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 .
DETAILED ACTION
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 10/31/2025, wherein new claim 48 is added, and claim 31 is amended to recite method of treating neurodegenerative disease or disorder comprising administering an orally disintegrating tablet (ODT) comprising: i) a micronized apilimod salt selected from apilimod hydrochloride, malonate, or L- tartrate salt; ii) gelatin: and iii) one or more pharmaceutically acceptable excipients wherein the ODT dissolves at least 80% under acidic conditions of pH at about 1-2 after 20 minutes of administration.
The amendment of ODT formulation overcome rejections of claims 31 and 34 anticipated by Ichida’372, Lichenstein’061, Lichenstein '502, or Lichenstein '688 under 35 USC 102. The rejections of claims 31 and 34 anticipated by Ichida’372, Lichenstein’061, Lichenstein '502, or Lichenstein '688 under 35 USC 102 are withdrawn.
As necessitated by amendment, claims 31, 34 and 48 are now rejected under 35 USC 103 as being unpatentable over Lichenstein et al. (US 20190255061 A1, “Lichenstein ’061) in view of Sugimoto et al. (US 7,927,623 B2) and Green et al.(US 9,192,580 B2).
Election/Restrictions
Applicant elected without traverse in the reply filed on 03/12/2025: (i): Group 2, claim 31-34; and (ii) Amyotrophic lateral sclerosis (ALS) as the disease species.
Claims 1-16, 23, 29, 32- 33 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election.
Status of Claims
Claims 1-16, 23, 29, 31-34 and 48 are pending in the instant application.
Claims 1-16, 23, 29, 32- 33 remain withdrawn.
Claims 31, 34 and 48 are under examination in this office action.
Response to Declaration
The Declaration under 37 CFR 1.132 by Dr. Keith Fandrick filed 10/31/2025 is fully considered.
Fandrick Declaration focused on dissolution profile of instantly amended orally disintegrating tablet (ODT). Fandrick Declaration argues the dissolution profile of an orally disintegrating tablet (ODT) has been closely linked to the intrinsic dissolution rate (IDR) of its active pharmaceutical ingredient (API)…and instantly claimed invention provides ODTs of specific apilimod salts (i.e., hydrochloride, malonate, and L-tartrate) that exhibit unexpectedly superior dissolution profiles compared to both the apilimod free base and other apilimod salts, including those with higher intrinsic dissolution rates (IDRs)(Declaration, para 3- 7).
RESPONSE: The examiner does not dispute intrinsic dissolution rate (IDR) is a key factor closely linked to dissolution profile of ODT formulation and instantly claimed apilimod salts exhibit better dissolution profile than free amine as presented by Fandrick Declaration. However, Sugimoto teaches intraorally rapidly disintegrating tablet comprising acid salt of a medicinal substance is preferably applicable to the free form in terms of taste, stability or operability . Sugimoto teaches dissolution test wherein samples were evaluated at 2, 5, 10, 15, 20, 25 and 30 minutes and the drug dissolution rate is preferably 80% and over for initial 30 minutes(See Col. 8, lines 53-54; Col. 22, Experiment 5). A skilled artisan would have reasonable expectation that micronized salt form (e.g. hydrochloride) of basic active ingredients (e.g. apilimod) would have better dissolution file under acidic conditions of pH at about 1- 2 based on the prior art and general knowledge of ODT formulation. It's noted Fandrick Declaration argument about the solubility of apilimod salts at non-acidic conditions(Declaration, para 11) is not a claimed technical feature of instantly apilimod salts ODT nor disclosed by instant specification. Sugimoto teaches property of oral disintegrating tablet which disintegration time in the oral cavity is within 60 seconds, preferably 45 seconds, and more preferably 30 seconds wherein the oral cavity is considered as non-acidic condition.
