IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Scribner et ai.
`
`AttomeyDocket No.: 1759.15100-DIV DIV
`
`Serial No.:
`
`10/617,976
`
`Filed:
`
`Title:
`
`11 ]uly2003
`
`Systems and Methods for Placing Materials into Bone
`
`Examiner: Unknown
`
`Group Art Unit: Unknown
`
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O: Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`INTRODUCTORY COMMENTS
`
`Please amend the application prior to the first Office Action and calculation of fees as
`
`follows:
`
`12/09/2003 EFLORES 00000045 10617976
`01 FC:2202
`63.00 OP
`
`STRYKER EXHIBIT 1017, pg. 1
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01434
`
`

`

`Application'Serial No. 10/617,976
`Preliininary Amendment
`Page - 2-
`
`AMENDMENTS TO THE CLAIMS
`
`1. (Canceled)
`2. (New). A system for treating a bone having an interior volume occupied, at least
`
`in part, by cancellous bone comprising
`
`an access tool sized and configured to establish a percutaneous access path to bone,
`
`a void forming tool sized and configured to be introduced through the percutaneous
`
`access path to fonn a void,
`
`..
`
`a nozzle sized and configured to pass through the percutaneous access path and
`
`including an interior passage to deliver a filling material into the void, and
`
`an auxiliary tool sized and configured to be received by the interior passage and urge
`
`filling material from the nozzle.
`
`3. (New). A system according to claim 2
`
`wherein the access tool comprises a cannula.
`
`4. (New). A system according to claim 2
`wherein the void forming tool is sized and configured to fonn a void that occupies
`less than the interior volume.
`
`5. (New). A system according to claim 2
`wherein the void forming tool is sized and configured to fonn a void that occupies
`less than about 90% of the interior volume.
`
`6. (New). A system according to claim 2
`wherein the void forming tool is sized and configured to fonn a void that occupies
`about 30% to about 90% of the interior volume.
`
`7. (New). A system according to claim 2
`wherein the void forming tool is carried by an elongate member sized and configured
`to pass through the percutaneous access path.
`
`8. (New). A system according to claim 2
`
`wherein the elongate member comprises a catheter.
`
`9. (New). A system according to claim 2
`wherein the void fonning tool is sized and configured to compact cancellous bone.
`10.
`(New). A system according to claim 2
`
`STRYKER EXHIBIT 1017, pg. 2
`
`

`

`ApplicatiorISerial No. 10/617,976
`Preliininaty Amendment
`Page - 3 -
`
`wherein the void fonning tool is sized and configured to lift fractured cortical bone.
`11. (New). A system according to c~ 2
`wherein the void fonning tobl is sized and configured to reduce a cortical bone
`
`fracture.
`
`12. (New). A system according to claim 2
`wherein the void fonning tool is sized and configured to move fractured cortical
`bone towards a natural anatomic position.
`13. (New). A system according to claim 2
`wherein the void fonning tool comprises an expandable body.
`
`14. (New). A system according to claim 13
`wherein the expandable body is inflatable.
`15. (New). A system according to claim 13
`wherein the expandable body comprises a balloon.
`16. (New). A system according to claim 13
`
`wherein the expandable body; when expanded, assumes a non-spherical shape.
`17. (New) .. A system according to claim 13
`wherein the expandable body is sized and configured to be removed from bone after
`formation of the void.
`'
`
`18. (New). A system according to claim 2
`wherein the void fonning tool is sized and configured to be removed from bone
`after formation of the void.
`
`19. (New). A system according to claim 2
`wherein the nozzle comprises an elongate tube.
`
`20. (New). A system according to claim 2
`further including a receptacle for holding a volume of filling material.
`21. (New). A system according to claim 20
`wherein the nozzle includes a connector to couple the nozzle to the receptacle.
`22. (New). A system according to claim 20
`wherein the nozzle includes a connector to releasably couple the nozzle to the
`
`receptacle.
`
`STRYKER EXHIBIT 1017, pg. 3
`
`

