Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/26/2026 has been entered.
Claim Status
Receipt of Remarks/Amendments filed on 6/26/2026 is acknowledged. Claims 70 and 72 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim Rejections/Objections
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 70 and 72 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over HOOD et al. (U.S. PG-Pub. No. 2009/0286789)(cited in IDS) in view of MANN et al. (WO 2007/089768 A2)(cited in IDS), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1)(cited in IDS), PLATTEEUW et al. (WO 2004091585 A1) (cited in IDS), European Medicine Agency (EMA) (European Medicine Agency Science Medicines Health, Orphan designation for treatment of primary myelofibrosis, October 1, 2010), Atallah et al. (Expert Rev Anticancer Ther. 2009 May; 9 (5): 663-670) and Mesa et al. (N Engl J Med, 363;12 September 16, 2010).
HOOD teaches a pharmaceutical composition, which is formulated for oral administration, comprising a therapeutically effective amount of a compound (A), i.e. formula (LVII) which has chemical structure as set forth below (see: [0018]; & Example 90):
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.
As such, the “tablets” or “capsules” read on the “unit dosage form” as claimed; and the “compound of formula (LVII)” taught by HOOD reads on the same compound of claim 70.
HOOD teaches that the composition includes one or more non-toxic pharmaceutically acceptable excipients, e.g. diluents and lubricating agent ([0084]).
HOOD teaches that the compound (A) can be present in a suitable dosage which can be adjusted, depending on the conditions of the patients to be treated (see: [0099]).
HOOD et al. teach the treatment of conditions which involve cellular proliferation, which can be administered in a single dose at 400 mg active ingredient for the symptomatic adjustment of the dosage to the patient to be treated. The compound can be administered on a regimen 1 time per day (page 33, paragraph 99). HOOD et al. teaches the compound is used to treat myeloproliferative disorders and specifically myeloid fibrosis (myelofibrosis) (page 30, paragraph 73).
HOOD teaches that the compound of formula (LVII) can be in free base (neutral) form, but which can be converted into hydrochloride salts by reacting the neutralized compound (A) with HCl solution to form the 2,4-diamine hydrochloride salt (see: e.g. [0227-0228]).
HOOD teaches a composition comprising the same compound as claimed admixed with one or more non-toxic pharmaceutically acceptable excipients, e.g. diluent and lubricating agent as claimed. HOOD also teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor (see: ABSTRACT; Para 0752). However, HOOD does not teach: (i) the weight ratio of the compound and filler/diluent as recited in instant claims; and also does not teach the amount of lubricating agent as recited in instant claims. The deficiencies are taught by the reference MANN and PFEFFER et al.
MANN teaches a pharmaceutical composition comprising inhibitors of JAK-2 for treating a disease mediated by JAK-2, and MANN teaches that the inhibitors of JAK-2 can be converted from its free base form to hydrochloride salt (HCl-salt form) with HCl acid (see: [0191]; [0208]). This teaching is similar to the teaching provided by HOOD.
MANN teaches that the composition, which contains JAK-2 inhibitors as active, can be formulated into a dosage for oral administration (see: [0132]) and comprises suitable pharmaceutical excipients or diluents, i.e. suspending agents (e.g. microcrystalline cellulose); binders (e.g. cellulose derivatives); lubricants (e.g. magnesium stearate, sodium lauryl sulfate) (see: [0133]; [0136]; [0138]).
The other reference PFEFFER teaches a method to prepare a pharmaceutical formulation, i.e. comprises a DPP-IV inhibitor, wherein the formulation is capable of being directly compressed into tablets by inclusion of desirable excipients to provide improved properties, e.g. high-compressibility to allow strong tablets to be made at low compression forces; good flow properties that can improve the flow of other excipients in the formula; and cohesiveness to prevent tablet from crumbling during processing, shipping and handling (see: [0069-0071]).
PFEFFER teaches that the desirable excipients include various diluents, binders, disintegrant, lubricants (see: [0060]), wherein one or more filler and/or diluent can be used, e.g. microcrystalline cellulose can be used in an amount, e.g. preferably about 70 % by weight (see: [0094]). As such, the “microcrystalline cellulose” as filler and diluent reads on the same filler/diluent and its amount, as recited in instant claims.
