DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 08/25/2026 has been entered. Claims 5, 13-24, and 28 are cancelled. Claims 30-34 are new. Claims 1-4, 6-12, 25-27, and 29-34 are pending in this application. Claims 27 and 29 are withdrawn. Claims 1-4, 6-12, 25, 26, and 30-34 are currently examined.
Priority
This application is a 371 of PCT/IN2022/050842 filed on 09/21/2022 and claims foreign priority of INDIA 202121042945 filed on 09/22/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-4, 6-12, 25, 26 and 30-34) in the reply filed on 08/25/2026 is acknowledged. The traversal is on the ground(s) that “claim 1, now limits the claim to specific compounds of Formulae V to XI, and does not cover Formula VI-E-1 as taught by Kinghorn et al. (WO 2015/153563)” (p. 11, last para.). This is not found persuasive because Formula V to XI and a solubilizing agent in amended claim 1 is taught by Yadav et al. under 102 and 103 Rejections below. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II). Claims 27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-4, 6-12, 25, 26 and 30-34 are currently under examination.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/14/2024 has been considered.
Claim Objections
Claims 1, 25, and 30 are objected to because of the following informalities: In claim 1, delete the incorrect and excessive recitation “its” (line 2); change the incorrect recitation “R11 and R12 can be substituted” (line 8) to “R11 and R12 are together to form a substituted” because single R11 or R12 cannot form lactone; insert the missing phrase “or are each” right after the recitation “lactone,” (line 9); spell out the abbreviated “PVPK-30” (line 11 on page 3) to “polyvinylpyrrolidone K30 (PVPK-30)”; and correct the misspelled “Kolidone” (line 12 on page 3) to become “Kollidone”. In claim 25, change the incorrect recitation “wherein it is” (line 1) to “wherein the composition is”. In claim 30, change the incorrect conjunction “and” (line 2), which combines listed species, to “or”. Appropriate correction is required.
Claim 1 is objected to because they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). Applicant is advised to insert parenthesis for the recitations “Formula V”, “Formula VI”, “Formula VII”, “Formula VIII”, “Formula IX”¸ “Formula X”¸ and “Formula XI” next to their corresponding chemical structures.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-12, 25, 26 and 30-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 1 recites “Formula IV… wherein R6 and R7 each independently is selected from -H, alkoxy, or alkyl… R11 and R12 each independently is selected from -H, or R11 and R12… -C(O)OC2H5; R is selected from… R17 is selected from alkyl” and “Formula IV, is selected from Formula V… Formula XI”. It is confusing to define Formula IV in two distinct scopes in the same claim, and thus the claim omits structural connections.
Regarding claim 1, the phrase "such as" (line 9) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 3, 4, and 10 are recites the broad recitation “polyvinylpyrrolidone” (line 10 on page 3), “a range of 10% to 95%” (line 2 of claim 3), “in the range of 2% to 20% by weight” (line 2 of claim 4), and “in the range of 0.2% to 40%” (line 2 of claim 10), respectively, and the claim also recites “polyvinylpyrrolidone K30 (PVPK-30)… mixture thereof” (line 11 on page 3), “preferably 40% to 95%, more preferably 50% to 95% by weight” (lines 2 to 3 of claim 3), “more preferably in the range of 4% to 10% by weight” (lines 2 to 3 of claim 4), and “preferably 0.2% to 20%, more preferably 0.2% to 11 % by weight” (lines 2 to 3 of claim 10), respectively, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Also, the “mixture thereof” would combine the broad recitation “polyvinylpyrrolidone” and the narrower recitation “PVPK-30)”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 6, 7, 25, 26, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yadav et al. (WO2018/193476 published on Oct. 25, 2018, also listed in IDS filed on 03/14/2024, or US 2019/0284222 published on Sep. 19, 2019, patented US 11,084,843 is provided here for citation, hereinafter referred to as Yadav ‘476) incorporated by Srivastava et al. (US 2015/0328245, Nov. 19, 2015 or EP2934549, Oct. 28, 2015, referenced by WO2018/193476, hereinafter referred to as Srivastava ‘245).
With regard to structural limitations “a pharmaceutical composition (or in a dosage form suitable for oral administration; or a tablet; or for use as a medicament in the treatment of cancer) comprising the compound of Formula IV selected from
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(Formula V) (or
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(Formula VI)) and a solubilizing agent selected from polyvinylpyrrolidone, citric acid, or polyethylene glycol” (claims 1, 2, 6, 7, 25, 26, and 34).
