Ex Parte Salgo et al

Patent Trials and Appeals Board

Jun 19, 2018

10283761 - (D) (P.T.A.B. Jun. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/283,761 10/30/2002
23377 7590 06/21/2018
BAKER & HOSTETLER LLP
CIRA CENTRE 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
FIRST NAMED INVENTOR
Ivan S. Salgo
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
103241.004918 I S4183 9028
EXAMINER
PREBILIC, PAUL B
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
06/21/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IV ANS. SALGO, JOSEPH H. GORMAN III,
and ROBERT C. GORMAN
Appeal2016-000566
Application 10/283,761
Technology Center 3700
Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
LEE L. STEPINA, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE 1
Appellants2 seek our review under 35 U.S.C. § 134(a) of the final
rejection of claims 2, 8, 23-29, 31, and 45. We have jurisdiction under 3 5
U.S.C. § 6(b).
We AFFIRM.
1 This matter came before the Board on regularly scheduled oral hearing on
May 22, 2018. The transcript is cited to herein with a "TR" prefix.
2 Appellants identify Trustees of the University of Pennsylvania as the real
party in interest. Appeal Br. 1.
Appeal2016-000566
Application 10/283, 7 61
PROCEDURAL POSTURE
This appeal presents the second appearance of this case before the
Board. An earlier appeal was disposed of in a Decision issued in 2013. Ex
Parte Salgo, Case no. 2011-004551, 2013 WL 4858339 (PTAB May 29,
2013) (hereinafter the "2013 Decision"). In the 2013 Decision, the Board,
among other things, sustained the Examiner's rejection of then pending
claim 23 over Gorman, Admitted Prior Art (APA), and Levine. Id. The
Board also entered a New Ground of Rejection of claim 25 over Garrison,
AP A, Levine, and Bolling. Id.
After the previous appeal, Appellants resumed prosecution before the
Examiner. Among other things, Appellants amended claim 23 by adding the
limitation: "wherein a, e1, e2 and h have values selected to mimic an actual
shape of a mitral valve." Claims App. In addition, Appellants submitted
sworn declarations ofY. Joseph Woo, M.D. ("Wood Dec.") and T. Sloane
Guy, M.D. ("Guy Dec."). Appellants also submitted a series of presentation
slides prepared by or on behalf of the co-inventors (hereinafter the "Gorman
Slides"). 3 The Gorman Slides do not contain a jurat, declaration, oath, or
similar representation attesting to the truth of the subject matter contained in
the slides. Furthermore, the slides do not contain any representation as to
whether and to what extent the subject matter contained in the slides falls
within the personal knowledge of the person( s) that participated in
preparation of the slides.
3 Co-inventor Gorman was permitted to address the Board during the oral
hearing associated with the 2013 Decision. See February 13, 2013 Hearing
Transcript. Gorman's statements during the hearing were not made under
oath. Our rules preclude the introduction of new evidence submitted for the
first time during appeal. See 37 C.F.R. §§ 4I.37(c)(v)(2), 4I.47(e)(l).
2
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After considering Appellants' claim amendments and declaration
testimony, the Examiner, once again, entered a final rejection of all pending
claims on October 21, 2014. See Final Action. The instant appeal is from
the Final Action of October 21, 2014. Id.
THE INVENTION
Appellants' invention relates to prosthetic mitral valve annuloplasty
rings. Spec. ,r,r 1-2. Claim 23, which contains the last limitation added by
amendment after the 2013 Decision emphasized with italics, is reproduced
below as illustrative of the claimed subject matter.
An annuloplasty ring, comprising:
an elongated curved non-planar member having a ring
shape defined in coordinates X, Y, and Z by:
X = a cos (0);
Y =a e1(e2 + sin (0)); and
Z =-ah cos (20);
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, "0" indicates an angular
displacement of each position around the member with respect
to an origin of a coordinate axis on the X-Y plane,
wherein "h" has a value in the range of 0.05 to 0.5, and
wherein a, e1, e2 and h have values selected to mimic an
actual shape of a mitral valve.
Claims App. emphasis added.
3
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Application 10/283, 7 61
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Garrison
Ryan
Bolling
us 5,972,030
US 2002/0129820 Al
US 2003/0093148 Al
Oct. 26, 1999
Sept. 19, 2002
May 15, 2003
Appellants' Admitted Prior Art (APA) set forth in paragraphs 7 and 22 of
the Specification.
