Ex Parte 6969390 et al

Patent Trial and Appeal Board

Sep 27, 2012

95000448 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/000,448 05/18/2009 6969390 101.0056-13REX 9508
22882 7590 05/20/2013
MARTIN & FERRARO, LLP
1557 LAKE O'PINES STREET, NE
HARTVILLE, OH 44632
EXAMINER
CLARK, JEANNE MARIE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
05/20/2013 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)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

NUVASIVE, INC.
Requester, Appellant

v.

Patent of WARSAW ORTHOPEDIC, INC.
Patent Owner, Respondent
____________________

Appeal 2012-004133
Reexamination Control 95/000,448
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Technology Center 3900
____________________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON and
DANIEL S. SONG, Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING

NuVasive (hereinafter "Requester") requests reconsideration under 37
C.F.R. § 41.79 (hereinafter "Req." or "Request") of our New Decision Under
37 C.F.R. § 41.77(f) mailed September 29, 2012 (hereinafter "New Dec." or
"New Decision"). We grant-in-part the Request to the extent that we

1 Issued November 29, 2005 to Michelson (hereinafter "'390 patent").
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consider the Requester's arguments and modify the original Decision in the
manner set forth infra.
The details of the reexamination history of the '390 patent resulting in
the issuance of the New Decision is set forth therein (New Dec. 2-3) but a
brief discussion of the history of the appeal is helpful for the purposes of this
Rehearing. During the reexamination of the '390 patent, the Examiner
declined to adopt various obviousness rejections proposed by the Requester
and the Requester appealed to the Board in Appeal 2010-007339.
We disagreed with the Requester that "one of ordinary skill in the art
would 'modify' the screw of Lowery by removing a portion of the screw
head as suggested by the Appellant." (Original Decision mailed October 21,
2010 (hereinafter "Orig. Dec." or "Original Decision") 12). We nonetheless
found the independent claims obvious based on the combination of Lowery
and Surer, Surer disclosing an implant screw having the recited screw head
configuration (Orig. Dec. 7-8).
While we generally agreed with the Appellant's assertion that the
screw head shape is a design choice, in reversing the Examiner's refusal to
reject the claims, we specifically stated that "the substitution of the screw of
Surer for the screw in the plating system of Lowery is merely a predictable
variation of Lowery that a person of ordinary skill can implement." (Orig.
Dec. 12). We further stated that "one of ordinary skill would recognize that
the screw of Lowery, when substituted by the screw of Surer, would yield
substantially the same result." (Orig. Dec. 13). Thus, we reversed the
Examiner's refusal to reject the independent claims of the '390 patent based
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on the combination of Lowery and Surer, and denominated our reversal as a
new ground under 37 C.F.R. § 41.77(b).
In response to the Original Decision by the Board, the Patent Owner
requested reopening of prosecution under 37 C.F.R. § 41.77(b)(1) and
amended the claims to submit new independent claims 46 and 47 similar to
the rejected independent claims, but further reciting specific limitations with
respect to the screw including:
"said upper facing surface of said upper portion having a
recess configured to cooperatively engage a driver instrument
adapted to insert said screw into the vertebral body,";
"said tip being configured to be one of self-tapping and
including a cutting flute,";
"said first shaft portion being generally cylindrical, said
second shaft portion being generally conical and having a larger
diameter proximate said head and smaller diameter adjacent
said first shaft portion,"; and
"said thread having an outer diameter that is generally
uniform along at least a substantial portion of each of said first
and second shaft portions."
(See generally, Request to Reopen Prosecution, filed November 22,
2010).
The Requester proposed 45 new rejections for these amended claims
(see generally, Third Party Request Comments (filed February 2, 2011) 11).
In the New Decision, we declined to adopt any of the properly submitted
new Proposed Rejections, and declined to consider rejections that were
deemed to improperly extend beyond the scope of the Board's Original
Decision. It is the New Decision for which the Requester presently seeks
reconsideration.

