Ex Parte Salgo et al

Patent Trial and Appeal Board

May 29, 2013

10283761 (P.T.A.B. May. 29, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte IVAN S. SALGO, JOSEPH H. GORMAN, III, and
ROBERT C. GORMAN
____________________

Appeal 2011-004551
Application 10/283,761
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, BENJAMIN D. M. WOOD, and
MITCHELL G. WEATHERLY, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Ivan S. Salgo et al. (Appellants) appeal under 35 U.S.C. § 134 from
the Examiner’s decision rejecting claims 2, 8, 23-29, 31, and 45. The
Examiner withdrew claims 30 and 32 from consideration. We have
jurisdiction under 35 U.S.C. § 6(b). An oral hearing in accordance with
37 C.F.R. § 41.47 was held on February 13, 2013.1
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION pursuant to 37 C.F.R. § 41.50(b).
The Claimed Subject Matter
Claim 23, reproduced below, is illustrative of the claimed subject
matter.
23. An annuloplasty ring formed from a given set of
coefficients a, e1, e2 and h comprising:
an elongated curved non-planar member having a ring
shape defined in coordinates X, Y, and Z by:
X = a cos(Θ);
Y = a e1(e2 + sin(Θ)); and
Z = -a h cos (2Θ);
wherein “a” represents a predetermined scale of the ring,
“h” defines a predetermined non-planarity of the member and
corresponds to an annular height divided by an annular width of
the member, e1 and e2 specify a predetermined eccentricity of
the ring in the X-Y plane, “Θ” indicates an angular
displacement of each position around the member with respect
to an origin of a coordinate axis on the X-Y plane, and wherein
“h” has a value in the range of 0.05 to 0.5.

1 37 C.F.R. § 41.47(e)(1) provides that “[a]t the oral hearing, appellant may
only rely on evidence that has been previously entered and considered by the
primary examiner and present argument that has been relied upon in the
brief or reply brief.” New evidence will not be entered into the record at the
oral hearing.
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Evidence
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Garrison US 5,972,030 Oct. 26, 1999
Ryan US 2002/0129820 A1 Sep. 19, 2002
Bolling US 2003/0093148 A1 May 15, 2003

Robert A. Levine, MD et al., Three-Dimensional Echocardiographic
Reconstruction of the Mitral Valve, With Implications for the Diagnosis of
Mitral Valve Prolapse, 80 Circulation 589-598 (Sep. 1989) (hereinafter
“Levine”).
Appellants rely on declarations by Ivan S. Salgo, Robert Gorman, and
Joseph Gorman III2 (hereinafter “Salgo Declaration,” “Gorman
Declaration,” and “Gorman III Declaration,” respectively, or “Salgo,
Gorman, and Gorman III Declarations,” collectively) under 37
C.F.R. § 1.132.
Rejections
Appellants request our review of the following rejections:
I. claims 2, 23-25, 28, 29, and 31 under 35 U.S.C. § 103(a) as
unpatentable over Garrison, Appellants’ admitted prior art (AAPA)
of paragraphs [0007] and [0022] of the present Specification, and
Levine;
II. claim 8 under 35 U.S.C. § 103(a) as unpatentable over Garrison,
AAPA, Levine, and Ryan; and
III. claims 26, 27, and 45 under 35 U.S.C. § 103(a) as unpatentable
over Garrison, AAPA, Levine, and Bolling.

