IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

Transcription

1 IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In re Patent of: Thudor, et al. U.S. Patent No.: 8,550,072 Attorney Docket No.: IP1 Issue Date: October 8, 2013 Appl. Serial No.: 13/311,433 Filing Date: December 5, 2011 Title: APPARATUS FOR DELIVERING HUMIDIFIED GASES Mail Stop Patent Board Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT NO. 8,550,072 PURSUANT TO 35 U.S.C , 37 C.F.R. 42

2 TABLE OF CONTENTS I. INTRODUCTION... 1 II. MANDATORY NOTICES UNDER 37 C.F.R Real Party-In-Interest Under 37 C.F.R. 42.8(b)(1)... 2 Related Matters Under 37 C.F.R. 42.8(b)(2)... 2 Lead And Back-Up Counsel Under 37 C.F.R. 42.8(b)(3)... 4 Service Information... 4 III. PAYMENT OF FEES 37 C.F.R IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R Grounds for Standing Under 37 C.F.R (a)... 5 Challenge Under 37 C.F.R (b) and Relief Requested... 5 V. SUMMARY OF THE 072 PATENT... 5 Specification and Claims... 5 Admitted Prior Art in the ʼ072 Patent... 9 Prosecution History Claim 11 is Not Entitled to Any Priority Date Earlier Than September 18, Person of Ordinary Skill in the Art VI. CLAIM CONSTRUCTION UNDER 37 C.F.R (B)(3) VII. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE 072 PATENT IS UNPATENTABLE Ground 1 Independent Claim 6 is Unpatentable Under 35 U.S.C. 102(b) Over Netzer Overview of the Netzer reference Netzer discloses all the limitations of independent claim ii

3 Ground 2 Independent Claim 6 is Unpatentable Under 35 U.S.C. 103 over Netzer Ground 3 Dependent Claim 7 is Unpatentable Under 35 U.S.C. 103 over Netzer in view of Levine The Prior Art Discloses A Humidifier Adjacent to Heater Overview of the Levine reference A POSITA would have combined Netzer with Levine Netzer and/or Levine disclose all the limitations of dependent claim Ground 4 Dependent Claim 11 is Unpatentable Under 35 U.S.C. 103 over Netzer in view of Bahr The Prior Art Discloses Simultaneously Connecting a Hose and its Electrical Components to a CPAP machine Overview of the Bahr reference A POSITA would have combined Netzer with Bahr Netzer and/or Bahr disclose all the limitations of dependent claim VIII. GROUNDS 1 AND 2 ARE NOT REDUNDANT IX. CONCLUSION iii

4 EXHIBIT LIST EX. # RMD1001 RMD1002 RMD1003 Exhibit Description U.S. Patent No. 7,111,624 ( Thudor I ) U.S. Patent No. 8,550,072 ( Thudor II ) [RESERVED] RMD1004 File History of U.S. Patent No. 7,111,624 RMD1005 File History of U.S. Patent No. 8,550,072 RMD1006 RMD1007 [RESERVED] PCT Publication No. WO 1998/04311 ( Netzer DE ) RMD1008 English Translation of PCT Publication No. WO 1998/04311 ( Netzer ) RMD1009 RMD1010 RMD1011 RMD1012 RMD1013 RMD1014 RMD1015 RMD1016 RMD1017 RMD1018 RMD1019 U.S. Patent No. 5,943,473 ( Levine ) [RESERVED] U.S. Patent Application Publication No. 2001/ ( Bahr ) Declaration of Mr. Alexander Virr New Zealand Patent Application No (Priority Document to the 624 Patent) [RESERVED] [RESERVED] U.S. Patent No. 6,398,197 ( Dickinson ) HC200 Series Nasal CPAP Blower & Heated Humidifier SleepStyle600 CPAP Series Operating Manual File History of U.S. Patent No. 6,918,389 (containing U.S. Patent Application No. 09/808,567) iv

5 EXHIBIT LIST RMD1020 RMD1021 RMD1022 RMD1023 RMD1024 RMD1025 RMD1026 RMD1027 [RESERVED] [RESERVED] [RESERVED] Patent Owner s Complaint for Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv GPC-WVG (S.D. Cal.) Patent Owner s Complaint for Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 2:16-cv R-AJW (C.D. Cal.) Patent Owner s Notice of Voluntary Dismissal Without Prejudice for Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 2:16-cv R-AJW (C.D. Cal.) Petitioners Complaint for ResMed Inc., et al. v. Fisher & Paykel Healthcare Corp. Ltd., et al., Case No. 3:16-cv JAH-MDD (S.D. Cal.) Petitioners Notice of Voluntary Dismissal Without Prejudice for ResMed Inc., et al. v. Fisher & Paykel Healthcare Corp. Ltd., et al., Case No. 3:16-cv JAH-MDD (S.D. Cal.) v

6 I. INTRODUCTION ResMed Limited, ResMed Inc. and ResMed Corp (collectively ResMed or Petitioners ) petition for inter partes review ( IPR ) of claims 6, 7, and 11 of U.S. Patent No. 8,550,072, assigned to Fisher & Paykel Healthcare Limited ( F&P ). The 072 patent relates to machines that deliver pressurized gases to a patient s airway, for example as part of continuous positive airway pressure ( CPAP ), a well-known therapy for sufferers of sleep apnea. RMD1002 at 1: CPAP machines include a housing with a motor that generates pressurized air, which is delivered to a patient via a tube and mask. RMD1012 at 26. Optionally, a humidifier can be slid onto the housing to humidify the air before it is blown into the tube and delivered to the patient mask. Id. at 27. The purported invention of the 072 patent is that the tube is located on the motor housing rather than the humidifier so that the humidifier can slide in and out of the motor housing without having to disconnect the tube. But locating a tube on the motor housing was well known at the time of the ʼ072 patent. Despite this being the case, prosecution of the 072 patent application was swift. RMD1005 at Shortly before the case was allowed, the applicant submitted an IDS citing a German-language version of PCT Publication No. 1

