UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`CORPAK MEDSYSTEMS, INC. and HALYARD HEALTH, INC,
`Petitioners
`
`v.
`
`KIRN MEDICAL DESIGN, L.L.C.,
`Patent Owner
`
`_______________
`
`Inter Partes Review No. IPR2017-00646
`Patent 6,631,715
`
`_______________
`
`
`
`EXCLUSIVE LICENSEE APPLIED MEDICAL TECHNOLOGY, INC.’S
`PRELIMINARY RESPONSE UNDER 37 C.F.R. § 42.107
`
`
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`CORPAK Ex 1015, Page 11
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`

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`TABLE OF CONTENTS
`
`Case IPR2017-00646
`Patent 6,631,715
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`
`
`I.
`
`II.
`
`Introduction ................................................................................................ 1
`
`The Person of Ordinary Skill in the Art ..................................................... 5
`
`III. Claim Construction ..................................................................................... 5
`
`A. The Phrase “Snapping the at Least One Tube into a Channel Formed
`in a Receiver” Means that Snapping Occurs With Respect to a Tube
`and a Channel ........................................................................................ 7
`
`B. The Term “Snapping” Is Used According to Its Ordinary and
`Customary Meaning of Joining of Two Parts Based on a Brief
`Deformation of One or Both Parts Being Joined ................................ 13
`
`C. “Snapping the at Least One Tube into a Channel Formed in a
`Receiver” Thus Means “Joining of a Tube and a Receiver, at a
`Channel Formed in the Receiver, Based on a Brief Deformation of the
`Tube and/or the Receiver, at an Opening into the Channel” .............. 18
`
`IV. The Petition Fails to Show a Reasonable Likelihood that Any Claim of
`the ‘715 Patent is Unpatentable ................................................................ 19
`
`A. Ground 1: Claim 18 Is Not Anticipated by Ballantyne Because
`Ballantyne Fails to Disclose Snapping a Tube into a Channel Formed
`in a Receiver ........................................................................................ 19
`
`B. Ground 2: Claim 18 Is Not Obvious Over Ballantyne Because
`Ballantyne Fails to Teach or Suggest Snapping a Tube into a Channel
`Formed in a Receiver .......................................................................... 27
`
`C. Ground 3: Claim 18 Is Not Obvious Over Ballantyne, in view of the
`‘448 Patent, Because Ballantyne, in view of the ‘448 Patent, Also
`Fails to Teach or Suggest Snapping a Tube into a Channel Formed in
`a Receiver ............................................................................................ 31
`
`D. Ground 4: Claim 18 Is Not Obvious Over Ballantyne, in view of the
`‘199 Patent and the ‘538 Patent, Because Ballantyne, in view of the
`‘199 Patent and the ‘538 Patent, Also Fails to Teach or Suggest
`Snapping a Tube into a Channel Formed in a Receiver ...................... 34
`
`V. Objective Evidence of Nonobviousness ................................................... 35
`
`VI. Conclusion ................................................................................................ 35
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`
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`ii
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`Case IPR2017-00646
`Patent 6,631,715
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`TABLE OF AUTHORITIES
`
`Cases
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2144–46 (2016)..................................................................... 6
`
`D’Agostino v. Mastercard Int’l, Inc.,
`No. 2016-1592, slip op. at 5 (Fed. Cir. Dec. 22, 2016) ................................... 6
`
`
`Google, Inc. et al. v. EVERYMD.COM LLC, No. IPR2014-00347
`Paper 9 at 24-25 (P.T.A.B. May 22, 2014) ...................................................... 2
`
`Graham v. John Deere Co.,
`383 U.S. 1, 17-18 (1966) ............................................................................... 27
`
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249, 1257 (Fed. Cir. 2007) ............................................................. 6
`
`In re Van Os,
`No. 2015-1975, slip op. at 5 (Fed. Cir. January 3, 2017) ........................ 31, 33
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 418 (2007) ........................................................................ 27, 29
`
`
`Net Moneyin, Inc. v. Verisign, Inc.,
`545 F.3d 1359, 1371 (Fed. Cir. 2008) ........................................................... 19
`
`Statutes
`
`35 U.S.C. § 312(a) .................................................................................................... 1
`
`35 U.S.C. § 314(a) ..................................................................................................... 1
`
`Other Authorities
`
`37 C.F.R. § 42.22(a)(2) ............................................................................................. 2
`
`37 C.F.R. § 42.100(b) ............................................................................................... 6
`
`37 C.F.R. § 42.104(b)(4) ....................................................................................... 2, 5
`
`
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`iii
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`Case IPR2017-00646
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`LIST OF EXHIBITS
`
`Description
`Ticona, “Design Calculations for Snap Fit Joints in Plastic Parts,” 2009
`
`Exhibit
`2001
`
`2002
`
`Ticona, “Snap-Fits for Assembly and Disassembly,” revised Jan. 2001
`
`Santa Clara University Engineering Design Center, “Design for
`
`Assembly,”
`
`2003
`
`http://www.dc.engr.scu.edu/cmdoc/dg_doc/develop/design/part/3300000