`

`Application-Serial No. 10/617,976
`Preliininary Amendment
`Page - 4-
`
`23. (New). A system according to claim 20
`wherein the receptacle comprises a syringe.
`24. (New). A system according to claim 2
`wherein the nozzle has a length and includes measured markings along the length.
`
`25. (New). A system according to claim 2
`
`wherein the auxiliary tool comprises an elongate body.
`26. (New). A system according to claim 25
`wherein the elongate body is a stylet.
`27. (New). A system according to claim 2
`wherein the auxiliary tool includes a handle.
`28. (New). A system according to claim 2
`wherein the auxiliary tool is sized and configured to fully occupy the interior passage
`
`of the nozzle.
`
`STRYKER EXHIBIT 1017, pg. 4
`
`

`

`\'"
`
`Application Serial No. 10/617,976
`Preliffiinary- Amendment
`Page - 5-
`
`REMARKS
`
`aaim 1 has been' canceled.
`New claims 2-28 are presented for prosecution.
`aaims 2-28 remain pending in the application.
`Entry-of this preliminary-amendment and allowance of claims 2-28 is respectfully requested.
`
`Respectfully Submitted,
`
`By GMu.;4 u. ,'tj,:""'.JJ?d7
`Patricia A Limbach
`Registration No. 50,295
`
`RYANKROJv.1HOLZ & MANION, S.C
`Post Office Box 26618
`Milwaukee, WISCOnsin 53226
`(262) 783 - 1300
`4 December, 2003
`
`KyphooI15100..01V DlV/Q)I2Q4 Pmim Atrwmd
`
`Enclosures: Amendment Transmittal Letter
`Return Postcard
`
`STRYKER EXHIBIT 1017, pg. 5
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/617,976
`
`0711 1/2003
`
`Robert M. Scribner
`
`1759.15100-DlV DlV
`
`4100
`
`09123/2004
`7590
`26308
`RYAN KROMHOLZ & MANION, S.C.
`POST OFFICE BOX 26618
`MILWAUKEE, WI 53226
`
`EXAMINER
`
`PHILOGENE, PEDRO
`
`ART UNIT
`
`3732
`
`PAPER NUMBER
`
`DATE MAILED: 09/23/2004
`
`Please find below andlor attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev. 10/03)
`
`STRYKER EXHIBIT 1017, pg. 6
`
`

`

`Office Action Summary
`
`101617.976
`
`Examiner
`
`Application No.
`
`Applicant(s)
`
`SCRIBNER ET AL.
`
`Art Unit
`
`I
`
`3732
`Pedro Philogene
`_ The MAILING DATE of this communication appears on the cover shOGt with the conuspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE J MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`• Extensions of time may be available under the provisions of 37 CFR 1.136(0). In no event. however, maya reply be timely filed
`after SI)( (6) MONTHS from the mailing date of this c;ommunil:8tion.
`If the period for reply specified abov. Is Ifi5 than thirty (30) days, a reply willlln the statutory minimum of thirty (30) days will be considered timely.
`If NO period ror reply Is specified above, the maximum .latulmy period will apply and wll expire SIX (6) MONTHS from the maDing dale of this c;ommunil:8tion.
`• Failure to reply within the set or extended period for reply will. by lStatu1e. cause \be application to become ABANDONED (35 U.s.C. § 133).
`Any reply ~ived by the Olli~ later than three monll\$ after the mailing date of this c:ommunil:8tion, even if timely filed, may redul:8 any
`eamed patent term adjustmenl See 37 CFR 1.704(b).
`
`Status
`
`1)[81 Responsive to communication(s) filed on 11 July 2003.
`2b)~ This action is non-final.
`2a)0 This action is FINAL.
`3)0 Since this application is in condition for allowance except for fonnal matters, prosecution as to the ments is
`closed In accordance with the practice under Ex parte Quayle. 1935 C.D. 11.453 O.G. 213.
`
`Disposition of Claims
`
`4)121 Claim(s) 2-28 isfare pending in the application.
`4a) Of the above daim(s) __ isfare withdrawn from consideration.
`5)0 Claim(s) __ isfare allowed,
`6)[8J Claim(s) 2-28 isfare rejected.
`7)0 Claim(s) __ isfare objected to.
`a)O Claim(s) __ are subject to restnction and/or election requirement.
`
`Application Papers
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ isfare: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held In abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d~
`11)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or fonn PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a daim for foreign pnority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the pnonty documents have been received.
`2.0 Certified copies of the pnonty documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a».
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) [8] Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) [8J Information Disclosure Statement(s) (PT0-1449 or PTOISBI08)
`Paper NO(II)IMail Date~.
`
`4) 0 Interview Summary (PTo-113)
`Paper No(sYMaU Dale. __ .
`5) 0 Notice of Informal Patent Application (PT0-152)
`6) 0 Other: __ .
`
`u.s. Patent aNI Trad ..... '" 011"
`PTOL-326 (Rev. 1-04)
`
`OffIce Actlon SummllfY
`
`Part of Paper No.lMail Date 08232004
`
`STRYKER EXHIBIT 1017, pg. 7
`
`