7 WO98/04311 to Netzer the primary reference relied on in Grounds 1-4 of this Petition. Id. at 19. Among other things, Netzer describes a CPAP machine with its patient tube on the motor housing rather than the humidifier. Importantly, the applicant never provided the Examiner with an English-language version of Netzer. Id. When considered in full, Netzer s English translation discloses each element of independent claim 6, and in combination with certain other references, renders obvious dependent claims 7 and 11 of the 072 patent. Not surprisingly in view of the incomplete record before him, the Examiner allowed the claims based on the mistaken belief that applicant s invention was patentable. ResMed therefore requests the Board institute inter partes review of the challenged claims. II. MANDATORY NOTICES UNDER 37 C.F.R Real Party-In-Interest Under 37 C.F.R. 42.8(b)(1) ResMed Limited, ResMed Inc. and ResMed Corp are the Real Parties-in- Interest. Related Matters Under 37 C.F.R. 42.8(b)(2) ResMed Corp is currently a defendant in a pending litigation in the Southern District of California involving the 072 patent. See Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv GPC-WVG (S.D. Cal.). Patent 2

8 Owner filed the complaint in this case on August 16, 2016, and alleges that ResMed infringes the 072 patent. RMD1023. On August 15, 2016, Patent Owner both filed and dismissed (without prejudice) a complaint in the Central District of California also alleging that ResMed infringes the 072 patent. RMD1024; RMD1025. Petitioners have also filed and dismissed (without prejudice) a complaint related to the 072 patent. On August 16, 2016, Petitioners filed a complaint in the Southern District of California alleging infringement of several patents held by Petitioners, and seeking declaratory judgment on non-infringement and invalidity of the 072 patent. RMD1026. Petitioners voluntarily dismissed this complaint without prejudice on August 18, RMD1027. Petitioners withdrawn action for declaratory judgment regarding the invalidity of the 072 patent has no effect under 35 U.S.C. 315(a) because it was voluntarily dismissed without prejudice. See Macuato U.S.A. v. BOS GmbH & KG, IPR , Paper No. 18 at pp (PTAB Jan. 24, 2013); see also Oracle Corp., et al. v. Click-to-Call Techs. LP, IPR , Paper No. 52 at pp (PTAB Oct. 28, 2014). Additionally, Patent Owner s pending suit against Petitioners regarding the 072 patent has no effect under 35 U.S.C. 315(b) since it was filed less than a year ago. 3

9 Petitioners are also seeking IPR of claims 6-7 and of the 072 patent on other grounds in a separate Petition. Petitioners are also seeking IPR of U.S. Pat. Nos. 7,111,624 and 8,091,547. The ʼ072 and ʼ547 patents resulted from division applications to the application that became the 624 patent. Lead And Back-Up Counsel Under 37 C.F.R. 42.8(b)(3) Petitioners provide the following designation of counsel. LEAD COUNSEL Stephen R. Schaefer, Reg. No. 37, RBC Plaza, 60 South Sixth Street Minneapolis, MN Tel: / Fax schaefer@fr.com BACK-UP COUNSEL Michael J. Kane, Reg. No. 39, RBC Plaza, 60 South Sixth Street Minneapolis, MN Tel: / Fax: kane@fr.com Service Information Please address all correspondence and service to the address of both counsel listed above. Petitioners also consent to electronic service by at IPR IP1@fr.com (referencing No IP1 and cc ing schaefer@fr.com and kane@fr.com). III. PAYMENT OF FEES 37 C.F.R Petitioners authorize charging Deposit Account for the petition fee set in 37 C.F.R (a) and for any other required fees. 4

10 IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R Grounds for Standing Under 37 C.F.R (a) Petitioners certify that the 072 patent is available for IPR and that Petitioners are not barred or estopped from requesting IPR. Challenge Under 37 C.F.R (b) and Relief Requested Petitioners requests IPR of claims 6, 7, and 11 of the 072 patent on the Grounds listed in the table below. In support, this Petition includes evidentiary declaration of Mr. Alexander Virr (RMD1012). Ground Claims Basis for Rejection 1 6 Anticipated under 35 U.S.C. 102(b) by PCT Publication No. WO98/04311 to Netzer 2 6 Obvious under 35 U.S.C. 103 over Netzer Obvious under 35 U.S.C. 103 over Netzer in view of U.S. Patent No. 5,943,473 to Levine Obvious under 35 U.S.C. 103 over Netzer in view of U.S. Patent Application Publication No. 2001/ to Bahr V. SUMMARY OF THE 072 PATENT Specification and Claims The 072 patent relates to devices used to deliver humidified gases to a patient, including humidifiers for continuous positive airway pressure ( CPAP ) treatment for obstructive sleep apnea ( OSA ). RMD1002 at 1:

11 As background, CPAP therapy delivers pressurized air to a patient s airway to help keep the airway open. RMD1012 at 27. The idea of using CPAP therapy to treat OSA was invented nearly thirty-five years ago in June 1980 by Dr. Colin Sullivan, whose early inventions formed the basis of Petitioners business. Id. As was well-known, a CPAP system has three main parts: a mask that delivers pressurized air to the mouth and/or nose; a tube that connects the mask to a motor; and a housing with a motor (sometimes referred to as a flow generator) that blows air into the tube. Id.; see also RMD1002 at 4:19-5:22; Fig. 2 (annotated below). Optionally, a humidifier may be used with the flow generator to humidify the air before it is blown into the hose and delivered to the patient via the mask. RMD1012 at 27; Fig. 2. The 072 patent focuses on how the humidifier connects to the housing of the flow generator. RMD1002 at 1:46-49, 5: The 072 patent s alleged 6

