Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 11
`Entered: February 16, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`GALDERMA LABORATORIES, INC.,
`Patent Owner.
`_______________
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`_______________
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 11
`Entered: February 16, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`GALDERMA LABORATORIES, INC.,
`Patent Owner.
`_______________
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`_______________
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2015-01778
`Patent 8,603,506 B2
`
`
`
`
`INTRODUCTION
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “Petitioner”) filed a Petition (Paper 1; “Pet.”) to institute an
`inter partes review of claims 1, 7, 8, 14, 15, and 20 of US 8,603,506 B2 (Ex.
`1001; “the ’506 patent”). Galderma Laboratories Inc. (“Patent Owner”)1
`filed a Patent Owner Preliminary Response. Paper 8 (“Prelim. Resp.”). We
`have jurisdiction under 35 U.S.C. § 314.
`For the reasons provided below, we determine Petitioner has not
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of at least one challenged claim of the ’506 patent. See 35
`U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.
`
`a. Related Proceedings
`Petitioner indicates that the ’506 patent has been asserted in the
`United States District Court for the District of Delaware (Civil Action No.
`15-670). Pet. 2; Paper 6, 2.
`In addition to the case before us, Petitioner has requested inter partes
`review of claims 1, 7, 8, 14, 15, and 20 of US 8,603,506 B2 on other
`grounds in Case Nos. IPR2015-01777 and IPR2015-01782.
`
`
`1 Petitioner further indicates that the Complaint in Civil Action No. 15-670
`states that Nestlé Skin Health S.A. is now the owner of the ’506 patent. Pet.
`2, n.1. Although Patent Owner does not directly address this assertion in the
`Preliminary Response, the USPTO Assignment Database indicates that
`patent is assigned to Galderma Laboratories, Inc. Absent additional
`information, we refer to Galderma Laboratories, Inc. as the Patent Owner.
`
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`
`b. The ’506 Patent
`The ’506 patent is directed to the treatment of “all known types of
`acne,” broadly defined as “a disorder of the skin characterized by papules,
`pustules, cysts, nodules, comedones, and other blemishes or skin lesions.”
`Ex. 1001, 4:23–32. The genus “acne” is expressly defined as encompassing
`acne rosacea (“rosacea”),2 a skin disorder “characterized by inflammatory
`lesions (erythema) and permanent dilation of blood vessels (telangectasia).”
`Id. at 4:31–43. The specification further states the “[t]he present invention is
`particularly effective in treating comedones.” Id. at 4:23–43.3
`By way of background, the ’506 patent discloses that the efficacy of
`systemically-administered tetracycline compounds in the treatment of acne
`is commonly believed to be due, “in significant part, to the direct inhibitory
`effect of the antibiotics on the growth and metabolism of [] microorganisms”
`that “release microbial mediators of inflammation into the dermis or trigger
`the release of cytokines from ductal keratinocytes.” Ex. 1001, 1:42–50. In
`addition to these antibiotic effects, the specification also notes that
`tetracyclines may have therapeutic anti-inflammatory effects due to, for
`example, the “inhibition of neutrophil chemotaxis induced by bacterial
`chemotactic factors,” the “inhibition of [polymorphonuclear leukocyte]
`derived collagenase, and by scavenging reactive oxidative species produced
`by resident inflammatory cells.” Id. at 2:21–32, 3:14–25.
`
`
`2 The parties agree that the term “acne rosacea” in the specification refers to
`rosacea. Pet. 30–31; Prelim. Resp. 15–16.
`3 Petitioner asserts, and Patent Owner does not contest, that comedones are
`not a feature of rosacea. Pet. 9, 25; see Prelim. Resp. 23–24; Ex. 1004 ¶ 13.
`
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`The ’506 patent teaches that although tetracyclines are administered in
`conventional antibiotic therapy, antibiotic doses of these compounds can
`result in undesirable side effects such as the reduction or elimination of
`healthy microbial flora and the production of antibiotic resistant
`microorganisms. Id. at 3:7–17, 3:31–36. To address the need for effective
`treatments that minimize these side effects, the ’506 patent discloses that “all
`known types of acne” may be treated by administering a tetracycline
`compound in an amount having “substantially no antibiotic activity (i.e.