`
`4.htm (last visited April 20, 2017)
`
`Gunter Erhard, “Flexing Elements,” in Designing with Plastics, 311-
`
`2004
`
`324, 2006
`
`2005 BASF, “Design Solutions Guide,” 2007
`
`Bayer Material Science LLC, “Snap-Fit Joints for Plastics – A Design
`
`Guide”
`
`2006
`
`http://fab.cba.mit.edu/classes/S62.12/people/vernelle.noel/Plastic_Snap_
`
`fit_design.pdf (last visited April 20, 2017)
`
`Stephen Mraz, “Fundamentals of Annular Snap-Fit Joints,” Machine
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`2007
`
`Design, Jan. 6, 2005
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`
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`iv
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`CORPAK Ex 1015, Page 14
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`Case IPR2017-00646
`Patent 6,631,715
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`
`I.
`
`Introduction
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`Exclusive Licensee Applied Medical Technology, Inc. (“AMT”) respectfully
`
`submits this Preliminary Response to the Petition of Corpak Medsystems, Inc. and
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`Halyard Health, Inc. (collectively “Petitioners”) seeking inter partes review of
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`claim 18 of United States Patent No. 6,631,715 (“the ‘715 patent,” Ex. 1001) on
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`four Grounds (“Petition” or “Pet.”).
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`Claim 18 of the ‘715 patent is directed to a method of placing and securing
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`at least one tube through a nose into a patient, and includes a step of “snapping the
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`at least one tube into a channel formed in a receiver.” The Petition is fatally
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`flawed because it effectively ignores that the claim requires snapping the tube
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`into a channel, not snapping two pieces of a clip together.
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`To merit institution, a petition must establish “a reasonable likelihood that
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`the petitioner would prevail with respect to at least 1 of the claims challenged in
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`the petition.” 35 U.S.C. § 314(a). In particular, a petition “may be considered only
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`if . . . the petition identifies, in writing and with particularity, each claim
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`challenged, the grounds on which the challenge to each claim is based, and the
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`evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. §
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`312(a). To meet these requirements, the Board’s rules specify that a petition for
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`inter partes review must identify how the challenged claims are unpatentable under
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`the statutory grounds asserted by Petitioner, and must specify where each element
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`
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`1
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`CORPAK Ex 1015, Page 15
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`of the claim is found in the prior art patents or printed publications relied upon. 37
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`C.F.R. § 42.104(b)(4). A petition must include “a detailed explanation of the
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`significance of the evidence including material facts . . . .” 37 C.F.R. §
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`42.22(a)(2). Summarizing and quoting from alleged prior art, without providing an
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`explicit correlation between the references and the limitations of a challenged
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`claim, is not sufficient to sustain a petition for inter partes review. See, e.g.,
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`Decision Denying Inter Partes Review (Paper 9) at 24-25, Google, Inc. et al. v.
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`EVERYMD.COM LLC, No. IPR2014-00347 (P.T.A.B. May 22, 2014).
`
`Yet in this case, none of the references cited in Grounds 1-4, whether
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`considered alone or in combination, discloses, teaches, or otherwise suggests the
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`claim element “snapping the at least one tube into a channel formed in a receiver.”
`
`Petitioners argue that the disclosure by United States Patent No. 5,185,005
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`(“Ballantyne,” Ex. 1002) of an anchoring clip comprising two pieces which are
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`snap-fitted together, upon the ends of a bridle and perhaps also upon a tube, such
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`that the ends of the bridle and the tube are secured within such a clip, e.g., by
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`compression and friction means, corresponds to the step of “snapping” the feeding
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`tube into a “receiver” as disclosed in Claim 18 and in the specification of the ‘715
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`patent. Pet. 20. Petitioners’ argument is deficient.
