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. and APPLIED MEDICAL TECHNOLOGY,
`INC.,
`Patent Owner
`
`_______________
`
`Inter Partes Review No. IPR2017-01990
`Patent 6,631,715
`
`_______________
`
`
`
`EXCLUSIVE LICENSEE APPLIED MEDICAL TECHNOLOGY, INC.’S
`PRELIMINARY RESPONSE UNDER 37 C.F.R. § 42.107
`
`
`
`
`
`
`
`
`
`
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`
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`

`

`Case IPR2017-01990
`Patent 6,631,715
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ................................................................................................ 1
`
`The Follow-On Petition in this Case Should Be Denied Because
`Petitioners Have Failed to Adequately Explain, or Even Address, Why
`Their Follow-On Petition Should Be Instituted in View of the
`Unreasonable Deficiency of Their Previous Petition and Their Delay in
`Filing Their Follow On Petition ................................................................. 5
`
`III. The Person of Ordinary Skill in the Art ................................................... 12
`
`IV. Claim Construction ................................................................................... 13
`
`A. “Securing at Least One Tube Through a Nose into a Patient”............ 14
`
`a. The Phrase “Securing at Least One Tube Through a Nose into
`a Patient” Is a Limitation of the Claim ..................................... 14
`
`b. The Phrase “Securing at Least One Tube Through a Nose into a
`Patient” Means “Attaching the Tube to the Patient, in a
`Generally Fixed Position, Through the Nose of the Patient, in a
`Manner that Prevents Dislodgement of the Tube during Use” . 15
`
`B. “Snapping the at Least One Tube into a Channel Formed in a
`Receiver” ............................................................................................. 18
`
`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 .............................................. 19
`
`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 ...................... 21
`
`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” .................................................................................... 28
`
`ii
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`Case IPR2017-01990
`Patent 6,631,715
`
`V.
`
`The Petition Fails to Show a Reasonable Likelihood that Any Claim of
`the ‘715 Patent is Unpatentable ................................................................ 28
`
`A. Ground 1: Claim 18 Is Not Obvious over Ballantyne, in View of
`Simmons, Because Modifying Ballantyne as Urged by Petitioners
`Would Have Rendered Ballantyne’s Apparatus and Method
`Unsatisfactory for Their Intended Purpose ......................................... 29
`
`B. Ground 2: Claim 18 Is Not Obvious Over Ballantyne, in View of
`Izumi, Because Modifying Ballantyne as Urged by Petitioners Again
`Would Have Rendered Ballantyne’s Apparatus and Method
`Unsatisfactory for Their Intended Purpose ......................................... 43
`
`C. Ground 3: Claim 18 Is Not Obvious Over Ballantyne, in view of
`Simmons and Bierman, Because Modifying Ballantyne as Urged by
`Petitioners Again Would Have Rendered Ballantyne’s Apparatus and
`Method Unsatisfactory for Their Intended Purpose ............................ 50
`
`VI. Objective Evidence of Nonobviousness ................................................... 61
`
`VII. Conclusion ................................................................................................ 61
`
`
`
`iii
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`Case IPR2017-01990
`Patent 6,631,715
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Apple Inc. v. Immersion Corp., Case IPR2017-00887,
`(P.T.A.B. August 25, 2017) (Paper 7) ......................................................... 7, 8
`
`
`Applied Medical Technology, Inc. v. Corpak Medsystems, Inc.,
`1:16-cv-02190 (N.D. Ohio) ............................................................................. 9
`
`
`Corpak Medsystems, Inc. v. Kirn Medical Design, L.L.C., Case IPR2017-00646,
