`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`
`
`
`
`
`
`
`
`Case IPR2020-00126
`Patent 8,048,032
`
`
`
`
`
`
`
`
`PETITIONER’S REQUEST FOR DIRECTOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d) AND UNITED STATES V. ARTHREX
`
`
`
`
`
`
`
`
`
`
`
`IPR2020-00126
`Patent 8,048,032
`
`TABLE OF CONTENTS
`
`1.
`
`2.
`
`3.
`
`B.
`
`A.
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARD ...................................................................................... 2
`II.
`III. THE BOARD’S FINDINGS RELATED TO CORROBORATION
`AND DILIGENCE SET DANGEROUS PRECEDENTS
`CONTRARY TO ESTABLISHED LAW, AND THE DIRECTOR
`SHOULD REVERSE. ..................................................................................... 2
`The Director must correct the Board’s faulty corroboration
`analysis. ...................................................................................................... 3
`The Director needs to clarify whether the non-inventor
`testimony, alone, is sufficient to corroborate the inventor
`testimony. ............................................................................................... 5
`Patent Owner’s non-inventor declarations do not corroborate
`inventor testimony that VSI determined that the inventions
`would work for their intended purpose—the Board relied on
`only inventor testimony. ........................................................................ 7
`The Board overlooked evidence disproving reduction to
`practice. ............................................................................................... 12
`The Director must correct the Board’s application of the
`“reasonably continuous” diligence standard. ........................................... 13
`IV. CONCLUSION .............................................................................................. 15
`
`
`
`
`
`ii
`
`
`
`IPR2020-00126
`Patent 8,048,032
`
`TABLE OF AUTHORITIES
`
`Cases
`Arctic Cat Inc. v. GEP Power Prods., Inc.,
`919 F.3d 1320 (2019) ..................................................................................... 13, 14
`ATI Techs. ULC v. Iancu,
`920 F.3d 1362 (Fed. Cir. 2019) ........................................................................ 3, 13
`Bos. Sci. Corp. v. Johnson & Johnson,
`481 F. Supp. 2d 1018 (N.D. Cal. 2007) .................................................................. 8
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) ............................................................................... 6
`Hahn v. Wong,
`892 F.2d 1028 (Fed. Cir. 1989) ............................................................................... 4
`In re Meyer Mfg. Corp.,
`411 F. App’x 316 (Fed. Cir. 2010) ........................................................................ 13
`Lacks Indus., Inc. v. McKechnie Vehicle Components USA, Inc.,
`322 F.3d 1335 (Fed. Cir. 2003) ...........................................................................4, 6
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .............................................................................7, 8
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ................................................................. 3, 4, 7, 11
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ............................................................................... 3
`Singh v. Brake,
`222 F.3d 1362 (Fed. Cir. 2000) ............................................................................... 3
`Toshiba Memory Corp. v. Anza Tech., Inc.,
`IPR2018-01597, 2020 WL 1229855 (PTAB Mar. 12, 2020) ............................... 13
`United States v Arthrex, Inc.,
`141 S. Ct. 1970 (2021) ........................................................................................... 2
`
`iii
`
`
`
`IPR2020-00126
`Patent 8,048,032
`Xilinx, Inc. v. Intell. Ventures Mgmt.,
`Appeal No. 2014-001131, 2014 WL 1679835 (PTAB Apr. 25, 2014) ................. 13
`Other Authorities
`MPEP § 2138.06 ...................................................................................................... 15
`PTO Guidance, Arthrex Q&As | USPTO ................................................................... 2
`
`
`
`
`
`
`iv
`
`
`
`IPR2020-00126
`Patent 8,048,032
`INTRODUCTION
`I.
`Petitioner seeks Director review of the Final Written Decision (“FWD,” Paper
`
`127) holding that the primary reference, Itou, is not prior art.1 The Director should
`
`reverse and remand for consideration of the asserted grounds on the merits.