The examiner agrees the dissolution profile of an orally disintegrating tablet (ODT) is the intrinsic property of orally disintegrating tablet (ODT). Orally disintegrating tablet (ODT) is a well-known oral dosage form in the pharmaceutical industry that has several advantages over conventional tablets, e.g. rapid disintegration, rapid onset of action, and improved patient compliance. Once the solid oral dosage of apilimod is formulated, the dissolution profile could be measured by a skilled artisan through routine experiment. The characterization and measurement of dissolution profile do not necessarily contribute to the structural limitation of the apilimod composition for the administration step of method for treating disease/disorder. A skilled artisan would reasonably expect apilimod salt ODT formulation would exhibit similar activity for treating neurodegenerative disease/disorder (e.g. ALS).
As argued in Fandrick Declaration, different salt form of active ingredients would have different chemical/physical properties, different solubility, different dissolution profile, etc. The dissolution profile of active ingredients are also affected by a variety of factor, e.g. salt form, concentration of active ingredients and inactive ingredients (e.g. excipients, disintegrant, etc.) and ratio thereof, etc. Instant claim 31 is amended to recite orally disintegrating tablet (ODT) comprising apilimod salt ( hydrochloride, malonate, or L- tartrate salt) in combination of gelatin and one or more pharmaceutically acceptable excipients for desired dissolution profile. Instant claims do not recite any dose amount of apilimod salt and/or any specific excipient that would contribute to the recited dissolution profile. Instant specification only disclosed dissolution profile of working example, e.g. apilimod hydrochloride, malonate, tartrate (50mg or 125mg) in combination with specific excipient (e.g. fish gelatin and mannitol) at specific concentration and ratio, which display various mean dispersion time (See Table 6, FIGs 4-7). Instant specification does not disclose any other concentration of apilimod salt >125mg (e.g. 200mg, 500mg,etc.), in combination with any other excipients at different ratios and dissolution profile thereof.
As such, instant disclosed dissolution profile of apilimod hydrochloride, malonate, and tartrate salt form in combination with fish gelatin and mannitol at specific concentration/ratio do not necessarily represent/predict embodiment genus of apilimod salt in combination with any excipient, at any concentration and at different ratio thereof encompassed by claim 31 that could achieve instantly claimed dissolution profile. In other words, instantly claimed unpredictable superior dissolution profiles of apilimod salts do not commensurate with the scope of claim 31.
Applicant is advised to further amend claims with limitation that are critical/essential to achieve the intended dissolution profile of apilimod( at least 80% after 20mins at pH 1-2) for the elected method of treating neurodegenerative disease/disorder (e.g. ALS) .
Fandrick Declaration argues the teachings of Ichida, Lichenstein’061, Lichenstein '502, or Lichenstein '688, in view of a reference that teaches OTD would not lead to the claimed invention with a reasonable expectation of success due to the unpredictable and counterintuitive dissolution behavior of the salts (IDRs) and their low solubility in non-acidic conditions (Declaration, para 9-10 and 12).
RESPONSE: As stated in MPEP 2144.08 II, obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Orally disintegrating tablet (ODT) is a well-known oral dosage form in the pharmaceutical industry that has several advantages over conventional tablets, e.g. rapid disintegration, rapid onset of action, and improved patient compliance, especially for pediatric, geriatric, psychiatric patients, etc. as taught by Sugimoto and Green. A skilled artisan would reasonably expect apilimod salt ODT formulation would exhibit similar activity for treating neurodegenerative disease/disorder (e.g. ALS). More importantly, instantly claimed unpredictable superior dissolution profiles of apilimod salts do not commensurate with the scope of claim 31.
Response to Arguments
Applicant's remarks filed 10/31/2025 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejections of claims 31 and 34 anticipated by Ichida’372, Lichenstein’061, Lichenstein '502, or Lichenstein '688 under 35 USC 102 are withdrawn. Applicant’s argument regarding anticipation by prior art under 35 USC 102 is moot.
As necessitated by amendment, claims 31, 34 and 48 are now rejected under 35 USC 103 as being unpatentable over Lichenstein et al. (US 20190255061 A1, “Lichenstein ’061) in view of Sugimoto et al. (US 7,927,623 B2) and Green et al.(US 9,192,580 B2). It’s noted Applicant’s argument based on the unpredictable dissolution behavior of apilimod salt is similar to Dr. Frandrick Declaration. Please see Response to Frandrick Declaration.
