UNITED STATES PATENT AND TRADEMARK OFFICE
`   
`   

  
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`   
`
`  
`
`
`
`Abiomed, Inc. and Abiomed R&D, Inc.
`     
`Petitioners
`!"#$#$%&"'()
`V.
`
`
`Maquet Cardiovascular, LLC
`

+,-.*/,0.
`Patent Owner
`!1#"&#)23&"')
`
` *
`
`
`Case IPR2017-01204
`/
`4567856459
`
`US. Patent No. 9,561,314
` 
`--:;<6=69
`
`
` 
`
`PATENT OWNER’S EXHIBIT 2023
`
` >?@  454=
`
`
`
`
`
`
`
`

`

`FILED ELECTRONICALLY
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`
`Appl. No.
`
`Applicant
`
`Filed
`
`Art Unit
`
`:
`
`:
`
`:
`
`:
`
`10/566,423
`
`Thorsten Siess
`
`January 30. 2006
`
`3766
`
`Examiner
`
`: Dinga, Roland
`
`Confirmation No. 2985
`
`Title
`
`Client/Matter
`
`Customer No.
`
`:
`
`:
`
`AN INTRACARDJAC PUMPING DEVICE
`
`JMPEL 72926
`
`68,919
`
`April 24, 2012
`
`Commissioner for Patents
`
`P. O. Box 1450
`
`Alexandria, VA 223 1 3- 1450
`
`Dear Sir:
`
`APPEAL BRIEF
`
`This Appeal Brief is being filed pursuant to the Notice of Appeal that was
`
`filed on January 9, 2012 in response to the Final Office Action of August 9, 2011
`
`and the Advisory Action of December 12, 2011. A Pre—Appeal Brief Request for
`
`Review was filed January 9, 2012 and a Notice of Panel Decision was issued on
`
`February 27, 2012 setting a deadline for filing an Appeal Brief of March 27, 2012.
`
`A request for a one month extension of time along with the requisite fees is being
`
`filed herewith.
`
`Maquet, Ex. 2023-1
`ABCDEFGHIJKHLMLNOP
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`INTRODUCTION
`
`The present invention relates to an intracardiac pump, and more particularly,
`
`to a pump configuration that prevents pump suction from causing injury to heart
`
`tissue. The claimed pump configuration includes a spacer element that extends
`
`from the inlet portion of the pump to prevent the pump from becoming adhered to
`
`heart tissue by suction.
`
`The present application, US Serial No. 10/566,423, was filed January 30,
`
`2006 based on a PCT filing and claiming priority from DE 103 36 902.3 filed
`
`August 8, 2003
`
`I.
`
`REAL PARTY IN INTEREST
`
`The real party in interest in this appeal is ABIOMED EUROPE GMBH,
`
`Neuenhofer Weg 3, 52074, Aachen, Germany. This patent application was
`
`originally assigned by the inventor THORSTEN SIESS to IMPELLA
`
`CARDIOSYSTEMS GMBH, Neuenhofer Weg 3, 52074, Aachen 52074, Germany
`
`by Assignment executed January 4, 2006, which was recorded by the US. Patent
`
`Office on January 30, 2006, beginning at Reel 017530, Frame 0215. Ownership of
`
`the patent rights were subsequently transferred to ABIOMED EUROPE GMBH.
`
`II.
`
`RELATED APPEALS AND INTERFERENCES
`
`None.
`
`III.
`
`STATUS OF CLAIMS
`
`The present application was originally filed with claims 1—9. Claims 1—3 and
`
`5—9 as amended, are currently pending, are under final rejection and are being
`
`appealed herewith.
`
`A clean copy of the claims being appealed is appended as Exhibit 1.
`
`5864411
`
`I‘J
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-2
`ABCDEFGHIJKHLMLNOL
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`IV.
`
`STATUS OF AMENDMENTS
`
`A response to the Final Office Action of August 9, 2011 in which no claims
`
`were amended was filed on November 9, 2011. In the Advisory Action of
`
`December 12, 2011, it was indicated that the applicant's arguments were not found
`
`to be persuasive.