`
`The Board erred in finding that Patent Owner’s predecessor, VSI, reduced the
`
`claimed coaxial guide catheter (or guide extension catheter) inventions to practice
`
`before Itou. The Board found that VSI assembled and tested prototypes embodying
`
`the inventions and determined that they would work for their intended purpose. The
`
`Board’s ruling on testing, however, cites only inventor testimony, in violation of
`
`established corroboration requirements. No document in the record relates to testing
`
`relevant prototypes or demonstrating that the prototypes would work for their
`
`intended purpose. The Board cited the declaration of a non-inventor, Erb, but not for
`
`any details regarding testing relevant prototypes (because he provides none).
`
`The Board’s decision departs from binding authority establishing the contours
`
`of corroboration requirements. Neither the Board’s decision nor Patent Owner’s
`
`briefing cites a single case or Board decision finding that an invention was
`
`demonstrated to work for its intended purpose based on only after-the-fact,
`
`litigation-driven testimony, much less on only inventor testimony. Director review
`
`
`1 Petitioner requested a Precedential Opinion Panel by email.
`
`1
`
`
`
`IPR2020-00126
`Patent 8,048,032
`is needed to guide the PTAB on the necessity of independent, sufficient evidence to
`
`corroborate reduction to practice, and to correct the Board’s errors here.
`
`The Board, in the alternative, found that Patent Owner showed diligent work
`
`toward constructive reduction to practice during the entire critical period. In so
`
`finding, the Board overcorrected in response to recent appellate decisions finding
`
`prior PTAB diligence analyses improperly stringent. The Board applied a diligence
`
`standard so relaxed that Patent Owner prevailed despite a record documenting little
`
`to no engineering work over an eight-month period. That is not the law. Director
`
`review is needed to create guidelines for the proper diligence analysis.
`
`II. LEGAL STANDARD
`Under Arthrex, the Director may review final written decisions, and the PTO
`
`has clarified that “[t]he Director’s review may address any issue, including issues of
`
`fact and issues of law, and will be de novo.” PTO Guidance, Arthrex Q&As | USPTO
`
`(emphases added); 141 S. Ct. 1970 (2021). Thus, under Arthrex, the Director reviews
`
`final written decisions de novo.
`
`III. THE BOARD’S FINDINGS RELATED TO CORROBORATION AND
`DILIGENCE SET DANGEROUS PRECEDENTS CONTRARY TO
`ESTABLISHED LAW, AND THE DIRECTOR SHOULD REVERSE.
`Itou is, on its face, prior art. So Patent Owner tried to swear behind the
`
`reference. To swear behind Itou, Patent Owner needed to prove prior reduction to
`
`practice or prior conception plus diligence from just before Itou through patent
`
`2
`
`
`
`IPR2020-00126
`Patent 8,048,032
`application. See ATI Techs. ULC v. Iancu, 920 F.3d 1362, 1369 (Fed. Cir. 2019);
`
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1007 (Fed.
`
`Cir. 2016).
`
`The Director must reverse the Board’s prior reduction to practice and
`
`diligence findings and confirm that Itou is prior art. The Board’s findings depart
`
`from established case law and PTAB practice. Inventor testimony about prior
`
`reduction to practice requires sufficient corroboration, including more than an
`
`interested witness’s vague testimony. And Patent Owner cannot prove diligence on
`
`a record showing scant patent prosecution activity and de minimis engineering
`
`work. The Director must correct these fundamental flaws in the Board’s analysis.
`
`A. The Director must correct the Board’s faulty corroboration
`analysis.
`To prove reduction to practice, Patent Owner needed to show “(1) construction
`
`of an embodiment . . . that met all the limitations of the [claimed invention]; . . .
`
`(2) determination that the invention would work for its intended purpose; and (3) the
`
`existence of sufficient evidence to corroborate inventor testimony regarding these
`
`events.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). Two
`
`distinct elements—constructing an embodiment (here, a prototype) and determining
`
`that it would work for its intended purpose—require sufficient corroborating
`
`evidence. And the corroboration requirement is “more stringent” than for
`
`conception. Singh v. Brake, 222 F.3d 1362, 1370 (Fed. Cir. 2000).
