CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 1 of 41
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MINNESOTA
`
`QXMédical, LLC,
`Plaintiff and
`Counterclaim-Defendant,
`
`
`
`v.
`Vascular Solutions LLC, Teleflex
`Innovations S.à.r.l., and Arrow
`International, Inc.,
`Defendants and
`Counterclaim-Plaintiffs.
`
`
`
`Case No. 17-cv-01969-PJS-TNL
`
`DEFENDANTS’ MEMORANDUM
`IN OPPOSITION TO PLAINTIFF’S
`SUMMARY JUDGMENT MOTION
`AND IN SUPPORT OF
`DEFENDANTS’ SUMMARY
`JUDGMENT MOTION
`
`
`
`
`
`Page 1
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 2 of 41
`
`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................................................... 1 
`ARGUMENT ....................................................................................................................... 2 
`I. 
`VSI Is Entitled To Summary Judgment On Indefiniteness. ..................................... 2 
`
`II. 
`
`III. 
`
`QXM’s Argument Fails As A Matter Of Law. ............................................. 3 
`A. 
`QXM’s Argument Fails For Lack Of Proof. ................................................. 4 
`B. 
`VSI Is Entitled To Summary Judgment On Recapture. ........................................... 6 
`QXM Must Prove By Clear And Convincing Evidence That VSI
`A. 
`Surrendered Subject Matter To Overcome Prior Art. ................................... 6 
`VSI Did Not Surrender Subject Matter To Overcome Prior Art. ................. 6 
`B. 
`The Boosting Catheter’s Substantially Rigid Portion Defines A Rail
`Structure Without A Lumen. .................................................................................... 9 
`QXM’s Boosting Catheter Literally Meets The “Without A Lumen”
`A. 
`Limitation. ..................................................................................................... 9 
`Alternatively, QXM’s Boosting Catheter Infringes Under The
`Doctrine Of Equivalents. ............................................................................. 11 
`The Structure Of The Boosting Catheter Is Equivalent To
`1. 
`Having No Lumen At All. ................................................................ 12 
`
`B. 
`
`2. 
`
`QXM’s Legal Defenses Do Not Bar VSI From Asserting
`Infringement Under The Doctrine Of Equivalents........................... 13 
`IV.  QXM Infringes The “One French” Claims. ........................................................... 17 
`QXM Directly Infringes The “One French” Claims Of The ’032
`A. 
`And ’776 Patents. ........................................................................................ 18 
`There Are Genuine Issues Of Material Fact Concerning Whether
`QXM Has Induced Infringement Of The “One French” Claims. ............... 19 
`
`B. 
`
`V. 
`
`VSI Is Entitled To Summary Judgment Regarding The Rigidity Of The
`Side Opening Segment Or Partially Cylindrical Opening Segment
`Compared To The Tubular Structure Or Distal End Portion. ................................ 23 
`
`
`
`i
`
`Page 2
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 3 of 41
`
`A. 
`B. 
`C. 
`
`QXM Waived Its Noninfringement Argument. .......................................... 23 
`QXM’s Claim Construction Contradicts The Intrinsic Evidence. .............. 24 
`QXM’s Boosting Catheter Has A Segment Defining A Side/Partially
`Cylindrical Opening That Is More Rigid Than Its Tubular Structure
`And Its Distal End Portion. ......................................................................... 26 
`VI.  Adams Does Not Anticipate Claim 53 Of The ’116 Patent. .................................. 28 
`A. 
`QXM Waived Its Argument that Adams Anticipates Claim 53. ................ 28 
`B. 
`If The Court Reaches This Issue, The Court Should Rule That
`Adams Does Not Anticipate Claim 53. ....................................................... 29 
`Adams Does Not Disclose A “Segment Defining A Side
`1. 
`Opening.” ......................................................................................... 29 
`
`2. 
`
`C. 
`
`Adams Does Not Disclose A “Segment Defining The Side
`Opening
` More Rigid Than The Distal End Portion Of The
`Tubular Structure.” ........................................................................... 30 
`VII.  The Boosting Catheter Infringes Claims 25, 36, 52, And 53 Of The ʼ776
`Patent. ..................................................................................................................... 31 
`A. 
`“Substantially Rigid Segment” .................................................................... 31 
`B. 
