Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________________
`
`
`
`
`
`TRUTEK CORP.
`Petitioner
`
`
`v.
`
`
`MATRIXX INITIATIVES, INC.
`Patent Owner
`
`
`
`U.S. Patent No. 10,736,931
`
`Case PGR2021-00005
`
`
`
`
`PETITION FOR POST GRANT REVIEW
`UNDER 35 U.S.C. §§ 321-329 AND 37 C.F.R. § 42.200
`
`
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`
`
`
`
`
`III.
`
`
`
`
`INTRODUCTION .......................................................................................1
`
`MANDATORY NOTICES ...........................................................................2
`
`A.
`
`B.
`
`C.
`
`
`E.
`
`F.
`
`Real Party In Interest ......................................................................3
`
`Related Matters (37 CFR § 42.8(b)(2)) ...........................................3
`
`Counsel and Service Information (37 CFR §§ 42.8(b)(3)
`and 42.10(a)) ..................................................................................4
`
`Payment of Fees .............................................................................4
`
`Time for Filing Petition .....................................................................4
`
`ADDITIONAL REQUIREMENTS FOR POST GRANT
`REVIEW .....................................................................................................5
`
`A.
`
`Certification of Grounds For Standing .............................................5
`
`IV. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED .....................5
`
`
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`Claims For Which Post Grant Review Is Requested .......................5
`
`Prior Art References ........................................................................5
`
`Relief Requested ...........................................................................10
`
`V.
`
`THE '931 PATENT ...................................................................................11
`
`
`
`
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`D.
`
`Specification ..................................................................................12
`
`Claims ...........................................................................................12
`
`Prosecution History .......................................................................12
`
`Person of Ordinary Skill in the Art .................................................12
`
`VI.
`
`CLAIM CONSTRUCTION ........................................................................13
`
`
`
`
`
`A.
`
`
`
`Independent Claim 1 .....................................................................13
`
`1.
`
`Luffa Operculata (L. operculata) .........................................13
`
`i
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`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`H.
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`I.
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`J.
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`K
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`L.
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`M.
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`N.
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`O.
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`P.
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`Q.
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`R.
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`2.
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`3.
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`4.
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`S. officinale (V. sabadilla) ...................................................14
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`Galphimia Glauca (G. glauca) ............................................14
`
`Inactive ingredients .............................................................15
`
`Dependent Claim 2 ........................................................................15
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`Dependent Claim 3 ........................................................................15
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`Dependent Claim 4 ........................................................................15
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`Dependent Claim 5 ........................................................................16
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`Dependent Claim 6 ........................................................................16
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`Dependent Claim 7 ........................................................................16
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`Dependent Claim 8 ........................................................................16
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`Dependent Claim 9 ........................................................................17
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`Dependent Claim 10 ......................................................................17
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`Dependent Claim 11 ......................................................................17
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`Dependent Claim 12 ......................................................................17
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`Dependent Claim 13 ......................................................................18
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`Dependent Claim 14 ......................................................................18
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`Dependent Claim 15 ......................................................................18
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`Dependent Claim 16 ......................................................................18
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`Dependent Claim 17 ......................................................................19
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`Dependent Claim 18 ......................................................................19
`
`THE CHALLENGED CLAIMS ARE NOT ENTITLED TO A PRIORITY
`DATE EARLIER THAN JANUARY 23, 2014 ............................................19
`
`VI.
`
`
`VII. OVERVIEW OF THE PRIOR ART ...........................................................19
`
`
`
`A.
`
`Similasan (Exhibit 1006) ..............................................................19
`
`ii
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`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`B
`
`ZICAM (Exhibit 1007) ....................................................................20
`
`C. Weiser (Exhibit 1008) ...................................................................21
`
`D.
`
`E.
`
`F.
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`G.
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`H.
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`I.
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`J.
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`K.
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`L.
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`M.
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`N.
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`O.
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`P.
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`Q.
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`R.
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`S.
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`T.
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`U.