PFEFFER teaches that the one or more lubricant can be used, e.g. magnesium stearate in an amount, i.e. preferably about 0.1% to about 2% by weight (see: [0097]). As such, the “lubricant” and its amount suggested by PFEFFER reads on the present “lubricant and its amounts” as recited in instant claims.
PFEFFER teaches that, preferably, the active can be included in 20-35% by weight on a dry weight basis in free form or in acid addition salt form (see: [0139]). As such, if the active is used in “about 35 % by weight” and the filler and/or diluent (e.g. microcrystalline cellulose) is used in an amount of “about 70 %” by weight, the weight ratio between the active and the filler/diluent would be 1:2. As such, said ratio reads on the similar weight ratio, i.e. 1:2, of the active compound and the filler/diluent as claimed can be used in order to obtain the desirable and improved formulation properties as discussed above. Thus, the weight ratio of the active compound and the filler/diluent, as recited in instant claims, are met.
The combination of HOOD, MANN and PFEFFER teaches all elements, i.e. the compound of (i); the filler/diluent and its weight ratio to the compound; and the lubricant. However, the cited references do not teach the specific microcrystalline cellulose (e.g. silicified microcrystalline cellulose) and lubricant (e.g. sodium stearyl fumarate), as recited in instant claims. The deficiency is taught by the reference PLATTEEUW et al.
PLATTEEUW teaches an oral dosage form using silicified microcrystalline cellulose (SMC) as the filler/diluent (see: Abstract), and the advantage of using the silicified form as it offers enhanced compressibility for forming drug tablet (see: page 3). As such, the “silicified microcrystalline cellulose” reads on the claimed microcrystalline cellulose, as recited in the instant claims.
PLATTEEUW also teaches examples of tablet containing, e.g. 10 mg of an active and 49 mg of silicified microcrystalline cellulose (see: page 25, Table 8: Example 10), which provides an active to SMC weight ratio of about 1:5 and it reads on the claimed weight ratio, as recited in the instant claims.
PLATTEEUW also teaches the use of “sodium stearyl fumarate” as the lubricant in the oral dosage form, and the advantage of such lubricant is that it tends to facilitate faster disintegration rate (see: page 9). As such, the “sodium stearyl fumarate” reads on the claimed lubricant, as recited in the instant claims.
PLATTEEUW also teaches using 1.05 mg of sodium stearyl fumarate with a total tablet weight of 70 mg (which is 1.4% w/w) in Example 16 (see: page 25, Table 8). As such, said lubricant amount falls in the claimed amount, as recited in the instant claims.
As discussed supra, Hood et al. teaches the compound is used to treat myeloproliferative disorders and specifically myeloid fibrosis (myelofibrosis) (page 30, paragraph 73). Hood also teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor (see: ABSTRACT; Para 0752). Hood does not expressly teach the compound is used to treat the specific types of myelofibrosis disorders recited in instant claims. Hood also does not expressly teach dihydrochloride monohydrate salt of the compound. However, EMA, Atallah and Mesa references cure these deficiencies.
EMA teaches a JAK2 inhibitor drug which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate (fedratinib), which is the same as the compound recited in instant claims. EMA teaches orphan designation of fedratinib had been granted in the United States for the treatment of both secondary and primary myelofibrosis. (see: entire document).
Atallah throughout the reference discloses treatment of myelofibrosis disorders with different JAK2 inhibitors. Attallh teaches TG101348 (fedratinib) being effective in reducing spleen size in patients with primary myelofibrosis, post polycythemia vera myelofibrosis and post essential thrombocythemia myelofibrosis. Atallah teaches that with JAK2 inhibitors, marked clinical improvement has been seen in patients on therapy, with significant decrease in spleen size and improved quality of life (see: page 3 and 7).
Mesa also throughout the reference teaches use of JAK 1 and JAK2 inhibitors in treatment of myelofibrosis. Mesa teaches that JAK1 and JAK2 inhibitor was associated with clinical benefits in patients with advanced (intermediate-2 or high risk) myelofibrosis. (see: abstract; discussion).