`(P.T.A.B. July 26, 2017) (Paper 9) ........................................1, 8, 9, 11, 19, 34
`
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ................................................................................... 13
`
`D’Agostino v. Mastercard Int’l, Inc.,
`No. 2016-1592 (Fed. Cir. Dec. 22, 2016) ...................................................... 13
`
`
`General Plastic Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357,
`(P.T.A.B. Sept. 6, 2017) (Paper 19) (Section II.B.4.i designated
`precedential) ........................................................................................... 5, 6, 7
`
`
`In re Cruciferous Sprout Litigation,
`301 F.3d 1343 (Fed. Cir. 2002) .................................................................... 14
`
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ...................................................................... 31
`
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ..................................................................... 13
`
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .................................................................... 31
`
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)....................................................................................... 30
`
`
`Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426,
`(P.T.A.B. June 22, 2017) (Paper 17) ............................................................... 7
`
`
`
`
`iv
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`Case IPR2017-01990
`Patent 6,631,715
`
`Statutes
`
`35 U.S.C. § 312(a) .................................................................................................... 4
`
`35 U.S.C. § 314(a) ............................................................................................. 2, 3, 5
`
`Other Authorities
`
`37 C.F.R. § 42.100(b) ............................................................................................. 13
`
`37 C.F.R. § 42.104(b)(4) ....................................................................................... 4, 5
`
`37 C.F.R. § 42.108(a) ............................................................................................ 2, 5
`
`
`
`
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`Case IPR2017-01990
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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
`
`2007
`
`Design, Jan. 6, 2005
`
`
`
`
`
`
`
`vi
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`Case IPR2017-01990
`Patent 6,631,715
`
`
`I.
`
`Introduction
`
`Exclusive Licensee Applied Medical Technology, Inc. (“AMT”) respectfully
`
`submits this Preliminary Response to the Petition of Corpak Medsystems, Inc. and
`
`Halyard Health, Inc. (collectively “Petitioners”) seeking inter partes review of
`
`claim 18 of United States Patent No. 6,631,715 (“the ‘715 patent,” Ex. 1001) on
`
`three Grounds (“Petition” or “Pet.”).
`
`Claim 18 of the ‘715 patent is directed to “[a] method of placing and
`
`securing at least one tube through a nose into a patient,” and includes a step of
`
`“snapping the at least one tube into a channel formed in a receiver.”
`
`Petitioners filed a previous Petition challenging patentability of claim 18 of
`
`the ‘715 patent on January 19, 2017, in IPR2017-00646. Ex. 1014. AMT filed a
`
`Patent Owner’s Preliminary Response to the previous Petition on April 28, 2017.
`
`Ex. 1015. The Board denied institution of the previous Petition. Corpak
`
`Medsystems, Inc. v. Kirn Medical Design, L.L.C., Case IPR2017-00646, slip op. at
`
`1-2 (P.T.A.B. July 26, 2017) (Paper 9) (“Decision Denying Institution,” Ex. 1013).
`
`Petitioners filed the present Petition on August 29, 2017. Accordingly, the Petition
`
`in the present case is a follow-on Petition, filed after Petitioners had received
`
`AMT’s Preliminary Response and the Board’s Decision Denying Institution of the
`
`previous Petition.
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`
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`1
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`

