DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-42 are pending upon entry of amendment filed on 6/7/24
Claims 1-42 are under consideration in the instant application.
3. Applicant’s IDS filed on 5/29/24, 9/13/24, 7/1/25 and 4/16/26 have been acknowledged.
4. NO oath is of record.
5. 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 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.
6. 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 of this title, 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.
7. Claims 1-42 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,079,948 (or 10,047,152 or 10,047,153 or 11,174,305 (IDS reference)) in view of U.S.Pub 2008/0071063 and U.S. Pub. 2006/0088523.
The ‘948 patent teaches pharmaceutical composition comprising Fel d1 antibody set forth in SEQ ID NO:18, 26, 306 and 314, identical to claimed SEQ ID NO:2, 10, 16 and 24, respectively (claims 1-12). Given that the claimed SEQ ID NO:2, 10, 16 or 24 comprises SEQ ID NO:4, 6, 8, 12, AAS, 14, 18, 20, 22, 26, KAS, 28, respectively, it meets the limitations of claims 1, 2, 30, 33 and 35. Further, the ‘948 patent teaches the use of SEQ ID NO:18/26, 306/314 alone and 18/26, 306 and 314 together (note claims 9-10).
IN addition, the ‘948 patent teaches addition of pharmaceutically acceptable carrier including polysorbate, container comprising the composition, delivery device and prefilled syringes (col. 40) to accommodate various routes of administrations. The dosage forms include 10-250mg (col. 40).
The disclosure of the ‘948 patent differs from the instant claimed invention in that it does not teach the use of about 10mM histidine buffer, sucrose at about 2.7-7.5%, arginine at about 60-130mM and 0.05-0.2% polysorbate as in claims 1-40 and kits comprising thereof as in claims 41-42 of the instant application, respectively.
The ‘063 publication teaches liquid stable formulations comprising about 10mM histidine, sucrose at about 5%, 1-200mM of amino acid including arginine and about 0.001-0.1% of polysorbate (p. 8-9, 36, 38) and the exemplary antibodies comprise wide variety of antigens (p. 19-22). The ‘063 publication teaches composition comprising histidine, sucrose, arginine and polysorbate reduce aggregates, improve viscosity and enhance stability of antibody (p. 2-3). Given that the identical formulations are being used to various antibodies, this would expect to stabilize the Fel dl antibody set forth in claim 1.
Likewise, the ‘523 publication teaches histidine about 10mM, antibody at 80-250mg/ml, sucrose at about 60-250mM and polysorbate at about 0.1% at pH 6 improves stability (p.2, claims) and kits (p. 35) comprising label for convenience.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to excipient concentrations as taught by the ‘063 and kits taught by the ‘523 publication into the monoclonal antibody taught by the ‘948 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of histidine, sucrose, arginine and polysorbate reduces viscosity and aggregates improve stability of antibody and kits would enhance convenience in packing for prefilled syringes for accurate dosage.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Pat. 9,079,948 in view of U.S.Pub 2008/0071063 and U.S. Pub. 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘948 patent recite a pharmaceutical composition comprising Fel d1 antibody set forth in SEQ ID NO:18, 26, 306 and 314, identical to claimed SEQ ID NO:2, 10, 16 and 24, respectively (claims 1-12). Given that the claimed SEQ ID NO:2, 10, 16 or 24 comprises SEQ ID NO:4, 6, 8, 12, AAS, 14, 18, 20, 22, 26, KAS, 28, respectively, it meets the limitations of claims 1, 2, 30, 33 and 35. Further, the ‘948 patent teaches the use of SEQ ID NO:18/26, 306/314 alone and 18/26, 306 and 314 together.
The claims of the ‘948 patent differs from the instant claimed invention in that it does not teach the use of about 10mM histidine buffer, sucrose at about 2.7-7.5%, arginine at about 60-130mM and 0.05-0.2% polysorbate as in claims 1-40 and kits comprising thereof as in claims 41-42 of the instant application, respectively.