Robert A. Levine, MD et al., Three-Dimensional Echocardiographic
Reconstruction of the Mitra! Valve, With Implications for the Diagnosis of
Mitra! Valve Prolapse, 80 Circulation 589-598 (Sept. 1989) (hereinafter
"Levine").
Appellants rely on the Woo and Guy declarations and the Gorman Slides.
See Appeal Br. Evidence Appendix.
The following rejections are before us for review:
1. Claims 2, 23, 24, 28, 29, and 31 are rejected under 35 U.S.C.
§ I03(a) as being unpatentable over Garrison, APA, and Levine.
2. Claim 8 is rejected under 35 U.S.C. § I03(a) as being unpatentable
over Garrison, AP A, Levine, and Ryan.
3. Claims 25-27, and 45 are rejected under 35 U.S.C. § I03(a) as
being unpatentable over Garrison, AP A, Levine, and Bolling.
Claim 23
OPINION
Unpatentability of Claims 2, 23, 24, 28, 29, and 31
over Garrison, AP A, and Levine
The Examiner finds that Garrison discloses annuloplasty rings that
exhibit a saddle shape. Final Action 3. The Examiner relies on AP A to
establish that the shape of a naturally occurring mitral valve during systole
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was known at the time of the invention. Id. 4 This finding by the Examiner
is reinforced by reference to Levine. Id. The Examiner concludes that it
would have been obvious to a person of ordinary skill in the art at the time
of the invention to modify the saddle shaped ring of Garrison to conform to
the shape of a naturally occurring valve. Id. at 4. According to the
Examiner, a person of ordinary skill in the art would have done this to return
the valve of an individual suffering from a prolapsed valve to a healthful
condition. Id.
Specifically referring to the limitation added by amendment to
claim 23 on July 31, 2013, the Examiner reiterates that the shape of the
naturally occurring valve was known at the time of the invention. Id. Thus,
the Examiner concludes that it would have been obvious to modify
Garrison's ring to conform to the actual shape of a healthy and naturally
occurring mitral valve. Id.
Appellants' first argument is that prior art annuloplasty rings had the
same shape for all patients, namely flat and D-shaped in the X-Y plane.
Appeal Br. 4. This argument is rejected as being contradicted by the
evidence of record. Garrison discloses that annuloplasty rings may have a
variety of shapes including "saddle shaped." Garrison, col. 6, 11. 42--47.
Moreover, Garrison discloses the selection of rings of an "appropriate size"
based on using a sizing device to size the valve opening. Id. col. 5, 11. 1-9;
col. 8, 11. 47-50.
4 In contradistinction to a prosthetic or artificial mitral valve, or components
thereof, we will refer to human, biological, anatomical mitral valves, and
components thereof, as "naturally occurring." Otherwise, we are generally
aware of the fact that mitral valve repair and replacement procedures may
use biological components transplanted from non-human animals.
5
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Next, Appellants accuse the Examiner of mischaracterizing the state
of the prior art. Appeal Br. 4. Appellants assert that the Examiner's
findings and conclusion that a person of ordinary skill in the art would have
sought to mimic the shape of a natural mitral valve annulus "is not supported
by any evidence of record, and, in fact, is contradicted by the available
evidence." Id. at 5. Appellants concede that Levine discloses characteristics
of the natural mitral valve annulus. Id. However, Appellants take the
position that Levine contains no teaching or suggestion that such
characteristics are relevant to preparation of an annuloplasty ring. Id.
In response, the Examiner notes that the evidence supporting the
rejection is derived, at least in part, from Appellants' own admissions.
Ans. 4--5. The Examiner reiterates that the healthful condition of a naturally
occurring mitral valve annulus was known to be a particular saddle shape at
the time of the invention. Id. at 5. Specifically in response to Appellants'
contention that there is no evidence to support an artisan's desire to mimic
the shape of a natural heart valve, the Examiner states that the motivation to
make such a modification is based upon a "well-known" principle in the art,
namely to return the affected body portion to a healthful condition. Id.
In reply, Appellants argue that the Examiner has supplied "no actual
evidence" that a person of ordinary skill in the art would have correlated the
shape of an annuloplasty ring to that of a naturally occurring mitral valve.
Reply Br. 3. Appellants assert that the Examiner's rejection is based upon
an "unsupported" and "erroneous" assumption that there was any
understanding among those of ordinary skill in the art that the naturally
occurring saddle shape bore any causal relationship to valve function. Id.
