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 .
Status of Application
The Amendments and Remarks filed on 04/16/26 are acknowledged.
Claims 3, 5-7, 10, 12-14, 16-19, 21-25, 27-31, 33-37, 39-42, 45-52, 54, 56-57, 60-61, 63-64, 66-68, and 72-72 were previously cancelled.
Claims 1, 4, 8-9, 11, 15, 20, 26, 32, 38, 44, 53, 58-59, 62, 65, and 69-71 were amended. Please note that claim 53 was amended but is identified as “(Previously presented).”
Claims 1-2, 4, 8-9, 11, 15, 20, 26, 32, 38, 43-44, 53, 55, 58-59, 62, 65, and 69-71 are pending and included in the prosecution.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 112(b)
In light of the claim amendments, the rejection of claims 1-2, 4, 8-9, 11, 15, 20, 26, 32, 38, 43-44, 53, 55, 58-59, 62, 65, and 69-71 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Maintained Rejections
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4, 8-9, 11, 15, 20, 26, 32, 38, 43-44, 53, 55, 58-59, 62, 65, and 69-71 are again rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (WO 2021/133809 A1 – “Campbell”) in view of Catron et al. (US 2010/0297194 A1 – “Catron”).
Instant claim 1 is drawn to a pharmaceutical composition comprising:
an intragranular phase, wherein the intragranular phase comprises:
an amorphous solid dispersion comprising Compound (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS) or polyvinylpyrrolidone/vinyl acetate copolymer (PVP-VA), and
a surfactant, wherein the surfactant is selected from poloxamer 407, poloxamer 188 and sodium lauryl sulfate; and
an extragranular phase, wherein the extragranular phase comprises at least one of the following: a surfactant, a disintegrant, a glidant, a lubricant, and a filler, and
wherein Compound (I) is N-(2-((3S,4R)-3-fluoro-4-methoxypiperidin-l-yl)pyrimidin-4-yl)-5-isopropyl-8-((2R,3 S)-2-methyl-3-((methylsulfonyl)methyl)azetidin-1-yl)isoguinolin-3-amine, and has the following structure:
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184
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.
Campbell teaches a compound represented by structural formula (I) or a pharmaceutically acceptable salt thereof useful for treating a cancer (Abstract). Campbell teaches inhibitors of mutant forms of EGFR including Synthetic Examples 1-43 (Page 2, last ¶). Example 42 (Page 170) discloses Compound 122 which is N-(2-((3S,4R)-3-fluoro-4-methoxypiperidin-1-yl)pyrimidin-4-yl)-5-isopropyl-8-((2R,3S)-2-methyl-3-((methylsulfonyl)methyl)azetidin-1-yl)isoquinolin-3-amine and is represented by the following structure:
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Campbell does not expressly teach a pharmaceutical composition comprising an intragranular phase comprising Compound 122 and an extragranular phase.
Catron teaches an orally deliverable pharmaceutical composition (Abstract and claim 1) comprising as a first active ingredient a compound of Formula I ([0046]), wherein the first active ingredient is ABT-263 or a pharmaceutically acceptable salt thereof ([0053]). The composition comprising ABT-263 can be administered in combination therapy with one or more therapeutic agents that include angiogenesis inhibitors ([0435]), which include EGFR inhibitors ([0436]). The composition is orally administered in a method of treating cancer (claims 1, 13-15). Catron discloses a solid dispersion comprising in amorphous form, a compound of Formula I or a pharmaceutically acceptable salt thereof dispersed in a solid matrix which comprises a pharmaceutically acceptable water-soluble polymeric carrier and a pharmaceutically acceptable surfactant ([0083]).
Catron also teaches that the polymeric carriers include HPMCAS and copolymers comprising monomers of N-vinyl pyrrolidone and vinyl acetate ([0300]). Example 16 discloses the preparation of solid dispersions of the active ingredient where the polymer was HPMC-AS ([0569]). Examples of surfactants useful in the compositions ([0312]) include poloxamer 188 and poloxamer 407 ([0316]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the EGFR inhibitor Compound 122, as taught by Campbell, in the orally deliverable pharmaceutical composition which contains angiogenesis inhibitors including EGFR inhibitors wherein the composition is in the form of an amorphous dispersion and contains polymers such as HPMC-AS and surfactants such as poloxamer 188 and poloxamer 407, as taught by Catron, and produce the instant invention.