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`Claim 18 specifically recites snapping at least one tube into a channel
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`formed in a receiver. The claim thus requires that snapping, or joining of two
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`2
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`parts based on a brief deformation of one or both parts being joined, occurs
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`with respect to a tube and a channel formed in the receiver in particular. The
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`deformation must involve the tube and/or the receiver, at the channel. The
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`deformation also must be brief. This is so regardless of whether or how two pieces
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`of an anchoring clip may be snap-fitted together. This also is so whether or not the
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`two pieces of the anchoring clip are snap-fitted together upon a tube.
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`Petitioners directly address the term “channel” only two times in their
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`arguments throughout the entire Petition. Pet. 20-21, 40. The first time is in a
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`comparison of Ballantyne’s disclosure of “an anchoring clip 12 [that] comprises
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`two pieces which are snap-fitted together upon the ends 20, 22 of bridle 10 and
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`perhaps also upon tube 18,” with Patentee’s own disclosure that “[c]hannels are
`
`provided for receiving the nasal tube and flexible member in a snap-fit matter.”
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`See, Pet. 20-21 (quoting Ex. 1002 at col. 8, ll. 6-17; Ex. 1001 at 1 (Abstract)). But
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`Petitioners’ comparison is flawed. The disclosure of Ballantyne cited by
`
`Petitioners as support only specifically discloses securing the tube within the clip
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`by compression and friction means. See, Ex. 1002 at col. 8, ll. 15-17. Unlike a
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`snap fit, as disclosed in the ‘715 specification and as commonly defined in
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`technical references, the deformation of the tube according to Ballantyne would
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`not be brief, but rather sustained, beginning as the two pieces of the clip are
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`3
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`snapped together, and then continuing so long as the two pieces of the clip remain
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`snapped together. That is not snapping a tube into a channel.
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`The second time that Petitioners directly address the term “channel” is in a
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`statement that “Ballantyne discloses ‘snapping . . . the tube into a channel’ as it
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`discloses an ‘anchoring clip 12’ that ‘snap-fits’ over the bridle and the tube.” Pet.
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`40. This statement is based on the same flawed comparison involving an
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`anchoring clip that comprises two pieces that are snap-fitted together, and thus is
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`incorrect.
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`Throughout the rest of the Petition, other than quoting claim 18 in its
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`entirety once in the “Overview,” and repeating the claim within various claim
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`charts, the Petitioners avoid mentioning the term “channel” at all. See, e.g., Pet. 9
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`(“Claim 18 recites elements directed to the aforementioned method adding only the
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`limitation that ‘at least one tube’ is ‘snapp[ed]’ into the receiver). Instead
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`Petitioners conflate snapping two pieces of a clip together, upon a tube, with
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`snapping a tube into a channel. This is not an explanation.
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`Petitioners thus fail to explain how Ballantyne, whether considered alone or
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`in combination with the other references submitted, discloses, teaches, or otherwise
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`suggests “snapping at least one tube into a channel formed in a receiver,” as
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`required by claim 18, and indeed Ballantyne, whether considered alone or in
`
`combination with the other references, does not. Thus, Petitioners’ analysis is
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`4
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`CORPAK Ex 1015, Page 18
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`deficient under 37 C.F.R. § 42.104(b)(4). The Petition has not established a
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`reasonable likelihood that the Petitioners would prevail with respect to claim 18.
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`Accordingly, AMT requests that the Board deny the Petition.
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`II. The Person of Ordinary Skill in the Art
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`For the purposes of this Preliminary Response, AMT adopts Petitioners’
`
`proposed definition of a person of ordinary skill in the art, which would have been
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`someone with at least: (1) a bachelor’s degree in biology, bioengineering,
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`biomedical engineering, zoology, or equivalent, with at least five years of relevant
`
`work experience, or (2) a more advanced degree, such as a master’s of science,
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`with fewer years of experience. Pet. 10-11; Ex. 1004 at ¶¶ 34-35. To the extent
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`necessary, the person of ordinary skill also would have collaborated with those
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`having ordinary skill in other areas including biological sciences, engineering,
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`medical device manufacturing, and/or design along with knowledge of the
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`scientific literature in the field. Pet. 10-11; Ex. 1004 at ¶¶ 34 -35.
