UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`SMITH & NEPHEW, INC.,
`Petitioner
`
`v.
`
`The University of North Carolina
`Patent Owner
`
`__________________
`
`In Re:
`U.S. Patent No. 6,955,677 to Dahners
`Appl. No. 10/271,635 filed October 15, 2002
`Issued October 18, 2005
`
`IPR Trial No. 2014-00112
`
`Before Grace Karaffa Obermann, Administrative Patent Judge
`and Lawrence J. Banks, Trial Paralegal.
`
`PATENT OWNER'S RESPONSE TO
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,955,677
`
`Page -1-
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`COUNSEL AND SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`
`CERTIFICATION OF GROUNDS FOR STANDING . . . . . . . . . . . . . . . . . . . . . . . . 3
`
`III. OVERVIEW OF THE CHALLENGE AND RELIEF REQUESTED . . . . . . . . . . . . 3
`A. Prior Art . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`B. Grounds for Challenge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`IV. OVERVIEW OF THE ‘677 PATENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`V.
`
`THE REFERENCES FAIL TO TEACH THE CLAIMED INVENTION OF THE
`'677 PATENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
`
`1.
`2.
`
`"A Tappable Contact Region” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
`“Non-threaded” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`
`VI.
`
`THE CHALLENGED CLAIMS ARE PATENTABLE . . . . . . . . . . . . . . . . . . . . . . . . 8
`
`A. The Challenged Claims Are patentable Over the Wolter and Frigg References . 8
`
`1. The Claims Are Not Anticipated By Wolter '117 . . . . . . . . . . . . . . . . . . . . . 8
`
`The Claims are Not Obvious Over Wolter 117 In View of
`a.
`Knowledge of One of Ordinary Skill at the Time of the Invention . . 10
`
`Wolter '889 does not Provide any of the Teachings Missing
`b.
`from Wolter '117 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
`
`Frigg '881 does not Provide any of the Teachings Missing from
`c.
`Wolter '117 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`
`Combining Wolter '117 and Wolter '011 or Wolter '889 with
`d.
`the Knowledge Of One Of Ordinary Skill Does not render any claim
`anticipated nor obvious
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`
`VI.
`
`CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`
`EXHIBIT LIST
`
`Validity Charts A through F submitted in Anglefix Tech, Inc. v. Smith
`& Nephew, Inc., Case No. 2:13-cv-02281
`
`Page -2-
`
`

`

`I.
`
`Counsel And Service Information
`
`Lead Counsel
`
`Joseph J. Zito
`Registration No. 32,076
`jzito@dnlzito.com
`
`Back-up Counsel
`
`Benjamin C. Deming
`Registration No.
`
`DNL ZITO
`1250 Connecticut Avenue, NW
`Suite 200
`Washington, DC 20036
`(202) 466-3500
`
`
`II. CERTIFICATION OF GROUNDS FOR STANDING
`
`The Patent Owner does not challenge the standing of Petitioner Smith & Nephew.
`
`III. OVERVIEW OF THE CHALLENGE AND RELIEF REQUESTED
`
`Petitioner Smith & Nephew has requested inter partes review of Claims 1-9, 11-12, 18,
`
`21-28, 30-31, 33-34, 39-44, 47-48, 54-60, 62-63, 65-66, and 71-74 of U.S. Patent No. 6,955,677.
`
`This request should be denied because there is no reasonable likelihood that Petitioner will
`
`prevail in establishing non patentability of any of the challenged claims.
`
`A. Prior Art
`
`Petitioner relied upon the following patents and published patent applications:
`
`1. DE 43 43 117 A1 to Wolter (“Wolter '117 ”)
`2. DE 196 29 011 A1 to Wolter (“Wolter '011”);
`3. DE 198 58 889 to Wolter (“Wolter '889”);
`4. CA 2 626 694 to Wagner et al. (“Wagner;”).
`5. U.S. Patent No. 6,206,881 to Frigg (“Frigg '881;”).
`
`Page -3-
`
`

