`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,
`
`Vv.
`
`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
`DenyingInstitution of Inter Partes Review
`37 CFR. § 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 (Paper1; ‘‘Pet.”) to institute an
`inter partes review ofclaims 1, 7, 8, 14, 15, and 20 of US 8,603,506 B2 (Ex.
`1001; “the ’506 patent”). Galderma Laboratories Inc. (“Patent Owner”)!
`
`filed a Patent OwnerPreliminary 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.
`
`' 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 Ownerdoesnot directly addressthis 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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`Case IPR2015-01778
`Patent 8,603,506 B2
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`b. The ’506 Patent
`
`The ’506 patentis directed to the treatmentof“all known types of
`
`acne,” broadly defined as “a disorder of the skin characterized by papules,
`
`pustules, cysts, nodules, comedones, and other blemishesor skin lesions.”
`
`Ex. 1001, 4:23-32. The genus“acne”is expressly defined as encompassing
`acne rosacea (“rosacea”),” a skin disorder “characterized by inflammatory
`lesions (erythema) and permanentdilation of blood vessels (telangectasia).”
`
`Id. at 4:31-43. The specification further states the “[t]he present inventionis
`
`particularly effective in treating comedones.” Jd. at 4:23-432
`
`By way of background, the ’506 patent discloses that the efficacy of
`
`systemically-administered tetracycline compoundsin 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 dermisortrigger
`
`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 [polymorphonuclearleukocyte]
`
`derived collagenase, and by scavenging reactive oxidative species produced
`
`by resident inflammatory cells.” Jd. at 2:21—32, 3:14-25.
`
`2 Theparties agree that the term “acnerosacea”in the specification refers to
`rosacea. Pet. 30-31; Prelim. Resp. 15-16.
`3 Petitioner asserts, and Patent Ownerdoes not contest, that comedonesare
`not a feature of rosacea. Pet. 9, 25; see Prelim. Resp. 23—24; Ex. 1004 § 13.
`
`3
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`The ’506 patent teachesthat 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 ofantibiotic 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” maybe treated by administering a tetracycline
`
`compoundin an amounthaving “substantially no antibiotic activity (i.e.
`
`substantially no antimicrobial activity)” and, thus, “does not significantly
`
`prevent the growth of... . bacteria.” Jd. at 3:37—50; 4:31-32; 5:31-35. The
`
`’506 patent defines “effective treatment” as “a reduction or inhibition of the
`
`blemishes andlesions 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 knownantibiotic 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 amountthat 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 compoundsinclude 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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`Case IPR2015-01778
`Patent 8,603,506 B2
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`doxycycline based on steady-state pharmacokinetics. Jd. at 5:49-52. In
`
`terms of serum concentration, doxycycline may also be administered in an
`amountthat results in a serum concentration between about 0.1 and 0.8
`
`ug/ml. Id. at 6:29-32.
`
`_ Example 38 of the ’506 patent discloses that in a six-month, placebo-
`controlledtrial for the treatment of acne* using 20 mg doxycycline hyclate,
`
`twice daily, doxycycline-treated patients showeda statistically significant
`reduction in both comedonesandinflammatory lesions (defined as “papules
`and pustules, less than or equal to 5 nodules”) as compared to placebo. Jd. 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
`
`comparedwith placebo.” Jd. at 20:33-37; see id. at 5:64-6:4.
`
`c. Representative Claim
`
`Claim 1 of the ’506 patentrecites:
`
`1. A method for treating papules and pustules of rosacea in a
`humanin 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 oninclusion 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
`Ownerdoesnot dispute this characterization. See Prelim. Resp. 21.
`
`5
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`The remaining asserted claimsrecite “an amount[of doxycycline]
`
`which provides a serum concentration in the range of about 0.1 to about 0.8
`
`ug/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
`
`Reference
`
`1,
`
`7,
`
`8,
`
`14,
`
`15, and 20.
`
`1, 7, 8, 14, 15, and 20
`
`1,
`
`7,
`
`8,
`
`14,
`
`15, and 20
`
`§ 102
`
`§ 103
`
`§ 103
`
`Ashley °572
`
`Ashley ’267°
`
`Ashley ’572°
`
`1, 7, 8,
`
`14,
`
`15, and 20
`
`§ 102
`
`OREACEA’
`
`a. The ’506 Priority Documents
`
`ANALYSIS
`
`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
`
`column1 ofthe 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
`
`> Ashley, US 7,232,572. Ex. 1020.
