UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`SABINSA CORPORATION,
`Petitioner,
`v.
`FRANCO CAVALERI,
`Patent Owner.
`_____________________
`
`Case No. PGR2022-00015
`
`U.S. Patent No. 10,945,970
`_____________________
`
`PETITION FOR POST-GRANT REVIEW
`OF U.S. PATENT NO. 10,945,970
`
`
`
`

`

`TABLE OF CONTENTS
`
`I.
`II.
`
`INTRODUCTION ............................................................................................1
`PGR REQUIREMENTS UNDER 37 C.F.R. § 42.204 ....................................1
`A. Grounds for Standing Under 37 C.F.R. § 42.204(a) .............................. 1
`B.
`Identification of Challenge Under 37 C.F.R. § 42.204(a) ...................... 1
`1.
`Statutory Grounds of Challenge...................................................1
`2.
`Relief Requested ..........................................................................2
`C. Mandatory Notices Under 37 C.F.R. § 42.8 .......................................... 3
`1.
`Real Party-in-Interest Pursuant to 37 C.F.R. § 42.8(b)(1) ...........3
`2.
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ............................3
`3.
`Identification of Lead and Back-Up Counsel Under 37
`C.F.R. § 42.8(b)(3) .......................................................................3
`Service Information under 37 C.F.R. § 42.8(b)(4) ......................3
`4.
`III. OVERVIEW OF THE ’970 PATENT .............................................................4
`A.
`The ’970 Patent Specification ................................................................ 4
`B.
`The ’970 Patent Claims ........................................................................ 10
`C.
`Summary of Relevant Portions of the File History .............................. 11
`IV. THIS PETITION IS NOT REDUNDANT WITH ANY PRIOR
`PETITIONS OR THE ARGUMENTS
`PRESENTED
`IN
`PROSECUTION ............................................................................................ 13
`BACKGROUND AND OVERVIEW OF TECHNOLOGY ........................ 15
`V.
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 17
`VII. CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3) .................. 17
`VIII. SCOPE AND CONTENT OF THE PRIOR ART ......................................... 18
`A.
`Li ........................................................................................................... 18
`B.
`Rhema ................................................................................................... 19
`C.
`Grebow ................................................................................................. 21
`D. Yang ..................................................................................................... 22
`E.
`Pushpakumari ....................................................................................... 24
`F.
`Hong ..................................................................................................... 26
`G. Kim ....................................................................................................... 29
`ii
`
`
`
`

`

`2.
`
`B.
`C.
`
`E.
`
`F.
`
`I.
`
`J.
`
`H. Antony .................................................................................................. 31
`IX. THE CHALLENGED CLAIMS ARE UNPATENTABLE .......................... 34
`A.
`Lack of Priority .................................................................................... 35
`1.
`Claims 1–7 of the ’970 patent lack priority to the ’554
`Provisional Application ............................................................ 36
`Claims 1–6 of the ’970 patent lack priority to the ’275
`PCT Application ....................................................................... 40
`Conclusion ................................................................................ 42
`3.
`Ground 1: Claim 4 of the ’970 patent is anticipated by Li. ................. 42
`Ground 2: Claims 5 and 6 of the ’970 patent are obvious over
`Li and the knowledge of a POSA ......................................................... 46
`1.
`Claim 5 ...................................................................................... 46
`2.
`Claim 6 ...................................................................................... 48
`D. Ground 3: Claim 5 of the ’970 patent is obvious over Li in
`combination with Rhema and Grebow ................................................. 49
`Ground 4: Claim 6 of the ’970 patent is obvious over Li in
`combination with Yang ........................................................................ 51
`Ground 5: Claims 1–3 and 7 of the ’970 patent are obvious over
`Pushpakumari in combination with Hong and Kim ............................. 52
`1.
`Claims 1, 2, and 7...................................................................... 52
`2.
`Claim 3 ...................................................................................... 55
`G. Ground 6: Claim 3 of the ’970 patent is obvious over
`Pushpakumari in combination with Hong, Kim, and Yang ................. 57
`H. Ground 7: Claim 7 of the ’970 patent is obvious over Antony in
`combination with Pushpakumari .......................................................... 58
`Ground 8: Claims 1–2, 4–5, and 7 of the ’970 patent are invalid
`for lack of written description and lack of enablement ........................ 61
`Ground 9: Claims 1–7 of the ’970 patent are invalid for
`indefiniteness ........................................................................................ 69
`1.
`Claims 1–7 do not indicate on what basis the percentages
`of curcuminoids are measured .................................................. 70
`The claims and specification do not indicate whether the
`percentages of curcuminoids is based on the total amount
`
`2.
`
`
`
`iii
`
`