Despite IDR of an API is a key factor of the dissolution of ODT containing API, there are other factors, e.g. different excipients, amount/ratio and combination thereof that would contribute to the final dissolution of ODT formulation. Instant claims do not recite any dose amount of apilimod salt and/or any other specific excipient in combination with gelatin that would contribute to the recited dissolution profile. An ordinary skilled would reasonably expect apilimod ODT formulation exhibit the same or super activity for treating ALS as taught by Lichenstein’ 061 in absence of dissolution profile. As stated in MPEP 2144.08 II, obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
Priority
Instant application 18/528,630 filed on 12/04/2023 is a national stage application of international application No. PCT/US2022/033107 filed June 10, 2022, which claims the benefit under 35 USC §119(e) to U.S. provisional application No. 63/202,438 (now expired) filed June 11, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119 (e ) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or earlier-filed nonprovisional application or provisional application for which benefit is claimed). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US provisional application No 63/202,438, fails to provide adequate support and/or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for instantly claimed method of treating amyotrophic lateral sclerosis (ALS) comprising administering to the subject the pharmaceutical composition of claim 1. US provisional application No 63/202,438 does NOT disclose any assay associated with amyotrophic lateral sclerosis (ALS), and does NOT disclose any assay wherein instant claimed pharmaceutical composition of claim 1 was administered to a subject.
Thus, the priority benefit cannot be granted since the claims do not comply with 35 USC 112 (description and enablement) as was set forth in In re Scheiber 199 USPQ 782; In re Lukach 169 USPQ 795: In re Chu 36 USPQ 2d 1089 (See MPEP 211.05). The priority of instant application is considered as June 10, 2022, the filing date of international application No. PCT/US2022/033107.
Claim Objections
Claim 31 is objected to because of the following informalities: There is punctuation mark/comma missing after iii) one or more pharmaceutically acceptable excipients.
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 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 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 31, 34 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Lichenstein et al. (US 20190255061 A1, hereafter “Lichenstein ’061”, Applicant’s IDS dated 07/17/2024, corresponding to US 10751345 B2, family member of WO 2019164861A1) in view of Sugimoto et al. (US 7,927,623 B2) and Green et al.(US 9,192,580 B2) (newly applied as necessitated by amendment).
Lichenstein ’061 disclosed a method for treating neurological disease or disorder (e.g. amyotrophic lateral sclerosis ALS) in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising apilimod, or a pharmaceutically acceptable salt thereof (See abstract, [0008]-[0010], claims 1-2, 9, 11, 14,17-18, 26-27).
Lichenstein ’061 disclosed embodiments wherein the neurological disease or disorder is amyotrophic lateral sclerosis ALS (See [0010], [0012]-[0013], [0023], claim 11,14). Lichenstein ’061 disclosed ALS is associated with various proteins/biomarkers, e.g. GPNMB, TDP- 43, and apilimod treatment may ameliorate the neuromuscular degradation found in ALS , and potentially improve patient survival(See Example 1, [0098]-[0101]). Lichenstein ’061 disclosed apilimod in a variety of salt form, e.g. chloride, tartrate, dimesylate, etc. (See [0009], [0030]-[0031]). Lichenstein ’061 disclosed dosage regimen of apilimod or salt thereof(See [0074]-[0076], [0084]).
Regarding pharmaceutical composition comprising apilimod, or a pharmaceutically acceptable salt thereof, Lichenstein ’061 disclosed variety of dosage form (e.g. tablet, capsule, etc.) of pharmaceutical composition comprising one or more pharmaceutical excipients/carrier (See [0081]-[0093]).
Regarding gelatin and other pharmaceutical excipients, Lichenstein ’061 teaches acceptable diluents, binding agents, lubricants, disintegrants, surface modifying agents, e.g. gelatin, mannitol, etc. (See [0086], [0089]).
Lichenstein ’061 collectively disclosed a method for treating neurological disease or disorder (e.g. amyotrophic lateral sclerosis ALS), comprising administering to the subject, a pharmaceutical composition comprising apilimod, or a pharmaceutically acceptable salt thereof (e.g. chloride, tartrate, etc.), and one or more pharmaceutical excipients (e.g. gelatin).