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to combine the compound of formula (LVII) taught by HOOD with the desirable pharmaceutically excipients, i.e. filler/diluent (e.g. microcrystalline cellulose) and lubricant in a suitable amount as taught by MANN and PFEFFER, because MANN and PFEFFER teach that the composition containing JAK-2 inhibitors as active can be formulated into a dosage for oral administration by adding suitable pharmaceutical excipients or diluents, i.e. suspending agents (e.g. microcrystalline cellulose); binders (e.g. cellulose derivatives); lubricants; and PFEFFER teaches that pharmaceutical formulation comprising active agent can be formulated to be capable of being directly compressed into tablets by including desirable excipients, e.g. microcrystalline cellulose (as filler/diluent) and lubricants, to provide improved properties, e.g. high-compressibility to allow strong tablets to be made at low compression forces; good flow properties that can improve the flow of other excipients in the formula; and cohesiveness to prevent tablet from crumbling during processing, shipping and handling. Therefore, it would have been obvious to one skilled in the art to manipulate and optimize the amounts of the lubricant and filler/diluent, and the ratio of the active compound to filler/diluent during routine experimentation to obtain the desired properties when formulation a unit dose such as a tablet.
With respect to the Cmax recited in the instant claims, it would have been obvious to one of ordinary skill in the art at the time of invention to use the teachings of Hood et al. and know that the compound of formula (LVII) would provide a Cmax as currently claimed. It would have been obvious to one of ordinary skill in the art at the time of the invention that the compound taught by Hood et al., is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition (Compound LVII) that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg as taught by Hood et al.) of compound represented by
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or its pharmaceutically acceptable salts or N-oxides is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
With respect to the instantly claimed limitation wherein the formulation is administered daily at 400 mg dose, Hood discloses an amount which overlaps the claimed dose and it would have been obvious to one skilled in the art to manipulate the dose during routine optimization and such a dose would be dependent upon parameters which include age, gender, size, etc. of the patient population. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regards to wherein the compound is dihydrochloride monohydrate, as discussed supra, Hood teaches that the compound of formula (LVII) can be in free base (neutral) form, but which can be converted into hydrochloride salts by reacting the neutralized compound (A) with HCl solution to form the 2,4-diamine hydrochloride salt (see: e.g. (0227-0228)). Further, Hood teaches the compound can include a pharmaceutically acceptable salts or hydrate thereof (para 0019). EMA teaches a JAK2 inhibitor drug which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate (fedratinib), which is the same compound as taught by Hood and recited in instant claims. Both Hood and EMA teach the compound is used to treat myelofibrosis and EMA teaches dihydrochloride monohydrate form of the compound to treat myelofibrosis. Therefore, absence any criticality of the claimed salt, it would have been obvious to include the claimed compound in the form of a dihydrochloride monohydrate.
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to substitute PFEFFER’s filler/diluent and lubricant with another suitable filler/diluent and lubricant, i.e. the silicified microcrystalline cellulose as filler/diluent and sodium stearyl fumarate as lubricant taught by PLATTEEUW, because PLATTEEUW teaches the advantage of using the silicified form as it offers enhanced compressibility for forming drug tablet and the advantage of using sodium stearyl fumarate as lubricant is that it helps to facilitate faster disintegration rate when forming drug tablet. Therefore, one ordinary skilled in the art would have recognized that the advantages provided by said silicified microcrystalline cellulose (as filler/diluent) and sodium stearyl fumarate (as lubricant) are desirable and said would have motivated one ordinary skilled in the art to substitute the silicified microcrystalline cellulose and sodium stearyl lubricant for those filler/diluent and lubricant taught by PFEFFER.
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to have used the compound and composition taught by Hood for treating the specific types of myelofibrosis disorders recited in instant claims, based on the teachings of EMA, Atallah and Mesa references. As discussed supra, Hood et al. teaches the compound is used to treat myeloproliferative disorders and specifically myeloid fibrosis (myelofibrosis) (page 30, paragraph 73). Hood also teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor (see: ABSTRACT; Para 0752). EMA teaches orphan designation of fedratinib had been granted in the United States for the treatment of both secondary and primary myelofibrosis. Atallah teaches that with JAK2 inhibitors (including fedratinib), marked clinical improvement has been seen in patients on therapy, with significant decrease in spleen size and improved quality of life in patients with primary myelofibrosis, post polycythemia vera myelofibrosis and post essential thrombocythemia myelofibrosis. EMA and Atallah teach the same compound/drug as taught by Hood for treatment of myelofibrosis and specifically, primary myelofibrosis, secondary myelofibrosis, post polycythemia vera myelofibrosis and post essential thrombocythemia myelofibrosis. Therefore, it would have been obvious to one skilled in the art to use the compound/composition of Hood for treatment of the specific types of myelofibrosis disorders.
