Some Natural Phenomena are Better than Others: How which Natural Phenomenon a Claim is Directed to Influences Alice Step 2

October 16, 2019

In patents for diagnostic methods, which natural phenomena the patent is directed to may be just as important as whether it is directed to a natural phenomenon at all. A January 2019 decision of the Patent Trial and Appeal Board (PTAB) suggests that which natural phenomena a court determines the patent claim is directed to under Alice step one could have significant implications for Alice step 2. The Board’s decision in Ex parte Lee stands in contrast to the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. And comparing the two side-by-side reveals that patent applicants have an incentive to not only argue whether their patent is directed to a natural phenomenon, but also to which natural phenomena it is directed.

Ex Parte Lee
 concerned an appeal from the Examiner’s determination that the diagnostic claims were patent ineligible. Claim 1 of the application was representative and describes:<... Read more

The Flip Side of Reasonable Expectation of Success is Unpredictability

October 11, 2019

The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more

USPTO Proposed Revisions to Rules on Patent Term Adjustment

October 9, 2019

特許期間調整に関する米国特許庁ルールの変更が提案されました

米国の出願審査が特許庁の遅延により極端に遅れた場合、その遅れの日数分だけプラスアルファで特許期間を長くするよう調整されます。一方で、出願人が期限延長を行うなど、自ら遅れの原因を作ってしまった場合、プラスアルファで長くなった日数分から出願人の遅延分が差し引かれることになります。このような特許期間調整(Patent Term Adjustment, PTA)により特許期間が1日でも長くなるとビジネス上大きなメリットとなり得るため、PTAを自ら減らすことのないよう拒絶応答を進めることが大事です。

先週10月4日付のFederal Registerにおいて米国特許庁は、PTAの計算方法に関する特許庁ルールの変更を提案しました。これは、今年1月のSupernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019)の判決内容に沿ってルールを変更することを目的としています。

Supernus事件では、出願人の遅延("a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application")によりPTAが差し引かれる際の日数の数え方が争点になりました。関係するのは37 CFR 1.704(c)(8)で、現行のルールは下記の通りです。<... Read more

Prior Art Introduced During Prosecution Has Important Implications for 101 Challenges

September 19, 2019

Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.... Read more

Prosecution History Estoppel And Amendments Tangential To Patentability

September 17, 2019

The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more

Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

Specification Must Adequately Disclose the Claimed Invention to Avoid Invalidation for Lack of Written Description

September 9, 2019

Drs. Stephen Quake and Christina Fan ("Quake") appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") finding the four claims of Quake's U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.... Read more

Thinking Outside the (Utility Patent) Box – Don't Overlook Design Patent Protection in the Life Sciences

August 30, 2019

Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined in scope by the content of the drawings rather than the words of a set of claims. Further, design patents have a 15 year term, as opposed to 20 years from filing for utility patents.... Read more

Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure

August 16, 2019

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more

Argument with Emphasis on "Particular" Combination of Salts Invoked Prosecution History Estoppel

August 16, 2019

 「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言(審査経過に基づくエストッペル)が適用された事例<... Read more