One of ordinary skill in the art would have been motivated to substitute the EGFR inhibitors of Catron with the EGFR inhibitor of Compound 122 as taught by Campbell because they belong to the same class of drugs, i.e., EGFR inhibitors, and are used for the same purpose, i.e., to treat cancer (Campbell – Abstract, Catron – claims 1, 13-15). One of ordinary skill in the art would have found it obvious to simply substitute one known element (EGFR inhibitor of Catron) for another (EGFR inhibitor of Campbell) to obtain predictable results (treatment of cancer). Please see MPEP 2141(III)(B).
From the teachings of the references, it is apparent that 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a pharmaceutical composition would have been obvious over the orally deliverable pharmaceutical composition (Abstract, claim 1), as taught by Catron.
Regarding instant claim 1, the limitations of an intragranular phase and an extragranular phase would have been obvious over the intragranular components and extragranular components ([0403], TABLES 29-32, [0625]-[0641]), as taught by Catron.
Regarding instant claims 1 and 71, the limitations of the amorphous solid dispersion comprising Compound (I) or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer, and (ii) a surfactant would have been obvious over the orally deliverable solid dispersion comprising in amorphous form, a compound of Formula I or a pharmaceutically acceptable salt thereof dispersed in a solid matrix comprises a pharmaceutically acceptable water-soluble polymeric carrier and a pharmaceutically acceptable surfactant ([0083]), additional therapeutic agents that include angiogenesis inhibitors ([0435]) and EGFR inhibitors ([0436]), as taught by Catron, and Compound 122, which is N-(2-((3S,4R)-3-fluoro-4-methoxypiperidin-l-yl)pyrimidin-4-yl)-5-isopropyl-8-((2R,3S)-2-methyl-3-((methylsulfonyl)methyl)azetidin-l-yl)isoquinolin-3-amine, and is an EGFR inhibitor (Page 170), as taught by Campbell.
Furthermore, regarding instant claim 1, the limitation of the amorphous solid dispersion would have been obvious over the solid dispersion in amorphous form, comprising the active ingredient dispersed in a solid matrix which comprises a pharmaceutically acceptable water-soluble polymeric carrier and a pharmaceutically acceptable surfactant ([0083]), wherein polymeric carriers include HPMCAS and copolymers comprising monomers of N-vinyl pyrrolidone and vinyl acetate ([0300] and [0569]), and surfactants include poloxamer 188 and poloxamer 407 ([0316]), as taught by Catron.
Regarding instant claim 1, the limitations of the extragranular phase comprising at least one of the following: a surfactant, a disintegrant, a glidant, a lubricant, and a filler would have been obvious over the extragranular components ([0403], TABLES 29-32, [0625]-[0641]), which include the filler Avicel 101™, the disintegrant sodium starch glycolate, and the lubricant magnesium stearate (TABLE 29), as taught by Catron.
Regarding instant claim 2, the limitation of the extragranular phase comprising a surfactant would have been obvious over the extragranular excipients ([0403]), wherein excipients include surfactants ([0043]), as taught by Catron.
Regarding instant claims 4 and 71, the limitations of the polymer would have been obvious over the polymeric carriers which include hydroxypropylmethylcellulose acetate succinate (HPMCAS) ([0300], [0357], and [0569]), a polymer of polyvinylpyrrolidone and polyvinylacetate (Kollidon ®SR of BASF AG) ([0359]), as taught by Catron.
Regarding instant claims 8 and 70, the limitations of Compound (I) free base or an equivalent amount of a pharmaceutically acceptable salt thereof and the polymer being in a weight percent ratio of about 1:1 would have been obvious over the active ABT-263 bis-HCl salt included at 10.75% by weight and 10.00% by weight of the polymer sodium starch glycolate ([0626]), as taught by Catron, which is calculated to be a weight percent ratio of 1.075:1 or about 1:1.
Regarding instant claim 9, the limitation of the composition comprising the amorphous solid dispersion from about 20% to about 80% by weight of the composition would have been obvious over the solid dispersion comprising in amorphous form, a compound of Formula I or a pharmaceutically acceptable salt thereof ([0083]), and the dosage form that comprises preferably at least about 40%, and most preferably at least about 45%, by weight of the solid dispersion product, based on the total weight of the solid dosage form ([0337]), as taught by Catron.