Further, as discussed supra, Mesa throughout the reference teaches use of JAK 1 and JAK2 inhibitors in treatment of myelofibrosis. Mesa teaches that JAK1 and JAK2 inhibitor was associated with clinical benefits in patients with advanced (intermediate-2 or high risk) myelofibrosis. Hood also teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor which is used to treat myelofibrosis. Therefore, one skilled in the art would have been motivated to utilize the compound/composition of Hood for treating patients with advanced (intermediate-2 or high risk) myelofibrosis because Mesa teaches JAK2 inhibitors are associated with clinical benefits in patients with advanced (intermediate-2 or high risk) myelofibrosis.
Therefore, from the combined teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued Pfeffer teaches DPP-IV inhibitor formulation, an entirely different class of drug, and one skilled in the art would have no priori reason to import Pfeffer’s excipient ratio into a fedratinib formulation without knowing they would produce the specific Cmax profile.
In response, as discussed supra, Hood teaches the composition comprising the claimed compound in a tablet form. Pfeffer teaches pharmaceutical formulation comprising DPP-IV inhibitor, wherein the formulation is capable of being directly compressed into tablets by inclusion of desirable excipients to provide improved properties, e.g. high compressibility to allow strong tablet to be made at low compression forces, good flow properties that can improve the flow of other excipients, and cohesiveness to prevent tablet from crumbling. Even though Pfeffer teaches a different active drug ingredient, both Hood and Pfeffer teaches pharmaceutical formulation in the form of a tablet comprising filler/diluent and lubricants. Pfeffer teaches the use of filler/diluent and lubricant and amounts/ratio thereof, wherein Pfeffer teaches the formulation is capable of being directly compressed into tablets by inclusion of desirable excipients to provide improved properties. As such, one skilled in the art would have found it obvious to utilize the excipient and amount/ratio taught by Pfeffer for improved properties in tablet formulation of Hood. Further, applicant have not provided any evidence of criticality of the claimed ratio of the excipient. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Applicant made similar argument regarding Platteeuw in that Platteeuw teachings of SMC and SSF were developed in the context of general tablet formulation and not for JAK2 inhibitor formulation. It was argued that there are numerous fillers in the art and selecting SMC and SSF would not have been obvious.
In response, as discussed in the 103 rejection above, Platteeuw teaches the advantage of using SMC is that it offers enhanced compressibility for forming tablet and advantage of SSF lubricant is that it tends to facilitate faster disintegration rate. Thus, even if Platteeuw does not teach the same active drug component, the reference teaches the formulation in the form of tablet and provides motivation for utilizing SMC and SSF. Thus, it would have been obvious to use these specific excipients as the prior art provides motivation to use them.
Applicant argued the claimed Cmax parameters are not the product of routine optimization and that they are not taught anywhere in the prior art.
In response, as discussed supra, the combination of the cited prior art teaches the composition comprising the claimed compound, excipients and amounts thereof. The prior art (HOOD et al.) teaches the same dosage (400 mg) as recited in the claims. Thus, a subject receiving the same composition as claimed and same amount of the active drug (fedratinib) would necessarily achieve the same Cmax profile. Further, it is generally known in the art that increasing the dose of the active drug would increase the Cmax and providing lower dose of the drug would lower the Cmax. Applicant have not shown or provided any evidence that this would not occur with fedratinib and that administering the composition taught in cited prior art would not provide the claimed Cmax. Thus, applicant’s arguments are not found persuasive at this time.
Applicant argued fedratinib was FDA approved for treatment of myelofibrosis and FDA approval is directly tied to the claimed invention and constitutes strong evidence of commercial success with clear nexus to the claimed invention.
In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. In ex parte proceedings before the Patent and Trademark Office, an applicant must show that the claimed features were responsible for the commercial success of an article if the evidence of nonobviousness is to be given any weight. See In re Huang, 100 F.3d 135, 140, 40 USPQ2d 1685, 1690 (Fed. Cir. 1996). Also see MPEP 716. Applicant have not provided any evidence that the claimed feature were responsible for commercial success and actual evidence of commercial success. Thus, applicant argument regarding commercial success is not persuasive at this time.
Applicant also argued the combination of SMC and SSF in the claimed weight ratio provided unexpected results.