`

`The Petitioner states on page 3 of the request that: "None of these patents or publications
`
`was before the Examiner during the prosecution of the ‘677 patent." This statement is however
`
`incorrect. Reference #5 Frigg '881 was in fact considered by the examiner and is cited on the
`
`face of the '677 patent.
`
`None of these references, alone or in combination, renders any of the challenged claims
`
`anticipated nor obvious.
`
`B. Grounds for Challenge
`
`Smith & Nephew has requested cancellation of Claims 1-9, 11-12, 18, 21-28, 30-31, 33-
`
`34, 39-44, 47-48, 54-60, 62-63, 65-66, and 71-74 as unpatentable under 35 U.S.C. §§ 102 and
`
`103. Attached to this petition are a series of charts illustrating the Petitioner's arguments and the
`
`teachings missing from the references cited by Petitioner.
`
`IV. OVERVIEW OF THE ‘677 PATENT
`
`Patent Owner notes that Requester references a presentation given by counsel in The
`
`United States District Court for the Western District of Tennessee, on September 27, 2013.
`
`Patent Owner objects to the use and reference to this presentation as improper hearsay and
`
`attorney argument. Presentation of counsel in a status conference in a District Court is not
`
`admissible evidence which can be submitted in a Inter Partes Review.
`
`The ‘677 patent discloses an orthopedic bone plate that can be used to repair bone
`
`fractures. Bone plates are typically made of metal and have holes for fastening the plate to the
`
`bone by fasteners, typically screws. The ‘677 patent teaches a unique structuring of the interior
`
`of a bone plate hole to provide for angular fixation of bone screw.
`
`Page -4-
`
`

`

`As discussed in the '677 patent, some bone plates contain holes with smooth inside
`
`surfaces. These holes are generally used with bone screws which have a thread on the screw
`
`shaft but not on the screw head. Surgeons would place the standard screws in the holes of the
`
`bone plate and screw the threaded shafts of the screws into the bone. A surgeon could insert the
`
`bone screw at various angles, as necessary, to optimize reaching bone fragments.
`
`However, use of standard screws had a known drawback: the screw is not rigidly
`
`fixed or “locked” to the plate, and, as such, a screw can toggle, shift, or otherwise move relative
`
`to the plate during post-operative patient movement. For this reason, standard screws are often
`
`referred to as “non-locking” screws. To overcome this drawback, screws with a threaded head
`
`which match a thread formed in the hole in the plate were developed to lock the screw to the
`
`plate. These designs are referred to as locking screw systems.
`
`Upon installation of the bone plate, the thread on the head of the locking screw mates
`
`with the corresponding thread on the inside surface of the plate hole. That mating “locks” or
`
`rigidly fixes the relationship between the screw and the plate at a pre-determined set angle to the
`
`plate, resulting in a higher resistance to toggling forces.
`
`Because the thread formed on the inside surface of the plate hole is structurally fixed at a
`
`constant axis angle, the locking screw could only be inserted into the hole at that angle for the
`
`screw head thread to mate with the plate hole thread. Thus, with that design, the surgeon always
`
`had to insert and thread the bone screw at the one, pre-determined angle of the plate hole axis.
`
`To overcome that drawback, Dr Dahners developed the technology embodied in the '677
`
`patent, which allows a surgeon to choose a desired angle of insertion between the bone plate an
`
`the screw and to lock the screw to the bone plate at that chosen angle. The '677 patent teaches
`
`Page -5-
`
`