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`Case IPR2017-01990
`Patent 6,631,715
`
`AMT requests that the Board exercise its discretion to deny institution of the
`
`follow-on Petition in this case pursuant to 35 U.S.C. § 314(a) and 37 C.F.R. §
`
`42.108(a). This is because Petitioners’ previous Petition challenging patentability
`
`of claim 18 included a deficiency that was unreasonable. Moreover, Petitioners
`
`had ample time to take advantage of AMT’s Preliminary Response and the Board’s
`
`Decision Denying Institution of the previous Petition. Yet, Petitioners have failed
`
`to adequately explain, or even address, why their follow-on Petition should be
`
`instituted under these circumstances.
`
`Specifically, in the previous case, Petitioners contended that claim 18 was
`
`unpatentable based on anticipation by United States Patent No. 5,185,005
`
`(“Ballantyne,” Ex. 1002), and also based on obviousness over Ballantyne alone,
`
`Ballantyne in view of United States Patent No. 4,778,448, and Ballantyne in view
`
`of United States Patent No. 6,173,199 and United States Patent No. 5,492,538. Ex.
`
`1014 at 11-12. Petitioners’ previous Petition was fatally flawed because it
`
`effectively ignored that claim 18 requires snapping a tube into a channel, not
`
`snapping two pieces of a clip together. See, Ex. 1015 at 1-2.
`
`Now, Petitioners ask the Board to institute their follow-on Petition in this
`
`case by arguing that claim 18 is obvious over Ballantyne, in view of various newly
`
`submitted references, namely United States Patent No. 5,752,511 (“Simmons,” Ex.
`
`1007), United States Patent No. 5,097,827 (“Izumi,” Ex. 1008), and PCT
`
`
`
`2
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`Case IPR2017-01990
`Patent 6,631,715
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`International Publication No. WO 99/20334 (“Bierman,” Ex. 1011). Pet. at 16.
`
`Despite having effectively ignored that claim 18 requires snapping the tube into a
`
`channel in their previous Petition, Petitioners seek to benefit from having prepared
`
`their follow-on Petition in light of Patent Owner’s previous Preliminary Response
`
`and the Board’s previous Decision Denying Institution. Yet, Petitioners fail to
`
`explain how effectively ignoring that the claim expressly requires snapping the
`
`tube into a channel in their previous Petition could have been reasonable.
`
`Petitioners also fail to explain whether they were aware of the various new
`
`references when they filed their previous Petition, and if so why they did not assert
`
`the references previously. For at least these reasons, AMT requests that the Board
`
`deny the Petition.
`
`AMT also requests that the Board deny institution of the Petition because
`
`Ballantyne, in view of the newly submitted references, fails to teach or suggest a
`
`method of placing and “securing at least one tube through a nose into a patient,”
`
`comprising “snapping the at least one tube into a channel formed in a receiver.”
`
`To merit institution, a petition must establish “a reasonable likelihood that
`
`the petitioner would prevail with respect to at least 1 of the claims challenged in
`
`the petition.” 35 U.S.C. § 314(a). A petition “may be considered only if . . . the
`
`petition identifies, in writing and with particularity, each claim challenged, the
`
`grounds on which the challenge to each claim is based, and the evidence that