The ‘063 publication teaches liquid stable formulations comprising about 10mM histidine, sucrose at about 5%, 1-200mM of amino acid including arginine and about 0.001-0.1% of polysorbate (p. 8-9, 36, 38) and the exemplary antibodies comprise wide variety of antigens (p. 19-22). The ‘063 publication teaches composition comprising histidine, sucrose, arginine and polysorbate reduce aggregates, improve viscosity and enhance stability of antibody (p. 2-3). Given that the identical formulations are being used to various antibodies, this would expect to stabilize the Fel dl antibody set forth in claim 1.
Likewise, the ‘523 publication teaches histidine about 10mM, antibody at 80-250mg/ml, sucrose at about 60-250mM and polysorbate at about 0.1% at pH 6 improves stability (p.2, claims) and kits (p. 35) comprising label for convenience.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to excipient concentrations as taught by the ‘063 and kits taught by the ‘523 publication into the monoclonal antibody taught by the ‘948 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of histidine, sucrose, arginine and polysorbate reduces viscosity and aggregates improve stability of antibody and kits would enhance convenience in packing for prefilled syringes for accurate dosage.
10. Claims 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Pat. 10,047,153 in view of U.S.Pub 2008/0071063 and U.S. Pub. 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘153 patent recite a pharmaceutical composition comprising Fel d1 antibody set forth in SEQ ID NO:18, 26, 306 and 314, identical to claimed SEQ ID NO:2, 10, 16 and 24, respectively (claims 1-12). Given that the claimed SEQ ID NO:2, 10, 16 or 24 comprises SEQ ID NO:4, 6, 8, 12, AAS, 14, 18, 20, 22, 26, KAS, 28, respectively, it meets the limitations of claims 1, 2, 30, 33 and 35. Further, the ‘153 patent teaches the use of SEQ ID NO:18/26, 306/314 alone and 18/26, 306 and 314 together.
The claims of the ‘153 patent differ from the instant claimed invention in that it does not teach the use of about 10mM histidine buffer, sucrose at about 2.7-7.5%, arginine at about 60-130mM and 0.05-0.2% polysorbate as in claims 1-40 and kits comprising thereof as in claims 41-42 of the instant application, respectively.
The ‘063 publication teaches liquid stable formulations comprising about 10mM histidine, sucrose at about 5%, 1-200mM of amino acid including arginine and about 0.001-0.1% of polysorbate (p. 8-9, 36, 38) and the exemplary antibodies comprise wide variety of antigens (p. 19-22). The ‘063 publication teaches composition comprising histidine, sucrose, arginine and polysorbate reduce aggregates, improve viscosity and enhance stability of antibody (p. 2-3). Given that the identical formulations are being used to various antibodies, this would expect to stabilize the Fel dl antibody set forth in claim 1.
Likewise, the ‘523 publication teaches histidine about 10mM, antibody at 80-250mg/ml, sucrose at about 60-250mM and polysorbate at about 0.1% at pH 6 improves stability (p.2, claims) and kits (p. 35) comprising label for convenience.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to excipient concentrations as taught by the ‘063 and kits taught by the ‘523 publication into the monoclonal antibody taught by the ‘153 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of histidine, sucrose, arginine and polysorbate reduces viscosity and aggregates improve stability of antibody and kits would enhance convenience in packing for prefilled syringes for accurate dosage.
11. Claims 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 11,174,305 in view of U.S.Pub 2008/0071063 and U.S. Pub. 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘305 patent recite a pharmaceutical composition comprising Fel d1 antibody set forth in SEQ ID NO:18, 26, 306 and 314, identical to claimed SEQ ID NO:2, 10, 16 and 24, respectively (claims 1-12). Given that the claimed SEQ ID NO:2, 10, 16 or 24 comprises SEQ ID NO:4, 6, 8, 12, AAS, 14, 18, 20, 22, 26, KAS, 28, respectively, it meets the limitations of claims 1, 2, 30, 33 and 35. Further, the ‘305 patent teaches the use of SEQ ID NO:18/26, 306/314 alone and 18/26, 306 and 314 together.