2 Appeal Br., Evidence App’x., items 3, 4, and 5, respectively.
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ISSUES
One issue raised in this appeal is whether, weighing all of the
evidence of record relied on by the Examiner and by Appellants in this
appeal, the subject matter of claim 23, namely, an annuloplasty ring having a
saddle shaped member with a value “h” defining a “predetermined non-
planarity of the member and correspond[ing] to an annular height divided by
an annular width of the member” in the range of 0.05 to 0.5 (which
corresponds to the claim limitation height Z = -a h cos (2Θ), with h between
0.05 and 0.5), would have been obvious to a person of ordinary skill in the
art at the time of Appellants’ invention.
A second issue raised in this appeal is whether the subject matter of
claim 25, namely, an annuloplasty ring having a saddle shaped member as
defined in claim 23, wherein the coefficients e1 and e2 vary based on Θ,
would have been obvious to a person of ordinary skill in the art at the time
of Appellants’ invention.
Other issues raised are whether the subject matter of claims 26, 27,
and 45 would have been obvious to a person of ordinary skill in the art at the
time of Appellants’ invention.
DISCUSSION
The Examiner found that Garrison discloses that saddle shaped
annuloplasty rings were known in the art at the time of Appellants’
invention. Ans. 4; see Garrison, col. 6, ll. 42-46 (stating that ‘[t]he
annuloplasty device may be any of the commercially-available annuloplasty
rings . . . , and may have any of a variety of shapes, including . . . saddle-
shaped”).
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The Examiner acknowledged that Garrison does not make clear that
the annuloplasty ring “would be of the shape to fit against the annulus of a
mitral valve” (i.e., that it would have the claimed height-to-width ratio, or
“h” value). Ans. 4. However, the Examiner found that Appellants’
Specification admits that the shape of the mitral valve during systole was
known at the time Appellants’ invention was made. Ans. 4; Spec., paras.
[0007], [0022].
The Examiner additionally found that Appellants’ Specification
admits that humans and other mammalian species have saddle shaped heart
valves with a height to width ratio of 15 to 20%, which falls within the
claimed range of 5 to 50%. Ans. 4; Spec., para. [0022] (stating that “it has
been reported that humans (and several other mammalian species) have
mitral annuli that are naturally saddle shaped with AHCWR [(i.e., a measure
of nonplanarity)] values in this 15 to 20% range”). Further, the Examiner
inferred that Appellants’ admissions reflect the teachings of Levine, which
recognize the saddle shape of the mitral valve and provide quantitative data
regarding healthy mitral valve shapes from which a height-to-width ratio
falling within the claimed range can be determined. Ans. 4, 9 (citing
Levine’s abstract; figure 5 at p. 595; p. 594, second column; and the passage
of Levine at p. 596, under the heading “Significance of This Shape”).
In the passage on page 596 cited by the Examiner, Levine teaches that
the annular nonplanarity of the saddle-shaped mitral valve accommodates
the constant length of the leaflet attached to the ventricle within the
circumference of the base of the left ventricle, which contracts in systole.
Levine, p. 596. Levine also teaches that a second function of the saddle
shape of the mitral valve may be to “provide a configuration more capable of
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withstanding the stresses imposed by left ventricular pressure.” Id. at 596-
97.
The Examiner then concluded that, based on the combined teachings
of Garrison, AAPA, and Levine, it would have been obvious “to make the
saddle shaped ring of Garrison to match a natural healthy valve shape so as
to return the valve of the individual with a prolapsed valve to a healthful
condition.” Ans. 4.
The Examiner has established a prima facie case of obviousness of the
subject matter of claim 23. The shape of the mitral valve was known in the
art at the time of Appellants’ invention. Garrison discloses saddle shaped
annuloplasty rings prior to Appellants’ invention, but does not specify any
values for nonplanarity and does not explicitly disclose that the annuloplasty
ring should be shaped to mimic the natural healthy valve or to fit against the