`ʼ776 Patent, Claim 36: “The guide extension catheter of claim 25,
`wherein the segment defining the angled proximal end of the
`partially cylindrical opening includes at least one inclined region that
`tapers into a non-inclined region.” .............................................................. 32 
`Claims 52 and 53: “The segment defining the angled proximal end
`of the partially cylindrical opening includes at least two inclined
`regions.” ...................................................................................................... 32 
`CONCLUSION ................................................................................................................. 33 
`
`
`
`
`
`
`ii
`
`Page 3
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 4 of 41
`
`TABLE OF AUTHORITIES
`
`Page
`
`
`
`CASES
`
`Accent Packaging, Inc. v. Leggett & Platt, Inc.,
`707 F.3d 1318 (Fed. Cir. 2013) .................................................................................... 19
`
`ACCO Brands, Inc. v. ABA Locks Manufacturer,
`501 F.3d 1307 (Fed. Cir. 2007) .................................................................................... 19
`
`AIA Eng’g Ltd. v. Magotteaux Int’l, S/A,
`657 F.3d 1264 (Fed. Cir. 2011) ...................................................................................... 6
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) .................................................................................... 29
`
`Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc.,
`2004 WL 2066823 (D. Minn. Sept. 7, 2004) ............................................................... 16
`
`Asyst Technologies, Inc. v. Emtrak, Inc.,
`402 F.3d 1188 (Fed. Cir. 2005) .................................................................................... 14
`
`Bombardier Recreational Prods., Inc. v. Arctic Cat Inc.,
`2017 WL 758335 (D. Minn. Feb. 24, 2017) ................................................................ 31
`
`BreathableBaby, LLC v. Crown Crafts, Inc.,
`2014 WL 3928526 (D. Minn. Aug. 12, 2014) ........................................................ 24, 28
`
`Brilliant Instruments, Inc. v. Guidetech, LLC,
`707 F.3d 1342 (Fed. Cir. 2013) .................................................................................... 14
`
`Broadcom Corp. v. Qualcomm Inc.,
`543 F.3d 683 (Fed. Cir. 2008) ...................................................................................... 20
`
`Buckman Co. v. Plaintiffs’ Legal Committee,
`531 U.S. 341 (2001) ..................................................................................................... 21
`
`Capital Sec. Sys., Inc. v. NCR Corp.,
`725 F. App’x 952 (Fed. Cir. 2018) ................................................................................. 5
`
`iii
`
`Page 4
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 5 of 41
`
`Commil USA, LLC v. Cisco Systems, Inc.,
`135 S.Ct 1920 (2015) ................................................................................................... 18
`
`Core Wireless Licensing S.A.R.L. v. Apple Inc.,
`899 F.3d 1356 (Fed. Cir. 2018) .............................................................................. 18, 19
`
`Crown Packaging Tech., Inc. v. Rexam Beverage Can Co.,
`559 F.3d 1308 (Fed. Cir. 2009) .................................................................................... 11
`
`Cubist Pharmaceuticals, Inc. v. Hospira, Inc.,
`805 F.3d 1112 (Fed. Cir. 2015) ...................................................................................... 6
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012) .................................................................................... 14
`
`DeMarini Sports, Inc. v. Worth, Inc.,
`239 F.3d 1314 (Fed. Cir. 2001) .................................................................................... 13
`
`DSU Med. Corp. v. JMS Co.,
`471 F.3d 1293 (Fed. Cir. 2006) .................................................................................... 19
`
`Electro Med. Sys. v. Cooper Life Sciences, Inc.,
`34 F.3d 1048 (Fed. Cir. 1994) ...................................................................................... 30
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ......................................................................................... 11, 15, 16
`
`Finisar Corp. v. DirecTV Group, Inc.,
`523 F.3d 1323 (Fed. Cir. 2008) .................................................................................... 29
`
`Finnigan Corp. v. ITC,
`180 F.3d 1354 (Fed. Cir. 1999) .................................................................................... 31
`
`Fiskars, Inc. v. Hunt Mfg. Co.,
`221 F.3d 1318 (Fed. Cir. 2000) .................................................................................... 13
`
`Glaxo Wellcome, Inc. v. Andrx Pharms., Inc.,
`344 F.3d 1226 (Fed. Cir. 2003) .................................................................................... 13
`
`Global-Tech Appliances, Inc. v. SEB S.A.,
`563 U.S. 754 (2012) ..................................................................................................... 20
`
`
`
`iv
`
