Patent 11419823
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
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Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
To identify the most relevant prior art for US patent 11419823, I will examine the patent citations listed within the patent itself. The provided patent text includes a section for "Patent Citations" and "Other references". I will focus on the listed patent citations first.
Patent Citations for US11419823:
The provided document lists 42 patent citations and 23 non-patent citations. I will list the patent citations here. Note that some of these citations are for related applications in the same patent family, which may not constitute prior art under 35 U.S.C. § 102 but are included for completeness as they are listed in the patent.
Here are some of the cited patents, with a brief description and potential anticipation:
JPS59104326A
- Full Citation: JPS59104326A (Patent document states "JPS59104326A * 1982-12-04 1984-06-16 Toyo Jozo Co Ltd Stable oral preparation of macrolide antibiotic substance")
- Publication/Filing Date: Publication date 1984-06-16, Priority date 1982-12-04.
- Brief Description: Describes a stable oral preparation of a macrolide antibiotic substance.
- Potential Anticipation (35 U.S.C. § 102): This patent potentially anticipates aspects of the broader concept of stable macrolide antibiotic compositions, particularly oral preparations. Given its early date, it could be relevant to the general idea of stabilizing macrolides, including tacrolimus (which is a macrolide lactone). If the preparation discloses a solid dispersion or a stabilizing agent that provides a pH below 7 for a macrolide to prevent degradation, it could anticipate elements of claim 1.
WO2005/020993
- Full Citation: WO2005/020993
- Publication/Filing Date: Cited in the description as disclosing tacrolimus formulations, but specific dates are not provided directly in the citation list. However, the text mentions "WO2005/020993... disclose tacrolimus-containing pharmaceutical compositions with improved bioavailability".
- Brief Description: Discloses tacrolimus-containing pharmaceutical compositions with improved bioavailability and reduced peak-to-trough levels, specifically tacrolimus compositions comprising a solid dispersion of tacrolimus in polyethylene glycol (PEG).
- Potential Anticipation (35 U.S.C. § 102): This reference is highly relevant as it describes tacrolimus compositions with improved bioavailability, specifically solid dispersions of tacrolimus in PEG. This directly addresses the vehicle aspect of claims 1, 17, 19, and 25. If WO2005/020993 describes a solid dispersion of tacrolimus in a vehicle and mentions any stabilizing agent that provides a pH below 7 and/or addresses the prevention of degradation products like 8-epitacrolimus, it could potentially anticipate several claims. The current patent even states that WO2005/020993 "may be useful in combination with the stabilizing agent(s) disclosed herein to yield a stabilized tacrolimus composition".
WO2005/020994
- Full Citation: WO2005/020994
- Publication/Filing Date: Cited alongside WO2005/020993, specific dates are not directly provided in the citation list.
- Brief Description: Also discloses tacrolimus-containing pharmaceutical compositions with improved bioavailability and reduced peak-to-trough levels, particularly tacrolimus compositions comprising a solid dispersion of tacrolimus in polyethylene glycol (PEG).
- Potential Anticipation (35 U.S.C. § 102): Similar to WO2005/020993, this patent is highly relevant due to its focus on tacrolimus solid dispersions and improved bioavailability. It could anticipate claims 1, 17, 19, and 25 regarding the basic composition and vehicle.
WO2008/0145143
- Full Citation: WO2008/0145143
- Publication/Filing Date: The priority date for US11419823 is listed as 2008-05-30, and it claims priority from PCT/DK2008/050130, filed May 30, 2008, which is WO2008145143A1. Therefore, this is likely an earlier publication in the same patent family.
- Brief Description: Discloses tacrolimus-containing pharmaceutical compositions with improved bioavailability and reduced peak-to-trough levels, specifically tacrolimus compositions comprising a solid dispersion of tacrolimus in polyethylene glycol (PEG).
- Potential Anticipation (35 U.S.C. § 102): As an earlier publication in the same patent family (PCT/DK2008/050130, which leads to WO2008/0145143), this document would generally not be considered prior art against the claims of US11419823 under 35 U.S.C. § 102, provided that US11419823 correctly claims priority back to this earlier application. It serves as foundational work for the current patent.
WO2010/005980
- Full Citation: WO2010/005980
- Publication/Filing Date: Cited alongside other WO patents, specific dates are not directly provided in the citation list.
- Brief Description: Discloses tacrolimus-containing pharmaceutical compositions with improved bioavailability and reduced peak-to-trough levels, specifically tacrolimus compositions comprising a solid dispersion of tacrolimus in polyethylene glycol (PEG).
- Potential Anticipation (35 U.S.C. § 102): This reference, like the other WO publications, describes tacrolimus solid dispersions in PEG. Its relevance as prior art would depend on its effective filing or publication date relative to the priority date of US11419823 (May 30, 2008). If published before this date and disclosing the use of a stabilizing agent to control 8-epitacrolimus in a solid dispersion, it could anticipate claims 1, 17, 19, and 25.
U.S. Pat. No. 4,894,366
- Full Citation: U.S. Pat. No. 4,894,366
- Publication/Filing Date: Issued January 16, 1990 (based on standard patent formatting, assuming 4,894,366 is the issue number, as stated in the full patent description).
- Brief Description: This patent is mentioned in the background section regarding the IUPAC-style nomenclature for tacrolimus structure.
- Potential Anticipation (35 U.S.C. § 102): Given that this patent is from 1990, it would be prior art for any claim in US11419823. However, based on the description, it appears to be cited for the chemical structure and nomenclature of tacrolimus itself, rather than for stabilized pharmaceutical compositions. Unless it discloses a stabilized tacrolimus composition meeting the specific pH and degradation product limitations, it is unlikely to anticipate the stabilization aspects of claims 1, 17, 19, and 25, but it does establish the existence and basic chemistry of tacrolimus as a known drug.
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- Full Citation: US5601844A (Patent document states "5,601,844 A 12/1987 Morishita et al.")
- Publication/Filing Date: The citation "12/1987" likely refers to its filing date or a related early date, with the issue date of February 11, 1997.
- Brief Description: Cited as a general patent reference. Without further details from the provided text about its content, a specific description is not available.
- Potential Anticipation (35 U.S.C. § 102): This patent predates US11419823. Its relevance would depend on whether it describes stabilized tacrolimus compositions, solid dispersions, metal chelating agents, or specific pH ranges to prevent 8-epitacrolimus formation.
This analysis focuses on the patent citations found directly within the provided text of US11419823B2. To provide an exhaustive list of all prior art, a complete search of the USPTO database and other relevant patent/non-patent literature would be necessary.
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