12 improvement over the prior art was locating the patient outlet tube on the housing rather than the humidifier so that the humidifier water chamber could be put on and removed from the housing without disconnecting the tube that delivers gas to the patient. Id. To this end, the specification describes pressurized flow of air going (1) from the housing of the flow generator to the humidifier; (2) from the humidifier to the housing; and (3) from the housing to the patient via a tube. Id. at 3:40-50, 4:61-5:5, Fig. 1. The water chamber 2 includes an inlet port 5 and an outlet port 6 of the chamber 2. Id. at 4: When inserted, the inlet port 5 and outlet port 6 of the water chamber 2 connect with a pressurized gases outlet 4 and a humidified gases return 7 of the CPAP machine 1, respectively. Id. at 4: These connections establish an air flow path that leads humidified air through the water chamber 2 and back to the CPAP machine 1 and then through breathing conduit connection 9. Id. at 5: A hose or tubing attached to the breathing conduit connection 9 delivers the pressurized air to the patient mask. Id. RMD1012 at 29. 7

13 The patent describes that the CPAP machine 1 and water chamber 2 are configured so that the water chamber 2 can slide on and off of the CPAP machine 1 in a single motion. RMD1002 at Abstract, 4:27-60, 5:

14 Figures 1 and 2 above depict the water chamber 2 being inserted into the CPAP machine 1. Id. at 3: When inserted, water chamber 2 is positioned next to a heating plate and fluid connections for the air flow path into and out of the water chamber 2 are established. Id. Admitted Prior Art in the ʼ072 Patent The background section of the 072 patent describes that prior art humidifier devices included most of the features of the 072 patent. For example, the Description of the Related Art section explains that humidified gases delivery treatment with a housing and slide-on humidifier chambers were well-known in the art: Humidifier chambers of this type are also now used in compact and portable ventilation machines, for example machines intended for the home treatment of obstructive sleep apnea (CPAP machines). Where the humidifier base is adapted for use with slide-on humidifier chambers, and the connection of the chamber to the machine is accomplished with a single sliding movement, the inlet air port is provided horizontally through the side of the chamber. Air enters the humidifier chamber through the inlet air port and the humidified air leaves the humidifier chamber into a breathing conduit through an exit port in the top of the humidifier chamber. RMD1002 at 1:35-45 (emphasis added). 9

15 The only difference between the prior art discussed in the background section and what is claimed in the 072 patent (claim 6) is that the patient outlet is on the housing of the CPAP machine rather than the humidifier chamber. RMD1012 at For example, the prior art humidifier chamber referenced in the background section of the ʼ072 patent appears to be shown in U.S. Patent No. 6,398,197 1 ( Dickinson ), also assigned to F&P. RMD1016. A side-by-side illustration of the prior art chamber from Dickinson and the chamber disclosed in the 072 patent is provided below for comparison: 1 F&P s product offerings help to further illustrate the difference between the prior art discussed in the Description of the Related Art section and what is claimed in the ʼ072 patent (claim 6). For example, F&P s HC200 Series Nasal CPAP Blower & Heated Humidifier ( HC200 ) appears to embody the admitted prior art humidifier chambers described in the 072 patent with the patient outlet coming from the chamber. Compare RMD1002 at 1:27-45, with RMD1017; RMD1012 at 45. In F&P s SleepStyle600 CPAP Series flow generator, F&P moved the patient outlet from the top of the humidifier chamber to the housing of the CPAP machine, as is contemplated by claim 6 of the ʼ072 patent. Compare RMD1002 at claim 6, with RMD1018; RMD1012 at

16 Patient directly connects hose to humidifier outlet Inlet for pressurised gases Pressurised gases inlet Outlet to return humidified gas to CPAP machine housing FIG Patent (RMD1016) FIG Patent (RMD1002) The prior art 197 patent humidifier chamber has a patient outlet 3 that directly connects to the tubing that sends humidified air to the patient mask, whereas the 072 patent directs humidified air back to the CPAP machine housing where an outlet on the housing connects to the patient tubing. The ʼ072 patent explains that locating the outlet to the patient on the CPAP machine housing addresses the problem where the patient has to disconnect the patient breathing conduit from the top of the humidifying chamber in a separate operation before removal of the chamber for the purpose of refilling. RMD1002 at 1: But that alleged improvement over the prior art was well-known in the prior art. RMD1012 at Prosecution History The 072 patent was filed December 5, 2011, as a division of the application that led to U.S. Patent No. 8,091,547. The 547 patent was itself a division of the application that led to U.S. Patent No. 7,111,624, which was a continuation-in-part 11

17 of the application that issued as U.S. Patent No. 6,918,389. The 072 patent also claims priority to New Zealand Patent Application No , filed March 21, RMD1002 at Cover Page. The 072 patent issued on October 8, Id. Prosecution of the ʼ072 patent application was rapid, as the Patent Office mailed a Notice of Allowance after the applicant s response to the very first office action. RMD1005 at 10. The action included no prior art rejections. Id. at In fact, the Examiner allowed the application once the applicant made some minor claim amendments to address indefiniteness rejections and filed a terminal disclaimer to overcome double patenting rejections. Id. at After putting the application in condition for allowance, the applicant submitted an IDS citing a non-translated German language version of WO98/04311 to Netzer the primary reference applied in Grounds 1-4 of this Petition. Id. at 19. The Examiner never considered an English translation of Netzer. Not surprisingly in view of the incomplete record before him, the Examiner allowed the claims based on the mistaken belief that locating the patient outlet tube on the housing rather than the humidifier so that the humidifier water chamber could be inserted and removed from the housing in a single motion was patentable. The Examiner included a statement of reasons for allowance. In it, the Examiner stated that the prior art of record alone or in combination is silent 12

