Ex Parte Santilli

Patent Trial and Appeal Board

Jul 26, 2017

11614238 (P.T.A.B. Jul. 26, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
KSI-16377.001 9034
EXAMINER
LEVINE, JOSHUA H
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
11/614,238 12/21/2006 Albert N. Santilli
07/26/201777096 7590
WAYNE D PORTER, JR
LAW OFFICES OF WAYNE D. PORTER, JR.
6200 ROCKSIDE WOODS BOULEVARD NORTH
SUITE 315
INDEPENDENCE, OH 44131
07/26/2017 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
Ex parte ALBERT N. SANTILLI
Appeal 2015-005664
Application 11/614,23s1
Technology Center 3700
Before WILLIAM A. CAPP, LEE L. STEPINA, and
FREDERICK C. LANEY, Administrative Patent Judges.
LANEY, Administrative Patent Judge.
DECISION ON APPEAL
Albert N. Santilli (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner’s decision rejecting claims 1, 6, 7, 9, 13, and 19—29.2 We have
jurisdiction over this appeal under 35 U.S.C. § 6(b).
We REVERSE, and enter NEW GROUNDS OF REJECTION.
1 According to Appellant, an additional interested party is Kapp Surgical
Instrument, Inc. Appeal Br. 1 (filed Nov. 24, 2014).
2 Claims 2—5, 8, 10-12, and 14—18 have been canceled. Appeal Br. 24—26.
Appeal 2015-005664
Application 11/614,238
INVENTION
Appellant’s invention “relates to prosthetic heart components made of
biological tissue and, more particularly, to tissue heart components,
particularly valves, that are precisely sized for an optimized fit.” Spec. 12.
Claims 1 and 13 are independent. Claim 1 is illustrative of the
claimed invention and reads as follows:
1. A method of manufacturing a replacement
prosthetic tissue heart component for a patient,
comprising the steps of:
scanning the patient's heart non-invasively by CT
angiography using a multislice scanner to create CT
images of the heart while the heart is beating;
wherein the images generated by the scanning
operation are two-dimensional and three-dimensional
images;
providing a programmable digital computer system
having a computer readable memory, where the computer
system is programmed to generate and view images and
thereby provide measurements of said heart components;
wherein the computer system imports the CT-scans
and uses the programmed algorithms to convert scan data
to create the three-dimensional images;
wherein the heart component to be replaced is
selected from the group consisting of tricuspid valves,
aortic valves, aortic valve conduits, mitral valves,
annuloplasty rings, pulmonic valves, pulmonic valve
conduits, and pericardial patches;
determining the specific dimensions of the said
heart component to be replaced from the images
generated by the non-invasive scan; and
manufacturing the said replacement heart
component using information from the images and the
specific dimensions of the heart component to be
replaced.
Appeal Br. 24 (Claims App.).
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Application 11/614,238
REJECTIONS
The following rejections are before us for review:
I. The Examiner rejected claims 1, 6, 7, 9, 13, and 19 under 35
U.S.C. § 102(b) as being anticipated by Jarvik (US
2006/0195004 Al, iss. Aug. 31, 2006).
II. The Examiner rejected claims 20, 22, 23, 25, 27, and 28 under
35 U.S.C. § 103(a) as unpatentable over Jarvik.
III. The Examiner rejected claims 21, 24, 26, and 29 under 35
U.S.C. § 103(a) as unpatentable over Jarvik and True Life
Anatomy (2003 winner of consensus software animations,
http:// www. consensus. eom. au/Soft ware Awards/ C S Aarchi ve/C S
A2003/Truelife.htm).
ANALYSIS
Rejection I
Claims 1 and 13, from which claims 6, 7, 9, and 19 depend, recite a
method for producing a replacement prosthetic heart component for a
patient, “wherein the heart component to be replaced is selected from the
group consisting of tricuspid valves, aortic valves, aortic valve conduits,
mitral valves, annuloplasty rings, pulmonic valves, pulmonic valve conduits,
and pericardial patches,” that includes the step of “manufacturing the said
replacement heart component using information from the images and the
specific dimensions of the heart component to be replaced.” Appeal Br. 24,
26 (Claims App.). Appellant asserts the Examiner fails to identify evidence
from Jarvik that shows manufacturing tricuspid valves, aortic valves, aortic
valve conduits, mitral valves, annuloplasty rings, pulmonic valves, pulmonic
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Application 11/614,238
valve conduits, or pericardial patches as a replacement prosthetic heart
component for a patient. Appeal Br. 12. The Examiner finds Jarvik
discloses an aortic valve replacement prosthetic heart component and the
recited method steps for manufacturing the component. Final Act. 7—8
(citing Jarvik H 17, 32, 35, Abstract). Having considered the evidence cited
by the Examiner, and the explanation thereof, we agree with Appellant for
the following reasons.
