28Nov 2017

Silvia Salvadori - Patent Examiner Withdraws Rejection Due to Impermissible Hindsight {4:18 minutes to read} In a recent decision, Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling based on impermissible hindsight.

Unfortunately, this decision is non-precedential.

The Patent at Issue

The patent at issue was Merck’s U.S. Patent No. 5,989,581, which is listed in the Orange Book for its NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) contraceptive product. Dependent claims 4 and 11 were at issue. Dependent claim 4 is representative.

Dependent claim 4 states: A drug delivery system wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.

The claims of the patent were directed as “a drug delivery system comprising of at least one compartment which comprises….”

Warner Chilcott Co. asserted invalidity of the claims in view of a reference which disclosed a two-compartment vaginal ring and that criticizes one-compartment vaginal rings.

Nevertheless, the district court found the Merck claims to be obvious.

The Federal Court reversed citing KSR:

A patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).

Even if all elements of the claim were known, we still must resolve whether a person of ordinary skill in the art would have found it obvious to combine these elements or modify them in a way that meets the claim.

In making this inquiry, we have cautioned that “the inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight.” Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012).

Thus, it is improper to combine references “like separate pieces of a simple jigsaw puzzle” without “explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place these pieces together.”InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349 (Fed. Cir. 2014).

The court concluded that starting from the teachings of the references—but without the impermissible hindsight—one skilled in the art would have had to use the issued patent as a roadmap.

Moreover, the Federal Circuit also raised the issue of the reasonable expectation of success in going from a two-compartment ring to a one-compartment ring, considering that the reference was teaching away from using a single compartment.

This opinion is very reassuring, since rarely the Examiner withdraws from rejections based on impermissible hindsight. It is important to remember that, even if references can be combined or modified, ”the resultant combination is not obvious unless the results would have been predictable to one of ordinary skill in the art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 538, 417, 82 USPQ2d 1385, 1396 (2007).

It must also be remembered that rejections on obviousness cannot be sustained by mere conclusory statements; instead, the examiner must articulate a reasoning with some rational underpinning to support the legal conclusion of obviousness explaining why a person of ordinary skill in the art would have made the stated modification.

Contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD Silvia Salvadori, PhD

www.salvadorilaw.com

silvia@salvadorilaw.com

(212) 897-1938

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