annulus of a mitral valve. However, Levine’s discussion of the significance
of the saddle shape of the mitral valve annulus and its nonplanarity provides
an apparent reason for one of ordinary skill in the art to design a saddle
shaped annuloplasty ring having a nonplanarity value “h” falling within the
known range of natural mitral valves, which is within the claimed range, in
order to provide the advantages thereof recognized by Levine (i.e.,
accommodating the constant length of the leaflet attached to the ventricle
within the circumference of the base of the left ventricle, which contracts in
systole, and providing a configuration more capable of withstanding the
stresses imposed by left ventricular pressure). Thus, the Examiner’s
articulated reason for the modification (i.e., “to return the valve of the
individual with a prolapsed valve to a healthful condition”) has rational
underpinnings.
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Appellants argue that the prior art relied upon by the Examiner does
not teach one skilled in the art how to create an annuloplasty ring for a given
set of coefficients a, e1, e2, and h with predetermined values predesigned for
a best-fit of a patient. App. Br. 4. According to Appellants, the prior art
rings had the same shape for all patients. Id.
Appellants’ arguments regarding annuloplasty rings customized for a
best-fit of the patient are not commensurate with the scope of claim 23,
which does not require any such customization. Claim 23 does not specify
values for the coefficients a, e1, and e2. Claim 23 defines a range for the
value of coefficient h, but does not require that this value correspond to any
anatomical measurement of a patient or be customized for a patient.
Appellants argue that Levine’s description of the mitral valve was
qualitative, and that a quantitative description of the mitral valve and an
understanding of the physiological benefit of that shape were not provided
until the work of Appellants. App. Br. 5.
This argument is not accurate. Levine developed a topographic
surfacing algorithm to describe the leaflet shape “quantitatively (a
mathematical method for producing a continuous three-dimensional surface
that best represents the discrete samples of that surface represented by the
two-dimensional leaflet traces).” Levine at 592, last para. Levine also
discusses deriving a plane of least squares fit and plotting the height of the
annulus above or below the plane of the least squares fit as a function of the
angle around the centroid, or geometric center of mass of the annulus. Id. at
593. Moreover, as noted above, Levine also discusses the significance of
that saddle shape and the annular nonplanarity thereof, and quantifies the
potential range of nonplanarity consistent with the proffered significance of
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the nonplanarity. Id. at 596-97. The manuscript of Appellants’ work,
alluded to on page 9 of the Appeal Brief,3 appears to confirm Levine’s
findings and conclusions with respect to the significance of the saddle shape
of the annulus and its nonplanarity.
Appellants assert that saddle shaped rings were not commercially
available at the time of filing of the Garrison patent. App. Br. 6. This
assertion appears inexplicably inconsistent with Appellants’ admission that
“[a]t least one known prosthesis, the Carpentier-Edwards Physio
Annuloplasty Ring currently marketed by EDWARDS LIFESCIENCES, has
a non-planar profile” and “a mild saddle shape with downwardly extending
lobes.” Spec., para. [0007]. Moreover, in any event, as correctly pointed
out by the Examiner (Ans. 7), commercial availability of the prior art is not
required in obviousness determinations.
Appellants additionally argue that absent the mathematical model
discovered by Appellants, creating a particular annuloplasty ring would not
have been possible. App. Br. 6. The Salgo, Gorman, and Gorman III
Declarations (para. (14))4 all include averments to the same effect.
However, Appellants’ assertions and averments do not address the
quantitative mathematical modeling described by Levine or adequately
explain why persons of ordinary skill in the art would not have been able to
use such modeling, or reproduce such modeling themselves, to produce
annuloplasty rings as called for in claim 23.

