Attorney Docket No. 104US1
`
`Page 1 of 10
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Matthew Curran
`
`Art Unit:
`
`3733
`
`Serial No.:
`
`11/093,409
`
`Examiner:
`
`Elana Beth Fisher
`
`Filing Date:
`
`March 29, 2005
`
`Title:
`
`Systems and Methods for Spinal Fusion
`
`
`Certificate of Transmission: Ihereby certify that this paper or fee is being transmitted to the USPTO Via EFS—Web on March 1, 2010.
`
`Signature: /Rory Schermerhorn
`
`Name: Rory Schermerhorn
`
`Mail Stop Amendment
`Commissioner for Patents
`
`PO Box 1450
`
`Alexandria VA 22313-1450
`
`Dear Sir:
`
`RESPONSIVE AMENDMENT
`
`In response to the Final Office Action mailed on August 27, 2009, having a three—month
`
`shortened period for response that expired on February 27, 2010, please amend the application as
`
`follows:
`
`1022
`
`1022
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`IN THE CLAIMS:
`
`Page 2 of 10
`
`1.
`
`(Currently Amended) A spinal fusion implant positionable within an interbody space
`
`between a first Vertebral endplate and a second Vertebral endplate, said interbody space being at
`
`least partially defined by a posterior aspect, and anterior aspect, and opposing lateral aspects, ‘th_e
`
`implant being positionable from a lateral approach to extend from one lateral aspect to the other,
`
`said implant comprising:
`
`a top surface including a plurality of ridges to engage said first Vertebral endplate when
`
`said implant is positioned within the interbody space, a bottom surface including a plurality of
`
`ridges to engage said second Vertebral endplate when said implant is positioned within the
`
`interbody space, a distal side, a proximal side, a first side wall defining an anterior side when
`
`said implant is positioned within the interbody space, and a second side wall defining a posterior
`
`side when said implant is positioned within the interbody space;
`
`wherein said implant has a length extending from said proximal side to said distal side, a
`
`width extending from said first side wall to said second side wall, and a height extending from
`
`said top surface to said bottom surface;
`
`wherein said length is
`
`
`
`..
`
`..
`
`.
`
`.
`
`.
`
`.
`
`::
`
`.
`
`.
`
`..
`
`::=.
`
`:.
`
`- .-: atleasttwo
`
`and a half times greater than said width;
`
`wherein said width is greater than said height;
`
`said implant further including first and second fusion apertures that each extend between
`
`the top and bottom surfaces and permit bone growth between the first Vertebral endplate and the
`
`second Vertebral endplate when said implant is positioned within the interbody space, said first
`
`and second fusion apertures being adjacent to one another and separated by a medial support
`
`extending parallel to said proximal and said distal sides and between said top and bottom
`
`surfaces;
`
`said implant further including at least one radiopaque marker situated between said top
`
`and bottom surfaces.
`
`1023
`
`1023
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 3 of 10
`
`2.
`
`(Previously Presented) The spinal fusion implant of Claim 1, wherein said implant is
`
`substantially radiolucent and composed of non—bone material.
`
`3.
`
`(Previously Presented) The spinal fusion implant of Claim 1, wherein said implant
`
`includes at least one visualization aperture extending through at least one of said first side wall
`
`and said second side wall.
`
`4.
`
`(Previously Presented) The spinal fusion implant of Claim 1, wherein the top and bottom
`
`surfaces of the implant are at least one of generally parallel with respect to each other, and
`
`generally angled with respect to each other to better match the natural curvature of the spine.
`
`5.
`
`(Previously Presented) The spinal fusion implant of Claim 1, wherein said first and
`
`second fusion apertures are one of generally rectangular and generally oblong in shape.
`
`6- 30. (Cancelled)
`
`31.
`
`(Previously Presented) The Spinal fusion implant of claim 1, further including at least
`
`one receiving element at least partially defined along said proximal side.
`
`32.
`
`(Previously Presented) The spinal fusion implant of claim 31, wherein said receiving
`
`element is engageable with an insertion instrument.
`
`33.
`
`(Previously Presented) The spinal fusion implant of claim 32, wherein said receiving
`
`element comprises a threaded aperture.
`
`34.
`
`(Previously Presented) The spinal fusion implant of claim 33, wherein said receiving
`
`implant further comprises a slot extending from said threaded aperture.
