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,
`
`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
`
`
`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.
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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.
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`“[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;
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`10
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`11
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`“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
`
`12
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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).
`
`13
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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,
`
`wenote 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).
`
`14
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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 comedonesand, 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% 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
`
`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
`
`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
`
`the disclosure of the doses, per se, Petitioner further arguesthat “neither of
`
`the ranges in independentclaims 1! and8is explicitly taught in the
`
`specification of the ‘506 Patent or any ofits 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
`
`
`
`‘Case IPR2015-01778
`Patent 8,603,506 B2
`
`does discuss various dosage levels, there are contradictory statementsas to
`
`whichare antibiotic and which are nonantibiotic (which also creates
`
`confusion around the claim elementin claims 1, 8, and 15 concerning the
`
`effect on skin microflora. (See Exhs.1004 §f 20, 21, 22, 23; 1001 col.5 Il.
`
`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, wefind 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 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
`
`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.
`
`16
`
`
`
`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 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
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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.
`
`18
`
`
`
`Case IPR2015-01778
`Patent 8,603,506 B2
`
`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
`
`
`
`Tech Center Routing Sheet
`
`
`
`
`
`
`
`
`
`
`IYOWSBY_
`Dal /l0/ / G
`
`Doc Code
`
`Doc Code Date
`
`Application #
`Date ofRequest
`
`OL/ALl
`
`(if not listed)
`
`[] 136A
`[] NPL
`[] CRFE
`
`Blanket Authorization to charge fee
`
`CRF Entered
`
`NonPatent Literature
`
`[] NRES
`[] 4-
`[] CTMS
`
`Amendment
`
`Misc. Office Action
`
`Letter restarting period of repsonse
`
`[| NTC.A.NONCPL
`[| AMSB
`[] DISQ
`
`Amendment Submitted with CPA/RCE
`
`Terminal Disclaimer Approval Form
`
`Notice of Non-Compliant Amendment
`
`[] ANE.I
`[| -PET.DEC.TC
`[] EXIN
`
`AmendmentAfter Final, Initialed by Examiner
`
`Examiner Interview
`
`Petition Decision Routed to TC
`
`[J APDEC
`[-] SA
`[] FOR
`
`Board of Appeals Decision
`
`Foreign Reference
`
`Supplemental Response or Amendment
`
`[| APEA
`[] SRFW
`[] IFW
`Examiner's Answerto Appeal Brief
`[| BIB
`[| N271
`[J SRNT
`Response to Amendment under 312
`[] N570
`[] WCLM
`
`Bibiliographic Data Sheet
`
`CLM
`
`Examiner Search Notes
`
`File Wrapper issue Information
`
`Fite Wrapper Search Information
`
`Claims
`
`Accepted Change to Powerof Attorney
`
`Claim Worksheet
`
`Cl NFDR
`[] CLMPTO
`[| WFEE
`
`USPTO Prepared Claim Set
`
`Formal Drawings Required
`
`Fee Worksheet
`
`[_] CRFD
`[] NOA
`[] XRUSH
`
`CRF Defective
`
`Notice of Allowability or Allowance
`
`Responseto a Printer Query
`
`
`
`fo! [ae
`
`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;
`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
