Paper No. ____
`Filed: June 24, 2015
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`
`
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`Filed on behalf of:
`
`INO Therapeutics LLC
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`Praxair Distribution, Inc.
`Petitioner,
`v.
`INO Therapeutics LLC
`Patent Owner.
`________________
`
`Case IPR2015-00891
`U.S. Patent No. 8,573,210
`________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
`
`
`
`
`
`
`Filed: June 24, 2015
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`
`
`
`Filed on behalf of:
`
`INO Therapeutics LLC
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`Praxair Distribution, Inc.
`Petitioner,
`v.
`INO Therapeutics LLC
`Patent Owner.
`________________
`
`Case IPR2015-00891
`U.S. Patent No. 8,573,210
`________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
`
`
`
`
`
`
`
`
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`I.
`
`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 4
`
`A.
`
`B.
`
`C.
`
`D.
`
`Inhaled Nitric Oxide (“iNO”) ................................................................ 4
`
`The ’210 Patent ..................................................................................... 5
`
`The ’210 Patent Claims ......................................................................... 9
`
`Petitioner’s Prior Art ........................................................................... 10
`
`III.
`
`PERSON OF ORDINARY SKILL ............................................................... 13
`
`IV. CLAIM CONSTRUCTION .......................................................................... 13
`
`V.
`
`LEGAL STANDARD ................................................................................... 14
`
`VI. THE BOARD SHOULD NOT INSTITUTE REVIEW
`BECAUSE THE PETITION RELIES ON SUBSTANTIALLY
`THE SAME PRIOR ART AND ARGUMENTS
`PREVIOUSLY PRESENTED TO THE OFFICE ......................................... 16
`
`VII. GROUND 1: THE BOARD SHOULD NOT INSTITUTE
`REVIEW BASED ON ALLEGED OBVIOUSNESS OVER
`THE ’083 PATENT IN COMBINATION WITH THE ’510
`PATENT, THE FR ’804 PUBLICATION, THE INOMAX
`LABEL, AND THE IR STANDARD ........................................................... 21
`
`A.
`
`B.
`
`C.
`
`The Challenged Claims ....................................................................... 21
`
`Petitioner’s Contentions ...................................................................... 23
`
`Petitioner Fails to Show that the Prior Art Teaches or
`Suggests All the Limitations of Independent Claim 1 ........................ 26
`
`1.
`
`Petitioner Fails to Provide Any Reason to
`Repurpose the Valve of the ’510 Patent to
`Communicate with a Control Module that Delivers
`a Gas Comprising NO to a Patient ............................................ 27
`
`i
`
`
`
`
`
`2.
`
`3.
`
`Petitioner Fails to Provide Any Reason to Store
`Gas Type as Disclosed in the FR ’804 Publication
`or Gas Concentration as Disclosed in the ’083
`Patent in the Valve Memory of the ’510 Patent ...................... 30
`
`The IR Standard and the INOMAX Label Do Not
`Make Up for the Deficiencies in the ’510 Patent,
`the FR ’804 Publication, and the ’083 Patent ........................... 38
`
`Petitioner Fails to Show that a POSA Would Have Had a
`Reason to Combine the Relied-Upon Prior Art .................................. 40
`
`Petitioner Fails to Show that the Prior Art Renders
`Obvious the Claims that Depend from or Otherwise
`Incorporate the Limitations of Claim 1 ............................................... 44
`
`1.
`
`2.
`
`3.
`
`Claims 6, 9, and 12 ................................................................... 44
`
`Claim 7 ...................................................................................... 46
`
`Claim 13 .................................................................................... 47
`
`D.
`
`E.
`
`VIII. GROUND 2: THE BOARD SHOULD NOT INSTITUTE
`REVIEW BASED ON ALLEGED OBVIOUSNESS OVER
`THE ’083 PATENT IN COMBINATION WITH THE ’510
`PATENT, THE FR ’804 PUBLICATION, THE INOMAX
`LABEL, THE IR STANDARD, AND THE ’533 PATENT ........................ 48
`
`IX. GROUND 3: THE BOARD SHOULD NOT INSTITUTE
`REVIEW BASED ON ALLEGED OBVIOUSNESS OVER
`THE ’083 PATENT IN COMBINATION WITH THE ’510
`PATENT, THE FR ’804 PUBLICATION, THE INOMAX
`LABEL, THE IR STANDARD, AND THE ’398 PATENT ........................ 50
`
`X.
