2017; 2017WO-IB057710.
XX
PR 06-DEC-2016; 2016US-0430738P.
XX
CC PA (GLAX ) GLAXOSMITHKLINE INTELLECTUAL PROPERTY.
XX
CC PI Hong Z, Johns BA, Gough GW;
XX
DR WPI; 2018-46731F/44.
XX
CC PT Alpha-4-beta-7 protein used in expression vector and recombinant host
CC PT cell and in therapy for treating disease in human, comprises
CC PT complementary determining region heavy chain and light chain CDRH1,
CC PT CDRH2, and CDRH3, CDRL1, CDRL2, and CDRL3.
XX
CC PS Claim 6; SEQ ID NO 14; 86pp; English.
XX
CC The present invention relates to a novel alpha4-beta7 binding protein
CC with increased neonatal Fc receptor (FcRn) binding affinity and/or
CC increased half-life. The alpha4-beta7 binding protein herein is an
CC antibody useful for treating HIV infection. The invention claims: (a) a
CC method for treating HIV infection in a subject by administering an
CC antiretroviral therapy (ART), and a humanized alpha4-beta7 antibody or
CC its fragment; (b) a nucleic acid sequence encoding the alpha4-beta7
CC antibody; (c) an expression vector comprising the alpha4-beta7 antibody
CC heavy chain and/or light chain nucleic acid sequence; (d) a recombinant
CC host cell comprising the nucleic acid sequence or the expression vector;
CC and (e) a method for producing the alpha4-beta7 antibody by culturing the
CC host cell. The present sequence represents an amino acid sequence of a
CC mutant heavy chain region of a humanized anti-alpha4-beta7 integrin
CC receptor (LPAM-1) IgG1 monoclonal antibody (mAb) (vedolizumab) useful for
CC treating HIV infection. The sequence contains humanized heavy chain
CC variable domain of ACT-1 mouse mAb and a human IgG1 heavy chain constant
CC domain mutant (YTE mutation).
XX
SQ Sequence 451 AA;
Query Match 100.0%; Score 2413; Length 451;
Best Local Similarity 100.0%;
Matches 450; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
Qy 121 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
Qy 181 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAG 240
Qy 241 APSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 APSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY 300
Qy 301 NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD 360
Qy 361 ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR 420
Qy 421 WQQGNVFSCSVMHEALHNHYTQKSLSLSPG 450
||||||||||||||||||||||||||||||
Db 421 WQQGNVFSCSVMHEALHNHYTQKSLSLSPG 450
BFJ43870
ID BFJ43870 standard; protein; 219 AA.
XX
AC BFJ43870;
XX
DT 26-JUL-2018 (first entry)
XX
DE Humanized anti-LPAM-1 IgG1 mAb light chain polypeptide SEQ: 9.
XX
KW Immunoglobulin G1; Immunoglobulin kappa; Integrin alpha-4;
KW LPAM-1 protein; alpha4-beta7 integrin receptor; anti-hiv;
KW antibody production; antibody therapy; beta-7; hiv infection;
KW humanized antibody; light chain; monoclonal antibody; therapeutic;
KW vedolizumab.
XX
OS Mus sp.
OS Homo sapiens.
OS Chimeric.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Region 1..112
FT /note= "Light chain variable region BFJ43868"
FT Region 113..219
FT /note= "Light chain constant region"
XX
CC PN WO2018104893-A1.
XX
CC PD 14-JUN-2018.
XX
CC PF 06-DEC-2017; 2017WO-IB057710.
XX
PR 06-DEC-2016; 2016US-0430738P.
XX
CC PA (GLAX ) GLAXOSMITHKLINE INTELLECTUAL PROPERTY.
XX
CC PI Hong Z, Johns BA, Gough GW;
XX
DR WPI; 2018-46731F/44.
XX
CC PT Alpha-4-beta-7 protein used in expression vector and recombinant host
CC PT cell and in therapy for treating disease in human, comprises
CC PT complementary determining region heavy chain and light chain CDRH1,
CC PT CDRH2, and CDRH3, CDRL1, CDRL2, and CDRL3.
XX
CC PS Claim 1; SEQ ID NO 9; 86pp; English.
XX
CC The present invention relates to a novel alpha4-beta7 binding protein
CC with increased neonatal Fc receptor (FcRn) binding affinity and/or
CC increased half-life. The alpha4-beta7 binding protein herein is an
CC antibody useful for treating HIV infection. The invention claims: (a) a
CC method for treating HIV infection in a subject by administering an
CC antiretroviral therapy (ART), and a humanized alpha4-beta7 antibody or
CC its fragment; (b) a nucleic acid sequence encoding the alpha4-beta7
CC antibody; (c) an expression vector comprising the alpha4-beta7 antibody
CC heavy chain and/or light chain nucleic acid sequence; (d) a recombinant
CC host cell comprising the nucleic acid sequence or the expression vector;
CC and (e) a method for producing the alpha4-beta7 antibody by culturing the
CC host cell. The present sequence represents an amino acid sequence of a
CC light chain region of a humanized anti-alpha4-beta7 integrin receptor
CC (LPAM-1) IgG1 monoclonal antibody (mAb) (vedolizumab) useful for treating
CC HIV infection. The sequence contains humanized light chain variable
CC domain of ACT-1 mouse mAb and a human kappa light chain constant domain.