`Page 5
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 6 of 41
`
`Greenliant Systems, Inc. v. Xicor LLC,
`692 F.3d 1261 (Fed. Cir. 2012) ...................................................................................... 6
`
`High Tech Medical Instrumentation, Inc. v. New Image Indus., Inc.,
`49 F.3d 1551 (Fed. Cir. 1995) ...................................................................................... 19
`
`Honeywell Int’l, Inc. v. Hamilton Sundstrand Corp.,
`370 F.3d 1131 (Fed. Cir. 2004) .................................................................................... 11
`
`Intel Corp. v. ITC,
`946 F.2d 821 (Fed. Cir. 1991) ...................................................................................... 18
`
`Medtronic, Inc. v. Guidant Corp.,
`465 F.3d 1360 (Fed. Cir. 2006) ...................................................................................... 6
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ....................................................................................................... 3
`
`Power Integrations, Inc. v. Fairchild Semiconductor International, Inc.,
`843 F.3d 1315 (Fed. Cir. 2016) .................................................................................... 15
`
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`563 F.3d 1358 (Fed. Cir. 2009) .................................................................................... 18
`
`Silicon Labs., Inc. v. Cresta Tech. Corp.,
`2016 WL 791792 (N.D. Cal. Mar. 1, 2016) ........................................................... 24, 28
`
`Sorensen v. ITC,
`427 F.3d 1375 (Fed. Cir. 2005) .................................................................................... 26
`
`Tate Access Floors, Inc. v. Interface Architectural Resources, Inc.,
`279 F.3d 1357 (Fed. Cir. 2002) .................................................................................... 32
`
`Toro Co. v. White Consol. Indus., Inc.,
`266 F.3d 1367 (Fed. Cir. 2001) .................................................................................... 12
`
`Trustees of Columbia Univ. in City of New York v. Symantec Corp.,
`811 F.3d 1359 (Fed. Cir. 2016) .................................................................................... 25
`
`Typhoon Touch Technologies, Inc. v. Dell, Inc.,
`659 F.3d 1376 (Fed. Cir. 2011) .................................................................................... 19
`
`
`
`v
`
`Page 6
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 7 of 41
`
`Vederi, LLC v. Google, Inc.,
`744 F.3d 1376 (Fed. Cir. 2014) .............................................................................. 24, 29
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) ................................................................................................. 11, 12
`
`Wilson Sporting Goods Co. v. David Geoffrey & Assoc.,
`904 F.2d 677 (Fed. Cir. 1990) ...................................................................................... 17
`
`Zygo Corp. v. Wyko Corp.,
`79 F.3d 1563 (Fed. Cir. 1996) ...................................................................................... 13
`
`STATUTES
`
`35 U.S.C. § 251(a) ............................................................................................................... 6
`
`35 U.S.C. § 271(a) ............................................................................................................. 18
`
`OTHER AUTHORITIES
`
`21 CFR 801.4 ..................................................................................................................... 21
`
`21 CFR 801.5 ..................................................................................................................... 21
`
`
`
`vi
`
`Page 7
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 8 of 41
`
`INTRODUCTION
`
`Vascular Solutions LLC, Teleflex Innovations S.à.r.l., and Arrow International,
`
`Inc. (collectively “VSI”) oppose QXMédical, LLC’s (“QXM”) motion for summary
`
`judgment and cross-move for summary judgment.
`
`QXM seeks summary judgment on six issues: (1) invalidity of all claims for
`
`indefiniteness, (2) invalidity of the ’760, ’776, and ’116 patents for recapture, (3) non-
`
`infringement of the ’032, ’413, and ’380 patents based on the “without a lumen”
`
`limitation, (4) non-infringement of the “one French” claims, (5) non-infringement of the
`
`claims requiring the “segment defining a side/partially cylindrical opening” to be more
`
`rigid than the “tubular structure” or the “distal end portion of the tubular structure,” and
`
`(6) anticipation of claim 53 of the ’116 patent by Adams. VSI opposes QXM’s motion
`
`on all issues, and cross-moves for summary judgment on all issues except for the issue of
`
`whether QXM induces infringement of the “one French” claims. VSI also moves for
`
`summary judgment of infringement on claims 25, 36, 52, and 53 of the ’776 patent.
`
`Accordingly, VSI respectfully requests that the Court rule as follows:
`
`1) Indefiniteness: deny QXM’s motion and grant summary judgment to VSI.
`
`2) Recapture: deny QXM’s motion and grant summary judgment to VSI.
