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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 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 1-3, 5-10, 12-17 and 19-25 are pending. Claims 4, 11 and 18 are canceled. Claims 1, 8, 15 and 23-25 have been amended.
4. Claims 1-3, 5-10, 12-17 and 19-25 are under examination.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 12/16/2025 has been considered by the examiner.
Rejections Maintained
Claim Rejections - 35 USC § 102
6. 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.
7. Claims 1-3, 5-10, 12-17 and 19-25 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dimopoulos et al (N. Engl. J. Med., 2016, Oct 6, 375(14): 1319-1331).
Regarding claims 1, 3, 5, 7-8, 10, 12, 14-15, 17, 19, and 21-22, Dimopoulos et al teaches a method of treating relapsed or refractory multiple myeloma in human patients, the method comprising administering to the patients daratumumab (an anti-CD38 antibody), lenalidomide, and dexamethasone, wherein the patients included those having high risk cytogenetic profile (Table 1), wherein 22.4% of the patients had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells, or 1 tumor cell per 106 white cells) (abstract and page 1326, column 1)), wherein the minimal residual disease status was evaluated by means of a next-generation sequencing assay of bone marrow obtained from patients who had a suspected complete response (page 1321, column 2, para 2). The antibody daratumumab inherently comprises the VH and VL amino acid sequences recited in instant claims 1, 8 and 15, the heavy and light chain amino acid sequences recited in instant claims 5, 12 and 19, as evidenced by instant specification (see paragraph [0072]).
Regarding new limitation “the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)” recited in claims 1, 8 and 15, Dimopoulos et al. discloses “consistent with the higher rates of deeper responses in the daratumumab group, the rate of results below the threshold for minimal residual disease was significantly higher in the daratumumab group than in the control group (by 3 to 5 times) at all evaluated thresholds (1 tumor cell per 104, 105, and 106 white cells)” (page 1326, column 1 and Fig. S4 in the Supplementary Appendix), indicating that some subjects have achieved a negative minimal residual disease (MRD) status at a sensitivity of 10-6 and these subjects would have reduced risk of relapse and/or disease progression.
Regarding claims 6, 13 and 20, Dimopoulos teaches that daratumumab is intravenously administered at a dose of 16 mg/kg weekly on days 1, 8, 15, and 22 for 8 weeks during cycles 1 and 2 (treatment cycle is 28 days) (same as once per week in a 28-day cycle), once every 2 weeks on days 1 and 15 for 16 weeks (cycles 3 through 6) (same as in a 28-day cycle during cycles 3 through 6), and every 4 weeks thereafter, lenalidomide is administered orally at a dose of 25 mg on days 1 to 21 of each cycle if the creatinine clearance was more than 60 ml per minute (or a dose of 10 mg daily if the creatinine clearance was 30 to 60 ml per minute) and dexamethasone at a dose of 40 mg weekly (patients older than 75 years of age or whose body-mass index less than 18.5 received dexamethasone at a dose of 20 mg weekly at the discretion of their physician) (page 1321, column 1).
Regarding claims 23-25, Dimopoulos et al teaches that the method increases progression-free survival compared to administering lenalidomide and dexamethasone without the anti-CD38 antibody (Fig. 1). Dimopoulos et al. teaches that the rate of progression-free survival at 12 months was 85.7% (95% CI, 80.9 to 89.4) in the daratumumab group, as compared with 63.2% (95% CI, 57.1 to 68.8) in the control group (page 1324, column 2). Dimopoulos et al. teaches “The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma.” The patients included those having high risk cytogenetic profile (Table 1).
Regarding claims 2, 9 and 16, Dimopoulos et al teaches that patients included patients having high risk cytogenetic profile (Table 1). Although Dimopoulos et al does not specifically disclose that the high risk cytogenetic profile comprises a chromosomal abnormality recited in claims 2, 9 and 16, Dimopoulos et al describes the study results of the phase 3 trial NCT02076009 (POLLUX). As evidenced by instant specification, patients with high-risk cytogenetics in the phase 3 trial NCT02076009 (POLLUX) had one or more of the following abnormalities t(4;14)(pl6;q32), t(14;16)(q32;q23), or del17p (see Example 2 and [00243] of the instant specification). Therefore, the patients in the prior art included those having one or more of the following abnormalities t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p.
Because the patients are same (as evidenced by the specification) and thus they possess the same chromosomal abnormalities.
See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) ("[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not."). See also Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) ("Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.").