`
`3
`
`
`
`IPR2020-00126
`Patent 8,048,032
`Even the most credible inventor testimony requires independent, sufficient
`
`corroborating evidence. Medichem, 437 F.3d at 1171-72. Corroborating evidence
`
`must be “independent of information received from the inventor.” Hahn v. Wong,
`
`892 F.2d 1028, 1032-33 (Fed. Cir. 1989). Thus, “an inventor’s testimony, standing
`
`alone, cannot support a claim of . . . priority,” and under the rule of reason, courts
`
`consider “the extent and details of the corroborating testimony.” Lacks Indus., Inc.
`
`v. McKechnie Vehicle Components USA, Inc., 322 F.3d 1335, 1349 (Fed. Cir. 2003).
`
`The law requires more than a standard credibility assessment.
`
`Here, the Board skipped a critical step in its reduction-to-practice analysis: it
`
`did not consider whether Patent Owner adduced evidence sufficient to corroborate
`
`the inherently self-serving inventor testimony that VSI tested prototypes and
`
`determined that the inventions would work for their intended purpose. The Board
`
`credited the inventors and relied on their declarations for every finding related to
`
`testing and determining that the inventions would work for their intended purpose.
`
`See infra § III.A.2. At best, the Board relied on the mere existence of threadbare
`
`non-inventor declarations to ratify the inventors’ declarations wholesale.
`
`No documents—no photographs, lab reports, test results, etc.—corroborate
`
`inventor testimony related to testing and determining that the inventions would work
`
`for their intended purpose. See CRTP Reply (Paper 78) at 17-19. The Board noted
`
`that Patent Owner adduced numerous documents in support of conception and
`
`4
`
`
`
`IPR2020-00126
`Patent 8,048,032
`reduction to practice, including component parts invoices, engineering drawings,
`
`and laboratory notebooks. Parts orders and engineering drawings may support Patent
`
`Owner’s claims that certain prototypes—the so-called April and July 2005
`
`prototypes—existed and embodied the inventions. See, e.g., FWD at 36-37; Ex-
`
`2089; Ex-2092; Ex-2113; Ex-2114. But the Board did not, and could not, rely on any
`
`documents to corroborate inventor testimony related to the second piece of the
`
`reduction-to-practice puzzle: prototype testing. The only document related to
`
`prototype testing is a photograph of a distinct, legally irrelevant prototype, a non-
`
`inventive over-the-wire (OTW) GuideLiner device. Ex-2018.
`
`Not one piece of documentary evidence shows that VSI determined, through
`
`testing, that the inventions would work for their intended purpose. Without
`
`documents relevant to the “intended purpose” element, the Board relied on only
`
`inventor testimony or, at best, the mere existence of non-inventor declarations to
`
`credit the inventors.
`
`1.
`
`The Director needs to clarify whether the non-inventor
`testimony, alone, is sufficient to corroborate the inventor
`testimony.
`It appears that the Board relied on the mere existence of non-inventor
`
`declarations to corroborate the inventors’ testimony wholesale. See, e.g., FWD at 48
`
`(noting that “[c]ritical aspects of [Root’s and Sutton’s] testimony are corroborated
`
`by other (non-inventor) testimony”). The Board erred, as a matter of law, in relying
`
`5
`
`
`
`IPR2020-00126
`Patent 8,048,032
`on only testimony—including the conclusory non-inventor testimony here—to find
`
`that VSI determined that the inventions would work for their intended purpose.
`
`No case, to Petitioner’s knowledge, has held that an interested, non-inventor
`
`witness’s testimony, alone, is sufficient to corroborate inventor testimony when no
`
`other evidence tends to show that the inventor determined that the inventions would
`
`work for their intended purpose.2 Corroboration requires more than an interested,
`
`non-inventor witness’s testimony. That principle dates to the late 19th century. See
`
`Lacks, 322 F.3d at 1350 (“Starting with the Supreme Court’s decision in The Barbed
`
`Wire Patent Case and ending with our recent decision in Union Carbide v. Shell Oil
`
`Co., courts have consistently required documentary corroboration of oral testimony
`
`by interested parties . . . .” (emphasis added) (citations omitted)).
