DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2026 has been entered.
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. Claims 203-210, 212-214, 234-236 and 304-320 are pending. Claims 1-202, 211, 215-233 and 237-303 are canceled. Claims 203, 204, 234-236 and 317-319 have been amended.
4. Claims 203-210, 212-214, 234-236 and 304-320 are under examination.
Information Disclosure Statement
5. The information disclosure statement filed on 8/20/2026 has been considered by the examiner.
Rejection Withdrawn
6. The rejection of claims 204 and 304-319 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement because the limitation “the combination dosing regimen is administered for at least 25.3 months” introduces new matter is withdrawn in view of applicant’s amendments.
7. The rejection of claims 203-210, 212-214, 234-236 and 304-319 and new claim 320 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Facon et al. (Blood, 2018, 132(Suppl 1); 8 pages, IDS filed on 12/23/2022), in view of Prescribing Information of DARZALEX (Daratumumab) (pub. date: 11/2015) and Ahmadi et al. (US2017/0044265A1, pub. date: 2/16/2017) is withdrawn in view of the new 103 rejection below.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 203-209, 213-214, 234-236, 304-308, 311-312 and 317-320 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Facon et al. (Blood, 2018, 132(Suppl 1); 8 pages, IDS filed on 12/23/2022), as evidenced by Facon et al, (Leukemia, 2025, 39:942-950, referred to Facon 2015 hereafter).
Note that the previous rejection has been modified in view of applicant’s amendments.
Regarding claims 203, 207 and 306, Facon et al discloses phase 3 randomized study of daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) in patients with newly diagnosed multiple myeloma ineligible for transplant (MAIA ) (Title). Facon et al. teaches a method of treating newly diagnosed multiple myeloma patients ineligible for high dose chemotherapy with autologous stem cell transplantation, comprising treating patients with 28-day cycles of Rd ± DARA, wherein R (lenalidomide) was administered with a dose of 25 mg (oral) QD on days 1-21, d (dexamethasone) is administered at a dose of 40 mg (oral) on days 1, 8, 15 and 22, DARA was given at 16 mg/kg (intravenously) QW for cycles 1-2, Q2W for cycles 3-6, and Q4W thereafter (page 2), wherein 44% of patients are ≥ 75 years of age (abstract). The Figure shows a trend that DRd improves progression-free survival (PFS) when compared to administration of Rd. Facon et al teaches that MRD negativity rate (10-5 sensitivity) will be measured at the primary endpoint (abstract).
Although Facon et al. does not specifically discloses that among patients who are ≥ 75 year of age, (i) DRd improves progression-free survival (PFS) when compared to administration of Rd, and (ii) the subject achieves a negative MRD status at a sensitivity of 10-5, these are considered inherent property of the method of Facon et al. Facon et al. teaches treating same patients (newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and who are ≥ 75 years of age) using same drugs (daratumumab, lenalidomide and dexamethasone) at same doses with same schedule. Practicing the method of prior art would inherently or necessarily lead to the same results. This is further evidenced by Facon 2025. Facon 2025 reports the results of the same clinical trial MAIA with longer follow up (64.5 month). Facon 2025 discloses that among patients who are ≥ 75 year of age, DRd improves progression-free survival (PFS) when compared to administration of Rd (Fig 2A and 2B) . Facon 2025 discloses among patients who are ≥75 years of age, D-Rd achieved sustained MRD negativity (26.9%) versus Rd (9.9%, p < 0.0001) (Table 2).
Regarding claims 204 and 317, Facon et al. discloses DARA was given at 16 mg/kg (intravenously) QW for cycles 1-2, Q2W for cycles 3-6, and Q4W thereafter (page 2).
Regarding claims 205 and 304, Facon et al. teaches that the addition of DARA to Rd in patients with transplant-ineligible NDMM significantly reduced the risk of progression or death by 45%, resulted in deeper responses with a complete response (CR) or better rate of 47.6% in the D-Rd arm compared with 24.7% in the Rd arm (p <0.0001).
Regarding claims 206 and 305, Facon et al. teaches that the very good partial response (VGPR) or better rate was 79.3% in the D-Rd arm compared with 53.1% in the Rd arm (p <0.0001) (pages 2-3).