`
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`3
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`supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a). A
`
`petition for inter partes review must identify how the challenged claims are
`
`unpatentable under the statutory grounds asserted by Petitioner. 37 C.F.R. §
`
`42.104(b)(4).
`
`In this case a person of ordinary skill in the art would not have been
`
`motivated to combine Ballantyne and the new references to reach the method of
`
`claim 18 for at least the following reasons. Modifying Ballantyne’s apparatus and
`
`method for securing a nasogastric tube to a patient, which specifically employs a
`
`bridle that passes through a patient’s nose and nasopharynx, and which is
`
`particularly intended to resist the efforts of an uncooperative or belligerent patient
`
`to withdraw or excessively move the tube, based on applying Simmons’s
`
`“solution” to Ballantyne’s “deficiencies,” as urged by Petitioners, Pet. 45, would
`
`not have resulted in an apparatus or method that would have resisted the efforts of
`
`an uncooperative or belligerent patient to withdraw or excessively move a tube.
`
`Indeed, such a modification would not have resulted in an apparatus or method
`
`employing a bridle at all. Moreover, modifying Ballantyne’s apparatus and
`
`method, in view of Izumi, or Simmons and Bierman, based on “a similar manner of
`
`securing a nasogastric/nasoenteric tube to arrest excessive movements,” with
`
`respect to Izumi, and to Simmons and Bierman, as also urged by Petitioners, Pet.
`
`55, 61, also would not have resulted in an apparatus or method that would have
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`4
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`Case IPR2017-01990
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`resisted the efforts of an uncooperative or belligerent patient to withdraw or
`
`excessively move a tube. The modifications urged by Petitioners thus would have
`
`rendered Ballantyne’s apparatus and method unsatisfactory for their intended
`
`purpose.
`
`Petitioners thus fail to explain how Ballantyne, in view of the new
`
`references, teaches or suggests a method of placing and “securing at least one tube
`
`through a nose into a patient,” comprising “snapping the at least one tube into a
`
`channel formed in a receiver,” as required by claim 18, and indeed Ballantyne, in
`
`view of the new references, does not. Thus, Petitioners’ analysis is deficient under
`
`37 C.F.R. § 42.104(b)(4). The Petition has not established a reasonable likelihood
`
`that the Petitioners would prevail with respect to claim 18. For this reason too,
`
`AMT requests that the Board deny the Petition.
`
`II. The Follow-On Petition in this Case Should Be Denied Because
`Petitioners Have Failed to Adequately Explain, or Even Address, Why
`Their Follow-On Petition Should Be Instituted In View of the
`Unreasonable Deficiency of Their Previous Petition and Their Delay in
`Filing Their Follow-On Petition
`
`The Board may exercise discretion in declining to institute inter partes
`
`reviews for follow-on petitions based on an evaluation of equities pursuant to 35
`
`U.S.C. § 314(a) and 37 C.F.R. § 42.108(a). General Plastic Industrial Co. v.
`
`Canon Kabushiki Kaisha, Case IPR2016-01357, slip op. at 15 (P.T.A.B. Sept. 6,
`
`
`
`5
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`