`

`Application/Control Number: 10/617,976
`Art Unit: 3732
`
`Page 2
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. See In re Goodman, 11
`F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225
`USPQ 645 (Fed. Cir. 1985); In fe Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA
`1982); In re Vogel, 422 F.2d 438,164 USPQ 619 (CCPA 1970);and, ln ra Thorington,
`418 F.2d 528,163 USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be
`used to overcome an actual or provisional rejection based on a nonstatutory double
`patenting ground provided the conflicting application or patent is shown to be commonly
`owned with this application. See 37 CFR 1.130(b}.
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3.73(b).
`
`Claims 2·28 are rejected under the judicially created doctrine of obviousness-
`
`type double patenting as being unpatentable over claims 1-21 of U.S. Patent No.
`
`6,241,734. Although the conflicting claims are not identical, they are not patentably.
`
`distinct from each other because it is clear that the all the elements of claims 2-28 are to
`
`be found in claims 1-21. The difference between claims 2-28 of the application and
`
`claims 1-21 of the patent lies in the fact that the patent claims includes many more
`
`elements and is thus much more specific. Thus the invention of claims 1-21 is in effect a
`
`"species" of the "generic" invention of claims 2·28. It has been held that the generic
`
`invention is Uanticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993). Since claims 2-28 are antiCipated by claims 1·21 of the patent, they are not
`
`patentably distinct from claims 1-21.
`
`Claim Rejections· 35 USC § 103
`
`STRYKER EXHIBIT 1017, pg. 8
`
`

`

`Application/Control Number: 10/617,976
`Art Unit: 3732
`
`Page 3
`
`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.
`
`Claims 2-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Scholten et al. (5,108,404) in viewofMikhail (5,718,707).
`
`With respect to daim 2, Scholten et al disdose a system for treating a bone
`
`having an interior volume occupied, at least in part, by cancellous bone comprising: an
`
`access tool (30) sized and configured to establish a percutaneous access path to bone
`
`a void forming tool (76) sized and configured to be introduced through the percutaneous
`
`access path to form a void, a nozzle; as set forth in column 7, lines 45-47, sized and
`
`configured to pass through the percutanous access path and including an interior
`
`passage to deliver a filling material into the void; as set forth in column 7, lines 45-68.
`
`It is noted that Scholten et al. did not teach of a an auxiliary tool sized and
`
`configured to be received by the interior passage and urge filling material from the
`
`nozzle; as claimed by applicant. However, in a similar art, Mikhail evidences the use of
`
`an auxiliary tool sized for dispensing 'and compacting bone graft material into a cavity.
`
`Therefore, given the teaching of Mikhail, it would have been obvious to one
`
`having ordinary skill in the art at the time the invention was made to incorporate an
`
`auxiliary tool in the device of Scholten et al; as taught by Mikhail to dispense and
`
`compact bone graft material into the cavity.
`
`STRYKER EXHIBIT 1017, pg. 9
`
`