`
`V.
`
`SUMMARY OF THE CLAIMED SUBJECT MATTER
`
`Claims 1—3 and 5—9 are directed to an intracardiac pump.
`
`Independent Claim 1:
`
`Independent claim 1 is supported in the specification and in the drawings as
`
`follows:
`
`1.
`
`An intracardiac pumping device (Fig. 1, #11-21) for percutaneous
`
`insertion, comprising a pump (Fig. 1, #11) connected at the proximal end
`
`(Fig. 1, #12) with a catheter (Fig. 1, #14) and at the suction-side distal end
`
`(Fig. 1, #13) with a canula (Fig. 1, #15) having inlet openings (Fig. 1, #17)
`
`remote from the pump (spec page 4, lines 18-20), characterized in that a
`
`flexible pigtail tip (Fig. 1, #20, 21) is provided at the canula distal of all of
`
`the inlet openings (spec page 2, lines 7—8), wherein said flexible pigtail tip
`
`forms a spacer for keeping said inlet openings spaced apart from adjacent
`
`heart walls (Fig. 1, #H; spec page 2, lines 8—10).
`
`VI. GROUNDS OF REJECTION TO BE REVIEWED ON APPEAL
`
`Pursuant to the final Office Action mailed August 9, 2011, the claims were
`
`rejected as follows:
`
`5864411
`
`3
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-3
`ABCDEFGHIJKHLMLNON
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Claims 1-3 and 4-9 were rejected under 35 U.S.C. § 103(a) as obvious over
`
`Siess et al (WO 2002/043791 per the translation in USZOO4/0044266) in view of
`
`Sammler et al (USPN 6,544,216) and further in view of Garcia (USPN 5,037,403).
`
`VII. ARGUMENT
`
`The present invention provides an intracardiac pump, and more particularly,
`
`a pump configuration that prevents pump suction from causing injury to heart
`
`tissue. None of the three references being relied upon by the Examiner recognizes
`
`any potential for problems that may arise when the inlet portion of a high capacity
`
`pump is inserted into the heart and its inlet is sucked up against and becomes
`
`adhered to heart tissue during operation of the pump. Moreover, none of the
`
`references recognize that such problem is exacerbated by the substantial movement
`
`a pump in such an orientation relative to the heart is subjected to during each
`
`pumping cycle of the heart (the pump's suction tends to pull it into the heart during
`
`diastole while it is prone to ejection from the heart during systole) which can
`
`frustrate efforts to avoid contact between the heart wall and the pump inlet. Not
`
`surprisingly, none of the references suggest a solution to such problems, let alone
`
`the particular solution that is being claimed in the rejected claims.
`
`The primary reference that is being relied upon by the Examiner comprises
`
`one of the present inventor's own patents. It is directed to an intravascular pump
`
`devoid of any spacing elements adjacent its proximal port nor distal port, either of
`
`which could serve as inlet in view of the disclosure that flow can be pumped
`
`through the device in either direction. It is to be noted that the reference lacks any
`
`discussion or even a recognition of the potential danger for irritating or injuring
`
`heart tissue that could result should the inlet ports become sucked up against heart
`
`tissue during the operation of the pump in the event the pump is for some reason
`
`used as an intracardiac device and its inlet is inserted into a heart chamber.
`
`586441l
`
`4
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-4
`ABCDEFGHIJKHLMLNOU
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Accordingly, motivation is clearly lacking in this reference for taking any steps or
`
`making any modification in an effort to mitigate a problem that is not recognized
`
`thereby.
`
`The Examiner then attempts to rely on the teachings of the secondary
`
`Sammler et a1 reference in an effort to overcome the above—described fundamental
`
`shortcoming of the primary reference by pointing to the guiding element (Figs. 4—6,
`
`# 35a, 46, 48) that extends from the distal end of the intracardiac pumping device.