`
`CONCLUSION .............................................................................................. 57
`
`
`
`ii
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`TABLE OF AUTHORITIES
`
`
`Cases
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ........................................................................................... 14
`
`Hartness Int’l Inc. v. Simplimatic Eng’g Co.,
`819 F.2d 1100 (Fed. Cir. 1987) ........................................................ 44, 49, 51
`
`In re Cuozzo Speed Techs., LLC,
`778 F.3d 1271 (Fed. Cir. 2015) ..................................................................... 13
`
`In re Kotzab,
`217 F.3d 1365 (Fed. Cir. 2000) ..................................................................... 15
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)................................................................................ 14, 15
`
`N. Am. Vaccine, Inc. v. Am. Cyanamid Co.,
`7 F.3d 1571 (Fed. Cir. 1993) ........................................................................... 8
`
`OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc.,
`701 F.3d 698 (Fed. Cir. 2012) ....................................................................... 30
`
`Standard Oil Co. v. Am. Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985) ......................................................................... 8
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ..................................................................... 15
`
`Statutes
`
`35 U.S.C. § 103(a) (pre-AIA) .......................................................................... passim
`
`35 U.S.C. § 314(a) .............................................................................................. 2, 14
`
`35 U.S.C. § 325(d) .............................................................................................. 2, 16
`
`Regulations
`
`37 C.F.R. § 42.64(b)(1) ............................................................................................ 11
`
`37 C.F.R. § 42.100(b) .............................................................................................. 13
`
`iii
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`
`
`
`
`37 C.F.R. § 42.104(b)(4) ............................................................................................ 2
`
`37 C.F.R. § 42.108(c) .......................................................................................... 2, 14
`
`P.T.A.B.
`BSP Software LLC v. Motio, Inc.,
`IPR2013-00307, Paper 10 (P.T.A.B. Nov. 29, 2013) ............................... 3, 40
`
`Cardiocom LLC v. Robert Bosch Healthcare Sys., Inc.,
`IPR2013-00439, Paper 26 (P.T.A.B. Jan. 16, 2014) ..................................... 41
`
`Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc.,
`IPR2013-00460, Paper 23 (P.T.A.B. Jan. 16, 2014) ..................................... 42
`
`E.I. du Pont de Nemours & Co. v. Monsanto Tech. LLC,
`IPR2014-00333, Paper 14 (P.T.A.B. Jul. 11, 2014) ...................................... 40
`
`Integrated Global Concepts, Inc. v. Advanced Messaging Techs., Inc.,
`IPR2014-01027, Paper 16 (P.T.A.B. Dec. 22, 2014) ............................... 2, 16
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2012-00003, Paper 7 (P.T.A.B. Oct. 25, 2012) .................................... 49
`
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (P.T.A.B. Jan. 22, 2015) ..................................... 16
`
`Moses Lake Indus., Inc. v. Enthone, Inc.,
`IPR2014-00243, Paper 6 (P.T.A.B. Jun. 18, 2014) .................................. 3, 42
`
`Nestlé Healthcare Nutrition, Inc. v. Steuben Foods, Inc.,
`IPR2015-00094, Paper 14 (P.T.A.B. May 4, 2015) ........................... 2, 30, 43