`

`Application/Control Number: 10/617,976
`Art Unit: 3732
`
`Page 4
`
`With respect to claims 3-28, the above combination of references teaches all the
`
`limitations; as set forth in Scholten et aI., column 4, lines 23-68, column 5-8, lines 1-68,
`
`column 9, lines 1-31, and as best seen in FIGS. 1-34 of Scholten et aI., and as set forth
`
`in columns 2-3,lines 1-67, and as best seen in FIGS.1-8 of Mikhail.
`
`Conclusion
`
`The prior art made of record and not relied upon is considered pertinent to
`
`applicant's disclosure.
`
`5,571,189
`
`5,788,703
`
`4,338,925
`
`6,248,110
`
`11-1996 .
`
`Kuslich
`
`08-1998
`
`07-1982
`
`06-2001
`
`Mittelmeier et al
`
`Miller
`
`Reiley et al.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Pedro Philogene whose telephone number is (703) 308-
`
`2252. The examiner can normally be reached on Monday to Friday 6:30 AM to 4:00
`
`PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Kevin P Shaver can be reached on (703) 308-2582. The fax phone number
`
`for the organization where this application or proceeding is assigned is 703-872-9306.
`
`STRYKER EXHIBIT 1017, pg. 10
`
`

`

`Application/Control Number: 10/617,976
`Art Unit: 3732
`
`PageS
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866·217·9197 (toll-free).
`
`Pedro Philogene
`August23,2004
`
`~A~ _
`PEDROj.I~
`
`PRIMARY EXAMINER
`
`STRYKER EXHIBIT 1017, pg. 11
`
`

`

`Customer No. 26308
`
`Applicant:
`
`Scribner et al.
`
`Serial No.:
`
`10/617,976
`
`11 July 2003
`
`Filed:
`
`Tide:
`
`Docket No.: 1759.15100-DIV DIV
`
`Examiner: P. Philogene
`
`Group Art Unit: 3732
`
`Systems and Methods for Placing Materials into Bone
`
`AMENDMENT A
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`INTRODUCTORY COMMENTS
`
`Tbis Amendment responds to the Office Action mailed September 23, 2004.
`
`An automatic one month extension of time to respond, up to and including January 23,
`
`2005, is respectfully requested. The requisite fee accompanies this Amendment.
`
`The Examiner's attention is directed to the Information Disclosure Statement that
`
`accompanies this Amendment.
`
`Please amend the application as follows:
`
`01/21/2005 AADOF01 00000016 10617976
`120.00 OP
`01 FC:1251
`
`STRYKER EXHIBIT 1017, pg. 12
`
`

`

`Application Seriai No. 10/617,976
`Amendment A
`Page - 2-
`
`AMENDMENTSTOTHECUUMS
`
`1 (Canceled)
`
`2
`
`(Currently amended). A system fer treaciag a befte ha. iflg aft intefier • eh:uRe
`
`eeetlpied, at least in part, by eafteelletls befte comprising
`
`an access tool sized and configured to establish a peretltaaeetls an access path
`
`through soft tissue to bone having an interior volume occupied. at least in part. by cancellous bone,
`
`a void forming tool sized and configured to be introduced through the peretltaaeetls
`
`access path to form a void in cancellous bone,
`
`a nozzle sized and configured to pass through the peretltafteetls access path and
`
`including an interior passage bore defining a fixed interior volume to receive and deliver a measured
`
`volume of filling material into the void, and
`
`an auxiliary tool sized and configured to be reeeived by advanced through the
`
`interior passage bore and urge filling material from the nozzle.
`
`3 (previously presented). A system according to claim 2
`
`wherein the access tool comprises a cannula.
`
`4 to 6 (Canceled).
`
`7 (Currently amended). A system according to claim 2
`
`wherein the void forming tool is carried by an elongate member sized and configured
`
`to pass through the peretltaaeetls access path.
`8 (Currently amended). A system according to claim '2:-1
`wherein the elongate member comprises a catheter.
`
`9 to 12 (Canceled)
`
`13 (previously presented). A system according to claim 2
`
`wherein the void forming tool comprises an expandable body.
`
`14 and 15 (Canceled)
`
`16 (previously presented). A system according to claim 13
`
`wherein the expandable body, when expanded, assumes a non-spherical shape.
`
`17 and 18 (Canceled)
`
`19 (previously presented). A system according to claim 2
`
`wherein the nozzle comprises an elongate tube.
`
`STRYKER EXHIBIT 1017, pg. 13
`
`