Appellants argue that the Examiner's rejection is so devoid of supporting
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evidence that it fails to rise to the level of a prima facie case. Reply Br. 3, 7;
TR 18:22- 19:2.
Appellants' argument that the Examiner failed to set forth a prima
facie case is without merit. The Examiner cites to Garrison, AP A, and
Levine as teaching or suggesting all of the limitations of claim 23 and then
offers a reason as to why a person of ordinary skill in the art would have
combined the prior art to achieve the claimed invention. Final Action 3--4.
This is sufficient to set forth a prima facie case of obviousness. See In re
Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (PTO establishes a prima facie
case by notifying applicant of the reasons for the rejection, together with
such information and references as may be useful in judging of the propriety
of continuing prosecution); see also 35 U.S.C. § 132. Examiners are
competent to make findings, informed by their scientific knowledge, as to
the meaning of prior art references and the motivation those references
would provide to persons of ordinary skill in the art. See In re Berg, 320
F.3d 1310, 1315 (Fed. Cir. 2003). Absent legal error or contrary factual
evidence, those findings can establish a prima facie case of obviousness. Id.
The Examiner's findings and conclusions are summarized as follows:
The AAP A and Levine et al provide Garrison with the
information needed to make an annuloplasty ring with a shape
that mimics the natural healthful mitral valve shape. In other
words, Garrison et al discloses making saddle shaped
annuloplasty rings but does not provide the details of the shape.
Therefore, one skilled in the art looking to reproduce the
Garrison et al invention would naturally look to other relevant
prior art to determine the best saddle shape configuration. In
doing so, the skilled artisan would naturally look to Levine et al
and others like it as providing crucial information on the shape
of healthful mitral valve annuli.
7
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Ans. 9-10. The Examiner's findings as to the meaning of the references and
the motivation that those reference would have provided to persons of
ordinary skill fall well within the Examiner's competence and authority
under Berg. Id.
We tum our attention now to whether the Examiner's findings of fact
are supported by a preponderance of the evidence. In re Caveny, 761 F.2d
671, 674 (Fed.Cir. 1985) (preponderance of the evidence is the standard that
must be met by the PTO in making rejections). Garrison is directed to
devices and methods for less-invasive surgical treatment of cardiac valves.
Garrison, Abstract. Garrison discloses annuloplasty rings that have a saddle
shape. Id. col.. 6, 11. 42--47. The "Background of the Invention" section of
Appellants' Specification admits that "medical professionals have known
that the mitral valve, as it exists in nature ... is saddle shaped." Spec. ,r 7.
The Background section further admits that, at least one known,
commercially available annuloplasty ring has "a mild saddle shape with
downwardly extending lobes," but allegedly is not the shape of the valve as
it exists in nature. Id. Appellants' Specification further admits that humans
and other mammalian species have mitral annuli that are naturally saddle
shaped with a height to width ratio in the range of 15 to 20%, which is
within the scope of their invention. Id. ,r 22. Levine is a 1989 journal article
directed to a technique to reproduce the three-dimensional shape of a natural
mitral valve. Levine, Abstract, p. 590. Levine's study reported that the
natural occurring mitral valve is saddle shaped. Id. p. 594; see also Fig. 4 at
p. 595.
The preponderance of the evidence amply supports the Examiner's
findings that the prior art teaches or suggests all of the limitations of
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claim 23. Thus, the dispute between the Examiner and Appellants centers
on whether a person of ordinary skill in the art, beginning with Garrison,
AP A, and Levine, would have found it obvious to achieve the claimed
invention with a reasonable expectation of success. Saddle shaped rings
predate the Appellants' date of invention. Garrison, col. 6, 11. 46-4 7.
Furthermore, the shape of the naturally occurring mitral valve was known.
AP A, ,r,r 7, 22; Levine, Fig. 4. To achieve the claimed subject matter, the
ordinary artisan needed only: (1) to "do the math" to reduce the known,
biological shape to a set of mathematical constraints; and (2) a reason to do
so accompanied by a reasonable expectation of success.
With respect to "doing the math," the Examiner takes the position that
mere discovery of an equation to model a known shape is not patentable
subject matter. Ans. 9. We agree. We do not view reducing a known shape
to a set of mathematical constraints as requiring more than ordinary skill. 5
"[G]enerally, a claim to a product does not become nonobvious simply
because the patent specification provides a more comprehensive explication
of the known relationships between the variables and the affected
properties." In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed.
