Life Science Patenting to Iancu – “We need help too!”

In his remarks presented at the recent 10th Annual Patent Law & Policy Conference at Georgetown University Law School, USPTO Director Andrei Iancu outlined the analytical framework for the new, eagerly awaited, PTO Guidance on patent eligible subject matter. Although his remarks touched on the judicial exception for claims directed to “pure discover[ies] of nature, like gravity or electromagnetism, and mentioned technologies such as computer viral screening and methods of medical treatment, the focus of his remarks was on the patent eligibility of “prohibited abstract ideas.”

He defined abstract ideas as falling into one of three categories: 1) mathematical concepts, 2) certain methods of organizing human interactions… [such as] advertising, marketing and sales activities [e.g., Bilski or Alice] and 3) mental processes, “which are concepts performed in the human mind, such as forming an observation, evaluation, judgment or opinion.” Director Iancu then focused on the overriding importance of determining whether or not a claim is simply directed to a judicial exception or is “a practical application of otherwise excluded subject matter….for example, we should be able to differentiate between [a claim drawn to] electromagnetism itself, on one hand, [and claims to] toys that communicate with each other using electromagnetic signals, on the other.” Not surprisingly, he cited Diehr approvingly.

His proposed analytical framework for examiners attempting to resolve the s. 101 question is first, to “look to see if the claims fall within the four statutory categories: process, machine, or composition of matter (This is not new, we always do this). If so, examiners then determine if the claims recite subject matter within one of the judicial exceptions, categorized as I just described (This is the new approach.)” If they do not the Examiner moves on to ss. 102, 103 and 112. If they do, the examiners “would assess whether the claims integrate the exception into a practical application of the otherwise excluded material. If so, the claim passes the 101 test and eligibility analysis is concluded.”

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Kumar v. Iancu – The Dangers of an Overstuffed Preamble/Note on 37 CFR Part 4.

Clopidogrel Tablets

On November 7, 2018, the Fed. Cir. issued a summary affirmance of the PTAB’s interference decision of September 6, 2016, in Kumar v. Sung (Patent Interference 14/322,039) which found that the claims of U.S. Pat. No. 8,541,422 were obvious over a single prior art reference. Since the Senior Party had dropped out – its patent was found to be obvious as well – the PTO intervened as the defendant in Kumar’s appeal to the Fed. Cir.

The PTO Brief filed in the appeal is of interest due to the thoroughness of its reasoning that, basically, affirmed breaking the preamble into two “limitations”, one of which gave life to the claim as a method of treatment and one which was ignored as a statement of intended use. The main claim is directed to a method of treating thrombosis with S-oxo-clopidogrel, the active metabolite of clopidogrel (Plavix®). While it was known that S-oxo-clopidogrel was more potent in mice than clopidogrel, the ‘422 patent attempted to claim the use of the metabolite to treat patients that do not respond well to clopidogrel:

  1. A method of [1] reducing or alleviating inter individual platelet response variability and metabolite loading in humans in [2] the treatment or prophylaxis of thrombosis or embolisms [1] observed following the administration of clopidogrel comprising administering to a person in need thereof, a composition containing an effective amount of S-oxo-clopidogrel or [an analog thereof or its salt] [Ed. note: I added the numbers to the preamble and shortened the irrelevant part of the claim.

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Yeda Res. and Dev. v. Mylan – “We don’t need no Stinkin’ Prior Art”

The quote is from “Treasure of the Sierra Madre” when a bandido leader is trying to convince Bogart that his gang are Federales, and Bogie asks to see their badges. In the context of Yeda Res. and Dev. v. Mylan, Appeal no. 2017-1594 et al. (Fed. Cir., October 12, 2018), it summarizes the Fed. Cir. panel’s difficulties in explaining its affirmance of the PTAB decision invalidating Yeda’s patents on a regimen for the administration of Copaxone. I am not going to comment on the merits of the obviousness rejection on appeal here, except to note that there was a lot of prior art in this area and some of it was close to the claimed regimen, which recited, essentially, administering six 40 mg doses over two weeks.

The prior art wasn’t the problem faced by the panel but, rather, that two publications were cited by Mylan’s expert and relied upon to some extent by the district court to support the obviousness rejection. These publications appeared after the filing date of Yeda’s patents and were not prior art under any section of 102. Yeda “cried foul”, arguing that the PTAB violated s. 311(b) by relying on these non-prior art publications.

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The Abstract Idea Defense in a Patent Infringement Suit Jumped the Shark in Nike v Puma

Jumped the SharkGuest Post from Janal Kalis.

Nike sued Puma for infringing its fly knit shoes.  Puma filed a motion to dismiss because the patents asserted by Nike are directed to an abstract idea.  As can be seen below, the Nike claims clearly are directed to a SHOE!!!!  The judge in the case denied Puma’s motion this week.  A bit of sanity in a patent world gone mad.

9078488:

  1. An article of footwear including an upper and a sole structure attached to the upper, the upper incorporating a knitted component formed of unitary knit construction, the knitted component comprising: at least one lenticular knit structure including a first portion and a second portion disposed on opposite sides of the lenticular knit structure; and a base portion disposed adjacent to the at least one lenticular knit structure; wherein the at least one lenticular knit structure extends away from the base portion on an exterior surface of the upper; and wherein the first portion of the at least one lenticular knit structure is associated with a first visual effect when the upper is viewed from a first viewing angle and the second portion of the at least one lenticular knit structure is associated with a second visual effect when the upper is viewed from a second viewing angle that is different than the first viewing angle.

8266749:

  1. A method of manufacturing an article of footwear, the method comprising: simultaneously knitting a textile element with a surrounding textile structure, the knitted textile element having at least one knitted texture that differs from a knitted texture in the surrounding knitted textile structure; removing the knitted textile element from the surrounding knitted textile structure; incorporating the knitted textile element into the article of footwear.

7637032:

  1. An article of footwear, comprising: an upper member substantially constructed from textile material, wherein the upper member includes an exterior portion substantially constructed from knitted textile material, the exterior portion including a first region having stability ribs integrally formed in the knitted textile material and a second region continuous with the first region, the second region not including stability ribs; wherein a first portion of the first region extends along a forefoot portion of the exterior portion of the upper member and a second portion of the first region extends along a lateral midfoot side of the exterior portion of the upper member; wherein a portion of the second region extends along a junction between the upper member and the sole member and between the first portion of the first region and the second portion of the first region on a lateral midfoot side of the exterior portion of the upper member; and a sole member engaged with the upper member.

Nike’s response to Puma’s motion.

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