Regarding claims 208 and 307, although Facon et al. does not specifically discloses that the subject has no disease progression at about 28 months from the start of treatment, it is considered inherent property of the method of Facon et al. Facon et al. teaches treating same patients (newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and who are ≥ 75 years of age) using same drugs (daratumumab, lenalidomide and dexamethasone) at same doses with same schedule. Practicing the method of prior art would inherently or necessarily lead to the same results.
Regarding claim 209 and 308, Facon et al. disclose that the patients are ineligible for autologous stem cell transplant and high dose chemotherapy and the patients include those who are ≥75 years of age (abstract).
Regarding claims 213 and 311, Facon discloses that dexamethasone is administered orally (abstract).
Regarding claim 214 and 312, Facon discloses that both lenalidomide and dexamethasone are administered orally (abstract), indicating they are self-administered.
Regarding claims 234-236 and 318-320, Facon et al. teaches a method of treating newly diagnosed multiple myeloma patients ineligible for high dose chemotherapy with autologous stem cell transplantation, comprising treating patients with 28-day cycles of Rd ± DARA, wherein R (lenalidomide) was administered with a dose of 25 mg (oral) QD on days 1-21, d (dexamethasone) is administered at a dose of 40 mg (oral) on days 1, 8, 15 and 22, DARA was given at 16 mg/kg (intravenously) QW for cycles 1-2, Q2W for cycles 3-6, and Q4W thereafter (page 2), wherein 44% of patients are ≥ 75 years of age (abstract).
Although Facon et al does not specifically disclose the results (e.g. CR, VGPR) for patients who are ≥ 75 years of age as recited in the claims, they are considered inherent property of the method of Facon et al. Facon et al. teaches treating same patients (newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and who are ≥75 years of age) using same drugs (daratumumab, lenalidomide and dexamethasone) at same doses with same schedule. Practicing the method of prior art would inherently or necessarily lead to the same results. This is further evidenced by Facon 2025. Facon 2025 reports the results of the same clinical trial MAIA with longer follow up (64.5 month). Facon 2025 discloses that among patients who are ≥75 year of age, DRd improves progression-free survival (PFS) when compared to administration of Rd (Fig 2A and 2B). Facon 2025 discloses among patients who are ≥75 years of age, D-Rd achieved sustained MRD negativity (26.9%) versus Rd (9.9%, p < 0.0001) (Table 2). Facon 2025 discloses the following results for the DRd group as compared to Rd group in the ≥ 75 years of age subgroup:
- Higher overall response rate (90% vs 81.4%);
- Higher rate of complete response or better (44.4% vs 28.6%);
- Higher rate of very good partial response (VGPR or better (78.1% vs 55.3%) (Table 2).
Facon 2025 discloses:
“Results from a subgroup analysis of patients from MAIA based on age (<70, ≥ 70 to <75, ≥75, and ≥80 years) were consistent with those reported for the ITT population. D-Rd demonstrated a meaningful benefit versus Rd in clinically relevant endpoints, including PFS, OS, ORR, and MRD-negativity rate, across age subgroups. Moreover, D-Rd induced higher rates of deep responses versus Rd across all age subgroups evaluated.” (emphasis added).
Applicant’s Arguments
The response states that Example 3 of the specification as filed examined the impact of age on the efficacy and safety of DRd vs. Rd in the patient population by conducting a subgroup analysis with patients <75 and ≥75 years (y) of age. After median follow-up of 28 months, significant PFS benefit of DRd vs. Rd was maintained in the ≥75 y subgroup (median NR vs 31.9 months; HR 0.63; 95% CI 0.44-0.92). The addition of daratumumab also resulted in a higher MRD-negative rate at the sensitivity threshold of 10-5 (19% vs 8%).
The subgroup analysis in Example 3 further reported the following efficacy and safety findings in the ≥75 y subgroup:
- Higher overall response rate (90% vs 81%);
- Higher rate of complete response or better (41% vs 25%);
- Higher rate of very good partial response or better (77% vs 53%);
- Fewer patients discontinued treatment due to treatment-emergent adverse events (TEAEs) (10% vs 21%); and
- Lower discontinuation rates (0% vs 2%).
