UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`ALBAAD MASSUOT YITZHAK, LTD. AND ALBAAD USA, INC.,
`
`Petitioners
`
`v.
`
`EDGEWELL PERSONAL CARE BRANDS, LLC
`
`Patent Owner
`
`U.S. Patent No. 9,192,522
`
`Filed: Mar. 5, 2007
`
`Issued: Nov. 24, 2015
`
`Title: Tampon Assembly Having Shaped Pledget
`
`________________
`
`Inter Partes Review No. IPR2017-0693
`
`________________
`
`PETITION FOR INTER PARTES REVIEW
`
`OF U.S. PATENT NO. 9,192,522
`
`

`
`TABLE OF CONTENTS
`
`Page
`I. INTRODUCTION……………………………………………………….………1
`
`
`
`II. FORMALITIES ................................................................................................. 1
`
`A. Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) ...................................... 1
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2)) .................................................. 1
`
`C. Designation of Counsel (37 C.F.R. § 42.8(b)(3)) and Power of Attorney
`(37 C.F.R. § 42.10(b)) ............................................................................... 2
`
`D. Proof of Service (37 C.F.R. §§ 42.6(e) and 42.105(a)), Service
`Information (37 C.F.R. § 42.8(b)(4)), and Payment of Fees (37 C.F.R. §
`42.103)….. ................................................................................................. 2
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW (37 C.F.R. § 42.104) ... 3
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) .......................................... 3
`
`B.
`
`Identification of Claims Being Challenged (37 C.F.R. § 42.104(b)) and
`Statement of Precise Relief Requested ...................................................... 3
`
`C. Threshold for Inter Partes Review (37 C.F.R. § 42.108(c)) ..................... 4
`
` D. Statement of Non-Redundancy…………………………………………4
`
`IV. THE ‘522 PATENT ........................................................................................... 5
`
`A. Overview ………………………………………………………………..5
`
`B. Summary of the Prosecution History ...................................................... 12
`
`1. Patent Application 10/834,386 – The ‘434 Patent .......................... 12
`
`2. Patent Application 11/713,974 – The ‘522 Patent .......................... 18
`
`C. Person of Ordinary Skill in the Art…………………….………………21
`
`V. CLAIM CONSTRUCTION............................................................................ .22
`
`A. “Plurality of Discrete Petals” (claims 1, 9, 15, 16, 22, 27, 34, 39) ........ 22
`
`i
`
`

`
`
`
`B.
`
`C.
`
`“generally elliptical” and “generally tapered” (claims 1, 8, 9, 14, 15, 21,
`23, 28, 35 and 39) .................................................................................... 25
`
`“ejection force of greater than about 5 ounces less than about 8 ounces”
`(claim15) ………………………………………………………………26
`
`D. “an outer radial dimension that decreases between the distal tip [the front
`end] of said pledget and a plane through said pledget where said taper
`begins” (claim 22, 29 and 34) ................................................................. 26
`
`E.
`
`“said tapered tip [region] contacting [or contacts] and supporting [or
`supports] at least said base regions of said [the] plurality of petals”
`(claims 1, 9, 15, 22, 27, 34, and 39) ........................................................ 27
`
`F.
`
`“first taper ratio” (claims 4, 10, 11, 22, 25, 27, 31, 34, 36, and 37) ....... 30
`
`G. “second taper ratio” (claims 4, 22, 25, 29, 31, 33, 34 and 37) ............... 30
`
`H. “a first long length that enables gradual insertion” (claim 9) ................. 30
`
`I.
`
`J.
`
`“wherein said pledget has a second taper ratio of said outer radial
`dimension at said second plane to a length of said tapered tip between
`said tip end and said second plane, of more than about 0.3 and less than
`about 1.0.” (claims 22 and 34) ................................................................ 31
`
`“said [discrete] petals being separated from each other by a plurality of cuts” (claims
`1, 9, 15, 27, 34, and 39) ................................................................................ 31
`
`VI. ANALYSIS OF THE CHALLENGED CLAIMS ..............................................
`
`A.
`
`Introduction ............................................................................................. 32
`
`1. Tapered Designs Were Not New in 2003 ....................................... 32
`
`2. Minimizing Ejection Force Was a Well-Known Design Parameter
`Before 2003 ..................................................................................... 37
`
`3. Using Cotton and Other Fibers Was Not New in 2003 .................. 39
`
`B. Grounds For Invalidity ............................................................................ 40
`
`1. Ground 1: Claims 1, 2, 4, 7, 8, 9, 10, 12, 14, 22, 23, 25, 27, 28, 29,
`31, 33, 34, 35, 36, 37, and 39 Were Anticipated By U.S. Patent No.
`6,432,075 (“Wada”) ........................................................................ 40
`
`ii
`
`
`

