DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 41-48, 51-58, and 60-62 are pending and under current examination in this application. Claims 1-40, 49, 50, and 59 have been cancelled. Amendments to claims 41-46, 48, 51, 52, 54-57, and 60, filed 11 August 2025, are acknowledged and are supported by the originally-filed disclosure. New claims 61 and 62 have been added and claims 47, 53, and 58 have been previously presented.
Information Disclosure Statement
The Information Disclosure Statement (IDS), submitted 11 August 2025, has been considered.
Response to Amendment
The following is a response to the Applicant’s Remarks filed with the Amendment dated 11 August 2025. The arguments presented have been fully considered.
Claim amendments to remove the terms "preferably" and "such as," and the cancellation of claim 59, overcome the indefiniteness rejections under 35 U.S.C. § 112(b), thus these rejections are withdrawn. The cancellation of claim 59 renders the 35 U.S.C. § 101 rejection moot.
The rejections under 35 U.S.C. § 102 and 103 have been withdrawn based on the newly cited limitations of the amended claims, however new 35 U.S.C. § 103 have been issued as set forth below.
New Rejections
The Applicant's amendment necessitates new grounds of rejection from the previous Office Correspondence dated 10 April 2025, since new claims have been added.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claims 61 and 62 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, regards as the invention.
Claims 61 and 62 are rejected under 35 U.S.C. 112(b) as being indefinite because the claims recite trademark names such as “K12”, “Kollidon 17PF”, “Kollidon 25”, “Kollidon 30” and “Kollidon 90”. The use of trademarks in a claim is improper as the precise meaning and scope of these terms is unclear. The precise chemical composition of a trademarked product can be proprietary, can change over time, or can vary by manufacturer or between suppliers. The claim must define the invention by its objective physical or chemical characteristics, not by a commercial brand name that is subject to change. Furthermore, the public is not adequately notified of the claim's scope, as it is defined by a proprietary commercial product rather than by objective, structural, or functional characteristics.
MPEP § 2173.05(u) "Use of Trademarks or Tradenames" states: "The use of a trademark or tradename in a claim is improper where the trademark or tradename does not refer to a product or process capable of description by its composition, structure, or other characteristics, but only serves to refer to the product or process as a whole."
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 41-48, 51-53, 56, 58 and 60-62 are rejected under 35 U.S.C. § 103 as being unpatentable over Grahek (WO2014009437A1; publication date 16 January 2014) in view of Angi et al. (US20190046437A1; publication date 14 February 2019, hereinafter referred to as Angi).
Regarding instant claims 41, 43-46, and 51, Grahek teaches an oral administration solid dosage form as, “According to the present invention the pharmaceutical composition preferably is an oral dosage form. Said oral dosage form may be selected from the group consisting of a tablet, a capsule, a sachet, a powder, a syrup or a liquid.” (page 14, paragraph 1) of amorphous matrix abiraterone acetate as, “According to the invention abiraterone acetate is used in crystalline form, in amorphous form or in dissolved form.” (page 9, paragraph 4) with a water-soluble polymer (polyvinylpyrrolidone and hydroxypropyl cellulose), antioxidant (butylated hydroxytoluene (BHT)), disintegrant (microcrystalline cellulose and croscarmellose sodium) and excipients (colloidal silica glidant and magnesium stearate lubricant/ anti-adherent) (Example 3 and Table 5, page 17-18). Further stating, “The inventive pharmaceutical composition may optionally further comprise one or more pharmaceutically acceptable excipients generally used in the art. Such excipients may include one or more fillers, diluents, lubricants, binders, granulating aids, disintegrating agents, colorants, flavoring agents, sweeteners, glidants, preservatives, stabilizers, solubilizers, antioxidants or buffers and other excipients depending on the route of administration and the dosage form used.” (page 13, paragraph 7). Wherein, the amorphous matrix formulations using water soluble polymers described in Example 3 and Table 5, would result in fast oral disintegration and rapid reconstitution in liquid immediate-release formulation.
Grahek does not teach the specific use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate.
Angi teaches pharmaceutically acceptable complex formulations comprising abiraterone acetate and pharmaceutically acceptable excipients and process for the preparation thereof (Abstract), in which at least one complexing agent chosen from polyvinylpyrrolidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, hydroxypropylcellulose, poloxamers, etc. and optionally, pharmaceutically acceptable excipients (claim 1). More specifically reciting, “In an embodiment, said complexing agent is chosen from polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers; poloxamers; polyvinylpyrrolidone...” (¶[0026]), “In an embodiment, said polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer is Soluplus [well-known synonym for a polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymer is Soluplus® (BASF)]…” (¶[0028]), and “In an embodiment, said excipient is sodium deoxycholate (SDC).” (¶[0032]).
