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
Status of 18/028,651
Claims 105-124 are currently pending.
Priority
Instant application 18/028,651, filed 3/27/2023, claims priority as follows:
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The priority documents submitted in the file wrapper are not translated to English and as a result, priority cannot be established. Thus, claims 105-124 are granted the effective filing date of 9/29/2021.
Information Disclosure Statement
All references from the IDS’s submitted on 9/5/2024, 12/13/2024, and 11/11/2025 have been considered unless marked with a strikethrough. References were marked with a strikethrough if the abstracts were not submitted in English or the references were not provided.
Objection to Abstract
The abstract is objected for minor informalities. The abstract reads, “An amorphous solid dispersions”, which intermixes singular and plural terminology. Appropriate correction is required.
Election/Restriction
Applicant’s election of Group I, claims 105-123, drawn to amorphous solid dispersions and compositions thereof, without traverse, in the reply filed 11/11/2025 is acknowledged. Applicant’s election of following composition:
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In the same reply, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 105-121 and 123 read on the elected species. Claims 122 and 124 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claim 114 recites the limitation “hydroxypropyl methylcellulose (HPMC or hypromellose)”, which is defined in the specification as a hydrophilic high-molecular weight material, and provides the example of HPMC-E5 (page 59, para [0165]). The material HPMC-E5 is known in the art to be a low viscosity polymer and thus, the election of polymer HPMC-E5LV is currently being interpreted as equivalent to HPMC-E5, and HPMC of claim 114.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 105-121 and 123 are rejected under 35 U.S.C. 103 as being unpatentable over Shenzhen HLK Pharmaceuticals Co., Ltd. (US 20170281631 A1, cited in the IDS of 9/5/2024, herein after “Shenzhen”).
Determining the scope and contents of the prior art
The reference Shenzhen teaches pharmaceutical formulations of palbociclib that contain an acidic auxiliary material and optionally a hydrophilic high-molecular material that can be used for enhancing in vivo absorption and bioavailability of palbociclib (abstract). With respect to claims 105-112, 114-115, 117, 119, 121, and 123, Shenzhen discloses Example 6, which is a solid dispersion with 100 mg of palbociclib, 200 mg of tartaric acid, water, and 200 mg of HPMC-E5 (page 5, paras [0066]-[0067]). Shenzhen further discloses that the acidic auxiliary material is selected from one or more pharmaceutically acceptable organic acids and optionally one or more pharmaceutically inorganic acids (page 2, para [0024]). The following organic acids include methanesulfonic acid and tartaric acid. As stated in the Restriction/Election section above, methanesulfonic acid is the first acid that is an organic acid that has a pKa of at most 2, tartaric acid is the second acid that has a pKa greater than 2, HPMC-E5 is the hydrophilic high-molecular weight material, and palbociclib is the active pharmaceutical ingredient. With respect to claim 123, the composition is present in water, which is considered a pharmaceutically acceptable carrier or excipient.
Ascertaining the differences between the prior art and the claims at issue
Shenzhen fails to teach an anticipatory example of a pharmaceutical formulation of methanesulfonic acid, tartaric acid, HPMC-E5LV, and palbociclib.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of palbociclib-containing amorphous solid dispersions. An artisan possess the technical knowledge necessary to make adjustments to the dispersions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said palbociclib-containing amorphous solid dispersions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine methanesulfonic acid with Example 6, containing tartaric acid, HPMC-E5LV, and palbociclib, because Shenzhen teaches a small number of pharmaceutically acceptable organic and inorganic acids as examples, and one of ordinary skill would expect the combination to be successful in amorphous solid dispersions to treat cancer. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of the chemicals for the same purpose to improve the overall activity of the amorphous solid dispersions and would have readily predicted success in light of the teachings of Shenzhen.
With respect to claims 113, 116-118, and 120-121, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by Shenzhen above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
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 105-121 and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,449,195 B2 (herein after the ‘195 Patent) in view of Shenzhen HLK Pharmaceuticals Co., Ltd. (US 20170281631 A1, cited in the IDS of 9/5/2024, herein after “Shenzhen”).
The ‘195 Patent teaches a single amorphous solid dispersion comprising palbociclib, tartaric acid, and a hydrophilic high-molecular weight material, of which HPMC-E5 is an example in claim 3, where the mass ratio of tartaric acid to palbociclib is 0.5:1 to 5:1.
Shenzhen teaches as disclosed above and at least those teachings are incorporated herein.
Though the ‘195 Patent fails to teach an anticipatory example of a pharmaceutical formulation of methanesulfonic acid, tartaric acid, HPMC-E5, and palbociclib, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine methanesulfonic acid with the composition of ‘195 Patent because Shenzhen teaches a small number of pharmaceutically acceptable organic and inorganic acids as examples, and one of ordinary skill would expect the combination to be successful in amorphous solid dispersions to treat cancer. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of the chemicals for the same purpose to improve the overall activity of the amorphous solid dispersions and would have readily predicted success in light of the teachings of Shenzhen.
