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 .
Receipt is acknowledged of Applicant’s Arguments and Request for Continued Examination filed on 11/28/2025. Claims 1, 2, 5-9, 12, 14-17 and 21-24 are pending and presented for examination.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of arguments filed on 11/28/2025. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Response to Arguments and Declaration
The Declaration of Sandesh Seth under 37 CFR 1.132 filed 05/09/2023 is insufficient to overcome the rejection of claims 1-3, 5-12, 14-17 and 21 based upon 103 rejections as set forth in the last Office action. Applicant's declaration has been carefully considered. Applicant argues that 225Ac chelated by DOTA conjugated to daratumumab via the reaction of daratumumab with p-SCN-Bn-DOTA significantly increases its antitumor potency while not impeding its ability mediated Fc-dependent effector functions
have been reviewed, but are not deemed to be persuasive for the reasons discussed in below.
Sager teaches that, daratumumab monotherapy showed substantial clinical activity with a ORR of 29%, and was well tolerated in patients with multiple myeloma and no patients discontinued because of drug related treatment-emergent adverse event, infusion-related reactions or death. Adding a chelating agent with a therapeutic radionuclide to the antibody daratumumab would generate radioimmunoconjugates, would be expected to be effective in producing signal detectable by radiological diagnostic equipment and the radioimmunoconjugates can be utilized to achieve one or more therapeutic effects and when used as a therapeutic agent, localization of the radioimmunoconjugates at a specific structure or site in the body. Administration of radiolabeled daratumumab would obviously increases the antitumor potency for treating a disease or disorder involving multiple myeloma cells. Secondary considerations may be used to overcome obviousness at time, evidence pertaining to secondary considerations must be taken into account whenever it has been properly presented; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a strong case of obviousness” that allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion); Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007) (“given the strength of the prima facie obviousness showing, the evidence on secondary considerations was inadequate to overcome a final conclusion” of obviousness); and Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). It would be obvious to attach an antibody to actinium-225 radionuclides with P-SCN-Bn-DOTA, a radiolabeling antibodies is a very well established targeted radiotherapeutic method, i.e., chelating one or more actinium-225 radionuclides with the P-SCN-Bn-DOTA/HuM195 immunoconjugate as taught by Simon (0004 and 0017). Further, Simon discloses that the advantages of the method disclosed include higher labeling yields, simplicity, and shorter labeling times and useful for the preparation of a kit formulation where the final radiolabeling can occur at the clinical site. Thus, combination of prior art teachings would result in attaching P-SCN-Bn-DOTA to the anti-CD38 antibody daratumumab and generate radioimmunoconjugate daratumumab in treating CD38 cancers. Thus, it is not unexpected that the combination of an therapeutic radionuclide with a therapeutic antibody would be more effective, as this is the whole premise of the well-established treatment known as radioimmunotherapy
Appellant argues that the data comparing the effectiveness of 225Ac-daratumumab in comparison with unlabeled daratumumab, a well known CD38-targeting human IgGik monoclonal antibody, demonstrating the potency of antitumor effect of 400 nCi 225Ac -daratumumab and the impact of the antibody’s ability to traffic and localize to the site of the C38+ tumor. In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 1, 2, 5-9, 12, 14-17 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over de Weers et al. (US 9,249,226) in view of Sagar Lonial et al. (Lancet, 387, 1551-1560, 2016), Simon et al. (US 2012/0220754) and Beatty et al. (EP 0337746).