`

`3.
`
`of the curcuminoids, or the total amount of the entire
`composition including excipients and carriers.......................... 73
`The numerous methods of calculation render claims 1–7
`indefinite. .................................................................................. 75
`SECONDARY CONSIDERATIONS ........................................................... 76
`X.
`XI. CONCLUSION .............................................................................................. 77
`CERTIFICATE OF COMPLIANCE .......................................................... - 1 -
`CERTIFICATION OF SERVICE ............................................................... - 2 -
`
`
`
`
`iv
`
`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .............................................. 35, 62, 63
`Arthrocare Corp. v. Smith & Nephew, Inc.,
`406 F.3d 1365 (Fed. Cir. 2005) .......................................................................... 42
`Becton Dickinson & Co. v. B. Braun Melsungen AG,
`Case IPR2017-01586, slip op. (PTAB Dec. 15, 2017) ....................................... 14
`Bosch Auto. Serv. Sols., LLC v. Matal,
`878 F.3d 1027 (Fed. Cir. 2017) .......................................................................... 60
`Dow Chem. Co. v. Nova Chems. Corp. (Canada),
`803 F.3d 620 (Fed. Cir. 2015) ................................................................ 69, 75, 76
`Ferring B.V. v. Watson Labs., Inc.-Fla.,
`764 F.3d 1382 (Fed. Cir. 2014) .......................................................................... 18
`Gardner v. TEC Sys., Inc.,
`725 F.2d 1338 (Fed. Cir. 1984) .......................................................................... 47
`Gen. Hosp. Corp. v. Sienna Biopharmaceuticals, Inc.,
`888 F.3d 1368 (Fed. Cir. 2018) .............................................................. 36, 38, 39
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ............................................................................ 19
`Harris Corp. v. IXYS Corp.,
`114 F.3d 1149 (Fed. Cir. 1997) .......................................................................... 63
`Jazz Pharms., Inc. v. Amneal Pharms., LLC,
`895 F.3d 1347 (Fed. Cir. 2018) .......................................................................... 20
`In re Katz Interactive Call Processing Patent Litig.,
`639 F.3d 1303 (Fed. Cir. 2011) .......................................................................... 35
`
`
`
`v
`
`

`

`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .......................................................................... 42
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 54
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`481 F.3d 1371 (Fed. Cir. 2007) ........................................................ 42, 63, 67, 68
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ............................................................................................ 69
`Noven Pharms., Inc. v. Amneal Pharms. LLC,
`C.A. No. 18-699-LPS, 2020 WL 11191445 (D. Del. Sep. 4, 2020) .................. 64
`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .......................................................................... 54
`Pall Corp. v. Micron Separations, Inc.,
`66 F.3d 1211 (Fed. Cir. 1995) ............................................................................ 17
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) .......................................................................... 36
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005) .......................................................................... 43
`Suffolk Techs., LLC v. AOL Inc.,
`752 F.3d 1358 (Fed. Cir. 2014) .......................................................................... 19
`Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355 (Fed. Cir. 2011) .......................................................................... 18
`Wyeth v. Abbott Laboratories,
`Civil Action Nos. 08–230 (JAP), 08–1021(JAP), 2012 WL 175023
`(D.N.J. Jan. 19, 2012) .................................................................................. 63, 64
`Statutes
`35 U.S.C. § 101 ........................................................................................................ 12
`35 U.S.C. § 102 .................................................................................................passim
`35 U.S.C. § 103 .......................................................................................................... 2
`vi
`
`
`
`

`

`35 U.S.C. § 112 .......................................................................................................... 2
`35 U.S.C. § 154 .......................................................................................................... 4
`35 U.S.C. § 325 ........................................................................................................ 13
`Other Authorities
`37 C.F.R. § 42.8 ......................................................................................................... 3
`37 C.F.R. § 42.63 ..................................................................................................... 26
`37 C.F.R. § 42.104 ............................................................................................. 17, 34
`37 C.F.R. § 42.204 ..................................................................................................... 1
`
`
`
`
`vii
`
`