`substantially no antimicrobial activity)” and, thus, “does not significantly
`prevent the growth of . . . bacteria.” Id. at 3:37–50; 4:31–32; 5:31–35. The
`’506 patent defines “effective treatment” as “a reduction or inhibition of the
`blemishes and lesions associated with acne” (id. 5:31–33), which may be
`achieved by administering non-antibiotic tetracycline compounds (i.e., those
`lacking substantial antibiotic activity) or by using sub-antibiotic doses of
`tetracycline compounds having known antibiotic effects (see, e.g., id. at
`3:26–29, 4:58–61, 5:1–9, 5:35–42). With respect to the latter, the
`specification indicates that a sub-antibiotic dose may comprise “10–80% of
`the antibiotic dose,” or “an amount that results in a serum tetracycline
`concentration which is 10–80% of the minimum antibiotic concentration.”
`Id. at 5:36–42; 6:7–12.
`The specification teaches that, whereas exemplary antibiotic doses of
`tetracycline compounds include 50, 75, and 100 milligrams per day of
`doxycycline, in an especially preferred embodiment, doxycycline (as
`doxycycline hyclate) is administered as a 20 milligram dose, twice daily. Id.
`at 5:43–45; 5:59–63. The specification teaches that this 40 milligram per
`day dose provides the maximum non-antibiotic (i.e., sub-antibiotic) of
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`doxycycline based on steady-state pharmacokinetics. Id. at 5:49–52. In
`terms of serum concentration, doxycycline may also be administered in an
`amount that results in a serum concentration between about 0.1 and 0.8
`μg/ml. Id. at 6:29–32.
`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. Id. at
`19:54–55; 20:24–32. The six-month doxycycline treatment “resulted in no
`reduction in skin microflora . . . nor an increase in resistance counts when
`compared with placebo.” Id. at 20:33–37; see id. at 5:64–6:4.
`
`c. Representative Claim
`Claim 1 of the ’506 patent recites:
`
`1. A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising
`administering orally to said human doxycycline, or a
`pharmaceutically acceptable salt thereof, in an amount
`that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 10-80% of a 50 mg dose of doxycycline per day; and
`(iii) results in no reduction of skin microflora during a six-month
`treatment, without administering a bisphosphonate compound.
`
`
`4 Petitioner asserts that Example 38 is directed to treating common acne
`(acne vulgaris), presumably based on inclusion criteria requiring the
`presence of comedones, non-inflammatory lesions which are not a symptom
`of rosacea. See Pet. 9, 23, 25; Ex. 1001, 1:20, 19:54; Ex. 1004 ¶ 13. Patent
`Owner does not dispute this characterization. See Prelim. Resp. 21.
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`The remaining asserted claims recite “an amount [of doxycycline]
`which provides a serum concentration in the range of about 0.1 to about 0.8
`μg/ml” (claims 7, 14, and 20), “40–80% of a 50 mg dose of doxycycline per
`day” (claim 8), and “doxycycline, or a pharmaceutically acceptable salt
`thereof, in an amount of 40 mg per day” (claim 15).
`
`d. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability.
`Claims challenged
`
`Basis
`§ 102
`
`Reference
`Ashley ’5725
`
`1, 7, 8, 14, 15, and 20
`
`1, 7, 8, 14, 15, and 20
`
`1, 7, 8, 14, 15, and 20
`
`1, 7, 8, 14, 15, and 20
`
`§ 103
`
`§ 103
`
`§ 102
`
`Ashley ’572
`
`Ashley ’2676
`
`OREACEA7
`
`ANALYSIS
`a. The ’506 Priority Documents
`The ’506 patent issued from a chain of continuation and divisional
`applications (collectively, “non-provisional parent applications”) first filed
`on April 5, 2002. Ex. 1001. More specifically, the ’506 patent issued from
`Application No. 13/277,789, filed October 20, 2011, which, as set forth on
`column 1 of the patent,
`is a continuation of U.S. application Ser. No. 11/876,478, filed
`on Oct. 22, 2007[,] now U.S. Pat. No. 8,052,983, allowed, which
`is a continuation of U.S. application Ser. No. 10/757,656, filed
`
`5 Ashley, US 7,232,572. Ex. 1020.
