Prior art — US Patent 7713947

As a technical patent analyst, I have searched the USPTO database for US Patent 7713947 and identified its patent citations to determine the most relevant prior art for potential anticipation under 35 U.S.C. § 102.

US Patent 7713947: Cladribine regimen for treating multiple sclerosis

Publication Date: 2010-05-11
Filing Date: 2005-12-20
Priority Date: 2004-12-22

The claims of US7713947 primarily focus on a method of treating multiple sclerosis via oral administration of cladribine, following a specific sequential regimen. This regimen includes:

An induction period with a total cladribine dose of about 1.7 mg/kg to about 3.5 mg/kg.
A cladribine-free period of between about 8 and about 10 months.
A maintenance period with a total cladribine dose lower than the induction dose.
A second cladribine-free period.

Below are the patent citations and their analysis for potential anticipation:

Identified Patent Citations and Anticipation Analysis:

1. US Patent No. 5,506,214

Full Citation: US 5,506,214, titled "Use of substituted adenine derivatives for treating multiple sclerosis", assigned to The Scripps Research Institute.
Publication/Filing Date: Priority Date: 1986-02-03; Publication Date: 1996-04-09.
Brief Description: This patent describes methods for treating multiple sclerosis using 2-chloro-2'-deoxyadenosine (cladribine) and other substituted adenine derivatives. It specifies parenteral (intravenous or subcutaneous) administration. The general regimen involves administering a cumulative dose of 0.1-1.0 mg/kg over 3-10 days, with the possibility of repeating treatment after 30-90 days.
Potential Anticipation under 35 U.S.C. § 102: This patent does not anticipate the claims of US7713947. While it discloses the use of cladribine for multiple sclerosis, it distinctly teaches parenteral (non-oral) administration. Crucially, it does not disclose the specific oral administration or the detailed sequential dosing regimen involving a long cladribine-free period of 8-10 months between induction and maintenance phases, nor the specific dose ranges claimed in US7713947.

2. US Patent No. 4,964,848

Full Citation: US 4,964,848, titled "Treatment of multiple sclerosis with lymphocytapheresis and chemo-immunosuppression", assigned to Bloom Philip M.
Publication/Filing Date: Priority Date: 1988-06-27; Publication Date: 1990-10-23.
Brief Description: This patent describes a method for treating autoimmune diseases, including multiple sclerosis, by combining lymphocytapheresis with chemo-immunosuppressive drugs such as cyclophosphamide, azathioprine, methotrexate, or cyclosporine. It does not involve cladribine as an active agent.
Potential Anticipation under 35 U.S.C. § 102: This patent does not anticipate any claims of US7713947. It relates to an entirely different therapeutic approach involving lymphocytapheresis and alternative immunosuppressive agents, without any mention of cladribine or the specific dosing regimen claimed in US7713947.

3. European Patent No. 0,626,853

Full Citation: EP 0,626,853 B1, titled "Use of substituted adenine derivatives for treating multiple sclerosis", assigned to The Scripps Research Institute.
Publication/Filing Date: Priority Date: 1992-02-19; Publication Date: 2000-04-26.
Brief Description: Similar to US 5,506,214, this patent suggests the use of cladribine for treating multiple sclerosis. Given its identical title and assignee to US 5,506,214, it is understood to cover similar subject matter, likely focusing on parenteral administration routes and associated dosing.
Potential Anticipation under 35 U.S.C. § 102: This patent does not anticipate the claims of US7713947 for the same reasons as US 5,506,214. It does not disclose oral administration or the specific sequential dosing regimen with a long cladribine-free period as claimed in US7713947.

4. International Publication No. WO 2004/087101 A2

Full Citation: WO 2004/087101 A2, titled "Oral formulations of cladribine", assigned to Ivax Corporation.
Publication/Filing Date: Priority Date: 2003-03-28; Publication Date: 2004-10-14. (This publication date precedes US7713947's priority date of 2004-12-22, making it potential prior art).
Brief Description: This publication describes novel pharmaceutical compositions of cladribine, specifically those using a cladribine-cyclodextrin complex, suitable for oral or transmucosal administration. It teaches these formulations enhance the oral bioavailability of cladribine and can be used for treating diseases like multiple sclerosis. The patent discusses various ratios of cladribine to cyclodextrin and general therapeutic administration.
Potential Anticipation under 35 U.S.C. § 102: This patent is highly relevant as it discloses oral formulations of cladribine for treating multiple sclerosis. This satisfies the "oral administration of a formulation comprising cladribine" element found in the claims of US7713947 (e.g., Claim 1, 20, 36). However, for direct anticipation under 35 U.S.C. § 102, a single prior art reference must disclose every element of a claim. WO2004/087101 A2, while enabling oral administration, does not explicitly disclose the entire specific sequential dosing regimen taught in US7713947, which includes a precise induction period total dose (1.7-3.5 mg/kg), a cladribine-free period of 8-10 months, a maintenance period with a lower total dose, and a subsequent cladribine-free period. Therefore, it does not anticipate the method claims of US7713947, as it lacks the disclosure of the complete specific regimen.

5. US Patent Application Publication No. 2010/0021429 A1

Full Citation: US 2010/0021429 A1, titled "Cladribine regimen for treating multiple sclerosis", assigned to Laboratories Serono SA.
Publication/Filing Date: Priority Date: 2006-05-24; Publication Date: 2010-01-28.
Brief Description: This is a US patent application publication with a similar title and assignee (Merck Serono SA, the current assignee of US7713947, was formerly Laboratories Serono SA) to the patent in question. It likely represents a continuation or related application.
Potential Anticipation under 35 U.S.C. § 102: As its earliest priority date (2006-05-24) is after the priority date of US7713947 (2004-12-22), US 2010/0021429 A1 cannot be considered prior art for anticipation purposes under 35 U.S.C. § 102 for US7713947.