`

`TABLE OF EXHIBITS
`
`Description
`U.S. Patent No. 10,945,970 (“the ’970 patent”)
`File History of the ’970 patent
`PCT Application No. PCT/CA2018/050275 (“the ’275 PCT
`Application”)
`Provisional Application No. 62/469,554 (“the ’554 Provisional
`Application”)
`Gupta, Subash et al., Discovery of Curcumin, a Component of
`the Golden Spice, and Its Miraculous Biological Activities, 39
`Clin. Exp. Pharmacol. Physiol. 283–299 (Mar. 2012) (“Gupta”)
`Li, Rui, et al., Metabolic and pharmacokinetic studies of
`curcumin, demethoxycurcumin, and bisdemethoxycurcumin in
`mice tumor after intragastric administration of nanoparticle
`formulations by liquid chromatography coupled with tandem
`mass spectrometry, 879 Journal of Chromatography B 2751–58
`(Sept. 15, 2011) (“Li”)
`Wichitnithad, Wisut, et al., A Simple Isocratic HPLC Method for
`the Simultaneous Determination of Curcuminoids in
`Commercial Turmeric Extracts, 20 Phytochem. Anal. 314–319
`(2009) (“Wichitnithad”)
`Certified Translation of Hong, Xingqui, et al., Effects of
`bisdemethoxycurcumin in reducing lipids and fighting lipid
`peroxidation, 4 Chin. J. Nat. Med. 121–24 (Mar. 2006)
`(“Hong”)
`Kim, Sung-Bae, et al., Hepatoprotective Effect and Synergism of
`Bisdemethoxycurcumin against MCD Diet-Induced
`Nonalcoholic Fatty Liver Disease in Mice, PLoS ONE (Feb. 16,
`2016) (“Kim”)
`Yang, Yi-Sun, et al., Lipid-Lowering Effects of Curcumin in
`Patients with Metabolic Syndrome: A Randomized, Double-
`Blind, Placebo-Controlled Trial, 28 Phythother. Res. 1770–1777
`(2014) (“Yang”)
`U.S. Patent Application No. 2014/0193533 (“Antony”)
`Pushpakumari, K.N., et al., Purification and Separation of
`Individual Curcuminoids from Spent Turmeric Oleoresin, a By-
`Product from Curcumin Production Industry, 5 Int’l J. Pharm.
`Sci. & Research 3246–54 (Aug. 2014) (“Pushpakumari”)
`
`viii
`
`Exhibit
`SAB1001
`SAB1002
`SAB1003
`
`SAB1004
`
`SAB1005
`
`SAB1006
`
`SAB1007
`
`SAB1008
`
`SAB1009
`
`SAB1010
`
`SAB1011
`SAB1012
`
`
`
`

`

`Exhibit
`SAB1013
`
`SAB1014
`SAB1015
`
`SAB1016
`
`SAB1017
`
`SAB1018
`SAB1019
`SAB1020
`
`Description
`Excerpts from Rowe, Raymond C. et al., Handbook of
`Pharmaceutical Excipients (6th ed. 2009).
`Excerpts from Stedman’s Medical Dictionary (27th ed. 2000)
`Rhema Made, New Curcumin Extract Found to Counteract
`Inflammation at the Genetic Level, Oct. 5, 2016 (“Rhema”)
`Grebow, Jennifer, New Curcumin Ingredient Aims for High
`Level of One Specific Curcuminoid to Boost Anti-Inflammatory
`Activity, Nutritional Outlook (Oct. 28, 2016) (“Grebow”)
`Original Version of Hong, Xingqui, et al., Effects of
`bisdemethoxycurcumin in reducing lipids and fighting lipid
`peroxidation, 4 Chin. J. Nat. Med. 121–24 (Mar. 2006)
`(“Hong”)
`Declaration of Duncan Hall
`Declaration of Mansoor M. Amiji, Ph.D.
`Curriculum Vitae of Dr. Mansoor M. Amiji
`
`
`
`ix
`
`