de Weers discloses pharmaceutical compositions comprising the monoclonal antibodies which bind to human CD38 antibody and therapeutic and diagnostic methods for using the antibodies (abstract). In one embodiment, provides a new class of anti-CD38 antibodies which through interacting with particular amino acids of human CD38 have a strong stimulating effect on the cADPR hydrolase activity of CD38 leading to decreased levels of cADPR. Furthermore, the anti-CD38 antibodies inhibit the ability of CD38 to catalyze the formation, via a base-exchange reaction, of nicotinic acid adenine dinucleotide 2′-phosphate (NAADP) (Col.2 line 65+). In one embodiment, discloses administration of a therapeutically effective amount of an anti-CD38 antibody may vary according to factors such as the disease state, age, sex, and weight of the individual, and the ability of the anti-CD38 antibody to elicit a desired response in the individua(Col. 18 Line 12). In one embodiment, discloses an antibody drug conjugate comprising an antibody conjugated to a cytotoxic agent, a radioisotope, or a drug (Col. 22 Line 65+). In one embodiment, discloses a method of inhibiting growth and/or proliferation migration or inducing phagocytosis of a cell expressing CD38, comprising administration of an antibody, an immunoconjugate, such that the growth and/or proliferation, migration or phagocytosis of the cell is inhibited and in yet another embodiment, discloses treating the disease or disorder is multiple myeloma, B-cell chronic lymphocyctic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma (Col. 23 Line 43 and Col. 30 Line 15-35). In embodiment, method comprises administration of one or more further therapeutic agents selected from group consisting of chemotherapeutic agent, an anti-inflammatory agent, or an immunosuppressive and/or immunomodulatory agent(Col. 31 and 32). In one embodiment, the anti-CD38 antibody is conjugated to a radioisotope or to a radioisotope-containing chelate. For example, the anti-CD38 antibody can be conjugated to a chelator linker, e.g. DOTA, DTPA or tiuxetan, which allows for the anti-CD38 antibody to be complexed with a radioisotope. A radiolabeled anti-CD38 antibody may be used for both diagnostic and therapeutic purposes. Non-limiting examples of radioisotopes include 3H, 14C, 15N, 35S, 90Y, 99Tc, 125I, 111In, 131I, 186Re, 213Bs, 225Ac and 227Th. (Col. 49 Line 47-58). Additional disclosure includes dosage regimens in the above methods of treatment and uses are adjusted to provide the optimum desired response (e.g., a therapeutic response). For example, a single bolus may be administered, several divided doses may be administered over time or the dose may be proportionally reduced or increased as indicated by the exigencies of the therapeutic situation. The efficient dosages and the dosage regimens for the anti-CD38 antibodies depend on the disease or condition to be treated and may be determined by the persons skilled in the art. An exemplary, non-limiting range for a therapeutically effective amount of a compound of the present invention is about 0.005-100 mg/kg, such as 0.05-100 mg/kg or 1-100 mg/kg, such as about 0.1-50 mg/kg, for example about 0.1-20 mg/kg, such as about 0.1-10 mg/kg, for instance about 0.1, 0.3, about 0.5, about 1, 2, 3, 4, 8, 16 or 24 mg/kg (Col. 64. Line 30+).
De Weers fails to disclose composition comprising labeled and unlabeled daratumumab antibody.
Sagar Lonial discloses a study of Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomized, phase 22 trial (Title). In this open-label, multicentre, phase 2 trial patients with multiple myeloma who were previously treated with at least three lines of therapy (including proteasome inhibitors and immunomodulatory drugs), or were refractory to both, were randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part2. Patients received 8 mg/kg every 4 weeks, or 16 mg/kg per week for 8 weeks, then every 2 weeks for 16, and then every 4 weeks thereafter (abstract). Sagar Lonial discloses that all 106 patients in the daratumumab 16 mg/kg group had been previously treated with proteasome inhibitors and immunomodulatory drugs (bortezomib, carfilzomib, lenalidomide, pomalidomide and thalidomide). All patients had received dexamethasone previously, and 82% patients had received more than three lines of therapy (table 1). Daratumumab monotherapy showed substantial clinical activity, with an ORR of 29%, and was well tolerated in patients with multiple myeloma who had been heavily treated; most patients were double refractory to bortezomib and lenalidomide, and many were refractory to pomalidomide or carfilzomib (page 1558). Daratumumab has a favorable safety profile compared with other available agents, and results in clinically manageable side-effects, and no patients discontinued because of drug-related treatment-emergent adverse events, infusion-related reactions or death (page 1559). Additional disclosure includes that daratumumab seems to be an effective option for patients with relapsed and refractory multiple myeloma for whom available treatments have been exhausted. Based on deep and durable responses and a favorable safety profile, daratumumab 16 mg/kg seems suitable for treatment of patients with multiple myeloma.