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`Clarke (Exhibit 1009) ....................................................................21
`
`Liu '574 (Exhibit 1010) ..................................................................22
`
`TeutM (Exhibit 1011) .....................................................................22
`
`Dorsch (Exhibit 1012) ...................................................................23
`
`Haslwanter '146 (Exhibit 1013) ....................................................23
`
`Clarot '440 (Exhibit 1014) .............................................................23
`
`Clarot '066 (Exhibit 1015) .............................................................24
`
`Clarot '107 (Exhibit 1016) .............................................................24
`
`Clarot '924 (Exhibit 1017) .............................................................24
`
`Clarot '343 (Exhibit 1018) .............................................................25
`
`Clarot '628 (Exhibit 1019) .............................................................25
`
`Ariza (Exhibit 1020) ......................................................................25
`
`Clymer '676 (Exhibit 1021) ...........................................................25
`
`Davis (Exhibit 1022) ......................................................................26
`
`Jefferson (Exhibit 1023) ...............................................................26
`
`FDA Advisory (Exhibit 1024) .......................................................26
`
`FDA Ziagen (Exhibit 1025) ...........................................................27
`
`Eshkol (Exhibit 1026) ...................................................................27
`
`V. Wiki Phenethanol (Exhibit 1027) .................................................27
`
`W.
`
`Yuen (Exhibit 1028) ......................................................................28
`
`VIII. GROUNDS FOR PETITION ....................................................................28
`
`iii
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`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`A.
`
`
`
`B.
`
`
`
`C.
`
`
`
`
`
`D.
`
`
`
`
`
`E.
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`
`
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`F.
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`
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`G.
`
`
`
`
`H.
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`
`
`
`
`I.
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`
`
`
`Claim 1 is obvious and unpatentable under 35 U.S.C. § 103
`over Similasan in view of Clarot Patent Application
`Publications ('107 and '628) ..........................................................28
`
`Claim 1 is obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM,
`and Dorsch, and further in view of Liu '574 .................................30
`
`Claim 2 is obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM,
`and Dorsch, and further in view of Haslwanter '146
`and Clarot Patent Application Publications ('440, '066, '107,
`'924, '343, and '628) ......................................................................31
`
`Claims 3-5 are obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM,
`and Dorsch, and further in view of Ariza, Clymer '676,
`and Clarot Patent Application Publications ('440, '066,
`'107, '343, and '628) .......................................................................32
`
`Claims 6 and 7 are obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, and further in view of Clarot Patent Application
`Publications ('107, '343, and '628) ..................................................36
`
`Claims 8-10 are obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, and further in view of Davis ..............................................37
`
`Claims 11-12 are Obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, and further in view of Clarot Patent Application
`Publications ('107, '924, '343, and '628) ..........................................38
`
`Claims 13 and 14 are obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, Clarot Patent Application Publications ('107 and '628)
`and further in view of Jefferson, Yuen. FDA Advisory, and
`FDA Ziagen .....................................................................................40
`
`Claim 15 is obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, Clarot Patent Application Publications ('107 and '628)
`and further in view of Eshkol and Wiki Phenethanol .....................42
`
`iv
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`J.
`
`Claims 16-18 are obvious and unpatentable under 35 U.S.C.
`§ 103 over Similasan in view of Weiser, Clarke, TeutM, and
`Dorsch, Clarot Patent Application Publications ('107 and '628) ........43
`
`
`THE BOARD SHOULD INSITUTE A POST GRANT REVIEW (PGR) ..........46
`
`CONCLUSION ...............................................................................................47
`
`TABLE OF AUTHORITIES
`
`IX.
`
`X.
`
`
`
`
`Cases:
`
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................13
`
`Statutes:
`
`35 U.S.C. §§ 102, 103, 321(c), 321-329
`
`Rules:
`
`Exhibit
`No.