Yadav ‘476 disclosed pharmaceutical compositions including compounds of Formula V (
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) and VI (
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) and pharmaceutically acceptable excipient including carrier, adjuvant, vehicle or mixtures thereof are provided. The pharmaceutical excipient can further include one or more binders, diluents, disintegrants, glidants, lubricants, stabilizers, surface active agents or pH-adjusting agents. The compositions may be formulated into dosage forms including liquid, solid, and semisolid dosage forms. Preferably, the compositions are administered orally, intravenously or intraperitoneally. In certain embodiments, the amount of compound in compositions may be such that it is effective to treat cancer (page 29/55, col. 16, lines 14-41). Srivastava ‘245 (incorporated here as referenced by Yadav ‘476) disclosed that solid dosage forms for oral administration include capsules, tablets, pills, powders, and granules. In such solid dosage forms, the active compound is mixed with at least one inert, pharmaceutically acceptable excipient or carrier such as sodium citrate or dicalcium phosphate and/or a) fillers or extenders such as starches, lactose, sucrose, glucose, mannitol, and silicic acid, b) binders such as, carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, and acacia, c) humectants such as glycerol, d) disintegrating agents such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate, e) solution retarding agents such as paraffin, f) absorption accelerators such as quaternary ammonium compounds, g) wetting agents such as, for example, cetyl alcohol and glycerol monostearate, h) absorbents such as kaolin and bentonite clay, and i) lubricants such as talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof. In the case of capsules, tablets and pills, the dosage form may also comprise buffering agents. Fillers may also employ high molecular weight polyethylene glycols. The solid dosage forms of tablets, dragees, capsules, pills, and granules can be prepared with coatings and shells such as enteric coatings and other coatings (page 12/27, [0064 and 0065]).
Thus, these teachings of Yadav ‘476 incorporated by Srivastava ‘245 anticipate Applicant’s claims 1, 2, 6, 7, 25, 26, and 34 because the presence of sodium citrate, polyvinylpyrrolidone, and/or polyethylene glycols, regardless of their intended functions, in the solid dosage form also serves as solubilizing agent.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-12, 25, 26 and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Yadav et al. (WO2018/193476 published on Oct. 25, 2018, also listed in IDS filed on 03/14/2024, or US 2019/0284222 published on Sep. 19, 2019, patented US 11,084,843 is provided here for citation, hereinafter referred to as Yadav ‘476) incorporated by Srivastava et al. (US 2015/0328245, Nov. 19, 2015 or EP2934549, Oct. 28, 2015, referenced by WO2018/193476, hereinafter referred to as Srivastava ‘245) in view of White et al. (US 2020/0297644, Sep. 24, 2020, hereinafter referred to as White ‘644). Claims 1, 2, 6, 7, 25, 26, and 34 are rejected here because they have been rejected by Yadav ‘476 incorporated by Srivastava ‘245 under 102 above. Thus, the above disclosures of Yadav ‘476 and Srivastava ‘245 are incorporated in their entirety here.
Yadav ‘476 incorporated by Srivastava ‘245 did not explicitly disclose the limitations “cyclodextrin or derivative thereof, polysorbate 80, PVPK-30, copovidone (Kollidone V A64)”, “the amount of Formula IV compound is in a range of 10% to 95% by weight”, “solubilizing agent is in the range of 2% to 20% by weight of the composition”, “the lubricant (or magnesium stearate, sodium stearyl fumarate, stearic acid and colloidal silicon dioxide) is in the range of 0.4% to 0.5% by weight”, “the binder (or hydroxypropyl betacyclodextrin, polysorbate 80, purified water) is in the range of 2% to q.s, by weight”, “the extragranular ingredient (or lactose monohydrate, silicified microcrystalline cellulose, cross carmellose sodium, colloidal silicon dioxide, or hydroxypropyl methyl cellulose) is in the range of 0.2% to 40% by weight”, “the intra granular ingredient (or lactose monohydrate, silicified microcrystalline cellulose, cross carmellose sodium, hydroxyl beta cyclodextrin, polysorbate 80, colloidal silicon dioxide, or hydroxypropyl methyl cellulose) is in the range of 0.3% to 14% by weight”, and/or “the film coating is a mixture of coating premix, sodium lauryl sulphate and water”, required by claims 1, 3, 4, 6, 8-12, and 30-33.