`
`While the Examiner focuses on the fact that the guiding element extends from the
`
`distal end of the device, he ignores the fact that such guiding element is in fact
`
`shown and described as extending from the outlet end of the device and indeed
`
`must extend from the outlet end. The present invention on the other hand
`
`absolutely requires and the claims unequivocally call for the spacer element to be
`
`positioned so as to keep the inlet openings spaced apart from adjacent tissue. The
`
`guiding element of the Sammler reference is incapable of maintaining the inlet
`
`openings 13 spaced apart from tissue in view of the fact that the inlet openings are
`
`positioned on the opposite end of the device. Moreover, it is absolutely imperative
`
`for the guiding element to be positioned adjacent the outlet end of the device in
`
`order for Sammler's guide element to perform its stated function, i.e. to guide by
`
`being "entrained by the natural blood flow” and thereby be "washed via the natural
`
`blood path first into the right ventricle 24 and then into the pulmonary artery 26“
`
`(col 4, lines 1-4). Since the inlet of a pumping device is necessarily upstream
`
`relative to the natural blood flow, a repositioning of Sammler's "guiding element"
`
`adjacent to the inlet would not be expected to be able to guide the downstream end
`
`of the device. Sammler therefore unequivocally teaches the positioning of the
`
`guiding element adjacent to outlet end of the pumping device.
`
`5864411
`
`5
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-5
`ABCDEFGHIJKHLMLNOV
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`In the "clarification" attached to the Panel Decision from Pre-Appeal Brief
`
`Review, the Examiner further offers that the Sammler reference was added the
`
`primary reference to show that a flexible catheter with the balloon could be added
`
`at the distal end of the cannula as shown in Figures 4-6 in order to act as a guiding
`
`element for the catheter. As is set forth above, in order for the described guiding
`
`element to be able to guide the device shown in Figures 4-6, it would be necessary
`
`for the distal end to serve as the outlet, not the inlet for blood flow. In distinction
`
`thereto, the rejected claims unequivocally call for the pump to be configured such
`
`that its distal end comprises its suction side, i.e. inlet end, and that the spacer
`
`element is to be positioned so as to keep the inlet spaced apart from adjacent tissue.
`
`Finally, the Examiner relies on the Garcia reference to substitute the pigtail
`
`described therein for the catheter and balloon guiding element taught by Sammler.
`
`In view of the fact that Sammler absolutely requires the guiding element to be
`
`attached to the outlet end of the pumping device as was established above,
`
`substitution of Garcia's pigtail therefor (which incidentally is also shown as being
`
`attached to the outlet end of a device) would not somehow result in a shifting of its
`
`point of attachment from the outlet side to the inlet side of the pumping device as
`
`is required in the rejected claims.
`
`At the very best, combining the three references would result in a structure
`
`in which a pigtail tip is attached to the outlet end of a pumping device. There is
`
`absolutely no motivation to attach the pigtail to the inlet of a pumping device as it
`
`would not be capable of guiding by entrainment in the natural blood flow as per
`
`Sammler nor preventing recoil during high pressure injection as per Garcia. None
`
`of the three references recognize any need for keeping the inlet end of a pumping
`
`device spaced apart from tissue. No motivation, other than the present patent
`
`586441l
`
`6
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-6
`ABCDEFGHIJKHLMLNOW
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`application, is identified for rearranging the elements of the three references to
`
`arrive at the structure as claimed.
`
`In response to the applicant's position that there is an utter lack of motivation
`
`for combining the references in the manner set forth in the Examiner's rejection,
`
`the Examiner points out that there is no requirement that a motivation to make a
`
`modification need be expressly articulated. The applicant agrees but points out
`
`that not only is an express articulation lacking, but even the mere implication,
`
`insinuation or inference of a motivation for doing so is lacking. None of the three
`
`references alone or in combination even recognize, let alone address the problem
`
`of preventing injury to heart tissue due to the suction of the pump. The primary
`
`reference lacks altogether any element attached to the inlet end of the pump while
`
`both of the secondary references merely teach the attachment of various elements
`
`to the outlet end of devices that can necessarily only perform their intended
`
`functions at the outlet or downstream end of the respective devices. As such, the
`
`combination of disclosures taken as a whole do not suggest any modification of the
`
`inlet end of an intracardiac pump. It is respectfully submitted that the combination
`
`of the references as proposed by the Examiner merely amounts to an arbitrary
`
`rearrangement of parts and that only the present patent application provides any
`
`motivation for even modifying the inlet end of an intracardiac pump, let alone in
`
`the particular configuration that is being claimed.