In response, applicant have not provided any persuasive evidence of unexpected results. “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Thus, without actual evidence of unexpected results, the statement and argument by applicant that the claimed composition provides unexpected results is not found persuasive at this time.
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 70 and 72 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,391,094 B2 in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), European Medicine Agency (EMA) (European Medicine Agency Science Medicines Health, Orphan designation for treatment of primary myelofibrosis, October 1, 2010), Atallah et al. (Expert Rev Anticancer Ther. 2009 May; 9 (5): 663-670) and Mesa et al. (N Engl J Med, 363;12 September 16, 2010).
The instant claims are drawn to a method of treating myeloproliferative disorder comprising administering to a subject in need thereof a unit dosage form comprising:
(i) a compound:
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or a pharmaceutically acceptable salt and/or hydrate thereof (e.g. a dihydrochloride monohydrate);
(ii) one or more fillers and/or diluents (e.g. microcrystalline cellulose, which is silicified microcrystalline cellulose);
wherein the ratio of the weight of the compound to the total weight of the one or more fillers and/or diluents is about 1:1.5 to about 1:9, or about 1:1.5 to about 1:2; and
(iii) about 0.5% to about 5% w/w of one or more lubricants (e.g. sodium stearyl fumarate);
Wherein the unit dosage form provides, when administered at 400 mg total daily dose of the compound, a Cmax that is achieved within 2 to 4 hours post administration; and/or a Cmax between 1717.33 ng/mL and 3886.67 ng/mL;
Wherein the myeloproliferative disorder is myelofibrosis, primary myelofibrosis, intermediate-2 myelofibrosis, high risk myelofibrosis, secondary myelofibrosis, post essential thrombocythemia myelofibrosis and post polycythemia vera myelofibrosis.
The conflicting claims are drawn to a method of treating myelofibrosis in a subject comprising administering a capsule comprising a formulation comprising:
(i) a compound that is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzene-sulfonamide dihydrochloride monohydrate;
(ii) a microcrystalline cellulose (e.g. silicified microcrystalline cellulose); and
(iii) sodium stearyl fumarate, which is present about 1% by weight of the formulation;
wherein the weight ratio of the N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide to the microcrystalline cellulose in the formulation is about 1:1.5 to about 1:9, or 1:1.5 to about 1:2.
It is noted that the conflicting application defined that “, the unit dosage form is in the form of a capsule” (see Pat “094: col. 2, line 51-52). As such, the conflicting “capsule” reads on the “unit dosage form” as claimed.
It is noted that the above compound in the conflicting claims has a chemical structure as set forth below, which reads on the compound and its dihydrochloride monohydrate as claimed:
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and
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.
In addition, the “microcrystalline cellulose” and “silicified microcrystalline cellulose” in the conflicting claims, as well as its “weight ratio to the conflicting compound” read on the “filler or diluent comprises microcrystalline cellulose, which is silicified microcrystalline cellulose” as claimed.
Further, the “sodium stearyl fumarate which is present in about 1% by weight” reads on the “lubricant and its amount present in the unit dosage (e.g. in the range from about 0.5% to 5%, or about 0.5% to about 2% by weight or about 1% by weight), comprises sodium stearyl fumarate” as claimed.
The ‘094 patent does not teach Wherein the unit dosage form provides, when administered at 400 mg total daily dose of the compound, a Cmax that is achieved within 2 to 4 hours post administration; and/or a Cmax between 1717.33 ng/mL and 3886.67 ng/mL. However, Hood et al. cures this deficiency.
The teachings of Hood et al. set forth above are incorporated herein. As discussed supra, HOOD et al. teach the treatment of conditions which involve cellular proliferation, which can be administered in a single dose at 400 mg active ingredient for the symptomatic adjustment of the dosage to the patient to be treated. The compound can be administered on a regimen 1 time per day (page 33, paragraph 99). HOOD et al. teaches the compound (which is the same as the instantly claimed compound in claim 70 (i)) is used to treat myeloproliferative disorders and specifically myeloid fibrosis (myelofibrosis) (page 30, paragraph 73).
The ’094 patent also does not expressly teach Wherein the myeloproliferative disorder is myelofibrosis, primary myelofibrosis, intermediate-2 myelofibrosis, high risk myelofibrosis, secondary myelofibrosis, post essential thrombocythemia myelofibrosis and post polycythemia vera myelofibrosis. However, EMA, Atallah and Mesa references cure this deficiency.