`
`SpaceCo Bus. Solutions, Inc. v. Moscovitch,
`IPR2015-00127, Paper 16 (P.T.A.B. May 14, 2015) ......................... 3, 35, 42
`
`
`
`
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`iv
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`Abbreviation
`
`TABLE OF ABBREVIATIONS
`
`
`Description
`
`’083 Patent
`
`U.S. Patent No. 5,558,083 [Ex. 1005]
`
`’209 Patent
`
`U.S. Patent No. 8,573,209
`
`’210 Patent
`
`U.S. Patent No. 8,573,210 [Ex. 1001]
`
`’398 Patent
`
`U.S. Patent No. 4,462,398 [Ex. 1010]
`
`’510 Patent
`
`U.S. Patent No. 7,114,510 [Ex. 1004]
`
`’533 Patent
`
`U.S. Patent No. 6,811,533 [Ex. 1008]
`
`’794 Patent
`
`U.S. Patent No. 8,776,794
`
`’795 Patent
`
`U.S. Patent No. 8,776,795
`
`’873 Application U.S. Patent Application No. 13/509,873
`
`’904 Patent
`
`U.S. Patent No. 8,291,904
`
`___:___
`
`The indicated column or page and lines of the patent or patent
`
`publication
`
`Central processing unit
`
`The indicated exhibit
`
`Food and Drug Administration
`
`French Publication No. 2 917 804 A1 [Ex. 1006]
`
`CPU
`
`Ex. ___
`
`FDA
`
`FR ’804
`
`Publication
`
`v
`
`
`
`
`
`Abbreviation
`
`Description
`
`IDS
`
`iNO
`
`Information Disclosure Statement
`
`Inhaled nitric oxide
`
`INOMAX Label Center for Drug Evaluation and Research, Application
`
`Number: NDA 20845, INOMAX®, Final Printed Labeling,
`
`available at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845
`
`_inomax_prntlbl.pdf (August 9, 2000) [Ex. 1014]
`
`IPR
`
`IR
`
`Inter partes review
`
`Infrared
`
`IR Standard
`
`ISO/IEEE 11073-30300, “Health informatics – Point-of-care
`
`medical device communication – Part 30300: Transport profile
`
`LED
`
`N2
`
`NO
`
`NO2
`
`O2
`
`– Infrared wireless” [Ex. 1007]
`
`Light-emitting diode
`
`Nitrogen
`
`Nitric oxide
`
`Nitrogen dioxide
`
`Oxygen
`
`Patent Owner
`
`INO Therapeutics LLC
`
`vi
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`
`
`Abbreviation
`
`Description
`
`Petition
`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,210
`
`Petitioner
`
`Praxair Distribution, Inc.
`
`POSA
`
`Person of ordinary skill in the art
`
`Preliminary
`
`Patent Owner’s Preliminary Response Under 37 C.F.R.
`
`Response
`
`§ 42.107
`
`
`
`vii
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`Case IPR2015-00891
`U.S. Patent No. 8,573,210
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`INO Therapeutics LLC (“Patent Owner”) respectfully submits this
`
`
`
`
`
`
`Preliminary Response to the Petition of Praxair Distribution, Inc. (“Petitioner”)
`
`seeking inter partes review (“IPR”) of U.S. Patent No. 8,573,210 (“the ’210
`
`Patent”).1
`
`I.
`
`INTRODUCTION
`
`Petitioner seeks to institute an IPR on the basis of alleged obviousness of all
`
`the ’210 Patent claims, which cover nitric oxide (“NO”) delivery devices, as well
`
`as methods for treating or preventing hypoxic respiratory failure in a patient using
`
`
`1 Petitioner has filed four other IPR petitions challenging Patent Owner’s related
`
`patents, including U.S. Patent No. 8,291,904 (“the ’904 Patent”), which is the
`
`subject of IPR2015-00884; U.S. Patent No. 8,573,209 (“the ’209 Patent”), which is
`
`the subject of IPR2015-00889; U.S. Patent No. 8,776,794 (“the ’794 Patent”),
`
`which is the subject of IPR2015-00888; and U.S. Patent No. 8,776,795 (“the ’795
`
`Patent”), which is the subject of IPR2015-00893. The ’209 Patent issued from
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`U.S. Patent Application No. 13/509,873 (“the ’873 Application”), and the ’904,
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`’210, ’794, and ’795 Patents issued from continuation or continuation-in-part
`
`applications claiming priority to the ’873 Application.
