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/Restrictions
Applicant’s election without traverse of Group I (Claims 1-2 and 4-19) in the reply filed on 25 August 2025 is acknowledged.
Claims 1-2, 6-10, and 12 have undergone amendments. Claims 4-5, 14-17, 20-21, and 29-43 have been cancelled. Thus, Claims 1-2, 6-13, and 18-19, submitted on 25 August 2025, represent all claims currently under consideration.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 7 February 2020.
Information Disclosure Statement
Four Information Disclosure Statements (IDSs), submitted on 1 May 2023, 31 May 2023, 4 October 2024, and 26 August 2025, are acknowledged and have been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: The word “phase” is listed twice in a row in the limitation “occurs predominantly in the M phase phase of the cell cycle”, and Claim 1 also states vincristine twice (once in the acronym for CHOP, and the second in the Markush list of compounds). Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2 and 7-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method of treating cancer by first determining whether or not the patient’s cancer has elevated MYCN expression level, MYCN gene copy number, or if the MYCN gene chromosomal location site is translocated without significantly more. The claims recite a series of steps. This judicial exception is not integrated into a practical application because the claimed method is a method of treatment following identification of a patient with cancer who meets the claimed criteria. The end result of the choices is that a person is either given the treatment or is not given the treatment.
When the claims are analyzed in terms of steps, two possibilities are encompassed. The first possibility is that the claims have no active steps because if the patient does not meet the recited criteria (i.e., is identified as not having elevated MYCN expression level, MYCN gene copy number, or if the MYCN gene chromosomal location site is translocated), administration of therapeutics does not occur. Therefore, no active step is present. The second possibility is that a patient is identified as having cancer which meets these criteria, and the administration of the therapeutics occurs.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed steps do not meet all of the required steps under 35 U.S.C. § 101.
Step 1: Statutory Category?: Yes. The claims recite a series of steps and therefore a process.
Step 2A- Prong 1: Judicial Exception Recited?: Yes. The claims as a whole recite a method of collecting data. The claimed invention is drawn to a method of identifying if a patient has elevated MYCN expression or a translocation event. This diagnostic step ascertains if a patient needs to be administered the treatment. If the diagnostic step is met, the individual undergoes the treatment.
Step 2A- Prong 2: Integrated into Practical Application?: No. The claims as a whole merely describe how to apply the idea of treating a patient using the claimed treatment method given a diagnostic step. There is no requirement that treatment is given to the patient. Simply determining if a patient has elevated MYCN expression or a translocation is not an active step, but a method of collecting data.
Step 2B- Prong 2- Inventive Concept?: No. As noted in the previous step, the claims as a whole merely describe how to apply the treatment of cancer given a diagnostic step of collecting patient data. There is no requirement that the treatment occurs. The claims merely recite that a patient is identified as either having elevated MYCN expression or not. When viewed as a whole, nothing in the claim adds significantly more to the idea of collecting data. The claims are ineligible.
Claim Rejections - 35 USC § 112(b)
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.
Claim 6 is 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. Claim 6 recites the limitation "the MYCN expression level or MYCN gene copy number in the cancer tissue" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as Claim 1 does not mention MYCN expression level or MYCN gene copy number within the cancer tissue.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 6-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Calderone (Journal of Cancer Therapy, 2014, 5, 1289-1302) in view of Coughlan (Pediatric Hematology and Oncology, 2017 August; 34 (5): 320-330).
Calderone performed a study on the use of YM155 for the treatment of neuroblastoma. Neuroblastoma exhibits a high incidence of chromosomal translocations, the most common being the gain of a portion of the long arm of chromosome 17, which includes the gene BIRC5/survivin. This gene is highly upregulated in neuroblastoma and correlates with poor survival. Survivin is a member of the inhibitor of apoptosis family of proteins and is involved in tumor cell survival and migration. YM155 is a small molecule inhibitor of survivin transcription and has shown efficacy in several cancer model systems. Cells were treated with YM155 and effects on migration, invasion, and apoptosis signaling were investigated. Tumor burden was also assessed in xenografted mice. Treatment with YM155 caused a dose-dependent decrease in survivin expression and induction of apoptosis. In a xenograft model, YM155 treatment inhibited tumor growth by 25-70%, reduced metastatic burden in the liver by 50%, and prolonged survival. The data suggests that YM155 is a possible therapeutic agent for metastatic neuroblastoma (Abstract). Genetic changes in the more aggressive forms of neuroblastoma are often segmental chromosome aberrations. A recent study determined that among 8800 tumors the most common segmental chromosomal aberration is gain of 17q, occurring in 48% of neuroblastomas. One gene of interest mapped to this region is baculoviral inhibitor of apoptosis-repeat containing 5 (BIRC5)/survivin, which his overexpressed in many cancers including neuroblastoma. Gain of 17q and overexpression of survivin also correlates with MYCN amplification. As gene amplification tends to drive neuroblastoma, there is a need for novel therapies that can modulate expression of these driver genes. In neuroblastoma, high survivin expression correlates with MYCN amplification, high risk group, recurrence, and decreased overall survival. Inhibition of survivin expression in neuroblastoma cells increases apoptosis and sensitization to chemotherapy. Additionally, survivin knockdown reduced migration of neuroblastoma cells (Introduction). The data presented in Table 1 confirms that cell lines with MYCN amplification also had the highest survivin expression (Section 3.1).