3 Ivan S. Salgo et al., Effect of Annular Shape on Leaflet Curvature in
Reducing Mitral Leaflet Stress, 106 Circulation 711-17 (2002) (hereinafter
“Salgo manuscript”).
4 Paragraphs 4-16 of the Salgo, Gorman, and Gorman III Declarations are at
least substantially identical to one another.
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Appellants argue that the Examiner failed to give adequate weight to
Appellants’ Declarations. App. Br. 7. We agree with the Examiner that this
is an unfair criticism, given the Examiner’s analysis of the Declarations on
pages 8-13 of the Office Action mailed February 2, 2009. See Final Rej. 5;
Ans. 8-12 (reiterating the analysis of the Declarations). Appellants
enumerate fifteen facts that they allege are set forth in the Declarations.
App. Br. 8-15. We address each of these asserted facts in turn.
Asserted Fact 1 (App. Br. 8; see Salgo, Gorman, and Gorman III
Decl., para. (4)) describes the misconception in the art prior to Levine’s
work that the mitral valve annulus was a flat orifice having a “D,” kidney, or
oval shape. Notably, Levine put to rest that misconception prior to
Appellants’ invention.
Asserted Facts 2 and 7, and the first sentence of asserted Fact 3 (App.
Br. 8; see Salgo, Gorman, and Gorman III Decl., para. (8)) do not accurately
characterize Levine, which, as noted above, describes quantitative
mathematical modeling of the surface of the mitral valve and plotting the
height of the annulus above or below the plane of the least squares fit as a
function of the angle around the centroid of the annulus, discusses the
significance of that saddle shape and the annular nonplanarity thereof, and
quantifies the potential range of nonplanarity consistent with the proffered
significance.
The second sentence of asserted Fact 3 and asserted Fact 4 (App. Br.
8; see Salgo, Gorman, and Gorman III Decl., para. (8)b.) appear to be
accurate. Levine is directed primarily to diagnosis of mitral valve prolapse,
and not to design of annuloplasty rings. However, the Examiner relies on
Levine only for its teachings with respect to the natural shape of the mitral
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valve annulus and its significance in proper valve function. See Ans. 8,
Declarations Rebuttal item (3) (stating, “Levine is not relied upon for
teaching how to build a ring”).
The first sentence of asserted Fact 5 (App. Br. 8; see Salgo, Gorman,
and Gorman III Decl., para. (6)), which states that “from 1988 to 2001 there
was absolutely no discussion to Appellants’ knowledge of a saddle shaped
annuloplasty ring in the mitral valve repair literature,” is of limited probative
value, in light of Garrison’s disclosure of a saddle shaped annuloplasty ring.
See Ans. 8 (pointing out that Garrison contemplates saddle shaped
annuloplasty rings). The remainder of asserted Fact 5 essentially reiterates
that no saddle shaped rings were “produced” by industry prior to 2001. See
Salgo, Gorman, and Gorman III Decl., para. (6). This fact is of limited
relevance to the determination of obviousness, as discussed above, without
direct evidence showing why this was the case and showing adoption and
production of saddle shaped rings by the industry after Appellants’
invention. Appellants concede that there is no direct evidence of record in
this application of adoption of saddle shaped annuloplasty rings following
Appellants’ invention.5
The pertinence of asserted Fact 6 (App. Br. 8; see Salgo, Gorman, and
Gorman II Decl., para. (7)), that prior to Appellants’ work no ring design
had been shown to be more efficacious than another and that no one skilled
in the art ever proposed the use of a saddle shaped annuloplasty ring based