`
`The Examiner had also previously argued that the modification of Sammler
`
`to have a pigtail tip would achieve the predictable result of minimizing trauma.
`
`Again, the Examiner is ignoring the fact that the modification of Sammler to have
`
`a pigtail tip would result in the pigtail tip being attached to the outlet end of the
`
`pumping device. As such, the pigtail tip would be incapable of minimizing trauma
`
`that would be caused by the inlet being sucked up against heart tissue. It is
`
`5864411
`
`7
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-7
`ABCDEFGHIJKHLMLNOT
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`respectfully submitted that combining the teachings of the references that are being
`
`relied upon by the Examiner would only predictably result in the positioning of a
`
`pigtail on an intracardiac pump where there is no danger of a suction-related
`
`injury. In contrast thereto, the unexpected result that is provided by the present
`
`invention is that the attachment of a pigtail to the inlet end of an intracardiac pump
`
`serves to protect heart tissue from injury that the cited references do not even
`
`recognize as being at risk.
`
`In sum, the present invention provides a simple and elegant solution to a
`
`problem that is not recognized by the cited art. Moreover, the combination of
`
`elements that appear in the cited art in the manner taught by the cited art would not
`
`result in the structure as it is being claimed. Attachment of a pigtail to the inlet end
`
`of an intracardiac pump is simply not taught or suggested nor justified by a fair
`
`reading of the cited art.
`
`Finally, it must also be noted that the Examiner has not identified any
`
`teachings in the cited art relating to certain elements that are specifically claimed in
`
`the dependent claims. More particularly, claim 5 calls for the inlet openings to be
`
`provided in an expansible suction basket including an inflow funnel. Such claimed
`
`structure was ignored in the rejections. Claim 8 calls for a guide wire to be
`
`provided that leads through the pump and into the pigtail. Again, this structure
`
`was not addressed in the rejections. Finally, claim 9 calls for the pigtail to have
`
`lateral auxiliary openings. No teaching was relied upon to reject this claim.
`
`5864411
`
`8
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-8
`ABCDEFGHIJKHLMLNOX
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`VIII. CLAIM APPENDIX
`
`See Exhibit 1.
`
`5864411
`
`9
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-9
`ABCDEFGHIJKHLMLNOY
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`IX. EVIDENCE APPENDIX
`
`None.
`
`5864411
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-10
`ABCDEFGHIJKHLMLNOPM
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`X. RELATED PROCEEDINGS APPENDIX
`
`None.
`
`5864411
`
`1 1
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-11
`ABCDEFGHIJKHLMLNOPP
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`XI. CONCLUSION
`
`As argued above, it is respectfully submitted that the present invention as claimed
`
`is not obvious in View of the cited reference. Reversal of the rejection of claims 1—
`
`3 and 5—9 is therefore respectfully requested.
`
`Respectfully submitted,
`
`FULWIDER PATTON LLP
`
`/Gunther O. Hanke/
`
`Gunther O. Hanke, Reg. No. 32,989
`
`5864411
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-12
`ABCDEFGHIJKHLMLNOPL
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`LIST OF EXHIBITS
`
`
`
`EXHIBIT
`DESCRIPTION
`
`
`
`
`1
`
`Appealed Claims
`
`5864411
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-13
`ABCDEFGHIJKHLMLNOPN
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`EXHIBIT 1
`
`Claims on Appeal:
`
`1.