Jarvik discloses a miniature blood pump with a shaped anatomic
adaptor 16 that fits within the cross sectional area of one of the three leaflets
of either the aortic or pulmonary valve. Jarvik 132, Figs. \—A. “The
anatomic adaptor has two facet like surfaces 18, 20, that match the size and
shape of the sealing surfaces of the two valve leaflets that close against
them.” Id. “The optimal shape for the anatomic adaptor 16, fills the
complete sinus of valsalva in which it is placed, with no crevices where
blood clots can form.” Id. 135. “The adaptor shape nests into the sinus of
valsalva and helps retain the miniature blood pump in place, and also helps
hold the facet like valve sealing surfaces in exact opposition to the closed
valve leaflets.” Id. “[WJhere the patient’s natural valve leaflets are
preserved, [the anatomic adaptor] shape is based on custom geometric
measurements from CT or MRI imaging of the individual patient’s natural
valve . . . [and] custom fabricate^]... to exactly fit the patient.” Id. Jarvik
teaches an object of the disclosed device is “to provide a transvalvular pump
custom matched to the individual patient’s anatomy for optimal
performance.” Id. 117. Put more simply, Jarvik discloses a medical pump
with an adaptor, which is customizable using measurements from CT or
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Application 11/614,238
MRI medical imagery to match the size and shape of the natural surfaces
that it will contact within the aortic or pulmonary valve.
Other than simply identifying paragraphs 17, 32, and 35 from Jarvik’s
Specification, the Examiner provides little guidance for how the disclosed
pump with a customizable adapter discloses, “manufacturing the said
replacement heart component using information from the images and the
specific dimensions of the heart component to be replaced,” as claims 1 and
13 recite. In particular, it is unclear how Jarvik’s pump qualifies as a
“replacement heart component” with “specific dimensions of the heart
component to be replaced.”
First, the Examiner does not provide any evidence that a skilled
artisan would have viewed the pump Jarvik discloses as a “replacement heart
component.” Although Jarvik discloses locating a pump within the area
created by a removed leaflet, the Examiner has not offered any reasonable
interpretation of “replacement heart component” that extends its scope to
any device that supplants a component in the heart. In the context of the
claims and the Specification, the broadest reasonable construction requires a
heart component that is intended to replicate (i.e., mimic) the component
being replaced. And, we cannot find any evidence suggesting the pump
Jarvik discloses is designed to replicate the leaflet it will replace.
Second, while Jarvik discloses that the pump may be customizable to
fit exactly within the void that a removed leaflet creates, we are unable to
find any supportive evidence that the pump, or its adaptor, replicates the
specific dimensions of the leaflet itself that is being replaced. Jarvik instead
describes customizing the size and shape of the leaflets remaining in the
aortic valve that will close against them. Jarvik 132. Moreover, the
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Application 11/614,238
Examiner does not offer any reasonable interpretation of the claim language
that would cover any article of manufacture that is designed to fit within the
specific cross sectional area created by the removed heart component,
regardless of whether the dimensions of the article do not resemble the heart
component being replaced in any other way. Nor are we able to find any
support for such an interpretation. There is no proof the pump and adaptor
that Jarvik discloses is designed to have the “specific dimensions” of the
leaflet being replaced, other than the dimension defining the space created
by its removal.
Finally, in response to Appellant’s argument that Jarvik does not
disclose manufacturing the recited heart components, the Examiner states,
claims 1 and 13 include a Markush group with its species
defining the genus of heart component. Therefore, if any one of
the species is considered anticipated then the genus is considered
anticipated. The genus of a heart component is considered
anticipated as Jarvik disclosed at least an aortic valve
(itransvalvular pump implanted into the non-coronary cusp of the
aortic valve . . .).
Final Act. 4 (citing Jarvik 122); Ans. 6. The Examiner’s response does not
address the pertinent issue. Regardless of the fact that claims 1 and 13
identify a “Markush group,” the Examiner does not identify why the
transvalvular pump implanted into the non-coronary cusp of the aortic valve
is proof Jarvik discloses manufacturing an aortic valve itself. Still further,
there is no evidence the pump is replacing an aortic valve or has the
“specific dimensions” of the aortic valve to be replaced.
Because a claim is anticipated only “if a single prior art reference
discloses each and every limitation of the claimed invention,” the
Examiner’s determination that Jarvik anticipates claims 1 and 13 is
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Application 11/614,238
improper. In re Rambus, Inc., 753 F.3d 1253, 1256 (Fed. Cir. 2014).
Although a preponderance of the evidence supports the Examiner’s finding
that Jarvik discloses many of the manufacturing steps recited in claims 1
and 13, Jarvik is insufficient as proof that the manufacturing method was
known to manufacture a “replacement heart components” (and, in particular,
an aortic valve) with the “specific dimensions of the heart component to be
replaced,” which is also a limitation of claims 1 and 13. Therefore, we do
not sustain the Examiner’s rejections of claims 1, 6, 7, 9, 13, and 19.