5 See Oral Hearing Transcript 17, ll. 20-22:
MR. SMITH: Okay. Well, even part from that part, the
post-invention adoption, let's just keep that aside, okay, because
I don’t believe that we have any direct evidence on that in the
record.
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on Levine, to the obviousness determination is not entirely clear. As noted
repeatedly above, whether based on Levine or not, Garrison clearly
contemplates saddle shaped annuloplasty rings.
Asserted Fact 8 (App. Br. 9; see Salgo, Gorman, and Gorman II Decl.,
para. (8)), that there was no appreciation in the art prior to Appellants’ work
of the importance or benefit of maintaining a saddle shape during mitral
valve repair, seemingly discounts or overlooks Garrison’s disclosure of
saddle shaped annuloplasty rings, and Levine’s discussion of the role of the
natural mitral valve shape in maintaining proper valve function and in
withstanding the stresses imposed by left ventricular pressure.
Asserted Facts 9-11 (App. Br. 9; see Salgo, Gorman, and Gorman III
Decl., para. (9)) tout Appellants’ work and point to the Salgo manuscript.
As already noted above, Appellants’ work and the Salgo manuscript
describing that work appear to confirm Levine’s findings and conclusions
with respect to the significance of the saddle shape of the annulus and its
nonplanarity.
Appellants assert that the Salgo manuscript “has received over 72
citations that demonstrate it as a reference paper on why the non-planar
shape is important.” App. Br. 9; see also Salgo, Gorman, and Gorman III
Decl., para. (9) (stating that the Salgo manuscript “has received over 35 [or
656] citations that demonstrate it as a reference paper on why the non-planar
shape is important”). However, Appellants have not submitted copies of, or
even excerpts from, any articles or papers to corroborate the alleged citations
and to permit the Examiner and this Board to evaluate those citations.