With respect to the molar ratios, weight ratios, total weight percents, and masses of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by the ‘195 Patent and Shenzhen above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 105-121 and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, and 9-10 of U.S. Patent No. 10,813,937 B2 (herein after the ‘937 Patent) in view of Shenzhen HLK Pharmaceuticals Co., Ltd. (US 20170281631 A1, cited in the IDS of 9/5/2024, herein after “Shenzhen”).
The ‘937 Patent teaches a single amorphous solid dispersion comprising palbociclib, tartaric acid, and a hydrophilic high-molecular weight material, of which HPMC-E5 is an example in claim 3, where the mass of palbociclib is 25 to 500 mg.
Shenzhen teaches as disclosed above and at least those teachings are incorporated herein.
Though the ‘937 Patent fails to teach an anticipatory example of a pharmaceutical formulation of methanesulfonic acid, tartaric acid, HPMC-E5, and palbociclib, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine methanesulfonic acid with the ‘937 Patent because Shenzhen teaches a small number of pharmaceutically acceptable organic and inorganic acids as examples, and one of ordinary skill would expect the combination to be successful in amorphous solid dispersions to treat cancer. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of the chemicals for the same purpose to improve the overall activity of the amorphous solid dispersions and would have readily predicted success in light of the teachings of the ‘937 Patent and Shenzhen.
With respect to the molar ratios, weight ratios, total weight percents, and masses of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by the ‘937 Patent and Shenzhen above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 105-121 and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 11-13 of U.S. Patent No. 10,894,049 B2 (herein after the ‘049 Patent) in view of Shenzhen HLK Pharmaceuticals Co., Ltd. (US 20170281631 A1, cited in the IDS of 9/5/2024, herein after “Shenzhen”).
The ‘049 Patent teaches methods of treating breast cancer with a single amorphous solid dispersion comprising palbociclib, tartaric acid, and a hydrophilic high-molecular weight material, of which HPMC-E5 is an example in claim 3.
Shenzhen teaches as disclosed above and at least those teachings are incorporated herein.
Though the ‘049 Patent fails to teach an anticipatory example of a pharmaceutical formulation of methanesulfonic acid, tartaric acid, HPMC-E5, and palbociclib, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine methanesulfonic acid with the ‘049 Patent because Shenzhen teaches a small number of pharmaceutically acceptable organic and inorganic acids as examples, and one of ordinary skill would expect the combination to be successful in amorphous solid dispersions to treat cancer. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of the chemicals for the same purpose to improve the overall activity of the amorphous solid dispersions and would have readily predicted success in light of the teachings of the ‘049 Patent and Shenzhen.
With respect to the molar ratios, weight ratios, total weight percents, and masses of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by the ‘049 Patent and Shenzhen above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 105-121 and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 9, 11-12, and 15 of U.S. Patent No. 11,464,779 B2 (herein after the ‘779 Patent) in view of Shenzhen HLK Pharmaceuticals Co., Ltd. (US 20170281631 A1, cited in the IDS of 9/5/2024, herein after “Shenzhen”).
The ‘779 Patent teaches a composition comprising palbociclib, an acidic auxiliary material comprising at least two pharmaceutically acceptable acids, and a hydrophilic high-molecular weight material, and methods of treating breast cancer with the composition.
Shenzhen teaches as disclosed above and at least those teachings are incorporated herein.
Though the ‘779 Patent fails to teach the molar ratios, weight ratios, total weight percents, and masses of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by the ‘779 Patent and Shenzhen above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 105-121 and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,471,418 B2 (herein after the ‘418 Patent).
The ‘418 Patent teaches an amorphous solid dispersion comprising a first acid, wherein the first acid is an organic acid that has a pKa of at most 2, a second acid wherein the second acid is an organic acid that has a pKa greater than 2, a hydrophilic high-molecular weight material, and palbociclib, wherein the molar ratio of the first acid to palbociclib is from 0.5:1 to 5:1 and the weight ratio of the second acid to palbociclib is from 0.1:1 to 10:1.
Though the ‘418 Patent fails to teach all of the molar ratios, weight ratios, total weight percents, and masses of the instant claims, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal cancer treatments. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of an “active pharmaceutical ingredient”, in this case palbociclib, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the molar ratios, weight ratios, total weight percents, and masses of acids, polymers, and active pharmaceutical ingredients, disclosed by the ‘418 Patent, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal molar ratios, weight ratios, total weight percents, and masses of tartaric acid, methanesulfonic acid, HPMC-E5LV, and palbociclib to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
Claims 105-121 and 123 are rejected. Claims 122 and 124 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621