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate to the invention of Grahek in Example 5, given that Angi teaches the use of such in abiraterone acetate formulations intended to increase solubility/dissolution rates of abiraterone acetate (see Angi ¶[0002]), which can be used in addition to those taught by Grahek. The combination of these known, art-recognized excipients in a single formulation represents a predictable variation within the scope of the combined teachings of Grahek and Angi. One would be motivated to do so because the use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate had been used for abiraterone acetate preparations prior to the invention, as evidence by Angi, for the same purpose of providing rapid reconstitution and disintegration of orally administered abiraterone acetate (see Angi ¶[0002]) as the instant invention.
Regarding instant claim 42, Grahek teaches, “Presence of amorphous abiraterone acetate in prepared adsorbate was confirmed by x-ray diffraction.” (page 25, Example 17) and “Thus, in one embodiment, the present invention is directed to a pharmaceutical composition comprising abiraterone acetate or a pharmaceutically acceptable salt, hydrate or solvate thereof, characterized in that, when exposed to a temperature of 40 °C and 75% relative humidity (RH) for 6 months, preferably 12 months, more preferably 18 months, even more preferably 24 months under air atmosphere, the total amount of oxidation degradation products does not increase by more than 1.5%, more preferably not more than 1.0%, even more preferably not more than 0.5%.” (page 6, paragraph 3); this teaches the “stable for at least 3 months” limitation.
Regarding instant claims 47 and 48, Grahek teaches in Example 2, Table 4, and Example 3, Table 5 (page 17 and 18), abiraterone acetate in an amount of 24.99% and 24.09%, respectively, by weight, based on the total weight of the matrix, thus encompassing the range of instant claim 47. Wherein, in Example 5, the tablet formulation from Example 2 was prepared as a nanoparticle suspension (ball milling), resulting in a final granulate that is an amorphous matrix in a solid particulate form (drying and sieving, 0.315 mm), thus encompassing the limitations of instant claims 47 and 48.
Regarding instant claim 52, Grahek teaches the use of 250 mg abiraterone acetate in Examples 1-5, 9, 11 and 13 (page 16-22), thus encompassing the limitations of instant claim 52.
Regarding instant claims 53 and 54, Grahek teaches, “The pharmaceutical composition of the present invention may be in the form of a solid dispersion, a nanosuspension, an adsorbate, a liquid lipidic formulation, e.g. a self-microemulsifying drug delivery system, or a pharmaceutical preparation comprising or derived from a solid dispersion, a nanosuspension, an adsorbate, a liquid lipidic formulation, e.g. a self-microemulsifying drug delivery system. According to the present invention the pharmaceutical composition preferably is an oral dosage form. Said oral dosage form may be selected from the group consisting of a tablet, a capsule, a sachet, a powder, a syrup or a liquid.” (page 13-14, last and first paragraphs), wherein solid dispersions, dried nanosuspensions, adsorbates and solidified lipidic formulations would be solid dosage form that disintegrates and release abiraterone acetate into an aliquot of liquid suitable for human consumption, thus encompassing the limitations of instant claim 53. Where said liquid taught by Grahek under the broadest reasonable interpretation would include any liquid of instant claim 54.
Regarding instant claim 56, Grahek teaches in Example 9 (page 21) the use of formulations of Example 3 and Table 5 (page 18) with the addition of 250 mg sucrose (1:1 ratio sucrose : abiraterone acetate), resulting in a 19.41% abiraterone acetate weight based on the total weight of the solid dosage form, thus teaching the limitation of instant claim 56.
Regarding instant claim 58, Grahek teaches, “In a further embodiment of the invention the pharmaceutical composition as described hereinabove is for use in the treatment of cancer, preferably metastatic prostate cancer.” (page 14, paragraph 2), thus teaching the limitation of instant claim 58.
Regarding instant claim 60, Grahek teaches, a process for the preparation of a pharmaceutical composition comprising abiraterone acetate (claim 1), a water-soluble polymer polyvinylpyrrolidone (Example 2 and Example 3, pages 17-18), an antioxidant (claim 3) (See Example 3, Table 5) processed by wet extrusion (Example 2, page 17), followed by milling and sieving to produce a particulate [size reduction] (Example 7, page 20), then blending the particulate with excipients and forming granules by manual milling (grinding with pestle and mortar) and compressing into a tablet (Example 9, page 21). Processing by blending to produce a powder blend comprising abiraterone acetate, one or more water-soluble polymers, one or more antioxidants and one or more disintegrants or dispersing agents is described by Grahek Example 3 (page 18, paragraph 1) in which granulates were mixed and tableted.