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`III. Claim Construction
`
`Claim 18 of the ‘715 patent is directed to a method of placing and securing
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`at least one tube through a nose into a patient comprising, among other steps,
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`“snapping the at least one tube into a channel formed in a receiver.” Ex. 1001 at
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`col. 9, ll. 8-22.
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`
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`5
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`Claim terms should be given their broadest reasonable interpretation in light
`
`of the specification of the patent and assigned their ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in the art at the time of
`
`the invention, in the context of the entire patent disclosure. 37 C.F.R. § 42.100(b);
`
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016); In re
`
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Claims should
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`always be read in light of the specification and teachings in the underlying patent.
`
`D’Agostino v. Mastercard Int’l, Inc., No. 2016-1592, slip op. at 5 (Fed. Cir. Dec.
`
`22, 2016). The specification is the single best guide to the meaning of a disputed
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`term. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
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`Petitioners have not expressly proposed constructions for any claim terms.
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`Pet. 10. However, Petitioners’ arguments are premised on an interpretation of the
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`phrase “snapping the at least one tube into a channel formed in a receiver” that
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`fails to account for snapping a tube into a channel, and that thus is inconsistent
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`with the broadest reasonable interpretation of the claim terms. Specifically, as
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`noted above, Petitioners provide only a flawed comparison of Ballantyne’s
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`disclosure of an anchoring clip that comprises two pieces that are snap-fitted
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`together, perhaps upon a tube, with Patentee’s disclosure of channels provided for
`
`receiving a nasal tube in a snap-fit matter. Pet. 20-21. Petitioners provide no other
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`specific explanation as to how Ballantyne, whether considered alone or in
`
`
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`6
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`CORPAK Ex 1015, Page 20
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`combination with the other references submitted, would disclose, teach, or
`
`otherwise suggest snapping at least one tube into a channel formed in a receiver.
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`Accordingly, AMT requests that the Board construe the phrase “snapping the at
`
`least one tube into a channel formed in a receiver.”
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`A. The Phrase “Snapping the at Least One Tube into a Channel
`Formed in a Receiver” Means that Snapping Occurs With
`Respect to a Tube and a Channel
`
`As noted, claim 18 recites “snapping the at least one tube into a channel
`
`formed in a receiver.” Properly construed, this means that snapping occurs with
`
`respect to a tube and a channel.
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`This is apparent based on the express language of claim 18, which
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`specifically refers to a tube and a channel, and provides for snapping the tube into
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`the channel. Ex. 1001 at col. 9, ll. 8-22.
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`This also is apparent based on the ‘715 specification, which discloses, in the
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`“Summary of the Invention,” “a receiver for securing [a] tube and [a] flexible
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`member,” and indicates that the receiver includes a channel having an opening, and
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`that “[a]t least portions of the channel opening, and preferably all of the opening,
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`are smaller than an outer diameter of the tube for receiving and securing, or
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`snapping, the tube into place.” Ex. 1001 at col. 2, ll. 31-40. The ‘715 specification
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`explains snapping a tube into a channel formed in a receiver as follows:
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`
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`7
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`CORPAK Ex 1015, Page 21
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`The preferred receiver 24 further includes a first channel 30
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`formed in member 25 for receiving the nasal tube T1. Preferably, the
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`channel 30 includes an opening along an axial direction thereof
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`which is smaller along at least portions of its length than an outer
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`diameter of the nasal tube T1 for securing the tube in the channel.
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`In other words, the size of the axial opening allows the nasal tube
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`T1 to be snapped into place. Advantageously, this significantly
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`simplifies the placement of the nasal tube T1 within the receiver 24
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`during installation.
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`Ex. 1001 at col. 5, ll. 23-32 (emphasis added).
`
`As can be seen, the ‘715 specification indicates that the receiver includes a
`
`channel that has an opening that is smaller than an outer diameter of a nasal tube
`
`that will be secured in the channel, and that this means that the nasal tube thus can
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`be snapped into place, i.e. into the channel. The ‘715 specification also indicates
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`that this significantly simplifies placement of the nasal tube within the receiver.
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`The specification also explains that “[i]n the present preferred method, the
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`step of securing the tube T1 includes the step of snapping the tube into a channel
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`30 formed in the receiver 24.” Ex. 1001 at col. 7, ll. 8-11 (emphasis added).