`
`1001
`
`1002
`
`1003
`
`37 C.F.R. §§ 42.22(a)(1), 42.24, 42.100(b), 42.202, 42.203, 42.204(a), 42.204(b)(2),
`42.8(a)(1), 42.8(b)(2), 42.8(b)(3)
`LIST OF EXHIBITS
`
`Description
`
`
`Clarot, et.al., U.S. Patent No. 10,736,931
`
`Clarot, et.al., U.S. Patent No. 9,555,069
`
`Clarot, et.al., U.S. Patent No. 9,034,401
`
`USPTO Form AO 120
`
`Declaration of Dr. Edward A. Lemmo
`
`Similasan Nasal Allergy ReliefTM Website
`(https://www.similasanusa.com/nasal-allergy-relief)
`
`ZICAM® Cold Remedy Nasal Spray Product Packaging
`
`
`1004
`
`1005
`
`1006
`
`1007
`
`v
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`1009
`
`1010
`
`1011
`
`1008 Weiser M1, Gegenheimer LH, Klien P, "A randomized equivalence
`trial comparing the efficacy and safety of Luffa comp.-Heel nasal
`spray with cromolyn sodium spray in the treatment of seasonal
`allergic rhinitis," Forsch Komplementarmed, 1999 Jun;9(3): 142-8.
`
`Clarke, John Henry, "Sabadilla," Materia Medica, 1902, This
`reference is prior art under 35 U.S.C. § 102.
`(https://www.materiamedica.info/en/materia-medica/john-henry-clarke/index#S)
`
`(Liu '574) - Liu, U.S. Patent Application Publication No.
`2013/0216574.
`
`TeutM.a, DahlerJ.b, SchneggC.c, "A Homeopathic Proving of
`Galphimia glauca," Abstract, Forsch Komplementarmed,
`2008:15:211-217 (https://doi.org/10.1159/000148825).
`
`Dorsch W., Wagner H., "New Histaminic Drugs from Traditional
`Medicine?," Abstract, Int. Arch. Allergy Immunol. 1991; 94:262-265
`(https://doi.org/10.1159/000235378).
`
`Haslwanter, et.al., U.S. Patent No. 6,841,146.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2003/0059440.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2004/0166066.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2004/0219107.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2005/0180924.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2006/0275343.
`
`Clarot, et.al., U.S. Patent Application Publication No. 2010/0004628.
`
`Ariza, A.C.; Deen, P.M.T.; Robben. J.H.; "The Succinate Receptor as
`a Novel Therapeutic Target for Oxidative and Metabolic Stress-
`Related Conditions," Front Endochronol (Lausanne) 2012:3:22,
`Published Online February 16, 2012.
`(https://www.nebi.nlm.nih.gov/pmc/articles/PMC3355999/)
`
`Clymer, et.al., U.S. Patent Application Publication No. 2007/0110676
`
`
`1020
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1021
`
`vi
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`
`
`Davis, M.D.; Walsh, B.K.; Dwyer, S.T.; Combs, C.; Vehse, N.; Paget-
`Brown, A.; Pajewski, T.; and Hunt, J.F.; Abstract, "Safety of an
`Alkalinizing Buffer Designed for Inhaled Medications in Humans,"
`Respiratory Care July 2013, 58 (7) 1226-1232.
`
`Jefferson, T.; Jones, M.A.; Doshi, P.; Del Mar, C.B.; Hama, R.;
`Thompson, M.J.; Spencer, E.A.; Onakpoya, I.; Mahtani, K.R.;
`Nuhan, D.; Howick, J.; Heneghan, C.J., "Neuraminidase inhibitors for
`preventing and treating influenza in healthy adults and children,"
`Cochrane Database of Systematic Review,
`DOI:10.1002/1465158.CD008965.pub4 PMC 6464969
`PMID 24718923 (January 1, 2014).
`
`"Safe and Appropriate Use of Influenza Drugs," Public Health
`Advisory, U.S. Food and Drug Administration (FDA),
`April 20, 2009 - reprinted from January 12, 2000.