Simon discloses a method for treating a cancer in a subject, the method comprising administering to the subject a pharmaceutically effective amount of an Ac-225 radioimmunoconjugate comprising a monoclonal antibody (mAb) (IgG). The Ac-225 radioimmunoconjugate is an [Ac-225]-p-SCN-Bn-DOTA/HuM1 95 radioimmunoconjugate (abstract and 0044). In one embodiment, includes a method for producing an actinium-225 (Ac-225) radioconjugate, comprising the steps of: conjugating a chelating agent to a biological molecule in a conjugation reaction mixture to generate a conjugated biological molecule, and chelating one or more actinium-225 radionuclides with the p-SCN-Bn-DOTA/HuM195 immunoconjugate in a chelation reaction mixture to generate Ac-225 radioconjugate (0004 and 0017). The "biological molecule" as used includes carbon-containing molecules, such as macromolecules, amino acids, antibodies, antibody, antibody fragment, or any other carrier which functions to recognize a specific biological target site (0050-0051). Typical radioimmunoconjugate dosages can be between about 0.001 and about 50 mg per kilogram of body weight, or between about 0.1 and about 10 mg/kg of body weight (0100). Simon discloses that the percent conjugation and chelation when making the radioconjugates is greater than 50%, greater than 70%, greater than 90%, greater than 95%, greater than about 96%, greater than about 97%, greater than about 98%, or greater than about 99% (would reads on labeled and unlabeled portion of protein, 0057- 0058). Additional disclosure includes that, radiopharmaceuticals can carry at least one radionuclide bound to a carrier, for example a targeting moiety. The radionuclide can produce a signal detectable by radiological diagnostic equipment. Because the radiation emitted by the radionuclide can have a toxic effect on tissues, the radioimmunoconjugates can be utilized to achieve one or more therapeutic effects and when used as a therapeutic agent, localization of the radioimmunoconjugates at a specific structure or site in the body can be used to concentrate the effects of the radioimmunoconjugate in a structures or sites to be treated and can reduce harmful effects at other structures and sites in the body (0003).
Beatty is made of record to illustrate that it is well known in the art for administering a composition comprising an unlabeled and labeled antibody simultaneously. Beatty discloses compositions and method for therapy or diagnosis of lesions in a mammal where the lesions are associated with a marker substance. The method comprises administering a labeled or unlabeled antibody to the mammal. Methods include enhancing biodistribution in a mammalian subject and specifically related to the use of monoclonal antibodies for localization, detection, and treatment of lesions, including tumors (abstract). Beatty discloses that the diagnostic and therapeutic use of radioactively labeled antibodies specific to substances produced by or associated with tumors is recognized in the prior art (page 2 lines 7-11). In one embodiment discloses that it is also possible to increase the biodistribution by combining the pretreatment and treatment steps so as to administer the unlabeled and labeled antibody simultaneously (page 3, lines 56-59) and an example in which unlabeled and labeled antibody were injected simultaneously (page 12, example 5; page 13, lines 5-7). Additionally, Beatty discloses a composition for use in therapy or diagnosis of lesions comprising a first amount of an antibody specific for a marker and a second amount of the same antibody, one of the said amounts of antibody being labelled with a detectable or therapeutic agent and the other being unlabeled, the said two amounts being for substantially simultaneous administration to the mammal (pages 15-16, claim 3).