`
`
`
`2. Ground 2: Claims 1, 4, 22, 25, 27, 29, 31, 33, 34, And 37 Of The
`‘522 Patent, Would Have Been Obvious Over Wada And Routine
`Engineering Principles .................................................................... 78
`
`3. Ground 3: Claims 15, 18 And 21 Of The ‘522 Patent, Would Have
`Been Obvious Over Wada And 3,699,962 (Hanke) ....................... 82
`
`4. Ground 4: Claims 15, 18 And 21 Of The‘522 Patent, Would Have
`Been Obvious Over Wada And Common Sense Engineering
`Principles In The Prior Art .............................................................. 85
`
`5. Ground 5: Claim 16 Would Have Been Obvious Over Wada, Hanke
`And U.S. Patent No. 3,433,225 (Voss) ........................................... 86
`
`VII. CONCLUSION ................................................................................................ 89
`
`
`
`iii
`
`
`

`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Bristol-Myers Squibb v. Ben Venue Laboraties,
`
`246 F.3d 1368 (Fed. Cir. 2001) ........................................................................ 38
`
`Brown, v. 3M,
`
`265 F.3d 1349 (Fed. Cir. 2001) ........................................................... 45, 50, 51
`
`Ex Parte LeMay, Gorham, and Jarmon
`
`2008 Pat. App LEXIS 6774 (BPAI 2008)………………...…16, 17, 36, 56, 57
`
`Facebook, Inc. v. Pragmatus AV, LLC,
`
`582 Fed. Appx. 864 (Fed. Cir. 2014) ................................................................ 22
`
`Gardner v. Tec Systems, Inc.,
`
`725 F.2d 1338 (Fed. Cir. 1984) ..................................................................13, 36
`
`Hotchkiss v. Greenwood,
`
`52 U.S. 248 (1850) ............................................................................................ 39
`
`In re Aller,
`
`220 F.2d 454 (CCPA 1955) .............................................................................. 36
`
`In re Boesch,
`
`617 F.2d 272 (CCPA 1980) .............................................................................. 36
`
`In re Geisler,
`
`116 F.3d 1465 (Fed. Cir. 1997) ........................................................................ 35
`
`In re Woodruff,
`
`919 F.2d 1575 (Fed. Cir. 1990) ........................................................................ 35
`
`International Business Machines Corp. v. Intellectual Ventures I LLC,
`
`IPR2014-01385, Paper 64 (Jan. 15, 2016) ........................................................ 22
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`
`134 S.Ct. 2120 (2014) ....................................................................................... 25
`
`Peters v. Active Mfg.,
`
`129 U.S. 530 (1889) .......................................................................................... 45
`
`iv
`
`
`

`
`
`
`Page(s)
`
`Polaroid Corp. v. Eastman Kodak Co.,
`
`789 F.2d 1556 (Fed. Cir. 1986) ........................................................................ 45
`
`Richie v. Vast Res,
`
`563 F.3d 1334 (Fed. Cir. 2009) ........................................................................ 39
`
`Statutes
`
`
`
`35 U.S.C. § 102(b) ..................................................................................................... 3
`
`35 U.S.C. § 103(a) ................................................................................................. 3, 4
`
`35 U.S.C. § 112 ..................................................................................................27, 30
`
`35 U.S.C. § 314(a) ..................................................................................................... 4
`
`35 U.S.C. §102(e) .................................................................................................... 40
`
`
`
`Rules
`
`37 C.F.R. § 42.10(b) .................................................................................................. 2
`
`37 C.F.R. § 42.103 ..................................................................................................... 2
`
`37 C.F.R. § 42.104 ..................................................................................................... 3
`
`37 C.F.R. § 42.104(a) ................................................................................................. 3
`
`37 C.F.R. § 42.104(b) ................................................................................................ 3
`
`37 C.F.R. § 42.105(a) ................................................................................................. 2
`
`37 C.F.R. § 42.108(c) ................................................................................................. 4
`
`37 C.F.R. § 42.15(a) ................................................................................................... 3
`
`37 C.F.R. § 42.24(d)…………………………………………………………..........3
`
`37 C.F.R. § 42.6(e) ..................................................................................................... 2
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 1
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 1
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 2
`
`
`
`v
`
`
`