`

`the provision of protrusions on the inner surface of a hole in a bone plate. The protrusions are
`
`can deflect or deform around the head of the screw to "lock" the screw at a desired angle. see for
`
`example '677 patent Col. 9: line 54 - 63:
`
`In the use of contact region 85, second thread 51 of head section
`40 is driven through a series of available interstices 89 (see, e.g.,
`FIGS. 2C and 2D) and between a series of protrusions 87 adjacent
`to these interstices 89. The driving of second thread 51 causes this
`series of protrusions 87 to contact second thread 51 and maintain
`fastener 10 at the desired insertion angle lA As described
`hereinabove, protrusions 87 contacting second thread 51 may or
`may not deform or otherwise move in response to the driving of
`second thread 51 into contact region 85.
`
`It is the unique provision of the protrusions that allows the screw of the Dahners' '677
`
`patent to be locked to the hole at an selectable angle.
`
`V.
`
`The References Fail to Teach the Claimed Invention of the '677 Patent
`
`The '677 patent teaches:
`"A Tappable Contact Region”
`1.
`
`The claim term, “tappable contact region,” does not have a plain and ordinary meaning as
`"tappable contact region" is not a common ordinary phrase. The '677 patent specifically teaches
`what is meant by a tappable contact region, throughout the specification. The tappable contact
`region is not a typical solid material into which threads are cu as is the common meaning of
`"tapping a thread." The tappable contact region, as taught and claimed in the specification is a
`treatment of the inner surface of the hole which provides for a region which can be deformed or
`deflected by the entry of the head of a screw to fr a temporary east for the screw head at a desired
`angle.
`
`For example:
`
`'677 patent Col. 7: line 3-7:
`
`The term “tappable” is used herein to denote that contact region 85
`is structured such that it can be tapped by second thread 51 of head
`section 40 of fastener 10 in response to forceful insertion and
`rotation of head section 40 into the material of contact region 85.
`As described below in connection with FIG. 3, this enables the
`
`Page -6-
`
`

`

`user to manipulate second thread 51 of head section 40 to form, in
`effect, a custom internal thread in contact region 85 sufficient to
`maintain fastener 10 at an arbitrary orientation in relation to
`receiving member 60 selected by the user. Id. (7:3-7).
`
`Col 7: line 38 - 42:
`It will be noted that the density of protrusions 87 over the area of
`inside surface 81, and the size of individual protrusions 87, are not
`limited by the invention, so long as the matrix formed on inside
`surface 81 renders contact region 85 tappable.
`
`Col 7; line 65 to Col 8: line 3
`In addition, depending on the density and size of protrusions 87
`and the pattern defined by the matrix, protrusions 87 may or may
`not be deformable as necessary to realize the tappable property of
`contact region 85.
`
`Col 10 : Lines 3 - 6:
`With the use of either contact region 85 or contact region 105, the
`driving of second thread 51 through aperture A in effect forms a
`custom internal thread in contact region 85 or 105 that is
`complimentary to the orientation and structure of . . .
`
`Col. 9: line 54 - 63:
`
`In the use of contact region 85, second thread 51 of head section
`40 is driven through a series of available interstices 89 (see, e.g.,
`FIGS. 2C and 2D) and between a series of protrusions 87 adjacent
`to these interstices 89. The driving of second thread 51 causes this
`series of protrusions 87 to contact second thread 51 and maintain
`fastener 10 at the desired insertion angle lA As described
`hereinabove, protrusions 87 contacting second thread 51 may or
`may not deform or otherwise move in response to the driving of
`second thread 51 into contact region 85.
`
`There is nothing permanent nor "tapped" about the tappable contact region. The '677
`
`patent teaches that the material "may or may not deform or otherwise move." When the term
`
`tapping is used in its ordinary meaning, the material is permanently cut away to form a thread.
`
`permanent removal is quite different from "may or may not deform or otherwise move." The
`
`custom internal thread need only be sufficient "to maintain the fastener at an arbitrary
`
`Page -7-
`
`

