Prior art

To identify the most relevant prior art for US patent 11,839,689 under 35 U.S.C. § 102, we examine the references cited within the patent and consider the patent's priority date of September 11, 2012. We also incorporate relevant information from the previous "Obviousness Analysis" section, which identified US 2014/0100256 A1 as a key prior art reference based on its earlier provisional filing date.

The following prior art documents are analyzed for their potential to anticipate claims 1, 8, and 15 of US 11,839,689.

Most Relevant Prior Art for US Patent 11,839,689

1. U.S. Patent 7,709,517 B2 (Chen et al.)

   • Full Citation: U.S. Patent No. 7,709,517 B2
   • Publication Date: May 4, 2010
   • Brief Description: This patent discloses the chemical compound enzalutamide (also referred to as MDV3100 or RD162) and methods for its use in treating various hyperproliferative disorders, including prostate cancer, breast cancer, and ovarian cancer. It provides the chemical structure of enzalutamide.
   • Potential Anticipation of Claims:
     • Claim 8 (Method of treating prostate cancer): This patent anticipates the general concept of treating prostate cancer with enzalutamide. However, Claim 8 of US 11,839,689 specifies administering "the pharmaceutical composition of claim 1," which includes specific formulation details (amorphous enzalutamide, HPMCAS, and a specific disintegrant concentration). Since US 7,709,517 B2 does not disclose these specific formulation details, it does not anticipate Claim 8 in its entirety under 35 U.S.C. § 102. It serves as prior art for the drug and its therapeutic use, making the use of an improved formulation for this purpose potentially obvious under § 103, but not strictly anticipatory of the specific formulation.

2. WO 2006/124118 A1

   • Full Citation: WO 2006/124118 A1
   • Publication Date: November 23, 2006
   • Brief Description: This international patent application is associated with the initial discovery and therapeutic applications of enzalutamide (MDV3100) as an androgen receptor signaling inhibitor, particularly for treating prostate cancer. It describes the compound and its broad pharmaceutical uses.
   • Potential Anticipation of Claims:
     • Similar to US 7,709,517 B2, this publication discloses the active pharmaceutical ingredient (enzalutamide) and its use in treating prostate cancer. However, it does not disclose the specific amorphous solid dispersion formulation with HPMCAS and the specified disintegrant concentration as required by Claim 1. Therefore, it does not anticipate Claims 1, 8, or 15 of US 11,839,689 under 35 U.S.C. § 102.

3. U.S. Patent Application Publication No. US 2014/0100256 A1 (Lorenz et al.)

   • Full Citation: U.S. Patent Application Publication No. US 2014/0100256 A1
   • Publication/Filing Date: Published April 10, 2014; claims priority to U.S. Provisional Application No. 61/533,702, filed September 12, 2011. The effective prior art date for disclosures supported by this provisional application is September 12, 2011, which precedes the priority date of US 11,839,689 (September 11, 2012).
   • Brief Description: This publication, titled "Formulations of Enzalutamide," describes solid formulations of enzalutamide, specifically focusing on solid amorphous dispersions with concentration-enhancing polymers to improve solubility and absorption. It explicitly names HPMCAS as a suitable polymer. The disclosure details ranges for drug loading (e.g., greater than 50 wt% and less than 70 wt% enzalutamide in the dispersion), the amorphous state of enzalutamide (at least 60% amorphous), and various excipients including disintegrants at specific concentrations in tablet formulations (e.g., 6-10 wt% disintegrant). It also references the use of enzalutamide for treating prostate cancer.
   • Potential Anticipation of Claims:
     • Claim 1 (Solid pharmaceutical composition): US 2014/0100256 A1 explicitly discloses a solid pharmaceutical composition comprising amorphous enzalutamide dispersed in HPMCAS, where at least 60% of the enzalutamide is amorphous (e.g., paragraph). It also describes tablet formulations containing 60% enzalutamide (by weight) in an HPMCAS dispersion (e.g., "60% A:HPMCAS-M dispersion" in paragraph), which when formulated for a 160 mg dose of enzalutamide (160 mg / 0.60 = 266.67 mg dispersion) matches the claimed enzalutamide amount. Furthermore, it explicitly states that such tablets comprise "6 to 10 wt % disintegrant," providing examples with 8 wt% croscarmellose sodium (e.g., paragraphs-). Therefore, US 2014/0100256 A1 appears to explicitly disclose every element of Claim 1, arranged as in the claim, and thus potentially anticipates it.
     • Claim 8 (Method of treating prostate cancer): This publication teaches administering the disclosed compositions (which, as discussed above, include those anticipating Claim 1) for treating hyperproliferative disorders such as prostate cancer (e.g., paragraph). Given that the composition of Claim 1 is potentially anticipated, and the method of using it for its known purpose (treating prostate cancer) is also disclosed, Claim 8 is potentially anticipated.
     • Claim 15 (Solid amorphous dispersion): US 2014/0100256 A1 discloses "a solid amorphous dispersion comprising enzalutamide and HPMCAS" (e.g., abstract, paragraph). It further specifies that "dispersions comprise greater than 50 wt % and less than 70 wt % enzalutamide" (e.g., paragraph), which directly encompasses the claimed range of "55% to 65% by weight." An example of a "60% A:HPMCAS-M dispersion" is also explicitly provided (e.g., paragraph), which falls within this range. Therefore, Claim 15 is potentially anticipated by this publication.