`
`
`
`LIST OF EXHIBITS
`
`Ex. No.
`
`Description
`
`1001 United States Patent No. 9,192,522, “the ‘522 patent,” issued Nov. 24,
`
`2015, from U.S. App. 11/713,974, Mar. 5, 2007
`
`1002 United States Patent No. 5,964,741, “the ‘741 Patent,” issued Oct. 12,
`
`1999, from U.S. App 09/178,162, Oct. 23, 1998
`
`1003 Office Action, dated September 8, 2005
`
`1004 Gardner v. Tec Systems, Inc., 725 F.2d 1338 (Fed. Cir. 1984, cert.
`
`denied, 469 U.S. 830 (1984))
`
`1005 Applicant’s Response, dated December 8, 2005
`
`1006 Office Action, dated February 15, 2006
`
`1007 Applicants’ Request for Reconsideration, dated April 20, 2006
`
`1008 Advisory Action, dated May 9, 2006
`
`1009
`
`Ex parte LeMay, Gorham, and Jarmon 2008 Pat. App. LEXIS 6774
`
`(BPAI 2008), dated September 24, 2008
`
`1010 Applicants’ Request for Continued Examination, dated November 28,
`
`2008
`
`1011 Office Action, dated May 27, 2009
`
`1012 Applicants’ Amendment, dated November 27, 2009
`
`vi
`
`
`

`
`
`
`1013 Office Action, dated February 18, 2010
`
`1014 Applicants’ Amendment, dated April 22, 2010
`
`1015
`
`Examiner’s Advisory Action, dated May 13, 2010
`
`1016
`
`Examiner’s Non-Final Rejection, dated December 22, 2010
`
`1017 Applicants’ Amendment, dated March 22, 2011
`
`1018 Office Action, dated June 10, 2011
`
`1019 Applicants’ Amendment and Request for Continued Examination, dated
`
`December 12, 2011
`
`1020 Notice of Allowability, dated February 16, 2012
`
`1021 United States Patent No. 8,197,434
`
`1022
`
`Transmittal of new U.S. application 11/713,974, filed March 5, 2007 in
`
`continuation of application 10/834,386, filed April 28, 2004
`
`1023 Office Action, dated July 7, 2009
`
`1024 Applicants’ Amendment, dated December 7, 2009
`
`1025 Office Action, dated March 23, 2010
`
`1026 Applicants’ Amendment after Final Action, dated May 21, 2010
`
`1027 Advisory Action, dated June 1, 2010
`
`vii
`
`
`

`
`
`
`1028 Applicants’ Request for Continued Examination, dated December 17,
`
`2010
`
`1029 Office Action, dated January 17, 2014
`
`1030 Applicants’ Amendment and Remarks, dated July 16, 2014
`
`1031 Office Action, dated October 22, 2014
`
`1032 Applicants’ Amendments, Remarks, and Request for Continued
`
`Examination, dated January 20, 2015
`
`1033 Office Action, dated April 10, 2015
`
`1034 Applicants’ Amendment and Remarks, dated June 18, 2015
`
`1035 Notice of Allowance, dated July 7, 2015
`
`1036 Declaration of Raymond J. Hull, Jr.
`
`1037
`
`Patent Owner’s Initial Infringement Claim Charts, dated August 9, 2016
`
`1038 Oxford English Dictionary definitions for “contact” and “support”
`
`1039 United States Patent No. 2,178,840
`
`1040 United States Patent No. 3,433,225
`
`1041
`
`Photographs of O.B. Tampons
`
`1042 Rely, Soft Petal Tampons
`
`1043 United States Patent No. 6,773,422
`
`viii
`
`
`