Example 3 concludes that efficacy of DRd in ≥75 v pts was consistent with the intention-to-treat (ITT) population, and DRd demonstrated acceptable tolerability regardless of age. Thus, the age- specific efficacy and safety conclusions reported in Example 3 were based on a specific subgroup analysis and were not simply based on the overall ITT results.
In contrast, Facon does not explicitly disclose that: (i) adding daratumumab to Rd improved PFS in patients who were 75 years of age or older (hereinafter "the age-specific PFS limitation"); or (ii) a patient who was 75 years of age or older achieved a negative MRD status at the claimed 10-5 sensitivity threshold (hereinafter "the age-specific MRD limitation"). Indeed, Facon does not report a subgroup analysis of PFS in patients who were 75 years of age or older. The age-specific PFS and MRD limitations are also not inherently disclosed by Facon.
MPEP 2163.07(a) states:
"To establish inherency, the extrinsic evidence 'must make clear that the missing
descriptive matter is necessarily present in the thing described in the reference,
and that it would be so recognized by persons of ordinary skill. Inherency,
however, may not be established by probabilities or possibilities. The mere fact
that a certain thing may result from a given set of circumstances is not
sufficient."' In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed.
Cir. 1999) (citations omitted).
Here, Facon is a meeting abstract reporting the prespecified interim analysis of the MAIA study. Facon discloses that:
- The clinical study randomized 737 patients (368 to DRd and 369 to Rd);
- 44% of the intent-to-treat patients were ≥75 y;
- The median PFS for the Rd arm was 31.9 months and not reached for the D-Rd arm; and
- The complete topline data set would be presented with additional efficacy endpoints, including MRD negativity rate. The fact that Facon reports results for the overall ITT population, which included patients 75 years of age or older, does not establish that the reported PFS improvement necessarily occurred in the claimed age-specific population.
Because Facon does not establish that adding daratumumab to Rd necessarily improves PFS in patients who were 75 years of age or older, the extrinsic evidence does not support a conclusion that the age-specific PFS limitation is inherently disclosed by Facon. Similarly, because Facon does not establish that a patient who was 75 years of age or older necessarily achieved a negative MRD status at a sensitivity threshold of 10-5, the extrinsic evidence also does not support a conclusion that the age-specific MRD limitation is inherently disclosed by Facon.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. Although Facon et al. does not specifically disclose the results specific for patients who are ≥ 75 years of age, they are considered inherent property of the method of Facon et al. Facon et al. teaches treating same patients (newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and who are ≥75 years of age) using same drugs (daratumumab, lenalidomide and dexamethasone) at same doses with same schedule. Practicing the method of prior art would inherently or necessarily lead to the same results. This is further evidenced by Facon 2025. Facon 2025 reports the results of the same clinical trial MAIA with longer follow up (64.5 month). Facon 2025 discloses that among patients who are ≥75 year of age, DRd improves progression-free survival (PFS) when compared to administration of Rd (Fig 2A and 2B). Facon 2025 discloses among patients who are ≥75 years of age, D-Rd achieved sustained MRD negativity (26.9%) versus Rd (9.9%, p < 0.0001) (Table 2).
Facon 2025 discloses the following results for the DRd group as compared to Rd group in the ≥ 75 years of age subgroup
- Higher overall response rate (90% vs 81.4%);
- Higher rate of complete response or better (44.4% vs 28.6%);
- Higher rate of very good partial response or better (78.1% vs 55.3%) (Table 2).
Facon 2025 discloses:
“Results from a subgroup analysis of patients from MAIA based on age (<70, ≥ 70 to <75, ≥75, and ≥80 years) were consistent with those reported for the ITT population. D-Rd demonstrated a meaningful benefit versus Rd in clinically relevant endpoints, including PFS, OS, ORR, and MRD-negativity rate, across age subgroups. Moreover, D-Rd induced higher rates of deep responses versus Rd across all age subgroups evaluated.” (emphasis added).
For the foregoing reasons, the rejection is deemed proper and is therefore maintained.
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 203-210, 213-214, 234-236, 304-309 and 311-320 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Facon et al. (Blood, 2018, 132(Suppl 1); 8 pages, IDS filed on 12/23/2022), as evidenced by Facon 2025 (Facon et al, Leukemia, 2025, 39:942-950), in view of Prescribing Information of DARZALEX (Daratumumab) (pub. date: 11/2015).