Applicant’s Arguments
The response states that independent claims 1, 8, and 15 are amended to recite "wherein…the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)." Dimopoulos does not disclose this feature in a subject having high-risk multiple myeloma. Dimopoulos et al teaches that 22.4% of the patients had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells, or 1 tumor cell per 106 white cell) (page 1326, column 1). However, Dimopoulos does not disclose minimal residual disease (MRD) data at a threshold of 1 tumor cell per 106 white cells. Dimopoulos does not disclose achieving a negative minimal residual disease status at a sensitivity of 0.0001% (10-6). Furthermore, Dimopoulos discloses that, in the daratumumab group, 15.4%of patients have high-risk multiple myeloma. (Page 1323, Table 1.) Dimopoulos does not perform a subgroup analysis of MRD status based on risk. There is no evidence of an overlap between patients having high-risk multiple myeloma (15.4%) and patients achieving negative MRD status (22.4%). Accordingly, it cannot be inferred from the disclosure of Dimopoulos if any high-risk multiple myeloma patient in the daratumumab group achieved negative MRD status, whether determined at a sensitivity of 10-5 or 10-6. Indeed, Dimopoulos discloses that, in the control group, 16.6%of patients have high-risk multiple myeloma and 4.6% of patients achieved negative MRD status at a sensitivity of 0.001% (10-5). Applicant shows that no patient in the control group achieved negative MRD status at a sensitivity of 0.001% (10-5) or 0.0001% (10-6). See, paragraphs [00279] and [00280] of Application as filed. Also see Exhibit 1 at 2092, Table 2.
Finally, the feature, a subject having high-risk multiple myeloma achieving negative MRD status at a sensitivity of 0.0001% (10-6), is not an inherent disclosure of Dimopoulos. As detailed above, the clause, "wherein ... the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)," is a result limitation that may be, but is not necessarily, met upon performance of the method recited earlier in claim 1, 8, or 15.
For at least these reasons, Dimopoulos does not anticipate independent claims 1, 8, and 15. The remaining claims depend, directly or indirectly, from an independent claim, and therefore are not anticipated by Dimopoulos for the same reasons.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive.
Regarding new limitation “the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)” recited in claims 1, 8 and 15, Dimopoulos et al. discloses “consistent with the higher rates of deeper responses in the daratumumab group, the rate of results below the threshold for minimal residual disease was significantly higher in the daratumumab group than in the control group (by 3 to 5 times) at all evaluated thresholds (1 tumor cell per 104, 105, and 106 white cells)” (page 1326, column 1 and Fig. S4 in the Supplementary Appendix), indicating that some subjects have achieved a negative minimal residual disease (MRD) status at a sensitivity of 10-6. Dimopoulos et al. teaches treating high risk relapsed or refractory multiple myeloma (Table 1). Because the method of the prior art is identical to the method of instant claims, practicing the method of prior art would inherently or necessarily lead to the same results. Furthermore, both Dimopoulos et al. and the instant specification describe the results of the same clinical trial (i.e. treating same patient populations using same treatment schedule), the results would necessarily be identical.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 1-3, 5-10, 12-17 and 19-25 remain rejected under 35 U.S.C. 103 as being unpatentable over Dimopoulos et al. (N. Engl. J. Med., 2016, Oct 6, 375(14): 1319-1331), in view of Rajkumar et al (Mayo Clin Proc, 2016, 91(1): 101-119).
The teachings of Dimopoulos et al have been set forth above as they apply to claims 1-3, 5-10, 12-17, and 19-25.
Regarding claims 2, 9 and 16, Dimopoulos et al teaches treating patients having high risk cytogenetic profile and stage III MM patients (Table 1).
Rajkumar et al teaches that stage III multiple myeloma is characterized by high-risk cytogenetics t(4;14), t(14;16), or del17p (Table 5), and approximately 40% of MM cases are characterized by the presence of trisomies in the neoplastic plasma cells (trisomic MM), while most of the rest have a translocation involving the immunoglobulin heavy chain (IgH) locus on chromosome14q32 (IgH translocated MM) (page 102, last paragraph), including t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p (Table 2).