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`U.S. Patent No. 8,573,210
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`such NO delivery devices. Petitioner bears the burden of demonstrating a
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`reasonable likelihood of prevailing on invalidity. 35 U.S.C. § 314(a); 37 C.F.R. §
`
`42.108(c). Yet, for reasons explained herein, the Petition does not establish prima
`
`facie obviousness, much less a likelihood of success.
`
`First, the Board should exercise its discretion pursuant to 35 U.S.C. § 325(d)
`
`and reject the Petition because substantially the same prior art and arguments were
`
`previously presented to the Office. See, e.g., Integrated Global Concepts, Inc. v.
`
`Advanced Messaging Techs., Inc., IPR2014-01027, Paper 16, at 2, 6-8 (P.T.A.B.
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`Dec. 22, 2014).
`
`Second, the Petition fails as a matter of proof. The Board has denied
`
`petitions where, as here, the prior art does not disclose or suggest one or more
`
`limitations of the challenged claims. See, e.g., Nestlé Healthcare Nutrition, Inc. v.
`
`Steuben Foods, Inc., IPR2015-00094, Paper 14, at 7-9 (P.T.A.B. May 4, 2015)
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`(denying a petition that did not demonstrate how a prior art routing valve
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`corresponded to the dispensing valve required by the claims); see also 37 C.F.R.
`
`§ 42.104(b)(4) (requiring petitions to “specify where each element of the claim is
`
`found in the prior art patents or printed publications relied upon”). Here, for
`
`example, Petitioner fails to show that the prior art discloses or suggests “a valve
`
`memory to store gas data comprising one or more of gas identification, gas
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`2
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`expiration date and gas concentration in the gas container and a valve processor
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`and a valve transceiver in communication with the valve memory to send and
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`receive wireless optical line-of-sight signals to communicate the gas data to the
`
`control module and to verify one or more of the correct gas, the correct gas
`
`concentration and that the gas is not expired,” which all of the claims of the ’210
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`Patent require.
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`Third, the Petition fails explain why a person of ordinary skill in the art
`
`(“POSA”) would have been motivated to combine and modify elements from
`
`various references in the manner alleged. Again, the Board has denied petitions
`
`alleging obviousness that lack this requisite showing. See, e.g., BSP Software LLC
`
`v. Motio, Inc., IPR2013-00307, Paper 10, at 21-22 (P.T.A.B. Nov. 29, 2013). In
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`particular, the Board has recognized that an IPR petition should be denied where,
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`as here, the petitioner merely alleges that a POSA “could” modify or combine
`
`various prior art elements, but fails to explain why a POSA would have done so.
`
`See, e.g., SpaceCo Bus. Solutions, Inc. v. Moscovitch, IPR2015-00127, Paper 16, at
`
`22 (P.T.A.B. May 14, 2015); Moses Lake Indus., Inc. v. Enthone, Inc., IPR 2014-
`
`00243, Paper 6, at 18 (P.T.A.B. Jun. 18, 2014). For example, in the present case,
`
`Petitioner fails to explain why a POSA would have repurposed a valve designed
`
`solely to assist with administrative functions, such as billing and inventory control,
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`to interact with a gas delivery control module in order to perform safety-related
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`functions. As explained in detail below, Petitioner’s arguments for combining the
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`relied-upon references are impermissible hindsight-driven attempts to piece
`
`together prior art elements in a manner a POSA would not have contemplated
`
`absent the teachings of the ’210 Patent. Further, Petitioner’s arguments disregard
`
`the teachings and purpose of the prior art.
`
`II. BACKGROUND
`
`A.
`
`Inhaled Nitric Oxide (“iNO”)
`
`Inhaled NO (“iNO”) is a gas used to treat children and neonates who cannot
`
`breathe on their own due to life-threatening heart conditions. iNO treatment
`
`relaxes an infant’s blood vessels so that blood flow and blood oxygen levels
`
`improve. Patent Owner’s iNO product, INOmax®, is approved for such treatment
`
`with term and near-term (>34 weeks gestation) neonates. Ex. 2001 at 1.