`
`1024
`
`1024
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 4 of 10
`
`35.
`
`(Currently Amended) A spinal fusion implant of non—bone construction postionable via a
`
`lateral trans—psoas surgical approach to the spine into a position within an interbody space
`
`between a first vertebra and a second vertebra, wherein said interbody space being at least
`
`partially defined by a posterior aspect, and anterior aspect, and opposing lateral aspects, said
`
`implant comprising:
`
`a top surface to contact said first vertebra when said implant is positioned within the
`
`interbody space, a bottom surface to contact said second vertebra when said implant is positioned
`
`within the interbody space, a distal side, a proximal side, a first side to face said anterior aspect
`
`of said disc space when said implant is positioned within the interbody space and a second side
`
`to face said posterior aspect of said disc space when said implant is positioned within the
`
`interbody space, wherein said implant is generally rectangular in shape having a length extending
`
`from said proximal side to said distal side of at least 40mm, a width extending from said first
`
`side to said second side of at least 15mm, and a height extending from said top surface to said
`
`bottom surface ranging from 8mm to 16mm, said implant further including a pair fusion
`
`apertures comprising one of a generally rectangular and generally oblong shape and extending
`
`between said top surface and bottom surface to permit bone growth between the first vertebra and
`
`the second vertebra, said pair of fusion apertures being separated by a medial support extending
`
`parallel to said proximal and said distal sides and between said top and bottom surfaces, said
`
`implant further including a at least one radiopaque marker situated between said top and bottom
`
`surfaces.
`
`36.
`
`(Previously Presented) The implant of claim 31, wherein said non—bone material is one of
`
`PEEK and PEKK.
`
`37.
`
`(Previously Presented) The implant of claim 31, wherein said implant includes at least
`
`one visualization aperture extending through at least one of said posterior side and said lateral
`
`side.
`
`1025
`
`1025
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 5 of 10
`
`38.
`
`(Previously Presented) The implant of claim 31, wherein a portion of said implant
`
`adjacent said distal side is tapered.
`
`39.
`
`(Previously Presented) The implant of claim 31, further including at least one anti-
`
`migration features comprising at least one of a set of ridges formed in the top surface, a set of
`
`ridges formed in the bottom surface, a set of ridges on the top and bottom surfaces, one or more
`
`spike elements protruding from the top surface, one or more spike elements protruding from the
`
`bottom surface, and one or more spike elements protruding from the top and bottom surface.
`
`40.
`
`(Previously Presented) The spinal fusion implant of claim 35, further including at least
`
`one receiving element at least partially defined along said proximal side.
`
`41.
`
`(Previously Presented) The spinal fusion implant of claim 40, wherein said receiving
`
`element is engageable with an insertion instrument.
`
`42.
`
`(Previously Presented) The spinal fusion implant of claim 41, wherein said receiving
`
`element comprises a threaded aperture.
`
`43.
`
`(Previously Presented) The spinal fusion implant of claim 42, wherein said receiving
`
`implant further comprises a slot extending from said threaded aperture.
`
`44.
`
`(New) The spinal fusion implant of claim 37, wherein said spinal fusion implant includes
`
`exactly four visualization apertures in communication with a first of said fusion apertures from
`
`said pair of fusion apertures and exactly four visualization apertures in communication with a
`
`second of said fusion apertures from said pair of fusion apertures.
`
`45.
`
`(New) The spinal fusion implant of claim 44, wherein two of said visualization apertures
`
`in communication with said first fusion aperture are situated in said first side, two of said fusion
`
`apertures in communication with said first fusion aperture are situated in said second side, two of
`
`said visualization apertures in communication with said second fusion aperture are situated in
`
`1026
`
`1026
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 6 of 10
`
`said first side, and two of said fusion apertures in communication with said second fusion
`
`aperture are situated in said second side.
`
`46.
`
`(New) The spinal fusion implant of claim 37, wherein said spinal fusion implant includes
`
`exactly six Visualization apertures in communication with a first of said fusion apertures from
`
`said pair of fusion apertures and exactly six Visualization apertures in communication with a
`
`second of said fusion apertures from said pair of fusion apertures.
`
`47.