White ‘644 disclosed pharmaceutically acceptable excipient selected from the group consisting of fillers, binders, suspending agents, disintegrants, lubricants, and combinations thereof. In some embodiments, the oral solid formulation comprises a suspending agent. In some embodiments, the suspending agent is polyvinylpyrrolidone and the amount of polyvinylpyrrolidone is from about 1 % to about 4% by weight. In some embodiments, the oral solid formulation comprises a lubricant. In some embodiments, the lubricant is magnesium stearate and the amount of magnesium stearate is from about 1 % to about 3% by weight. Hydrophilic agents might be included in the coat to promote wetting of the coat when in contact with gastrointestinal fluids. Such hydrophilic agents include polyvinylpyrrolidone (Povidone® or Kollidon®), polyvinyl alcohol, polyethylene oxide, vinylpyrrolidone-vinyl acetate copolymer (Kollidon® VA64). The hydrophilic agent is present in an amount from about 12% to about 26% by dry weight of the coat. The tackiness of polymeric films is important for the coating of solid dosage forms. The anti-tacking agents include magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, glyceryl monostearate, talc, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and mixtures thereof (pages 7/59 to 12/59, [0083, 0086, 0088, 0128, 0129]). In some cases, the pharmaceutical formulations include disintegration agents or disintegrants to facilitate the breakup or disintegration of a substance. Examples of disintegration agents include methylcrystalline cellulose, methylcellulose, croscarmellose, or a cross-linked cellulose. In some instances, the pharmaceutical formulations include filling agents such as lactose, calcium sulfate, microcrystalline cellulose, cellulose powder, pregelatinized starch, hydroxypropylmethycellulose (HPMC), sodium chloride, polyethylene glycol, and any combination thereof. Lubricants and glidants are also optionally included in the pharmaceutical formulations. Exemplary lubricants include, e.g., stearic acid, calcium hydroxide, talc, sodium stearyl fumerate, sodium stearates, glycerol, sodium chloride, leucine, a polyethylene glycol (e.g., PEG-4000), colloidal silica, a surfactant, and any combination thereof. Solubilizers include compounds such as polyvinylpyrrolidone, hydroxypropylmethyl cellulose, hydroxypropyl cyclodextrins, polyethylene glycol 200-600, propylene glycol, and dimethyl isosorbide and any combination thereof. Suspending agents include compounds such as polyvinylpyrrolidone, e.g., polyvinylpyrrolidone K25, or polyvinylpyrrolidone K30, vinyl pyrrolidone/vinyl acetate copolymer (S630), polyethylene glycol, e.g., the polyethylene glycol has a molecular weight of about 300 to about 6000, sodium carboxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, polysorbate-80, hydroxyethylcellulose (page 24/59, [0260, 0261, 0262, 0264, 0266]). In some embodiments, the formulation is stable at about 25±5° C. for at least 2 months or for at least 24 months (page 9/59, [0101]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute generic carriers or excipients as taught by Yadav ‘476 incorporated by Srivastava ‘245 with specific agents to serve as solubilizing or suspending agents, lubricants, binders, fillers, disintegrants, and coating agents, in view of White ‘644, followed by optimization of each component of the composition to obtain stable and control-released formulations for treating cancer, as described above. Thus, one of skill in the art would have a reasonable expectation that by substituting generic carriers or excipients as taught by Yadav ‘476 incorporated by Srivastava ‘245 with specific agents to serve as solubilizing or suspending agents, lubricants, binders, fillers, disintegrants, and coating agents, in view of White ‘644, followed by optimization of each component of the composition to obtain stable and control-released formulations for treating cancer, one would achieve Applicant’s claims 1-4, 6-12, 25, 26 and 30-34. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[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). See MPEP § 2144.05 [R-01.2024] [II.A].
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.
(I) Claims 1, 2, 6, 7, 25, 26, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 11,084,843 (Applicant: GODAVARI BIOREFINERIES LIMITED, Aug. 10, 2021) incorporated by Srivastava et al. (US 2015/0328245, Nov. 19, 2015 or EP2934549, Oct. 28, 2015, referenced by Pat ‘843, hereinafter referred to as Srivastava ‘245). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘843 claims “A compound of Formula V:
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” (claim 1) and “A pharmaceutical composition comprising the compound of claim 1 and pharmaceutically acceptable excipient including carrier, adjuvant, vehicle or mixtures thereof, for use in treatment of cancer including cancer that is breast… and stomach cancer” (claims 4 and 5). Srivastava ‘245 (incorporated here as referenced by Pat ‘843) disclosed that solid dosage forms for oral administration include capsules, tablets, pills, powders, and granules. In such solid dosage forms, the active compound is mixed with at least one inert, pharmaceutically acceptable excipient or carrier such as sodium citrate or dicalcium phosphate and/or a) fillers or extenders such as starches, lactose, sucrose, glucose, mannitol, and silicic acid, b) binders such as, carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, and acacia, c) humectants such as glycerol, d) disintegrating agents such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate, e) solution retarding agents such as paraffin, f) absorption accelerators such as quaternary ammonium compounds, g) wetting agents such as, for example, cetyl alcohol and glycerol monostearate, h) absorbents such as kaolin and bentonite clay, and i) lubricants such as talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof. In the case of capsules, tablets and pills, the dosage form may also comprise buffering agents. Fillers may also employ high molecular weight polyethylene glycols. The solid dosage forms of tablets, dragees, capsules, pills, and granules can be prepared with coatings and shells such as enteric coatings and other coatings (page 12/27, [0064 and 0065]).