`

`2017) (Paper 19) (Section II.B.4.i designated precedential). In exercising such
`
`discretion, the Board considers seven non-limiting factors, as follows:
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`Case IPR2017-01990
`Patent 6,631,715
`
`1.
`
`whether the same petitioner previously filed a petition directed to
`
`the same claims of the same patent;
`
`2.
`
`whether at the time of filing of the first petition the petitioner knew
`
`of the prior art asserted in the second petition or should have known
`
`of it;
`
`3.
`
`whether at the time of filing of the second petition the petitioner
`
`already received the patent owner’s preliminary response to the
`
`first petition or received the Board’s decision on whether to
`
`institute review in the first petition;
`
`4.
`
`the length of time that elapsed between the time the petitioner
`
`learned of the prior art asserted in the second petition and the filing
`
`of the second petition;
`
`5.
`
`whether the petitioner provides adequate explanation for the time
`
`elapsed between the filings of multiple petitions directed to the
`
`same claims of the same patent;
`
`the finite resources of the Board; and
`
`the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`
`determination not later than 1 year after the date on which the
`
`Director notices institution of review.
`
`6.
`
`7.
`
`Id. at 16.
`
`
`
`As stated by the Board, “[o]ur intent in formulating the factors was to take
`
`undue inequities and prejudices to Patent Owner into account.” Id. at 17.
`
`Regarding factor 3, the Board explained that “[t]he absence of any restrictions on
`
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`Case IPR2017-01990
`Patent 6,631,715
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`follow-on petitions would allow petitioners the opportunity to strategically stage
`
`their prior art and arguments in multiple petitions, using our decisions as a
`
`roadmap, until a ground is found that results in the grant of review,” which “is
`
`unfair to patent owners and is an inefficient use of the inter partes review process
`
`and other post-grant review processes.” Id. at 17-18. The Board also explained
`
`that “[c]onsidering other factors (i.e., factors 2, 4, and 5) allows us to assess and
`
`weigh whether a petitioner should have or could have raised the new challenges
`
`earlier.” Id. at 18.
`
`The Board has applied an objective standard in determining whether a
`
`particular claim construction by the Board should have been expected by a
`
`petitioner. See, id. at 21. The Board has indicated that a period of as little as one
`
`month between the Board issuing a decision denying institution and a petitioner
`
`filing a follow-on petition can provide a petitioner with “ample time to take
`
`advantage” of the decision “in crafting its arguments” in the follow-on petition.
`
`See, Apple Inc. v. Immersion Corp., Case IPR2017-00887, slip op. at 8 (P.T.A.B.
`
`August 25, 2017) (Paper 7). The Board faults petitioners for failing to explain
`
`delays in filing follow-on petitions. See, e.g., General Plastic, slip op. at 10. The
`
`Board also faults petitioners for failing to explain whether, at the time of filing a
`
`first petition, the petitioners knew, or should have known, of prior art references
`
`newly submitted with their follow-on petitions. See, e.g., Nautilus Hyosung Inc. v.
`
`
`
`7
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`Case IPR2017-01990
`Patent 6,631,715
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`Diebold, Inc., Case IPR2017-00426, slip op. at 13 (P.T.A.B. June 22, 2017) (Paper
`
`17). The Board also faults petitioners for failing to provide adequate, non-strategic
`
`reasons for delays in filing follow-on petitions or other justifications for allowing a
`
`follow-on petition to proceed. See, e.g., Apple, slip op. at 8-10.
`
`Petitioners’ previous Petition was deficient because it effectively ignored
`
`that claim 18 requires snapping a tube into a channel, not snapping two pieces of a
`
`clip together. As discussed in AMT’s previous Patent Owner’s Response,
`
`Petitioners directly addressed the term “channel” only two times in their arguments
`
`throughout the entire previous Petition, in both cases relying on a disclosure of
`
`Ballantyne of “an anchoring clip 12 [that] comprises two pieces which are snap-
`
`fitted together upon the ends 20, 22 of bridle 10 and perhaps also upon tube 18,”
`
`which disclosed securing a tube within a clip by compression and friction means,
`
`not snapping a tube into a channel. See, Ex. 1015 at 3; Ex. 1014 at 20-21, 40; Ex.
`
`1002 at col. 8, ll. 12-17. Throughout the rest of the previous Petition, other than
`
`quoting claim 18 in its entirety once in the “Overview,” and repeating the claim
`
`within various claim charts, the Petitioners avoided mentioning the term “channel”
`
`at all. See, Ex. 1015 at 4; see, e.g., Ex. 1014 at 9.
`
`The Board denied institution, reasoning that “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, based on the express language of the claim, Ex. 1013 at 8, that
`
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`8
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`Case IPR2017-01990
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`Ballantyne does not disclose snapping a tube into a channel formed in a receiver,
`
`Ex. 1013 at 14, and that Petitioners had otherwise failed to account for this
`
`limitation, see, Ex. 1013 at 19.
`
`The deficiency of the previous Petition was not reasonable. As noted by the
`
`Board in its previous Decision Denying Institution, and as is apparent from the
`
`claim itself, claim 18 expressly requires “snapping the at least one tube into a
`
`channel formed in a receiver.” AMT also had provided notice to Petitioners of
`
`AMT’s position regarding the meaning of “snapping the at least one tube into a
`
`channel formed in a receiver,” well before Petitioners filed their previous Petition.