`

`orientation." The is no permanent thread formed as is unquestionably clear from the
`
`specification of the '677 patent. The lack of true "tapping" is one of the elements that
`
`distinguishes the '677 patent from the prior art which is inherently limited by the dependence on
`
`traditional tapping.
`
`2. “Non-threaded”
`
`Some of the claims require that the tappable contact region be “non-threaded.” Non-
`
`threaded means not having a thread or a partial thread that functions as a thread.
`
`V. THE CHALLENGED CLAIMS ARE PATENTABLE
`
`Patent owner relies upon the following summary and the attached detailed charts in
`
`demonstrating the lack of a likelihood of success of Petitioner's arguments of invalidity. The
`
`attached charts were presented in District Court in support of validity.
`
`A. The Challenged Claims Are patentable Over the Wolter and Frigg References
`
`1. The Claims Are Not Anticipated By Wolter '117
`
`Wolter '117 is pre-threaded and thus not "non-threaded" and is not "tappable." Counter-
`
`threading or cross-threading, as taught in Walters '117, is the engagement of corresponding
`
`threads in a non-corresponding way. This is distinct from the claimed "non-threaded tappable"
`
`contact region.
`
`Wolter describes two matching threads with mutual alignment see Wolter 117 abstract:
`
`"The invention relates to a fixation system for bones comprising a bone plate having at
`least one through hole, at least one bone screw inserted into a through hole, seat surfaces
`of the bone plate and the bone screw that allow for mutual alignment at various angles,
`and means for fixing the bone screw at a specific angle relative to the plate. The object is
`to create a system having an angularly fixed screw orientation, less complexity and a
`
`Page -8-
`
`

`

`smaller volume. To this end, the means for fixation comprise a threaded connection of
`the seat surfaces of the bone plate and the bone screw formed on at least one seat surface
`by a preformed thread by screwing in the bone screw at the specific angle."
`
`Wolter does not teach a "non-treaded tappable contact region." Wolter teaches matching threads
`
`that can be cross-treaded to resist unscrewing.
`
`Cross-threading has inherent problems, including resistance to the progress of a screw
`
`(binding) which can result in incomplete screw engagement and/or the protrusion of screw heads
`
`above the plate surface. Cross-threading also limits the degree and selection of screw angles and
`
`will resist certain angles tending to realign in to certain physically preferred cross-threaded
`
`angles.
`
`Wolter does not have a "tappable contact region." Wolter teaches cylindrical threads:
`
`“To this end, the bone screw can have a spherical seat surface on a screw head, and the
`bone plate can have a cylindrical, conical or spherical seat surface in a through hole.”
`(Wolter 117 at 2:42-3:1).
`
`“The internal threads 10 are formed on seat surfaces 11, which are cylindrical according
`to partial representation a . . . .” (Wolter 117 at 7:3-6).
`
`“17. The system according to one of the claims 1 to 16, characterized in that the seat
`surface(11) of the bone plate (8) is cylindrical, conical, or spherical.” (Wolter 117 at
`11:1-4).
`
`See also Wolter 117 at Fig. 1(a).
`
`
`Cylindrical threads are not a "non-threaded tappable contact region." There is no teaching of a
`
`non-threaded hole in Wolter and no cylindrical "non-threaded tappable" hole illustrated in
`
`Wolter. The specific description in Wolter 117, that: " Every thread has four thread segments
`
`17, the profiles of which converge toward each of the two ends 18, 19." is directly contrary to the
`
`"non-threaded tappable" contact region of the claims.
`
`Thread segments which align for cross-threading are not the claimed protrusions and
`
`Page -9-
`
`

`

`spaces which form a "non-threaded tappable contact region." Although the thread segments are
`
`separated by spaces and protrude inward, they do not form a non-threaded tappable contact
`
`region. As set forth in Wolter 117, they form "seat surfaces of the bone plate and the bone screw
`
`that allow for mutual alignment at various angles, . . . comprise a threaded connection of the seat
`
`surfaces of the bone plate and the bone screw formed on at least one seat surface by a preformed
`
`thread by screwing in the bone screw at the specific angle." Thus having the same inherent
`
`disadvantages of thread binding etc. described above.
`
`The Claims are Not Obvious Over Wolter 117 In View of Knowledge of One
`a.
`of Ordinary Skill at the Time of the Invention.
`
`Patent Owner disputes the unsupported statements that limitations are inherent and "it
`
`would have been obvious to modify" and "it would have been obvious to combine." There is no
`
`identification of what is inherent, why it is inherent and no identification of what the obvious
`
`modification or combination would be or why it would be obvious. There is no identification of
`
`the other prior art that would be used to modify or combine. Petitioner has not met its burden of
`
`even beginning to allege an obviousness argument and thus there is nothing to rebut. In addition,
`
`there is no prior art which discloses a non-threaded tappable contact region.
`
`b.
`
`Wolter '889 does not Provide any of the Teachings Missing from Wolter '117
`
`Wolter 889 does not teach any cylindrical holes or vertical profiles. The holes of Wolter
`
`889 are ovals, not circles or cylinders and all have lopsided vertical surfaces.
`
`However, Wolter 889 ('562) teaches slots, not holes and is thus completely inapplicable
`
`to the '677 patent.
`
`Page -10-
`
`