Cir. 2012). Similarly, Appellants' argument that the claimed product
exhibits improved performance over the Garrison ring does not reflect the
correct standard for an obviousness analysis as it is well settled that
5 In response to questions from the Board during the Oral Hearing about
reducing the natural shape, already known through imaging studies, to
geometric proportions, Appellants' counsel essentially concedes that merely
reducing the known shape to a set of mathematical constraints - "was the
whole invention here." See TR 8:7-23; see also TR 9:18-23; 10:11-15.
Counsel emphasizes the lack of "computational guidelines" in the applied
art. TR 21:12-13.
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improved performance, alone, is not sufficient. See In re Huang, 100
F.3d 135, 139 (Fed. Cir. 1996) ("even though applicant's modification
results in great improvement and utility over the prior art, it may still not be
patentable if the modification was within the capabilities of one skilled in
the art").
The obviousness inquiry requires a determination that a skilled artisan
would have been motivated to combine the teachings of the prior art
references to achieve the claimed invention, and that the skilled artisan
would have had a reasonable expectation of success in doing so. Kinetic
Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir.
2012). The presence or absence of a motivation to combine references in an
obviousness determination is a question of fact. See Par Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014). "For obviousness under
§ 103, all that is required is a reasonable expectation of success." In re
O'Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988); see also Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) ("the expectation of
success need only be reasonable, not absolute").
With respect to whether a reasonable expectation of success may be
derived from the applied art, Levine proposes that:
[T]he saddle shape of the entire valve in systole may provide a
configuration more capable of withstanding the stresses
imposed by left ventricular pressure, recalling, for example, the
shape of the Saddledome Olympic stadium in Calgary, Alberta,
design to support weight over a wide area.
Levine pp. 596-597. Levine concludes the journal article by stating:
This three-dimensional technique should enhance our ability to
ask appropriate clinical questions and develop new criteria that
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better associate mitral valve shape with clinical and pathologic
consequences.
Id. p. 597.
In view of the teachings of Levine, we think the Examiner has stated a
sufficient reason as to why a person of ordinary skill in the art would have
combined the prior art to achieve the claimed subject matter with a
reasonable expectation of success. Ans. 5. Essentially, the Examiner draws
an inference that there is a relationship between the shape of a naturally
occurring organ and the successful functioning thereof. Id. Therefore,
according to the Examiner, it would have been obvious to mimic the shape
of a naturally occurring valve in designing a prosthetic valve component. Id.
Indeed, the Examiner considers the relationship between the size, shape, and
successful functioning of prosthetic organs vis-a-vis naturally occurring
organs to be "well-known." Ans. 5. This constitutes sound articulated
reasoning supported by a rational underpinning that is sufficient to support
the rejection. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)(requiring
an obviousness conclusion to be based on explicit articulated reasoning with
rational underpinning) cited with approval in KSR Int 'l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007).
Nevertheless, Appellants dispute this point, arguing that it is
"unsupported - and erroneous" in view of contrary evidence submitted by
Appellants. Reply Br. 3. Appellants argue that:
The Examiner's position begs the following question: if it was
known that the natural shape of the mitral valve annulus is
saddle shaped, and it was obvious (as alleged by the Examiner)
that it is important to use the natural shape of the valve annulus
in order to ensure proper valve function, then why weren't all
annuloplasty rings at the time the present application was filed
saddle shaped?
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Id. n.1. This argument is based on faulty reasoning. The Examiner has
provided persuasive evidence that saddle shaped rings were known in the
prior art. We need not and will not require the Examiner to account for the
existence and performance of alternative shapes and designs. Furthermore,
it is well-settled that "absent a showing of long-felt need or the failure of
others, the mere passage of time without the claimed invention is not
evidence ofnonobviousness." Kahn, 441 F.3d at 990-91 (citations omitted).
Levine's work into the shape of a naturally occurring mitral valve was
published in September of 1989. Garrison's patent application disclosing
saddle shaped rings was filed in October of 1997. Garrison, p. 1. The
record before us does not even suggest, much less establish, that Garrison's
saddle shaped ring was a failure. Furthermore, we are not convinced that an
unduly long period of time transpired between Garrison's filing date ( 1997)
and that of Appellants (2002). In short, we are not persuaded that
Appellants' claimed subject matter reflects more than the exercise of
ordinary computational skill to "to do the math" to reduce the naturally
occurring shape to a set of mathematical constraints.