18 regarding a pressurised gases outlet adapted to make separable fluid connection with an inlet of a water chamber, a humidified gases return adapted to make separable fluid connection with an outlet of the water chamber, and being adjacent to, and aligned with a pressurised gases outlet, such that both the separable connections are made by a single motion. Id. at 16. He also identified the Kenyon and Levine references, the latter of which is applied in Ground 3 of this Petition, as being the closest prior art of record. Id. But that alleged improvement over the prior art was well-known in the prior art. As shown below, Netzer in fact discloses all of the elements of the claims that the Examiner identified in the stated reasons for allowance. Claim 11 is Not Entitled to Any Priority Date Earlier Than September 18, The 072 patent was filed December 5, 2011, but claims priority to three U.S. parent applications, and claims foreign priority to an application filed March 21, 2000 (New Zealand Application No ). RMD1002 at Cover Page. The September 18, 2002, 624 patent application, to which the ʼ072 patent claims priority, includes a significant amount of new material that was not disclosed in the earlier priority applications. RMD1012 at Importantly, the applicant did 13

19 not disclose the subject matter of claim 11 2 before the September 18, 2002, filing date of the application that led to the 624 patent. RMD1012 at Claim 11 of the ʼ072 patent requires a patient outlet that includes a connector for receiving a breathing hose and at least one auxiliary electrical connection plug or socket or pneumatic connection plug or port, for a simultaneous connection when connecting a breathing circuit having complementary electrical or pneumatic connectors. Indeed, the auxiliary electrical connection plug or socket and the pneumatic connection plug or port were first disclosed in the descriptions of the preferred and alternative embodiments in the application that led to the ʼ624 patent. 3 Because neither priority application discloses these auxiliary electrical or 2 Petitioners also do not concede that support for the other claims at issue can be found in the priority documents, and reserve the right to demonstrate that any of the claims may not be entitled to an earlier priority date than September 18, For example, the ʼ624 application describes a disadvantage of earlier configurations that required separate electrical wiring connections are required to make use of a heated respiratory conduit. RMD1004 at 124:30-125:1. This disadvantage was not listed in the ʼ567 or NZ applications. RMD1012 at 39. Additionally, the 624 patent application added that the connector which includes 14

20 pneumatic connectors, RMD1012 at 38-39, claim 11 of the ʼ072 patent is not entitled to a priority date earlier than September 18, Person of Ordinary Skill in the Art In view of the subject matter of the 072 patent, a person of ordinary skill in the art ( POSITA ) as of any of the claimed priority dates as early as March 2000 would have had a bachelor s degree in mechanical engineering, biomedical engineering, or a related discipline, and at least five years of relevant product design experience in the field of medical devices or respiratory therapy, or an equivalent advanced education. See RMD1012 at This level of knowledge and skill is applied throughout the Petition. VI. CLAIM CONSTRUCTION UNDER 37 C.F.R (B)(3) For inter partes review, a claim in an unexpired patent is given its broadest reasonable construction in light of the specification in which it appears. 37 C.F.R (b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, (2016). Claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. an additional electrical and/or pneumatic connection 54 for the conduit is integral to the connection manifold of the CPAP machine 8 in the detailed description section. RMD1004 at 130:14-21; 132:11-16, 133:6-9; RMD1012 at

21 In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Constructions offered in the Petition are intended to aid this proceeding, and do not waive any arguments concerning indefiniteness or claim breadth in proceedings applying different construction standards. VII. THE CHALLENGED CLAIMS OF THE 072 PATENT ARE UNPATENTABLE Ground 1 Claim 6 is Unpatentable Under 35 U.S.C. 102(b) Over Netzer Overview of the Netzer Reference 4 Netzer describes a gas supply device and humidifier for respiratory gas treatment, such as for the treatment of sleep apnea. RMD1008 at 2. Nearly two years before the earliest priority date of the 072 patent, Netzer disclosed a device whose patient outlet was provided in a housing of the device (gas supply device 1) separate and apart from the humidification chamber (liquid container 9), which could be easily inserted on or removed from the housing by a single motion. RMD1012 at With reference to the drawings, Figure 1 illustrates a top view of the gas supply device 1. The larger box at the top of the figure depicts an outline of the 4 PCT Publication No. WO98/04311 to Netzer published February 5, 1998, and is therefore prior art under 35 U.S.C. 102(b). See RMD1007; RMD1002 at Cover. 16

22 housing of the gas supply device 1. Within the device housing is a respiratory gas source 2 (e.g., a blower, pump, or gas cylinder), a flow guiding element 3, and a humidifier housing 8. RMD1008 at 8. At bottom, a liquid container 9 is shown removed from the device. Id. at 7. The liquid container 9 holds water for the humidifier. Respiratory gas source 2 (e.g., blower) Flow guiding element 3 (e.g., tubes for gas flow path) Gas supply device 1 Respiratory gas outlet 4 (for connection to patient hose) Humidifier housing 8 (receptacle for liquid container 9) Liquid container 9 (water chamber) Netzer s gas supply device 1 can operate with or without the humidifier 5 activated. Id. at 7. Depending on whether the humidifier is being used, the device 1 directs the flow of gas from the respiratory gas source 2 to one of two flow paths (illustrated below) to gas outlet 4. Id. at 8. The first flow path 6a bypasses the humidifier 5, and instead leads straight to the gas outlet 4 for delivery to the 17