`

`Wolter 889 ('562) does not disclose ". . . defining an aperture generally coaxially
`
`disposed about an aperture axis." The slot of Wolter 889 ('562) does not have an axis, the slot
`
`accommodates movement of a screws along the length of the slot R for compression. There are
`
`no angular positions illustrated, taught or enabled in Wolter 889 ('562).
`
`Wolter 889 ('562) provides no disclosure of any insertion angles and provides no
`
`illustrations nor enablement for angles. The citation to non-illustrated objects of the invention is
`
`non-enabling. The Wolter 889 ('562) slot has no non-threaded tappable contact region. A screw
`
`at most contacts one part of the non-circular ledge. Wolter 889 ('562) makes no mention of any
`
`insertion angles. The citation to non-illustrated objects of the invention is non-enabling.
`
`Petitioner's chart does not even address the ". . . at a variable insertion angle defined
`
`between the longitudinal axis of the bone screw and the aperture axis," portion of this claim
`
`element and thus admits it is missing from Wolter 889 ('562).
`
`Variable angles and variable angle fixation are not illustrated nor enabled and not
`
`inherent from the disclosure. Bone surgery requirements are very specific and generalized
`
`statements about intended features are insufficient to enable one skilled in the art to implement.
`
`This description is non-enabled in Wolter 889 ('562), does not constitute "tapping" and does not
`
`Page -11-
`
`

`

`accomplish "rigid angle fixation" as recited in the claim. Variable angles and variable angle
`
`fixation are not illustrated nor enabled and not inherent from the disclosure. Bone surgery
`
`requirements are very specific and generalized statements about intended features are
`
`insufficient to enable one skilled in the art to implement.
`
`c.
`
`Frigg '881 does not Provide any of the Teachings Missing from Wolter '117
`
`Frigg fails to teach tapping or angled fixation. Frigg teaches a single angle fixed
`
`threaded hole and was cited during prosecution. Frigg fails to render any claims unpatentable
`
`for the reasons recited in the original prosecution.
`
`Combining Wolter '117 and Wolter '011 or Wolter '889 with the Knowledge
`d.
`Of One Of Ordinary Skill Does not render any claim anticipated nor obvious.
`
`Making a tappable region out of a soft solid material, Wolter 011, does not disclose the
`
`claimed invention of the '677 patent as it has many disadvantages over the non-threaded tappable
`
`contact region of the '677 patent. While a soft material may allow a screw to form threads
`
`therein, (however, in Wolter 011 the threads are already formed before screw insertion so the
`
`disclosure is inconsistent and thus non-enabling as prior art) there will be little to no resistance
`
`for the screw to back out. The irregular protrusions and / or wire mesh of the '677 patent deforms
`
`in an irregular manner as opposed to being cut in the manner of a soft material and resists
`
`reversal of the screw.
`
`The "cutting of threads" is not the claimed invention. The soft material disclosed by
`
`Wolter 011 does not "rigidly fix the bone screw." In addition, Wolter '011 does not teach angled
`
`insertion of the screw. There is no explanation nor illustration in Wolter '011of what is meant
`
`by: "Due to the design of the through hole 15 and the screw head 21, different angular
`
`Page -12-
`
`