`6 Ashley, US 7,211,267. Ex. 1016.
`7 ORACEATM, Physicians’ Desk Reference (61st ed. 2007), available at
`http://www.pdr.net. Ex. 1043.
`
`6
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`on Jan. 14, 2004, abandoned, which is a divisional application of
`U.S. application Ser. No. 10/117,709, filed on Apr. 5, 2002, now
`U.S. Pat. No. 7,211,267, which claims the benefit of U.S.
`Provisional Application No. 60/281,916, filed Apr. 5, 2001, and
`U.S. Provisional Application No. 60/325,489, filed Sep. 26,
`2001.
`
`As illustrated in the flow chart on page 12 of Patent Owner’s
`Preliminary Response, Ashley ’267 issued from the earliest non-provisional
`application in this chain, whereas Ashley ’572 issued from a related, non-
`priority application. Petitioner contends that Ashley ’267, Ashley ’572, and
`ORACEA qualify as prior art because the challenged claims of the ’506
`patent lack written descriptive support in the non-provisional parent
`applications and are, therefore, not entitled to claim the benefit of the filing
`date of those applications under 35 U.S.C. § 120. Pet. 5–6.
`The parties do not dispute that the’506 patent and the non-provisional
`parent applications share substantially the same specification. Indeed,
`Petitioner cites to the ’506 patent in arguing that the non-provisional parent
`applications fail to provide written descriptive support for the challenged
`claims. See, e.g., Pet. 22; Prelim. Resp. 12. Accepting that the ’506 patent
`is representative of the disclosure in these earlier-filed applications, we
`adopt Petitioner’s convention of citing to the ’506 patent as a surrogate for
`the specification of any of the non-provisional parent applications.
`Patent Owner argues that Petitioner’s attack on the written descriptive
`support in the priority documents should be rejected as a thinly-veiled
`attempt to circumvent 35 U.S.C. § 311(b), which permits inter partes review
`“only on a ground that could be raised under section 102 or 103.” See
`Prelim. Resp. 39–42. Although recognizing that “the Board has the
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`authority to determine priority entitlement . . . where there is legitimate
`intervening prior art,” Patent Owner contends that this authority is cabined
`to situations where the priority documents do not share the same
`specification with the challenged patent. Prelim. Resp. 39 (citations
`omitted). We do not find Patent Owner’s distinction persuasive; nor is this a
`matter of first impression. See Bioactie Labs. v. BTG Int’l Inc., Case
`IPR2015-01305 (PTAB Dec. 15, 2015) (Paper 19) (finding that Petitioner
`failed to demonstrate that parent application having same specification as
`challenged patent lacked written descriptive and enablement support with
`respect to challenged claims). Accordingly, we address the substance of
`Petitioner’s priority challenge.
`
`b. Claim Construction
`In an inter partes review, the Board interprets a claim term in an
`unexpired patent according to its broadest reasonable construction in light of
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In
`re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1278–81 (Fed. Cir. 2015),
`cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 84 U.S.L.W. 3218
`(U.S. Jan. 15, 2016) (No. 15-446). Under that standard, and absent any
`special definitions, we assign claim terms their ordinary and customary
`meaning, as would be understood by one of ordinary skill in the art at the
`time of the invention,8 in the context of the entire patent disclosure. In re
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). And
`
`
`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. 5; Pet. 36 (both quoting Ex. 1004 ¶ 11).
`
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`“[a]lthough an inventor is indeed free to define the specific terms used to
`describe his or her invention, this must be done with reasonable clarity,
`deliberateness, and precision. ‘Where an inventor chooses to be his own
`lexicographer and to give terms uncommon meanings, he must set out his
`uncommon definition in some manner within the patent disclosure’ so as to
`give one of ordinary skill in the art notice of the change.’” In re Paulsen, 30
`F.3d 1475, 1480 (Fed. Cir. 1994) (citation omitted). “In such cases, the
`inventor’s lexicography governs.” Phillips v. AWH Corp., 415 F.3d 1303,
`1316 (Fed. Cir. 2005) (en banc). Only terms which are in controversy need
`to be construed, however, and then only to the extent necessary to resolve
`the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999). For this reason, we provide express constructions for
`only the following terms.