`
`
`
`1044 United States Patent No. 6,299,573
`
`1045 United States Design Patent No. 250,663
`
`1046 United States Patent No. 3,674,026
`
`1047
`
`International Publication No. WO 98/06365
`
`1048 United States Patent No. 5,693,009
`
`1049 United States Patent No. 3,429,312
`
`1050 United States Patent No. 3,699,962
`
`1051 United States Patent No. 3,895,634
`
`1052 United States Patent No. 4,857,044
`
`1053 United States Patent No. 5,681,894
`
`1054 United States Patent No. 3,409,011
`
`1055 Menstruation, Menstrual Hygiene and Woman’s Health in Ancient
`
`Egypt by Petra Habiger, dated 1998
`
`[http://www.mum.org/germnt5.htm]
`
`1056 United States Patent No.6,432,075
`
`1057
`
`Second Amended Complaint, dated September 6, 2016
`
`1058 ALBAAD0002079, as produced in the ‘075 and ‘522 patent Litigation
`
`1059 Wikipedia article on Ellipses [https://en.wikipedia.org/wiki/Ellipse]
`
`ix
`
`
`

`
`1060 U.S. Patent No. 3,805,786
`1060
`
`U.S. Patent No. 3,805,786 1061
`
`1061 U.S. Patent No. 5,683,358
`U.S. Patent No. 5,683,358
`
`
`
`x
`
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,192,522
`
`I.
`
`INTRODUCTION
`
`Albaad Massuot Yitzhak, Ltd. and Albaad USA, Inc., (collectively “Albaad”
`
`or “Petitioners”) petition for Inter Partes Review (“IPR”) of claims 1, 2, 4, 7-10,
`
`12, 14-16, 18, 21-23, 25, 27-29, 31, 33-37, and 39 (“the Challenged Claims”) of
`
`U.S. Patent No. 9,192,522 (“the ‘522 patent; Ex. 1001), assigned to Edgewell
`
`Personal Care Brands, LLC (“Patent Owner” or “PO”).
`
`II.
`
`FORMALITIES
`
`A. Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`The real parties-in-interest are Albaad Massuot Yitzhak, Ltd. and Albaad
`
`USA, Inc.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ‘522 patent (Ex. 1001) is a continuation in part (“CIP”) of U.S. App.
`
`10/834,386 filed April 28, 2004 (now U.S. Patent 8,197,434), which claims
`
`priority to provisional application No. 60/467,482, dated May 2, 2003.
`
`Patent Litigation: On January 21, 2016, Patent Owner served a complaint
`
`alleging infringement of the ‘522 patent, and U.S. Patent Nos. 6,432,075 and
`
`9,107,775 (the ’075 and ‘775 patents respectively), Case No. 1:2015-cv-01188-
`
`RGA (D. Del). On August 8, 2016, the Patent Owner filed an Amended Complaint
`
`alleging infringement of the ‘075, ‘522, ‘775 and added U.S. Patent No. 8,551,034
`
`(“the ‘034 patent”).
`
`1
`
`

`
`
`
`On September 6, 2016, Patent Owner filed a Second Amended Complaint
`
`alleging infringement of the ‘075, ‘522 and ‘034 patents. Claims concerning the
`
`‘775 patent were dropped.
`
`Other IPRs: In addition, to this petition, Albaad is filing simultaneously a
`
`Petition concerning the ‘075 patent.
`
`C. Designation of Counsel (37 C.F.R. § 42.8(b)(3)) and Power of
`
`Attorney (37 C.F.R. § 42.10(b))
`
`Lead Counsel: David A. Loewenstein (Reg. No. 35,591) tel. 646-878-0806.
`
`Backup Counsel: Guy Yonay (Reg. No. 52,388); tel. 646-878-0808, both at
`
`Pearl Cohen Zedek Latzer Baratz LLP, 1500 Broadway, 12th Fl., New York, NY,
`
`10036; fax 646-878-0801.
`
`A Power of Attorney accompanies this Petition under 37 C.F.R. § 42.10(b).
`
`D.
`
`Proof of Service (37 C.F.R. §§ 42.6(e) and 42.105(a)), Service
`
`Information (37 C.F.R. § 42.8(b)(4)), and Payment of Fees (37
`
`C.F.R. § 42.103)
`
`This Petition is being served simultaneously with its filing on the
`
`correspondence address for the counsel of record for the ’522 patent and for the
`
`related litigation as stated in the attached Certificate of Service. Please address all
`
`correspondence to Petitioners’ lead counsel at the postal address, telephone and
`
`facsimile numbers shown above and via e-mail to:
`
`
`
`2
`
`