The teachings of EMA, Atallah and Mesa set forth above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘094, Hood, EMA, Atallah and Mesa and administer the drug/compound (fedratinib) taught by ‘094 and Hood at a dose of 400 mg as suggested by Hood. Both Hood and ‘094 teach the same compound for treating the same condition (myelofibrosis) and thus, it would have been obvious to a skilled artisan to utilize a dosage (i.e., 400 mg) which is taught and known in the art as suggested by Hood.
With respect to the Cmax recited in the instant claims, it would have been obvious to one of ordinary skill in the art at the time of invention to use the teachings of Hood et al. and know that the compound of formula (LVII) would provide a Cmax as currently claimed. It would have been obvious to one of ordinary skill in the art at the time of the invention that the compound taught by ‘094 and Hood et al., is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition (Compound LVII) that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg as taught by Hood et al.) of the compound taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘094, Hood, EMA, Atallah and Mesa and have used the compound and composition taught by ‘094 for treating the specific types of myelofibrosis disorders recited in instant claims. As discussed supra, ‘094. teaches the compound is used to treat myelofibrosis. Hood teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor (see: ABSTRACT; Para 0752). EMA teaches orphan designation of fedratinib had been granted in the United States for the treatment of both secondary and primary myelofibrosis. Atallah teaches that with JAK2 inhibitors (including fedratinib), marked clinical improvement has been seen in patients on therapy, with significant decrease in spleen size and improved quality of life in patients with primary myelofibrosis, post polycythemia vera myelofibrosis and post essential thrombocythemia myelofibrosis. EMA and Atallah teach the same compound/drug as taught by ‘094 for treatment of myelofibrosis and specifically, primary myelofibrosis, secondary myelofibrosis, post polycythemia vera myelofibrosis and post essential thrombocythemia myelofibrosis. Therefore, it would have been obvious to one skilled in the art to use the compound/composition of ‘094 for treatment of the specific types of myelofibrosis disorders.
Further, as discussed supra, Mesa throughout the reference teaches use of JAK 1 and JAK2 inhibitors in treatment of myelofibrosis. Mesa teaches that JAK1 and JAK2 inhibitor was associated with clinical benefits in patients with advanced (intermediate-2 or high risk) myelofibrosis. Hood teaches that the compound, i.e. formula (LVII) is an inhibitor of JAK kinase and specifically a JAK2 inhibitor which is used to treat myelofibrosis. Therefore, one skilled in the art would have been motivated to utilize the compound/composition of ‘094 for treating patients with advanced (intermediate-2 or high risk) myelofibrosis because Mesa teaches JAK2 inhibitors are associated with clinical benefits in patients with advanced (intermediate-2 or high risk) myelofibrosis.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 70 and 72 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12357621B2 in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), MANN et al. (WO 2007/089768 A2), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1) and PLATTEEUW et al. (WO 2004091585 A1).
‘621 claims a method of treating myelofibrosis in a subject comprising orally administering to the subject a compound of formula I and formula II. Compound of formula II is the same as the claimed compound. ‘621 claims the compound of formula II is administered at daily dose of 400 mg. The dihydrochloride monohydrate of compound of formula II is administered. Myelofibrosis is primary myelofibrosis, secondary myelofibrosis, and other forms of myelofibrosis are also recited.
‘621 does not teach the filler/diluent and lubricant and amounts/ratios thereof recited in the claims and the Cmax recited in the claims. However, Hood, Mann, Pfeffer and Platteeuw cure these deficiencies.
The teachings of Hood, Mann, Pfeffer and Platteeuw discussed supra are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘621, Hood, Mann, Pfeffer and Platteeuw and incorporate the filler/diluent and lubricant in amounts/ratios taught by the combination of Hood, Mann, Pfeffer and Platteeuw. As discussed supra, Hood teaches the claimed compound in combination with diluent and lubricating agents. Mann, Pfeffer and Platteeuw teach the specific types of filler/diluent and lubricants in amounts/ratios which read on the claimed amount/ratio. Also, as discussed in the 103 rejection above, Mann, Pfeffer and Platteeuw provide the motivation to include the claimed filler/diluent and lubricant in a formulation. Thus, the inclusion of these excipients would have been obvious to one skilled in the art.