Lichenstein’ 061 is silent about apilimod oral disintegrating tablet and dissolution rate thereof. Dissolution profile are the property/direct result of composition once the solid oral dosage of apilimod is formulated and measured by a skilled artisan. The characterization and measurement of stability and dissolution profile do not necessarily contribute to the structural limitation of the apilimod composition.
Sugimoto teaches orally rapidly disintegrating tablets for poorly water-soluble drug under neutral or alkaline conditions which are converted into acid salts for the purpose of achieving rapid dissolution, improved bioavailability and early onset of efficacy thereof(See abstract, Col. 2, lines 28-34, 51-65; Col. 3, lines 1-59, claims 1-2, 4-5). Sugimoto teaches intraorally rapidly disintegrating tablet comprising acid salt of a medicinal substance is preferably applicable to the free form in terms of taste, stability or operability( See Col. 7, lines 28-33). Sugimoto teaches exemplary acids include organic acids having pKa of 4 or below, such as fumaric acid, tartaric acid, etc.(See Col. 4, lines 50-54)(which reads on salt form of instant claims). Sugimoto teaches embodiments of active ingredients which solubility under acid conditions (e.g. pH 1-2) is 10-fold or 100-fold compared with the solubility in water at pH 7, wherein higher solubility might lead to higher dissolution under acidic conditions (See Col. 4, lines 39-45).
Sugimoto teaches preparation of oral disintegrating tablet comprises process of granulation, spraying, etc. which is construed as micronization (See Col. 9 and 10, Examples 1-5). Sugimoto teaches embodiments with the mean particle diameter within the range of 30 to 500um, preferably 50 to 300 um, more preferably 100 to 200 um(See Col 4. lines 31-34)(which reads on micronized).
Sugimoto teaches mannitol is water-soluble saccharide which furnishes the tablet with good solubility and sweetness and further teaches orally rapidly disintegrating tablets comprising active ingredients and mannitol (See Examples 1, 2, 5).
Sugimoto teaches property of oral disintegrating tablet which disintegration time in the oral cavity is within 60 seconds, preferably 45 seconds, and more preferably 30 seconds(See Col. 8, lines 36-37; Col. 21, Experiment 3; claim 2). Sugimoto also teaches dissolution test wherein samples were evaluated at 2, 5, 10, 15, 20, 25 and 30 minutes and the drug dissolution rate is 70% and over, preferably 80% and over for initial 30 minutes(See Col. 8, lines 53-54; Col. 22, Experiment 5).
Green teaches preparation of rapidly dispersing composition using fish gelatin and mannitol(See abstract; Col. 3, lines 30-67; .Examples 3-5; claims 1-5). Green teaches benefit of no-gelling, non-hydrolyzed fish gelatin in preparing rapidly dispersing dosage forms using, which releases the active ingredient rapidly on contact with a fluid(e.g. saliva), in terms of processing parameters and product qualities (See Col. 3, lines 30-55;).Green teaches oral disintegrating solid dosage form containing fish gelatin “have a faster disintegration time, a better taste and a better mouth feel than dosage forms containing mammalian derived gelatin. Moreover, there is no need for sweeteners and flavors to be added to mask the taste or smell of the gelatin since fish gelatin has an acceptable taste and smell …greatly reduced with attendant cost benefits. … In addition, since fish gelatin is soluble in cold water, the heating step, which is required when mammalian derived gelatin is used, can be omitted thereby producing cost savings in heating costs and shorter mixing times.” (See Col. 11, lines 26-46).
Green explicitly teaches embodiments comprising 1.5% of active ingredients(salt form), 4.0% of fish gelatin, 3.0% of mannitol, and 90.9% of water with disintegration time of 0.78 seconds (See Example 3)
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to explore dosage form of apilimod composition taught by Lichenstein’ 061 with the teaching of oral disintegrating tablet taught by Sugimoto and Green, and arrive at the instantly claimed invention with reasonable expectation of success. Where 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. MPEP 2144.05. An ordinary skilled would reasonably expect apilimod ODT formulation would exhibit the same activity for treating ALS as taught by Lichenstein’ 061. It would have been obvious to one of the ordinary skill in the art to explore the dosage amount/range based on the teachings of prior art and routine optimization based on general knowledge of apilimod and solid oral formulation and arrive at the desired dissolution profile. The measurement of stability and dissolution profile do not necessarily contribute to the structural limitation of the apilimod composition.