Regarding instant claim 11, the limitation of the surfactant selected from poloxamer 407, poloxamer 188 and sodium lauryl sulfate and the surfactant present in an amount from about 0.25% to about 20% by weight of the composition, based on the total weight of the composition would have been obvious over poloxamer 407 ([0312]), poloxamer 188 ([0278], [0312], [0555]), and sodium lauryl sulfate ([0278], [0320], [0351], [0390], [0392]-[0394], TABLE 22) and the use of poloxamer (Pluronic™ F127) at 4.00% in Formulations 26 and 28, and at 1.00% in Formulation 27 (TABLE 28), as taught by Catron.
Regarding instant claim 15, the limitation of the surfactant in the intragranular phase at about 0.1% to about 20% would have been obvious over the use of poloxamer (Pluronic™ F127) at 4.00% in Formulations 26 and 28, and at 1.00% in Formulation 27 (TABLE 28), as taught by Catron. The limitation of the surfactant in the extragranular phase at about 0% to about 20% would have been obvious over the extragranular excipients ([0403]), wherein excipients include surfactants ([0043]), and the amount of surfactant of 4.00% and 1.00% (TABLE 28), as taught by Catron. One of ordinary skill in the art would have found it obvious to include the surfactants at the same amounts in both the intragranular and extragranular portions.
Regarding instant claim 20, the limitation of a disintegrant selected from crospovidone, croscarmellose sodium, and sodium starch glycolate would have been obvious over the disintegrants crospovidone ([0371], [0386], [0406], [0407], TABLE 28), croscarmellose sodium ([0386], [0572], [0583], [0597], TABLE 27), sodium starch glycolate ([0386]), the use of disintegrants at about 0.2% to about 30%, by weight of the composition ([0386]), the use of crospovidone at 1.50% by weight in Formulations 26 and 27 (TABLE 28), the use of croscarmellose sodium at 15% in Formulation 28 (TABLE 27), the typical use of sodium starch glycolate at about 1% to about 20% by weight of the composition ([0387]), the use of sodium starch glycolate at 10.00% by weight in Formulations 28, 29, and 30 (TABLE 28), as taught by Catron. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 26, the limitations of a glidant and the amount of the glidant would have been obvious over the glidants or flow regulators colloidal silica ([0365]), e.g., Aerosil™ also referred to as colloidal silicon dioxide ([0371]), corn starch, potato starch ([0320]), and talc ([0320], [0393]) used as an anti-adherent at about 0.05% to about 10%, by weight of the composition ([0393]), as taught by Catron. Please see MPEP 2144.05.
Regarding instant claim 32, the limitations of a lubricant and the amount of the lubricant would have been obvious over the talc ([0320], [0371], [0393]) used as an anti-adherent at about 0.05% to about 10%, by weight of the composition ([0393]), lubricants magnesium and calcium stearates, sodium stearyl fumarate, polyethylene glycols having a molecular weight of about 1,000 to about 6,000 ([0371]), and the use of lubricants in an amount of about 0.05% to about 10% by weight of the composition ([0392]), as taught by Catron. Please see MPEP 2144.05.
Regarding instant claim 38, the limitations of fillers and the amount of the fillers would have been obvious over the lactose ([0320]), mannitol, microcrystalline cellulose (Avicel™) ([0371]) and diluents which are present in an amount of about 5% to about 95% by weight of the composition ([0384]), as taught by Catron. Please see MPEP 2144.05.
Regarding instant claim 43, the limitations of the intragranular phase and the extragranular phase comprising mannitol and microcrystalline cellulose would have been obvious over the mannitol and microcrystalline cellulose (Avicel™) ([0371], Formulations 31-36 - TABLE 29), as taught by Catron.
Regarding instant claim 44, the limitations of a non-functional polymer coating and the amount of the non-functional polymer coating would have been obvious over the coating agents ([0320], [0395]) and film forming agents including hydroxypropylmethylcellulose, hydroxypropylcellulose, a polyethylene glycol ([0375]) wherein the film coat usually accounts for less than about 5% by weight of the dosage form, as taught by Catron.