Note: With respect to administration of composition comprising daratumumab consisting of 5 to 50 wt% of an actinium-225 labeled and 50 to 95% of an unlabeled daratumumab limitation would have been obvious to one of ordinary skill in the art by varying the amount of the labeled and unlabeled daratumumab in composition, the administration protocol can be optimized based on the present disclosure to elicit a maximal improvement in symptoms. Physicians, pharmacologists, and other skilled artisans are able to determine the most therapeutically effective treatment regimen, which will vary from patient to patient. The potency of a specific composition and its duration of action can require administration on an infrequent basis, including co-administrating sequentially or simultaneously that have desirable pharmacokinetic characteristics and desirable attributes. One of ordinary skill in the art would have a reasonable expectation of success because routine optimization of the prior art procedure is within the capability of one of ordinary skill in the art. See MPEP § 2144.05 which states: [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Furthermore, the optimization of the pharmaceutical formulation with ingredients well known in the pharmaceutical art is considered well within the competence level of an ordinary skilled artisan in the pharmaceutical sciences, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
It would have been prima facie obvious to one of ordinary skill in the art incorporate daratumumab into de Weers composition for treating multiple myeloma. The person of ordinary skill in the art would have been motivated to make those modifications because Sagar teaches that Daratumumab monotherapy showed substantial clinical activity, with an ORR of 29%, and was well tolerated in patients with multiple myeloma who had been heavily treated; most patients were double refractory to bortezomib and lenalidomide, and many were refractory to pomalidomide or carfilzomib has a favorable safety profile compared with other available agents, and results in clinically manageable side-effects, and no patients discontinued because of drug-related treatment-emergent adverse events, infusion-related reactions or death (page 1558 and 1559) and reasonably would have expected success because daratumumab seems to be an effective option for patients with relapsed and refractory multiple myeloma for whom available treatments have been exhausted.
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a method for producing an actinium-225 (Ac-225) radioconjugate by chelating one or more actinium-225 radionuclides with the p-SCN-Bn-DOTA/HuM195 immunoconjugate in a chelation reaction mixture as taught by Simon into Sagar Lonial composition. It would further have been obvious to administer the antibodies as radiolabeled and unlabeled fractions as taught by Beatty with the labeled and unlabeled fractions of antibodies and daratumumab administered either sequentially, simultaneously or single composition as taught by Beatty. An ordinarily skilled artisan would have been motivated to combine the teachings of Simon, and Beatty with Sagar Lonial and have used radiolabeled antibodies at the disclosed dosages in the treatment of multiple myeloma, relapsed/refractory as the references demonstrate that labeling antibodies with a radioisotope, including 225Ac, can potentiate their efficacy for tumor control. An ordinarily skilled artisan would have been further motivated to administer unlabeled antibodies in order to increase selective delivery of the radioactivity to the target organ while reducing toxicity to normal tissues as taught by Beatty. A skilled person would have had a reasonable expectation of success as the applied references are all drawn to the use of antibodies for the treatment of cancer, including multiple myeloma, and demonstrate that anti-CD38 antibodies have been successfully labeled with radioisotopes and used for treatment.
Response to Arguments
Applicant arguments filed on 11/28/2025 have been fully considered but they are not persuasive. Applicant argues that cited references does not teach or suggests wherein the 225-Ac labelled portion of the daratumumab comprises 225-Ac chelated by DOTA conjugated to daratumumab or an effective amount of daratumumab consisting of 5 to 50 wt% of an Actinium-225 labeled and 50 to 95 wt% of an unlabeled daratumumab as recited in claim 1. This argument is not persuasive since Sager teaches that, daratumumab monotherapy showed substantial clinical activity with a ORR of 29%, and was well tolerated in patients with multiple myeloma and no patients discontinued because of drug related treatment-emergent adverse event, infusion-related reactions or death and adding a chelating agent with a therapeutic radionuclide to the antibody as taught by Simon, method for producing an actinium-225 (Ac-225) radioimmunoconjugate, comprising the steps of: conjugating a chelating agent to a biological molecule in a conjugation reaction mixture, and chelating one or more actinium-225 radionuclides with the p-SCN-Bn- DOTA/HuM195 immunoconjugate to generate a Ac-225 radioimmunoconjugate (0004 and 0017) would generate 225-Ac labelled portion of the daratumumab. Simon discloses that when making the radioimmunoconjugates, the degree of chelation and conjugation is advantageously high, greater than 50%, greater than 70%, greater than 90%, greater than 95%, greater than about 96%, greater than about 97%, greater than about 98%, or greater than about 99% (would reads on labeled and unlabeled portion of antibody, because during chelation portion of the antibody may be labeled and unlabeled) (0057- 0058). Sagar discloses the dose-escalation study of daratumumab in phase-2 clinical trials, patients received doses of 0.005 to 24 mg/kg of daratumumab. Preclinical studies showed that daratumumab induced target-cell killing of CD38-expressing tumor cells by means of multiple mechanisms, including complement-mediated and antibody- dependent cell-mediated cytotoxic effects, antibody-dependent cellular phagocytosis, apoptosis, and to a lesser extent, inhibition of the enzymatic activity of CD38 (page 1208). Thus, it would have been obvious to one skilled in the art at the time the invention was made to modify the daratumumab by conjugating with a chelating agent in a conjugation reaction mixture, and chelating one or more actinium-225 radionuclides with the p-SCN-Bn-DOTA to generate a conjugated daratumumab (Ac-225-labeled daratumumab and unlabeled daratumumab) as taught by Simon in expectation of achieving better treatment of diseases or disorders involving cells expressing CD38 and improve the diagnostic potential of radioimmunoconjugates.