The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore dosage form for apilimod for better disintegrating profile, and bioavailability, etc. A skilled artisan would be motivated to combine the teachings of Lichenstein’ 061, Sugimoto and Green because Sugimoto explicitly teaches orally rapidly disintegrating tablets comprising acid salts of poorly water-soluble drug under neutral or alkaline conditions have benefit of rapid dissolution, improved bioavailability and early onset of efficacy. Green teaches the benefit of preparing oral rapidly dispersing dosage forms using no-gelling, non-hydrolyzed fish gelatin, which has better taste, simplified process step and lower preparation cost, etc. The combined teachings of prior art and experimentation/ optimization based on general knowledge of apilimod and solid oral formulation would provide a new dosage form of apilimod salt in oral disintegrating tablet with rapid dissolution profile, improved taste and bioavailability and less cost for treating neurological disease( e.g. ALS ).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of apilimod and solid oral formulation. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 31, 34 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14 of U.S. Patent No. 10751345 B2, in view of Sugimoto et al. (US 7,927,623 B2) and Green et al.(US 9,192,580 B2).
Reference claims refer to a method for treating a neurological disease or disorder in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising apilimod, or a pharmaceutically acceptable salt thereof.
Reference claims are silent about amended ODT formulation.
The collective teachings of Sugimoto and Green are elaborated in preceding 103 rejections and applied as before. Sugimoto collectively teaches orally rapidly disintegrating tablets comprising acid salts of poorly water-soluble drug under neutral or alkaline conditions have benefit of rapid dissolution, improved bioavailability and early onset of efficacy. Green teaches the benefit of preparing oral rapidly dispersing dosage forms using no-gelling, non-hydrolyzed fish gelatin and mannitol, which has better taste, simplified process step and lower preparation cost, etc.
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to apilimod composition taught by reference claims with the teaching of oral disintegrating tablet taught by Sugimoto and Green, and arrive at the instant claims with reasonable expectation of success. An ordinary skilled would reasonably expect apilimod ODT formulation would exhibit the same activity for treating ALS as taught by reference claims.
The instant application shares one common applicant/inventor/assignee with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 31, 34 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 12, 14, 17-19, 21 of U.S. Patent No.11439649 B2 in view of Sugimoto et al. (US 7,927,623 B2) and Green et al.(US 9,192,580 B2).
Reference claims are directed to “a method for treating a neurological disease or disorder in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising apilimod, or a pharmaceutically acceptable salt thereof, in combination with an antioxidant”.
Reference claim 2 recite the apilimod is apilimod dimesylate. Reference claims 14 and 16 explicitly recite amyotrophic lateral sclerosis, ALS. The antioxidant of reference claims is considered as a pharmaceutically carrier. Reference 12 recites composition in an oral dosage form or a sublingual dosage form which is considered as comprising a pharmaceutically carrier. Reference claims are silent about ODT formulation.
The collective teachings of Sugimoto and Green are elaborated in preceding 103 rejections and applied as before. Sugimoto collectively teaches orally rapidly disintegrating tablets comprising acid salts of poorly water-soluble drug under neutral or alkaline conditions have benefit of rapid dissolution, improved bioavailability and early onset of efficacy. Green teaches the benefit of preparing oral rapidly dispersing dosage forms using no-gelling, non-hydrolyzed fish gelatin and mannitol, which has better taste, simplified process step and lower preparation cost, etc.
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to apilimod composition taught by reference claims with the teaching of oral disintegrating tablet taught by Sugimoto and Green, and arrive at the instant claims with reasonable expectation of success. An ordinary skilled would reasonably expect apilimod ODT formulation would exhibit the same activity for treating ALS as taught by reference claims.
The instant application shares one common applicant/inventor/assignee with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628