`
`3) “Without a Lumen”: deny QXM’s motion and grant summary judgment of
`
`literal infringement to VSI, or alternatively rule that material fact issues
`
`preclude summary judgment.
`
`4) “One French”: grant summary judgment to VSI that QXM is directly
`
`infringing the ’032 and ’776 patents, and deny QXM’s motion for the
`
`1
`
`Page 8
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 9 of 41
`
`additional reason that genuine issues of material fact preclude summary
`
`judgment on whether QXM is inducing infringement of all of the “one French”
`
`claims.
`
`5) Rigidity comparisons: deny QXM’s motion and grant summary judgment to
`
`VSI.
`
`6) Anticipation: deny QXM’s motion and grant summary judgment to VSI.
`
`7) Infringement: grant summary judgment that QXM infringes claims 25, 36, 52,
`
`and 53 of the ’776 patent.
`
`ARGUMENT
`VSI IS ENTITLED TO SUMMARY JUDGMENT ON INDEFINITENESS.
`
`I.
`
`QXM argues that the tubular section of the Boosting Catheter is “rigid enough to
`
`allow the device to be advanced within the guide catheter,” allegedly meeting the Court’s
`
`definition of “substantially rigid.” Because the tubular section is flexible, QXM contends
`
`the claims are indefinite because there is “no meaningful distinction that would enable a
`
`person of skill in the art to distinguish ‘substantially rigid’ from ‘flexible.’” (Br. at 2.)1
`
`QXM’s argument fails for two reasons. First, as a matter of law, QXM fails to
`
`establish that a person of skill cannot determine the scope of the claims with reasonable
`
`certainty. Second, QXM fails to prove indefiniteness by clear and convincing evidence.
`
`QXM’s tests do not demonstrate that the Boosting Catheter’s distal tube is “substantially
`
`
`1 Citations to “Br. at ___” refer to QXM’s opening brief (Dkt. 124). Citations to “Merrill
`Ex. __” refer to exhibits to Merrill Declaration filed by QXM. (Dkt. 125). Citations to
`“Ex. __” refer to exhibits attached to the Declaration of Patrick J. O’Rear. Citations to
`“Keith __” refer to the Declaration of Peter Keith.
`
`
`
`2
`
`Page 9
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 10 of 41
`
`rigid” because QXM ignored the claim language, and definitely did not prove that its
`
`distal tube is rigid enough to advance the device claimed by VSI’s patents.
`
`A. QXM’s Argument Fails As A Matter Of Law.
`“[A] patent is invalid for indefiniteness if its claims, read in light of the
`
`specification delineating the patent, and the prosecution history, fail to inform, with
`
`reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus,
`
`Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). The definiteness requirement
`
`ensures that the claims provide notice of what infringes or anticipates. Id. at 909-910.
`
`“Reasonable” certainty is required, not “absolute precision.” Id. at 910.
`
`Under the Court’s construction, the test for infringement is whether the Boosting
`
`Catheter contains a segment that is “rigid enough to allow the device to be advanced
`
`within the guide catheter”—i.e., rigid enough to act as a pushrod. QXM’s expert, Brian
`
`Brown, agreed that one skilled in the art would know and could test whether something is
`
`rigid enough to advance the device. (Ex. 2 at 51-54, 59-60.) He also agreed that “under
`
`the Court’s current claim construction, the Boosting Catheter does have a substantially
`
`rigid portion.” (Ex. 2 at 10.) QXM’s argument fails because the term “substantially
`
`rigid” delineates the scope of the claims with reasonable certainty.
`
`QXM assumes that the terms “substantially rigid” and “flexible” are mutually
`
`exclusive. That’s a logical fallacy—something “substantially rigid” necessarily has some
`
`“flexibility”—and the claims refute QXM’s assumption. The ’032, ’413, and ’380
`
`patents specify that the “substantially rigid” portion is “more rigid along a longitudinal
`
`axis[] than the flexible tip portion” (see, e.g., ’032 patent, cl. 1), which would be
`
`
`
`3
`
`Page 10
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 11 of 41
`
`superfluous if “substantially rigid” and “flexible” were already mutually exclusive.
`
`The ’760, ’776, and ’116 patents do not claim a “flexible” portion—only a “tubular
`
`structure.” (See, e.g., ’760 patent, cl. 25.) QXM cannot explain why the distinction
`
`between “substantially rigid” and “flexible” matters to those claims.