`
`An intracardiac pumping device for percutaneous insertion,
`
`comprising a pump connected at the proximal end with a catheter and at the
`
`suction-side distal end with a canula having inlet openings remote from the pump,
`
`characterized in that a flexible pigtail tip is provided at the canula distal of all of
`
`the inlet openings, wherein said flexible pigtail tip forms a spacer for keeping said
`
`inlet openings spaced apart from adjacent heart walls.
`
`2.
`
`The pumping device of claim 1, wherein the pigtail tip comprises a
`
`non—sucking projection.
`
`3.
`
`The pumping device of claim 1 wherein the pigtail tip comprises a
`
`hollow hose whose lumen is in communication with that of the canula.
`
`5.
`
`The pumping device of claim 1, wherein the inlet openings are
`
`provided in an expansible suction basket including an inflow funnel.
`
`6.
`
`The pumping device of claim 1, wherein the pigtail tip has an outer
`
`diameter that is smaller than that of the canula.
`
`7.
`
`8.
`
`The pumping device claim 1, the canula has a preformed bend.
`
`The pumping device of claim 1, wherein a guide wire is provided that
`
`leads through the pump and is adapted to be advanced from the canula into the
`
`pigtail tip.
`
`9.
`
`The pumping device of claim 1, wherein the pigtail tip has lateral
`
`auxiliary openings.
`
`5864411
`
`USSN: 10/566,423
`Client/Matter #: IMPEL.72926
`
`Maquet, Ex. 2023-14
`ABCDEFGHIJKHLMLNOPU
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OEETCE
`
`
`
`
`F STNAMED
`Thorsten Siess
`
`10/566,423
`
`01/30/2006
`
`09/25/2012
`
`7590
`24201
`FULWIDERPATTON LLP
`HOWARD HUGHES CENTER
`6060 CENTER DRIVE, TENTH FLOOR
`LOS ANGELES, CA 90045
`
`UNITED STATES DEPARTMENT OF COIVLMERCE
`United States Patent and Trademark Ofi'ice
`Address: COMMISSIONER FOR PATENTS
`P O. Box 1450
`Alexandria, Virginia 22313-1450
`WWW uspto gov
`
`IIVIPEL.72926
`
`2985
`
`‘
`
`‘
`
`DINGA, ROLAND
`
`3766
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/25/2012
`
`ELECTRONIC
`
`Please find below and/0r attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e-mail address(es):
`
`d0cketla@fulpat.c0m
`eOfficeAction @fulpat.com
`
`PTOL-90A (Rev 04/07)
`
`Maquet, Ex. 2023-15
`ABCDEFGHIJKHLMLNOPV
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria, VA 22313-1450
`www.03plo.gov
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`Application Number: 10/566,423
`Filing Date: January 30, 2006
`Appellant(s): SIESS, THORSTEN
`
`Gunther O. Hanker
`
`For Appellant
`
`EXAMINER‘S ANSWER
`
`This is in response to the appeal brief filed 04/24/2012 appealing from the Office action
`
`mailed 08/09/2012.
`
`Maquet, Ex. 2023-16
`ABCDEFGHIJKHLMLNOPW
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 3
`
`(1) Real Party in Interest
`
`The examiner has no comment on the statement, or lack of statement, identifying
`
`by name the real party in interest in the brief.
`
`The examiner is not aware of any related appeals, interferences, or judicial
`
`proceedings which will directly affect or be directly affected by or have a bearing on the
`
`Board’s decision in the pending appeal.
`
`(2) Related Appeals and lnterferences
`
`The examiner is not aware of any related appeals, interferences, or judicial
`
`proceedings which will directly affect or be directly affected by or have a bearing on the
`
`Board’s decision in the pending appeal.
`
`(3) Status of Claims
`
`The following is a list of claims that are rejected and pending in the application:
`
`Claims 1-3 and 5-9.
`
`(4) Status of Amendments After Final
`
`The examiner has no comment on the appellant’s statement of the status of
`
`amendments after final rejection contained in the brief.
`
`(5) Summary of Claimed Subject Matter
`
`The examiner has no comment on the summary of claimed subject matter
`
`contained in the brief.