The claims of the ‘305 patent differs from the instant claimed invention in that it does not teach the use of about 10mM histidine buffer, sucrose at about 2.7-7.5%, arginine at about 60-130mM and 0.05-0.2% polysorbate as in claims 1-40 and kits comprising thereof as in claims 41-42 of the instant application, respectively.
The ‘063 publication teaches liquid stable formulations comprising about 10mM histidine, sucrose at about 5%, 1-200mM of amino acid including arginine and about 0.001-0.1% of polysorbate (p. 8-9, 36, 38) and the exemplary antibodies comprise wide variety of antigens (p. 19-22). The ‘063 publication teaches composition comprising histidine, sucrose, arginine and polysorbate reduce aggregates, improve viscosity and enhance stability of antibody (p. 2-3). Given that the identical formulations are being used to various antibodies, this would expect to stabilize the Fel dl antibody set forth in claim 1.
Likewise, the ‘523 publication teaches histidine about 10mM, antibody at 80-250mg/ml, sucrose at about 60-250mM and polysorbate at about 0.1% at pH 6 improves stability (p.2, claims) and kits (p. 35) comprising label for convenience.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to excipient concentrations as taught by the ‘063 and kits taught by the ‘523 publication into the monoclonal antibody taught by the ‘305 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of histidine, sucrose, arginine and polysorbate reduces viscosity and aggregates improve stability of antibody and kits would enhance convenience in packing for prefilled syringes for accurate dosage.
12. Claims 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-24 and 30-32 of U.S. Pat. 12,252,530 in view of U.S.Pub 2008/0071063 and U.S. Pub. 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘530 patent recite a pharmaceutical composition comprising Fel d1 antibody set forth in SEQ ID NO:18, 26, 306 and 314, identical to claimed SEQ ID NO:2, 10, 16 and 24, respectively (claims 1-12). Given that the claimed SEQ ID NO:2, 10, 16 or 24 comprises SEQ ID NO:4, 6, 8, 12, AAS, 14, 18, 20, 22, 26, KAS, 28, respectively, it meets the limitations of claims 1, 2, 30, 33 and 35. Further, the ‘530 patent teaches the use of SEQ ID NO:18/26, 306/314 alone and 18/26, 306 and 314 together.
The claims of the ‘530 patent differs from the instant claimed invention in that it does not teach the use of about 10mM histidine buffer, sucrose at about 2.7-7.5%, arginine at about 60-130mM and 0.05-0.2% polysorbate as in claims 1-40 and kits comprising thereof as in claims 41-42 of the instant application, respectively.
The ‘063 publication teaches liquid stable formulations comprising about 10mM histidine, sucrose at about 5%, 1-200mM of amino acid including arginine and about 0.001-0.1% of polysorbate (p. 8-9, 36, 38) and the exemplary antibodies comprise wide variety of antigens (p. 19-22). The ‘063 publication teaches composition comprising histidine, sucrose, arginine and polysorbate reduce aggregates, improve viscosity and enhance stability of antibody (p. 2-3). Given that the identical formulations are being used to various antibodies, this would expect to stabilize the Fel dl antibody set forth in claim 1.
Likewise, the ‘523 publication teaches histidine about 10mM, antibody at 80-250mg/ml, sucrose at about 60-250mM and polysorbate at about 0.1% at pH 6 improves stability (p.2, claims) and kits (p. 35) comprising label for convenience.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to excipient concentrations as taught by the ‘063 and kits taught by the ‘523 publication into the monoclonal antibody taught by the ‘530 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of histidine, sucrose, arginine and polysorbate reduces viscosity and aggregates improve stability of antibody and kits would enhance convenience in packing for prefilled syringes for accurate dosage.
13. No claims allowable.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
August 25, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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