`
`"Information for Healthcare Professionals: Abacavir (marketed as
`Ziagen) and Abacavir-Containing Medications," U.S. Food and Drug
`Administration (FDA), December 11, 2013 - reprinted from July 24,
`2008.
`
`Eshkol N., Sendovski M., Bahalul M., Katz-Esov T., Kashi Y.,
`Fishman A., "Production of 2-phenylethanol by a stress tolerant
`Sacchromyces cerevisiae strain," Jour. Appl. Microbiol, ISSN 1364-
`5072 (2009) 534-542, 539.
`
`Phenylethyl Alcohol - Wikipedia Page.
`
`Yuen, G.J., Weller, S., Parkes, G.E., A Review of the
`Pharmacokinetics of Abacavir, Clin. Pharmacokinet 47, 351-371
`(2008). https://doi.org/10.2165/00003088-200847060-00001
`
`U.S. Patent Application No. 15/386,318
`
`U.S. Patent Application No. 14/699,676
`
`U.S. Patent Application No. 14/327,339
`
`U.S. Provisional Application No. 61/930,881
`
`
`vii
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`Petitioner Trutek Corp. ("Petitioner") requests post grant review of claims
`
`1-18 ("Challenged Claims") of U.S. Patent No. 10,736,931 ("'931 Patent') (Exhibit
`
`1001).
`
`I.
`
`
`
`INTRODUCTION
`
`The '931 Patent was issued to inventors Timothy L. Clarot and Arlene M.
`
`Ascarate on August 11, 2020, and it is assigned to Matrixx Initiatives, Inc.
`
`("Patent Owner"). The '931 Patent is titled, "Pharmaceutical Compositions
`
`Comprising Plant Extracts, And Methods For Reducing Duration Of A Common
`
`Cold Using Same." However, all of the claims of the '931 Patent are method
`
`claims directed to reducing the duration of common cold symptoms in humans.
`
`The '931 Patent is a continuation of the U.S. Patent Application that resulted in
`
`issuance of U.S. Patent No. 9,555,069 ("'069 Patent") (Exhibit 1002), which in
`
`turn is a continuation of the U.S. Patent Application that resulted in issuance of
`
`U.S. Patent No. 9,034,401 ("'401 Patent") (Exhibit 1003). The Challenged
`
`Claims (i.e., claims 1-18) recite the use of a composition comprising a
`
`combination of three active ingredients (i.e., L. operculata, S. officinale, and G.
`
`glauca). Independent claim 1 recites the use of these three active ingredients.
`
`The therapeutic effects of these three botanicals were known in the art prior to
`
`January 23, 2014, the earliest date to which any of the claims of the '931 Patent
`
`could claim priority, and it would have been easy and obvious to combine them,
`
`and doing so would yield predictable results. In fact, the very combination of
`
`these three active ingredients was known in the art prior to the earliest priority
`
`1
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`date of the claims of the '931 Patent. The remaining inactive ingredients recited
`
`in claim 1 were also known in the art in the very combination recited in the claim.
`
`
`
`Claim 1 is the only independent claim of the '931 Patent. Claims 2-18
`
`depend either directly or indirectly from claim 1. Claim 2 recites the composition
`
`of claim 1 additionally comprising a thickener selected from a Markush group. A
`
`Markush grouping fails if any one of the components of the group is prior art.
`
`Indeed the composition of claim 1 with the addition of hypromelose is prior art.
`
`
`
`The compositions recited in dependent claims 3-18 contained inactive
`
`ingredients that were known in the art prior to January 23, 2014. The functions of
`
`these combined inactive ingredients are to provide a basis for creating a practical
`
`and marketable product to introduce the active ingredients into a user's nasal
`
`cavities. Combining these inactive ingredients with the three active ingredients
`
`would have been easy and obvious to combine them, and doing so would yield
`
`predictable results.
`
`
`
`Because the combination of all the ingredients would have been easy and
`
`obvious to combine, and because using such a combination as recited would
`
`yield predictable results, the Challenged Claims are invalid.