`

`alignments of the bone screw 14 to the bone plate 13 are possible.” From the Figures in Wolter
`
`'011, it is clear that a plurality of different insertion angles would not be possible.
`
`Wolter 011 does not have a "tappable contact region" see above and no cylindrical hole.
`
`Wolter 011 emphasizes that the holes are tapered. There is no reason to combine a reference
`
`which emphasizes the use of a conical hole (011) with a reference which suggests that a
`
`cylindrical hole could be used (117). The use of a cylindrical hole teaches away and would
`
`destroy the intent of Wolter 011.
`
`There is no basis for the assertion that it would have been obvious to combine Wolter 011
`
`with any other reference. Wolter has no protrusions nor interstices and there is no reason to add
`
`these to Wolter. Such a modification would destroy the teachings of Wolter 011. For example,
`
`Wolter 011 teaches making the insert out of soft material, soft protrusions, as taught and claimed
`
`would deform too easily and fail to perform. Wolter teaches forming threads in a soft solid
`
`insert, threads would not be formed properly in soft protrusions.
`
`VI. CONCLUSION
`
`Patent Owner submits that Requester has failed to establish a reasonable likelihood of
`
`success in establishing that any of the challenged claims is unpatentable. Patent Owner
`
`therefore requests that the Board deny inter partes review.
`
`Respectfully Submitted:
`on behalf of Patent Owner,
`The University of North Carolina
`
`By: /s/ Benjamin C. Deming
`
`Page -13-
`
`

`

`Joseph J. Zito, Reg. No. 32,076
`Benjamin C. Deming Reg. No. 65,307
`DNL ZITO
`1250 Connecticut Avenue, NW
`Suite 200
`Washington, DC 20036
`(202) 466-3500
`jzito@dnlzito.com
`bdeming@dnlzito.com
`
`Page -14-
`
`

`

`CERTIFICATE OF SERVICE
`I hereby certify that a true and correct copy of PATENT OWNERS RESPONSE TO
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,955,677 was served
`on February 7, 2014, via e-mail and FedEx next business day delivery service to the
`correspondence address of record for the Petitioner:
`
`Christy G. Lea
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`Registration. No. 51,754
`christy.lea@knobbe.com
`Customer No. 20,995
`Attorney for Petitioner
`Smith & Nephew, Inc.
`
` /s/ Joseph J. Zito
`
`Page -15-
`
`

`

`CASE IPR2014-00112
`Patent 6,955,677
`
`Appendix of Exhibits
`
`
`
`A. Validity Chart A: Wolter 117
`
`B. Validity Chart B: Wolter 011
`
`C. Validity Chart C: Wolter 889
`
`D. Validity Chart D: Wolter 562
`
`E. Validity Chart E: Wolter PCT and Wolter 461
`
`F. Validity Chart F: Wolter 461
`
`Patent Owner’s Response to Petition for IPR
`
`

`

`
`
`
`
`
`
`
`
`
`
`Exhibit A
`
`Exhibit A
`
`
`
`
`
`

`

`Claim Claim Language
`1
`A surgical plate
`adapted for fixation
`with a bone screw,
`comprising first and
`second opposing major
`surfaces, an inside
`surface extending
`between the first and
`second major surfaces
`and defining an
`aperture generally
`coaxially disposed
`about an aperture axis,
`
`Plaintiff’s Validity Contentions re: U.S. Patent No. 6,955,677
`Exhibit A: Wolter 117 - Page 1
`
`Defendant’s Invalidity Contentions
`“The invention relates to a fixation system for
`bones comprising a bone plate and at least one
`bone screw.” (Wolter 117 at 1:2-4).
`
`Plaintiff’s Validity Contentions
`Plaintiff does not dispute that bone plates with
`holes for accommodating bone screws existed in
`the prior art.
`
`“Various bone plates 8, which are represented in
`parts a-c of Fig. 1, can be assigned to this bone
`screw 1. A common feature of the bone plates 8
`is that these have a through hole 9 for the
`passage of the shank 2 and for receiving the
`head 3 of the screw 1.” (Wolter 117 at 6:41-
`7:2).
`
`Fig. 1(a) shows first and second opposing major
`surfaces and an inside surface extending there
`between defining an aperture.
`
`See also Wolter 117 at Figs. 1(b)-(c).
`
`To the extent Plaintiff alleges Wolter 117 does
`not disclose
`this claim element, (1)
`this
`limitation is inherent, (2) it would have been
`obvious to modify Wolter 117 in light of the
`knowledge of a person of ordinary skill in the
`art at the time of the invention, and/or (3) it
`would have been obvious to combine Wolter
`117 with other art identified in the Invalidity
`Contentions at the time of the invention. For
`example, Smith & Nephew contends that it
`
`Plaintiff disputes the unsupported statements
`that "this limitation is inherent" and "it would
`have been obvious to modify" and "it would
`have been obvious to combine." There is no
`identification of what is inherent, why it is
`inherent and no identification of what the
`obvious modification or combination would be
`or why it would be obvious. There is no
`identification of the other prior art that would be
`used to modify or combine. Defendant has not
`
`