`
`
`2 The Board cites Cooper v. Goldfarb, 154 F.3d 1321 (Fed. Cir. 1998), noting certain
`
`reasonable limits to the corroboration requirement. FWD at 48. But in Cooper,
`
`documentary evidence established that the inventor had performed certain
`
`experiments (including histological slides), and specific non-inventor testimony
`
`confirmed one particular aspect of the experiment. Cooper, 154 F.3d at 1330. Cooper
`
`did not hold that absent any documentary evidence showing that the inventor
`
`determined that the invention would work for its intended purpose, non-inventor
`
`testimony is sufficient corroborating evidence.
`
`6
`
`
`
`IPR2020-00126
`Patent 8,048,032
`The same reasoning applies in the reduction-to-practice context. An interested
`
`witness’s testimony—even non-inventor testimony—is not sufficient to corroborate
`
`presumed-biased inventor testimony. Interested witnesses—like inventors—are
`
`inherently unreliable, and well-established corroboration requirements are designed
`
`to guard against unreliable, self-serving testimony. See Medichem, 437 F.3d at 1170
`
`(noting that the corroboration requirement guards against fraud and “provides an
`
`additional safeguard against courts being deceived by inventors who may be tempted
`
`to mischaracterize the events of the past through their testimony”); Mahurkar v. C.R.
`
`Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996) (The corroboration “requirement
`
`arose out of a concern that inventors testifying in patent infringement cases would
`
`be tempted to remember facts favorable to their case by the lure of protecting their
`
`patent or defeating another’s patent. . . . [T]he rule provides a bright line for both
`
`district courts and the PTO to follow in addressing the difficult issues related to
`
`invention dates.”). Non-inventors may still qualify as interested, unreliable
`
`witnesses. Here, Erb, a current Teleflex (Patent Owner) employee, and Schmalz, a
`
`former VSI employee, are still interested witnesses. Even if they had testified in the
`
`same manner and detail as the inventors (they did not, see infra), an interested
`
`witness’s testimony, standing alone, is not sufficient to corroborate inventor
`
`testimony regarding reduction to practice.
`
`2.
`
`Patent Owner’s non-inventor declarations do not
`corroborate inventor testimony that VSI determined that the
`
`7
`
`
`
`IPR2020-00126
`Patent 8,048,032
`
`inventions would work for their intended purpose—the
`Board relied on only inventor testimony.
`Even if non-inventor testimony, alone, were sufficient to corroborate inventor
`
`testimony related to whether an invention would work for its intended purpose, the
`
`Board did not cite any corroborating non-inventor testimony related to determining
`
`that the inventions would work for their intended purpose. Indeed, no non-inventor
`
`provides independent information relevant to the “intended purpose” element.
`
`The Board found reduction to practice based on VSI’s purported testing to
`
`determine that the prototypes would work for their intended purpose: “to increase
`
`backup support for delivery of interventional cardiology devices,” with “crossing
`
`tough or total occlusions [being] one noted benefit of the invention.” FWD at 55-56.
`
`Without exception, reduction to practice requires demonstrating that the invention
`
`would work for its intended purpose. CRTP Sur-Sur-Reply (Paper 112) at 9-10.
`
`Demonstrating that an invention would work for its intended purpose requires testing
`
`in all but simple cases. Id. Courts have found that catheters, in particular, require
`
`testing. See, e.g., Mahurkar, 79 F.3d at 1578; Bos. Sci. Corp. v. Johnson & Johnson,
`
`481 F. Supp. 2d 1018, 1024 (N.D. Cal. 2007) (reduction to practice after patentee
`
`“submitted documentation of the successful test results of a catheter embodying the
`
`. . . invention”). Thus, the Board evaluated whether VSI’s testing “was sufficient to
`
`determine that the RX GuideLiner prototypes would work for the intended purpose.”
`
`FWD at 55.