`
`(6) Grounds of Rejection to be Reviewed on Appeal
`
`The examiner has no comment on the appellant’s statement of the grounds of
`
`rejection to be reviewed on appeal. Every ground of rejection set forth in the Office
`
`Maquet, Ex. 2023-17
`ABCDEFGHIJKHLMLNOPT
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 4
`
`action from which the appeal is taken (as modified by any advisory actions) is being
`
`maintained by the examiner except for the grounds of rejection (if any) listed under the
`
`subheading “WITHDRAWN REJECTIONS.” New grounds of rejection (if any) are
`
`provided under the subheading “NEW GROUNDS OF REJECTION.”
`
`(7) Claims Appendix
`
`The examiner has no comment on the copy of the appealed claims contained in
`
`the Appendix to the appellant’s brief.
`
`(8) Evidence Relied Upon
`
`5,037,403
`
`6,544,216
`
`Garcia
`
`Sammler et al
`
`20040044266
`
`Siess et al
`
`08-1991
`
`04-2003
`
`03-2004
`
`WO2002/O43791
`
`wsseelahl
`
`06-2002
`
`06-2002
`
`(9) Grounds of Rejection
`
`The following ground(s) of rejection are applicable to the appealed claims:
`
`Claim Rejections - 35 USC § 103
`
`1.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Maquet, Ex. 2023-18
`ABCDEFGHIJKHLMLNOPX
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 5
`
`2.
`
`Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Siess et al (WO 2002/043791,herein Siess), relying on the translation provided by
`
`the US national stage application (U82004/0044266) of that international application
`
`pending any request by appellant for a machine translation (in view of Sammler et al
`
`(US6544216) previously cited) and further in view of Garcia (US 5,037,403).
`
`3.
`
`Regarding claims 1-3,6-8, Siess discloses a pumping device (10) percutaneous
`
`insertion[see figures 12; abstract;[0026]]. Catheter (13) connect the pump 10 at it
`
`proximal end and at the suction side distal end with a cannula (18) having inlet 24
`
`openings remote from the pump (10)[F|G.1-2;[0026](in the case opening (17) is
`
`considered “outlet” and (24) “inlet” )]. Siess discloses an opening for passage of
`
`guidewire (34)[fig.1-2,9-15;[0036,0038] and in claim 6]. Siess failed to disclose a flexible
`
`projection provided at the cannula distal of all of the inlet openings, wherein the flexible
`
`projection forms a spacer for keeping the inlet openings spaced apart from adjacent
`
`heart walls. However, Sammler discloses a flexible projection (see elements
`
`46,48)[F|G.4-6] at the distal end of cannula (14a,14b) [FlG.4-6] , the flexible projection
`
`(46,48) is capable of forming a spacer for keeping the distal end of the cannula spaced
`
`apart from adjacent heart walls[FlG.4-6]. The projection has an opening (49)[F|G.6] and
`
`projection (46,48) has an outer diameter that is smaller than that of the
`
`cannula(14a,14b) and projection is a hollow hose whose lumen (49,50) is in
`
`communication with that of the cannula (14a,14b)[F|G.4-6]. Thus, it would have been
`
`obvious to one with ordinary skills in the art by the time the invention was made to
`
`modify Siess with the flexible projection of Sammler in order to achieve the predictable
`
`Maquet, Ex. 2023-19
`ABCDEFGHIJKHLMLNOPY
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 6
`
`results of prevent the distal end of the cannula from touching the heart walls and
`
`blocking the inlet. Neither Siess nor Sammler discloses a pigtail tip. Garcia discloses
`
`that the distal end of catheter (1 0) defines a "pigtail" (18) that is to stay a spiral section
`
`as shown [see figure.1 ; col.3, lines 39-40; col.2, lines 53-68]. Thus it would have been
`
`obvious to one with ordinary skills in the art by the time the invention was made to
`
`modify Sammler to have a pigtail tip in view of Garcia since to substitute one apparatus
`
`for the other to achieve the predictable result of minimizing trauma [Col.2, lines 61 -62].