Regarding the Cmax, it would have been obvious to one of ordinary skill in the art that the compound taught by the reference claims is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg) of compound is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 70 and 72 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11400092B2 in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), MANN et al. (WO 2007/089768 A2), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1), PLATTEEUW et al. (WO 2004091585 A1) and European Medicine Agency (EMA) (European Medicine Agency Science Medicines Health, Orphan designation for treatment of primary myelofibrosis, October 1, 2010).
‘092 claims a method for treating a patient having myeloproliferative disorder comprising administering to the patient compound I or salt and/or hydrate thereof. The myeloproliferative disorder is myelofibrosis including primary and secondary myelofibrosis. Other claimed myelofibrosis are recited as well.
‘092 does not teach dihydrochloride monohydrate salt of the claimed compound, the dose of 400 mg. ‘092 also does not teach the filler/diluent and lubricant and amounts/ratios thereof recited in the claims and the Cmax recited in the claims. However, Hood, Mann, Pfeffer, Platteeuw and EMA cure these deficiencies.
The teachings of Hood, Mann, Pfeffer, Platteeuw and EMA discussed supra are incorporated herein.
With regards to wherein the compound is dihydrochloride monohydrate, as discussed supra, EMA teach the compound is used to treat myelofibrosis and EMA teaches dihydrochloride monohydrate form of the compound to treat myelofibrosis. Therefore, absence any criticality of the claimed salt, it would have been obvious to include the claimed compound in the form of a dihydrochloride monohydrate.
With respect to the instantly claimed limitation wherein the formulation is administered daily at 400 mg dose, Hood discloses an amount which overlaps the claimed dose and it would have been obvious to one skilled in the art to manipulate the dose during routine optimization and such a dose would be dependent upon parameters which include age, gender, size, etc. of the patient population. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to incorporate the filler/diluent and lubricant in amounts/ratios taught by the combination of Hood, Mann, Pfeffer and Platteeuw. As discussed supra, Hood teaches the claimed compound in combination with diluent and lubricating agents. Mann, Pfeffer and Platteeuw teach the specific types of filler/diluent and lubricants in amounts/ratios which read on the claimed amount/ratio. Also, as discussed in the 103 rejection above, Mann, Pfeffer and Platteeuw provide the motivation to include the claimed filler/diluent and lubricant in a formulation. Thus, the inclusion of these excipients would have been obvious to one skilled in the art.
Regarding the Cmax, it would have been obvious to one of ordinary skill in the art that the compound taught by the reference claims is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg) of compound is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 70 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 14-15, 17, 19, 23-27, 32-34, 39-41 of copending application no. 18692057 (US20240358722A1) in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), MANN et al. (WO 2007/089768 A2), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1), PLATTEEUW et al. (WO 2004091585 A1).
‘057 claims a method of treating a myeloproliferative disorder in a patient comprising administering to the patient an effective amount of compound of formula I (same as the claimed compound) to treat myelofibrosis. The dihydrochloride monohydrate of the compound is administered. The compound is administered at a dose of 400 mg. Myelofibrosis is primary myelofibrosis along with other types recited in the reference claims.
‘057 does not teach the filler/diluent and lubricant and amounts/ratios thereof recited in the claims and the Cmax recited in the claims. However, Hood, Mann, Pfeffer and Platteeuw cure these deficiencies.
The teachings of Hood, Mann, Pfeffer and Platteeuw discussed supra are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘057, Hood, Mann, Pfeffer and Platteeuw and incorporate the filler/diluent and lubricant in amounts/ratios taught by the combination of Hood, Mann, Pfeffer and Platteeuw. As discussed supra, Hood teaches the claimed compound in combination with diluent and lubricating agents. Mann, Pfeffer and Platteeuw teach the specific types of filler/diluent and lubricants in amounts/ratios which read on the claimed amount/ratio. Also, as discussed in the 103 rejection above, Mann, Pfeffer and Platteeuw provide the motivation to include the claimed filler/diluent and lubricant in a formulation. Thus, the inclusion of these excipients would have been obvious to one skilled in the art.
Regarding the Cmax, it would have been obvious to one of ordinary skill in the art that the compound taught by the reference claims is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg) of compound is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 70 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 22-38 of copending application no. 18257770 (US20240058336A1) in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), MANN et al. (WO 2007/089768 A2), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1), PLATTEEUW et al. (WO 2004091585 A1).