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I. A. Combination of Lowery, Surer and Davne (Issues 4 and 5)
The Requester argues that in the New Decision, the Board made a fact
finding that was not urged by the parties and erred in finding that "it appears
more likely than not that the screws of Lowery and Surer did not exhibit the
screw breakage issues identified and addressed by Davne in providing the
tapered root diameter of design 'd.' considering the increased diameter at the
shoulders, and thus, increased strength provided thereby." (Req. 2 quoting
New Dec. 25-26). The Requester argues that this finding is erroneous
because it is inconsistent with the background section of the '390 patent
which describes a second generation of plating systems as including Lowery,
and subsequently mentions that "screw breakage continues to be experienced
and occurs most commonly at the junction of the screw to the posterior
aspect of the plate." (Col. 2, ll. 46-54; col. 3, ll. 7-9).
In reconsidering the record, we agree with the Requester that we
overlooked the background of the '390 patent in the New Decision which
fairly suggests that the screw breakage is experienced in the screw disclosed
in Lowrey. Consequently, we modify the New Decision and withdraw
therefrom the portion beginning with "Whereas the Requester refers to the
disclosure of Davne" on page 25 and ending with "and is inadequate to
support the conclusion of obviousness. See KSR, 550 U.S. at 418, 421" on
page 26.
However, having withdrawn the above portion of the New Decision
and having reconsidered the matter, we decline to alter our ultimate decision
to not adopt the Requester's proposed rejection. In particular, the proposed
rejection relies on the combination of Lowery, Surer and Figure 1D of
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Davne (Third Party Request Comments (filed February 2, 2011) 11). In
suggesting the combination, the Requester asserts that:
it would have been obvious in view of Davne to modify the
screw shaft shape of Lowery/Surer so as to have a generally
conical upper portion and a generally cylindrical lower portion
for a screw shaft so as to reduce screw breakage issues. Also, a
skilled artisan would have been prompted to incorporate the
first and second shaft portions (as taught by Davne) to the
resulting screw of Lowery and Surer because it is merely
"[c]ombining prior art elements according to known methods to
yield predictable results." MPEP § 2143(A); KSR, 82
U.S.P.Q.2d at 1395 ("The combination of familiar elements
according to known methods is likely to be obvious when it
does no more than yield predictable results.").
(Id. at 11-12, emphasis added).

As noted by the Requester, in its Background of the Invention section,
the '390 patent discusses problems and breakage in prior art plating systems,
and further explains that second generation of plating systems has been
developed or proposed in response the those problems (col. 2, ll. 27-48).
This second generation of plating systems included the plating system of
Lowery, as well as numerous others such as Morscher, Synthes, Danek
Orion, Codman Shurtleff, and Smith Nephew Richards, among others (col.
2, ll. 48-53). While the background of the '390 patent also states that screw
breakage continues to be experienced, it specifically highlights that Synthes
and Smith Nephews Richard systems are particularly vulnerable to the
breakage problem (col. 3, ll. 7-14). The screw of Lowery is not specifically
highlighted as being particularly vulnerable to breakage.
Turning to Davne which is relied upon by the Requester for disclosing
a conical portion, Davne specifically states:
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The most recent modification tapered the root diameter (Figure
1D) in this junctional area, and when breakage occurs, it is at
the end of the taper.
(Davne S187, col. 2, emphasis added).
Thus, the screw of Davne also experiences breakage in use. In view
of Davne's disclosure, the Requester's asserted reason (Req. 4) for
incorporating the conical portion of Davne in the combination of Lowery
and Surer is not well founded, and is likely to be based on impermissible
hindsight which utilizes the claims of the '390 patent as a template.
Similar considerations apply to the Requester's assertion that a person
of ordinary skill in the art "would have been prompted to incorporate the
first and second shaft portions (as taught by Davne)" and that the invention
merely combines prior art elements according to known methods (Third
Party Request Comments (filed February 2, 2011) 12). Such broad and
generalized assertions of obviousness set forth by the Requester are not
adequate rationales to combine the prior art elements because they are not
supported by fact-based reasoning. While we agree with the Requester that
specific motivation to combine is not required for obviousness (Req. 4), the
law is also clear that "a patent composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art." KSR Int’l v. Teleflex, Inc., 550 U.S.
398, 418 (2007). In this regard, the "factfinder should be aware . . . of the
distortion caused by hindsight bias and must be cautious of arguments reliant
upon ex post reasoning." Id. at 421.
The Requester further argues that "the changes between the
Lowery/Surer combination and the added limitations are nothing more than
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predictable design variations that are well within the skill of the art." (Req.
4). However, the evidence of record which demonstrates many different
plating systems that incorporate plates and screws having various different
shapes and configurations tend to indicate the contrary, i.e., that such
designs are not mere predictable variations with results varying in the degree
of success. In our view, the Requester's assertion that it would be nothing
more than predictable design variations to arrive at the claimed plating
system having screws with the recited features is based on impermissible
hindsight.
While we consider the above discussion sufficient for the purposes of
this Rehearing, we nonetheless briefly address the other unpersuasive
arguments. Both unamended and amended claims required the root diameter
of a first shaft portion to be less than the root diameter of the second shaft
portion. The Requester disagrees with the Board's finding of fact that the
shoulder of the screws in Lowery is greater than the diameter of the rest of
the screw shaft (Req. 3). However, Figure 5 of Lowery shows a slightly
larger shoulder and drawings can be relied upon for what they reasonably
show. Moreover, the Requester has itself asserted that Lowery discloses this
limitation.2

