Ex Parte Eidenschink

Patent Trial and Appeal Board

Jan 31, 2019

14178780 (P.T.A.B. Jan. 31, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/178,780 02/12/2014
530 7590 02/04/2019
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
600 SOUTH A VENUE WEST
WESTFIELD, NJ 07090
FIRST NAMED INVENTOR
Tracee Eidenschink
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.
STJUDE 3.0-201 1093
EXAMINER
EASTWOOD, DAVID C
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
02/04/2019 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):
eOfficeAction@ldlkm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TRACEE EIDENSCHINK
Appeal2018-000427 1
Application 14/178,780
Technology Center 3700
Before KEVIN F. TURNER, EDWARD A. BROWN, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision to reject claims 1---6, 8, 9, 13, and 16-19. 2 We have jurisdiction
under 35 U.S.C. § 6(b ).
We AFFIRM.
1 St. Jude Medical, Cardiology Division, Inc. is the Appellant and is listed in
the Appeal Brief as the real party in interest. Appeal Br. 2.
2 Claims 7, 10-12, 14, and 15 are withdrawn. Appeal Br. 10-11 (Claims
App.).
Appeal2018-000427
Application 14/178,780
CLAIMED SUBJECT MATTER
The claims are directed to a system and method for filtering and
removing debris from the bloodstream of a patient. Spec. ,r 2. Claims 1 and
18, reproduced below with emphases added, are illustrative of the claimed
subject matter:
1. A vessel protector, comprising:
a body formed from a filtering material, the body having a
collapsed configuration and a tubular expanded configuration
with an open proximal end and an open distal end, and having
openings of a size no smaller than about 80 um2 and no larger
than about 3 00 um2;
a first snare attached to one end of the body; and
a first pull-wire connected to the first snare, whereby the
exertion of a pulling force on the first pull-wire contracts the first
snare and thereby closes the one end of the body.
Appeal Br. 10 (Claims App.). 3
18. A method for protecting blood vessels during a medical
procedure, comprising:
inserting a vessel protector system into a patient's body,
the vessel protector system including a vessel protector and a
sheath, the vessel protector having a body formed from a filtering
material, the body having a collapsed configuration and a tubular
expanded configuration, and having openings of a size no smaller
than about 80 um2 and no larger than about 300 um2, and the
sheath being movable relative to the body between a first position
for holding the body in the collapsed configuration, and a second
position for releasing the body for movement to the expanded
configuration;
positioning the vessel protector system adjacent an open
end of at least one blood vessel; and
moving the sheath to the second position to deploy the
body, whereby the body moves to the tubular expanded
configuration covering the open end of the at least one blood
3 Appellant uses the units "um" to indicate "µm" and "um2" to indicate
"µm2.,,
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Application 14/178,780
vessel to filter blood passing through the body into the at least
one blood vessel.
Id. at 12.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Yodfat
Sepetka
Brady
Greenberg
Adams
US 2003/0125801 Al July 3, 2003
US 6,663,650 B2 Dec. 16, 2003
US 2006/0276887 Al Dec. 7, 2006
US 2007 /0055365 Al Mar. 8, 2007
US 2014/0249568 Al Sept. 4, 2014
REJECTIONS
I. Claims 1-6, 8, 9, 13, and 16-19 are rejected under 35 U.S.C.
§ 112, second paragraph, as indefinite.
II. Claims 18 and 19 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Y odfat and Greenberg.
III. Claims 18 and 19 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Adams and Greenberg.
IV. Claims 1-6, 8, 9, 13, and 16 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Yodfat, Greenberg, and Brady.
V. Claims 1-6, 8, 9, 13, 16, and 17 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Adams, Greenberg, and Sepetka.
OPINION
Rejection I, Indefiniteness
The Examiner determines that the term "about," as recited before the
endpoints of the numerical ranges in each of independent claims 1, 16, and
18, renders these claims indefinite. See Final Act. 7-8. Specifically, the
Examiner states, "the instant specification fails to disclose with sufficient
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Application 14/178,780
specificity the degree to which the term 'about' should be afforded." Id.
The Examiner likens claims 1, 16, and 18 to claims that were determined to
be indefinite in Amgen, Inc. v. Chugai Pharm Co., Ltd., 927 F.2d 1200 (Fed.
Cir. 1991). Id. at3--4.
Appellant contends "one of ordinary skill in the art would know that
the claims' recitation of 'about' in the terms 'about 80 um2 ' and 'about 300
um2 ' is intended to account for the manufacturing variation, or 'tolerance,'
in the size of the openings," and "infringement of the claims could be clearly
determined by measuring the size of the openings of an accused device."
Appeal Br. 5. Appellant asserts that the term "about" as recited in the
independent claims merely reflects the practicalities of manufacturing a filter
material, and, in the context of the recited limitations, a person of ordinary
skill in the art would understand this. Id. at 6.
In response, the Examiner finds that Greenberg qualifies as "close
prior art" as discussed in Amgen, and, therefore, given the lack of guidance
provided by the Specification as to the meaning of the term "about" in
claims 1, 16, and 18, these claims are properly rejected as indefinite. Ans.
4--5; see also Amgen, 927 F.2d at 1218.
Appellant has the better position. The decision in Amgen included an