`
`II.
`
`
`
`MANDATORY NOTICES
`
`As set forth below and pursuant to 37 C.F.R. § 42.8(a)(1), the following
`
`mandatory notices are provided as part of this petition.
`
`
`
`
`
`2
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`A.
`
`Real Party In Interest
`
`
`
`The real party in interest is Trutek Corp. Trutek Corp. is not controlled by
`
`any other entity.
`
`
`
`
`
`B.
`
`Related Matters (37 CFR § 42.8(b)(2))
`
`The '931 Patent is related to a civil action in the District of New Jersey,
`
`Trutek Corp. v. Matrixx Initiatives, Inc., et.al., Case No. 3:19-cv-17647, filed
`
`September 5, 2019. The complaint alleges inter alia, counts of patent
`
`infringement, theft of trade secrets under federal and New Jersey statutes, and
`
`breaches of contract. The Application of the '931 Patent is a continuation of the
`
`Application of the '069 Patent, which in turn is a continuation of the Application of
`
`the '401 Patent. The complaint alleges that the claimed subject matter of both
`
`the '069 and '401 Patents were derived from Petitioner's trade secrets in violation
`
`of three confidential disclosure agreements between Petitioner and Patent
`
`Owner. The USPTO was notified that the '069 and '401 Patents are a subject of
`
`the lawsuit on Form AO 120 (Exhibit 1004).
`
`
`
`On August 27, 2020, Trutek Corp. submitted IPR2020-01511 challenging
`
`claims 1-10 of the '401 Patent. On September 3, 2020, Trutek Corp. submitted
`
`IPR2020-01554 challenging claims 1-7 of the '069 Patent.
`
`3
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`C.
`
`Counsel and Service Information (37 CFR §§ 42.8(b)(3) and
`42.10(a))
`
`
`Stanley H. Kremen
`Reg. No. 51900
`Patents Group LLC
`uspto@patentsgroup.com
`4 Lenape Lane
`East Brunswick, New Jersey 08816
`Telephone: (732) 593-7294
`Facsimile: (732) 312-5218
`
`Amirali Y. Haidri
`Reg. No. 29164
`Law Offices of Amirali Y. Haidri
`amiraliyhaidri@aol.com
`110 Hillside Avenue
`Suite #104
`Springfield, New Jersey 07081-3007
`Telephone: (908) 688-8700
`Facsimile: (908) 688-8445
`
`
`
`
`
`
`
`
`
`
`E.
`
`Payment of Fees
`
`Pursuant to 37 C.F.R. §§ 42.203 and 42.15(b), the requisite filing fee of
`
`$47,500 (request fee of $20,000, and post-institution fee of $27,500) for a
`
`Petition for Post Grant Review is submitted herewith. Claims 1-18 of the '931
`
`Patent are challenged. Payment of fees ($40,475) is submitted concurrently to
`
`the USPTO directly by Petitioner via wire transfer.
`F.
`Time for Filing Petition
`
`
`
`
`
`The '931 Patent was issued on August 11, 2020, and the instant Petition
`
`was timely filed no later than the date that is nine months after the date of grant
`
`of a patent. 35 U.S.C. § 321(c) and 37 CFR § 42.202.
`
`4
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`III.
`
`ADDITIONAL REQUIREMENTS FOR POST GRANT REVIEW
`
`
`
`
`
`A.
`
`Certification of Grounds For Standing
`
`Petitioner certifies under 37 CFR § 42.204(a) that the '931 Patent is
`
`available for Post Grant Review and Petitioner is not barred or estopped from
`
`requesting Post Grant Review of the Challenged Claims on the grounds identified
`
`in this petition.
`
`
`
`The earliest possible effective filing date for the '931 Patent is January 23,
`
`2014, which is the filing date of U.S Provisional Patent Application No.
`
`61/930,481. Thus the '931 Patent is subject to AIA and eligible for Post Grant
`
`Review.