`6 Ashley, US 7,211,267. Ex. 1016.
`7ORACEA™,Physicians’ Desk Reference (61* ed. 2007), available at
`http://www.pdr.net. Ex. 1043.
`
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`Patent 8,603,506 B2
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`on Jan. 14, 2004, abandoned, whichis 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.
`
`Asillustrated 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
`
`ORACEAqualify 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 ofthose 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-provisionalparent
`
`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 ofciting to the °506 patent as a surrogate for
`
`the specification of any of the non-provisional parent applications.
`Patent Ownerarguesthat Petitioner’sattack 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 groundthat could be raised undersection 102 or 103.” See
`
`Prelim. Resp. 39-42. Although recognizing that “the Board has the
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`authority to determinepriority entitlement .
`
`.
`
`. where there is legitimate
`
`intervening priorart,” Patent Owner contendsthat this authority is cabined
`
`to situations wherethe 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; noris this a
`
`matter of first impression. See Bioactie Labs. vy. 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); Jn
`
`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 termstheir ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in theart at the
`
`time of the invention,® in the context of the entire patent disclosure. In re
`
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). And
`
`8 Patent Ownerprovisionally adopts, as do we,Petitioner’s definition of a
`person ofordinary skill in the art as “a licensed and practicing dermatologist
`with aslittle as one year of treating patients in a hospital, clinical, and/or
`private setting.” Prelim. Resp. 5; Pet. 36 (both quoting Ex. 1004
`11).
`
`8
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`“[a]lthoughaninventoris 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 choosesto be his own
`
`lexicographer and to give terms uncommon meanings, he mustset out his
`
`uncommondefinition in some mannerwithin the patent disclosure’ so as to
`
`give one ofordinary skill in the art notice of the change.’” Jn re Paulsen, 30
`
`F.3d 1475, 1480 (Fed. Cir. 1994) (citation omitted). “In such cases, the
`
`inventor’s lexicography governs.” Phillips v. AWH Corp., 415F.3d 1303,
`
`1316 (Fed. Cir. 2005) (en banc). Only terms whichare 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 constructionsfor
`
`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 notclassify
`
`rosacea as a form of acne (Pet. 22; Ex. 1004 J 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 symptomsofrosacea,
`however, neither party contends that uncommon meaningsapply. Pet. 30—
`
`31; Prelim. Resp. 6-8. We therefore construe rosacea as a form of acne
`
`having symptomsincluding papules, pustules, erythema, and telangiectasia,
`
`where the predominantlesions are papules and pustules. See Ex. 1001,
`
`4:23-43; Ex. 1004, {§ 7, 19 (“The predominantlesions [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 statementthat “‘[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,
`
`composedof leukocytes, with or without cellular debris, may contain
`
`bacteria or may besterile... .’” 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.” Jd. 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 bumpsrising 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 methodfor treating papules and pustules ofrosacea”
`
`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 mentionedtwicein the specification and using the
`
`“antiquated and outdated term,” acne rosacea. Pet. 22. And although
`
`commonacne (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 togetherin a single genusas types of
`
`‘acne.’” Jd. Moreover, Petitioner argues, among the symptomsthe ’506
`
`patent attributes to acne generally, comedonesare not symptomatic of
`
`rosacea, whereas papules and pustules “are only mentioned in connection
`
`with treating acne vulgaris in Example 38 .. . and once again inalist of
`
`possible symptomscharacterizing the genusin ‘acne.’” Jd. at 23 (citations
`
`omitted).
`
`Wedo notfind Petitioner’s arguments persuasive. Asaninitial
`
`matter, we note that Petitioner has not established that the term “acne
`
`rosacea” was “antiquated and outdated”as ofthe 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
`understoodthat term to indicate rosacea—a condition commonly knownto
`
`encompassinflammatory 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 meaningsif “done with
`
`reasonableclarity, 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 acneas “a disorder of the skin
`
`characterized by papules, pustules .
`
`.
`
`. and other blemishesor skin lesions,”
`
`and notes that rosacea evinces specific characteristics of “inflammatory
`
`lesions (erythema) and permanentdilation of blood vessels (telangiectasia).”