23 patient. Id. The second flow path 6b runs through the humidifier 5 before flowing to gas outlet 4. Id. A valve assembly 10 opens or closes different sections of the flow guiding element 3 to form either the first gas flow path 6a or the second gas flow path 6b. Id. at 8. First Gas Flow Path 6a (Bypassing Humidifier 5) Second Gas Flow Path 6b (Through Humidifier 5) In some embodiments, insertion of the liquid container 9 into the device 1 activates the humidifier 5, and removal of the liquid container 9 de-activates the humidifier 5. RMD1008 at 10. When the humidifier 5 is activated, the valve assembly 10 directs gases through the second flow path 6b, and a heating unit in the region of liquid container 9 turns on to heat the water in the liquid container 9. Id. The design of Netzer s device 1 allows the patient to insert and remove the liquid container 9 without manually re-configuring any hoses or connections for humidified or non-humidified use. RMD1012 at 52. For insertion, the patient 18

24 slides the liquid container 9 into the humidifier housing 8, and in a single slide-on motion (i) switches on a humidifier heating unit, (ii) establishes a first fluid connection between an inlet 22 of the liquid container 9 and a gases outlet opening of the flow guiding element 3, (iii) establishes a second fluid connection between an outlet 23 of the liquid container 9 and a gases return opening of the flow guiding element 3, and (iv) actuates the valve assembly 10 to close the first gas flow path 6a and to open the second gas flow path 6b. RMD1008 at 7-10; RMD1012 at 32. To facilitate insertion of the liquid container 9, Netzer provides lateral guide profiles 26 on the liquid container 9, and corresponding guide grooves 27 in the humidifier housing 8. RMD1008 at 10, Fig. 1. When the patient inserts liquid container 9 into the device 1, the guide profiles 26 engage their corresponding grooves 27 in the humidifier housing 8. Id. 19

25 Humidifier housing 8 Guide grooves 27 Insertion direction Lateral guide profiles 26 Liquid container 9 Regardless of which flow path 6a or 6b is open, or whether the humidifier is in use, the device 1 includes a single gas outlet 4, which is located on the CPAP machine not the humidifier, for connection to a patient conduit (e.g., a flexible hose that leads to a mask or nasal pillow). Id. at 8, Figs Netzer s device thus obviates the need for the patient to re-connect the conduit when switching between humidified and non-humidified operation, or when removing the liquid container 9 for refilling or cleaning, for example. RMD1012 at 54 Netzer Discloses all the Limitations of Claim 6. The following claim chart sets forth in detail exemplary disclosure from Netzer showing how this prior art reference discloses each element of independent claim 6. See also RMD1012 at 76 (including claim chart). 20

26 ʼ072 Patent Claims [6.1] An apparatus for use in humidified gases delivery treatment comprising: [6.2] a blower for generating a supply of pressurized gases, Exemplary Disclosure of Netzer Netzer discloses an apparatus for use in humidified gases delivery treatment, gas supply device 1 that includes a gas humidifier 5. Netzer discloses that the apparatus (gas supply device 1) is for use in humidified gases delivery treatment. RMD1008 at 2 ( The invention relates to a gas supply device for sleep apnea having a respiratory gas source, which leads to at least one respiratory opening of a patient via a flow guiding element, wherein the flow guiding element is connected to a gas humidifier for delivering a liquid stored in a liquid reservoir in portions to the respiratory gas to be supplied. ); RMD1012 at Netzer discloses a blower as respiratory gas source 2. Netzer discloses that the blower (respiratory gas source 2) is for generating a supply of pressurized gases. RMD1008 at 7 ( A gas supply device for sleep apnea, indicated as a whole with the numeral 1, has a respiratory gas source 2, which leads to a respiratory gas outlet 4 via a flow guiding element 3. The respiratory gas source 2 is formed by a blower in the figures, with which the ambient air surrounding the device is transported in the flow guiding element 3. However, the respiratory gas source could also be, by way of example, a pump or a gas cylinder, which supplies the pressurized gas contained therein to the flow guiding element 3 via a valve. ); RMD1012 at

27 ʼ072 Patent Claims Exemplary Disclosure of Netzer Respiratory gas source 2 [6.3] a pressurized gases outlet in fluid connection with said supply of pressurized gases and adapted to make separable fluid connection with an inlet of a water chamber in order to provide gases flow to said chamber, Netzer discloses a pressurized gases outlet in the housing as the opening of flow guiding element 3 downstream of bypass inlet 14, a water chamber as liquid container 9, and an inlet of the water chamber as container inlet 22. Netzer discloses that said pressurized gases outlet is in fluid connection with said supply of pressurized gases and is adapted to make separable fluid connection with said inlet (container inlet 22) of said water chamber (liquid container 9) in order to provide gases flow to said chamber (liquid container 9). RMD1008 at 8 ( The main flow blocking valve 11 is interconnected, in the direction of flow, downstream of the bypass inlet 14 and upstream of the bypass outlet 15 in the flow guiding element 3. The two bypass flow blocking valves 12 are interconnected in the bypass inlet 14 or the bypass outlet 15, respectively. ); id. at 9 ( The container inlet 22 and the container outlet 23 of the liquid container 9 are each disposed at a spacing above the maximum liquid level. ); id. at Figs. 1, 2, and 4; RMD1012 at