`
`
`
`DLoewenstein@pearlcohen.com and GYonay@pearlcohen.com.
`
`The Director is authorized to charge the fee of $28,600 under 37 C.F.R. §
`
`42.15(a) and any additional fee required for this Petition to Deposit Account 50-
`
`3355.
`
`Petitioners consent to service by email.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`(37 C.F.R. § 42.104)
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioners certify that the ‘522 patent is available for IPR and that
`
`Petitioners are not barred or estopped from requesting IPR challenging the
`
`identified claims on the grounds stated in this Petition.
`
`B.
`
`Identification of Claims Being Challenged (37 C.F.R. § 42.104(b))
`
`and Statement of Precise Relief Requested
`
`Petitioners request the Board to institute an IPR of the Challenged Claims
`
`and to find them unpatentable based on the following:
`
`Ground
`
`Claim(s)
`
`Reference(s)
`
`Statute (Pre-AIA)
`
`1, 2, 4, 7, 8, 9, 10,
`12, 14, 22, 23, 25,
`27, 28, 29, 31, 33,
`34, 35, 36, 37, and
`39
`
`Wada
`
`35 U.S.C. § 102 (e)
`
`4, 22, 25, 27, 29,
`31, 33, 34, and 37
`
`Wada and Common Sense
`Application of Routine
`
`35 U.S.C. § 103
`
`3
`
`1
`
`2
`
`
`
`

`
`Engineering Principles
`
`15, 18 and 21
`
`Wada and Hanke
`
`35 U.S.C. § 103
`
`15, 18 and 21
`
`Wada and Common Sense
`Application of Routine
`Engineering Principles
`
`35 U.S.C. § 103
`
`16
`
`Wada, Hanke and Voss
`
`35 U.S.C. § 103
`
`3
`
`4
`
`5
`
`
`
`C. Threshold for Inter Partes Review (37 C.F.R. § 42.108(c))
`
`As discussed in more detail below, this Petition, including the Declaration of
`
`Raymond J. Hull, Jr. (“Hull”), demonstrate that the Challenged Claims are invalid,
`
`more than satisfying the statutory requirement. See 35 U.S.C. § 314(a).
`
`D.
`
`Statement of Non-Redundancy
`
`The Grounds for rejection are not redundant because each Ground for
`
`rejection bases the rejection on different proofs. Ground 2 raises obviousness
`
`rejections with respect to certain claims in Ground 1, which addresses anticipation.
`
`Grounds 3 and 4 overlap regarding three claims that claim (improperly)
`
`functionality (i.e., ejection force); the secondary reference in Ground 3 is Hanke,
`
`whereas Ground 4 shows ejection force was a well-known design parameter in the
`
`art, and is not limited to Hanke.
`
`4
`
`
`
`
`
`

`
`
`
`IV. THE ‘522 PATENT
`
`A. Overview
`
`The ‘522 patent is entitled a “Tampon Assembly Having a Shaped Pledget,”
`
`which is nothing more than a well-known tubular plastic device that contains the
`
`tampon, called a pledget (element 12 below); the tube (or barrel, element 14) has
`
`several flexible, triangular plastic pieces called a “petals” (elements 26), at the end
`
`of the barrel. The plunger (element 16) pushes the pledget out of the tube, and in
`
`the process expands the “petals.” (Ex. 1001, 3:7-11), allowing the pledget to be
`
`inserted, after which the applicator assembly is withdrawn.
`
`
`
`Ex. 1001, Fig 1; see also Fig. 2, 26 (petals) and Fig. 6, 26 (petals).
`
`The alleged innovation is having a “maximum of three petals,” “a tapered
`
`insertion tip,” and a “tapered pledget” which is said to provide “support to the
`
`petals” (see Ex. 1001, “Summary of the Invention”). “Support” means the pledget
`
`“contacts” the petals’ inner surface, preventing them from collapsing inwardly into
`
`the tube upon insertion. (3:45-46). However, the concept of “support” or
`
`
`
`5
`
`

`
`
`
`“contacts” does not fit the traditional definitions of those words. The pledget’s
`
`radius only needs to be 75% of the barrel’s radius, or only 10% of barrel’s surface
`
`area (see infra, pp. 27-30), which means the pledget need not touch the petal’s
`
`inner surface prior to insertion.
`
`Some claims (see e.g., 2, 4, 22, 27, and 34) have limitations directed to a
`
`“first taper ratio” or a “second taper ratio,” (both terms are undefined in the
`
`specification). However, some claims define them to mean the taper of the barrel’s
`
`insertion tip and the pledget’s tip, respectively. (See e.g., claim 22).
`
`The specification states:
`
`“The taper of [the barrel’s] insertion tip 24 is defined as a
`
`ratio of the maximum radial dimension of insertion tip
`
`24, namely radial dimension 36 at plane 30, divided by
`
`length 34.”
`
`
`
`6
`
`
`
`