`

`I.
`
`INTRODUCTION
`Sabinsa Corporation (“Petitioner”) respectfully petitions for post-grant
`
`review (“PGR”) of claims 1–7 of U.S. Patent No. 10,945,970 (“the ’970 patent”),
`
`purportedly owned by Franco Cavaleri (“Patent Owner”). SAB1001. For the
`
`reasons addressed below, claims 1–7 should be found unpatentable and canceled.
`
`II.
`
`PGR REQUIREMENTS UNDER 37 C.F.R. § 42.204
`A. Grounds for Standing Under 37 C.F.R. § 42.204(a)
`Petitioner certifies that the ’970 patent is available for PGR. The ’970 patent
`
`issued on March 16, 2021, less than nine months prior to the filing of this PGR.
`
`See SAB1001 at cover. In addition, the earliest date to which the ’970 patent can
`
`claim priority is after March 16, 2013. See id. Further, Petitioner certifies it is not
`
`barred or estopped from requesting a PGR challenging the claims 1–7 of the ’970
`
`patent on the grounds identified herein.
`
`Identification of Challenge Under 37 C.F.R. § 42.204(a)
`B.
`Petitioner requests that the Patent Trial and Appeal Board (“Board”)
`
`invalidate claims 1–7 of the ’970 patent for the reasons identified below.
`
`Statutory Grounds of Challenge
`1.
`Petitioner challenges claims 1–7 of the ’970 patent and requests that this
`
`claim be cancelled based on the following grounds, which are supported by the
`
`Declaration of Mansoor M. Amiji. (SAB1019):
`
`
`
`1
`
`

`

`Ground
`1
`
`Claims
`4
`
`References
`Basis
`35 U.S.C. § 102(a) Li (SAB1006)
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`5–6
`
`35 U.S.C. § 103
`
`Li (SAB1006)
`
`5
`
`6
`
`35 U.S.C. § 103
`
`35 U.S.C. § 103
`
`Li (SAB1006) in combination with
`Rhema (SAB1015) and Grebow
`(SAB1016)
`
`Li (SAB1006) in combination with
`Yang (SAB1010)
`
`1–3, 7
`
`35 U.S.C. § 103
`
`3
`
`35 U.S.C. § 103
`
`Pushpakumari (SAB1012)
`in combination with Hong
`(SAB1008 and SAB1017)
`and Kim (SAB1009)
`
`Pushpakumari (SAB1012)
`in combination with Hong
`(SAB1008 and SAB1017),
`Kim (SAB1009), and Yang
`(SAB1010)
`
`7
`
`35 U.S.C. § 103 Antony (SAB1011) in
`combination with
`Pushpakumari (SAB1012)
`
`1, 2, 4,
`5, 7
`
`35 U.S.C. § 112(a) Lack of written description
`and lack of enablement
`
`1–7
`
`35 U.S.C. § 112(b)
`
`Indefiniteness
`
`Relief Requested
`2.
`Petitioner requests that the Board cancel claims 1–7 of the ’970 patent as
`
`unpatentable under 35 U.S.C. §§ 102(a), 103, 112(a), and/or 112(b).
`
`
`
`2
`
`

`

`C. Mandatory Notices Under 37 C.F.R. § 42.8
`Real Party-in-Interest Pursuant to 37 C.F.R. § 42.8(b)(1)
`1.
`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner certifies that Sabinsa
`
`Corporation is the real-party-in-interest.
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2)
`2.
`Petitioner is unaware of any judicial or administrative matters that would
`
`affect, or be affected by, a decision in this proceeding. Patent Owner has not
`
`asserted the ’970 patent in any civil actions in the United States.
`
`3.
`
`Identification of Lead and Back-Up Counsel Under 37
`C.F.R. § 42.8(b)(3)
`Petitioner identifies the following lead and backup counsel:
`
`Lead Counsel
`Richard J. Berman (Reg. No. 39,107)
`ARENT FOX LLP
`1717 K Street NW
`Washington, DC 20006
`Telephone: 202.857.6000
`Fax: 202.857.6395
`Richard.Berman@arentfox.com
`
`
`Back-Up Counsel
`Bradford C. Frese (Reg. No. 69,772)
`ARENT FOX LLP
`1717 K Street NW
`Washington, DC 20006
`Telephone: 202.857.6496
`Fax: 202.857.6395
`Bradford.Frese@arentfox.com
`
`Service Information under 37 C.F.R. § 42.8(b)(4)
`4.
`Please address all correspondence to above-identified counsel at:
`
`ARENT FOX LLP
`1717 K Street NW
`Washington DC 20006
`
`Petitioner consents to electronic service.
`
`
`
`3
`
`