`
`i. Rosacea
`The parties agree that the ’506 patent identifies rosacea (“acne
`rosacea”) as a form of acne. Pet. 30–31; Prelim. Resp. 7. Although
`Petitioner contends that one of ordinary skill in the art would not classify
`rosacea as a form of acne (Pet. 22; Ex. 1004 ¶¶ 12, 13), we apply the
`inventor’s clearly expressed definition that “acne include[s] . . . acne
`rosacea” (Ex. 1001 4:31–41). With respect to the symptoms of rosacea,
`however, neither party contends that uncommon meanings apply. Pet. 30–
`31; Prelim. Resp. 6–8. We therefore construe rosacea as a form of acne
`having symptoms including papules, pustules, erythema, and telangiectasia,
`where the predominant lesions are papules and pustules. See Ex. 1001,
`4:23–43; Ex. 1004, ¶¶ 7, 19 (“‘The predominant lesions [in rosacea] are
`papules and pustules.’ ([Ex. 1056] at 680; see also Exh. 1046, at 852, 958;
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`Exh. 1047, at 1023, 1175.).”
`
`ii. Papules and Pustules
`The ’506 patent does not define the terms “papules” and “pustules” as
`other than as “[i]nflammatory lesions” or blemishes of the skin. See Ex.
`1001, 3:17–19, 4:24–27, 19:54–55. Patent Owner argues that papules and
`pustules should be accorded their plain and customary meanings. Prelim.
`Resp. 8–9. Petitioner does not expressly suggest a meaning for these terms
`but points to its expert’s statement that “‘[a] papule is a small, solid, elevated
`lesion . . . smaller than 1 cm in diameter, and the major portion of a papule
`projects above the plane of the surrounding skin,’” whereas, “‘[a] pustule is
`a circumscribed, raised lesion that contains a purulent exudate. . . . Pus,
`composed of leukocytes, with or without cellular debris, may contain
`bacteria or may be sterile . . . .’” Pet. 31–32; Ex 1004 ¶ 19 (both quoting Ex.
`1056, 27, 31). Petitioner contends that “[t]hese definitions align well with
`those provided by applicant during prosecution.” Id. at 31 (citing Ex. 1070,
`6).
`
`In view of the above, and applying the broadest reasonable definition
`consistent with the specification, we interpret “papules and pustules” as
`inflammatory lesions or blemishes of the skin, where “papules” are solid,
`rounded bumps rising from the skin that are each usually less than 1
`centimeter in diameter, and “pustules” are small, inflamed, pus-filled,
`blister-like lesions of the dermis or epidermis.
`
`c. Written Descriptive Support in the Continuation Applications
`
`i. “A method for treating papules and pustules of rosacea”
`In contending that the parent applications lack written descriptive
`support for treating papules and pustules of rosacea, Petitioner notes that
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`rosacea is only mentioned twice in the specification and using the
`“antiquated and outdated term,” acne rosacea. Pet. 22. And although
`common acne (acne vulgaris) and rosacea are both skin conditions involving
`inflammatory papules and pustules, “no dermatologists of ordinary skill in
`the art would have lumped them together in a single genus as types of
`‘acne.’” Id. Moreover, Petitioner argues, among the symptoms the ’506
`patent attributes to acne generally, comedones are not symptomatic of
`rosacea, whereas papules and pustules “are only mentioned in connection
`with treating acne vulgaris in Example 38 . . . and once again in a list of
`possible symptoms characterizing the genus in ‘acne.’” Id. at 23 (citations
`omitted).
`We do not find Petitioner’s arguments persuasive. As an initial
`matter, we note that Petitioner has not established that the term “acne
`rosacea” was “antiquated and outdated” as of the earliest filing date of the
`chain of applications leading to issuance of the ’506 patent. Nor does
`Petitioner establish that one of ordinary skill in the art would not have
`understood that term to indicate rosacea—a condition commonly known to
`encompass inflammatory papules and pustules, albeit not comedones. See
`Pet. 22; Prelim. Resp. 18–19; Ex. 1004 ¶ 13; Ex. 1034, 144.