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`Accordingly, the specification also expressly describes this feature in terms of a
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`method step, and uses the same terms as in claim 18 itself in doing so.
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`The significance of these disclosures of the ‘715 specification to proper
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`interpretation of the terms of claim 18 can be appreciated by comparison with other
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`8
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`CORPAK Ex 1015, Page 22
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`disclosures of the ‘715 patent that provide further context. For example, regarding
`
`structure and operation of the receiver 24, the ‘715 specification explains, with
`
`reference to FIGS. 4 and 5 (reproduced below) that the receiver can consist of a
`
`body having first and second pivotally connected member portions, and that the
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`first and second member portions of the body can be snap-fitted together after
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`snapping of the tube into the channel, as follows:
`
`With reference to FIGS. 4 and 5, there is shown a receiver 24 for
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`securing the nasal tube T1 and the end portions 11 and 12 of the
`
`flexible tube 10. In the present preferred embodiment of the
`
`invention, the receiver consists of a molded plastic main body
`
`having first and second pivotally connected member portions 25
`
`and 26. The members 25 and 26 are connected by a living hinge 27
`
`formed during molding of the receiver 24. Integrally formed snap-
`
`type locking hooks 28 extend from member 25 and mating holes 29
`
`are formed in member 26 for firmly securing the members together
`
`following placement of the nasal tube T1 and end portions 1 and 12
`
`during use.
`
`Ex. 1001 at col. 5, ll. 8-19 (emphasis added).
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`9
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`Case IPR2017-00646
`Case IPR2017-00646
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`Patent 6,631,715
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`
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`Ex. 1001 at FIG. 4.
`EX. 1001 at FIG. 4.
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`10
`10
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`
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`Ex. 1001 at FIG. 5.
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`The ‘715 specification also indicates that “[a] mating channel 31 may be
`
`formed in member 26,” and that “[p]referably, the channels 30 and 31 form a hole
`
`through the receiver 24 which firmly grasps the exterior of the nasal tube T1 to
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`prevent dislodgement by the patient or otherwise and without occluding the lumen
`
`of the tube.” Ex. 1001 at col. 5, ll. 32-36. Fig. 7d (reproduced below) provides a
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`cross-sectional view showing “the flexible member after placement in the nose,
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`trimming of the ends of the flexible member, placement of the nasal tube, and
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`application of the receiver.” Ex. 1001 at col. 3, l. 65, to col. 4, l. 8.
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`
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`11
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`
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`Ex. 1001 at FIG. 7d.
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`These disclosures of the ‘715 specification and figures make clear that
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`snapping a tube into a channel formed in a receiver is distinct from securing
`
`first and second members of the receiver together by use of snap-type locking
`
`hooks and mating holes thereof. Fig. 4 shows channel 30 having an opening
`
`smaller than the inner diameter of channel 30. Fig. 5 shows that upon closing the
`
`receiver 24, channel 30 and mating channel 31 align to form a hole that has the
`
`same inner diameter as channel 30. Fig. 7d shows a nasal tube T1 positioned
`
`within the hole. As can be seen by comparison of FIG. 4 and FIG. 7d, the nasal
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`tube T1 appears to have an outer diameter approximately equal to the inner
`
`diameter of the hole, and thus approximately equal to the inner diameter of channel
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`
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`12
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`30 and larger than the opening of channel 30. Importantly, although the ‘715
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`specification discloses that the receiver can include integrally formed snap-type
`
`locking hooks and mating holes for firmly securing first and second members
`
`together, the specification makes clear that it is advantageous to first place the
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`nasal tube T1 in the receiver by snapping the nasal tube T1 into a channel as
`
`described above, and then to secure the first and second members of the
`
`receiver together. See, Ex. 1001 at col. 5, ll. 15-19, 23-32. This can be
`
`accomplished by snapping a nasal tube T1 through an opening of channel 30 that is
`
`smaller than the outer diameter of the nasal tube T1, such that the nasal tube T1
`
`becomes positioned within the channel 30, before securing the first and second
`
`members of the receiver 24 together. See, Ex. 1001 at col. 5, ll. 15-19, 23-32, FIG.
`
`4, FIG. 7d.
`
`B. The Term “Snapping” Is Used According to Its Ordinary and
`Customary Meaning of Joining of Two Parts Based on a Brief
`Deformation of One or Both Parts Being Joined
`
`Considering interpretation of the phrase “snapping at least one tube into a
`
`channel formed in a receiver” in more detail, the ‘715 specification refers to the
`
`receiver as including a channel with an opening that is “smaller than an outer
`
`diameter of the tube for receiving and securing, or snapping, the tube into place.”