28 ʼ072 Patent Claims Exemplary Disclosure of Netzer [6.4] a humidified gases return, adapted to make separable fluid connection with an outlet said chamber in order to receive humidified gases from said chamber, Netzer discloses a humidified gases return in the housing as the opening of flow guiding element 3 upstream of bypass outlet 15, and an outlet of said water chamber (liquid container 9) as container outlet 23. Netzer discloses that said humidified gases return is adapted to make separable fluid connection with said outlet (container outlet 23) of said chamber (liquid container 9) in order to receive humidified gases from said chamber (liquid container 9). RMD1008 at 8 ( The main flow blocking valve 11 is interconnected, in the direction of flow, downstream of the bypass inlet 14 and upstream of the bypass outlet 15 in the flow guiding element 3. The two bypass flow blocking valves 12 are interconnected in the bypass inlet 14 or the bypass outlet 15, respectively. ); id. at 9 ( The container inlet 22 and the container outlet 23 of the liquid container 9 are each disposed at a spacing above the maximum liquid level. ); id. at Figs. 1, 2, and 4; RMD1012 at

29 ʼ072 Patent Claims Exemplary Disclosure of Netzer [6.5] and being adjacent to, and aligned with said pressurized gases outlet, such that both said separable connections are made by a single motion, and Netzer discloses that said humidified gases return (opening of flow guiding element 3 upstream of bypass outlet 15) is adjacent to, and aligned with said pressurized gases outlet (opening of flow guiding element 3 downstream of bypass inlet 14), such that both said separable connections are made by a single motion. RMD1008 at 8 (describing an insertion direction of liquid container 9 as being indicated by arrow E in Fig. 1); id. at 10 ( Lateral guide profiles 26 are provided on the liquid container 9, which engage in corresponding guide grooves 27 in the humidifier housing 8. By this means, the insertion of the liquid container 9 in the humidifier housing 8 is facilitated, and the positioning of the liquid container 9 within the humidifier housing 8 is improved ); id. at Figs. 1-2; RMD1012 at

30 ʼ072 Patent Claims Exemplary Disclosure of Netzer [6.6] a patient outlet, in fluid connection with said humidified gases return in order to receive humidified gases from said humidified gases return and provide humidified gases to said patient outlet, Netzer discloses a patient outlet as respiratory gas outlet 4. Netzer discloses that the patient outlet (respiratory gas outlet 4) is in fluid connection with said humidified gases return (opening of flow guiding element 3 upstream of bypass outlet 15) in order to receive humidified gases from said humidified gases return and provide humidified gases to said patient outlet (respiratory gas outlet 4). RMD1008 at 7 ( A gas supply device for sleep apnea, indicated as a whole with the numeral 1, has a respiratory gas source 2, which leads to a respiratory gas outlet 4 via a flow guiding element 3. ); id. at 8 ( An air hose, not shown in detail, can be connected to the respiratory gas outlet 4, connecting the device 1 to a, likewise not shown in detail, face mask, which can be placed on the nasal region of a patient. ); RMD1012 at

31 ʼ072 Patent Claims Exemplary Disclosure of Netzer [6.7] said patient outlet being in fluid connection with or adapted to make fluid connection with a breathing conduit for delivery of humidified gases to a patient. Netzer discoses that said patient outlet (respiratory gas outlet 4) is in fluid connection with or adapted to make fluid connection with a breathing conduit for delivery of humidified gases to a patient. RMD1008 at 8 ( An air hose, not shown in detail, can be connected to the respiratory gas outlet 4, connecting the device 1 to a, likewise not shown in detail, face mask, which can be placed on the nasal region of a patient. ); RMD1012 at Ground 2 Claim 6 is Unpatentable Under 35 U.S.C. 103 Over Netzer As discussed above, Netzer anticipates claim 6 of the ʼ072 patent. Because anticipation is the epitome of obviousness, a disclosure that anticipates under 35 U.S.C. 102 also renders the claim unpatentable under 35 U.S.C See In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982); In re Meyer, 599 F.2d 1026,

32 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Accordingly, Petitioners have demonstrated that claim 6 is unpatentable as obvious over Netzer. Moreover, various features of claim 6 asserted to be anticipated by Netzer are also admitted to be prior art by the 072 patent. For example, the 072 patent admits that: Humidification systems are known which include a heater base and a disposable humidifier chamber which is fitted onto the heater base and within which a supply of water can be heated by the heater base. Air enters the humidifier chamber through an inlet air port in the roof of the chamber where it is humidified by the evaporation of water from the water supply before leaving the chamber through an exit port in the roof of the humidifier chamber. Humidifier chambers of this type are also now used in compact and portable ventilation machines, for example machines intended for the home treatment of obstructive sleep apnoea (CPAP machines). Where the humidifier base is adapted for use with slide-on humidifier chambers, and the connection of the chamber to the machine is accomplished with a single sliding movement, the inlet air port is provided horizontally through the side of the chamber. Air enters the humidifier chamber through the inlet air port and the humidified air leaves the humidifier chamber into a breathing conduit through an exit port in the top of the humidifier chamber. RMD1002 at 1:

33 This reinforces the unpatentability of many of the features discussed in the preceding section. For example, this admitted prior art concedes claim 6 s elements [6.1] [6.3] and [6.6] [6.7] to be known. RMD1012 at And as described in the previous section, claim 6 s elements [6.4] [6.5] of locating a tube on the housing was well known at the time of the ʼ072 patent. Id. Likewise, the admitted prior art teaches that it was well known in the art to adapt a humidifier base for use with slide-on humidifier chambers, and that the connection of the chamber to the machine could be accomplished with a single sliding movement. Id. It therefore would have been obvious to modify Netzer using these features that the ʼ072 patent admits were already known in the art for the same purpose. Id. Ground 3 Claim 7 is Unpatentable Under 35 U.S.C. 103 Over Netzer in View of Levine The Prior Art Discloses A Humidifier Adjacent to Heater. Claim 7 depends on claim 6 and additionally requires, among other things, a chamber heater where a single motion urges the base of the chamber in contact with the heater. In particular claim 7 reads: An apparatus for use in humidified gases delivery treatment as claimed in claim 6 wherein said apparatus includes a chamber heater and said single motion also urges a base of said chamber in contact with said heater. Netzer discloses such a chamber heater. RMD1008 at 10; RMD1012 at 51. The only claim limitation that Netzer may not explicitly disclose is the term a base of 28