`
`(New) The spinal fusion implant of claim 46, wherein three of said Visualization
`
`apertures in communication with said first fusion aperture are situated in said first side, three of
`
`said fusion apertures in communication with said first fusion aperture are situated in said second
`
`side, three of said Visualization apertures in communication with said second fusion aperture are
`
`situated in said first side, and three of said fusion apertures in communication with said second
`
`fusion aperture are situated in said second side.
`
`48.
`
`(New) The spinal fusion implant of claim 1, wherein said spinal fusion implant includes
`
`exactly four Visualization apertures in communication with said first fusion aperture and exactly
`
`four Visualization apertures in communication with said second fusion aperture.
`
`49.
`
`(New) The spinal fusion implant of claim 48, wherein two of said Visualization apertures
`
`in communication with said first fusion aperture are situated in said first side, two of said fusion
`
`apertures in communication with said first fusion aperture are situated in said second side, two of
`
`said Visualization apertures in communication with said second fusion aperture are situated in
`
`said first side, and two of said fusion apertures in communication with said second fusion
`
`aperture are situated in said second side.
`
`50.
`
`(New) The spinal fusion implant of claim 1, wherein said spinal fusion implant includes
`
`exactly six Visualization apertures in communication with said first fusion aperture and exactly
`
`six Visualization apertures in communication with said second fusion.
`
`1027
`
`1027
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 7 of 10
`
`51.
`
`(New) The spinal fusion implant of claim 50, wherein three of said Visualization
`
`apertures in communication with said first fusion aperture are situated in said first side, three of
`
`said fusion apertures in communication with said first fusion aperture are situated in said second
`
`side, three of said Visualization apertures in communication with said second fusion aperture are
`
`situated in said first side, and three of said fusion apertures in communication with said second
`
`fusion aperture are situated in said second side.
`
`1028
`
`1028
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Page 8 of 10
`
`REMARKS
`
`Claims 1 and 31 have been amended and new claims 44-51 have been added. The
`
`independent claims have been amended to expediently advance prosecution on the merits without
`
`prejudice to pursue the subject matter as originally presented, for example, in a continuation. No
`
`new subject matter has been added.
`
`Accordingly, claims 1-5 and 31-51are currently pending. Applicants respectfully submit
`
`that all pending claims are in condition for allowance and an indication to that effect is
`
`respectfully requested.
`
`Claim Rejections- 35 U.S.C. 103(a) Michelson, Frey, and Kuntz
`Claims 1-5 31-34 and 48-51
`
`Claim 1 and particular dependents were rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over US Patent 5,860,973 to Michelson (“Michelson”) in View of US Patent
`
`6,830,570 to Frey et al. (“Frey”) and US Patent 4,349,921 to Kuntz et al. (“Kuntz”). The
`
`Applicants respectfully submit that even if there was an articulated reason that would have
`
`prompted a skilled artisan to combine these references as proposed in the Office Action (an issue
`
`that is not conceded herein), the proposed combination of Michelson, Frey, and Kuntz would
`
`nevertheless fail to disclose all the elements of claim 1.
`
`Unlike claim 1, none of the Michelson, Frey, or Kuntz references discloses “first and
`
`second fusion apertures being adjacent to one another and separated by a medial support
`
`extending parallel to said proximal and said distal sides and between said top and bottom
`
`surfaces.” Indeed, the Office Action does not contend that Michelson or Kuntz provides such
`
`teaching. Instead the Office Action relies on the Frey reference for disclosure of “fusion
`
`apertures (1018a, 1018b, 1020a, 1020b) that are adjacent each other and separated by a medial
`
`support (1019, 1024).” (See Office Action at pp. 3.) Applicants respectfully submit that Frey
`
`fails to disclose the claimed structure. Instead, Frey includes “upper openings 1018a and 1018b
`
`separated by an upper strut 1019,” and “lower openings 1020a and 1020b separated by a lower
`
`strut 1021,” neither of which extend between the top and bottom surfaces as required by claim
`
`1. Furthermore, neither of the upper strut or lower strut are parallel to the proximal and distal
`
`1029
`
`1029
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`ends.
`
`Page 9 of 10
`
`Accordingly, the subject matter of claim 1 is patentable over Michelson, Frey, Kuntz and
`
`all other references cited in the record. Dependent claims 2-5, 31-34, and 48-51 are patentable
`
`for at least the same reasons as claim 1 and for the additional inventive combinations described
`
`therein.