(II) Claims 1-4, 6-12, 25, 26 and 30-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, and 11 of U.S. Patent No. 11,680,078 (Applicant: GODAVARI BIOREFINERIES LIMITED, Jun.20,2023, CON of Application No. 16/336,460, now Pat No. 11,084,843) in view of White et al. (US 2020/0297644, Sep. 24, 2020, hereinafter referred to as White ‘644). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘078 claims “A compound of Formula IV:
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, wherein the compound is compound of Formula VI:
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or of Formula VII:
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; or for use in the treatment of cancer)” (claims 1-3 and 8), and “A pharmaceutical composition comprising the compound as claimed in claim 1 and a pharmaceutically acceptable excipient including carrier, adjuvant, vehicle or mixtures thereof” (claim 11). White ‘644 disclosed pharmaceutically acceptable excipient selected from the group consisting of fillers, binders, suspending agents, disintegrants, lubricants, and combinations thereof. In some embodiments, the oral solid formulation comprises a suspending agent. In some embodiments, the suspending agent is polyvinylpyrrolidone and the amount of polyvinylpyrrolidone is from about 1 % to about 4% by weight. In some embodiments, the oral solid formulation comprises a lubricant. In some embodiments, the lubricant is magnesium stearate and the amount of magnesium stearate is from about 1 % to about 3% by weight. Hydrophilic agents might be included in the coat to promote wetting of the coat when in contact with gastrointestinal fluids. Such hydrophilic agents include polyvinylpyrrolidone (Povidone® or Kollidon®), polyvinyl alcohol, polyethylene oxide, vinylpyrrolidone-vinyl acetate copolymer (Kollidon® VA64). The hydrophilic agent is present in an amount from about 12% to about 26% by dry weight of the coat. The tackiness of polymeric films is important for the coating of solid dosage forms. The anti-tacking agents include magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, glyceryl monostearate, talc, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and mixtures thereof (pages 7/59 to 12/59, [0083, 0086, 0088, 0128, 0129]). In some cases, the pharmaceutical formulations include disintegration agents or disintegrants to facilitate the breakup or disintegration of a substance. Examples of disintegration agents include methylcrystalline cellulose, methylcellulose, croscarmellose, or a cross-linked cellulose. In some instances, the pharmaceutical formulations include filling agents such as lactose, calcium sulfate, microcrystalline cellulose, cellulose powder, pregelatinized starch, hydroxypropylmethycellulose (HPMC), sodium chloride, polyethylene glycol, and any combination thereof. Lubricants and glidants are also optionally included in the pharmaceutical formulations. Exemplary lubricants include, e.g., stearic acid, calcium hydroxide, talc, sodium stearyl fumerate, sodium stearates, glycerol, sodium chloride, leucine, a polyethylene glycol (e.g., PEG-4000), colloidal silica, a surfactant, and any combination thereof. Solubilizers include compounds such as polyvinylpyrrolidone, hydroxypropylmethyl cellulose, hydroxypropyl cyclodextrins, polyethylene glycol 200-600, propylene glycol, and dimethyl isosorbide and any combination thereof. Suspending agents include compounds such as polyvinylpyrrolidone, e.g., polyvinylpyrrolidone K25, or polyvinylpyrrolidone K30, vinyl pyrrolidone/vinyl acetate copolymer (S630), polyethylene glycol, e.g., the polyethylene glycol has a molecular weight of about 300 to about 6000, sodium carboxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, polysorbate-80, hydroxyethylcellulose (page 24/59, [0260, 0261, 0262, 0264, 0266]). In some embodiments, the formulation is stable at about 25±5° C. for at least 2 months or for at least 24 months (page 9/59, [0101]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute generic carriers or excipients as taught by Pat ‘078 with specific agents to serve as solubilizing or suspending agents, lubricants, binders, fillers, disintegrants, and coating agents, in view of White ‘644, followed by optimization of each component of the composition to obtain stable and control-released formulations for treating cancer, as described above. Thus, one of skill in the art would have a reasonable expectation that by substituting generic carriers or excipients as taught by Pat ‘078 with specific agents to serve as solubilizing or suspending agents, lubricants, binders, fillers, disintegrants, and coating agents, in view of White ‘644, followed by optimization of each component of the composition to obtain stable and control-released formulations for treating cancer, one would achieve Applicant’s claims 1-4, 6-12, 25, 26 and 30-34. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[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). See MPEP § 2144.05 [R-01.2024] [II.A].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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