`
`8
`
`
`
`IPR2020-00126
`Patent 8,048,032
`But the Board relied on only inventor testimony to find that VSI performed
`
`the requisite testing, citing “proof” of testing from only inventor declarations. See,
`
`e.g., FWD at 43-44 (finding that “[t]he prototypes were tested using bench-top
`
`coronary models . . . to simulate the native anatomy and environment” and “[t]he
`
`testing done using this model included performing pull tests as well as simulations
`
`comprising the following steps: a) inserting a standard guide catheter into the
`
`coronary model; b) advancing the prototype into the guide catheter until the
`
`prototype’s distal end extended beyond the guide catheter’s distal end; and c)
`
`delivering a stent or balloon catheter into and through both devices,” citing only
`
`inventor testimony), 44 (“Both Mr. Root and Mr. Sutton attest that this testing was
`
`sufficient to confirm that the RX GuideLiner would work for its intended purpose,
`
`namely facilitating delivery of interventional cardiology devices into challenging
`
`coronary anatomy by providing increased backup support as compared to a guide
`
`catheter alone.”). The Board cited no evidence corroborating this testimony. Id.
`
`The Board’s decision confirms that Patent Owner did not offer any non-
`
`inventor testimony to confirm that VSI tested relevant prototypes before the U.S.
`
`filing of Itou on September 23, 2005. The Board included a passing reference to
`
`single paragraph from Erb’s declaration, but the Board did not—and could not—use
`
`Erb for independent confirmation that VSI tested relevant prototypes (the April and
`
`July 2005 prototypes). See Ex-2122 ¶ 11 (discussing only early prototypes and tests
`
`9
`
`
`
`IPR2020-00126
`Patent 8,048,032
`for delivery of stents and balloons that he “was not personally involved in”). Erb
`
`offers no details regarding which prototypes’ testing he was “involved in,” the timing
`
`of relevant testing, details of that testing, or whether that testing demonstrated that
`
`the inventions worked for their intended purposes. Id.; see also CRTP Reply at 19-
`
`21; CRTP Sur-Sur-Reply at 12-13. He machined early components that no one
`
`argues embodied the claims. Ex-2118, App’x A-E (charting only April and July 2005
`
`prototypes as embodying the claims). Erb offers no prototype or testing specifics or
`
`detail regarding how VSI knew that prototypes “worked.” His role during “testing”
`
`was to “stand[] there next to whoever was testing.” CRTP Reply at 20. Indeed, the
`
`Board does not appear to appreciate the limits of Erb’s knowledge, mischaracterizing
`
`his work as “developing these [the relevant April and July] prototypes.” FWD at 37.
`
`Erb did not develop the prototypes that Patent Owner relies on for reduction to
`
`practice, did not test those prototypes, and can offer no specifics about who tested
`
`them and when, with what result. His five-and-a-half-page declaration, which does
`
`not even specify that whatever testing he recalls occurred before Itou, does not
`
`provide sufficient corroboration.
`
`Schmalz, Patent Owner’s other primary non-inventor witness, offers even less
`
`than Erb, and the Board does not cite her when finding that VSI tested prototypes
`
`and determined that the inventions would work for their intended purpose. She
`
`admitted that she has no personal knowledge of the relevant prototypes. CRTP Reply
`
`10
`
`
`
`IPR2020-00126
`Patent 8,048,032
`at 21. She cannot judge whether an invention would work for its intended purpose—
`
`she is not an engineer. Id. Instead, the former VP of Regulatory and Clinical Affairs
`
`could only assume reduction to practice based on an incomplete Product
`
`Requirements Document—a document that the Board appreciated is “somewhat less
`
`probative in showing actual reduction to practice.” FWD at 44.
`
`Patent Owner’s non-inventor declarations, which neither fill gaps in the
`
`documentary record nor confirm the detail that the inventors provide related to
`
`prototype testing, fall short under established law. The law requires evidence
`
`sufficient to corroborate inventor testimony related to determining that the
`
`inventions would work for their intended purpose. Medichem, 437 F.3d at 1169.