`
`IV. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED
`
`(37 CFR § 42.204(B) AND 37 CFR § 42.22(A)(1))
`
`
`
`The precise relief requested by Petitioner is that claims 1-18 are found
`
`unpatentable and canceled from the '931 Patent.
`
`
`
`
`
`
`
`
`A.
`
`Claims For Which Post Grant Review Is Requested
`(37 CFR § 42.204(b)(2))
`
`Petitioner requests Post Grant Review of claims 1-18 of the '931 Patent.
`
`B.
`
`Prior Art References
`
`
`
`Exhibit 1006 (Similasan) - Similasan Nasal Allergy ReliefTM Website is
`
`prior art under 35 U.S.C. § 102(a).
`
`(https://www.similasanusa.com/nasal allergy relief)
`
`The Similasan Nasal Allergy ReliefTM Product is prior art under 35 U.S.C.
`
`§ 102(b).
`
`5
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`Exhibit 1007 (ZICAM) - ZICAM® No-Drip Nasal Spray packaging is prior
`
`art under 35 U.S.C. § 102(a) and the product is prior art under 35 U.S.C. §
`
`102(b).
`
`
`
`Exhibit 1008 (Weiser) - Weiser M1, Gegenheimer LH, Klien P, "A
`
`randomized equivalence trial comparing the efficacy and safety of Luffa
`
`comp.-Heel nasal spray with cromolyn sodium spray in the treatment of
`
`seasonal allergic rhinitis," Forsch Komplementarmed, 1999 Jun;6(3): 142-
`
`8. This reference is prior art under 35 U.S.C. § 102.
`
`Exhibit 1009 (Clarke) - Clarke, John Henry, "Sabadilla," Materia Medica,
`
`1902, This reference is prior art under 35 U.S.C. § 102.
`
`(https://www.materiamedica.info/en/materia-medica/john-henry-clarke/index#S)
`
`Exhibit 1010 (Liu '574) - Liu, U.S. Patent Application Publication No.
`
`2013/0216574. This reference is prior art under 35 U.S.C. § 102.
`
`Exhibit 1011 (TeutM) - TeutM.a, DahlerJ.b, SchneggC.c, "A Homeopathic
`
`Proving of Galphimia glauca," Abstract, Forsch Komplementarmed,
`
`2008:15:211-217 (https://doi.org/10.1159/000148825). This reference is
`
`prior art under 35 U.S.C. § 102.
`
`
`
`
`
`
`
`
`
`
`
`Exhibit 1012 (Dorsch) Dorsch W., Wagner H., "New Histaminic Drugs
`
`from Traditional Medicine?," Abstract, Int. Arch. Allergy Immunol. 1991;
`
`94:262-265 (https://doi.org/10.1159/000235378) This reference is prior
`
`art under 35 U.S.C. § 102.
`
`
`
`Exhibit 1013 (Haslwanter '146) - Haslwanter, et al., U.S. Patent No.
`
`6,841,146. This reference is prior art under 35 U.S.C. § 102.
`
`6
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`Exhibit 1014 (Clarot '440) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2003/0059440. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1015 (Clarot '066) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2004/0166066. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1016 (Clarot '107) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2004/0219107. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1017 (Clarot '924) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2005/0180924. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1018 (Clarot '343) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2006/0275343. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1019 (Clarot '628) - Clarot, et.al., U.S. Patent Application
`
`Publication No. 2010/0004628. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1020 (Ariza) - Ariza, A.C.; Deen, P.M.T.; Robben. J.H.; "The
`
`Succinate Receptor as a Novel Therapeutic Target for Oxidative and
`
`Metabolic Stress-Related Conditions," Front Endochronol (Lausanne)
`
`2012:3:22, Published Online February 16, 2012. This reference is prior art
`
`under 35 U.S.C. § 102.
`
`7
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`(https://www.nebi.nlm.nih.gov/pmc/articles/PMC3355999/)
`
`
`
`Exhibit 1021 (Clymer '676) - Clymer, et.al., U.S. Patent Application
`
`Publication No. 2007/0110676. This reference is prior art under 35 U.S.C.