Coughlan teaches current treatment methods for neuroblastoma. Most intermediate risk patients (81%) received a chemotherapy regimen that included carboplatin, etoposide, cyclophosphamide, and doxorubicin (Abstract). In their analysis, cyclophosphamide was the chemotherapeutic most frequently administered. Among low-risk patients, approximately 11% received a regimen consisting of carboplatin and etoposide followed by cyclophosphamide and doxorubicin (Systemic Therapies). Cyclophosphamide (43%), vincristine (37%), and doxorubicin (27%) were found to be the three most frequently used agents in an analysis of data from the Childhood Cancer Survivor Study from between 1970 and 1986 (Discussion).
Calderone and Coughlan are considered analogous to the claimed invention as all are involved in the treatment of neuroblastoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to combine the use of YM155 with the claimed chemotherapeutic agents as Coughlan teaches that these are commonly used in the treatment of neuroblastoma. This combination is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Calderone demonstrates the utility of YM155 for the treatment of neuroblastoma, while Coughlan demonstrates that the claimed chemotherapeutics are commonly used in the treatment of neuroblastoma; the artisan would recognize this and be motivated to combine them to arrive at a more effective combination therapy. Calderone does not teach the use of YM155 in combination with a second chemotherapeutic agent selected from one or more of CHOP, vinblastine, vinorelbine, cabazitaxel, docetaxel, paclitaxel, eribulin, estramustine, or ixabepilone. However, it would be prima facie obvious to one of ordinary skill in the art to combine YM155 with one of the agents selected as each are known individually to be useful for the treatment of neuroblastoma (See MPEP § 2144.06 I) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The timing of the administration of these therapeutics is also prima facie (See MPEP § 2144.04 IV (C)); In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Regarding the specific methods for identifying gene expression, Calderone teaches the measurement of MYCN expression levels using cDNA microarray (Section 2.3, Whole Genome Expression). However, the artisan would recognize that the techniques which are claimed are equivalent performing a cDNA microarray. Thus it would be obvious to one of ordinary skill in the art to apply these other techniques to study the expression of MYCN in a patient in need thereof.
Claims 1, 6, 13, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Voges (Cell Death and Disease, 2016, 7) in view of Coughlan (Pediatric Hematology and Oncology, 2017 August; 34 (5): 320-330).
Voges (See IDS, 1 May 2023) studied the use of YM155 in neuroblastoma cells with acquired drug resistance. YM155 is a drug candidate introduced as a survivin suppressant. The authors investigated the efficacy of YM155 in neuroblastoma cells with acquired drug resistance. Clinical YM155 concentrations affected the viability of drug-resistant neuroblastoma cells through survivin depletion and p53 activation. MDM2 inhibitor-induced p53 activation further enhanced YM155 activity. Upregulation of ABCB1 (causes YM155 efflux) and downregulation of SLC35F2 (causes YM155 uptake) mediated YM155-specific resistance. YM155-adapted cells displayed increased ABCB1 levels, decreased SLC35F2 levels, and a p53 mutation, and were also characterized by decreased sensitivity to RNAi-mediated survivin depletion, confirming survivin as a critical YM155 target in neuroblastoma. The cell lines which were tested in these experiments were MYCN-amplified neuroblastoma cell lines UKF-NB-3 and UKF-NB-6 (Discussion). The parental cell lines (no resistance mechanisms introduced) displayed IC50s towards YM155 on the order of 0.5 nM, and YM155 induced survivin depletion and p53 induction in both cell lines (Discussion).