`
`The context of the invention also refutes QXM’s assumption. As the Court
`
`recognized, “the substantially rigid portion must have a considerable degree of flexibility.
`
`Otherwise, it would not be able to navigate past sharp bends in the vascular system of a
`
`human being.” (Dkt. 102 at 13.) In interventional cardiology, the difference between
`
`“rigid” and “flexible” is often subtle, and depends on the function of the part in question.
`
`(Keith ¶88, 91.) Even in common parlance, the terms “substantially rigid” and “flexible”
`
`can both be used to describe a diving board or a sapling or an archer’s bow. There is no
`
`reason that something cannot be both “flexible” and “substantially rigid.”
`
`QXM’s Argument Fails For Lack Of Proof.
`
`B.
`Even if one could prove indefiniteness by showing that the Boosting Catheter’s
`
`tubular structure is “substantially rigid,” QXM fails to prove that fact by clear and
`
`convincing evidence.
`
`Brown performed two tests involving modified Boosting Catheter components. In
`
`the first, he spliced together sections of Boosting Catheter tubing to form a full-length
`
`child catheter that he could advance into a guide catheter inside a heart model. (Merrill
`
`Ex. 1 ¶¶456-61 & Ex. C.) In the second, Brown removed the proximal handle and used
`
`the tubing to advance the Boosting Catheter pushrod-end first into the guide catheter.
`
`(Merrill Ex. 1 ¶¶462-64 & Ex. C.)
`
`
`
`4
`
`Page 11
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 12 of 41
`
`Neither of these tests demonstrate that the Boosting Catheter’s tubular section is
`
`“substantially rigid,” because neither advanced “the device” required by VSI’s patent
`
`claims. Brown’s full-length over-the-wire catheter is not representative of the Boosting
`
`Catheter because the tubing segments were bonded together over an additional layer of
`
`Teflon, stiffening the device. (Keith ¶94, 103.) Moreover, as VSI’s expert explains,
`
`Brown’s devices do not fit the claims, which dictate a rapid-exchange configuration.
`
`(Keith ¶95; id. at 93.) Brown’s devices do not meet many of the requirements of the
`
`claims, including that the “substantially rigid portion” defines “a rail structure without a
`
`lumen”; that the “substantially rigid segment” is positioned proximal of the tubular
`
`structure and a side opening segment; or that interventional cardiology devices may be
`
`inserted into a guide catheter and advanced alongside the substantially rigid portion, into
`
`the side opening, and into the tubular structure. (Id. ¶96-102.) Legally, QXM cannot
`
`ignore the requirements of the claims. Capital Sec. Sys., Inc. v. NCR Corp., 725 F. App’x
`
`952, 957 (Fed. Cir. 2018) (non-precedential). In short, neither the spliced-together, full-
`
`length over-the-wire catheter nor the reversed Boosting Catheter meets the claimed
`
`requirements of a “substantially rigid” portion.
`
`Brown could have made a rapid-exchange device with a pushrod as rigid as the
`
`Boosting Catheter’s tube. Such a pushrod would have to be more rigid to push a device
`
`because it has more room to buckle and gains less support from the guide catheter walls
`
`than a full tube. (See Dkt. 102 at 14.) Mr. Brown recognized that a tube with less room
`
`to buckle is more pushable. (See Merrill Ex. 1 ¶459.) Although Mr. Brown claims he
`
`used the “worst case” combination of a six French (“6F”) Boosting Catheter tube with an
`
`
`
`5
`
`Page 12
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 13 of 41
`
`eight French (“8F”) guide catheter, the fit is still much closer than a pushrod in a guide
`
`catheter. (Keith ¶104-05.)
`
`Because QXM cannot demonstrate indefiniteness by clear and convincing
`
`evidence, VSI requests that the Court grant summary judgment to VSI.
`
`II.
`
`VSI IS ENTITLED TO SUMMARY JUDGMENT ON RECAPTURE.
`A. QXM Must Prove By Clear And Convincing Evidence That VSI
`Surrendered Subject Matter To Overcome Prior Art.
`
`A patentee has a statutory right to broaden the scope of its patents through reissue.
`
`35 U.S.C. §251(a). A patentee may not “regain[], through reissue, subject matter that
`
`was surrendered during prosecution of the original patent in an effort to obtain allowance
`
`of the original claims.” Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360, 1373 (Fed. Cir.