‘770 claims a method of treating a myeloproliferative disorder in a patient comprising administering to the patient an effective amount of compound of formula I (same as the claimed compound) to treat myelofibrosis. The dihydrochloride monohydrate of the compound is administered. The compound is administered at a dose of 400 mg. Myelofibrosis is primary myelofibrosis along with other types recited in the reference claims.
‘770 does not teach the filler/diluent and lubricant and amounts/ratios thereof recited in the claims and the Cmax recited in the claims. However, Hood, Mann, Pfeffer and Platteeuw cure these deficiencies.
The teachings of Hood, Mann, Pfeffer and Platteeuw discussed supra are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘770, Hood, Mann, Pfeffer and Platteeuw and incorporate the filler/diluent and lubricant in amounts/ratios taught by the combination of Hood, Mann, Pfeffer and Platteeuw. As discussed supra, Hood teaches the claimed compound in combination with diluent and lubricating agents. Mann, Pfeffer and Platteeuw teach the specific types of filler/diluent and lubricants in amounts/ratios which read on the claimed amount/ratio. Also, as discussed in the 103 rejection above, Mann, Pfeffer and Platteeuw provide the motivation to include the claimed filler/diluent and lubricant in a formulation. Thus, the inclusion of these excipients would have been obvious to one skilled in the art.
Regarding the Cmax, it would have been obvious to one of ordinary skill in the art that the compound taught by the reference claims is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg) of compound is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 70 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending application no. 19236392 (US20250367174A1) in view of HOOD et al. (U.S. PG-Pub. No. 2009/0286789), MANN et al. (WO 2007/089768 A2), PFEFFER et al. (U.S. PG-Pub. No. 2006/0210627 A1), PLATTEEUW et al. (WO 2004091585 A1) and European Medicine Agency (EMA) (European Medicine Agency Science Medicines Health, Orphan designation for treatment of primary myelofibrosis, October 1, 2010).
‘392 claims a method of treating a hematological malignancy in a subject comprising administering to the subject an effective amount of compound of formula II (same as the claimed compound). The dihydrochloride monohydrate of the compound is administered. The compound is administered at a dose of 400 mg.
‘392 does not teach the filler/diluent and lubricant and amounts/ratios thereof recited in the claims and the Cmax recited in the claims. ‘392 also does not teach treating myelofibrosis and the specific types recited in instant claims. However, EMA, Hood, Mann, Pfeffer and Platteeuw cure these deficiencies.
The teachings of EMA, Hood, Mann, Pfeffer and Platteeuw discussed supra are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘770, EMA, Hood, Mann, Pfeffer and Platteeuw and incorporate the filler/diluent and lubricant in amounts/ratios taught by the combination of Hood, Mann, Pfeffer and Platteeuw. As discussed supra, Hood teaches the claimed compound in combination with diluent and lubricating agents. Mann, Pfeffer and Platteeuw teach the specific types of filler/diluent and lubricants in amounts/ratios which read on the claimed amount/ratio. Also, as discussed in the 103 rejection above, Mann, Pfeffer and Platteeuw provide the motivation to include the claimed filler/diluent and lubricant in a formulation. Thus, the inclusion of these excipients would have been obvious to one skilled in the art.
Regarding the Cmax, it would have been obvious to one of ordinary skill in the art that the compound taught by the reference claims is the same compound that is currently claimed. As such, following the prior art teaching that if the same compound/composition that is used in a method of treating myeloproliferative disorder such as myeloid fibrosis (myelofibrosis) comprising the administration to a subject in need thereof a therapeutically effective amount (400 mg) of compound is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, a formulation that provides a steady state patient Cmax of the compound that is achieved within 2 to 4 hours post administration; and/or a steady state patient Cmax of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration, without evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘770, EMA, Hood, Mann, Pfeffer and Platteeuw and treat a hematological malignancy which is myelofibrosis. As discussed supra, Hood and EMA teach the compound of formula II (claimed compound) used to treat myelofibrosis and specifically primary and secondary myelofibrosis as taught in EMA. Thus, one skilled in the art would have found it obvious to treat hematological malignancy such as myelofibrosis because the prior art teaches the compound of formula II is known to treat this disease.
Therefore, from the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant stated double patenting rejection will be addressed upon allowance. Since applicant have not provided any substantial arguments, double patenting rejections are maintained.
Conclusion
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