`

`Application Seriai No. 1"0/617,976
`Amendment A
`Page - 3 -
`
`20 (Currendy Amended). A system according to claim 2
`
`further including a receptacle for holding a volume of filling material. and.
`
`wherein the nozzle includes a connector to couple the nozzle to the receptacle.
`
`21 to 23 (Canceled).
`
`24 (previously presented). A system according to claim 2
`
`wherein the nozzle has a length and includes measured markings along the length.
`
`25 (previously presented). A system according to claim 2
`
`wherein the auxiliary tool comprises an elongate body.
`
`26 to 28 (Canceled).
`
`29 (New). A system according to claim 2
`
`wherein the nozzle is made from a generally flexible material.
`
`30 (New). A system according to claim 2
`
`wherein the nozzle is made from a generally rigid material.
`
`31 (New). A system according to claim 2
`
`wherein the [tlling material comprises at least one of a flowable material that hardens
`
`to a rigid state, a bone cement, autograft material, allograft material, calcium carbonate,
`
`demineralized bone matrix material, and calcium phosphate.
`
`32 (New). A system comprising
`
`a cannula sized and configured to establish an access path through soft tissue to
`
`bone having an interior volume occupied, at least in part, by cancellous bone,
`
`a void forming tool sized and configured to be introduced through the cannula to
`
`form a void in cancellous bone,
`
`a nozzle that can be manipulated independent of the cannula and that is sized and
`
`configured to pass through the cannula, the nozzle including an interior bore to receive and deliver a
`
`measured volume of filling material into the void, and
`
`an auxiliary tool that can be manipulated independendy of the nozzle and the
`
`cannula and that is sized and configured to be advanced through the interior bore and urge filling
`
`material from the nozzle, the auxiliary tool, when fully advanced, substantially fully occupying the
`
`entire interior bore of the nozzle.
`
`33 (New). A system according to claim 32
`
`STRYKER EXHIBIT 1017, pg. 14
`
`

`

`·
`"
`Application Serial No. 10/617,976
`Amendment A
`Page - 4-
`
`wherein the filling material comprises at least one of a flowable material that hardens
`
`to a rigid state, a bone cement, autograft material, allograft material, calcium carbonate,
`
`demineralized bone matrix material, and calcium phosphate.
`
`34 (New). A system according to claim 32
`
`wherein the nozzle is made from a generally flexible material.
`
`35 (New). A system according to claim 32
`
`wherein the nozzle is made from a generally rigid material.
`
`36 (New). A system according to claim 32
`
`wherein the void forming tool comprises an expandable body.
`
`STRYKER EXHIBIT 1017, pg. 15
`
`