`To the extent a dermatologist would not, as Petitioner argues, “have
`lumped [acne vulgaris and rosacea] together in a single genus,” does not
`persuade us that written description is lacking. An inventor may choose to
`be his own lexicographer and give terms uncommon meanings if “done with
`reasonable clarity, deliberativeness, and precision.” See In re Paulsen, 30
`F.3d 1475, 1480 (Fed. Cir. 1994). In the present case, we find no ambiguity
`in the ’506 patent’s definition of the invention as directed to the treatment of
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`“all known types of acne,” including both acne vulgaris and rosacea. See
`Ex. 1001, 4:31–43.
`The ’506 patent characterizes the genus acne as “a disorder of the skin
`characterized by papules, pustules . . . and other blemishes or skin lesions,”
`and notes that rosacea evinces specific characteristics of “inflammatory
`lesions (erythema) and permanent dilation of blood vessels (telangiectasia).”
`Id. at 4:23–30, 41–43. We are not persuaded that written description is
`lacking because not all of the symptoms attributed to the genus acne apply to
`rosacea, or that a symptom specific to rosacea (i.e, telangiectasia) may only
`be treated surgically. See Pet. 23. Rather, we find it sufficient that the
`specification teaches the treatment of papules and pustules of the genus
`“acne”—expressly defined by the inventor as including rosacea.
`We also agree with Patent Owner’s position that Example 38 of the
`’506 patent further supports the treatment of papules and pustules of rosacea.
`See Prelim. Resp. 20. Example 38 discloses that a six-month treatment with
`20 mg doxycycline, twice daily, resulted in a statistically significant
`reduction in inflammatory lesions (defined as “papules and pustules, less
`than or equal to 5 nodules”) as compared to placebo. Ex. 1001, 19:37–2037.
`Petitioner contends that Example 38 fails to support the treatment of
`papules and pustules of rosacea because it is directed to the treatment of
`acne vulgaris, rather than rosacea. See Pet. 23. We do not find this logic
`compelling, particularly in view of Petitioner’s admissions regarding the
`commonality of papules and pustules in the two conditions. Petitioner
`admits that acne vulgaris and rosacea are both skin conditions involving
`inflammatory papules and pustules (Pet. 22); that such “[p]apules and
`pustules are extremely common to both common acne (acne vulgaris) and
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`rosacea (as well as other skin disorders)”; and that “the resulting papules and
`pustules in both diseases share common underlying properties in that they
`are inflammatory in nature” (id. at 32; Ex. 1004, ¶ 19).
`We find the above admissions sufficient to support our conclusion. In
`addition, Petitioner’s statements regarding the correlation between the
`papules and pustules of common acne and rosacea are further underscored in
`Petitioner’s Paragraph IV Notice Letter to Galderma Laboratories L.P.
`(“Letter”) indicating that Petitioner sought FDA approval to market a
`proposed 40 mg doxycycline product for use in treating inflammatory
`lesions of rosacea. Ex. 2005.9 According to the Letter, “the prior art and the
`disclosure of the ’506 Patent itself, makes the correlation between acne and
`rosacea indisputable.” Ex. 2005, 39. With respect to the ’506 Patent, the
`Letter further states that “the specification defines acne as a genus
`encompassing the species acne vulgaris and acne rosacea . . . [,] discusses
`the papules and pustules of acne as incorporating both inflammatory and
`infectious symptoms, and similarly notes that rosacea is also accompanied
`with inflammatory lesions, among other symptoms.” Id. Moreover, the
`Letter contends, “the prior art is replete with statements made concerning the
`similarities between the inflammation accompanying acne and the
`inflammation accompanying rosacea,” and “makes it quite clear that the
`papules and pustules of both acne and rosacea are inflammatory in nature
`
`
`9 Letter from Petitioner to Chief Executive Officer, Galderma Laboratories
`L.P. titled, “Notice of Paragraph IV Certification Re Dr. Reddy’s
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.’s Doxycycline
`Capsules 40mg; U.S. Patent Nos. 7,211,267; 7,232,572; and 8,603,506”
`(June 22, 2015).