`
`2006). Recapture applies only if VSI surrendered subject matter “in order to overcome a
`
`prior art rejection.” Cubist Pharmaceuticals, Inc. v. Hospira, Inc., 805 F.3d 1112, 1121-
`
`22 (Fed. Cir. 2015); see Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1267
`
`(Fed. Cir. 2012).
`
`Recapture is a question of law with underlying factual determinations. Medtronic,
`
`465 F.3d at 1373. QXM must prove recapture by clear and convincing evidence. AIA
`
`Eng’g Ltd. v. Magotteaux Int’l, S/A, 657 F.3d 1264, 1272 (Fed. Cir. 2011).
`
`VSI Did Not Surrender Subject Matter To Overcome Prior Art.
`
`B.
`QXM argues that the ’760, ’776, and ’116 patents violate the rule against
`
`recapture because they omit the requirement that the substantially rigid portion define a
`
`rail structure “without a lumen.” That argument depends on QXM’s contention that
`
`
`
`6
`
`Page 13
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 14 of 41
`
`“without a lumen” was added to avoid the Solar reference. (Br. at 12.) As QXM’s expert
`
`admitted, Solar itself proves that QXM is wrong.
`
`When “without a lumen” was added, the PTO had rejected the pending claims as
`
`obvious in light of Niazi and Solar and had rejected VSI’s description of the substantially
`
`rigid portion as “non-tubular” and “non-circular” for lack of written description. (Merrill
`
`Ex. 14 at 2-4.) VSI amended the claims to remove “non-tubular” and “non-circular” and
`
`added a requirement that the substantially rigid portion be “more rigid along a
`
`longitudinal axis than” the flexible tip portion. (Merrill Ex. 15 at 3.) Before the
`
`examiner acted on that amendment, VSI agreed to an examiner’s amendment adding “rail
`
`structure without a lumen,” so the relevant portion of the allowed claims reads:
`
`a substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis than,
`the flexible tip portion and defining a rail structure without
`a lumen and ...
`
`(Merrill Ex. 16 at 7 (examiner’s amendment in bold).)
`
`QXM asserts that “VSI included the ‘rail structure without a lumen’ limitation ...
`
`to avoid Solar’s hypotube or flexible wire pushrod.” (Br. at 12.) That’s impossible,
`
`because adding “rail structure without a lumen” does not avoid Solar. Solar’s device is
`
`depicted below:
`
`
`
`7
`
`
`
`Page 14
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 15 of 41
`
`Solar’s “advancement member 5” is a pushrod. The advancement member is
`
`“[p]referably ... formed of a flexible wire or, alternately, of spring hollow hypotubing.”
`
`(Merrill Ex. 18 ¶25; Keith ¶109-10.) QXM’s expert admitted that Solar’s wire pushrod is
`
`a rail structure without a lumen:
`
`Q: [T]he solid wire embodiment, that one doesn’t have a
`lumen, correct?
`
`A. Correct.
`
`Q: So, that’s a substantially rigid portion that forms the
`proximal shaft that doesn’t have a lumen, correct?
`
`A: Correct.
`
`Q: And that would be a rail structure without a lumen,
`correct?
`
`A: Correct.
`
`(Ex. 2 at 50-51.) The examiner cannot have added “without a lumen” to overcome Solar,
`
`because Solar had a rail structure “without a lumen.” (Keith ¶¶107-08, 111.)
`
`The examiner’s reason for allowance confirms that “without a lumen” played no
`
`role in granting the claims over prior art. The examiner cited the “claimed rail structure,”
`
`but not the “without a lumen” requirement: “While many of the structures are known, the
`
`arrangement of a claimed rail structure with the claimed flexible tip that is insertable
`
`through a hemostatic valve is not taught or suggested by the prior art.” (Merrill Ex. 16 at
`
`7.) If “without a lumen” had distinguished Solar, the examiner would have said so in the
`
`reasons for allowance. Instead, the examiner’s statement indicates that the arrangement
`
`including the “claimed rail structure” is patentable whether or not the rail structure is
`
`“without a lumen.” (See id.)
`
`
`
`8
`
`Page 15
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 16 of 41
`
`The PTO instructs its examiners to review reissue patents carefully to check for
`
`recapture problems, which are peculiar to reissue patents. (Ex. 3 at 3-10.)2 The recapture
`
`issue here is not subtle: the original claims required a “substantially rigid portion ...
`
`defining a rail structure without a lumen” and the reissued patent claims eliminated
`
`“without a lumen.”