`
`In related copending litigation styled Applied Medical Technology, Inc. v. Corpak
`
`Medsystems, Inc., 1:16-cv-02190 (N.D. Ohio), AMT’s Initial Infringement
`
`Contentions, as served on Petitioner Corpak on November 8, 2016, stated as
`
`follows:
`
`For reference, Corpak’s CORGRIP device includes a clamp. The
`
`clamp is a receiver, i.e. for the nasal tube. The receiver has a channel
`
`formed therein, corresponding to the groove formed in the clamp.
`
`Securing the clamp to the nasal tube by pressing the nasal tube
`
`into the groove results in snapping of the nasal tube into the
`
`groove. This is snapping, based on the nasal tube having an outer
`
`diameter, and the groove having an opening corresponding to a
`
`narrow gap, such that the outer diameter of the nasal tube is slightly
`
`greater than the narrow gap of the opening of the groove. Thus,
`
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`Case IPR2017-01990
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`pressing is required to force the nasal tube to pass through the narrow
`
`gap, and once the nasal tube is in the groove, pulling would be
`
`required to free the nasal tube from the groove.
`
`
`Exhibit 1009 at 10 (emphasis added).
`
`Yet, Petitioners provided no explanation in their previous Petition regarding
`
`how interpreting the claim in a way that effectively ignores this limitation could be
`
`reasonable, and indeed it is not. Petitioners also waited until after receiving
`
`AMT’s Preliminary Response and the Board’s Decision Denying Institution before
`
`filing their follow-on Petition.
`
`Petitioners have failed to adequately explain, or even address, why their
`
`follow-on Petition should be instituted under these circumstances. Although
`
`Petitioners contend that “[t]he current petition is not redundant of the prior IPR
`
`petition,” Pet. 5, this is not an explanation. Thus, consideration of at least factors
`
`1-6 weighs heavily toward denying institution of the follow-on Petition in this
`
`case.
`
`Specifically, based on the timing of Petitioners’ filing of their follow-on
`
`Petition, factors 1 and 3 strongly weigh against institution. Considering factor 1
`
`first, as noted above, the same Petitioners previously filed a Petition on January 19,
`
`2017, in IPR2017-00646, directed to claim 18 of the ‘715 patent, and thus to the
`
`same claims of the same patent. Ex. 1014 at 1. Turning to factor 3, as also noted,
`
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`10
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`Case IPR2017-01990
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`
`at the time of filing of their follow-on Petition, on August 29, 2017, the Petitioners
`
`had already received AMT’s Preliminary Response to the previous Petition, as filed
`
`four months earlier, on April 28, 2017, and had already received the Board’s
`
`Decision Denying Institution, as entered one month earlier, on July 26, 2017. See,
`
`Ex. 1015; Ex. 1013. Petitioners thus had ample time to take advantage of both in
`
`crafting arguments for their follow-on Petition.
`
`Moreover, based on Petitioners’ previous Petition having been unreasonably
`
`deficient, as well as Petitioners’ failure to adequately explain, or even address, why
`
`their follow-on Petition should be instituted under these circumstances, factors 2,
`
`4, 5, and 6 also weigh against institution. Regarding factor 2, Petitioners have
`
`failed to explain whether, at the time of filing of their previous Petition, the
`
`Petitioners knew of the prior art asserted in their follow-on Petition, or should have
`
`known of it. Regarding factor 4, Petitioners have failed to indicate how much time
`
`elapsed between the time the Petitioners learned of the new references asserted in
`
`their follow-on Petition and the filing of their follow-on Petition. Regarding factor
`
`5, Petitioners have failed to provide any explanation, let alone an adequate one, for
`
`the time elapsed between the filings of their previous Petition and their follow-on
`
`Petition. Petitioners should have reasonably expected that the Board would
`
`interpret claim 18 to require snapping a tube into a channel based on the express
`
`
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`11
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`Case IPR2017-01990
`Patent 6,631,715
`
`language of the claim, and thus should have conducted a diligent search to identify
`
`at least one reference disclosing this limitation before filing their previous Petition.
`
`Regarding factor 6, Petitioners’ failure to adequately explain, or even
`
`address, why their follow-on Petition should be instituted also is an inefficient use
`
`of the inter partes review process. Petitioners should have been aware that this
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`issue would be raised, and should have addressed the issue in their follow-on
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`Petition, but did not.
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`
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`For at least these reasons, the Board should exercise its discretion and deny
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`institution of the follow-on Petition in this case.
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`III. The Person of Ordinary Skill in the Art
`
`For the purposes of this Preliminary Response, AMT adopts Petitioners’
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`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
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`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. 15-16; Ex. 1004 at ¶¶ 30 -31. 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. 15-16; Ex. 1004 at ¶¶ 30 -31.
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`
`
`12
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`