Regarding instant claims 61 and 62, K12, Kollidon 17PF, Kollidon 25, Kollidon 30 or Kollidon 90 are well-known specific polyvinylpyrollidone brands that would be included under the broadly claimed polyvinylpyrrolidone taught by Grahek, thus teaching the limitations of instant claims 61 and 62.
Claims 41, 53, and 54 are rejected under 35 U.S.C. § 103 as being unpatentable over Grahek (WO2014009437A1; publication date 16 January 2014) in view of Angi et al. (US20190046437A1; publication date 14 February 2019, hereinafter referred to as Angi), and in further view of Koziol (US20150337003A1; publication date 26 November 2015).
Grahek and Angi teach the limitations of instant claims 41 and 53, from which instant claim 54 depends, as described above, however the references do not teach the specific limitations of instant claim 54.
Grahek teaches, ”The pharmaceutical composition of the present invention may be in the form of a solid dispersion, a nanosuspension, an adsorbate, a liquid lipidic formulation, e.g. a self-microemulsifying drug delivery system, or a pharmaceutical preparation comprising or derived from a solid dispersion, a nanosuspension, an adsorbate, a liquid lipidic formulation, e.g. a self-microemulsifying drug delivery system. According to the present invention the pharmaceutical composition preferably is an oral dosage form. Said oral dosage form may be selected from the group consisting of a tablet, a capsule, a sachet, a powder, a syrup or a liquid.” (page 13-14, last and first paragraphs), wherein solid dispersions, dried nanosuspensions, adsorbates and solidified lipidic formulations would be solid dosage form that disintegrates and release abiraterone acetate into an aliquot of liquid suitable for human consumption, where said liquid taught by Grahek could include any liquid.
Koziol teaches compositions of abiraterone acetate and abiraterone analogs wherein, “The oral formulation may also consist of administering a compound disclosed herein in water or fruit juice…” (paragraph [0178]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to use water or juices of instant claim 54, given other abiraterone acetate compositions known for the same purpose prior to the invention were administered with these liquids.
Claims 41, 53, and 55 are rejected under 35 U.S.C. § 103 as being unpatentable over Grahek (WO2014009437A1; publication date 16 January 2014) in view of Angi et al. (US20190046437A1; publication date 14 February 2019, hereinafter referred to as Angi), and in further view of Legen (WO2014009434A1; publication date 16 January 2014).
Grahek and Angi teach the limitations of instant claims 41 and 53, from which instant claim 55 depends, as described above, however the references do not teach the specific limitations of instant claim 55.
Grahek teaches in Example 3 (page 17-18) a composition containing amorphous form abiraterone acetate (from ethanol dissolution), which would enhance solid dosage dissolution, the use of either polyvinylpyrrolidone or hydroxypropyl cellulose which promotes rapid wetting and enhances solubility, the use of the superdisintegrant croscarmellose sodium critical for rapid disintegration at 4.8% and a low 0.8% level of lubricant minimizing hydrophobic interference, but with the use of microcrystalline cellulose which is not a rapid disintegrant. This composition will necessarily disintegrate, thus encompassing the broadest limitation of instant claim 55. Further, the disintegration time for the composition of Example 3 is likely less than 3-5 minutes for the formulation and dissolution time is likely less than 5-10 minutes in 50-250 mL liquid if the amorphous state is maintained, where addition of lactose and sodium starch glycolate as a second disintegrant in Example 13 would further reduce the dissolution time, likely to less than 1-3 minutes, although not explicitly measured in either example.
Legen teaches self-microemulsifying drug delivery system comprising abiraterone acetate that can be converted to a solid-state tablet wherein, “In another embodiment the pharmaceutical composition comprising the inventive self-microemulsifying drug delivery system exhibits a dissolution profile such that more than 80%, preferably 85%, more preferably 90% of 250 mg of the compound of formula (I), preferably of abiraterone acetate or a pharmaceutically acceptable salt, hydrate or solvate thereof is released within 15 minutes, wherein the release rate is measured in Apparatus 2 (USP, Dissolution, paddle, 50 rpm) using 900 ml of FaSSIF (pH 6.5) and FeSSIF (pH 5.0) media at 37°C ± 0.5°C. As used herein "FaSSIF" relates to the "Fasted State Simulated Intestinal Fluid", a dissolution medium developed by Prof. Dr. Dressman (Goethe-Univ. Frankfurt). As used herein the "FeSSIF" relates to the "Fed State Simulated Intestinal Fluid", a dissolution medium developed by Prof. Dr. Dressman (Goethe-Univ. Frankfurt). The preparation of both dissolution media has been widely published (e.g. in Margreth Marques, Dissolution Technologies, page 16, May 2004).” (page 22, paragraphs 1-3).