`

`III. OVERVIEW OF THE ’970 PATENT
`The ’970 patent is titled “Curcumin-Based Compositions and Methods of
`
`Use Thereof.” SAB1001 at cover. The ’970 patent lists Franco Cavaleri as the
`
`Applicant, Inventor. Id. The ’970 patent was issued on March 16, 2021, and has
`
`been granted an extension or adjustment under 35 U.S.C. § 154(b) by 207 days. Id.
`
`The ’970 patent was filed on August 24, 2018. Id. The ’970 patent purports to be a
`
`continuation-in-part of Application No. PCT/CA2018/050275, filed on March 8,
`
`2018, and also purports to claim priority to Provisional Application No.
`
`62/469,554, filed on March 10, 2017. Id.
`
`A. The ’970 Patent Specification
` The ’970 patent states that it “relates to certain curcumin-containing
`
`compositions and methods of use thereof, which can be used to increase low-
`
`density lipoprotein cholesterol (LDL) receptor expression levels and thereby lower
`
`LDL levels in a plurality of cells or subject.” SAB1001 at 1:15–19; SAB1019
`
`(Amiji), ¶ 59. The ’970 patent also discusses use of certain curcumin-containing
`
`compositions to modulate MSK1 production to “ameliorate a variety of health
`
`conditions.” SAB1001 at 1:19–23; SAB1019 (Amiji), ¶ 59.
`
`In particular,
`
`the claims
`
`recite compositions containing certain
`
`concentrations of curcumin I, II, and III. As the ’970 patent explains, “[a] natural
`
`curcumin extract comprises a mixture of curcumin I, desmethoxycurcumin
`
`
`
`4
`
`

`

`(curcumin II), and bisdemethoxycurcumin (curcumin III).” SAB1001 at 4:23–25;
`
`SAB1019 (Amiji), ¶ 60. These compounds are alternatively referred to as
`
`curcumin, DMC, and BDMC, respectively, in the field. Each of these compounds
`
`undergo tautomerization between keto and enol forms. The enol form of curcumin
`
`I is shown in the ’970 patent:
`
`SAB1001 at 4:32–40; SAB1019 (Amiji), ¶ 60. The keto form of curcumin II is
`
`shown in the ’970 patent:
`
`
`
`SAB1001 at 4:45–53; SAB1019 (Amiji), ¶ 60. The keto form of curcumin III is
`
`shown in the ’970 patent:
`
`
`
`
`
`SAB1001 at 4:60–67; SAB1019 (Amiji), ¶ 60.
`
`
`
`5
`
`

`

`The specification discloses that:
`
`the
`to certain preferred embodiments,
` According
`invention provides that curcumin II and curcumin III may
`be extracted from turmeric plant rhizome (Curcuma
`longa) and subsequently concentrated to the desired
`levels. Alternatively, the invention provides that the
`curcumin II and curcumin III molecules may be
`chemically synthesized and used
`to
`formulate a
`therapeutic composition described herein. As explained
`below, the desired concentration of curcumin II is at least
`15%, 30%, 50%, 70%, or 90% (w/v) curcumin II, while
`the desired concentration of curcumin III is at least 5%,
`30%, 50%, 70%, or 90% (w/v) curcumin III.
`SAB1001 at 5:1–11; SAB1019 (Amiji), ¶ 62.
`
`The ’970 patent discloses eight examples. See generally SAB1001;
`
`SAB1019 (Amiji), ¶ 63. Examples 1, 2, and 3 discuss the results of testing of the
`
`effects of commercially-available curcumin extract (95.3% pure, containing 77.7%
`
`curcumin I, 16.9% curcumin II, and 0.9% curcumin III) and individual
`
`curcuminoids (97.7% pure curcumin I; 97.3% pure curcumin II; and 97.7% pure
`
`curcumin III) on cell survival, MSK1 levels, and LDL receptor expression in
`
`various in vitro experiments. See generally SAB1001 at 8:66–12:38; SAB1019
`
`(Amiji), ¶ 63.
`
`Examples 4–8 disclose various curcumin formulations. For instance,
`
`Example 4 discloses “Curcumin Formulation One,” which is described as “a
`
`preferred embodiment[] of a composition that is encompassed by the present
`
`invention.” SAB1001 at 12:39–42. This composition “includes 30-40% curcumin I
`
`
`
`6
`
`