Applicant argues that no motivation to combine Sagar, Sollini, Simon, Beatty, and Wang to achieve the claimed invention including 5 to 50 wt% of an Actinium-225 labeled and 50 to 95 wt% of an unlabeled daratumumab and no reasonable expectation of success in attaining the claimed invention. This argument is not persuasive since the motivation to combine the references does not necessarily have to match with what applicant wants to accomplish. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below). In the instant case, primary reference discloses pharmaceutical compositions comprising the monoclonal antibodies which bind to human CD38 antibody and therapeutic and diagnostic methods for using the antibodies and the anti-CD38 antibody is conjugated to a radioisotope or to a radioisotope-containing chelate. For example, the anti-CD38 antibody can be conjugated to a chelator linker, e.g. DOTA, DTPA or tiuxetan, which allows for the anti-CD38 antibody to be complexed with a radioisotope. A radiolabeled anti-CD38 antibody may be used for both diagnostic and therapeutic purposes. Non-limiting examples of radioisotopes include 3H, 14C, 15N, 35S, 90Y, 99Tc, 125I, 111In, 131I, 186Re, 213Bs, 225Ac and 227Th. (Col. 49 Line 47-58), while Sagar reference discloses a study of Daratumumab monotherapy in patients and showed substantial clinical activity, with an ORR of 29%, and was well tolerated in patients with multiple myeloma who were randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part 2 and Simon reference is relied upon to show that it is known in the art a method for producing an actinium-225 (Ac-225) radioimmunoconjugate, chelating one or more actinium-225 radionuclides with the p-SCN-Bn- DOTA/HuM195 immunoconjugate to generate a Ac-225 radioimmunoconjugate. Thus, it would have been obvious to one skilled in the art at the time the invention was made to modify the daratumumab by conjugating with a chelating agent in a conjugation reaction mixture, and chelating one or more actinium-225 radionuclides with the p-SCN-Bn-DOTA to generate a conjugated daratumumab (Ac-225-labeled daratumumab and unlabeled daratumumab) as taught by Simon in expectation of achieving better treatment of diseases or disorders involving cells expressing CD38 and improve the diagnostic potential of radioimmunoconjugates. . Thus, in view of the teachings of Weers and cited reference, there would have been a reasonable expectation that a composition comprising labeled and unlabeled daratumumab could be successfully prepared and used in a method for treating a multiple myeloma.
Applicant argues that none of the references describe any range of a proper dose or range of proper timing for the claimed composition. This argument is not persuasive since Weers discloses an exemplary, non-limiting range for a therapeutically effective amount of a compound of the present invention is about 0.005-100 mg/kg, such as 0.05-100 mg/kg or 1-100 mg/kg, such as about 0.1-50 mg/kg, for example about 0.1-20 mg/kg, such as about 0.1-10 mg/kg, for instance about 0.1, 0.3, about 0.5, about 1, 2, 3, 4, 8, 16 or 24 mg/kg (Col. 64. Line 30+), while Sagar discloses randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part2. Patients received 8 mg/kg every 4 weeks, or 16 mg/kg per week for 8 weeks, then every 2 weeks for 16, and then every 4 weeks thereafter (abstract).
Conclusion
No claims are allowed at this time.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618