`

`Plaintiff’s Validity Contentions re: U.S. Patent No. 6,955,677
`Exhibit A: Wolter 117 - Page 2
`
`Claim Claim Language
`
`1
`
`and a non-rotatable,
`non-threaded tappable
`contact region
`disposed on the inside
`surface of the aperture,
`the tappable contact
`region having an
`inside diameter large
`enough to permit a
`bone screw to pass
`therethrough at a
`variable insertion
`angle defined between
`the longitudinal axis of
`the bone screw and the
`aperture axis,
`
`Defendant’s Invalidity Contentions
`would have been obvious
`to one having
`ordinary skill in the art to combine Wolter 117
`with other Wolter references taken alone or as
`modified by other prior art references because
`they share common authorship and describe
`similar apparatuses and methodologies.
`“In a preferred embodiment, the preformed
`thread comprises spaced-apart thread segments,
`the separating regions of which benefit the
`penetration of a counter-thread at various screw-
`in angles.” (Wolter 117 at 3:33-37).
`
`“The bone plate 8 according to Fig. 7 has, in the
`through hole 9, an internal thread 10 comprising
`spaced-apart thread segments 17. Every thread
`has four thread segments 17, the profiles of
`which converge toward each of the two ends 18,
`19.” (Wolter 117 at 8:16-21).
`
`Fig. 7 of Wolter 117:
`
`See also Wolter 117 at 4:16-24; 5:3-6; 6:22-27;
`8:22-28; Fig. 8.
`
`To the extent Plaintiff alleges Wolter 117 does
`not disclose
`this claim element, (1)
`this
`limitation is inherent, (2) it would have been
`
`Plaintiff’s Validity Contentions
`met its burden of even beginning to allege an
`obviousness argument and thus there is nothing
`to rebut. In addition, there is no prior art which
`discloses a non-threaded
`tappable contact
`region.1
`
`Wolters is pre-threaded and thus not "non-
`threaded" and is not "tappable."
`
`the
`is
`Counter-threading or cross-threading
`engagement of corresponding threads in a non-
`corresponding way. This is distinct from the
`claimed "non-threaded tappable" contact region.
`
` Wolters describes two matching threads with
`mutual alignment see Wolters 117 abstract: "The
`invention relates to a fixation system for bones
`comprising a bone plate having at least one through
`hole, at least one bone screw inserted into a through
`hole, seat surfaces of the bone plate and the bone
`screw that allow for mutual alignment at various
`angles, and means for fixing the bone screw at a
`specific angle relative to the plate. The object is to
`create a system having an angularly fixed screw
`orientation, less complexity and a smaller volume.
`To this end, the means for fixation comprise a
`threaded connection of the seat surfaces of the bone
`plate and the bone screw formed on at least one seat
`surface by a preformed thread by screwing in the
`bone screw at the specific angle."
`
`Plaintiff disputes the unsupported statements
`
`