`
`
`
`For the purpose of this Petition, Petitioners assume, under the broadest
`
`reasonable interpretation (ignoring any section 112 issues), that this statement
`
`above defines the “first taper ratio” geometrically.
`
`The “second taper ratio” apparently means the pledget tip’s taper ratio. (See
`
`claim 3). The specification states:
`
`“When shaped pledget 12 has a taper ratio (e.g.,
`
`dimension 44 divided by dimension 42) that is greater
`
`than the taper ratio 30 of insertion tip 24, length 42 of
`
`shaped pledget 12 should occupy at least about 50% of
`
`length 34 of insertion tip.”
`
`
`See Figure 4 below:
`
`
`
`7
`
`
`
`

`
`
`
`For the purpose of this Petition, Petitioners will use this geometric
`
`description as the definition of the “second taper ratio.”
`
`Essentially, the “taper ratios” are defined as the fraction:
`
`𝑀𝑎𝑥𝑖𝑚𝑢𝑚 𝑅𝑎𝑑𝑖𝑢𝑠
`𝐿𝑒𝑛𝑔𝑡ℎ
`
`
`
`Claim 22 is representative of the alleged invention (highlights have been
`
`added to illustrate the relevant limitation):
`
` A
`
` tampon assembly, comprising:
`
`
`
` a
`
` barrel region having a single layer plastic tubular wall forming a first end
`and a second end,
`
`
`
`
`said barrel having a plurality of discrete petals at said first end that form an
`insertion tip region,
`
`
`said petals being formed by a plurality of cuts that form a break of material
`through said tubular wall,
`
`
`said petals having an inner surface, each of the plurality of cuts having a
`terminal end adjacent a base region of said plurality of discrete petals,
`
`
`each of said plurality of cuts extending along said barrel region for a first
`length measured from said first end to said terminal end,
`
`
`
`8
`
`
`22.
`
`
`22a.
`
`
`22b.
`
`
`22c.
`
`
`22d.
`
`
`22e.
`
`
`
`
`
`

`
`said insertion tip having an inner surface,
`
`
`said insertion tip region having a first taper ratio defined as a radius of
`said barrel at said base region divided by a length of said insertion tip
`region,
`
`
`said first taper ratio being more than about 0.3 to less than about 1.0
`throughout said insertion tip region;
`
`
` a
`
`
`
` plunger being slidably received in said barrel region; and
`
` a
`
` tapered pledget having an insertion end region that has been compressed
`to form a tapered insertion tip,
`
`
`said tapered tip having a length that is less than said first lengths of said
`plurality of cuts,
`
`
`wherein said tapered tip contacts and supports at least the base regions of
`said plurality of petals adjacent to the terminal ends of said plurality of cuts
`while said tampon assembly is being inserted into said body for mitigating
`against said plurality of petals pinching a user,
`
`
`
`wherein said tapered tip of said pledget has an outer radial dimension that
`decreases between a distal tip end of said pledget and a plane through said
`pledget where said taper begins,
`
`
`
`wherein said pledget has a second taper ratio of said outer radial
`dimension at said plane to a length of said tapered tip between said tip
`end and said second plane, of more than about 0.3 and less than about
`1.0.
`
`
`9
`
`
`
`22f.
`
`
`22g.
`
`
`22h.
`
`
`22i.
`
`
`22j.
`
`
`22k.
`
`
`22l.
`
`22m.
`
`22n.
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`
`
`

`
`
`
`
`
`The “second plane” in 22n is undefined, but presumably means a point
`
`where the pledget changes shape from a straight cylinder (parallel lines in the
`
`drawings above) to the tapered tip (see Figure 4, element 48 above).
`
`Briefly, the other claims share most of the same limitations, some phrased
`
`slightly differently.
`
`Independent claim 1:
`
`“a tapered pledget having an end region that has been
`
`compressed to form a tapered insertion tip that has a
`
`greater density than an adjacent region… supporting at
`
`least said base regions of said plurality of petals adjacent
`
`to said terminal ends of said plurality of cuts…”
`
`
`
`Independent claim 9:
`
`“wherein said barrel region having said tapered insertion
`
`tip provides a first long length that enables gradual
`
`insertion of said barrel region…”
`
`And
`
`“wherein, prior to ejection from said barrel region … an
`
`outer surface of said tapered pledget contacts and
`
`
`
`10
`
`