New Grounds Of Rejection
Unpatentability Over Jarvik And Admitted Prior Art
Claims 1 and 13
Notwithstanding the foregoing reversal of the anticipation grounds of
rejection, we are convinced the broad scope of claims 1 and 13, and the
Examiner’s supportable factual findings, demonstrate these claims are
unpatentable in view of Jarvik and Appellant’s description of prior
knowledge in paragraph 3—5 of the Specification (referred to hereinafter as,
“AAPA”). The AAPA makes clear that the desirability of providing a
precise fit for a replacement heart valve was known. See Spec. 14
(“Surgeons must settle for choosing the closest size from among tissue
valves of varying predetermined sizes; the surgeon then must do his or her
best to form or adapt the valve to fit the area in the patient where the
prosthetic valve will be placed.”). When considering the obviousness of
claimed subject matter, it is appropriate to consider whether “a person of
ordinary skill in the art, possessed with the understandings and knowledge
reflected in the prior art, and motivated by the general problem facing the
inventor, would have been led to make the combination recited in the
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Application 11/614,238
claims.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). From the evidence
of record in this case, we conclude a skilled artisan, based on the
understandings and knowledge reflected in Jarvik and AAPA, and motivated
by the general need to replace a patient’s diseased or damaged heart valve
with a replica heart valve that provides a precise fit, would have been led to
make the arrangement recited in the claims.
We first note that we agree with the Examiner’s findings that Jarvik
discloses that it was known to use a CT scanner to obtain two and three-
dimensional imagery for the purpose of getting specific dimensional
information about a heart component and to enable a prosthetic heart device
to be manufactured to match the shape and size of a patient’s heart
component. See Final Act. 4—8; Ans. 6—9. As such, although Jarvik does
not disclose manufacturing the heart components specifically recited in
claims 1 and 13, we agree, for the reasons articulated by the Examiner, that
Jarvik discloses each of the remaining manufacturing steps claims 1 and 13
recites. Because Jarvik discloses using a CT scanner to generate medical
imagery of a heart component, i.e., leaflets, for manufacturing a pump with
surfaces that “match the size and shape of the sealing surfaces of the two
valve leaflets that close against them” (Jarvik 132), and because a skilled
artisan recognized an implanted aortic valve needs to fit the patient precisely
(AAPA 14), the skilled artisan artisan would have been led to use the
known technique of using CT scanner imagery to get the specific
dimensional geometry of a patient’s aortic valve to manufacture an aortic
valve that matches the size and shape of the one being replaced. Therefore,
pursuant to 37 C.F.R. § 41.50(b), we enter a NEW GROUNDS OF
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Application 11/614,238
REJECTION, and reject claims 1 and 13 under 35 U.S.C. § 103(a) as
unpatentable over Jarvik and APAA.
Claims Depending From Claims 1 and 13
Regarding the dependent claims, we leave it to the Examiner, upon
return of this application for further prosecution, to determine whether it is
appropriate to allow or reject the dependent claims in light of the new
ground of rejection that we have entered. No inference should be drawn
from our lack of entering a new ground of rejection of other claims.3
Rejection II
Claims 20, 22, and 23 depend from claim 1, and claims 25, 27, and 28
depend from claim 13. The Examiner’s rejection of these claims, therefore,
rely upon the same unsupported findings discussed above with respect to
independent claims 1 and 13. See Final Act. 8—9. The Examiner does not
remedy the deficiencies of claims 1 and 13. Asa result, for similar reasons
set forth above for independent claims 1 and 13, we likewise do not sustain
the Examiner’s rejection of claims 20, 22, 23, 25, 27, and 28.
We note the Examiner’s rejection of claims 20, 22, 23, 25, 27, and 28
on obviousness grounds simply identifies the elements missing and finds
that those elements were well known without any articulated reason with
some rational underpinning for why a skilled artisan would have known to
3 See 37 C.F.R. § 41.50(b); see also Manual of Patent Examining Procedure
(MPEP), 8th ed., rev. 8, July 2010, § 1213.02. Under 37 C.F.R. § 41.50(b),
the Board may, in its decision, make a new rejection of one or more of any
of the claims pending in the case. Because the exercise of authority under
37 C.F.R. § 41.50(b) is discretionary, no inference should be drawn from the
decision to exercise that discretion with respect to some but not all of the
claims on appeal.
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Application 11/614,238
make the claimed combinations. See id. The Federal Circuit has held,
however, that “[a] rejection on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d at 988.
Rejection III
Claims 21 and 24 depend from claim 1, and claims 26 and 29 depend
from claim 13. The Examiner’s rejection of these claims, therefore, relies
upon the same unsupported findings discussed above with respect to
independent claims 1 and 13. See Final Act. 9. The Examiner does not
remedy the deficiencies of the rejection of claims 1 and 13. Asa result, for
similar reasons set forth above for independent claims 1 and 13, we likewise
do not sustain the Examiner’s rejection of claims 21, 24, 26, and 29.
DECISION
We reverse the Examiner’s rejections of claims 1, 6, 7, 9, 13, and 19-
29.
We enter a NEW GROUND OF REJECTION of claims 1 and 13,
pursuant to 37 C.F.R. § 41.50(b), under 35 U.S.C. § 103(a) as unpatentable
over Jarvik and APAA.
37 C.F.R. § 41.50(b) provides that “[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 Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
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Application 11/614,238
(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. . . .
Further guidance on responding to a new ground of rejection can be
found in MPEP § 1214.01.
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)(l)(iv).
REVERSED; 37 C.F.R, $ 41.50(b)
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