2 See, e.g., Requester's Appeal Brief (filed November 12, 2009) in Appeal
2010-007339, page 6 stating "Lowery discloses … all of the limitations of
claim 1, except the specifically claimed two-portion shape of the screw
head"; and pages 7-8 which omits this limitation in stating: "To be clear
about what feature of [unamended] claim 1 is missing from Lowery, it is the
combination of the following limitations of claim 1 for the screw head: 1)
that the head's lower portion be wider than the upper portion, 2) that each
one of the head's lower portion and the head's upper portion has an upper
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The Requester also argues that Surer's "increased diameter of the
screw shoulder is not at a location that would address the known prior art
problem of screw breakage at the junction of the posterior, or bottom, of the
plate" because the increased shoulder resides "primarily within, and in some
cases, entirely within, the plate itself and not at the junction of the bottom of
the plate." (Req. 3-4, citing Figures 2 and 3 of Surer). However, Figure 1 of
Surer which shows the greatest level of detail of the screw illustrates that at
the junction of the bone and plate, the screw shaft has the increased diameter
of the shoulder (Surer, Fig. 1).

B. Combination of Lowery, Surer, Frigg and Orion (Issue 6)
The Requester again points out, and we agree, that we overlooked the
background discussion in the '390 patent with respect to Lowery (Req. 5).
Consequently, we also modify the New Decision and withdraw the portion
beginning with "Similar to our discussion supra with respect to Davne" on
page 28 and ending with "or direct our attention to the disclosure of Frigg in
support of its assertion" also on page 28.
However, having withdrawn the above portion of the New Decision
and having reconsidered the matter, we decline to alter our ultimate decision
to not adopt the Requester's proposed rejection for the additional reasons set
forth in the New Decision (New Dec. 28).
The Requester argues that contrary to the Board's finding, the conical
transition region of Frigg is "proximate" the screw head as required by the

facing surface, and 3) that the lower portion's upper facing surface be 'at
least in part in a plane that crosses the mid-longitudinal axis of the screw.'"

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claims because that is a relative term "and the portion of the screw shaft that
the claim requires to be 'proximate' the screw head is in fact nearer to the
screw head [in Frigg] than the portion of the screw (the lower portion) that is
proximate the distal tip of the screw." (Req. 5-6). We remain unpersuaded.
We consider it unreasonable to read "proximate" to encompass a significant
intervening cylindrical portion such as that disclosed in Frigg, especially
given that the plating system screws are necessarily limited in size by virtue
of their application. Thus, we find that Frigg does not disclose a conical
transition region that is proximate the screw head.
The Requester also asserts that "the upper portion of the screw shaft
being generally tapered or generally cylindrical is a matter of predictable
design choice." We find this predictable design choice argument to be
unpersuasive and likely to be based on hindsight using the claims at issue as
a template. See KSR, 550 U.S. 418, 421.

