DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Species
Applicant’s election of species of reducing condition following storage daratumumab at about 20mg/ml in the reply filed on 1/15/2026 is acknowledged.
Claims 1-30 are pending and examiner for a pharmaceutical composition comprising daratumumab, histidine, sorbitol and surfactant with turbidity of the position is NTU on merits.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 10/30/2025 and 1/15/2026 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
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.
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.
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.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Weers et al (US Patent No. 7829673, published Nov 2010) in view of Barghorn et al (US20090035307, published Feb 5, 2009).
The instant specification teaches the anti-CD38 antibody Daratumumab comprising VH and VL domains sequences of SEQ ID NO: 3 and 4 respectively [0126].
De Weers et al disclose pharmaceutical composition comprising active component anti-CD38 antibody (antiCD38BP, page 119, line 35+ and claims 7, 9 and 25), wherein antiCD38BP comprises VH and VL domains of SEQ ID NOs: 17 and 12 respectively that have identical sequences as the instant VH and VL of SEQ ID NO: 4 and 5 (Daratumumab) respectively as evidenced by sequence alignment below. De Weers et al teach the recombinant anti-CD38 presented as monomer, maybe small amount dimers (page 89, line 9) with high concentration obtained by immunoaffinity column chromatographic resin and determined by SDS-PAGE (bridging page 107-108), which is formulated as a solution for injection in pharmaceutical composition that further comprises pharmaceutical acceptable antioxidant and carrier including sorbitol and surfactants etc. (bridging page 124-125, and 125 line 10-15).
QY=SEQ ID NO: 4 (VH):
US-11-886-932A-17
Patent No. 7829673
APPLICANT: DE WEERS, MICHEL
………….
PRIOR APPLICATION NUMBER: 60/667,579
PRIOR FILING DATE: 2005-04-01
PRIOR APPLICATION NUMBER: DK PA 200500429
NUMBER OF SEQ ID NOS: 71
SEQ ID NO 17
ORGANISM: Homo sapiens
Query Match 100.0%; Score 643; Length 124;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
Qy 121 SS 122
||
Db 121 SS 122
QY= SEQ ID NO: 5 (VL):
US-11-886-932A-12
Patent No. 7829673
GENERAL INFORMATION
APPLICANT: DE WEERS, MICHEL
NUMBER OF SEQ ID NOS: 71
SEQ ID NO 12
LENGTH: 107
Query Match 100.0%; Score 556; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIK 107
De Weers et al do not specifically list ingredients with concentrations used for formulation of pharmaceutical composition.
Barghorn et al also teach monoclonal antibody formulated in pharmaceutical composition for treating a human disease, wherein the formulation of the composition comprising histidine (1-50mM, prefer 5-10mM), Surfactant polysorbated 20 (0.005-0.01% w/v), antioxidant or stabilizer, methionine (5-10mM) and sorbitol etc. Barghorn et al also teach the pH of the soluble composition is 5.0-7.0.
Using the standard protocol to formulate fluidity pharmaceutical composition for injection as described in the references by De Weers and Barghorn would meet the industrial standard of Nephelometric Turbidity Units (NTU)<6.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to formulate a pharmaceutical composition comprising anti-CD38 antibody as active component and pharmaceutically accepted carriers with expected result. One of ordinary skill in the art before the effective filing date of was made would have been motivated with reasonable expectation of success to formulate the anti-CD38 antibody into a pharmaceutical composition in order to treat abnormal conditions associated with CD38 antigen activity or expression because Barghorn et al have shown all the ingredients as carriers for formulating an antibody in a pharmaceutical composition and De Weers et al have shown an active component, anti-CD38 antibody, that has inhibitory activity for a condition associated with abnormal CD38 activity and expression. One skilled in the art would be motivated with reasonable expectation of success to make a pharmaceutical composition with the carriers at ranges of concentrations as disclosed by Barghorn to arrive at current invention. Therefore, the references in combination teach every limitation of the claims and the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention was made, absent unexpected results.
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 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.
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
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.
Over Patents:
Claims 1-30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over following Patents:
Claims 1-37 of U.S. Patent No. 10,385,135 (original application 15/340290),
Claims 1-37 of U.S. Patent No. 10,781,261 (original application 16/380994),
Claims 1-37 of U.S. Patent No. 11,566,079 (original application 16/840153),
Claims 1-37 of U.S. Patent No. 11,708,419 (original application 17/116822),
Claims 1-37 of U.S. Patent No. 11,708,420 (original application 17/116835),
Claims 1-20 of U.S. Patent No. 11,732,051 (original application 16/927947),
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical composition comprising the same active agent, ant-CD38 antibody with the same structures (VH and VL domain sequences of SEQ ID NOs: 4 and 5), and the same pharmaceutically acceptable ingredients.
The listed patents above and present application are from the same family.