The teachings of Coughlan are previously described and are fully incorporated into this rejection.
Voges and Coughlan are considered analogous to the claimed invention as all are involved in the treatment of neuroblastoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to combine the use of YM155 with the claimed chemotherapeutic agents as Coughlan teaches that these are commonly used in the treatment of neuroblastoma. This combination is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Voges demonstrates the utility of YM155 for the treatment of neuroblastoma, while Coughlan demonstrates that the claimed chemotherapeutics are commonly used in the treatment of neuroblastoma; the artisan would recognize this and be motivated to combine them to arrive at a more effective combination therapy. Voges does not teach the use of YM155 in combination with a second chemotherapeutic agent selected from one or more of CHOP, vinblastine, vinorelbine, cabazitaxel, docetaxel, paclitaxel, eribulin, estramustine, or ixabepilone. However, it would be prima facie obvious to one of ordinary skill in the art to combine YM155 with one of the agents selected as each are known individually to be useful for the treatment of neuroblastoma (See MPEP § 2144.06 I) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The timing of the administration of these therapeutics is also prima facie (See MPEP § 2144.04 IV (C)); In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claims 1, 2, 6-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2025/0092463; Publication Date: 20 March 2025; Claims priority to 13 August 2018 and 16 November 2018) in view of Coughlan (Pediatric Hematology and Oncology, 2017 August; 34 (5): 320-330).
Li provides methods of using a MYC gene as a biomarker for predicting therapeutic efficacy of survivin inhibitors such as YM155 monobromide in cancer therapy, and related kits, compositions, and methods for diagnosing and treating cancer in a subject in need thereof (Abstract). Embodiments of the present disclosure include methods of treating cancer in a subject in need thereof, comprising determining MYC gene copy number of MYC gene chromosomal location site in a sample of cancer tissue from the subject and administering YM155 monobromide to the subject if MYC gene copy number in the cancer tissue is increased relative to that of a MYC gene copy number reference, or if MYC gene chromosomal location site in the cancer tissue is translocated to that of a MYC gene chromosomal location site reference, thereby treating the cancer (Paragraphs 0005-0008). In some embodiments, the MYC gene copy number in the cancer tissue is increased by about or at least about 1.5, 2, 3, 4, 5, 6, 7, 8, 9, or 10-fold relative to that of the MYC gene copy number reference (Paragraph 0016). Some embodiments comprise determining MYC gene copy number in the cancer tissue by array comparative genome hybridization (aCGH), single nucleotide polymorphism array, copy number variation sequencing, or multiplex ligation dependent probe amplification. Some embodiments comprise determining MYC gene chromosomal site location in the cancer tissue by in situ hybridization, fluorescence in situ hybridization, next generation sequencing, or comparative genome hybridization. Some embodiments comprise obtaining the MYC gene copy number reference from a database or determining the MYC gene copy number reference from a non-cancerous tissue from a control. Some embodiments comprise obtaining the MYC gene chromosomal location site reference from a database, or determining the MYC gene location site reference from a non-cancerous tissue from a control, optionally by ISH, FISH, NGS, or CGH (Paragraph 0017). Some embodiments comprise obtaining the sample of cancer tissue from the subject. In certain embodiments, the sample of cancer tissue is a surgical sample, a biopsy sample, a pleural effusion sample, or an ascetic fluid sample obtained from the subject, optionally selected from neuronal tissue (Paragraph 0018). In certain embodiments the subject is a human subject (Paragraph 0019). In certain embodiments the cancer is selected from… neuroblastoma (Paragraph 0020). In certain embodiments, the MYC gene is selected from MYCC and MYCN. In specific embodiments, the MYC gene is MYCN and the cancer is selected from neuroblastoma, small cell lung cancer, prostate cancer, alveolar rhabdomyosarcoma, medulloblastoma, glioblastoma multiforme, retinoblastoma, and breast cancer (Paragraph 0021). Figure 7 shows that YM155 inhibits cell proliferation of human neuroblastoma cell lines, especially cell lines characterized by increased copy number of MYCN (Paragraph 0037).
The teachings of Coughlan are previously described and are fully incorporated into this rejection.