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`Patent Owner and its predecessors have developed several NO delivery
`
`systems. These systems deliver pharmaceutical gas comprising NO to provide a
`
`constant concentration of iNO, as set by the user, to the patient throughout the
`
`inspired breath. Ex. 1005 at abstract; Ex. 1012 at 3. For example, the delivery
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`system might receive gas from an NO cylinder having 800 ppm NO source
`
`concentration, which is much higher than the recommended concentration for
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`administration to a patient (e.g., 20 ppm). To reduce the NO concentration, the
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`delivery system proportionally delivers the 800 ppm NO source gas from the NO
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`cylinder to inspiratory flow in the breathing circuit to achieve the desired, lower
`
`concentration (e.g., 20 ppm). The NO delivery systems also analyze the actual NO
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`concentration that is delivered to the patient to ensure that the delivered NO
`
`concentration is within a certain tolerance of the concentration set by the user. Ex.
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`1005 at 5:51-56; Ex. 1012 at 3.
`
`To further ensure the safe delivery of iNO, Patent Owner developed its
`
`INOmax DSIR® NO delivery systems, which communicate with Patent Owner’s
`
`INOmax® gas cylinders in order to, among other things, carry out pre-use safety
`
`checks. For example, Patent Owner’s delivery systems automatically verify the
`
`expiration date and cylinder concentration using infrared (“IR”) communication
`
`between the INOmax DSIR® and the INOmax® cylinder. Ex. 2002 at 9. These
`
`products are commercial embodiments of Patent Owner’s technology described
`
`and claimed in the ’210 Patent.
`
`B.
`
`The ’210 Patent
`
`The ’210 Patent, titled “Nitric Oxide Delivery Device,” is directed to an NO
`
`delivery device, including a valve assembly, for use in a gas delivery system for
`
`administering NO therapy to a patient. Ex. 1001 at 1:14-16, 1:50-52, 2:4-7. As
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`exemplified in the ’210 Patent’s FIG. 1, the gas delivery system comprises a valve
`
`assembly 100 attached to a gas source 50, a control module 200, and a gas delivery
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`mechanism, such as a ventilator 400:
`
`
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`Id. at 6:5-15, FIG. 1.
`
`The valve assembly comprises a valve and a circuit with a valve memory in
`
`communication with a valve processor and a valve transceiver. Id. at 1:52-56. The
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`valve memory stores gas data such as the gas composition (e.g., NO), gas
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`concentration, expiration date, and other information. Id. at 7:18-21. The valve
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`transceiver communicates with a central processing unit (“CPU”) in the control
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`module, for example, via wireless optical line-of-sight signals (such as IR signals)
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`that are transmitted between the valve transceiver and a CPU transceiver. Id. at
`
`1:56-63, 2: 28-30, 2:54-62. This communication between the valve and CPU
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`transceivers allows the system to compare patient information stored in the control
`
`module’s CPU memory with the gas data stored in the valve memory. Id. at 3:25-
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`28. In the event the control module detects a potential safety risk, e.g., an expired
`
`gas, an incorrect gas type, or an incorrect gas concentration, an alarm is emitted.
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`Id. at 3:28-31, 11:50-12:33, FIG. 13. The communication between the valve and
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`CPU transceivers can also alert a user if unnecessary gas is being delivered, if a
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`valve remains closed when it should be open, or if the desired dose has been
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`delivered. Id. at 13:30-15:28.
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`The two main references on which Petitioner relies as allegedly teaching the
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`’210 Patent’s claimed NO delivery device, i.e., U.S. Patent Nos. 7,114,510 (“the
`
`’510 Patent”) and 5,558,083 (“the ’083 Patent”), are both discussed and
`
`incorporated by reference in the ’210 Patent. Ex. 1001 at 7:43-47, 10:1-4. The
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`’210 Patent explains that the ’510 Patent discloses a sensor disposed within an
`
`actuator and cooperating with a magnet to sense whether the actuator is turned on
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`or off. Id. at 7:43-47. The ’210 Patent explains that the ’083 Patent describes a
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`method of how a delivery module delivers gas to a ventilator circuit. Id. at 10:1-4.