`

`(such as about 35% curcumin I); 9-11% curcumin II (such as about 10% curcumin
`
`II); and 45%-55% curcumin III (such as about 50% curcumin III).” SAB1001 at
`
`12:42–45; SAB1019 (Amiji), ¶ 64. Example 4 further discloses that “[p]referably,
`
`such composition is formulated into a capsule that can be administered orally. In
`
`such embodiments, the capsule may comprise additional fillers and agents, such as
`
`a vegetable capsule (hydroxypropyl methylcellulose), water, microcrystalline
`
`cellulose, magnesium stearate, and silicon dioxide.” SAB1001 at 12:46–50;
`
`SAB1019 (Amiji), ¶ 65. Example 4, however, does not disclose how the curcumin
`
`composition is made, how the particular percentages of curcuminoids are measured
`
`or mixed, or the relative weights or concentrations of curcuminoids to the
`
`“additional fillers and agents” in the capsule formulation.
`
`Example 5 discloses “Curcumin Formulation Two,” which is described as
`
`“another preferred embodiment[] of a composition that is encompassed by the
`
`present invention.” SAB1001 at 12:55–58; SAB1019 (Amiji), ¶ 66. This
`
`composition “includes 45-55% curcumin I (such as about 50% curcumin I); 10-
`
`20% curcumin II (such as about 15% curcumin II); and 20%-40% curcumin III
`
`(such as about 30% curcumin III).” SAB1001 at 12:58–62; SAB1019 (Amiji),
`
`¶ 66. Like Example 4, Example 5’s composition “is preferably formulated into a
`
`capsule that can be administered orally. Likewise, in such embodiments, the
`
`capsule may comprise additional fillers and agents, such as a vegetable capsule
`
`
`
`7
`
`

`

`(hydroxypropyl methylcellulose), water, magnesium stearate, and silicon dioxide.”
`
`SAB1001 at 12:62–67; SAB1019 (Amiji), ¶ 67. And like Example 4, Example 5
`
`does not disclose how the curcumin composition is made, how the particular
`
`percentages of curcuminoids are measured or mixed, or the relative weights or
`
`concentrations of curcuminoids to the “additional fillers and agents” in the capsule
`
`formulation.
`
`Example 6 discloses “Curcumin Formulation Three,” which is described as
`
`“yet another preferred embodiment[] of a composition that is encompassed by the
`
`present invention.” SAB1001 at 13:5–8; SAB1019 (Amiji), ¶ 68. This composition
`
`“includes (or consists of) natural curcumin extract, which is supplemented with
`
`additional (and preferably purified) curcumin III, such that the final curcumin III
`
`concentration is greater than 5% (w/v)[]” such that “[i]n certain embodiments, the
`
`final curcumin III concentration is at least 30% (w/v) curcumin III or, more
`
`preferably, at least 50% (w/v) curcumin III.” SAB1001 at 13:8–15; SAB1019
`
`(Amiji), ¶ 68. Like Examples 4 and 5, Example 6’s composition “may be
`
`formulated as a capsule, and the capsule may (optionally) comprise additional
`
`fillers and agents, such as a vegetable capsule (hydroxypropyl methylcellulose),
`
`water, magnesium stearate, and silicon dioxide.” SAB1001 at 13:15–19; SAB1019
`
`(Amiji), ¶ 69. And again, like Examples 4 and 5, Example 6 does not disclose how
`
`the curcumin composition is made, how the particular percentages of curcuminoids
`
`
`
`8
`
`