`
`§ 102.
`
`
`
`Exhibit 1022 (Davis) - Davis, M.D.; Walsh, B.K.; Dwyer, S.T.; Combs, C.;
`
`Vehse, N.; Paget-Brown, A.; Pajewski, T.; and Hunt, J.F.; Abstract, "Safety
`
`of an Alkalinizing Buffer Designed for Inhaled Medications in Humans,"
`
`Respiratory Care July 2013, 58 (7) 1226-1232. This reference is prior art
`
`under 35 U.S.C. § 102.
`
`
`
`Exhibit 1023 (Jefferson) - Jefferson, T.; Jones, M.A.; Doshi, P.; Del Mar,
`
`C.B.; Hama, R.; Thompson, M.J.; Spencer, E.A.; Onakpoya, I.; Mahtani,
`
`K.R.; Nuhan, D.; Howick, J.; Heneghan, C.J., "Neuraminidase inhibitors
`
`for preventing and treating influenza in healthy adults and children,"
`
`Cochrane Database of Systematic Review,
`
`DOI:10.1002/1465158.CD008965.pub4 PMC 6464969 PMID 24718923
`
`(January 1, 2014). This reference is prior art under 35 U.S.C. § 102.
`
`
`
`Exhibit 1024 (FDA Advisory) - "Safe and Appropriate Use of Influenza
`
`Drugs," Public Health Advisory, U.S. Food and Drug Administration (FDA),
`
`April 20, 2009 - reprinted from January 12, 2000. This reference is prior
`
`art under 35 U.S.C. § 102.
`
`
`
`Exhibit 1025 (FDA Ziagen) - "Information for Healthcare Professionals:
`
`Abacavir (marketed as Ziagen) and Abacavir-Containing Medications,"
`
`8
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`U.S. Food and Drug Administration (FDA), December 11, 2013 - reprinted
`
`from July 24, 2008. This reference is prior art under 35 U.S.C. § 102.
`
`
`
`Exhibit 1026 (Eshkol) - Eshkol N., Sendovski M., Bahalul M., Katz-Esov
`
`T., Kashi Y., Fishman A., "Production of 2-phenylethanol by a stress
`
`tolerant Sacchromyces cerevisiae strain," Jour. Appl. Microbiol, ISSN
`
`1364-5072 (2009) 534-542, 539. This reference is prior art under 35
`
`U.S.C. § 102.
`
`
`
`
`
`Exhibit 1027 (Wiki Phenethanol) - Phenylethyl Alcohol - Wikipedia Page.
`
`This reference is prior art under 35 U.S.C. § 102.
`
`Exhibit 1028 (Yuen) - Yuen, G.J., Weller, S., Parkes, G.E., A Review of
`
`the Pharmacokinetics of Abacavir, Clin. Pharmacokinet 47, 351-371
`
`(2008).
`
` https://doi.org/10.2165/00003088-200847060-00001.
`
` This
`
`reference is prior art under 35 U.S.C. § 102.
`
`9
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`
`
`C.
`
`Relief Requested
`
`Petitioner requests IPR and cancellation of the Challenged Claims on the
`
`specific grounds set forth below, which are supported by the declaration of Dr.
`
`Edward Lemmo (Exhibit 1005).
`
`Ground
`
`1
`
`Claims
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`1
`
`2
`
`3-5
`
`6-7
`
`8-10
`
`Proposed Statutory Rejection
`
`Obvious and unpatentable under 35
`U.S.C. § 103 by Similisan in view of
`Clarot Patent Application Publications
`('107 and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, Dorsch, and Liu
`'574 and further in view of Clarot Patent
`Application Publications ('107 and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch, and
`further in view of Haslwanter '146 and
`Clarot Patent Application Publications
`('440, '066, '107, '924, '343, and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch, and
`further in view of Ariza, Clymer '676, and
`Clarot Patent Application Publications
`('440, '066, '107, '343, and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch, and
`further in view of Clarot Patent Application
`Publications ('107, '343, and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch,
`Clarot Patent Application Publications
`('107 and '628) and further in view of
`Davis.