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 the method of Dimopoulos to treat multiple myeloma comprising t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p chromosomal abnormality in view of Rajkumar et al. One of ordinary skill in the art would have been motivated to do so because Dimopoulos et al teaches treating patients having high risk cytogenetic profile and stage III MM patients (Table 1), and Rajkumar et al teaches that stage III multiple myeloma is characterized by high-risk cytogenetics t(4;14), t(14;16), or del17p (Table 5), and approximately 40% of MM cases are characterized by the presence of trisomies in the neoplastic plasma cells (trisomic MM), while most of the rest have a translocation involving the immunoglobulin heavy chain (IgH) locus on chromosome14q32 (IgH translocated MM) (page 102, last paragraph), including t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p (Table 2). One of ordinary skill in the art would have had a reasonable expectation of success because Dimopoulos et al teaches treating patients having high risk cytogenetic profile and stage III MM patients (Table 1), and Rajkumar et al teaches that carfilzomib, lenalidomide and dexamethasone (KRD) has been used clinically to treat high-risk myeloma (page 106, column 2).
Response to Arguments
Applicant presented same arguments as for the 102(a)(1) rejection. The arguments are not persuasive for the same reasons discussed above.
Double Patenting
10. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
11. Claims 1-3, 5-10, 12-17, and 19-25 remain 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), in view of Rajkumar et al (Mayo Clin Proc, 2016, 91(1): 101-119).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of reference application disclose a method of treating a subject with newly diagnosed multiple myeloma, comprising administering to the subject daratumumab as a combination therapy comprising: about 16 mg/kg daratumumab administered once a week on weeks 1 to 8, once in two weeks on weeks 9 to 24 and thereafter once in four weeks, b) about 25 mg lenalidomide administered daily on days 1 to 21 of repeated 4-week cycles, and c) about 20 mg to about 40 mg dexamethasone administered per week, wherein daratumumab is administered intravenously, lenalidomide is administered orally and dexamethasone is administered intravenously or orally,
wherein the method achieves an improved clinical efficacy endpoint when compared to a clinical efficacy endpoint achieved if the subject were administered a combination of lenalidomide and dexamethasone, wherein the improved clinical efficacy endpoint is an increased likelihood of achieving a complete response (CR), an increased likelihood of achieving a negative status for minimal residual disease (MRD), a reduced risk of progression of multiple myeloma or death, wherein the subject with newly diagnosed multiple myeloma is ineligible for high dose chemotherapy (HDC) and autologous stem cell transplant (ASCT).
The claims of copending application do not tech treating relapsed, refractory or relapsed and refractory multiple myeloma having the chromosomal abnormalities recited in claims 2, 9 and 16.
Rajkumar et al teaches that stage III multiple myeloma is characterized by high-risk cytogenetics t(4;14), t(14;16), or del17p (Table 5), and approximately 40% of MM cases are characterized by the presence of trisomies in the neoplastic plasma cells (trisomic MM), while most of the rest have a translocation involving the immunoglobulin heavy chain (IgH) locus on chromosome14q32 (IgH translocated MM) (page 102, last paragraph), including t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p (Table 2). Rajkumar et al. teaches that in a phase 2 trial, daratumumab as a single agent produced a response rate of approximately 30% in heavily pretreated patients (page 113, column 2). Rajkumar et al. disclose that lenalidomide plus dexamethasone is an effective regimen in treating high-risk MM (page 106, column 2, para 3, page 112, column 1, para 3).
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 the method of copending application to treat high risk relapsed and refractory multiple myeloma comprising t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p chromosomal abnormality in view of Rajkumar et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of reference application disclose that the method can be used to treat newly diagnosed MM and Rajkumar et al teaches that daratumumab as a single agent produced a response rate of approximately 30% in heavily pretreated patients (page 113, column 2), Rajkumar et al. disclose that lenalidomide plus dexamethasone is an effective regimen in treating high-risk MM (page 106, column 2, para 3, page 112, column 1, para 3), and stage III multiple myeloma is characterized by high-risk cytogenetics t(4;14), t(14;16), or del17p (Table 5), and approximately 40% of MM cases are characterized by the presence of trisomies in the neoplastic plasma cells (trisomic MM), while most of the rest have a translocation involving the immunoglobulin heavy chain (IgH) locus on chromosome14q32 (IgH translocated MM) (page 102, last paragraph), including t(4;14)(p16;q32), t(14;16)(q32;q23), or del17p (Table 2).
Applicant’s Arguments
The response states that MPEP states, "If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as
a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent." See § 804.I.B.1.(b)(i).
Here, the instant application has an earlier effective U.S. filing date, October 31, 2017 (2017-10-31), compared with that of 16/797,301 (February 22, 2019 (2019-02-22)). As such, once this provisional nonstatutory double patenting rejection is the only rejection remaining in the application, reconsideration and withdrawal of the rejection are respectfully requested.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive because the rejection is not the only rejection remaining in the application at this time.