`

`are measured or mixed, or the relative weights or concentrations of curcuminoids
`
`to the “additional fillers and agents” in the capsule formulation.
`
`Example 7 discloses “Curcumin Formulation Four,” which is described as
`
`“yet another preferred embodiment[] of a composition that is encompassed by the
`
`present invention.” SAB1001 at 13:24–27; SAB1019 (Amiji), ¶ 70. This
`
`composition “includes (or consists of) natural curcumin extract, which is
`
`supplemented with additional (and preferably purified) curcumin II, such that the
`
`final curcumin II concentration is greater than 15% (w/v)[]” such that “[i]n certain
`
`embodiments, the final curcumin II concentration is at least 30% (w/v) curcumin II
`
`or, more preferably, at least 50% (w/v) curcumin II.” SAB1001 at 13:28–34;
`
`SAB1019 (Amiji), ¶ 70.
`
`Like Examples 4, 5 and 6, Example 7’s composition “may be formulated as
`
`a capsule, and the capsule may (optionally) comprise additional fillers and agents,
`
`such as a vegetable capsule (hydroxypropyl methylcellulose), water, magnesium
`
`stearate, and silicon dioxide.” SAB1001 at 13:34–38; SAB1019 (Amiji), ¶ 71.
`
`Example 8 discloses “Curcumin Formulation Five,” which is described as
`
`“yet another preferred embodiment,” and which “may consist of a combination
`
`(mixture) of the curcumin-enriched compositions described in Examples 6 and 7
`
`above.” SAB1001 at 13:43–47; SAB1019 (Amiji), ¶ 72.
`
`
`
`9
`
`

`

`The ’970 Patent Claims
`B.
`The ’970 patent has 7 claims, which are reproduced below. Claim 1 of the
`
`’970 patent recites the following:
`
`1. A composition that comprises:
`(a) 30-40% curcumin I;
`(b) 9-11% curcumin II; and
`(c) 45%-55% curcumin III, wherein the composition is
`formulated as a capsule, pill, tablet, granule, solution or a
`suspension in an aqueous or non-aqueous liquid, oil-in-
`water or water-in-oil emulsion, elixir, syrup, paste, or dry
`powder.
`SAB1001 at 14:10–17. Claims 2 and 3 depend from Claim 1, and recite the
`
`following:
`
`2. The composition of claim 1, which comprises about
`35% curcumin I, about 10% curcumin II, and about 50%
`curcumin III.
`3. The composition of claim 1, wherein the composition
`is formulated as the capsule, which further comprises
`hydroxypropyl methylcellulose, water, microcrystalline
`cellulose, magnesium stearate, and silicon dioxide.
`Id. at 14:18–24.
`
`Claim 4 of the ’970 patent recites the following:
`
`4. A composition that comprises:
`(a) 45-55% curcumin I;
`(b) 10-20% curcumin II; and
`
`
`
`10
`
`

`

`(c) 20%-40% curcumin III, wherein the composition is
`formulated as a capsule, pill, tablet, granule, solution or a
`suspension in an aqueous or non-aqueous liquid, oil-in-
`water or water-in-oil emulsion, elixir, syrup, paste, or dry
`powder.
`Id. at 14:25–32. Claims 5 and 6 depend from claim 4, and recite the following:
`
`5. The composition of claim 4, which comprises about
`50% curcumin I, about 15% curcumin II, and about 30%
`curcumin III.
`6. The composition of claim 4, wherein the composition
`is formulated as the capsule, which further comprises
`hydroxypropyl methylcellulose, water, microcrystalline
`cellulose, magnesium stearate, and silicon dioxide.
`Id. at 14:33–39.
`
`Claim 7 of the ’970 patent recites the following:
`
`7. A composition that comprises a curcumin extract,
`which is supplemented with additional (a) curcumin II,
`(b) curcumin III, or (c) both curcumin II and curcumin
`III, such that the composition comprises:
`(i) at least 50% curcumin II; or
`(ii) at least 50% curcumin III,
`wherein the composition is formulated as a capsule, pill,
`tablet, granule, solution or a suspension in an aqueous or
`non-aqueous liquid, oil-in-water or water-in-oil emulsion,
`elixir, syrup, paste, or dry powder.
`Id. at 14:40–49.
`
`Summary of Relevant Portions of the File History
`C.
`The application resulting in the ’970 patent, U.S. Patent Application No.
`
`16/111,502 (“the ’502 Application”) was filed on August 24, 2018. SAB1001. The
`11
`
`
`
`