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`and should be treated in the same way.” Id. at 38–39.
`In view of the above, we find that Petitioner does not persuade us that
`the non-provisional parent applications lack descriptive support for the
`treatment of papules and pustules of rosacea as set forth in the asserted
`claims of the ’506 patent.
`
`ii. “A method for treating papules and pustules of rosacea .
`. . comprising administering . . . doxycycline, or a
`pharmaceutically acceptable salt thereof”
`Petitioner argues further the parent applications lack written
`descriptive support for administering doxycycline as recited in the claimed
`method. Specifically, Petitioner asserts that “nothing in the specification . . .
`point[s] a dermatologist of ordinary skill in the art to select doxycycline
`from at least hundreds of identified compounds and to do so when treating
`not just rosacea, but its papules and pustules.” Pet. 25. We do not find this
`argument compelling.
`As discussed above, Petitioner has not demonstrated a lack of support
`for the treatment of papules and pustules of rosacea generally. Nor do we
`find any lack of support for the use of doxycycline for treating “all known
`types of acne,” including rosacea (see Ex. 1001, 4:31–43), which, as
`discussed above, was commonly recognized as involving inflammatory
`papules and pustules. With respect to the use of doxycycline in particular,
`we note that while the specification highlights the use of doxycycline to treat
`comedones (see id. at 4:44–45; 5:59–60; 7:1–4), which are not associated
`with rosacea (Ex. 1004 ¶ 13), it also more generally describes the
`administration of a 20 mg dose of doxycycline hyclate, twice daily, as “an
`especially preferred embodiment” (id. at 5:59–60; see also id. at 4:62–67).
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`Considering the specification as a whole, we do not read the ’506
`patent as directed solely to the treatment of comedones, or types of acne
`characterized by comedones and, accordingly, find that Petitioner has not
`established a lack of written descriptive support for the use of doxycycline to
`treat papules and pustules of rosacea.
`
`iii. “10-80% of a 50 mg dose of doxycycline per day;” “40–
`80% of a 50 mg dose of doxycycline per day;” “40 mg
`per day” “an amount which provides a serum
`concentration in the range of about 0.1 to about 0.8
`μg/ml”
`Petitioner contends also the parent applications lack written
`descriptive support for dosage regimen of doxycycline recited in the claimed
`method. Specifically, Petitioner asserts that “[n]othing in the specification
`teaches the use of any particular amount of an antibiotic or nonantibiotic
`compound to treat rosacea and certainly nothing teaches that one could
`administer, for example, 10-80% of a 50mg dose to treat rosacea’s papules
`and pustules.” Pet. 25–26. Emphasizing the treatment of rosacea rather than
`the disclosure of the doses, per se, Petitioner further argues that “neither of
`the ranges in independent claims 1 and 8 is explicitly taught in the
`specification of the ‘506 Patent or any of its predecessor patents as a proper
`dose of doxycycline to treat papules and pustules of rosacea. The 40mg
`dose of claim 15 is likewise not disclosed for the treatment of papules and
`pustules of rosacea.” Pet. 28. As discussed above, however, Petitioner has
`not established a lack of written descriptive support for the use of
`doxycycline to treat papules and pustules of rosacea.
`With respect to the specific amounts of doxycycline recited in the
`challenged claims, Petitioner merely states that, “where the specification
`
`15
`
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`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`does discuss various dosage levels, there are contradictory statements as to
`which are antibiotic and which are nonantibiotic (which also creates
`confusion around the claim element in claims 1, 8, and 15 concerning the
`effect on skin microflora. (See Exhs.1004 ¶¶ 20, 21, 22, 23; 1001 col.5 ll.
`38–40, 43–44, 54–58.)” Pet. 28. We note that the specification describes
`antibiotic doses of doxycycline as including 50 milligrams per day (Ex.