The instant claims are drawn to
A pharmaceutical composition comprising daratumumab, histidine, sorbitol, and a surfactant, wherein the turbidity of the pharmaceutical composition is about 6 Nephelometric Turbidity Units (NTU) or less following storage for 1 month at 250C and 60% relative humidity,
wherein the pharmaceutical composition comprises the daratumumab at a concentration of about 20 mg/mL to about 120 mg/mL,
wherein the pharmaceutical composition is at pH of 5.3-5.8, 5.0-6.0,
wherein the pharmaceutical composition further comprises an antioxidant, that is methionine,
wherein the surfactant is polysorbate 20 and the polysorbate 20 is at a concentration of about 0.01% w/v to about 0.1% w/v.
Daratumumab has the VH and VL domain sequences of SEQ ID NO: 4 and 5 (see Pg pub [0126] of the instant application).
The claims of Patent ‘135 are drawn to:
A pharmaceutical composition comprising about 1,800 mg/15ml of an anti-CD38 antibody and about 30,000 U of a hyaluronidase, wherein the anti-CD38 antibody is of an IgG1 isotype and comprises a heavy chain variable region sequence of SEQ ID NO: 4 and a light chain variable region sequence of SEQ ID NO: 5, and wherein the hyaluronidase is rHuPH20 (SEQ ID NO: 22),
wherein the pharmaceutical composition further comprising
about 5 mM to about 50 mM histidine;
about 50 mM to about 100-300 mM sorbitol;
about 0.01% w/v to about 0.1% polysorbate-20 (PS-20);
about 0.1 mg/mL to about 2.5 mg/mL methionine……
The claims of Patent ‘261 are drawn to
A pharmaceutical composition comprising about 120 mg/ml of an anti-CD38 antibody and about 2000U/ml of a hyaluronidase, wherein the anti-CD38 antibody is of an IgG1 isotype and comprises a heavy chain variable region sequence of SEQ ID NO: 4 and a light chain variable region sequence of SEQ ID NO: 5, and wherein the hyaluronidase is rHuPH20 (SEQ ID NO: 22),
wherein the pharmaceutical composition further comprising
about 5 mM to about 50 mM histidine;
about 50 mM to about 400 mM sorbitol;
about 0.01% w/v to about 0.1% polysorbate-20 (PS-20);
about 0.1 mg/mL to about 2.5 mg/mL methionine, pH is 5.5……
The claims of Patent ‘079, ‘419, ‘420, and ‘051 are drawn to the same pharmaceutical composition as the claimed composition of ‘261 patent above (see claims of the patents).
All sets of the claims are drawn to the same pharmaceutical composition comprising the same active ingredient CD38 antibody plus the same pharmaceutically acceptable components with the same/similar concentrations. The only difference is that the claims of all the patents comprise an additional component hyaluronidase, which is absent in the presently claimed composition. Since the claimed composition of the patents have an additional component that makes the claims of patents having smaller scope than the instant claims, the claims of the patents listed above would anticipate or be obvious over the claimed invention.
Over applications:
Claims 1-30 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
Claims 1-30 of Copending Application No.19/198946 (Notice of Allowance was issued Jan 2026),
Claims 21-39 of Copending Application No.18/329562 (Terminal disclaimers were filed).
Although the conflicting claims are not identical, they are not patentably distinct from each other because all sets of claims are drawn to a pharmaceutical composition comprising the same active agent, ant-CD38 antibody with the same structures (VH and VL domain sequences of SEQ ID NOs: 4 and 5) and the same pharmaceutically acceptable ingredients.
The listed applications above and present application are from the same family.
The instant claims are set forth above.
The claims of applications ‘946 and ‘562 are as set forth as the claims of ‘261 patent above.
All sets of the claims are drawn to the same pharmaceutical composition comprising the same active ingredient CD38 antibody plus the same pharmaceutically acceptable components with the same/similar concentrations. The only difference is that the claims of two applications comprise an additional component hyaluronidase, which is absent in the present claims. Since the claimed compositions of the two applications comprises an additional component that makes the claims having smaller scope, the claims of the applications ‘946 and ‘562 would anticipate and be obvious over the presently claimed invention.
These are provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Claims 1-30 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of copending Application No.19/449144. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims encompass the same pharmaceutical composition.
The application ‘144 and present application are from the same family.
The instant claims are set forth above.
The claims of application ‘144 are drawn to
A method of treating multiple myeloma in a subject, comprising subcutaneously administering to the subject a pharmaceutical composition comprising: a) daratumumab at a concentration of about 120 mg/mL, and b) rHuPH20 recombinant hyaluronidase,
wherein the pharmaceutical composition has a pH of 5.0 to 6.0.
wherein the pharmaceutical composition comprises a buffer comprises
histidine at a concentration of about 5 mM to about 50 mM,
a saccharide that is sorbitol at a concentration 100-300mM,
surfactant that is polysorbate 20 at a concentration of about 0.01% w/v to about 0.1% w/v, and antioxidant methionine at a concentration of about 0.1 mg/mL to about 2.5 mg/m.
Both sets of claims encompass the same pharmaceutical composition. Since the same pharmaceutical composition claimed in the instant application has been used in the claimed method of the copending application ‘144, a material (composition) used in a method would anticipate the same material claimed in the present invention.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642