`
`And yet the PTO blessed VSI’s elimination of “without a lumen” three separate
`
`times. One of the examiners who reissued the ’760 and ’776 patents eliminating the
`
`“without a lumen” requirement was Bradley Osinski, the same examiner who allowed
`
`VSI’s ’032, ’413, and ’850 patents with claims reciting that requirement. (O’Rear Dec.
`
`¶¶29-30.) In all, seven patent examiners reviewed VSI’s reissue patents; none raised this
`
`recapture issue. (O’Rear Dec. ¶¶38-39.)
`
`III. THE BOOSTING CATHETER’S SUBSTANTIALLY RIGID PORTION
`DEFINES A RAIL STRUCTURE WITHOUT A LUMEN.
`A. QXM’s Boosting Catheter Literally Meets The “Without A Lumen”
`Limitation.
`
`The figure below is an enlarged cross-section of the Boosting Catheter’s pushrod:
`
`
`
`
`2 Contrary to QXM’s argument (Br. at 12), there is no presumption that every amendment
`following a prior art rejection is an irrevocable surrender. The guidelines simply say that
`a patentee need not express an intent to surrender if a limitation is added to overcome a
`prior art rejection. (See Ex. 3 at 3-4.)
`
`
`
`9
`
`Page 16
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 17 of 41
`
`(Keith ¶28.) QXM makes the pushrod
`
`
`
` (O’Rear Ex. 7 at 239-55; Br. at 14.) Between the wires and the sheath are two tiny
`
`gaps, one filled with a bonding agent (10) and one left unfilled. (Br. at 14.) The unfilled
`
`void is approximately 6% of the area inside the sheath. (Keith ¶19-20.)
`
`QXM argues that this configuration has two lumens: (i) the entire space inside the
`
`sheath, and (ii) the “residual gap between the wires,” i.e., the tiny unfilled void. (Br. at
`
`14.) Neither is a “lumen.”
`
`A “Cavity” Must Be Unfilled Or Hollow.
`
`1.
`This Court has construed “lumen” to have its plain and ordinary meaning: “the
`
`cavity of a tube.” (Dkt. 102 at 25.) The same dictionaries the Court cited to define
`
`“lumen” (Dkt. 102 at 23-24) confirm that the plain and ordinary meaning of “cavity” is a
`
`“hollow,” “unfilled” area. (See Exs. 4-6.) QXM argues that the
`
` tube has
`
`a lumen even though it is 94% filled with the wires and bonding agent. Indeed, QXM
`
`argues that a completely filled tube has a “lumen” “regardless of whether it has something
`
`occupying it or not.” (Merrill Ex. 21 ¶¶145-46; see also Ex. 2 at 80-84.) This argument
`
`reads “cavity” out of the Court’s construction, and is contrary to any reasonable notion of
`
`the term “lumen.” A tube cannot be completely, or even 94%, filled and still have a
`
`lumen. If QXM’s
`
` sheath forms a “tube,” that tube has no lumen.
`
`2.
`A “Residual Gap Between the Wires” Is Not “The Cavity Of A
`Tube.”
`
`QXM’s second argument is that the “residual gap between the wires is also a
`
`lumen.” (Br. at 14.) The “residual gap between the wires” is left over when the sheath is
`
`
`
`10
`
`Page 17
`
`Medtronic Exhibit 1468
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 133 Filed 04/30/19 Page 18 of 41
`
`
`
`(O’Rear Ex. 7 at 239-55.) This microscopic gap between the wires and a portion of the
`
`sheath comprises about 6% of the total cross-sectional area inside the sheath. (Keith
`
`¶20.) No reasonable jury could consider this “residual gap between the wires” as a
`
`separate tube or as “the cavity” of the tube (11) itself. (See id. ¶¶22-24.)
`
`B.
`
`Alternatively, QXM’s Boosting Catheter Infringes Under The Doctrine
`Of Equivalents.
`
`The doctrine of equivalents exists to ward off “efforts of copyists to evade liability
`
`for infringement by making only insubstantial changes to a patented invention.” Festo
`
`Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 727 (2002). This
`
`doctrine recognizes that “language in the patent claims may not capture every nuance of
`
`the invention or describe with complete precision the range of its novelty.” Id. at 731-32.
`
`The “essential inquiry” is whether “the accused product or process contain[s]
`
`elements identical or equivalent to each claimed element of the patented invention[.]”
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997). Equivalence
`
`is determined by either (1) the “function-wa