The Board issued four decisions denying institution of inter partes review (IPR) in TC 1600 during the week of September 3.  Summaries of the decisions follow.

L’Oréal USA, Inc. (“L’Oréal”) v. University of Massachusetts (“UMass”), IPR2018-00778 and L’Oréal v. UMass, IPR2018-00779 (Decisions Denying Institution, Entered September 7, 2018).  L’Oréal submitted two Petitions challenging claims 1-7 and 9 of U.S. Patent No. 6,423,327 (“the ’327 patent) and claims 1-7 and 9 of U.S. Patent No. 6,645,513 (“the ’513 patent).  Both of the Petitions challenged the patentability of the claims on one ground of anticipation and two grounds of obviousness based on two references: Japanese patent publication No. JP H9-157153 A (“JP ’153”) and German patent publication No. DE 195 45 107 A1 (“DE ’107”).  UMass filed a preliminary response.  Claim 1 of both the ’327 patent and the ’513 patent are directed to methods for “enhancing the condition of unbroken skin” that require a step of “topically applying to the skin a composition comprising a concentration of adenosine…wherein the adenosine concentration” is “applied to the dermal cells” (emphasis added).  In the ’327 patent, the claimed adenosine concentration is “10-4 to 10-7” while the ’513 patent claims require an adenosine concentration of “10-3 to 10-7”.

L’Oréal proposed claim constructions for the limitations recited above.  Regarding the limitation reciting “topically applying to the [unbroken] skin a composition comprising a concentration of adenosine,” the Board adopted L’Oréal’s proposed construction because there was no dispute that a “topical” application to unbroken skin requires application “directly to the outer, epidermal layer of the skin that is intact and does not have any damage, such as wounds or cuts, burns, etc., such that the inner, dermal layer of the skin is not exposed.”

Regarding the limitation relating to the layer of skin to which the claimed adenosine concentration is applied, L’Oréal argued that the limitation should be construed to require the adenosine concentration to be applied to “the unbroken, outer epidermal layer of a region of the skin containing the dermal cells,” whereas UMass argued that the claimed adenosine concentration is applied to the dermal cells themselves.  Siding with the Patent Owner, the Board pointed to the claim language that explicitly requires the claimed adenosine concentration to be “applied to the dermal cells,” not to the outer epidermal layer of a region of the skin as L’Oréal would require.

Consequently, the Board denied institution on all anticipation and obviousness grounds because L’Oréal failed to identify evidence in JP ’153 or DE ’107 reflecting a concentration of adenosine that is applied to dermal cells.

 

Aurobindo Pharma USA Inc. (“Aurobindo”) v. Andrx Corporation (“Andrx”) et al., IPR2018-00530 (Decision Denying Institution, Entered September 5, 2018).  In its petition, Aurobindo challenged claims 1-21 of U.S. Patent No. 6,790,459 (“the ’459 patent”) on a single obviousness ground based on six references: Cheng, Timmins, Wagner, Lewis, Gibaldi, and DeFronzo.  After considering Andrx’s preliminary response, the Board exercised its discretion under 35 U.S.C. §314(a) to decline institution of the (IPR) in this case.

Citing the factors set forth in Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB Sept. 6, 2017) (Paper 19) (precedential) (“General Plastic”), the Board’s decision was influenced by the following facts weighing in favor of its denial:

  • Aurobindo filed a first petition for IPR (the “First Petition”) that challenged the same claims of the ’459 patent seven months prior to filing the petition in this IPR.
  • Aurobindo knew of the Cheng, Timmins, and Lewis references at the time it filed the First Petition because those references were relied upon in the First Petition. And without an explanation from Petitioner, the Board found it reasonable to assume that Petitioner could have found the Wagner, Gibaldi and DeFronzo references through reasonable diligence in its prior searches—and thus should have known of those references.
  • Aurobindo admitted that it used the Board’s decision denying institution of the first IPR as a roadmap to shift its strategy and reformulate its challenge for this IPR.

Aurobindo provided no explanation—other than to address the deficiencies cited in the Board’s denial of the first IPR—as to why they filed this IPR.

The Board emphasized that under General Plastic, Aurobindo’s use of the Board’s previous decision as a roadmap to cure the deficiencies in its first, failed petition is unfair to patent owners and an inefficient use of its resources.  Further sealing the fate of Aurobindo’s petition, the Board invited Aurobindo to request authorization to file a reply to Andrx’s Preliminary Response to address the General Plastic factors, but Aurobindo never took the opportunity to do so.  Thus, the Board found it appropriate to exercise its discretion under 35 U.S.C. §314(a) to deny institution in this IPR.

 

Hologic, Inc. (“Hologic”) v. bioMérieux, Inc. (“bioMérieux”), IPR2018-00567 (Decision Denying Institution, Entered September 4, 2018).  In its petition, Hologic challenged claims 1-15 of U.S. Patent No. 9,047,262 (“the ’262 patent”) on two obviousness grounds based on four references: Backus, Bell, Sooknanan, and Myers.  After considering bioMérieux’s preliminary response, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of both grounds.

Citing the factors set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586 (Paper 8, Dec. 15, 2017) (informative), the Board’s decision was influenced by the following facts weighing in favor of its denial:

  • The Backus and Bell references are listed on the cover of the ’262 patent, and although Backus and Bell were not explicitly relied upon by the Examiner to reject any claims of the ’262 patent, the Backus reference was used to reject similar claims during prosecution of the’262 patent’s parent application and the Bell reference was discussed during interviews held with the Examiner during the prosecution of the’262 patent’s parent application.
  • The Examiner considered substantively the same reference as the Myers reference relied upon by Hologic during the prosecution of the ’262 patent.
  • The Sooknanan reference is cumulative to the prior art evaluated during the examination of the ’262 patent.
  • The Examiner made extensive fact findings related to the Backus, Bell, Sooknanan, and Myers references—even though those findings were taught in other references.
  • The reference the Examiner relied upon as a primary reference during examination of the ’262 patent—Montagnier—was a stronger reference than Myers, and was relied upon by the Examiner for essentially the same reason that Petitioner cites Myers for in this IPR.
  • The Sooknanan reference does not add anything material to the Examiner’s discussion of what was already known in the art.
  • The Petitioner failed to cite or discuss 35 U.S.C. § 325(d) and failed to state whether the Examiner erred in its evaluation of the prior art.
  • The Examiner allowed the claims after bioMérieux narrowed the claims and submitting a Declaration under 37 C.F.R. §1.132—and bioMérieux failed to persuade the Board that the Examiner erred in relying on that declaration or that the Board should reconsider the Examiner’s decision.

Ultimately, the Board exercised its discretion to deny institution under 35 U.S.C. § 325(d) because bioMérieux overcame rejections based on substantially similar arguments to those submitted by Hologic in this IPR, and Hologic failed to persuade the Board that the Examiner erred in its decision to allow the claims over bioMérieux’s evidence.