C. Combination of Lowery, Surer, Blair and Orion (Issues 7 and 8)
The Requester again points out that we overlooked the
background discussion in the '390 patent relative to Lowery
(Req. 6). We agree and we further modify the New Decision to
withdraw the portion on page 30beginning with "Moreover,
both Lowery and Surer already provide" and ending with
"addressed by the teaching of Blaire which is relied upon by the
Requester."
However, having withdrawn the above portion of the New Decision
and having reconsidered the matter, we decline to alter our ultimate decision
to not adopt the Requester's proposed rejection for the additional reasons set
forth in the New Decision (New Dec. 29-30).
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The Requester also argues that "although the upper portion of the
screw shaft in Blair is indeed generally cylindrical, it is manifestly well-
known, for example in view of the Orion plate reference, that all or portion
of a screw shaft may be tapered" and so, the changes are routine design
changes and obvious design variations (Req. 6-7). Again, we consider the
Requester's proposed rejection to be based on impermissible hindsight that
utilizes the claims of the '390 patent as a template in modifying the screw of
Lowery/Surer. See KSR, 550 U.S. 418, 421.

D. Combination of Lowery, Surer, Allard and Orion (Issues 9 and
10)
The Requester argues that the Board's application of Allard is based
on improperly narrow interpretation of the limitation "generally cylindrical"
as requiring a "perfectly cylindrical structure" and that the Board's finding
regarding Allard is contrary to the figures therein (Req. 7-8). However, we
observe that the New Decision does not require a perfectly cylindrical
structure as asserted. Instead, we found Allard's disclosure to be, at best,
ambiguous and stated:
However, we find that Figure 7 appears [to] illustrate that the
shaft of the screw of Allard is tapered and generally conical
throughout its entire length (FF 15). At best, Allard is
ambiguous about the shape of the shaft which is being depicted
with respect to a generally cylindrical portion. There is certainly
no express disclosure in Allard of a generally cylindrical shaft
portion together with a generally conical shaft portion as noted
by the Examiner (Determination 28). In view of the absence of
such express disclosure - either in words or by drawing - we
simply do not have sufficient evidence that would have guided
one of ordinary skill in the art to have selected, without
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hindsight, a screw shaft with the required conical and
cylindrical portions.
(New Dec. 32, emphasis added).

The Requester also argues that the claims do not require the first shaft
portion to be of any particular length or percentage and thus, "only a small
portion of the distal portion of the screw shaft" need be generally cylindrical
(Req. 7-8). However, we do not consider such interpretation to be
reasonable as it allows the limitation to be rendered meaningless since a
miniscule portion of a conical section could be taken and characterized as
cylindrical
Moreover, we consider the Requester's proposed rejection to be based
on impermissible hindsight that utilizes the claims of the '390 patent as a
template in modifying the screw of Lowery/Surer. See KSR, 550 U.S. 418,
421. Thus, in view of the above in addition to the reasons set forth in the
New Decision (New Dec. 32-34), we decline to modify our decision not to
adopt the proposed rejection.