New Grounds of Objection and Rejection
Claim Objections
12. Claims 1-3, 5-10, 12-17 and 19-25 are objected to because of the following informalities:
The claims recite a limitation of at a sensitivity of 0.01%, 0.001%, or 0.0001%. The exact meaning of the limitation is unclear.
Claim Rejections - 35 USC § 112
13. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
14. Claims 1-3, 5-10, 12-17 and 19-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “high risk” in the claims is a relative term which renders the claim indefinite. The term “high risk” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Moreover, the high risk multiple myeloma (MM) can be interpreted as a relapsed or refractory MM as recited in claim 3, a late stage MM (which would be high risk as compared to an early stage MM), or MM having one or more chromosomal abnormalities as in claim 2, therefore, the metes and bounds of the claimed invention cannot be determined and the claims are indefinite.
Claim Rejections - 35 USC § 112
15. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
16. Claims 7, 14, 21 and 22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 depends from claim 1. Claim 1 recites a new limitation “the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)”. One embodiment (part b) of claim 7 is drawn to the method of claim 1, wherein the negative minimal residual disease status is determined at a sensitivity of 0.01%, 0.001%, 0.0001%, or a combination thereof. According to claim 1, the negative MRD status can only be determined at a sensitivity of at least 0.0001%. Therefore, claim 7 does not properly depend from claim 1.
Claim 14 depends from claim 8. Claim 8 recites a new limitation “the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)”. One embodiment (part b) of claim 14 is drawn to the method of claim 8, wherein the negative minimal residual disease status is determined at a sensitivity of 0.01%, 0.001%, 0.0001%, or a combination thereof. According to claim 8, the negative MRD status can only be determined at a sensitivity of at least 0.0001%. Therefore, claim 14 does not properly depend from claim 8.
Claims 21 and 22 depend from claim 15. Claim 15 recites a new limitation “the subject achieves a negative minimal residual disease status at a sensitivity of 0.0001% (10-6)”. Claim 21 is drawn to a method of claim 15, wherein the method achieves a negative minimal residual disease status in the subject. Thus claim 21 does not further limit claim 15. One embodiment (part b) of claim 22 is drawn to the method of claim 15, wherein the negative minimal residual disease status is determined at a sensitivity of 0.01%, 0.001%, 0.0001%, or a combination thereof. According to claim 15, the negative MRD status can only be determined at a sensitivity of at least 0.0001%. Therefore, claim 22 does not properly depend from claim 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
17. 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 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
18. Claim 1-3, 5-10, 12-17 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19/418,900 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 of copending Application No. 19/418,900 (reference application) disclose a method of treating a subject with relapsed or refractory multiple myeloma, comprising administering a combination dosing regimen in 4-week cycles, wherein the combination dosing regimen comprises administering: a) about 16 mg/kg daratumumab intravenously once per week for cycles 1 and 2, once every two weeks for cycles 3 to 6, followed by once every four weeks for each cycle thereafter, b) about 25 mg lenalidomide once daily orally on days 1-21 of each cycle, and c) about 20 mg to about 40 mg dexamethasone weekly for each cycle, wherein the subject has received at least one prior therapy; and wherein the subject is minimal residual disease (MRD) negative after at least 6 months of achieving a complete response,
wherein the minimal residual disease is determined at a sensitivity threshold of 0.0001%,
wherein the minimal residual disease is evaluated using a bone marrow aspirate sample,
wherein the subject exhibits progression-free survival of at least 12 months following initiation of the combination dosing regimen.
wherein the subject has suffered an early relapse prior to administration of the combination dosing regimen,
wherein the subject has high-risk multiple myeloma, the subject has one or more chromosomal abnormalities comprising: a) t(4;14)(p16;q32); b) t(14;16)(q32;q23); c) del17p; d) t(4;14)(p16;q32) and t(14;16)(q32;q23); e) t(4;14)(p16;q32) and del17p; f) t(14;16)(q32;q23) and del17p; or g) t(4;14)(p16;q32), t(14;16)(q32;q23) and del17p,
wherein the subject is minimal residual disease (MRD) negative at the time of achieving a complete response or stringent complete response.
As one can see, the instant claims are not patentably distinct from the claims of the copending application.
Conclusion
19. No claims are allowed.
20. 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 on Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1643