Li and Coughlan are considered analogous to the claimed invention as all are involved in the treatment of neuroblastoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to combine the use of YM155 with the claimed chemotherapeutic agents as Coughlan teaches that these are commonly used in the treatment of neuroblastoma. This combination is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Li demonstrates the utility of YM155 for the treatment of neuroblastoma, while Coughlan demonstrates that the claimed chemotherapeutics are commonly used in the treatment of neuroblastoma; the artisan would recognize this and be motivated to combine them to arrive at a more effective combination therapy. Li does not teach the use of YM155 in combination with a second chemotherapeutic agent selected from one or more of CHOP, vinblastine, vinorelbine, cabazitaxel, docetaxel, paclitaxel, eribulin, estramustine, or ixabepilone. However, it would be prima facie obvious to one of ordinary skill in the art to combine YM155 with one of the agents selected as each are known individually to be useful for the treatment of neuroblastoma (See MPEP § 2144.06 I) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The timing of the administration of these therapeutics is also prima facie (See MPEP § 2144.04 IV (C)); In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or 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 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.
Claims 1, 2, 6-13 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-15 and 17 of copending Application No. 18/903,442 (Amended Claims of 10 December 2024) (‘442) in view of Coughlan (Pediatric Hematology and Oncology, 2017 August; 34 (5): 320-330).
Claim 1 of ‘442 is directed to a method for treating cancer in a subject in need thereof, comprising determining MYC gene copy number, or MYC gene chromosomal location site in a sample of cancer tissue from the subject; and administering YM155 to the subject if the MYC gene copy number in the cancer tissue is increased relative to that of a MYC gene copy number reference, or if MYC gene chromosomal location site in the cancer tissue is translocated relative to that of a MYC gene chromosomal location site reference, thereby treating cancer in the subject in need thereof. Claim 6 claims the method of Claim 1 wherein the MYC gene copy number in the cancer tissue is increased by about or at least about 1.5, 2, 3, 4, 5, 6, 7, 8, 9, or 10-fold relative to that of the MYC gene copy number reference. Claim 7 claims the method of claim 1 comprising determining MYC gene copy number in the cancer tissue by array comparative genome hybridization, single nucleotide polymorphism array, copy number variation sequencing, or multiplex ligation-dependent probe amplification. Claim 8 claims the method of claim 1 comprising determining MYC gene chromosomal location site in the cancer tissue by in situ hybridization, fluorescence in situ hybridization, next generation sequencing, or comparative genome hybridization. Claim 9 claims the method of claim 1, comprising obtaining the MYC gene copy number reference from a database, or determining the MYC gene copy number reference from a non-cancerous tissue from a control, optionally by aCGH, SNP array, CNV sequence, or MLPA. Claim 10 claims the method of claim 1 comprising obtaining the MYC chromosomal location site reference from a database, or determining the MYC gene chromosomal location site reference from a non-cancerous tissue from control, optionally by ISH, FISH, NGS, or CGH. Claim 11 claims the method of claim 1 comprising obtaining the sample of cancer tissue from the subject. Claim 12 claims the method of claim 1 wherein the sample of cancer tissue is a surgical sample, a biopsy sample, a pleural effusion sample, or an ascetic fluid sample obtained from the subject, optionally selected from neuronal tissue. Claim 13 claims the method of claim 1 wherein the subject is a human subject. Claim 14 claims the method of claim 1 wherein the cancer is selected from a group which includes neuroblastoma. Claim 15 claims the method of claim 1 wherein the MYC gene is selected from MYCC and MYCN. Claim 17 claims the method of claim 15 wherein the MYC is MYCN and the cancer is selected from a group which includes neuroblastoma.
The teachings of Coughlan are previously described and are fully incorporated into this rejection.
‘442 and Coughlan are considered analogous to the claimed invention as all are involved in the treatment of neuroblastoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to combine the use of YM155 with the claimed chemotherapeutic agents as Coughlan teaches that these are commonly used in the treatment of neuroblastoma. This combination is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). ‘442 claims he treatment of neuroblastoma utilizing YM155, while Coughlan demonstrates that the claimed chemotherapeutics are commonly used in the treatment of neuroblastoma; the artisan would recognize this and be motivated to combine them to arrive at a more effective combination therapy. ‘442 does not teach the use of YM155 in combination with a second chemotherapeutic agent selected from one or more of CHOP, vinblastine, vinorelbine, cabazitaxel, docetaxel, paclitaxel, eribulin, estramustine, or ixabepilone. However, it would be prima facie obvious to one of ordinary skill in the art to combine YM155 with one of the agents selected as each are known individually to be useful for the treatment of neuroblastoma (See MPEP § 2144.06 I) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The timing of the administration of these therapeutics is also prima facie (See MPEP § 2144.04 IV (C)); In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 6-13 and 18-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625