XX
SQ Sequence 219 AA;
Query Match 100.0%; Score 1141; Length 219;
Best Local Similarity 100.0%;
Matches 219; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSV 120
Qy 121 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL 180
Qy 181 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
|||||||||||||||||||||||||||||||||||||||
Db 181 SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 219
Accordingly, it would have been prima facie obvious to use the YTE variant of Hong in the aqueous formulations of Diluzio to provide an intravenous or subcutaneous formulation in vials, syringes or a manufacture comprising instructions (kits) comprising single or multiple doses further comprising polysorbate or poloxamer, histidine, arginine and EDTA and about 300, 600 or 900 mg of the YTE variant because those are formulations are taught in the art for an α4β7 targeting molecule, while the YTE variant would have the advantage of a longer half-life. Accordingly, one of skill in the art would see substitution of the YTE variant as simple substitution of one known element for another to obtain predictable results. Then with respect to the formulation being substantially aggregate free, having the melting temperature or glycosylation pattern. It is noted that these are properties of the formulations as claimed and the prior art suggests formulations materially and structurally identical to the claimed formulations such that, absent a showing otherwise, the formulations suggested by the prior art meet these limitations and the instructions (non-functional printed matter) does not distinguish the claims from the formulations suggested by the prior art (see MPEP § 2112.01).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, absent a showing otherwise.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 18-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 18-19 of copending Application No. 19/302,809. In this case, the corresponding claims between the two applications are word-for-word identical. This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7 and 11 of copending Application No 18/774,099 in view of Diluzio et al (US 10,040,855 B2, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-3, 6-7 and 11 of copending Application No 18/774,099 recite formulations comprising 150-200 mg/ml of α4β7 targeting molecule comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:1, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:3, wherein the first is for intravenous administration and the second is for subcutaneous administration and which comprises polysorbate or poloxamer, histidine, arginine and EDTA (see in particular claims 6 and 10) (this molecule is 100% identical to instant SEQ ID NO:3 and instant SEQ ID NO:1).
Diluzio et al disclose that which is set forth above.
Accordingly, the claimed formulations would be seen as obvious variations of the copending claims because those are formulations are taught in the prior art for an α4β7 targeting molecule. Accordingly, one of skill in the art would see making those formulations in the instant claims as combining elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-14 and 16-24 of copending Application No 18/774,143 in view of Diluzio et al (US 10,040,855 B2, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-9, 11-14 and 16-24 of copending Application No 18/774,143 recite methods of treating inflammatory bowel disease by administering formulations of an α4β7 targeting molecule comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:1, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:3 (see in particular claims 1, 11-12 and 24) (this molecule is 100% identical to instant SEQ ID NO:3 and instant SEQ ID NO:1).
Diluzio et al disclose that which is set forth above.
Accordingly, the claimed formulations would be seen as obvious variations of the copending claims because those are formulations are taught in the prior art for an α4β7 targeting molecule. Accordingly, one of skill in the art would see making those formulations in the instant claims as combining elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No 19/302,809. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-17 of copending Application No 19/302,809 would recite identical compositions except the instant claims require the formulation be aqueous which is not recited in the copending claims.
However, the claimed formulations would be seen as obvious variations of the copending claims because aqueous formulations are well known in the art and would be made to treat patients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent 12,304,956, IDS in view of Diluzio et al (US 10,040,855 B2). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-18 of US Patent 12,304,956 recite dosing regimens for use in methods of treating inflammatory bowel disease, such as Crohn’s or ulcerative colitis by administering formulations comprising from about 150 mg/ml to about 200 mg/ml of an α4β7 targeting molecule comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:1, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:3, wherein the first is for intravenous administration and the second is for subcutaneous administration and wherein the first dose comprises 600 mg and the second dose comprises 300 mg (see in particular claims 1-3 and 9-11) (this molecule is 100% identical to instant SEQ ID NO:3 and instant SEQ ID NO:1).
Diluzio et al disclose that which is set forth above.
Accordingly, the claimed formulations would be seen as obvious variations of the copending claims because those are formulations are taught in the prior art for an α4β7 targeting molecule. Accordingly, one of skill in the art would see making those formulations in the instant claims as combining elements according to known methods to yield predictable results.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent 12,404,334, IDS in view of Diluzio et al (US 10,040,855 B2). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-18 of US Patent 12,404,334 recite methods of treating inflammatory bowel disease, such as Crohn’s or ulcerative colitis by administering formulations comprising from about 150 mg/ml to about 200 mg/ml of an α4β7 targeting molecule comprising:(i) a heavy chain consisting of an amino acid sequence according to SEQ ID NO:1, and(ii) a light chain consisting of an amino acid sequence according to SEQ ID NO:3, wherein the first is for intravenous administration and the second is for subcutaneous administration and wherein the first dose comprises 600 mg and the second dose comprises 300 mg (see in particular claims 1-3 and 9-11) (this molecule is 100% identical to instant SEQ ID NO:3 and instant SEQ ID NO:1).
Diluzio et al disclose that which is set forth above.
Accordingly, the claimed formulations would be seen as obvious variations of the copending claims because those are formulations are taught in the prior art for an α4β7 targeting molecule. Accordingly, one of skill in the art would see making those formulations in the instant claims as combining elements according to known methods to yield predictable results.
Conclusion
No claims are allowed.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 21, 2026
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