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to prepare solid dosage abiraterone acetate forms for oral administration within the dissolution rate limitations of instant claim 55, given this immediate release dissolution range had been used for other abiraterone acetate preparations for the same purpose prior to the invention.
Claim 57 is rejected under 35 U.S.C. § 103 as being unpatentable over Grahek (WO2014009437A1; publication date 16 January 2014) in view of Angi et al. (US20190046437A1; publication date 14 February 2019, hereinafter referred to as Angi), and in further view of Kocherlakota (WO2019186444A1; publication date 03 October 2019).
Regarding instant claim 57, Grahek teaches Example 9 (page 21), composition 003X2 (which also includes BHT as reported in Figure 6, Mixture 7), with ratios of Example 3 results in a 19.41% or 19.87% abiraterone acetate with or without disintegrant croscarmellose sodium, respectively, both within the instant claim range of 1-20% abiraterone acetate; 19.41% or 19.87% hydroxypropyl metylcellulose water soluble polymer with or without disintegrant croscarmellose sodium, respectively, within the instant claim range of 5-60% water soluble polymer; 38.82% or 39.75% microcrystalline cellulose filler/diluent with or without disintegrant croscarmellose sodium, respectively, within the instant claim range of 35-90% fillers and/or diluents; 19.41% or 19.87% sucrose binder with or without disintegrant croscarmellose sodium, respectively, within the instant claim range of 5-20% binders; 41.15% microcrystalline cellulose and croscarmellose sodium disintegrants or 39.75% without disintegrant croscarmellose sodium, respectively, within the instant claim range of 5-45% disintegrants; 0.39% or 0.40% magnesium stearate and 0.19% or 0.20% colloidal silica lubricant, anti-adherent, and glidant, with or without disintegrant croscarmellose sodium, respectively, within the instant claim range of 0.1-5% lubricants, 0.1-5% anti-adherents, and 0.1-5% glidants; and, 0.03% butylated hydroxytoluene antioxidant, with or without disintegrant croscarmellose sodium, within the instant claim range 0.01-2% antioxidants. Further, Grahek teaches, “The pharmaceutical composition of any of the previous items, characterized in that it further comprises one or more excipients selected from fillers, diluents, lubricants, binders, disintegrating agents, colorants, flavoring agents, sweeteners, glidants, preservatives, stabilizers, solubilizers, antioxidants and buffers.” (page 30, number 29), including the use of flavoring agents and/or sweeteners, but does not explicitly state 0.05-5% flavoring agents and/or sweeteners.
Kocherlakota teaches oral abiraterone acetate compositions 0.31% flavoring agents and 0.31% sweetener (saccharine) (Example 2), which alone and cumulatively (0.635) are within the range of the instant claim.
Grahek does not teach the specific use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate.
Angi teaches pharmaceutically acceptable complex formulations comprising abiraterone acetate and pharmaceutically acceptable excipients and process for the preparation thereof (Abstract), in which at least one complexing agent chosen from polyvinylpyrrolidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, hydroxypropylcellulose, poloxamers, etc. and optionally, pharmaceutically acceptable excipients (claim 1). More specifically reciting, “In an embodiment, said complexing agent is chosen from polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers; poloxamers; polyvinylpyrrolidone...” (¶[0026]), “In an embodiment, said polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer is Soluplus [well-known synonym for a polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymer is Soluplus® (BASF)]…” (¶[0028]), and “In an embodiment, said excipient is sodium deoxycholate (SDC).” (¶[0032]).
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate to the invention of Grahek, given that Angi teaches the use of at least one complexing agent as such which can be used in addition to those taught by Grahek (see Angi instant claim 1) and the use of sodium deoxycholate in abiraterone acetate formulations intended to increase dissolution rates of abiraterone acetate. The combination of these known, art-recognized excipients in a single formulation represents a predictable variation within the scope of the combined teachings of Grahek and Angi. One would be motivated to do so because the use of polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate had been used for other abiraterone acetate preparations for the same purpose prior to the invention. In addition, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to prepare a composition according to the limitations of instant claim 57, given the composition percentages specified for the formulation were known for the same purpose in preparing oral administration compositions of abiraterone acetate. It would have been obvious to formulate the composition of Grahek using the standard, well-known excipient ranges taught by Kocherlakota through routine optimization to achieve a pharmaceutically elegant and effective dosage form.