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`Ex. 1001 at col. 2, ll. 37-40 (emphasis added). This is consistent with the ordinary
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`and customary meaning of “snapping” as joining of two parts based on a brief
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`13
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`deformation of one or both parts being joined. Numerous technical references that
`
`are directed to designing plastic parts for joining and assembly describe snap-fit
`
`joints in these terms.
`
`For example, a design guide published by Ticona, “Design Calculations for
`
`Snap Fit Joints in Plastic Parts,” 2009, describes snap-fits as formfitting joints. Ex.
`
`2001 at 3. According to the guide, “[a]ll these joints basically involve a projecting
`
`lip, thicker section, lugs or barbed legs moulded on one part which engage in a
`
`corresponding hole, recess or undercut in the other.” Ex. 2001 at 3. The guide
`
`indicates that “[d]uring assembly, the parts are elastically deformed,” and that “[i]n
`
`the majority of applications, the joints are not subject to permanent loads (e.g. from
`
`internal pressure).” Ex. 2001 at 3. Also for example, another reference of Ticona,
`
`“Snap-Fits for Assembly and Disassembly,” 2000, indicates that “[t]here are a
`
`wide variety of snap-fit joint designs,” with cantilever beams and cylindrical snap-
`
`fit joints being the most often used designs. Ex. 2002 at 1.
`
`Also for example, a technical reference published by the Santa Clara
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`University Engineering Design Center, titled “Design for Assembly,” describes
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`snap fit joints as follows:
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`Snap-fit joints rely on the ability of a plastics [sic] part to be
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`deformed, within the proportional limit, and returned to its original
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`shape when assembly is complete. As the engagement of the parts
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`continues, an undercut relieves the interference. At full engagement,
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`there is no stress on either half of the joint. The maximum interference
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`during assembly should not exceed the proportional limit. After
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`assembly, the load on the components should only be sufficient to
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`maintain the engagement of the parts.
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`Ex. 2003 at 3/9.
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`Also for example, a book chapter of Gunter Erhard, “Flexing Elements,” in
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`Designing with Plastics, 2006, explains that as snap-fit features are being
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`assembled, the assembly force follows a characteristic pattern, such that “[a]fter a
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`steep rise, the assembly force reaches a peak, falls to a lower level where it remains
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`fairly constant as the lead angle causes the part to deform, and then falls back to
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`zero, once the joint area of the part snaps into place.” Ex. 2004 at 314. An
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`example of the characteristic pattern of the assembly force is as follows:
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`Ex. 2004 at 316, FIG. 8.11.
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`The general information about snap-fit joints quoted above would have been
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`familiar to a person of ordinary skill in medical device manufacturing and/or
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`design as of the filing date of the ‘715 patent.
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`Accordingly, a person of ordinary skill, reading the claim in light of the
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`specification and the common meaning of the snap-fit joints, would understand
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`that the deformation associated with two parts being joined relates specifically to
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`deformation of snap-fit features of the parts being joined, at the snap-fit joint, not
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`to deformation of other features or parts remote from the snap-fit joint. This is
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`apparent because the references refer to snap-fit joints and features of parts, such
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`as a projecting lip, a thicker section, lugs, or barbed legs, which are joined to create
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`the joints. See, Ex. 2001 at 3; see also, Ex. 2005 at V-2; Ex. 2006 at 3. Thus, with
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`reference to the ‘715 specification, snapping a tube into a channel formed in a
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`receiver would be understood to involve deformation of the tube and/or the
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`receiver, at an opening into the channel. Also, with reference to Ballantyne,
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`joining two pieces of an anchoring clip together, based on a snap-fit feature, would
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`be understood to involve snapping the two pieces of the clip together, not snapping
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`a tube and the clip together as Petitioners apparent interpretation would suggest.
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`This would be so whether or not a tube was positioned between the two pieces of
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`the clip.