With respect to the issue of a reason to combine the prior art,
Appellants argue that the testimony of Woo and Guy is sufficient to tip the
balance of evidence in their favor. Appeal Br. 5-7; Reply Br. 3-5.
However, the Examiner properly considered this declaration testimony and
remained unpersuaded. Ans. 6-9. Having also reviewed this testimony, we
are similarly unpersuaded and remain mindful that we should "disregard the
testimony of an expert that is plainly inconsistent with the record, ... or
based on an incorrect understanding of the claim[s]." Homeland
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Housewares, LLC v. Whirlpool Corp., 865 F.3d 1372, 1378 (Fed. Cir. 2017)
( citations omitted).
Dr. Woo testifies that Levine's 1989 paper merely describes the
annular shape as it exists in nature, but does not address how the saddle
shape influences valve function. Woo Dec. ,r,r 7-9. However, Levine
clearly states that the saddle shape of the valve may be more capable of
withstanding the stresses imposed by left ventricular pressure. Levine
pp. 596-597. Moreover, Levine relates the saddle shape of a naturally
occurring mitral valve to the mechanical advantages achieved by using a
saddle shape in a known building structure. Id. Thus, contrary to Woo's
testimony, Levine explicitly recognizes that mechanical advantages are
obtainable by using a saddle-shape as opposed to a flat structure. Levine's
teaching provides ample reason for a designer of an annuloplasty ring to
mimic the shape of a natural occurring mitral valve.
Dr. Guy testifies that, to his knowledge, all commercially available
annuloplasty rings were "one size fits all." Guy Dec. ,r 7. Thus, Guy does
not appear to be familiar with the teachings of Garrison that techniques to
size a valve opening were known in the prior art. 6 Garrison, col. 5, 11. 1-9.
Guy further testifies that prior to Appellants' work, all commercially
available annuloplasty rings, including "the Carpentier ring" were not
designed to mimic the natural shape of the mitral valve. Guy Dec. ,r 7. Guy
testifies that Carpentier did not adopt a saddle-shaped annuloplasty design
until introduction of the Physio II ring in 2009. Id. ,r 9. Guy further testifies
6 To the extent that Guy is testifying under the impression that there is a
patentable distinction between prior art that is "commercially available" and
prior art that is disclosed in patents and printed publications, his testimony is
no more or less persuasive.
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that the problem of leaflet failure persisted until the first saddle-shaped
annuloplasty rings became available around 2004. Id. ,r 10. Guy expresses a
belief that saddle shaped annuloplasty rings were not made prior to 2004
because "the significance of the annular shape on leaflet stresses was not
understood" prior to the inventors work. Id. ,r 11.
We note several weaknesses with Guy's declaration testimony. First,
Guy fails to acknowledge the established fact that saddle shaped
annuloplasty rings were known in the prior art. See AP A Spec. ,r 7,
Garrison, col. 6, 11. 45--4 7. Appellants' Specification admits that the prior art
Carpentier-Edwards Physio Annuloplasty Ring has a non-planar, saddle
shape. Spec. ,r 7. Appellants acknowledge that an annuloplasty ring with an
annular height to width ratio ("AHCWR") of as low as 5 percent falls within
the scope of the present invention. Id. ,r 22. However, neither Guy's
declaration, nor any other evidence submitted by Appellants, provides an
AHCWR measurement of saddle shaped annuloplasty rings that are known
to have existed in the prior art. 7
Secondly, Guy's testimony that "[t]he problem of leaflet failure
persisted until the first saddle-shaped annuloplasty rings became available
around 2004," amounts to a mere naked assertion unsupported by any
objective scientific data. Guy Dec. ,r 10. As Guy fails to admit of
knowledge of saddle-shaped rings in the prior art, he has no objective basis
for drawing a scientific conclusion that the leaflet failure problem alluded to
in his testimony is related to known, prior art, saddle-shaped rings. In
District Court, an expert's testimony must be "based on sufficient facts or
7 MR SMITH: " ... No one has a sample of that ring, It's unknown."
TR4:8-9.
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data." See Fed. Rules ofEvid. 702(b). While evidentiary standards may be
relaxed in administrative proceedings before the PTO, we, nevertheless, take
into account the lack of underlying facts and data in assessing the weight to
be given Guy's testimony.