`
`Id. at 4:23-30, 41-43. Weare not persuadedthat written description is
`
`lacking because notall of the symptomsattributed 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.
`
`Wealso 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 ofrosacea becauseit is directed to the treatment of
`
`acne vulgaris, rather than rosacea. See Pet. 23. We do notfindthis 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 commonto both commonacne(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).
`
`.
`
`Wefind the above admissionssufficient to support our conclusion. In
`
`addition, Petitioner’s statements regarding the correlation between the
`
`papules and pustules of commonacneand rosaceaare 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 productforuse in treating inflammatory
`lesions of rosacea. Ex. 2005.’ 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 acnevulgaris 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.” Jd. 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 “makesit 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 betreated in the same way.” Jd. at 38-39.
`
`In view of the above, wefind that Petitioner does not persuade usthat
`
`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 methodfor treating papules and pustules ofrosacea.
`.. 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 whentreating
`
`not just rosacea, butits papules and pustules.” Pet. 25. We do notfind this
`argument compelling.
`|
`Asdiscussed 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 doxycyclinein particular,
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`wenote that while the specification highlights the use of doxycycline to treat
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`‘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
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`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
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`patent as directed solely to the treatment of comedones,or types of acne
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`characterized by comedonesand, accordingly,find that Petitioner has not
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`established a lack of written descriptive support for the use of doxycycline to
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`treat papules and pustules of rosacea.
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`iii.
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`“10-80% ofa 50 mg dose ofdoxycycline per day,” “40-
`80% ofa 50 mg dose ofdoxycycline per day;” “40 mg
`per day” “an amount which provides a serum
`concentration in the range ofabout 0.1 to about 0.8
`Leg/ml”
`
`Petitioner contendsalso the parent applications lack written
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`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 amountof an antibiotic or nonantibiotic
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`compoundto treat rosacea and certainly nothing teaches that one could
`_
`administer, for example, 10-80% of a 50mgdoseto treat rosacea’s papules
`and pustules.” Pet. 25-26. Emphasizing the treatment of rosacea rather than
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`the disclosure of the doses, per se, Petitioner further arguesthat “neither of
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`the ranges in independentclaims 1! and8is explicitly taught in the
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`specification of the ‘506 Patent or any ofits predecessor patents as a proper
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`dose of doxycycline to treat papules and pustules of rosacea. The 40mg
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`dose of claim 15 is likewise not disclosed for the treatment of papules and
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`pustules of rosacea.” Pet. 28. As discussed above, however, Petitioner has
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`not established a lack of written descriptive support for the use of
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`doxycycline to treat papules and pustules of rosacea.
`
`With respect to the specific amounts of doxycycline recited in the
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`challenged claims, Petitioner merely states that, “where the specification .
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`15
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`Patent 8,603,506 B2
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`does discuss various dosage levels, there are contradictory statementsas to
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`whichare antibiotic and which are nonantibiotic (which also creates
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`confusion around the claim elementin claims 1, 8, and 15 concerning the
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`effect on skin microflora. (See Exhs.1004 §f 20, 21, 22, 23; 1001 col.5 Il.
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`38-40, 43-44, 54-58.)” Pet. 28. We note that the specification describes
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`antibiotic doses of doxycycline as including 50 milligrams per day (Ex.
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`1001, 5:43-45); the maximum non-antibiotic dose of doxycycline as 40
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`milligrams per day,i.e., 20 milligrams, twice daily (id. at 5:49-51); and that
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`a six-month treatment with this maximum non-antibiotic dose “resulted in
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`no reduction in skin microflora”(id. at 20:33-35). Absent any further
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`explanation of the alleged contradictions and confusion, wefind that
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`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 column3, 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
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`bisphosphonate compound.” Pet. 29; see also Ex. 1001 at 8:14—15 (“[T]he
`
`tetracycline compoundsare administered without administering a
`
`bisphosphonate compound.”). Despite these express teachings, Petitioner
`contendsthatthe 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.
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`16
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`v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012) (“Negative claim
`
`limitations are adequately supported whenthe specification describes a
`reason to exclude the relevantlimitation.”)). Petitioner’s argumentis
`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:
`|
`Whenviewedin 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 boundsof protection he will seek.”’).
`Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015).
`
`Accordingly, wefind that Petitioner has not demonstrated a lack of written
`description for this term.