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`A person of ordinary skill also would understand that the deformation
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`associated with the two parts being joined would be brief. This is apparent because
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`the references highlight that deformation occurs during assembly, that snap-fit
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`joints rely on the ability of a plastic part to be deformed, then returned to its
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`original shape when assembly is complete, and that assembly force reaches a peak,
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`falls to a lower level as a lead angle causes a part to deform, and then falls back to
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`zero once the joint area of the part snaps into place. See, Ex. 2001 at 3; Ex. 2003 at
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`3/9; Ex. 2004 at 314; see also, Ex. 2007 at 1/9. Thus, with reference to the ‘715
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`specification, snapping a tube into a channel formed in a receiver would be
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`understood to include a deformation of the tube and/or receiver, at an opening into
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`the channel, which is brief, lasting just during the operation of joining the tube and
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`the receiver at the channel, not for an extended period. This stands in contrast to
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`compression and friction means based on snapping two pieces of a clip together,
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`upon a tube, as Petitioners’ apparent interpretation would suggest.
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`Patentee’s use of “snapping” in claim 18 and the ‘715 specification is
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`consistent with this ordinary and customary meaning. As noted above, the ‘715
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`specification explains that the channel includes an opening along an axial direction
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`thereof that is smaller along at least portions of its length than an outer diameter of
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`the nasal tube for securing the tube in the channel, or in other words, that the size
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`of the axial opening allows the nasal tube to be snapped into place. Ex. 1001 at
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`col. 2, ll. 37-40, col. 5, ll. 23-32. Moreover, the channel and the tube are returned
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`to their original shapes when assembly is complete. See, Ex. 1001 at FIGS. 4, 5,
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`and 7. Accordingly, placing the nasal tube into the channel through the axial
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`opening would involve deformation of the tube and/or the receiver, at the channel,
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`and the deformation would be brief.
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`C. “Snapping the at Least One Tube into a Channel Formed in a
`Receiver” Thus Means “Joining of a Tube and a Receiver, at a
`Channel Formed in the Receiver, Based on a Brief Deformation of
`the Tube and/or the Receiver, at an Opening into the Channel”
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`For the reasons provided above, the broadest reasonable interpretation of
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`“snapping” that is consistent with the ‘715 specification and understanding of the
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`term by one of ordinary skill in the art is “joining of two parts based on a brief
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`deformation of one or both parts being joined.” As discussed, the phrase
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`“snapping the at least one tube into a channel formed in a receiver” means that
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`snapping occurs with respect to a tube and a channel. Accordingly, the broadest
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`reasonable interpretation of “snapping the at least one tube into a channel formed
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`in a receiver” is “joining of a tube and a receiver, at a channel formed in the
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`receiver, based on a brief deformation of the tube and/or the receiver, at an opening
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`into the channel.”
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`18
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`IV. The Petition Fails to Show a Reasonable Likelihood that Any Claim of
`the ‘715 Patent Is Unpatentable
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`Petitioner proposes four grounds of unpatentability. Pet. 12, 28, 40, 51.
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`Case IPR2017-00646
`Patent 6,631,715
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`Ground 1. Claim 18 is anticipated by Ballantyne.
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`Ground 2. Claim 18 is obvious over Ballantyne.
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`Ground 3. Claim 18 is obvious over Ballantyne, in view of United States
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`Patent No. 4,778,448 (“the ‘448 patent,” Ex. 1007).
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`Ground 4. Claim 18 is obvious over Ballantyne, in view of United States
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`Patent No. 6,173,199 (“the ‘199 patent,” Ex. 1008) and United States Patent No.
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`5,492,538 (“the ‘538 patent,” Ex. 1011).
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`A. Ground 1: Claim 18 Is Not Anticipated by Ballantyne Because
`Ballantyne Fails to Disclose Snapping a Tube into a Channel
`Formed in a Receiver
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`According to Ground 1, Petitioners propose that claim 18 is anticipated by
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`Ballantyne. Pet. 12. For reasons that follow, Petitioners have not met their burden
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`of proving a reasonable likelihood of success on Ground 1.
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`“[U]nless a reference discloses within the four corners of the document not
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`only all limitations claimed but also all of the limitations arranged or combined
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`in the same way as recited in the claim, it cannot be said to prove prior invention
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`of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net
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`Moneyin, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (emphasis
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`added).
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`As noted above, claim 18 is directed to a method of placing and securing at
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`least one tube through a nose into a patient comprising, among other steps,
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`“snapping the at least one tube into a channel formed in a receiver.” Ex. 1001 at
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`col. 9, ll. 8-22.
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`Ballantyne fails to disclose snapping at least o