34 said chamber in contact with said heater. But this feature was traditionally known in the field of medical devices and respiratory therapy. RMD1012 at 56. For example, Levine discloses a base (base plate 48) of a chamber (humidifier 10) that contacts a heater (heating surface 94) in use. RMD1009 at 4:34-38, Fig. 1. And for the reasons articulated below and contained in the declaration of Mr. Virr, one of ordinary skill in the art would have been motivated to combine Netzer with Levine to implement this well-known and conventional means of applying heat to the base of a water container. RMD1012 at Overview of the Levine Reference Levine was filed May 29, 1997, and published August 24, 1999, and is therefore prior art under 35 U.S.C. 102(a) and 102(e). RMD1009 Cover Page. Levine discloses a heated cartridge humidifier for delivering humidified respiratory gases to patients. RMD1009 at Abstract. Levine discloses that humidifier cartridge 10 slides into engagement with the heating unit 12. Id. at 4:31-37 ( The dimensions of the peripheral lip 60 and notch lip 70 of the base plate 48 are such that the cartridge 10 may be slid into the channel 96 to engage the bracket 95. ); see id. at 2:48-67, Fig

35 The base of the humidifier cartridge 10 includes a base plate 48 having a central conductive portion 50. Id. at 3: When the humidifier 10 engages with the heating unit 12, the conductive portion 50 of the base plate 48 contacts heating surface 94 and thermally conducts heat from the heating surface 94 to the water contained in humidifier chamber 20. Id. at 4:33-38; see also id. at 2:3-15, 4:11-15; RMD1012 at 56. A POSITA Would Have Combined Netzer with Levine. A person of ordinary skill in the art at the time of the 072 patent would have combined Netzer with Levine to implement the well-known and conventional means of applying heat to the base of a water container. RMD1012 at 78. As with the 072 Patent, RMD1002, Netzer describes a water chamber (liquid container 9) that slides into engagement with a CPAP device to complete a gases flow path through the water chamber. RMD1008 at 8. Upon engaging the liquid container 9, Netzer discloses that a heating unit external to the liquid container 9 is activated to vaporize water in the container to humidify gases passing through the liquid container 9. Id. at 10. Indeed, Netzer even discloses that the heating unit is disposed in the region of liquid container 9 when the liquid container 9 is engaged in the device. Id. at 10. A POSITA at the time of the 072 patent would have understood that the heating unit in Netzer would have been disposed beneath 30

36 the liquid container 9 in order to conduct heat from the heating unit, through a base of the container 9, and to the water. RMD1012 at 78. It was ubiquitously known in 2000, both for CPAP humidifiers and other appliances, to provide a heating plate adjacent and in contact with the base of a water chamber. RMD1012 at 79. People commonly interact with devices that include a heating plate and a water chamber in their daily lives, such as coffeemakers, tea kettles, and stovetops. Nobody would question that these conventional appliances have been heating water chambers by conduction (e.g., Mr. Coffee machines) long before the year 2000 (the earliest claimed priority date of the 072 patent). RMD1012 at 79. Moreover, arranging Netzer s heating unit in the base of the humidifier housing 8 is simply the logical place where the heating unit would be disposed in the region of liquid container 9. Id. A person of ordinary skill in the art would have understood that disposing the heating unit elsewhere (e.g., on the ceiling of the humidifier housing 8 or on one of the sidewalls) would not efficiently vaporize water in the container 9, and/or could interfere with other structures in the humidifier 5 such as guide grooves 27 or switch 25. RMD1008 at Fig. 1; RMD1012 at 79. Indeed, even the background section of the 072 patent admits that conventional humidification systems include a heater base and a disposable humidifier chamber which is fitted onto the 31

37 heater base and within which a supply of water can be heated by the heater base. RMD1001 at 1: Levine discloses one such example of a humidification device (heater cartridge humidifier 10) whose heater (heating surface 94) is conventionally disposed beneath and in contact with a base of a water chamber (heater cartridge humidifier 10). RMD1012 at 80. Levine describes that the humidifier 10 slides into operational alignment above the heating surface 94 so that the conductive portion 50 of the humidifier s base plate 48 will be conductively heated by the heating surface 94. RMD1009 at 4: A person of ordinary skill at the time of the 072 patent would have been motivated to incorporate Levine s heating surface 94 into Netzer s humidifier 5 beneath the liquid container 9 in order to efficiently heat water in the liquid container 9. RMD1012 at 80. Moreover, a person of ordinary skill would arrange Levine s heating surface 94 in contact with a heat conducting material of the base of the liquid container 9 of Netzer to ensure efficient heat conduction and minimize the heater s energy consumption. RMD1008 at 2 (indicating that one objective of Netzer s system was to reduce the high power consumption of humidifiers); RMD1012 at Furthermore, a skilled artisan would have seen a reason to design Netzer s CPAP device so that its heating unit was a heater base disposed beneath and in contact with a base of a water chamber, as disclosed by Levine, because Netzer s 32