The teachings of Facon et al. have been set forth above as they apply to claims 203-209, 213-214, 234-236, 304-308, 311-312 and 317-320.
Regarding claims 210 and 309, Facon does not specifically teach that the patients have normal hepatic function before treatment.
Regarding claims 313-316, Facon does not disclose that daratumumab is provided for administration by a manufacturer of daratumumab in a single-dose vial comprising 100 mg daratumumab in 5 mL of solution or in a single-dose vial comprising 400 mg daratumumab in 20 mL of solution, wherein each single-dose vial comprising 100 mg daratumumab in 5 mL of solution contains 0.9 mg glacial acetic acid, 127.5 mg mannitol, 2 mg polysorbate 20, 14.8 mg sodium acetate trihydrate, 17.5 mg sodium chloride and water for injection, and each single-dose vial comprising 400 mg daratumumab in 20 mL of solution contains 400 mg daratumumab, 3.7 mg glacial acetic acid, 510 mg mannitol, 8 mg polysorbate 20, 59.3 mg sodium acetate trihydrate, 70.1 mg sodium chloride and water for injection, wherein daratumumab is diluted into 0.9% sodium chloride prior to administration.
Prescribing Information of Daratumumab teaches that the population PK analysis included 189 patients with normal hepatic function and 34 with mild hepatic impairment patients, no clinical differences in the exposure to daratumumab were observed between patients with mild hepatic impairment and those with normal hepatic function (page 14, para 1). Prescribing Information of Daratumumab teaches that daratumumab has not been studied in patients with moderate or severe hepatic impairment (page 14, para 1).
Prescribing Information of Daratumumab discloses that daratumumab is provided for administration by a manufacturer of daratumumab in a single-dose vial comprising 100 mg daratumumab in 5 mL of solution or in a single-dose vial comprising 400 mg daratumumab in 20 mL of solution, wherein each single-dose vial comprising 100 mg daratumumab in 5 mL of solution contains 0.9 mg glacial acetic acid, 127.5 mg mannitol, 2 mg polysorbate 20, 14.8 mg sodium acetate trihydrate, 17.5 mg sodium chloride and water for injection, and each single-dose vial comprising 400 mg daratumumab in 20 mL of solution contains 400 mg daratumumab, 3.7 mg glacial acetic acid, 510 mg mannitol, 8 mg polysorbate 20, 59.3 mg sodium acetate trihydrate, 70.1 mg sodium chloride and water for injection, wherein daratumumab is diluted into 0.9% sodium chloride prior to administration ((see pages 18 and 19 product label).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated patients having normal hepatic function using the method of Facon in view of the Prescribing Information. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the Prescribing Information of Daratumumab teaches that the population PK analysis included 189 patients with normal hepatic function and 34 with mild hepatic impairment patients, no clinical differences in the exposure to daratumumab were observed between patients with mild hepatic impairment and those with normal hepatic function (page 14, para 1). Prescribing Information of Daratumumab teaches that daratumumab has not been studied in patients with moderate or severe hepatic impairment (page 14, para 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used daratumumab described in the Prescribing Information in the method of Facon. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the Prescribing Information discloses in detail how to use the commercially available daratumumab to treat patients having myeloma.
Applicant’s Arguments
The response states that Facon does not disclose, teach, or suggest the age-specific PFS limitation or the age-specific MRD limitation. Prescribing Information does not teach or suggest either the age-specific PFS limitation or the age-specific MRD limitation. As such, Prescribing Information does not remedy the deficiency in Facon's teaching. Accordingly, claim 203 is nonobvious in view of Facon and Prescribing Information. Ahmadi also does not teach or suggest either the age-specific PFS limitation or the age- specific MRD limitation. As such, Ahmadi does not remedy the deficiency in the teachings of Facon and Prescribing Information.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive for the same reasons discussed in the 102(a)(1) rejection.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
12. 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.