`

`Claim Claim Language
`
`1
`
`and the tappable
`contact region is
`formed so as to allow
`for being tapped by an
`external thread of the
`bone screw to rigidly
`affix the bone screw to
`the tappable contact
`region at a selected
`one of a plurality of
`different insertion
`angles that can be
`selectively formed
`between the axis of the
`bone screw and the
`aperture axis.
`
`Plaintiff’s Validity Contentions re: U.S. Patent No. 6,955,677
`Exhibit A: Wolter 117 - Page 3
`
`Defendant’s Invalidity Contentions
`obvious to modify Wolter 117 in light of the
`knowledge of a person of ordinary skill in the
`art at the time of the invention, and/or (3) it
`would have been obvious to combine Wolter
`117 with other art identified in the Invalidity
`Contentions at the time of the invention. For
`example, Smith & Nephew contends that it
`would have been obvious
`to one having
`ordinary skill in the art to combine Wolter 117
`with other Wolter references taken alone or as
`modified by other prior art references because
`they share common authorship and describe
`similar apparatuses and methodologies.
`
`“When the bone screw is screwed into the bone
`at a certain angle, the at least one thread forms a
`threaded connection of the seat surfaces, which
`secures the screw on the plate at the screw-in
`angle thereof. The threaded connection can be
`established through the deformation of the
`material, and can be secured by means of a non-
`positive connection (frictional contact) and/or a
`bonded connection (friction weld).” (Wolter 117
`at 3:7-16).
`
`“The bone screw 1 can be screwed into one of
`the bone plates 8 with various angular
`orientations. If the screw axis is slanted relative
`to the hole axis, material deformation takes
`place in the region of the thread 6, 10, which
`results in a friction connection or friction-weld
`connection between the screw 1 and the plate 8.
`
`Plaintiff’s Validity Contentions
`that "this limitation is inherent" and "it would
`have been obvious to modify" and "it would
`have been obvious to combine." There is no
`identification of what is inherent, why it is
`inherent and no identification of what the
`obvious modification or combination would be
`or why it would be obvious. There is no
`identification of the other prior art that would be
`used to modify or combine. Defendant has not
`met its burden of even beginning to allege an
`obviousness argument and thus there is nothing
`to rebut. In addition, there is no prior art which
`discloses a non-threaded
`tappable contact
`region.
`
`Wolters does not teach a "non-treaded tappable
`contact region." Wolters
`teaches matching
`threads that can be cross-treaded to resist
`unscrewing.
`
`inherent problems,
`Cross-threading has
`including resistance to the progress of a screw
`(binding) which can result in incomplete screw
`engagement and/or the protrusion of screw
`heads above the plate surface. Cross-threading
`also limits the degree and selection of screw
`angles and will resist certain angles tending to
`realign in to certain physically preferred cross-
`threaded angles.
`
`

`

`Plaintiff’s Validity Contentions re: U.S. Patent No. 6,955,677
`Exhibit A: Wolter 117 - Page 4
`
`Claim Claim Language
`
`Defendant’s Invalidity Contentions
`At the same time, the plate 8 bears against the
`bones to be treated.” (Wolter 117 at 7:9-18).
`
`Plaintiff’s Validity Contentions
`
`See also Wolter 117 at 3:33-43; 5:3-6; 5:27-38;
`Figs. 7-8.
`
`To the extent Plaintiff alleges Wolter 117 does
`not disclose
`this claim element, (1)
`this
`limitation is inherent, (2) it would have been
`obvious to modify Wolter 117 in light of the
`knowledge of a person of ordinary skill in the
`art at the time of the invention, and/or (3) it
`would have been obvious to combine Wolter
`117 with other art identified in the Invalidity
`Contentions at the time of the invention. For
`example, Smith & Nephew contends that it
`would have been obvious
`to one having
`ordinary skill in the art to combine Wolter 117
`with other Wolter references taken alone or as
`modified by other prior art references because
`they share common authorship and describe
`similar apparatuses and methodologies.
`“Various bone plates 8, which are represented in
`parts a-c of Fig. 1, can be assigned to this bone
`screw 1. A common feature of the bone plates 8
`is that these have a through hole 9 for the
`passage of the shank 2 and for receiving the
`head 3 of the screw 1.” (Wolter 117 at 6:41-
`7:2).
`
`See also Wolter 117 at Figs. 1(a)-1(c).
`
`Plaintiff disputes the unsupported s