`
`CONCLUSION
`
`Petitioner does not convinceus 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 patentis 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
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`art.'? Consequently, Petitioner has failed to establish a reasonablelikelihood
`
`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
`
`ORDEREDthat the Petition is denied as to all challenged claims of
`
`the’506 patent.
`
`10 Accordingly, we need not reach Patent Owner’s argumentthat the Board
`should deny the Petition because the sameorsubstantially the same
`arguments were previously considered by the Office. See Prelim. Resp. 42-
`45.
`
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`PETITIONER:
`
`William L. Mentlik
`Michael H. Teschner
`Brian R. Tomkins
`MaeganA.Fuller
`LITTENBERG, KRUMHOLZ & MENTLIK, LLP
`WMentlik.ipr@ldlkm.com
`MTeschner.ipr@ldikm.com
`BTomkins.ipr@ldlkm.com
`MFuller.ipr@Idlkm.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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`Tech Center Routing Sheet
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`IYOWSBY_
`Dal /l0/ / G
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`Doc Code
`
`Doc Code Date
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`Application #
`Date ofRequest
`
`OL/ALl
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`(if not listed)
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`[] 136A
`[] NPL
`[] CRFE
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`Blanket Authorization to charge fee
`
`CRF Entered
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`NonPatent Literature
`
`[] NRES
`[] 4-
`[] CTMS
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`Amendment
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`Misc. Office Action
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`Letter restarting period of repsonse
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`[| NTC.A.NONCPL
`[| AMSB
`[] DISQ
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`Amendment Submitted with CPA/RCE
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`Terminal Disclaimer Approval Form
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`Notice of Non-Compliant Amendment
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`[] ANE.I
`[| -PET.DEC.TC
`[] EXIN
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`AmendmentAfter Final, Initialed by Examiner
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`Examiner Interview
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`Petition Decision Routed to TC
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`[J APDEC
`[-] SA
`[] FOR
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`Board of Appeals Decision
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`Foreign Reference
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`Supplemental Response or Amendment
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`[| APEA
`[] SRFW
`[] IFW
`Examiner's Answerto Appeal Brief
`[| BIB
`[| N271
`[J SRNT
`Response to Amendment under 312
`[] N570
`[] WCLM
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`Bibiliographic Data Sheet
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`CLM
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`Examiner Search Notes
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`File Wrapper issue Information
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`Fite Wrapper Search Information
`
`Claims
`
`Accepted Change to Powerof Attorney
`
`Claim Worksheet
`
`Cl NFDR
`[] CLMPTO
`[| WFEE
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`USPTO Prepared Claim Set
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`Formal Drawings Required
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`Fee Worksheet
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`[_] CRFD
`[] NOA
`[] XRUSH
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`CRF Defective
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`Notice of Allowability or Allowance
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`Responseto a Printer Query
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`
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`fo! [ae
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`In the Claims
`
`Claims 11-15 and 18-20 are pending. |
`Claims 1-10, 16, 17, 21, and 22 were previously cancelled.
`
`Claims 11-15 and 18-20 are cancelled herein.
`
`Claims 23-35 are newly presented herein.
`
`The status of the claims is as follows:
`
`1-22 (Cancelled)
`
`o
`WA.(New)
`
`-
`A toy gun, comprising:
`
`a barrel;
`
`a chamber adaptedto receive and accommodatea projectile, the chamber is
`
`spaced from a muzzle of the barrel;
`
`a mechanism for discharging the projectile from the muzzle;
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`a smoke generator arranged to emit smoke from the chamber and themuzzle
`
`when the discharging mechanism has been actuated to discharge the projectile;
`
`wherein the mechanism fordischarging the projectile is arranged to bein
`gaseous communicationwitha first gas passageway, and the smoke generatoris"
`arranged to be in gaseous communication with a second gas passageway, wherein
`a gas flowsat the first gas passagewayis conveyedat a different flow rates to that
`
`of a gas flow at the second gas passageway.
`
`
`
`24.(New)
`
`The toy gun of claim 23, wherein the first gas passagewayis adapted
`
`to conveygasat a first flow rate and the second gas passagewayis adapted to
`
`convey gas in a second flowrate, with the first flow rate being faster than the
`
`second flow rate.
`
`The toy gun of cla