`

`Application Serial No. 10/617,976
`Amendment A
`Page - 5 -
`
`REMARKS
`
`Claim 1 remains cancelled. Claims 4 to 6; 9 to 12; 14; 15; 17; 18; 21 to 23; and 26 to 28 have
`
`been canceled by this amendment. Claims 2; 7; 8; and 20 have been amended. New claims 29 to 36
`
`are presented.
`
`Claims 2; 3; 7; 8; 13; 16; 19; 20; 24; 25; and 29 to 36 remain in the application, for a total of
`
`eighteen claims. Of these, claims 2 and 32 are independent system claims.
`
`Reexamination and reconsideration are respectfully requested in view of the amendments
`
`and the remarks that follow.
`
`The Applicant acknowledges the Examiner's rejection of the claims as submitted by
`
`Preliminary Amendment under the judicially created doctrine of obviousness double patenting.
`
`Because these claims have been amended and newly submitted claims are still undergoing
`
`prosecution, Applicant respectfully seeks to postpone consideration of any terminal disclaimer until
`
`the nature and scope of allowable subject matter have been indicated. Applicant will proceed with
`
`prosecution and address the other grounds for rejection, subject to any double patenting rejection
`
`that the Examiner may maintain at the close of prosecution.
`
`Claims 2; 3; 7; 8; 13; 16; 19; 20; 24; 25 stand rejected under 35 U.S.c. § 103(a) based upon
`
`Scholten et al (US 5,108,404) in view of Mikhail (US 5,718,707). Applicant believes the amended
`
`and new claims defIne subject matters not taught or suggested by Scholten and/or Mikhail.
`
`Scholten does not teach or suggest an auxiliary tool, as defIned in independent claims 2 and
`
`32, that is sized and confIgured to be advanced through the interior bore of a nozzle (which itself
`
`passes through an access path established through soft tissue to bone), to urge filling material in a
`
`measured way from the nozzle. Mikhail is not compatible with Scholten and does not teach or
`
`suggest the incorporation of an auxiliary tool as defIned in the claims into Scholten.
`
`Regarding independent claims 2 and 32, Mikhail does not teach or suggest the use of an
`
`access path established through soft tissue into bone as defIned in the claims. Mikhail hangs his
`
`dispensor on the proximal end of the femur in an open surgical procedure. Mikhail can not be fairly
`
`characterized as teaching or suggesting the use of a nozzle that passes through a soft tissue access
`
`path, much less an auxiliary tool that is advanced through that nozzle. Mikhail's dispensor is
`
`incompatible with any system that makes access to bone through soft tissue.
`
`STRYKER EXHIBIT 1017, pg. 16
`
`

`

`Application Seriai No. 1'0/617,976
`Amendment A
`Page - 6 -
`
`Further, regarding independent claim 2, Mikhail does not teach or suggest a nozzle that
`
`includes an interior bore that defines a flxed interior volume so that a measured volume of filling
`
`material can be delivered, as deflned in claim 2. The interior volume of Mikhail's nozzle barrel 22
`
`varies with advancement of the plunger 60. Mikhail cannot be fairly characterized as teaching or
`
`suggesting the advancement of an auxiliary tool through a bore that deflnes a flxed interior volume,
`
`so that a measured volume of fllling material can be delivered, as defined in claim 2. Mikhail does
`
`not even contemplate the need to measure the volume of fllling material delivered, and, as a result,
`
`Mikhail ffils but does not measure the ffil. Mikhail's dispensor is incompatible with a system that
`
`delivers a measured volume of filling material through soft tissue to a void formed in a bone.
`
`Regarding new independent claim 32, Mikhail does not teach or suggest a nozzle that is
`
`manipulated independent of a cannula, and an auxiliary tool that is manipulated independent of the
`
`nozzle, as defined in claim 32. Mikhail does not use a cannula, and his auxiliary tool is integrated
`
`with the nozzle. Furthermore, Mikhail does not teach or suggest an auxiliary tool, that when fullY'
`
`advanced within the nozzle, substantially fully occupies the entire interior bore of the nozzle, as also
`
`deflned in new claim 32. Mikhail's ejector member 34 occupies but a small end region of the nozzle
`
`barrel 22.
`
`If anything, a person of ordinary skill knowing of Scholten and Mikhail (but not the subject
`
`matters defined in the claims), would perhaps have thought to couple Mikhail's dispensor at the
`
`proximal end of Scholten's nozzle. Without prior knowledge of the subject matters of the claims, a.
`
`person of ordinary skill would not have thought to dismantle Mikhail's dispensor so it could be
`
`passed down a cannula. Without prior knowledge of the subject matters of the claims, a person of
`
`ordinary skill would not have disconnected Mikhail's ejector member 34 from the nozzle barrel 22,
`
`transformed the variable volume barrel into a nozzle with a fixed volume bore, and fitted the
`
`disconnected and transformed elements down a cannula.
`
`For these reasons, Applicant respectfully asks the Examiner to withdraw his rejections based
`
`upon Scholten and Mikhail.
`
`STRYKER EXHIBIT 1017, pg. 17
`
`