`

`’502 Application was filed as a continuation-in-part of PCT Application No.
`
`PCT/CA2018/050275 (“the ’275 PCT Application”), which PCT application
`
`claims the benefit of United States Provisional Application No. 62/469,554 (“the
`
`’554 Provisional Application”). SAB1002 at 103.
`
`The ’502 Application included additional matter in its specification that was
`
`not contained in the ’275 PCT Application or ’554 Provisional Application.
`
`Specifically, Examples 4–8 were added in the ’502 Application, but are not present
`
`in either the ’275 PCT Application or ’554 Provisional Application.
`
`The claims of the ’502 Application, as filed, recited compositions containing
`
`certain percentages of curcumin I, II, and III. SAB1002 at 154. On May 18, 2018,
`
`the examiner issued a non-final rejection of claims 1–5 and 7–11 based on 35
`
`U.S.C. § 101, on the basis that these claims were directed to a naturally occurring
`
`product that did not recite any additional elements. Id. at 86–88. In response to this
`
`rejection, on August 11, 2020, the inventor amended claims 1, 4, and 7 to recite the
`
`additional limitation that “the composition is formulated as a capsule or dry
`
`powder.” Id. at 78–79. The applicant argued that paragraph [0039] provided
`
`written description support for this limitation. Id. at 81.
`
`On August 20, 2020, the examiner issued a non-final rejection of claims 7, 8,
`
`and 12. Claims 7 and 8 were rejected as being anticipated by Gow (U.S. Patent
`
`Application Pub. No. 2008/0193573). SAB1002 at 62–63. Claims 7, 8, and 12
`
`
`
`12
`
`

`

`were rejected as obvious over Gow and Teles (U.S. Patent Application Pub. No.
`
`2015/0366815). Id. at 64–65.
`
`On October 20, 2020, the inventor amended the claims a second time.
`
`Claims 1, 4, and 7 were amended to recite that the composition could be
`
`formulated as, in addition to a capsule or dry powder, a “pill, tablet, granule,
`
`solution or a suspension in an aqueous or non-aqueous liquid, oil-in-water or
`
`water-in-oil emulsion, elixir, syrup, [and] paste[.]” SAB1002 at 54–56. Claim 7
`
`was further amended as well, and claims 8–10 were canceled. Id. at 56. In arguing
`
`for the amendments to the dosage forms, the inventor pointed to paragraph [0038]
`
`for support for the additional delivery forms. Id. at 57. Subsequently, the claims
`
`were allowed. Id. at 8.
`
`IV. THIS PETITION IS NOT REDUNDANT WITH ANY PRIOR
`PETITIONS OR
`THE ARGUMENTS
`PRESENTED
`IN
`PROSECUTION
`Petitioner submits the grounds in this Petition are neither redundant nor
`
`duplicative of the grounds previously presented to the Office in prosecution of the
`
`’970 patent, and that the Board should refuse to exercise its discretion under 35
`
`U.S.C. § 325(d) to deny institution. This is the first Petition against the ’970 patent,
`
`and as such the only question remaining is whether the Petition is redundant with
`
`arguments considered in prosecution. In considering whether to deny institution
`
`under Section 325(d), the Board generally considers six non-exclusive factors:
`
`
`
`13
`
`

`

`1. the similarities and material differences between the
`asserted art and
`the prior art
`involved during
`examination;
`2. the cumulative nature of the asserted art and the prior
`art evaluated during examination;
`3. the extent to which the asserted art was evaluated
`during examination;
`4. the extent of the overlap between the arguments made
`during examination and the manner in which a petitioner
`relies on the prior art or a patent owner distinguishes the
`prior art;
`5. whether a petitioner has pointed out sufficiently how
`the Office erred in evaluating the asserted prior art; and
`6. the extent to which additional evidence and facts
`presented in the petition warrant reconsideration of the
`prior art or arguments.
`Trial Practice Guide Update (July 2019) at 29–30 (citing Becton Dickinson & Co.
`
`v. B. Braun Melsungen AG, Case IPR2017-01586, slip op. at 17–18 (PTAB Dec.
`
`15, 2017) (Paper 8) (informative).
`
`Each of these factors either weighs in favor of institution, or does not apply.
`
`First and foremost,