`
`When it considered whether VSI tested prototypes and determined that they
`
`would work for their intended purpose, the Board erred and performed a standard
`
`credibility assessment rather than demand independent corroboration of reduction to
`
`practice. “[T]he raison d’etre of the corroboration requirement is our refusal to base
`
`priority determinations on a court’s uncorroborated assessments of a testifying
`
`inventor’s credibility. Even the most credible inventor testimony is a fortiori
`
`required to be corroborated by independent evidence.” Medichem, 437 F.3d at 1171-
`
`72. The Director should weigh in on this important legal issue and require the Board
`
`to delineate between corroboration and credibility. Petitioner asks the Director to
`
`provide guidance regarding what constitutes adequate corroborating evidence when
`
`11
`
`
`
`IPR2020-00126
`Patent 8,048,032
`determining whether an invention worked for its intended purpose. If the Board can
`
`rely on only the existence of non-inventor testimony, as here, to credit everything an
`
`inventor says, it will eviscerate the rule of reason. Without correction, reduction-to-
`
`practice analyses will revert to simple credibility assessments—precisely what the
`
`law’s corroboration requirement prohibits.
`
`3.
`
`The Board overlooked evidence disproving reduction to
`practice.
`Under the rule of reason, the Board must consider all evidence of record as a
`
`whole. But the Board overlooked critical evidence demonstrating that VSI could not
`
`have reduced the claimed inventions to practice before Itou. For example, inventor
`
`Root assumed a design lock in August 2005 when testifying regarding the timing of
`
`reduction to practice. But the record shows that VSI did not freeze its design until
`
`years later, undermining Root’s testimony. See CRTP Reply at 23. The Board also
`
`did not consider evidence that design changes forced the engineering team to cancel
`
`design verification testing—“performance testing to verify the design works as
`
`intended”—in December 2005. Id. at 25-26 (citing Ex-1768). Nor did the Board
`
`consider evidence that bonding distal and proximal sections to assemble a complete,
`
`working RX prototype “took substantial engineering and testing” and, thus, did not
`
`happen immediately after receiving the component parts. Id. at 27 (citing Ex-1770).
`
`The Board’s failure to consider this evidence demonstrating that the inventors did
`
`not have a working embodiment of the invention warrants Director review.
`
`12
`
`
`
`IPR2020-00126
`Patent 8,048,032
`The Director must correct the Board’s application of the
`B.
`“reasonably continuous” diligence standard.
`“[T]o antedate a reference, the applicant . . . must have reasonably continued
`
`activity to reduce the invention to practice.” ATI, 920 F.3d at 1369. “Reasonable
`
`diligence must be shown throughout the entire critical period.” Arctic Cat Inc. v.
`
`GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). In the past, the Board correctly
`
`applied the diligence standard. See, e.g., Toshiba Memory Corp. v. Anza Tech., Inc.,
`
`IPR2018-01597, 2020 WL 1229855, at *15-17 (PTAB Mar. 12, 2020) (Patent Owner
`
`did not establish diligence when it could not account for a several-week period);
`
`Xilinx, Inc. v. Intell. Ventures Mgmt., Appeal No. 2014-001131, 2014 WL 1679835,
`
`at *12 (PTAB Apr. 25, 2014) (“In the absence of an adequate explanation, [six
`
`weeks] of delay is sufficient, in and of itself, to defeat Patent Owner’s claim of
`
`diligence.”); cf. In re Meyer Mfg. Corp., 411 F. App’x 316, 319-20 (Fed. Cir. 2010)
`
`(unexplained two-month gap did not show diligence). But here, the Board appears
`
`to have overcorrected, perhaps through misunderstanding the ATI and Arctic Cat
`
`decisions. The Board erred, requiring almost nothing to establish diligence.
`
`Patent Owner adduced evidence of only scattered “diligence” events between
`
`September 23, 2005, and May 3, 2006—few related to actual work on an RX device:
`
`• October 2005: counsel opened patent application file (no work until later).
`
`• November 2005: VSI created an engineering drawing.
`
`• January and March 2006: counsel worked on patent application.