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`Thus, the ’210 Patent acknowledges the contributions that the ’510 and ’083
`
`Patents made to the state of the art, and goes on to describe and claim further
`
`advances not contemplated by those patents (or any other prior art, for that
`
`matter).2 Contrary to Petitioner’s assertion, the ’210 Patent is not simply the sum
`
`of the ’510 and ’083 Patents. The ’210 Patent discloses an integrated system in
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`which the valve and the gas delivery control module work together to ensure that
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`gas is safely delivered to a patient. In contrast, the valve of the ’510 Patent and the
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`gas delivery module of the ’083 Patent serve unrelated functions and have no
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`reason to communicate with each other.
`
`
`2 Of note, Petitioner grounds all of its obviousness arguments on these same two
`
`references that the ’210 Patent inventors identified as containing components (e.g.,
`
`an open/close sensor and a delivery module) that can be used to help implement
`
`their invention. However, that the ’210 Patent inventors identified such
`
`components in the ’510 and ’083 Patents does not suggest that a POSA would have
`
`combined them, as inventors are extraordinarily skilled. See N. Am. Vaccine, Inc.
`
`v. Am. Cyanamid Co., 7 F.3d 1571, 1580 (Fed. Cir. 1993) (Rader, J., dissenting);
`
`Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985).
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`8
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`C. The ’210 Patent Claims
`The challenged claims of the ’210 Patent are directed to an NO delivery
`
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`
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`device for delivering a gas comprising NO (claims 1-11) and a method for treating
`
`or preventing hypoxic respiratory failure in a patient that involves using an NO
`
`delivery device (claims 12-16). The challenged claims recite that a circuit
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`supported within the NO delivery device’s valve assembly includes “a valve
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`memory to store gas data comprising one or more of gas identification, gas
`
`expiration date, and gas concentration in the gas container” and “a valve processor
`
`and a valve transceiver in communication with the valve memory to send and
`
`receive wireless optical line-of-sight signals to communicate the gas data to the
`
`control module and to verify one or more of the correct gas, the correct gas
`
`concentration and that the gas is not expired.” As recited, for example, in claims
`
`6, 9, and 12, communication between the NO delivery device of claim 1 and the
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`control module enables the comparison of the gas data with patient information
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`stored in the control module’s CPU memory. Thus, the NO delivery system can
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`emit an alarm and/or cease delivery of the therapy if the gas data and the patient
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`information do not match, as recited, for example, in claims 8, 13, and 14.
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`9
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`Case IPR2015-00891
`U.S. Patent No. 8,573,210
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`Petitioner’s Prior Art
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`D.
`Petitioner’s first alleged obviousness ground relies on the combination of
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`five references: the ’083 Patent (Ex. 1005), the ’510 Patent (Ex. 1004), French
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`Publication No. 2 917 804 A1 (“the FR ’804 Publication”) (Ex. 1006), the
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`INOMAX Label (Ex. 1014), and the IR Standard (Ex. 1007). Petition at 9-10. As
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`explained below, these references are directed to several disparate purposes.
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`The primary reference on which Petitioner relies, the ’083 Patent, discloses
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`an NO delivery system that can be used with a ventilator to provide gas therapy to
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`a patient. Ex. 1005 at 2:13-30. This system includes a CPU used to monitor and
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`adjust the gas flow. Id. at 2:31-3:25. The system relies on flow rate and
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`concentration data measured at various points downstream from where the NO
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`therapy gas and any additional diluting gas (e.g., N2 or O2) enter the delivery
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`system. See id. at FIG. 1 (NO sensor 65, gas sensing bench 52). The ’083 Patent
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`does not disclose, teach, suggest, or even allude that its delivery system should
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`receive any information from a gas cylinder or the cylinder’s valve assembly.