`1001, 5:43–45); the maximum non-antibiotic dose of doxycycline as 40
`milligrams per day, i.e., 20 milligrams, twice daily (id. at 5:49–51); and that
`a six-month treatment with this maximum non-antibiotic dose “resulted in
`no reduction in skin microflora” (id. at 20:33–35). Absent any further
`explanation of the alleged contradictions and confusion, we find that
`Petitioner has not established a lack of written descriptive support for the use
`of the claimed doses.
`
`iv. “Administering . . . doxycycline, or a pharmaceutically
`acceptable salt . . . without administering a bisphonate
`compound”
`Petitioner recognizes that column 3, lines 46–50 of the specification
`expressly teaches administration of “a tetracycline compound in an amount
`that is effective to treat acne but has substantially no antibiotic activity (i.e.
`substantially no antimicrobial activity), without administering a
`bisphosphonate compound.” Pet. 29; see also Ex. 1001 at 8:14–15 (“[T]he
`tetracycline compounds are administered without administering a
`bisphosphonate compound.”). Despite these express teachings, Petitioner
`contends that the limitation “without administering a bisphonate compound,”
`is without written descriptive support because the specification provides no
`reason to exclude a bisphonate compound. Pet. 28–29 (citing Santarus, Inc.
`
`16
`
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`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012) (“Negative claim
`limitations are adequately supported when the specification describes a
`reason to exclude the relevant limitation.”)). Petitioner’s argument is
`premised on a reading of Santarus that would require the specification to
`detail the benefits of a negative limitation. The Federal Circuit, however,
`has since clarified that Santarus did not articulate such a new and heightened
`standard for negative claim limitations:
`When viewed in its proper context, Santarus simply reflects
`the fact that the specification need only satisfy the requirements
`of § 112, paragraph 1 as described in this court’s existing
`jurisprudence,
`including
`through compliance with MPEP
`§ 2173.05(i) (“If alternative elements are positively recited in the
`specification, they may be explicitly excluded in the claims.”)
`and In re Johnson, 558 F.2d at 1018 (“It is for the inventor to
`decide what bounds of protection he will seek.”).
`Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015).
`Accordingly, we find that Petitioner has not demonstrated a lack of written
`description for this term.
`
`CONCLUSION
`Petitioner does not convince us that non-provisional parent
`applications of the ’506 patent (as represented by the specification of the
`’506 patent) fail to provide adequate written descriptive support for the
`challenged claims. Accordingly, we do not agree with Petitioner’s
`contention that the ‘506 patent is not entitled to the benefit of the April 5,
`2002, filing date of the earliest of those applications under 35 U.S.C. § 120
`such that Ashley ’572, Ashley ’267, and/or ORACEA would qualify as prior
`
`17
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`Case IPR2015-01778
`Patent 8,603,506 B2
`
`art.10 Consequently, Petitioner has failed to establish a reasonable likelihood
`that it would prevail in showing that claims 1, 7, 8, 14, 15, and 20 are
`unpatentable in view of the asserted references.
`
`ORDER
`
`Accordingly, it is
`ORDERED that the Petition is denied as to all challenged claims of
`the ’506 patent.
`
`
`
`
`
`
`
`
`10 Accordingly, we need not reach Patent Owner’s argument that the Board
`should deny the Petition because the same or substantially the same
`arguments were previously considered by the Office. See Prelim. Resp. 42–
`45.
`
`18
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`Case IPR2015-01778
`Patent 8,603,506 B2
`
`
`PETITIONER:
`William L. Mentlik
`Michael H. Teschner
`Brian R. Tomkins
`Maegan A. Fuller
`LITTENBERG, KRUMHOLZ & MENTLIK, LLP
`WMentlik.ipr@ldlkm.com
`MTeschner.ipr@ldlkm.com
`BTomkins.ipr@ldlkm.com
`MFuller.ipr@ldlkm.com
`
`
`PATENT OWNER:
`
`Stephen Maebius
`Sujnit Talapatra
`Michael Houston
`FOLEY & LARDNER LLP
`smaebius@foley.com
`stalapatra@foley.com
`mhouston@foley.com
`
`Gerald Flattmann
`PAUL HASTINGS LLP
`geraldflattmann@paulhastings.com
`
`
`19
`
`
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