Third, Guy's testimony does not appear to be offered from the
standpoint of a hypothetical person of ordinary skill in the art. Rather,
Guy's testimony appears to be directed to actual practitioners in the field,
without regard to their knowledge of the art applied by the Examiner in the
rejection. However, obviousness is determined by reference to a
"hypothetical" person of ordinary skill in the art. See Custom Accessories,
Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).
This person is an imaginary being created by Congress to provide a standard
ofpatentability. See Kimberly-Clark Corp. v. Johnson & Johnson, 745
F.2d 1437, 1454 (Fed.Cir. 1984). This hypothetical person is presumed to
be aware of all the pertinent prior art. Custom Accessories, 807 F.2d at 962.
This person possesses ordinary creativity. See KSR, 550 U.S. at 421. Guy's
testimony is not directed to whether a hypothetical person of ordinary skill
and creativity, armed with the teachings of the applied art, would have been
motivated to combine the applied art with a reasonable expectation of
success. Thus, Guy's testimony, at best, is tangential to the issue directly
before us.
In analyzing whether there is a reasonable expectation of success, we
must inquire into what "success" is to be expected. The respective
arguments of the Examiner and Appellants admit of two possibilities. The
first possibility is that success is achieved by reducing the naturally
occurring saddle shape to the mathematical constraints recited in claim 23.
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Claims App. The second possibility is that the success entails decreased
mortality among patients attributable to a reduced failure rate of prosthetic
mitral valves. See e.g., Appeal Br. 6, Guy Dec. ,r 8, 10. "The reasonable
expectation of success requirement refers to the likelihood of success in
combining references to meet the limitations of the claimed invention."
Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F .3 d 13 59,
1367 (Fed. Cir. 2016). In other words, "one must have a motivation to
combine accompanied by a reasonable expectation of achieving what is
claimed in the patent-at-issue." Id. With respect to the first possibility, we
are of the opinion that a person of ordinary skill in the art would have had a
reasonable expectation of success of reducing the naturally occurring saddle
shape to the claimed mathematical constraints using no more than ordinary
skill. With respect to the second possibility, claim 23 merely requires a ring
that exhibits a set of mathematical constraints. Claims App. The claim does
not require that implementation of the device results in decreased patient
mortality. However, even analyzing the case under the second possibility,
we agree with the Examiner that a person of ordinary skill in the art, in
mimicking the natural shape, would have had a reasonable expectation of
returning the patient to a "healthful condition." Ans. 3; Levine, pp. 596-97
( configuration more capable of withstanding the stresses imposed by left
ventricular pressure).
The oft recurring and overarching theme advanced by Appellants is
that, at the time of the invention, artisans of ordinary skill did not
"recognize" or "appreciate" the "significance" or "importance" of
conforming the shape of an annuloplasty ring to that of a natural occurring
mitral valve. Appeal Br. 4 ("those of ordinary skill in the art did not
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recognize the significance of the annular saddle shape"), id. at 5 ("no
understanding ... that the particular shape of a natural mitral valve annulus
was significant"), id. at 6 ("inability by those skilled in the art to recognize
the significance"); TR 20: 11-13 ("no understanding of the importance of the
saddle shape"); see also Reply Br. 3, 4, 5; Woo Dec. ,r,r 9, 12, 13, 16, 18, 21;
Guy Dec. ,r,r 11, 12, 14. Initially, we confess that it is unclear to us whether
Appellants' expressions regarding "understanding the significance" are
intended as a mere alternative expression for a person of ordinary skill in the
art having a reason to modify or combine the prior art with a reasonable
expectation of success. To the extent that it is so limited, we have already
addressed this issue and, for reasons previously discussed, are persuaded that
a person of ordinary skill in the art would have found it obvious to combine
the prior art to achieve the claimed invention with a reasonable expectation
of success.
However, to the extent that Appellants' seek for us to impose
"understanding the significance" as a standard of patentability under
Section 103 over and above that of a reasonable expectation of success, we
decline to do so. "[I]t is not a requirement of patentability that an inventor
correctly set forth, or even know, how or why the invention works."