Response to Arguments
Applicant Arguments/Remarks, filed 11 August 2025, have been fully considered in light of the amended claims. As such, the rejections under 35 U.S.C. § 102 and 103 have been withdrawn based on the newly cited limitations of the amended claims, however new 35 U.S.C. § 103 have been issued.
The Applicant argues that the prior art does not teach or suggest the specific combination of excipients (polyvinylpyrrolidone, polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate) with amorphous abiraterone acetate to achieve improved bioavailability. Applicant contends that Grahek teaches away from amorphous forms due to stability issues and that the secondary references (Legen, Koziol, Kocherlakota) do not fill this gap.
However, the Examiner maintains that the proposed combination is motivated by the prior art. The cited references collectively provide a motivation to combine their teachings. Grahek provides the core invention: an amorphous solid dispersion of abiraterone acetate for improved stability. Angi teaches the use of polyvinylpyrrolidone, polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers (SOLUPLUS) and sodium deoxycholate as suitable excipients in solid dispersions to improve the solubility and dissolution rate of poorly soluble drugs. It would have been obvious to a person of ordinary skill in the art to use SOLUPLUS, a known solubility-enhancing polymer and a known excipient of sodium deoxycholate to improve wetting and dissolution, in the amorphous abiraterone acetate formulations of Grahek to further improve dissolution, thereby achieving the rapid reconstitution/disintegration and release profiles claimed. Combining these known elements with the amorphous solid dispersion of Grahek is an obvious formulation strategy to achieve the claimed rapid release into an aliquot of liquid. A person of ordinary skill in the art, seeking to formulate an amorphous abiraterone acetate dosage form with optimal performance, would be motivated to select and combine excipients known to be effective for amorphous systems from the available arsenal in the art, including those specifically suggested by Grahek and Angi and known from other references like Legen, Koziol, and Kocherlakota for their solubility-enhancing properties.
The Applicant’s argument that Grahek "teaches away" from amorphous forms is a mischaracterization. The invention by Grahek is predicated on amorphous solid dispersions. The observation in Example 17 that one particular amorphous formulation was unstable does not condemn the entire concept; rather, it highlights a routine problem in formulation science that a person of ordinary skill in the art is equipped to solve. Grahek itself provides solutions to this problem, such as the use of antioxidants (a feature also claimed by Applicant). A person of ordinary skill in the art would understand that stability can be optimized through routine experimentation with different polymers and stabilizers, as in the kind of experimentation described in Grahek and the secondary references.
Applicant's arguments regarding improved bioavailability and the "spring and parachute" effect are not commensurate in scope with the claims. The claims are broadly directed to a composition containing the three excipients and amorphous abiraterone acetate. While the specification may show that some embodiments exhibit improved dissolution, the Applicant has not provided comparative data showing that the specific, now-claimed combination of polyvinylpyrrolidone, polyvinylcaprolactam-polyvinyl acetate-polyethylene-glycol graft copolymers and sodium deoxycholate yields unexpectedly superior results compared to the prior art formulations, such as those in Grahek and Angi that use subsets of these components. The observed improvement in bioavailability is attributed to the amorphous state itself, a known phenomenon, and not shown to be unexpectedly enhanced by this specific ternary excipient combination. Therefore, the results are considered to be the predictable outcome of applying known formulation principles and unexpected results have not been shown for the claimed combination.
In conclusion, the arguments regarding patentability over the prior art are not persuasive. The combination of Grahek and Angi with Legen, Koziol, and/or Kocherlakota provide clear reasoning with a rational underpinning for the claimed invention. The claimed subject matter represents the predictable use of known excipients in a known type of formulation (i.e., amorphous solid dispersion) for a known drug, to achieve a known and expected result of improved solubility and dissolution.
Support for a prima facie case of obviousness, based on facts gleaned from the prior art, including all of the limitations of newly amended claims has been established. Further, "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." (In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981)). As such, the argument is not persuasive. Accordingly, the Examiner has reconsidered all of the rejections, in light of the amended claims and provided arguments and remarks, new rejections of claims under 35 U.S.C. § 103 have been issued.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (87 CFR 1.17(a)) 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615