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 election filed June 12, 2026, is acknowledged and has been entered. Applicant has elected dexamethasone and bortezomib as species.
Claims 1-30 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) have been considered.
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 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.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,385,135, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody and amount of about 1,800 mg in 15 ml (120 mg/ml) in a composition with about 10 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 100-300 mM sorbitol at pH of 5.6. and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib(see claims 1-27 and 35-37 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-37 of U.S. Patent No. 10,385,135 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,781,261, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody and amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 50-400 mM sorbitol at pH of 5.5 and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib (see claims 1-27 and 35-37 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-37 of U.S. Patent No. 10,781,261 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,566,079, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 50-400 mM sorbitol at pH of 5.5 and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib (see claims 1-27 and 35-37 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-37 of U.S. Patent No. 11,566,079 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,732,051, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at an amount of about 120 mg/ml in a composition with about 8 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 270 mM sorbitol and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib (see claims 1-18 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration at a pH of 5.3 to 5.8.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid at pH between 5-7 (see ¶ 0482, 0494 and 0497).
Accordingly, claims 1-18 of U.S. Patent No. 11,732,051 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,708,420, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 50-400 mM sorbitol at a pH of 5.6 and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib (see claims 1-26 and 37 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-37 of U.S. Patent No. 11,708,420 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,708,419, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 50-400 mM sorbitol at a pH of 5.6 and methods of treating multiple myeloma with the compositions and further administering dexamethasone and bortezomib (see claims 1-26 and 37 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-37 of U.S. Patent No. 11,708,419 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 12,698,337, IDS, Gu et al (US 2013/0149313 A1) and Ashkenazi et al (US 2010/0247531 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody at an amount of about 120 mg/ml in a composition with about 5-10 mM of histidine, PS-20 at about 0.04% w/v, about 0.1-2.5 mg/ml of methionine and about 100-300 mM sorbitol or trehalose at a pH of 5.3-5.8 (see claims 1-25 and 37-44 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration or treating multiple myeloma with dexamethasone and bortezomib.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Ashkenazi et al treating multiple myeloma with dexamethasone and bortezomib in combination with other agents (see ¶ 0553).
While the patented claims are drawn to formulations, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. In this case, it is noted that column 2 of the patent recites that formulations of the invention useful for treating multiple myeloma.
Accordingly, the instant claims would be seen as an obvious variation of the subject matter claimed in the patent because the patent discloses the instantly claimed use of the compound claimed in the patent and
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because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma in further combination with administering dexamethasone and bortezomib would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,583,936, IDS, Gu et al (US 2013/0149313 A1) and Ashkenazi et al (US 2010/0247531 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.01-0.1% w/v, about 0.1-2.5 mg/ml of methionine and about 100-300 mM sorbitol at a pH of 5.3-5.8 (see claims 1-14 and 30 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration or treating multiple myeloma with dexamethasone and bortezomib.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Ashkenazi et al treating multiple myeloma with dexamethasone and bortezomib in combination with other agents (see ¶ 0553).
While the patented claims are drawn to formulations, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. In this case, it is noted that column 2 of the patent recite that formulations of the invention useful for treating multiple myeloma.
Accordingly, the instant claims would be seen as an obvious variation of the subject matter claimed in the patent because the patent discloses the instantly claimed use of the compound claimed in the patent and
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because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma in further combination with administering dexamethasone and bortezomib would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,637,519, IDS, Gu et al (US 2013/0149313 A1) and Ashkenazi et al (US 2010/0247531 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.01-0.1% w/v, about 0.1-2.5 mg/ml of methionine and about 100-300 mM sorbitol at a pH of 5.3-5.8 (see claims 1-14 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration or treating multiple myeloma with dexamethasone and bortezomib.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Ashkenazi et al treating multiple myeloma with dexamethasone and bortezomib in combination with other agents (see ¶ 0553).
While the patented claims are drawn to formulations, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. In this case, it is noted that column 2 of the patent recite that formulations of the invention useful for treating multiple myeloma.
Accordingly, the instant claims would be seen as an obvious variation of the subject matter claimed in the patent because the patent discloses the instantly claimed use of the compound claimed in the patent and
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because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma in further combination with administering dexamethasone and bortezomib would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,742,018, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite methods of using the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at an amount of about 120 mg/ml in a composition with about 5-50 mM of histidine, PS-20 at about 0.01-0.1% w/v, about 0.1-2.5 mg/ml of methionine and about 100-300 mM sorbitol at a pH of 5.5 and further administering dexamethasone and bortezomib (see claims 1-25 and 30 in particular). The claims of the patent do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-30 of U.S. Patent No. 12,742,018 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the patented formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,735,501, IDS and Gu et al (US 2013/0149313 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite methods of using the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at an amount of about 120 mg/ml in a composition and further administering dexamethasone and bortezomib (see claims 1-14 in particular). The claims of the patent do not recite the formulations comprising histidine, PS-20 methionine and sorbitol at a pH of 5.5 also comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations can comprise arginine as a bulking agent BS and trehalose as a cryoprotectant and antibody compositions with about 1-50 mM of histidine, PS-20 at about 0.01-0.1% w/v, about of 1-50 mM methionine and sorbitol at a pH of 5.0-7.0 and antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482, 0494 and 0497).
Accordingly, claims 1-28 of U.S. Patent No. 12,735,501 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to a formulation with histidine, PS-20 and methionine and sorbitol at a pH of 5.0-7.0 would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent Application 19/777,052 and Gu et al (US 2013/0149313 A1)
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite methods of using the same antibody (daratumumab comprises SEQ ID NO:12 and 13) at about 120 mg/ml in a composition with about 5-15 mM of histidine, PS-20 at about 0.04% w/v, about 1 mg/ml of methionine and about 270 mM sorbitol at a pH of 5.3-5.8 and further administering dexamethasone and bortezomib (see claims 1-15 and 30 in particular). The claims do not recite the formulations comprising mannitol, sodium chloride or acetic acid for administration.
Gu et al disclose antibody formulations for administration can comprise mannitol, sodium chloride or acetic acid (see ¶ 0482 and 0494).
Accordingly, claims 1-30 of U.S. Patent Application 19/777,052 either anticipate the instant claims or the instant claims would be seen as an obvious variation because adding mannitol, sodium chloride or acetic acid to the formulation for administration to treat multiple myeloma would be seen as combining prior art elements according to known methods to yield predictable results and any difference in the formulation for use in methods of treating myeloma would be seen as routine optimization of a result-effective variable (see MPEP 2144.05), absent a showing otherwise.
Therefore, all of the instant claims are not patentably distinct from the patented claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
October 8, 2026