`
`supports said petals …”
`
`What “gradual insertion” means is undisclosed.
`
`
`
`Independent claim 15:
`
`
`
`“wherein said pledget is ejectable from said barrel region
`
`with an ejection force of greater than about 5 ounces
`
`less than about 8 ounces.”
`
`
`
`Independent claim 27:
`
`Claim 27 is very similar to claim 22, but does not include the wherein
`
`language about the second taper ratio.
`
`
`
`Independent claim 34:
`
`Claim 34 does not have the first taper ratio, but has the wherein clause
`
`concerning the pledget’s second taper ratio.
`
`
`
`Independent claim 39:
`
`“wherein said barrel region has a composition comprising
`
`a blend of about 0 wt. % to about 100 wt. % low-
`
`density polyethylene and about 100 wt. % to about 0
`
`
`
`11
`
`

`
`wt. % thermoplastic elastomer, based on a total weight
`
`of the composition.”
`
`The plain meaning of this limitation includes 100% low-density
`
`
`
`polyethylene.
`
`
`
`B.
`
`Summary of the Prosecution History
`
`On April 28, 2004, application No. 10/834,386 (“the ‘386 application”) was
`
`filed, claiming priority on a May 2, 2003 provisional. (Ex. 1001). On March 5,
`
`2007 application No. 11/713,974 (“the ‘974 application”) was filed as a CIP of the
`
`‘386 application. The ‘386 application issued on June 12, 2012 as U.S. Patent No.
`
`8,197,434. The ‘974 application issued as the ‘522 patent on November 24, 2015.
`
`
`
`1.
`
`The ‘386 Application
`
`The ‘386 application was rejected on September 8, 2005 based on Moder
`
`(USP No. 5,964,741, Ex. 1002), for a variety of reasons. Among other things, the
`
`Examiner stated that Moder had: a plurality of petals; a barrel; a plunger; and a
`
`pledget with a shaped tip “so that said shaped tip supports a portion of said inner
`
`surface area [of the insertion tip].” (Ex. 1003, p. 5*). Moreover, the Examiner
`
`
`* The page numbers refer to the page in the footer following the Exhibit number,
`not the page in the document.
`
`
`
`12
`
`

`
`
`
`stated:
`
`“Mere changes in size or dimensional relationships are
`
`not sufficient
`
`to patentably distinguish a claimed
`
`invention over the prior art.”
`
`(Ex. 1003, p. 7, citing Gardner v. Tec Systems, Inc., 725 F.2d 1338 (Fed. Cir.
`
`1984), cert. denied, 469 U.S. 830 (1984)) (copy at Ex. 1004).
`
`The two figures at issue in Moder are (Ex. 1003, pp. 5 and 6)
`
`
`
`
`
`13
`
`

`
`
`
`In a December 8, 2005 response, Applicants argued:
`
`
`
`“Moder fails to illustrate or describe the pledget in place
`
`in the telescoping tubes in the Figures. Thus, Moder does
`
`not disclose or suggest that the pledget is disposed in the
`
`barrel so that the shaped tip supports a portion of the
`
`inner surface area of the insertion tip, as provided by
`
`claim 11[similar to the “supporting” limitations above]”
`
`(Ex. 1005, p. 9, ¶ 1)
`
`Applicants repeatedly argued that the device’s “perceived and actual level of
`
`comfort” was superior to Moder. (Ex. 1005; pp. 10, ¶ 4; 12, ¶¶ 1 and 3). However,
`
`the ‘522 patent’s specification includes no empirical data, and what a “perceived,”
`
`
`
`14
`
`