6 The Salgo Declaration alludes to 35 citations, while the Gorman and
Gorman III Declarations allude to 65 citations.
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Consequently, Appellants’ statements in their Appeal Brief and in their
Declarations with respect to those citations are of little probative value.
Asserted Fact 12 (App. Br. 9; see Salgo, Gorman, and Gorman III
Decl., para. (11)) is directed to Garrison’s failure to specify the relative
dimensions of the annuloplasty ring for customization for a particular
patient. As noted above, claim 23 does not require customization for a
particular patient. The only coefficient, or relative dimension, for which a
value, or range of values, is specified in claim 23 is the predetermined non-
planarity h. The Examiner does not rely on Garrison as disclosing the non-
planarity. Rather, the Examiner relies on the teachings of Levine and AAPA
for this feature.
Asserted Facts 13-15 (App. Br. 9-10; see Salgo, Gorman, and Gorman
III Decl., para.(12)) appear unduly dismissive of Levine’s discussion of a
quantitative mathematical surfacing algorithm describing the saddle shape of
the leaflets (p. 592), of the plotting of the height of the annulus around the
circumference of the valve as a function of angle around the centroid
(p. 593), of the significance of the saddle shape and nonplanarity to valve
performance and durability (pp. 594-95), and of the potential range of
nonplanarity consistent with the proffered significance.
The Salgo, Gorman, and Gorman III Declarations allude to a “long-
felt need for innovation” (para. (7)). However, Appellants provide no
objective evidence to establish long-felt need. Establishing long-felt need
requires objective evidence that skilled artisans recognized a problem that
existed for a long period of time without solution. In particular, the evidence
must show that the need was a persistent one that was recognized by those of
ordinary skill in the art. In re Gershon, 372 F.2d 535, 539 (CCPA 1967).
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Further, the long-felt need must not have been satisfied by another before the
invention by applicant. Newell Companies v. Kenney Mfg. Co., 864 F.2d
757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there
was no long-felt need or, indeed, a problem to be solved.”) Lastly, the
invention must in fact satisfy the long-felt need. In re Cavanagh, 436 F.2d
491, 496 (CCPA 1971).
After weighing the totality of the evidence before us in this appeal,
including both the evidence relied upon by the Examiner and the evidence
relied upon by Appellants, we conclude, as the Examiner did, that the
evidence of obviousness outweighs the evidence of nonobviousness. The
Examiner did not err in concluding that the subject matter of claim 23,
namely, an annuloplasty ring having a saddle shaped member with a value
“h” defining a “predetermined non-planarity of the member and
correspond[ing] to an annular height divided by an annular width of the
member” in the range of 0.05 to 0.5 (i.e., height Z = -a h cos (2Θ), with h
between 0.05 and 0.5), would have been obvious to a person of ordinary
skill in the art at the time of Appellants’ invention. We thus sustain the
rejection of claim 23 and of claims 2, 24, 28, 29, and 31, which Appellants
state stand or fall with claim 23 (App. Br. 11), as unpatentable over
Garrison, AAPA, and Levine.
In contesting the rejection of claim 8 as unpatentable over Garrison,
AAPA, Levine, and Ryan, Appellants merely rely on their arguments
directed to claim 23. App. Br. 11. Thus, for the reasons discussed above
with respect to the rejection of claim 23, we also sustain the rejection of
claim 8.
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Claim 25 depends from claim 23 and further requires that e1 and e2
vary based on Θ. The Examiner’s rejection of claim 25 does not explicitly
address this feature, aside from asserting, “[a] saddle shape inherently has
the convex and concave features required by present claims 23 and
dependent claims 2, 8, 24-29, 31, and 45.” See Ans. 4. As pointed out by
Appellants (App. Br. 12), the variation of e1 and e2 based on Θ is not an
inherent feature of a saddle shape.
Appellants argue that Garrison and Levine do not disclose or suggest
varying eccentricities e1 and e2 based on Θ, as called for in claim 25. Id. In
response, the Examiner asserts that “merely saying they vary with respect to
each other is considered to be obvious over the applied prior art of Garrison,
Levine and the admitted prior art.” Ans. 14. This assertion is nothing more
than a bald conclusion unsupported by the necessary findings and reasoning
to support the legal conclusion of obviousness. Thus, we reverse the
Examiner’s rejection of claim 25 as unpatentable over Garrison, AAPA, and
Levine.
In contesting the rejection of claims 26, 27, and 45, Appellants argue,
in essence, that the features recited therein would not have been inherent
from the suggestions of Garrison and Levine of a saddle shape or from
Bolling’s suggestion that an annuloplasty ring may have a D-shape in plan
view. App. Br. 12. While this argument is convincing for claims 26 and 27,
which specify values for e1 and e2 based on Θ, it is not convincing for claim
45, which simply requires the values of e1 and e2 to be selected to form a D-
shaped ring in plan view. Appellants do not contest the Examiner’s finding
that Bolling teaches it was known in the art to make a saddle shaped ring
that also has a D-shape in the X-Y plane, or identify error in the Examiner’s
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conclusion that it would have been obvious to use a saddle shape with a D-
shape in plan view “as a means to best return the valve to its natural healthy
condition.” See Ans. 5. Appellants’ arguments with respect to
customization of the size and shape of the annuloplasty ring to the patient
(Reply Br. 4) are directed to aspects of Appellants’ invention which are not
recited in claim 45, and thus do not identify error in the Examiner’s rejection
of claim 45.
Thus, we sustain the Examiner’s rejection of claim 45 as unpatentable
over Garrison, AAPA, Levine, and Bolling, but we reverse the like rejection
of claims 26 and 27.
NEW GROUND OF REJECTION
The Examiner’s determination that the subject matter of claim 45
would have been obvious necessarily is also a determination that the subject
matter of claim 25, from which claim 45 depends, would have been obvious.
See Ormco Corp. v. Align Tech., 498 F.3d 1307, 1319 (Fed. Cir. 2007)
(when a dependent claim is “found to have been obvious, the broader claims
. . . must also have been obvious”). Thus, pursuant to our authority under
37 C.F.R. § 41.50(b), we reject claim 25 under 35 U.S.C. § 103(a) as
unpatentable over Garrison, AAPA, Levine, and Bolling.
DECISION
The Examiner’s decision rejecting claims 2, 8, 23-29, 31, and 45 is
affirmed as to claims 2, 8, 23, 24, 28, 29, 31, and 45, and is reversed as to
claims 25-27. We enter a new rejection of claim 25.
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FINALITY OF DECISION
Regarding the affirmed rejection(s), 37 C.F.R. § 41.52(a)(1) provides
“Appellant[s] may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the Examiner's rejection(s) of one or more
claims, this decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an
appropriate amendment of the claims so rejected or
new evidence relating to the claims so rejected, or
both, and have the matter reconsidered by the
examiner, in which event the proceeding will be
remanded to the examiner. . . .

(2) Request rehearing. Request that the
proceeding be reheard under § 41.52 by the Board
upon the same record. . . .
Should Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. § 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
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If Appellants elect prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejection, including any timely request for rehearing thereof.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)

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