Regarding instant claims 53, 55, 58, and 59, the limitations of the components would have been obvious over the orally deliverable solid dispersion comprising in amorphous form, a compound of Formula I or a pharmaceutically acceptable salt thereof dispersed in a solid matrix comprises a pharmaceutically acceptable water-soluble polymeric carrier and a pharmaceutically acceptable surfactant ([0083]), additional therapeutic agents that include angiogenesis inhibitors ([0435]) and EGFR inhibitors ([0436]), polymers HPMCAS ([0300] and [0357]), a polymer of polyvinylpyrrolidone and polyvinylacetate (Kollidon ®SR of BASF AG) ([0359]), surfactants ([0043]), poloxamer 407 ([0312]), poloxamer 188 ([0278], [0312], [0555]), and sodium lauryl sulfate ([0278], [0320], [0351], [0390], [0392]-[0394], TABLE 22), the disintegrants crospovidone ([0371], [0386], [0406], [0407], TABLE 28), croscarmellose sodium ([0386], [0572], [0583], [0597], TABLE 27), sodium starch glycolate ([0386]), glidants or flow regulators colloidal silica ([0365]), e.g., Aerosil™ also referred to as colloidal silicon dioxide ([0371]), corn starch, potato starch ([0320]), and talc ([0320], [0393]), and lubricants magnesium and calcium stearates, sodium stearyl fumarate, polyethylene glycols having a molecular weight of about 1,000 to about 6,000 ([0371]), mannitol and microcrystalline cellulose (Avicel™) ([0371], Formulations 31-36 - TABLE 29), as taught by Catron, and Compound 122 which is an EGFR inhibitor (Page 170), as taught by Campbell. One of ordinary skill in the art would have found it obvious to use the guidance of intragranular and extragranular portions provided by Catron and include the ingredients in the portions based on the desired release and stability.
Regarding instant claim 58, the limitation of Compound (I) free base or an equivalent amount of a pharmaceutically acceptable salt thereof and the HPMC-AS being in a weight percent ratio of about 1:1 would have been obvious over the active ABT-263 free base or bis-HCl salt included at about 2.5% to about 40% ([0332]) and the HPMC-AS polymeric carrier ([0308]) included at about 20% to about 90% ([0309]), as taught by Catron, and Compound 122 (Page 170), as taught by Campbell. One of ordinary skill in the art would have found it obvious to include Compound 122 of Campbell in the weight % range of the EGFR inhibitor of Catron, i.e., about 2.5 to about 40%, and include polymeric carriers such as HPMC-AS in an amount of about 20% to about 90% as taught by Catron and find that the claimed weight percent ratio of 1:1 would have been obvious. Given 20% of active (which lies within the range about 2.5 to about 40%) and 20% of HPMC-AS (the lower limit of the range of about 20% to about 90%), a weight percent ratio of 1:1 is achieved.
Regarding instant claim 62, the limitation of the capsule would have been obvious over the capsules ([0077], [0128], [0231], [0236], TABLE 32), as taught by Catron.
Regarding instant claim 65, the limitation of the tablet would have been obvious over the tablets ([0128], [0279], TABLE 33), as taught by Catron.
Regarding instant claim 69, the limitation of the dosage of the active ingredient would have been obvious over the therapeutically effective doses of ABT-263 in human patients of 200 mg/day ([0035]), as taught by Catron and Compound 122 which is an EGFR inhibitor (Page 170), as taught by Campbell. One of ordinary skill in the art would have found it obvious to determine the therapeutically effective dosage of the active ingredient based on the cancer being treated, the patient’s weight, age, and other medications, etc.
Response to Arguments
Applicant’s arguments (Pages 14-18, filed 04/16/26) with respect to the rejection of claims 1-2, 4, 8-9, 11, 15, 20, 26, 32, 38, 43-44, 53, 55, 58-59, 62, 65, and 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Catron have been fully considered but are not persuasive.
Applicant argues that tablet formulation 31 and capsule formulation 39, as disclosed by Catron, comprise poloxamer 407 as the surfactant in the intragranular phase but neither of these two formulations comprise an amorphous dispersion of the API and a polymer that is HPMCAS or PVP-VA as in the instantly claimed compositions. Applicant argues that even if one skilled in the art is motivated to replace ABT-263 with Compound (I) in the pharmaceutical compositions disclosed in Catron, it does not arrive at Applicant's claimed compositions requiring an amorphous solid dispersion of Compound (I) or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer that is HPMCAS or PVP-VA in the intragranular phase.
This is not persuasive because Catron clearly teaches a solid dispersion in amorphous form, comprising the active ingredient dispersed in a solid matrix which comprises a pharmaceutically acceptable water-soluble polymeric carrier and a pharmaceutically acceptable surfactant ([0083]), as well as intragranular components ([0403], TABLES 29-32, [0625]-[0641]). One of ordinary skill in the art would have been motivated to use the polymeric carriers taught by Catron including HPMCAS and copolymers comprising monomers of N-vinyl pyrrolidone and vinyl acetate ([0300] and [0569]), as well as the surfactants taught by Catron including poloxamer 188 and poloxamer 407 ([0316]) in the intragranular components.