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`The ’510 Patent discloses a valve that can be used on a gas cylinder for
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`recording and storing data useful for preparing billing invoices, inventory control,
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`and other record-keeping functions. Ex. 1004 at 1:34-42. In particular, the ’510
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`Patent valve senses and records when the cylinder’s actuator is opened and closed,
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`and the duration of open time. Id. at 3:44-53. This data is then used to generate
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`invoices based on the actual gas usage. Id. at 1:16-30, 1:52-53. The ’510 Patent
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`does not disclose, teach, suggest, or even allude that any data in its valve should be
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`used to control the delivery of therapy gas or perform safety checks. Indeed, the
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`’510 Patent only alludes to a gas delivery system at two points, and neither
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`reference in the ’510 Patent suggests any sort of communication between the
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`delivery system and the cylinder valve for therapy gas delivery, safety checks, or
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`any other purpose. See id. at 2:52-55, 6:17-21.
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`The FR ’804 Publication discusses the general concept of comparing the gas
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`type in a gas bottle with the gas type intended to be used. Ex. 1006 at 17.3 The
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`reference states that a control module that compares the gas type data can be
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`installed “at the point used,” for example, “in a connection part of the bottle to the
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`valve.” Id. at 19. The FR ’804 Publication is generally directed to “the field of gas
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`3 Patent Owner’s references herein to the English language pages of Ex. 1006 do
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`not waive any objections to Ex. 1006 that Patent Owner may have under the
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`Federal Rules of Evidence or any other applicable rules. See 37 C.F.R.
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`§ 42.64(b)(1) (objections to evidence submitted during a preliminary proceeding
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`due following institution of the trial).
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`supply of operating circuits by means of bottles,” and states that it can be used in
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`“an industrial plant or a health facility,” but does not disclose anything to do with
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`the delivery of NO gas or any other type of gas therapy. Id. at 17, 19.
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`The INOMAX Label is the printed labeling originally approved by the U.S.
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`Food and Drug Administration (“FDA”) for Patent Owner’s iNO product,
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`INOmax®, but without the structural formula of NO and without Figure 1 (as
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`indicated by the symbols “” on Ex. 1014 at 1 and 2).
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`The IR Standard discusses how to use IR wireless communication in the
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`medical device field. Ex. 1007 at 2.
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`Petitioner’s second and third alleged obviousness grounds additionally rely
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`on a sixth reference, either U.S. Patent No. 6,811,533 (“the ’533 Patent”) (Ex.
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`1008) or U.S. Patent No. 4,462,398 (“the ’398 Patent”) (Ex. 1010), respectively.
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`Petition at 10. The ’533 Patent pertains to an implanted medical device, such as an
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`infusion pump, that can communicate with a control device. Ex. 1008 at 1:18-24.
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`The ’398 Patent pertains to a respirator that supplies pulses of gas in response to
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`sensing the patient’s inspiration. Ex. 1010 at 2:59-3:14. The ’398 Patent respirator
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`also detects apnea events, and can respond by sounding an alarm and supplying
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`additional gas. Id. at 3:15-30. Neither the ’533 Patent nor the ’398 Patent relates
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`to the delivery of iNO.
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`III. PERSON OF ORDINARY SKILL
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`Petitioner asserts that “a person of ordinary skill in the art of the ’210 Patent
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`as of January 6, 2011 would have had a bachelor’s degree in electrical engineering,
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`computer science, computer engineering, or the equivalent, and would have had at
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`least two years’ experience in biomedical engineering designing medical gas
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`delivery or monitoring systems.” Petition at 8. Patent Owner reserves the right to
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`dispute Petitioner’s definition of a POSA if IPR is instituted. For present purposes,
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`the definition does not matter, as the Petition’s failings do not depend on the level
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`of ordinary skill in the art.
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`IV. CLAIM CONSTRUCTION
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`Claims are given their “broadest reasonable construction in light of the
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`specification of the patent in which [they] appear.” 37 C.F.R. § 42.100(b); see also
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`In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1281 (Fed. Cir. 2015).
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`Petitioner asserts that “a person of ordinary skill in the art would have
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`understood each term of each claim of the ’210 Patent to have its plain and
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`ordinary meaning, and would have understood that no term requires special
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`construction for purposes of this proceeding.” Petition at 9. Solely for purposes of
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`this Preliminary Response, Patent Owner does not dispute that the claim terms of
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`the ’210 Patent have their plain and ordinary meaning, since Petitioner is unlikely
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`to prevail no matter how the claims are construed.