`

`Case IPR2017-01990
`Patent 6,631,715
`
`IV. 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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`Claim terms should be given their broadest reasonable interpretation in light
`
`of the specification of the patent and assigned their ordinary and customary
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`meaning, as would be understood by one of ordinary skill in the art at the time of
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`the invention, in the context of the entire patent disclosure. 37 C.F.R. § 42.100(b);
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`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016); In re
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`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.
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`D’Agostino v. Mastercard Int’l, Inc., No. 2016-1592, slip op. at 5 (Fed. Cir. Dec.
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`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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`For the reasons that follow, AMT requests that the Board construe the
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`phrases “securing at least one tube through a nose into a patient,” and “snapping
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`the at least one tube into a channel formed in a receiver.”
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`
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`
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`
`13
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`

`

`Case IPR2017-01990
`Patent 6,631,715
`
`A. “Securing at Least One Tube Through a Nose into a Patient”
`
`
`
`Petitioners have not proposed a construction for the phrase “securing at least
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`one tube through a nose into a patient.” See, Pet. 14-15. However, Petitioners’
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`arguments for obviousness are premised on an interpretation of the phrase that fails
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`to account for preventing dislodgement of the tube by the patient, and that thus is
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`inconsistent with the broadest reasonable interpretation of the claim term.
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`Accordingly, AMT requests that the Board construe the phrase “securing at least
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`one tube through a nose into a patient.”
`
`a. The Phrase “Securing at Least One Tube Through a Nose into a
`Patient” Is a Limitation of the Claim
`
`As an initial matter, AMT submits that the phrase “securing at least one tube
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`through a nose into a patient,” properly construed, is a limitation of claim 18. As
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`can be seen, the phrase is recited in the preamble of claim 18. “In general, a
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`preamble limits the claimed invention if it recites essential structure or steps, or if
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`it is ‘necessary to give life, meaning, and vitality’ to the claim.” In re Cruciferous
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`Sprout Litigation, 301 F.3d 1343, 1347 (Fed. Cir. 2002). In the present case, the
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`preamble recites “at least one tube.” This provides antecedent basis for the “the at
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`least one tube” as recited in the body of the claim. The preamble thus recites an
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`essential structure of the claim. Petitioners have not argued otherwise. See, Ex.
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`1004 at ¶ 61, n. 8. For at least these reasons, the phrase “securing at least one tube
`
`through a nose into a patient” is a limitation of the claim.
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`
`
`14
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`

`

`Case IPR2017-01990
`Patent 6,631,715
`
`b. The Phrase “Securing at Least One Tube Through a Nose into a
`Patient” Means “Attaching the Tube to the Patient, in a Generally
`Fixed Position, Through the Nose of the Patient, in a Manner that
`Prevents Dislodgement of the Tube during Use”
`
`
`
`The phrase “securing at least one tube through a nose into a patient,”
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`properly construed, means “attaching the tube to the patient, in a generally fixed
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`position, through the nose of the patient, in a manner that prevents dislodgement of
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`the tube during use.” This is the purpose of nasal bridles, such as those disclosed
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`and claimed in the ‘715 patent.
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`This interpretation is supported by the ‘715 specification, which discloses
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`“[a] bridle system for placing and securing a nasal tube in a patient [that] includes
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`a flexible member having a magnet attached to a first end thereof for insertion into
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`a nare of a patient’s nose, [and] a magnetic probe for insertion into a second nare
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`of the nose,” and that the “[t]he system further includes a receiver for securing the
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`nasal tube and flexible member externally, adjacent the nose to prevent
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`dislodgement by the patient or otherwise.” Ex. 1001 at Abstract (emphasis
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`added).
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`This interpretation also is supported by the ‘715 patent’s focus on providing
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`an improved nasal tube bridle system, in the context of prior art systems for
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`securing nasal tubes to patients. The ‘715 specification indicates that “[m]any
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`different methods have been used to place nasal tubes, such as feeding tubes,
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`nasogastric tubes, and nasotracheal tubes into patients and to secure the tubes once
`
`
`
`15
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`

`

`Case IPR2017-01990
`Patent 6,631,715
`
`placed.” Ex. 1001 at col. 2, ll. 15-17. These include Ballantyne’s method, which
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`“requires a bridle which is pulled into a nare of a patient's nose, around the
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`posterior nasal septum, and out the other nare by a cord attached to the bridle and
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`an insertion tool.” Ex. 1001 at col. 1, ll. 18-22. These also include a method of
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`Meer, U.S. Pat. No. 4,778,448, which “requires ends of a bridle to be inserted into
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`first and second nares of a patient’s nose until the ends are visible in the posterior
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`pharynx of the patient.” Ex. 1001 at col. 1, ll. 45-49. These also include
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`“[a]dditional methods for securing nasal tubes,” including “attaching the tubes
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`directly to the skin of the recipient utilizing an adhesive such as tape or the like, as
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`described for example in U.S. Pat. Nos. 4,114,626 and 4,282,871, or sutures.” Ex.
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`1001 at col. 1, ll. 64-67, col. 2, l. 1. The ‘715 specification indicates that “there is
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`a need identified for an improved bridle system and related method for placing and
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`securing nasal tubes which allows rapid, easy looping of a bridle around the
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`posterior nasal septum with minimal patient discomfort and no risk of mandibular
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`dislocation.” Ex. 1001 at col. 2, ll. 9-13.
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`This interpretation is consistent with usage of the term “securing,” with
`
`respect to attaching nasal tubes to patients, in the nasal t