`

`·
`.'
`Application Serial No. 10/617,976
`Amendment A
`Page - 7 -
`
`Applicant respectfully submits that claims 2; 3; 7; 8; 13; 16; 19; 20; 24; 25; and 29 to 36 stand
`
`in condition for allowance.
`
`BY~~~---r-+~ ____ ~~~ ________ __
`
`RYAN KROMHOLZ & MANION, S.c.
`Post Office Box 26618
`Milwaukee, Wisconsin 53226
`(262) 783 - 1300
`12 January 2005
`Customer No. 26308
`
`KYPHON/11S'.15100.0IV OIV/05011l AMI!NDMENT It
`
`Enclosures: Amendment Transmittal
`Return postcard
`
`STRYKER EXHIBIT 1017, pg. 18
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313·1450
`www.uspto.gov
`
`APPLICA nON NO.
`
`10/617,976
`
`FILING DATE
`
`07/11/2003
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMA nON NO.
`
`Robert M. Scribner
`
`1759.15100-DIV DlV
`
`4100
`
`04/0812005
`26308
`7590
`RYAN KROMHOLZ & MANION, S.c.
`POST OFFICE BOX 26618
`MILWAUKEE, WI 53226
`
`EXAMINER
`
`PHILOGENE. PEDRO
`
`ART UNIT
`
`3732
`
`PAPER NUMBER
`
`DATE MAILED: 04/08/2005
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev. 10/03)
`
`STRYKER EXHIBIT 1017, pg. 19
`
`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`10/617,976
`
`Examiner
`
`SCRIBNER ET Al.
`
`Art Unit
`
`3732
`Pedro Philogene
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE;2 MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, maya reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will. by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication. even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)[2] Responsive to communication(s) filed on 03 February 2005.
`2a)[2] This action is FINAL.
`2b)0 This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11,453 O.G. 213.
`
`Disposition of Claims
`
`4)[2] Claim(s) 2.3.7.8.13.16.19,20.24.25 and 29-36 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s)
`is/are allowed.
`6)[2] Claim(s) 2.3,7.8,13.16.19.20,24.25 and 29-36 is/are rejected.
`7)0 Claim(s)
`is/are objected to.
`8)0 Claim(s)
`are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The speCification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a) ..
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (t).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`:
`
`Attachment(s)
`1) [2] Notice of References Cited (PTO-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PTO-94S)
`3) [2] Information Disclosure Statement(s) (PTO-1449 or PTO/SB/OS)
`Paper No(s)/Maii Date 1118105' 10128104,
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Maii Date. __ '
`5) 0 Notice of Informal Patent Application (PTO-152)
`6) 0 Other: __ '
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 1-04)
`
`Office Action Summary
`
`Part of Paper No.lMail Date 04062005
`
`STRYKER EXHIBIT 1017, pg. 20
`
`

`

`Application/Control Number: 10/617,976
`Art Unit: 3732
`
`Page 2
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. See In re Goodman, 11
`F.3d 1046,29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225
`USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA
`1982); In re Vogel, 422 F .2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington,
`418 F.2d 528,163 USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be
`used to overcome an actual or provisional rejection based on a nonstatutory double
`patenting ground provided the conflicting application or patent is shown to be commonly
`owned with this application. See 37 CFR 1.130(b).
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3.73(b).
`
`Claims 2,3,7,8,13,16,19,20,24,25,29-36 are rejected under the judicially created
`
`doctrine of obviousness-type double patenting as being unpatentable over claims 1-21
`
`of U.S. Patent No. 6,241,734. Although the conflicting claims