`
`4.
`
`Regarding claim 5, Siess discloses an inlet opening (24) in an inflow funnel
`
`shape capable of expanding[see figures.1-2]
`
`5.
`
`Regarding claim 9, Siess discloses substantially the invention as claimed but
`
`failed to disclose the pigtailed tip has lateral auxiliary openings. However, Garcia
`
`discloses a pigtail tip that has lateral auxiliary openings [see fig.1 ; element (16)]. Thus, it
`
`would have been obvious to one with ordinary skills in the art by the time the invention
`
`was made to modify Siess to have a pigtail tip that has lateral auxiliary openings in
`
`order to provide additional support in case the other openings fails.
`
`(10) Response to Argument
`
`Appellant's main argument is that none of the references relied upon by the
`
`examiner recognizes any potential for problems that may arise when the inlet portion of
`
`a high capacity pump is inserted into the heart and its inlet is sucked up against and
`
`becomes adhered to heart tissue during operation of the pump. None of the references
`
`suggest a solution to such problem.
`
`Maquet, Ex. 2023-20
`ABCDEFGHIJKHLMLNOLM
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 7
`
`In response to appellant's argument that the references fail to show certain
`
`features of appellant’s invention, it is noted that the features upon which appellant
`
`relies (i.e., the potential for problems that may arise when the inlet portion of a high
`
`capacity pump is inserted into the heart and its inlet is sucked up against and
`
`becomes adhered to heart tissue during operation of the pump) are not recited in the
`
`rejected claim(s). Although the claims are interpreted in light of the specification,
`
`limitations from the specification are not read into the claims. See In re Van Geuns,
`
`988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
`
`Appellant argued that the examiner attempts to rely on the teachings of
`
`secondary reference of Sammler in an effort to overcome the shortcomings of Siess by
`
`pointing to the guiding element 35a,46,48 in figure 4-6, and that the examiner has
`
`ignored the fact that such guiding element is in fact shown and described as extending
`
`from the outlet end of the device, while the present invention on the other hand
`
`absolutely requires and the claims unequivocally call for the spacer element to be
`
`positioned so as to keep the inlet openings spaced apart from adjacent tissue.
`
`In response to that, the examiner added Sammler reference to Siess just to
`
`show that a flexible catheter with the balloon could added at the distal end of the
`
`cannula as shown in figures.4-6 in order to act as a guiding element for the
`
`catheter[col.4,lines 44-col.5,lines 1-8]. Sammler wasn’t use to modify Siess open
`
`(24)[figures.1-2], which was already considered by examiner as an inlet. Thus, the
`
`flexible catheter of Sammler is going to be used in a distal end that has an inlet.
`
`Maquet, Ex. 2023-21
`ABCDEFGHIJKHLMLNOLP
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 8
`
`Appellant continue the same argument on Garcia as Sammler. In response to
`
`that, Garcia and Sammler wasn’t use to modify Siess open (24)[figures.1-2], which was
`
`already considered by examiner as an inlet. The reference of Garcia was added to
`
`Siess et al and Sammler to show that the distal end of the catheter of Seiss et
`
`al/Sammler could have a pigtail shape as in Garcia figure.1 for permitting easier
`
`maneuvering of the catheter through the ventricle and also for helping to minimize
`
`trauma [col.2,lines 53-65]. The examiner has taken the position that, by having the distal
`
`end in a pigtail shape, the catheter would perform the same function of appellant's
`
`spacer for keeping heart wall apart from the catheter openings.
`
`In response to appellant’s argument against the references individually, one
`
`cannot show nonobviousness by attacking reference individually where the rejections
`
`are based on combinations of references. see In re Keller, 642 F.2d413, 208 USPQ 871
`
`(CCPA 1981).
`
`Appellant also, argued that no motivation, other than the present patent
`
`application is identified for rearranging the elements of the three references to arrive at
`
`the structure as claimed.