`
`
`
`as opposed to an “actual,” level of comfort is, is not described anywhere in the
`
`specification or file history. (Ex. 1005, pp. 10 and 12).
`
`On February 15, 2006, the Examiner issued a final rejection, rejecting the
`
`claims again for substantially the same reasons. With respect to the “supporting”
`
`limitations, the Examiner noted: “the pledget (14) is pushed up against the inside
`
`petals (109) when pressure is applied to the plunger (35), thus providing support
`
`until it is [sic] the plunger (35) is pressed hard enough to finally expel the pledget
`
`(14)…” (Ex. 1006, p. 9).
`
`On April 17, 2006, the Applicants filed a Request for Reconsideration,
`
`reiterating many of the same arguments, including arguing that Moder had a
`
`“conventional blunt end as clearly shown in Figures 1, 4, 13, 15 and 47.” (Ex.
`
`1007, pp. 8, ¶¶ 1 and 5).
`
`On May 9, 2006, the Examiner rejected that assertion “because the tip of
`
`Moder is tapered (fig 47),” and concluded “[t]he asserted difference is that the
`
`instant invention has an increased taper which facilitates pushing through the
`
`petals. This asserted difference is merely one of degree, the device does not
`
`perform in a different manner.” (Ex. 1008, p. 3).
`
`The Applicants appealed on August 28, 2006. Following briefing, the Board
`
`affirmed the Examiner’s rejection of all claims. The Board held that Moder
`
`disclosed a tapered pledget, and a contrary assertion was “erroneous.” The Board
`
`
`
`15
`
`

`
`
`
`also held that Moder’s pledget occupied “at least 90% of the volume of the barrel
`
`insertion tip and very close to 100% of the petals inner surfaces when the pledget is
`
`push through to the tip.” (Ex parte LeMay, Gorham, and Jarmon 2008 Pat. App.
`
`LEXIS 6774 at *14 (BPAI 2008); copy at Ex. 1009).
`
`The Board rejected all claims and held (copy at Ex. 1009; emphasis added):
`
`“Appellants’ specific arguments to the claimed ratio
`
`facilitating insertion comfort (Appeal Br. 11) goes to the mode
`
`of operation of the device and does not present factual evidence
`
`and/or comparative data sufficient to rebut the prima facie case
`
`of unpatentablity established by the Examiner … (p. *13)
`
`The Examiner found and it uncontested that at at least
`
`some point in the insertion process, the underlying surfaces of
`
`the petals 109 in Moder are supported when the pledget in
`
`pushed through the petals. (FF8). The Examiner also found that
`
`the applicator in Moder and that of Appellants’ perform in a
`
`similar manner (FF 9) and thus the percentage of contact
`
`between the pledget and barrel tip surfaces does not patentably
`
`distinguish the claims from the prior art.” (p. *14)
`
`*
`
`*
`
`*
`
` “We conclude the selection of a shaped tip with relative
`
`
`
`16
`
`

`
`
`
`dimensions defined in claims 8, 9 and 14 is no more than a
`
`matter of obvious design choice for a person of ordinary skill in
`
`this art.” (p. *15).
`
`Claim 1 on appeal (from which 8, 9 and 14 depended) included a limitation
`
`“a first taper ratio of more than about 0.3 to less than 1.0.” The Board held that
`
`Moder met this limitation. (Ex. 1009, p. 11).
`
`The BPAI’s findings and conclusions should be binding here.
`
`Applicants then filed a Request for Continued Examination (“RCE”). (Ex.
`
`1010). A different Examiner rejected all claims in the RCE on May 27, 2009,
`
`based on a new reference, Rentmeester (USP 5,792,096). (Ex. 1011, pp. 3 and 5).
`
`On November 25, 2009, Applicants filed an Amendment and argued that
`
`Rentmeester “only provides pleats… and does not disclose or suggest petals...”
`
`(Ex. 1012, p. 6; emphasis in original). Those amended claims were rejected on
`
`February 18, 2010. (Ex.1013). The Examiner said, that Rentmeester disclosed a
`
`pledget with a tapered tip “that is in contact with the inner surface of the insertion
`
`tip…” and is “fully capable of preventing collapsing petals…” (Ex.1013, p. 4).
`
`On April 22, 2010, Applicants filed an Amendment after Final. (Ex. 1014).
`
`However, the application was not in condition for allowance. (Ex. 1015, p. 2).
`
`All claims were rejected on December 22, 2010. (Ex. 1016).
`
`On March 22, 2011, Applicants filed an Amendment; all claims were finally
`
`
`
`17
`
`

`
`
`
`rejected on June 10, 2011. (Ex. 1018).
`
`Applicants filed an amendment and RCE on December 12, 2011, amended
`
`the claims to further describe the petals as “discrete” with “cuts that form a break
`
`of material.” (Ex. 1019, p. 3). A Notice of Allowability was issued on February
`
`12, 2012. (Ex. 1020).
`
`U.S. Patent No. 8,197,434 issued on June 12, 2012. (Ex. 1021).
`
`2.
`
`The ‘974 Application
`
`On March 5, 2007,