`
`Claims 35-47
`
`Claim 35 and particular dependents were rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Michelson in View of Frey and Kuntz. The Applicants respectfully submit that
`
`even if there was an articulated reason that would have prompted a skilled artisan to combine
`
`these references as proposed in the Office Action (an issue that is not conceded herein), the
`
`proposed combination of Michelson, Frey, and Kuntz would nevertheless fail to disclose all the
`
`elements of claim 35.
`
`Unlike claim 1, none of the Michelson, Frey, or Kuntz references discloses “first and
`
`second fusion apertures being adjacent to one another and separated by a “pair of fusion apertures
`
`being separated by a medial support extending parallel to said proximal and said distal sides
`
`and between said top and bottom surfaces.” As noted above, the Office Action does not
`
`contend that Michelson or Kuntz provide such a teaching, relying instead upon on the Frey
`
`reference.
`
`(See Office Action at pp. 3.) Applicants respectfully submit that neither of the
`
`“upper strut” and “lower strut” which the Office Action points to for the teaching of a medial
`
`support extend between the top and bottom surfaces as required by claim 35. Furthermore,
`
`neither of the upper strut or lower strut are parallel to the proximal and distal ends as also
`
`required by claim 35.
`
`Accordingly, the subject matter of claim 35 is patentable over Michelson, Frey, Kuntz
`
`and all other references cited in the record. Dependent claims 36-47 are patentable for at least
`
`the same reasons as claim 1 and for the additional inventive combinations described therein.
`
`1030
`
`1030
`
`

`
`Attorney Docket No. 104US1
`Serial No. 11/093,409
`Filing Date: March 29, 2005
`Title: SYSTEMS FOR METHODS FOR SPINAL FUSION
`
`Conclusion
`
`Page 10 of 10
`
`It is believed that all of the pending claims have been addressed. However, the absence of
`
`a reply to a specific rejection, issue or comment does not signify agreement with or concession of
`
`that rejection, issue or comment. In addition, because the arguments made above may not be
`
`exhaustive, there may be reasons for patentability of any or all pending claims (or other claims)
`
`that have not been expressed. Finally, nothing in this paper should be construed as an intent to
`
`concede any issue with regard to any claim, except as specifically stated in this paper, and the
`
`amendment of any claim does not necessarily signify concession of unpatentability of the claim
`
`prior to its amendment. Applicants specifically reserve the right to pursue the subject matter of
`
`independent claims 1 and 35 (prior to amendment herein) in a continuing application.
`
`The foregoing amendments have been submitted to place the present application in
`
`condition for allowance. Prompt allowance of claims 1-5 and 31-51 is earnestly solicited.
`
`Applicants hereby authorizes a payment of the $555.00 fee for the 3 month Extension of Time
`
`
`
`Request to be charged to Deposit Account No.: 50-2040 for Customer No.: 30 328. The
`
`Applicants have previously paid fees for a total of 26 claims. With the addition of 8 new claims
`
`the number of claims now stands at 26. As such, no other fees are believed to be due at this time,
`
`however, in the event that there are any additional fees to be charged or payments to be credited,
`
`the Applicants hereby request that any charges or credits be made to Deposit Account No.: 5_0-
`
`E for Customer No.: fig. In the event that there are any questions concerning this
`
`Amendment or the application in general, the Examiner is cordially invited to telephone the
`
`undersigned attorney so that prosecution may be expedited.
`
`
`Date: March 1 2010
`
`NuVasive, Inc.
`7475 Lusk Boulevard
`
`San Diego, CA 92121
`Tel.: (858) 909-1845
`
`Respectfully submitted,
`
`/Rory Schermerhom/
`
`Rory Schermerhom, Esq.