13. Claims 203-209, 212-214, 234-236, 304-308, 310-312 and 317-320.
remain/are rejected under 35 U.S.C. 103 as being unpatentable over Facon et al. (Blood, 2018, 132(Suppl 1); 8 pages, IDS filed on 12/23/2022), as evidenced by Facon et al. (Leukemia, 2025, 39:942-950, referred to Facon 2025 hereafter), in view of Dimopoulos et al. (N Engl J Med, 2016, 375:1319-1331, IDS filed on 12/23/2022).
The teachings of Facon et al have been set forth above as they apply to claims 203-209, 213-214, 234-236, 304-308, 311-312 and 317-320.
Regarding claims 212 and 310, Facon does not teach that dexamethasone is administered as pre-medication on daratumumab administration days.
Dimopoulos et al. teaches a method of treating patients having relapsed and refractory multiple myeloma, the method comprising administering to the patients daratumumab, lenalidomide and dexamethasone at doses and schedules which are essentially the same as the method of Facon et al (page 1321, column 1), wherein dexamethasone was administered at a dose of 20 mg before infusion as prophylaxis for infusion-related reactions (page 1321, column 1). Dimopoulos et al. teaches that patients in either group who were older than 75 years of age or whose body-mass index (the weight in kilograms divided by the square of the height in meters) was less than 18.5 received dexamethasone at a dose of 20 mg weekly at the discretion of their physician (page 1321, column 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a dose of 20 mg dexamethasone for patients who are <75 years of age and/or who have a body mass index of <18.5 in view of Dimopoulos et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Dimopoulos et al. teaches patients in either group who were older than 75 years of age or whose body-mass index was less than 18.5 received dexamethasone at a dose of 20 mg weekly at the discretion of their physician (page 1321, column 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered 20 mg dexamethasone as a premedication on daratumumab administration days in view of Dimopoulos et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Dimopoulos et al. teaches administering a dose of 20 mg of dexamethasone before infusion of daratumumab as prophylaxis for infusion-related reactions
Double Patenting
14. 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.
15. Claims 203-210, 212-214, 234-236 and 304-320 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 203-210, 212-214, 234-236 and 304-320 of copending Application No. 16/797,301 (reference application), as evidenced by Facon et al. (Leukemia, 2025, 39:942-950, referred to Facon 2025 hereafter), in view of Prescribing Information of DARZALEX (Daratumumab) (pub. date: 11/2015).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of copending application disclose a method of treating a subject with newly diagnosed multiple myeloma, comprising administering a combination dosing regimen in 4-week cycles, wherein the combination dosing regimen comprises administering to the subject: a) about 16 mg/kg daratumumab intravenously weekly for cycles 1 and 2, every two weeks for cycles 3 to 6, followed by every four weeks for cycles 7 and beyond, b) about 25 mg lenalidomide once daily orally on days 1-21 of each cycle, and c) about 20 mg or about 40 mg dexamethasone weekly for each cycle, wherein the subject is ineligible for autologous stem cell transplant and high dose chemotherapy, is ≥75 years of age, and has a body mass index of < 18.5,
wherein the subject achieves a negative status for minimal residual disease at 28 months of administration of the combination dosing regimen,
wherein the about 20 mg or about 40 mg dexamethasone is administered as a pre-medication on daratumumab administration days,
wherein the subject further achieves a stringent complete response, a complete response, a very good partial response, a duration of response of more than 34.7 months, the subject achieves a progression-free survival (PFS) of more than 31.9 months.
The claims of the copending application do not disclose that the patients have a normal hepatic function before treatment, and do not disclose limitations of claim 313-316.
The teachings of Prescribing Information of DARZALEX (Daratumumab) have been set forth above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated patients having normal hepatic function using the method of copending application in view of the Prescribing Information. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the Prescribing Information of Daratumumab teaches that the population PK analysis included 189 patients with normal hepatic function and 34 with mild hepatic impairment patients, no clinical differences in the exposure to daratumumab were observed between patients with mild hepatic impairment and those with normal hepatic function (page 14, para 1). Prescribing Information of Daratumumab teaches that daratumumab has not been studied in patients with moderate or severe hepatic impairment (page 14, para 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used daratumumab described in the Prescribing Information in the method of copending application. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the Prescribing Information discloses in detail how to use the commercially available daratumumab to treat patients having myeloma.
Conclusion
16. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG SANG/Primary Examiner, Art Unit 1643
Prosecution Insights