Newman v. Quigg, 877 F.2d 1575, 1581, (Fed. Cir. 1989); see also Fromson
v. Advance Offset Plate, Inc., 720 F.2d 1565, 1570 (Fed.Cir.1983) ("[I]t is
axiomatic that an inventor need not comprehend the scientific principles on
which the practical effectiveness of his invention rests."). The fact that
Appellants may have better understood the scientific principles on which the
practical effectiveness of their annuloplasty ring rests, does not impart
patentability to otherwise obvious subject matter. Here, it is enough that a
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person of ordinary skill in the art would have had a reasonable expectation
of success in combining the teachings of the prior art whether or not such
person understood its practical effectiveness to the same degree as
Appellants. Pfizer, 480 F.3d at 1364.
In summary, all Appellants have achieved here is to take a known,
naturally occurring, saddle shape and reduce it to a set of mathematical
constraints. TR 8:7-23 ("[That] was the whole invention here"). Such is an
exercise of ordinary skill, not invention. We have considered Appellants'
remaining arguments and find them to be without merit. We sustain the
Examiner's unpatentability rejection of claim 23.
Claims 2, 24, 28, 29, and 31
Claims 2, 24, 28, 29, and 31 are not argued separately and fall with
claim 23. Appeal Br. 11.
Unpatentability of Claim 8
over Garrison, AP A, Levine, and Ryan.
Claim 8 is not argued separately and falls with claim 23. Appeal
Br. 11.
Unpatentability of Claims 25-27 and 45
over Garrison, AP A, Levine, and Bolling
Claims 25-27 and 45 depend, directly or indirectly, from claim 23.
Claims App. The Examiner finds, and Appellants do not dispute, that
Bolling discloses the limitations of claims 25-27, and 45. Final Action 5,
Appeal Br. 12.
Appellants' argument against this ground of rejection is that Bolling
does not qualify as prior art to claims 25-27, and 45, because Appellants
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claim priority to a provisional application that predates Bolling. Appeal
Br. 12, Reply Br. 7.
In response, the Examiner takes the position that the effective filing
date of the claims is October 30, 2002, due to the mathematical relationships
set forth in base claim 23. Ans. 10-11.
For a patent to be entitled to priority based on an earlier application,
the earlier application must comply with the written description requirement
of 35 U.S.C. § 112(a). See Bradford Co. v. Conteyor N Am., Inc., 603 F.3d
1262, 1269 (Fed. Cir. 2010). To satisfy the written description requirement,
the disclosure must reasonably convey to those skilled in the art that the
inventor was in possession of the claimed subject matter as of the claimed
priority date. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
1991). In the case of Los Angeles Biomedical Research Institute at Harbor-
UCLA Medical Center v. Eli Lilly and Co., 849 F.3d 1049 (Fed. Cir. 2017),
the Federal Circuit upheld a determination by the Board that a patentee was
not entitled to the priority date of its provisional application because it
lacked adequate written description support for the claimed subject matter.
Id. at 1057.
In the instant case, the only disclosure in the provisional application
that Appellants direct our attention to as providing written description
support for claims 25-27, and 45 is Figure 2A. Appeal Br. 12. In contrast,
claim 23 recites a list of mathematical constraints that are not to be found in
Figure 2A of the provisional application. Claims App. We agree with the
Examiner that Appellants have failed to provide written description support
in the provisional application for the mathematical constraints in claim 23.
Thus, claims 25-27, and 45, which depend from claim 23 also lack written
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Application 10/283, 7 61
description support in the provisional application. Consequently, the
Examiner properly relies on Bolling as prior art for this ground of rejection.
In view of the foregoing discussion, we sustain the Examiner's
unpatentability rejection of claims 25-27 and 45 over Garrison, AP A,
Levine, and Bolling. 8
DECISION
The decision of the Examiner to reject claims 2, 8, 23-29, 31, and 45
is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
8 Although Bolling is not cited as applied art in the rejection of claim 23, we
note that applicable law provides that a broader independent claim cannot be
nonobvious where a dependent claim stemming from that independent claim
is invalid for obviousness. See Soverain Software LLC v. Victoria's Secret
Direct Brand Management, LLC, 778 F.3d 1311, 1315 (Fed. Cir. 2015).
Furthermore, while we do not rely on Bolling as applied art to the rejection
of claim 23, Bolling is, nevertheless, instructive as evidence of the
background knowledge of a person of ordinary skill in the art at the time of
Appellants' invention and is instructive regarding the capability of a person
of ordinary skill in the art to combine the teachings of the applied art to
achieve the invention of claim 23. See Randall v. Rea, 733 F.3d 1355,
1361-1363 (Fed. Cir. 2013).
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