`
`In response to appellant's argument that there is no motivation to combine the
`
`reference, the examiner recognizes that obviousness may be established by combining
`
`or modifying the teachings of the prior art to produce the claimed invention where there
`
`is some teaching, suggestion or motivation to do so found either in the references
`
`themselves or in the knowledge general available to one of ordinary skill in the art. See
`
`In re Fine, 837 F.2d 1071, 5 USPQZd 1596 (Fed.Cir.1988).
`
`Maquet, Ex. 2023-22
`ABCDEFGHIJKHLMLNOLL
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`Application/Control Number: 10/566,423
`Art Unit: 3766
`
`Page 9
`
`Finally, appellant argued that the examiner has not identified any teachings in the
`
`cited art relating to certain elements that are specifically claimed in the dependent
`
`claims 5, 8, and 9.
`
`In response to that, the limitations of these claims are addressed as seem in
`
`paragraph 3-5 as set forth above.
`
`In conclusion, all rejections are maintained and appellant’s arguments are not
`
`found persuasive.
`
`(11) Related Proceeding(s) Appendix
`
`No decision rendered by a court or the Board is identified by the examiner in the
`
`Related Appeals and Interferences section of this examiner’s answer.
`
`For the above reasons, it is believed that the rejections should be sustained.
`
`Respectfully submitted,
`
`/ROLAND
`
`DINGA/
`
`Examiner, Art Unit 3766
`
`Conferees:
`
`/CARL H LAYNO/
`
`Supervisory Patent Examiner, Art Unit 3766
`
`/Niketa |. Patel/
`
`Supervisory Patent Examiner, Art Unit 3762
`
`Maquet, Ex. 2023-23
`ABCDEFGHIJKHLMLNOLN
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`FILED ELECTRONICALLY
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`
`Appl. No.
`
`:
`
`10/566,423
`
`Confirmation No. 2985
`
`Applicant
`
`: Thorsten Siess
`
`Filed
`
`:
`
`January 30, 2006
`
`Art Unit
`
`: 3766
`
`Examiner
`
`: Roland Dinga
`
`Title
`
`: AN INTRACARDIAC PUMPING DEVICE
`
`Docket No.:
`
`:
`
`IMPEL 72926
`
`Customer No.
`
`: 24210
`
`November 19, 2012
`
`Mail Stop Appeal Brief — PATENTS
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`REPLY BRIEF
`
`This Reply Brief is responsive to the Examiner's Answer mailed
`
`September 25, 2012 relating to the above—referenced appeal. This reply is in
`
`compliance With 37 C.F.R. § 41.41 and is being filed Within the two month time
`
`period set forth therein.
`
`Maquet, Ex. 2023-24
`ABCDEFGHIJKHLMLNOLU
`IPR2017-01204
`QRSLMPTOMPLMU
`
`

`

`ARGUMENT
`
`In the 'Response to Argument', the Examiner insists that the "features" that
`
`the applicant is relying on for patentability are not recited in the rejected claims
`
`and that therefore, applicant's argument for patentability fails. In fact, the
`
`Examiner is improperly characterizing part of applicant's argument for
`
`patentability, i.e. the identification of problems that are solved by the invention as
`
`it is claimed that are not solved by devices described in the cited art nor even
`
`recognized in such references, as an unclaimed element of the invention and asserts
`
`that since such "features" are not recited in the rejected claims, the applicant's
`
`position fails. Applicant respectfully submits that the Examiner is confusing
`
`structure with a problem that is solved by the claimed structure and that therefore,
`
`it is the Examiner's position that is flawed.
`
`Applicant's argument for non-obvious is not an element of an apparatus
`
`claim. Moreover, such argument would not be expected to carry any patentable
`
`weight as it is not structural in nature. However, the argument does serve to
`
`underscore why it is that the structural difference that does exist between the
`
`present invention as claimed and the devices that are shown in the cited references
`
`is not obvious, i.e. why it would not be obvious to modify the prior art devices or
`
`recombine various elements thereof so as to arrive at the present invention as
`
`claimed. The critical structural fea