Example 38 of the ’506 patent discloses that in a six-month, placebo- controlled trial for the treatment of acne4 using 20 mg doxycycline hyclate, twice daily, doxycycline-treated patients showed a statistically significant reduction in both comedones and inflammatory lesions (defined as “papules and pustules, less than or equal to 5 nodules”) as compared to placebo.
8 Patent Owner provisionally adopts, as do we, Petitioner’s definition of a person of ordinary skill in the art as “a licensed and practicing dermatologist with as little as one year of treating patients in a hospital, clinical, and/or private setting.” Prelim. Resp. 7; Pet. 25 (both quoting Ex. 1004 ¶ 11).
Golub states that, [i]n several studies on humans, routinely prescribed, antimicrobially-effective doses of tetracyclines ... were found to reduce the collagenase activity in the fluid of the periodontal pocket which originates from the adjacent host tissues.
The current study was carried out to determine whether a newer, semi-synthetic tetracycline, doxycycline, could be administered to humans in a low-dose regimen[,] which would effectively inhibit collagenase activity in the gingival tissue as well as in the crevicular fluid.
Case IPR2015-01782 Patent 8,603,506 B2 tissue type, we note that Golub’s study number one, a “more complex clinical protocol” involving 60 milligrams of doxycycline per day, showed suppressed collagen activity but did not significantly reduce inflammation.