`
`13
`
`
`
`IPR2020-00126
`Patent 8,048,032
`• March 15 and April 12, 2006: Sutton and counsel exchanged emails.
`
`• Spring 2006: VSI purchased generic component parts (mostly hypotube).
`
`CRTP Reply at 28-29 (with timeline plotting diligence evidence). VSI did not touch
`
`the project for entire months. The Board glossed over a three-month period with one
`
`data point of documented engineering activity, followed by a month of total
`
`inactivity. In ignoring these gaps, the Board found diligence on a sparse record of
`
`sporadic prosecution work (indeed, a week-and-a-half’s worth of work over eight
`
`months), a handful of components parts purchases, and a company with shifting
`
`priorities. Id. at 28-30. Unlike here, the Arctic Cat court excused periods of inventor
`
`inactivity only because evidence showed that the inventor “put[] the invention into
`
`someone else’s hands for needed testing.” Arctic Cat, 919 F.3d at 1332.
`
`The Board ignored not only the quantity of RX work during the relevant
`
`period but also the quality of that work. Patent Owner adduced virtually no evidence
`
`of engineering work. In September 2005, VSI purchased forming tips (an auxiliary
`
`product for shaping the distal tip of a variety of devices), and the Board assumed
`
`that “VSI was continuing to refine the prototypes.” FWD at 63. In October and
`
`November 2005, updates to the VSI Board identified projected timelines for
`
`regulatory filings, all of which put the RX version of the GuideLiner behind the
`
`OTW version. Id. at 64. The Board assumed parallel engineering work, but the
`
`record demonstrates the opposite: VSI, time and again, pushed out its aspirational
`
`14
`
`
`
`IPR2020-00126
`Patent 8,048,032
`RX deadlines due to lagging engineering work. CRTP Reply at 28-29. In March and
`
`April 2006, VSI purchased more hypotubing, but nothing in the record indicates
`
`whether or when VSI used those components to continue work on RX.
`
`Work cited to show reasonable diligence must directly relate to reduction to
`
`practice. MPEP § 2138.06. But the Board relied on the inventor’s conclusions,
`
`offered without supporting documents and bolstered only by similarly sweeping
`
`conclusions from a non-inventor. FWD at 63 (citing Root’s testimony that “they
`
`worked on [the RX project] continuously until they brought it to market” and
`
`Schmalz’s testimony that “at no time between the start of the regulatory process . . .
`
`and the filing of the patent application . . . was the rapid exchange GuideLiner project
`
`abandoned or paused”).
`
`The Board pulled more inferences from the sparse record than Patent Owner
`
`(who devoted a page-and-a-half to diligence, CRTP Response (Paper 39) at 28-29,
`
`and nothing additional in sur-reply, see CRTP Sur-Reply (Paper 97) at 12),
`
`effectively eviscerating the “reasonably continuous” standard. Petitioner seeks
`
`Director review to fix the misapplication of the standard and to clarify whether large
`
`gaps of time in work, as here, can constitute diligence.
`
`IV. CONCLUSION
`The Director should review the Final Written Decision and find that Itou is
`
`prior art.
`
`15
`
`
`
`IPR2020-00126
`Patent 8,048,032
`
`
`Dated: July 21, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`s/ Cyrus A. Morton
`Cyrus A. Morton
`Reg. No. 44,954
`Robins Kaplan LLP
`2800 LaSalle Plaza
`800 LaSalle Avenue
`Minneapolis, MN 55402
`Attorney for Petitioner
`
`16
`
`
`
`IPR2020-00126
`Patent 8,048,032
`
`CERTIFICATE OF SERVICE
`
`I certify that on July 21, 2021, a copy of Petitioner’s Request for Director
`
`Rehearing Pursuant to 37 C.F.R. § 42.71(d) and United States v. Arthrex was served
`
`in its entirety by electronic mail on Patent Owner’s counsel at the following
`
`addresses indicated in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
`
`Alexander S. Rinn
`pkohlhepp@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`s/ Cyrus A. Morton
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioner
`
`17
`
`
`Dated: July 21, 2021
`
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