38 sideways-insertion design would have indicated to a skilled artisan that it used a heater base (because the lateral guide profiles 26 indicate a mechanism for retaining the liquid reservoir in firm contact with a heating base), and because Levine describes similar lateral guide structures (humidifier 10 slides into the channel 96 to engage the bracket 95) as providing a mechanism to maintain the humidifier 10 in operational alignment upon the heating surface 94 so that the conductive portion 50 [of the humidifier 10] will be conductively heated by the heating surface 94. RMD1009 at 4: Netzer is silent on the heating feature that it utilizes and a skilled artisan designing a CPAP device based on Netzer s teachings would necessarily be prompted to select an appropriate heating mechanism from the prior art, and Levine describes an appropriate heating mechanism. Indeed, because this combination of features simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. KSR Int l v. Teleflex Inc., 550 U.S. 398, 417 (2007). Netzer and/or Levine Disclose all the Limitations of claim 7. The following claim chart sets forth in detail exemplary disclosure from Netzer and Levine showing how the combination of these references discloses each element of claim 7. See also RMD1012 at 81 (including claim chart). 33

39 ʼ072 Patent Claims [7.1] An apparatus for use in humidified gases delivery treatment as claimed in claim 6 wherein [7.2] said apparatus includes a chamber heater and Exemplary Disclosure of Netzer and/or Levine As discussed above, Netzer discloses an apparatus for use in humidified gases delivery treatment as claimed in claim 6. RMD1012 at Netzer discloses that said apparatus (gas supply device 1) includes a chamber heater as a heating unit. RMD1008 at 10 ( The gas humidifier 5 has a heating unit, hot shown in greater detail, disposed in the region of the liquid container 9 for generating steam. This is electrically connected to a spring-loaded electrical switch 25. This switch 25 is acted on by the liquid container 9 when it is placed in its usage position in the humidifier housing 8, and is then located in its actuation position. When the liquid container 9 is inserted, the heating unit is thus automatically switched on for generating steam. ). Levine also discloses an apparatus for use in humidified gases delivery treatment that includes a chamber heater, as heating surface 94. RMD1009 at 4:23-26 ( The upper end 80 of the housing 76 has a heating surface 94 which is partially surrounded by a generally semicircular bracket 95. ); id. at Fig. 1; RMD1012 at 48-54; 56. [7.3] said single motion also urges a base of said chamber in contact with said heater. Netzer discloses that said single motion also urges a base of said chamber (liquid container 9) in contact with said heater (heating unit). RMD1008 at 10 ( The gas humidifier 5 has a heating unit, hot shown in greater detail, disposed in the region of the liquid container 9 for generating steam. This is electrically connected to a spring-loaded electrical switch 25. This switch 25 is acted on by the liquid container 9 when it is placed in its 34

40 ʼ072 Patent Claims Exemplary Disclosure of Netzer and/or Levine usage position in the humidifier housing 8, and is then located in its actuation position. When the liquid container 9 is inserted, the heating unit is thus automatically switched on for generating steam. ). RMD1012 at Base 19 of liquid container 9 To the extent that Netzer does not explicitly discuss that the base of said chamber (liquid container 9) contacts said heater (heating unit), Levine discloses as much. Levine discloses a water chamber as humidifier 10, a base of said water chamber as base plate 48 (including central conductive portion 50), and a chamber heater as heating surface 94. Levine discloses that the base (base plate 48) of said chamber (humidifier 10) contacts said heater (heating surface 94) in use. RMD1009 at 4:34-38 ( The locking tab 98 is then moved to the vertical position as indicated in FIG. 1 to maintain the humidifier 10 in operational alignment upon the heating surface 94. In this position, the conductive portion 50 will be conductively heated by the heating surface 94. ); id. at Fig. 1; RMD1012 at 56,

41 ʼ072 Patent Claims Exemplary Disclosure of Netzer and/or Levine Ground 4 Claim 11 is Unpatentable Under 35 U.S.C. 103 Over Netzer in View of Bahr The Prior Art Discloses Simultaneously Connecting a Hose and its Electrical Components to a CPAP machine. Claim 11 depends on claim 6 and additionally requires, among other things, that the patient outlet include (i) gas and (ii) electrical or pneumatic connectors for simultaneously connecting with a breathing hose and the electrical or pneumatic components of the hose. In particular claim 11 reads: An apparatus for use in humidified gases delivery treatment as claimed in claim 6, wherein said patient outlet includes a connector for receiving a breathing hose and at least one auxiliary electrical connection plug or socket or pneumatic connection plug or port, for a simultaneous connection when connecting a breathing circuit having complementary electrical or pneumatic connectors. Netzer, RMD1008, discloses ways for a patient to connect a breathing hose, and any electrical components of the hose, to a CPAP machine. RMD1012 at 48-36

42 54; 56, The limitation that this reference may not explicitly disclose is that the patient outlet include at least one auxiliary electrical connection plug or socket or pneumatic connection plug or port, for a simultaneous connection when connecting a breathing circuit having complementary electrical or pneumatic connectors. But this feature was traditionally known in the field of medical devices and respiratory therapy. RMD1012 at For example, Bahr discloses a patient outlet (gas port 44) that includes at least one auxiliary electrical connection plug or socket (electrical contacts 48a, 48b). Id. at 60. Bahr further discloses that the auxiliary electrical connection plug or socket (contacts 48a, 48b) is used for simultaneous connection when connecting a breathing circuit having complementary electrical connectors (contacts 18a, 18b). RMD1011 at 22, Fig. 3; RMD1012 at 60. And for the reasons articulated below and in the sections discussing Netzer, as well as those contained in the declaration of Mr. Virr, one of ordinary skill in the art would have been motivated to combine Netzer with Bahr to implement this well-known and conventional means of minimizing the work required for a patient to connect a breathing hose, and any electrical components of the hose, to a CPAP machine. RMD1012 at Overview of the Bahr Reference Bahr was filed February 7, 2001, and published later that year in August. As discussed above, the features recited in claim 11 first appeared in the application 37