`
`Registration No. 58,148
`
`1031
`
`1031
`
`

`
`Electronic Patent Application Fee Transmittal
`
`Filing Date:
`
`29-Mar-2005
`
`Title of Invention:
`
`Systems and methods for spinal fusion
`
`Utility under 35 USC111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`Basic Filing:
`
`Miscellaneous Filing
`
`Patent Appeals and Interference:
`
`Post-Allowance-and-Post Issuance
`
`Extension-of-Time:
`
`Extension - 3 months with $0 paid
`
`2253
`
`1
`
`555
`
`555
`
`1032
`
`

`
` S“:-S1-;(t$a)| in
`
`Total in USD (S)
`
`Miscellaneous:
`
`1033
`
`1033
`
`

`
`Electronic Acknowledgement Receipt
`
`m—
`
`Title of Invention:
`
`Systems and methods for spinal fusion
`
`I—
`
`Payment information:
`
`yes—
`Submitted with Payment
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees) Charge any Additional Fees required under 37 C.F.R. Sectio
`
`—Auth°“zedUser
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Patent application and reexamination processing fees)
`
`1034
`
`

`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`FHeLBfing:
`
`Document
`Number
`
`Document Description
`
`File SIze(Bytes)/
`Message Digest
`
`Pages
`Multl
`Part /.zip (if appl.)
`
`104US1RA_3-1-10_f.pdf
`
`8069fa6697d52b08de5a007c3f55e1e6fbf2
`5628
`
`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Fee Worksheet (PTO-875)
`
`fee-info.pdf
`
`0c3b64b140e2b512f3e8334afa3b8e7213e
`9dd4b
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/R0/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`1035
`
`1035
`
`

`
`
`
`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.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`1 1/093,409
`
`03/29/2005
`
`Matthew Curran
`
`104US1
`
`6640
`
`NuVasiVe —
`°5””“°
`759°
`C/0 CPA Global
`FIsHER, ELANA BETH
`
`PO BOX 52050
`Minneapolis, MN 55402
`
`ART UNIT
`‘3733
`
`PAPER NUMBER
`
`MAIL DATE
`
`05/18/2010
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`1
`
`6
`
`1036
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`11/093,409
`
`Examine,
`
`ELANA B. FISHER
`
`CURRAN ET AL.
`
`A,, Unit
`
`3733 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`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)IXI Responsive to communication(s) filed on 02 March 2010.
`
`2a)IXI This action is FINAL.
`
`2b)I:I This action is non-final.
`
`3)I:I 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)IXI C|aim(s) is/are pending in the application.
`
`4a) Of the above c|aim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I C|aim(s)
`
`is/are allowed.
`
`6)IXI C|aim(s) 1-5 and 31-51 is/are rejected.
`
`7)I:I C|aim(s) j is/are objected to.
`
`8)I:I C|aim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`Certified copies of the priority documents have been received.
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`Certified copies of the priority documents have been received in Application No.
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`Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) E Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
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`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N0(S)/M3” Data E
`5) I:I Noiioo of informal Paioiii Aloloiioaiioii
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
`1037
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`Part of Paper No./Mail Date 20100515
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`1037
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`Application/Control Number: 1 l/093,409
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`Page 2
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`Art Unit: 3733
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`DETAILED ACTION
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`Claim Rejections - 35 USC § 1 03
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`l.
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`The following is a quotation of 35 U.S.C. l03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section l02 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.
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`2.
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`Claims 1-5 and 3 1-51 are rejected under 35 U.S.C. l03(a) as being unpatentable over
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`Michelson (U.S. Patent 5,860,973) in view of Boriani et al. (U.S. Patent 6,l59,2l l) and Kuntz
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`(U.S. Patent 4,349,921).
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`Michelson discloses a spinal fusion implant (900) positionable from a lateral
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`approach to extend from one lateral aspect to the other that is generally rectangular in
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`shape and comprising parallel top and bottom surfaces (902, 904) comprising a plurality
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`of ridges (FIG l6), a tapered distal side, a proximal side, and first and second sidewalls
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`(see diagram provided), such that a length extends between the distal and proximal sides,
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`a width extends between the first and second sidewalls, and a height extends between the
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`top and bottom surfaces (902, 904). The length is at least 40mm, the width is at least
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`l5mm and the height is in the range of 8mm to 16mm (Column l0, lines 42-47).
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`Additionally, the implant includes at least one visualization aperture extending through at
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`least one of the first and second sidewalls (FIG 16).
