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 26, 2026, is acknowledged and has been entered. Claims 7, 11, 15, 21, 26-27 and 30 have been amended.
The species election without traverse filed June 26, 2026, is acknowledged and has been entered. The first species requirement has been withdrawn by the Office after further consideration. With respect to the second species, Applicant has elected sorbitol as the species of saccharide.
Claims 1-30 are pending.
Claims 8-15 and 23-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species of invention, there being no allowable generic or linking claim.
Claims 1-7 and 16-22 are under examination.
Priority
Applicant’s claim under 35 USC §§ 119 and/or 120 for benefit of the earlier filing dates of applications 18/329,562, 17/116,835, 16/460,754, 15/340,290 and 62/250,016, is acknowledged.
However, claims 1-7 and 16-22 do not properly benefit under 35 U.S.C. §§ 119 and/or 120 by the earlier filing dates of the priority documents claimed, since the claims do not find support in the priority documents. In this case, support for the claimed products are not found in the priority documents. Notably, the priority documents appear to only recite monomer percentage of compositions of Formulation 1 and 2 in Table 14 and Table 19 respectively, and the instant claims are broader than Formulation 1 and 2.
To receive benefit of the earlier filing date under 35 USC §§ 119 and/or 120, the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application); the disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Accordingly, the effective filing date of claims 1-7 and 16-22 is deemed the filing date of the instant application, namely April 2, 2026.
Information Disclosure Statement
The information disclosure statements (IDS) have been considered.
Objections
As the claims introduce matter not previously set forth in the priority application, the application is objected to for reciting it is a continuation as it should be designated a continuation-in-part.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not recite support for the subject matter of examined claims 1-7 and 16-22.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansson et al (WO 2017/079150 A1, IDS).
With respect to claims 1-7 Jansson et al disclose that Formulation 2 (120 mg/mL daratumumab, 10 mM Histidine, 300 mM Sorbitol, 0.04% PS20, 1 mg/mL Methionine, 2000U/mL rhuPH20, pH 5.5) is about 99.1% monomer by size exclusion chromatography at zero months of storage (see pages 75-76 and Table 19). Notably, 10 mM Histidine and 300 mM Sorbitol is reasonably considered about 8 mM Histidine and 270 mM Sorbitol, absent a showing otherwise.
Therefore, the products of Jansson et al are deemed to anticipate the claimed products absent a showing otherwise.
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 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.
Claims 1 and 16-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
The ‘673 patent teaches human CD38 antibodies that read on claimed daratumumab (p. 142, DARZALEX) (col. 127-133). Further, the ‘673 patent teaches treatment of multiple myeloma with dexamethasone (note col. 135) and unit dose form of the antibody composition (col. 121, 131-132). The exemplary dosages of daratumumab includes ranges between 0.1-100mg/kg (col. 132). The ‘673 patent teaches that preparation of pharmaceutical formulations are generally known in the art and that the antibody is at 99% homogeneity in the composition (purity) such that the antibody composition would have at least 98% monomer as measured by size exclusion chromatography at zero months of storage, absent a showing otherwise(col. 55, 123).
The disclosure of the ‘673 patent differs from the instant claimed invention in that it does not teach or suggest the use daratumumab at about 20mg/ml, a histidine buffer at about 8 mM at pH 5.3-5.8 , sorbitol at about 270 mM, polysorbate at about 0.04% w/v or methionine at about 1 mg/ml.
The ‘111 publication teaches antibody formulations at about 120 mg/ml that is suitable for subcutaneous administration. (note ¶ [0318] and claims). The ‘111 publication teaches using histidine and methionine as stabilizers (note ¶ [0335]).
The ‘977 publication teaches antibody formulations at about 20 mg/ml (also discloses 120 mg/ml) comprising histidine, sorbitol, polysorbate 20 at about 0.04% w/v and methionine at a pH from 5.3-5.8 (note ¶ [0005, 0037, 0107, 0125] and claims). The suitable buffer and excipient conditions include histidine at 1-50mM, stabilizer of sorbitol at about 250mM and methionine at 5-25mM (note [0019, 0035-0038, 166-185]) to stabilize antibody formulation.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize daratumumab at about 20/mg/ml and excipient concentrations as taught by the ‘111 and 977 publications in the daratumumab antibody formulation of the ‘673 patent to obtain formulations to administer in methods of treating multiple myeloma because the antibody and excipients were recognized as result effective variables which should be optimized so that one would be motivated to vary and optimize the components to create stable and functional formulations with therapeutic effectiveness that can then be administered. Notably, the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise. As the components of antibody formulations were disclosed in these references, the claimed formulations would also be seen as combining prior art elements according to known methods to yield predictable results. Furthermore, one of skill in the art would have expected success in making such formulations as encompassed by these claims because ‘673 patent disclose that formulation of antibodies is within ordinary skill in the art.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
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 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Pat. 10,385,135 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘135 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Pat. 10,781,261 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘261 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab (claims the sequences of this antibody). The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Pat. 11,566,079 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘079 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab (claims the sequences of this antibody). The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat. 11,732,051 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘051 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Pat. 11,708,419 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘419 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab (claims the sequences of this antibody). The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-77 of US Patent No. 11,634,499, IDS in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘499 patent recites a method of a making drug product that is daratumumab as recited in the instant claims and formulating it in compositions with similar formulation details (see in particular claims 74-77).
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Pat. 11,708,420 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘420 patent recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, hyaluronidase, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Pat. 12,583,936 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘936 patent recites a pharmaceutical composition comprising about 120mg/ml of daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, hyaluronidase, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Pat. 12,637,519 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘519 patent recites a pharmaceutical composition comprising daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the patented claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
Therefore, all of the claims are not patentably distinct from the patented claims.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-60 of U.S. Application 19/563,621 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘621 application recites method of treating multiple myeloma comprising subcutaneous administration of pharmaceutical composition comprising about 120mg/ml of daratumumab. The pharmaceutical composition comprises about 1-50mM of histidine, hyaluronidase, 300mM of sorbitol and polysorbate.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application 19/449,233 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘233 application recites method of treating multiple myeloma comprising subcutaneous administration of pharmaceutical composition comprising about 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application 19/449,144 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘144 application recites method of treating multiple myeloma comprising subcutaneous administration of pharmaceutical composition comprising about 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application 19/637,868 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘868 application recites methods of treating multiple myeloma pharmaceutical composition comprising about 20 mg/ml or 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application 19/647,596 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘596 application recites a pharmaceutical composition comprising about 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application 19/658,174 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘174 application recites a method of treating multiple myeloma comprising subcutaneous administration of a pharmaceutical composition comprising about 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-68 of U.S. Application 18/329,562 in view of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘562 application recites a pharmaceutical composition comprising about 20 mg/ml or 120mg/ml of daratumumab.
The teachings of U.S. Pat. 7,829,673 (IDS reference), U.S. Pub. 2011/0066111 (IDS reference) and U.S. Pub. 2011/0044977 (IDS reference) are set forth above.
Accordingly, the compositions would be seen as an obvious variation of the copending claims in view of the prior art because the art taught that one of skill in the art can vary and determine antibody formulations as desired and needed, so antibody formulations and their components were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the formulations would be seen as routine optimization, absent a showing otherwise and because 99% purity was desired the compositions would be at least 98% monomer at zero months storage absent a showing otherwise.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 18, 2026
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