`
`10
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`Ground
`
`7
`
`8
`
`9
`
`Claims
`
`11-12
`
`13-14
`
`15
`
`10
`
`16-18
`
`Proposed Statutory Rejection
`
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch, and
`further in view of Clarot Patent Application
`Publications ('107, '924, '343, and '628).
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch,
`Clarot Patent Application Publications
`('107 and '628) and further in view of
`Jefferson, Yuen. FDA Advisory, and
`FDA Ziagen.
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, and Dorsch,
`Clarot Patent Applications ('107 and '628)
`and further in view of Eshkol and Wiki
`Phenethanol.
`Obvious and unpatentable under 35
`U.S.C. § 103 over Similasan in view of
`Weiser, Clarke, TeutM, Dorsch, and
`Clarot Patent Applications ('107 and '628).
`
`
`
`
`
`V.
`
`
`
`THE '931 PATENT
`
`The '931 Patent issued on August 11, 2020 from U.S. Patent Application
`
`No. 15/386,318 ["'318 Application"] (Exhibit 1028) filed on December 21, 2016,
`
`which is a continuation of U.S. Patent Application No. 14/699,676 ["'676
`
`Application"] (Exhibit 1029) filed on April 29, 2105, which in turn is a
`
`continuation of U.S. Patent Application No. 14/327,339 [issued as the '401
`
`Patent ] (Exhibit 1030) filed on July 9, 2014, which in turn claimed priority to U.S.
`
`Provisional Application No. 61/930,881 (Exhibit 1031) filed on January 23, 2014.
`
`11
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`
`
`
`
`A.
`
`Specification
`
`The '931 Patent recites methods for reducing the duration of common
`
`cold symptoms using a pharmaceutical composition comprising Luffa Operculata
`
`(L. operculata), S. officinale (V. sabadilla), and Galphimia Glauca (G. glauca).
`
`Use of the composition allegedly reduces the duration of common cold symptoms
`
`"such as nasal congestion, runny nose, watery eyes, dry/scratchy throat, and
`
`sneezing.1
`
`B.
`
`Claims
`
`
`
`Petitioner challenges claims 1-18 under 35 U.S.C. § 103. Claims 1 is
`
`independent reciting methods of reducing the duration of common cold
`
`symptoms using pharmaceutical compositions recited broadly in claim 1. Claims
`
`2-16 recite specific ingredients of the composition that are described generically
`
`in claim 1. Claims 17 and 18 recite administration of the composition.
`
`
`
`
`
`C.
`
`Prosecution History
`
`Claims 1-18 of the '318 Application were amended to overcome 35 U.S.C.
`
`§ 112 rejections allowed by the examiner thereafter.
`
`
`
`
`
`D.
`
`Person of Ordinary Skill in the Art
`
`In his Declaration (Exhibit 1005), Dr. Edward Lemmo opined on the nature
`
`of a person of ordinary skill in the art. It is not necessary for such a person to
`
`have an advanced degree, but rather to have experience in formulating
`
`homeopathic compositions and over-the-counter supplements. Such a person
`
`would be familiar with the literature regarding the efficacy and safety of
`
`homeopathic ingredients as well as recommended dosage ranges.
`
`1 '931 Patent 2:41-48.
`
`12
`
`

`

`Petition for Post Grant Review of U.S. Patent No. 10,736,931
`
`VI.
`
`CLAIM CONSTRUCTION
`
`
`
`Claims in an IPR are construed according to the standard set forth in
`
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R.
`
`§42.100(b).
`
`
`
`
`
`A.
`
`Independent Claim 1
`
`This is a method claim that recites administering a composition to a
`
`human exhibiting common cold symptoms. The active ingredients in the
`
`compositi