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`However, Michelson fails to disclose that the spinal fusion implant (900) includes
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`first and second fusion apertures extending between the top and bottom surfaces. Boriani
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`et al. disclose a spinal fusion implant (l2) comprising top and bottom surfaces (l4, l6)
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`1038
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`1038
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`Application/Control Number: 11/093,409
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`Page 3
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`Art Unit: 3733
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`including first and second fusion apertures (20) that are adjacent to one another and
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`separated by a medial support (28) extending parallel to proximal and distal sides (18)
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`and between the top and bottom surfaces (FIG 1). The apertures are generally rectangular
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`and oblong in shape. It therefore would have been obvious to one skilled in the art to
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`modify the spinal fusion implant taught by Michelson by adding fusion apertures that
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`extend between the top and bottom surfaces, as is taught by Boriani et al., because the
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`apertures and the medial support promote fusion of upper and lower vertebrae to one
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`another via the addition of packed bone graft material (Boriani et al.; Column 4, line 10-
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`1 3).
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`Michelson additionally discloses that the implant (900) includes exactly four or
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`six visualization apertures (906) in communication with a first of said fusion apertures
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`from said pair of fusion apertures and exactly four or visualization apertures (906) in
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`communication with a second of said fusion apertures from said pair of fusion apertures.
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`Two or three of said visualization apertures (906) in communication with said first fusion
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`aperture are situated in said first side, two or three of said visualization apertures (906) in
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`communication with said first fusion aperture are situated in said second side, two or
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`three of said visualization apertures (906) in communication with said second fusion
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`aperture are situated in said first side, and two or three of said visualization apertures
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`(906) in communication with said second fusion aperture are situated in said second side
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`(FIG 16; Column 10)
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`Michelson further fails to disclose that the implant (900) comprises a least one
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`receiving element. Boriani et al. disclose a spinal fusion implant (12) that additionally
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`Application/Control Number: 11/093,409
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`Page 4
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`Art Unit: 3733
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`comprising a least one receiving element (22) comprising a threaded aperture engagable
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`with an insertion instrument and a slot extending from the threaded aperture (FIG 7). It
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`therefore would have been obvious to one skilled in the art to modify the implant taught
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`by Michelson by having at least one receiving element along its proximal side, as is
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`taught by Boriani et al., because it allows for an insertion instrument to securely attach to
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`the implant for controlled insertion into the disc space.
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`Additionally, Michelson fails to disclose the specific material of the implant.
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`Boriani et al. disclose a spinal implant (12) that is made of a radiolucent material
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`(Column 2). Additionally, Kuntz discloses a spinal implant (10) made of a radiolucent
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`material, such as high density polyethylene that additionally comprises a radiopaque
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`marker (Column 7, lines 52-60). It therefore would have been obvious to one skilled in
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`the art to modify the implant taught by Michelson such that it is made up of a radiolucent
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`material and also comprises a radiopaque marker between the top and bottom surfaces, as
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`is taught by Boriani et al. and Kuntz, because the radiolucent material has "high strength
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`and durability" and the radiopaque marker allows for “the position of the posthesis be
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`confirmed radiologically" (Kuntz; Column 7, lines 52-60).
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`Michelson in view of Boriani et al. and Kuntz further fail to disclose that the
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`length of the implant is at least two and a half times greater that the width of the implant.
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`It would have been obvious to one having ordinary skill in the art at the time the
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`invention was made to have the length be at least two and a half times greater than the
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`width, since it has been held that discovering an optimum value of a result effective
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`Application/Control Number: 11/093,409
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`Page 5
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`Art Unit: 3733
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`variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215
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`(CCPA 1980).
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`Finally, Michelson in view of Kuntz et al. and Kuntz fail to disclose that the
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`implant is made of one of PEEK and PEKK. It would have been obvious to one having
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`ordinary skill in the art at the time the invention was made to have the material of the
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`implant be one of PEEK and PEKK, since it has been held to be within the general skill
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`of a worker in the art to select a known material on the basis of its suitability for the
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`intended use as a matter of obvious design choice. In re Les/tin, 125 USPQ 416.
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`First and Second
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`Response to Arguments
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`3.
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`Applicant's arguments with respect to claims 1-5 and 31-43 have been considered but are
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`moot in view of the new ground(s) of rejection.
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`Conclusion
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`4.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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`Application/Control Number: 11/093,409
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`Page 6
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`Art Unit: 3733
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`A shortened statutory period for reply to this final action is set to expire THREE
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