Catron is not relied upon for teaching the API. The primary reference, Campbell, teaches this limitation. One of ordinary skill in the art would have been motivated to substitute the EGFR inhibitors of Catron with the EGFR inhibitor of Compound 122 as taught by Campbell because they belong to the same class of drugs, i.e., EGFR inhibitors, and are used for the same purpose, i.e., to treat cancer (Campbell – Abstract, Catron – claims 1, 13-15). One of ordinary skill in the art would have found it obvious to simply substitute one known element (EGFR inhibitor of Catron) for another (EGFR inhibitor of Campbell) to obtain predictable results (treatment of cancer). Please see MPEP 2141(III)(B).
Applicant argues that Catron discloses in Table 29 tablet formulations 32-36, which have similar excipients as formulation 31, but do not include poloxamer surfactant, and Catron teaches away or at minimum provides no motivation for one skilled in the art to add surfactant in API blend to improve bioavailability of the pharmaceutical compositions, especially, in the intragranular phase of the compositions.
This is not persuasive because the teaching of Catron is not limited to tablet formulations 32-36. Catron clearly teaches the inclusion of Pluronic F-127 or poloxamer 407 in tablet 31 in the intragranular potion (TABLE 29), thereby providing guidance and motivation to one of ordinary skill in the art to add poloxamer to the intragranular portion of a composition.
Applicant argues that as demonstrated in the instant application, the addition of a surfactant in the intragranular phase improves the dissolution profile and bioavailability of the claimed pharmaceutical compositions, which cannot be reasonably expected based on Campbell and Catron.
This is not persuasive because the improvement in the dissolution profile and bioavailability of the claimed pharmaceutical compositions, as argued by Applicant, are associated with specific compositions having specific concentrations of components. However, instant claim 1 does not recite any amounts, concentrations, or ranges related to the components of the pharmaceutical composition. Please see MPEP 2145. Furthermore, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Also, the improvement in the dissolution profile and bioavailability would have been expected given the teaching of the same composition; the same components including the API, the polymer, the surfactant, and other excipients; and the same arrangement of the components, i.e., an intragranular phase and an extragranular phase, in the prior art references Campbell and Catron.
Therefore, the rejection of 12/31/25 is maintained.
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.
Claim 1 is again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 45 of copending Application No. 18/573,222 (“the ‘222 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a pharmaceutical composition comprising Compound (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymer, and therefore, encompass overlapping or coextensive subject matter.
The difference is that instant claim 1 recites a pharmaceutical composition comprising: an intragranular phase, wherein the intragranular phase comprises: an amorphous solid dispersion comprising Compound (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymer, and a surfactant; and an extragranular phase, wherein the extragranular phase comprises at least one of the following: a surfactant, a disintegrant, a glidant, a lubricant, and a filler, whereas claim 1 of the ‘222 Application does not recite these limitations.
However, the specific amorphous solid dispersion of instant claim 1 is a species of the pharmaceutical composition recited in claim 45 of the ‘222 Application and renders it obvious. Since claim 45 of the ’222 Application recites the transitional phrase “comprising,” it allows the inclusion of additional components such as the amorphous dispersion, intragranular phase, and extragranular phase recited in instant claim 1.
Since the instant application claims a pharmaceutical composition comprising Compound (I) or a pharmaceutically acceptable salt thereof, it is obvious over the claims of the ‘222 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Pages 18-19, filed 04/16/26) with respect to the provisional rejection of claim 1 on the ground of nonstatutory obviousness-type double patenting over claims 1 and 45 of the ‘222 Application have been fully considered but are not persuasive.
Applicant argues that there is no teaching, suggestion or motivation provided in claims 1 and 45 of the ‘222 Application to prepare a pharmaceutical composition comprising an intragranular phase and extragranular phase as recited in instant claim 1.
This is not persuasive because even though claims 1 and 45 of the ‘222 Application do not recite the intragranular phase and extragranular phase components as recited in instant claim 1, the specific components of the pharmaceutical composition including the amorphous solid dispersion in the intragranular phase and extragranular phase of instant claim 1 is a species of the pharmaceutical composition recited in claim 45 of the ‘222 Application and renders it obvious. Since claim 45 of the ’222 Application recites the transitional phrase “comprising,” it allows the inclusion of additional components such as the amorphous dispersion, intragranular phase, and extragranular phase recited in instant claim 1.
Therefore, the rejection of 12/31/25 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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