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`V. LEGAL STANDARD
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`To institute IPR, Petitioner must show a reasonable likelihood of prevailing
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`on invalidity. See 35 U.S.C. § 314(a) (prohibiting the institution of IPR absent “a
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`reasonable likelihood that the petitioner would prevail”); see also 37 C.F.R.
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`§ 42.108(c). A patent claim is obvious “if the differences between the subject
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`matter sought to be patented and the prior art are such that the subject matter as a
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`whole would have been obvious at the time the invention was made to a person
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`having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C.
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`§ 103(a) (pre-AIA). The trier of fact must assess (a) the level of ordinary skill in
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`the art, (b) the scope and content of the prior art, (c) differences between the prior
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`art and the claims at issue, and (d) any objective indicia of nonobviousness.
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`Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966); KSR Int’l Co. v. Teleflex
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`Inc., 550 U.S. 398, 406-07 (2007) (reaffirming that the Graham factors continue to
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`define the obviousness inquiry).
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`As stated in KSR, “a patent composed of several elements is not proved
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`obvious merely by demonstrating that each of its elements was, independently,
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`known in the prior art.” KSR, 550 U.S. at 418. “This is so because inventions in
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`most, if not all, instances rely upon building blocks long since uncovered, and
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`claimed discoveries almost of necessity will be combinations of what, in some
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`sense, is already known.” Id. at 418-19. For this reason, “it can be important to
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`identify a reason that would have prompted a person of ordinary skill in the
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`relevant field to combine the elements in the way the claimed new invention does.”
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`Id. at 418; see also Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed.
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`Cir. 2011) (“Obviousness requires more than a mere showing that the prior art
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`includes separate references covering each separate limitation in a claim under
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`examination .… Rather, obviousness requires the additional showing that a person
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`of ordinary skill at the time of the invention would have selected and combined
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`those prior art elements in the normal course of research and development to yield
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`the claimed invention.”).
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`Obviousness is judged as of “the time the invention was made,” 35 U.S.C.
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`§ 103(a) (pre-AIA), and care must be taken to avoid the influence of hindsight on
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`the inquiry. KSR, 550 U.S. at 421. “A critical step in analyzing the patentability of
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`claims pursuant to section 103(a) is casting the mind back to the time of invention,
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`to consider the thinking of one of ordinary skill in the art, guided only by the prior
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`art references and the then-accepted wisdom in the field.” In re Kotzab, 217 F.3d
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`1365, 1369 (Fed. Cir. 2000).
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`VI. THE BOARD SHOULD NOT INSTITUTE REVIEW BECAUSE THE
`PETITION RELIES ON SUBSTANTIALLY THE SAME PRIOR ART
`AND ARGUMENTS PREVIOUSLY PRESENTED TO THE OFFICE
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`As this Board has explained, 35 U.S.C. § 325(d) “gives the Director
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`discretion to take into account whether, and reject a petition because, the same or
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`substantially the same prior art or arguments previously were presented to the
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`Office.” Merial Ltd. v. Virbac, IPR2014-01279, Paper 13, at 8-9 (P.T.A.B. Jan. 22,
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`2015). Indeed, the Board has denied petitions challenging a patent based on
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`substantially the same prior art and arguments that were before the examiner
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`during ex parte prosecution. See, e.g., Integrated Global Concepts, IPR2014-
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`01027, Paper 16, at 2, 6-8; Merial, IRP2014-01279, Paper 13, at 23-28. As
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`explained below, the Board should exercise its discretion to deny the Petition in
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`this case because Petitioner relies on substantially the same references and
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`arguments that Patent Owner successfully overcame during prosecution of the ’210
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`Patent and its parent ’873 Application.
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`During prosecution of the ’210 Patent, the Examiner considered the two
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`main references on which Petitioner relies for allegedly teaching the structural
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`components required by the ’210 Patent claims, i.e., the ’083 and ’510 Patents.4
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`Ex. 1001 at 1
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