II. Grounds Based on the Combination of Surer and Oxland
As noted supra, in the Original Decision, the Board reversed the
Examiner's refusal to reject the original independent claims of the '390
patent subject to appeal in Appeal 2010-007339, and denominated the
reversal as new grounds of rejection under 37 C.F.R. § 41.77(b). (See Orig.
Dec. 12-14). The rejection entered by the Board was based on the
combination of Lowery and Surer (id.).
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Of the Requester's 45 newly proposed rejections for the amended
claims, Proposed Rejections V.A.1) through D.4) were based on the
combination of Surer and Oxland (see generally, Third Party Request
Comments (filed April 11, 2011) 29-33; Third Party Request Comments
(filed February 2, 2011) 64-110). In the New Decision, we declined to
consider these rejections because they improperly extend beyond the scope
of the Board's decision under 37 C.F.R. § 41.77 (New Dec. 35). The
Requester argues that the Board erred as a matter of law in refusing to
consider these newly proposed rejections that are based on the combination
of Surer and Oxland (Req. 8-11). We disagree.
The Requester asserts that the rejections were directed to "the [patent]
owner's response [i.e. the newly amended claims]" but the Board did not
provide analysis or citation that supports its refusal to review the newly
proposed rejections based on the combination of Surer and Oxland (Req. 8-
9). The Requester further asserts that it has complied with the rules which
"limit the scope of a patent owner's response (amendment or new evidence)
and a requester's comments (limited to issues raised by Board's opinion or
owner's response)," and observes that there is "no provision in § 41.77 that
suggests it is appropriate for the Board to refuse to consider properly
submitted comments." (Req. 10-11).
The Requester misstates the rules. The pertinent portion of the rules
states:
Such written comments [of any requester] must be limited to
the issues raised by the Board's opinion reflecting its decision
and the owner's response.
(See 37 C.F.R. § 41.77(c), emphasis added).
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Thus, the rule is clear the Requester's comments be limited to issues
raised by the Board in its decision "and" the Patent Owner's response, not
merely based on the Board's opinion "or" the Patent Owner's response as
asserted.
These rejections (Proposed Rejections V.A.1 through D.4) go beyond
the rejection entered by the Board because the primary reference Surer relied
upon in the newly proposed rejections of the Requester differs from that of
the entered new ground of rejection, and the application of the secondary
references including Oxland differs from the original rejections on appeal.
Thus, because these newly proposed rejections are based on the combination
Surer and Oxland and substantively differ from the rejection entered by the
Board in its new ground, they cannot be said to be limited to the issues
raised by the Board's decision. As explained in the New Decision and
maintained herein,
Rejections relying on such a combination were not at issue in
the '7339 Decision. Hence, the newly Proposed Rejections
V.A.1) to D.4) improperly extend beyond the scope of the New
Ground of Rejection entered by the Board and are not proper
under the provisions of 37 C.F.R. § 41.77.
(New Dec. 35).
Under the Requester's reasoning, there is no limit to what can be
presented by the Requester because anything can be argued to be in response
to the Patent Owner's response, thereby rendering the language of the rule
meaningless.
The other newly proposed rejections based on the combination of
Lowery and Surer, including those that relied on additional new prior art
(Proposed Rejections IV.A.1 through G4) are proper in that they are in
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response to the Patent Owner's response (i.e., the added limitations via the
amendment) and the Board's entered new ground. As such, these newly
proposed rejections have been addressed in the New Decision and above in
this Decision on Request for Rehearing.
The Requester further asserts that the Board did not provide analysis
or citation that supports its refusal to review the newly proposed (Req. 9).
While the explanation in the New Decision and its reference to the pertinent
rules appear to be clear, we have further clarified the New Decision in our
discussion herein.
The Requester points out that the Examiner fully considered the newly
proposed rejections3 and argues that it should not be deprived of Board
review (Req. 10). However, we observe that it is the Board that has
jurisdiction over the grant of the Patent Owner's request to reopen, and the
entry of the Requester's comments under 37 C.F.R. §§ 41.77(b)(1) and
41.77(c). Thus, while the Examiner's Determination is helpful to the Board
in "reconsider[ing] the matter and issu[ing] a new decision" under 37 C.F.R.
§ 41.77(f), the Board is not bound or restricted thereby.
Finally, the Requester argues that the Board's position of not
reviewing "properly raised proposed rejections" denies due process (Req.
11). However, as discussed above, the newly proposed rejections based on
the combination of Surer and Oxland are not "properly raised." The other
newly proposed rejections were "properly raised," and thus, were addressed
by the Board.

3 We observe that the Examiner, upon considering these proposed rejections,
still declined to adopt them (see generally, Examiner's Determination mailed
March 10, 2011).
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CONCLUSIONS
We agree with the Requester that we overlooked the background
discussion of Lowery in the specification of the '390 patent.
Correspondingly, we modify the New Decision as noted supra. However, as
also explained supra, we decline to modify the New Decision as to its result
and decline to enter the Requester's proposed rejections. Thus, the Request
for Reconsideration is Granted-In-Part.

GRANTED-IN-PART

PATENT OWNER:
MARTIN & FERRARO, LLP
1557 LAKE O’PINES STREET, NE
HARTVILLE, OH 44632

THIRD PARTY REQUESTER;

FISH & RICHARDSON P.C.
PO BOX 1022
MINNEAPOLIS, MN 55440-1022