explicit caution that the holding therein "should not be understood as ruling
out any and all uses of [the term 'about'] in patent claims. It may be
acceptable in appropriate fact situations ... even though it is not here."
Amgen, 927 F.2d at 1218. The Court also indicated that even without the
use of the term "about," the claims at issue were indefinite. Id. at 1218. The
Court's cautionary language highlights that the determination of
indefiniteness based on the use of the word "about" is to be based on the
facts presented in each case. In Amgen, the two principal factors that the
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Application 14/178,780
Court found probative were that the only available method to measure the
"specific activity" that was claimed using the term of degree "about" was
itself an imprecise form of measurement and that the term "about" was a
significant factor in the patentee's ability to obtain allowance of the claims
at issue over the prior art. Id. at 1217-1218. Here, the cross-sectional areas
of the pores of the filter material are readily susceptible of being accurately
measured by any number of methods inasmuch as they relate to physical
dimensions of the pores. Further, as will be seen in the ensuing discussion
of the rejections based on the prior art, the claimed size of the openings is
not critical to the patentability of the claims. As such, the outcome in
Amgen is not particularly germane to the present situation. For these
reasons, we do not sustain this rejection.
Rejection II, Yodfat and Greenberg
(a)
The Examiner relies on Y odfat to teach many of the elements recited
in claim 18, but relies on Greenberg to teach that, in a blood filtering
element, a "pore diameter should be at least 1 Oµm and preferably 20µm in
diameter ... which would provide an open size range of 78.5 µm2-3 l 4
µm2." Final Act. 9-10; see also Greenberg ,r 5. Further, the Examiner
determines that "[i]t would have been obvious to ... provide the filtering
deflecting means of Adams with the open size range as disclosed by
Greenberg since Greenberg discloses that this opening size is preferable for
allowing blood flow while preventing the passage of clots and emboli
(paragraph 5)." Final Act. 10-11.
Appellant argues that the Examiner erred in finding that Greenberg
discloses that the size of the pores in its filter media are preferably 20 µm in
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diameter. Appeal Br. 8. Specifically, Appellant asserts, "Greenberg's
paragraph [0005] does not disclose 'openings of a size ... no larger than
about 300 um2,' but rather, discloses pores of at least 10 um in diameter
(area of78.5 um2) or pores of at least 20 um in diameter (area of314 um2)."
Id.
In response, the Examiner states:
Greenberg teaches pores that encompass the disclosed range of
between about 80µm2 and about 300µm2 which corresponds to
no smaller than about 80µm2 and no larger than about 300µm2 by
teaching "pores of at least 10 µmin diameter ( area of 78.5 µm2)"
which discloses openings which are no smaller than about 80µm2
and no larger than about 300µm2.
Ans. 9 (emphasis omitted). Thus, the Examiner finds that Greenberg's
disclosure of pores having diameters ofat least 10 µm (areas of at least 78.5
µm2) satisfies the pore size requirement in claim 18 because this disclosure
teaches pore sizes falling within (as well as above) the recited 80 µm2-300
µm2 range. Accordingly, the Examiner implicitly interprets claim 18 as
allowing for pore sizes to also exceed the 3 00 µm2 upper limit of the range.
In reply, Appellant contends that the range of pore sizes set forth in
claim 18 applies to all the pores in the filter material, i.e., that the filter
material does not allow passage of particles larger than the 300 µm2 upper
limit. See Reply Br. 1-3. Consequently, according to Appellant, the
disclosure in Greenberg of filter material having pores with diameters of at
least 10 µm (areas of at least 78.5 µm2) fails to meet the requirement that the
pores have openings of a size no smaller than about 80 µm2 and no larger
than about 300 µm2. See id.
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During examination of a patent application, pending claims are given
their broadest reasonable construction consistent with the Specification. In
re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
The correct inquiry in giving a claim term its broadest reasonable
interpretation in light of the specification is not whether the
specification proscribes or precludes some broad reading of the
claim term adopted by the examiner. And it is not simply an
interpretation that is not inconsistent with the specification. It is
an interpretation that corresponds with what and how the
inventor describes his invention in the specification, i.e., an
interpretation that is "consistent with the specification."
In re Smith Int'!, Inc., 871 F.3d 1375, 1382-1383 (Fed. Cir. 2017) (quoting
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997)). Claim 18 recites a
method for protecting blood vessels during a medical procedure. Appeal Br.
12 (Claims App.). Paragraphs 20 and 21 of the Specification describe
accomplishing this function by blocking particulates that are greater than a
certain size while allowing the passage of blood, and paragraph 21 explains
that openings in the filter material having a size of "between about 80 µm2
and 300 µm2" perform this function. This discussion in paragraph 21 is the
only place in the Specification that mentions the recited 80 µm2-300 µm2
pore size range. Accordingly, the broadest reasonable interpretation of
claim 18, consistent with the Specification, precludes using a filter material
having pore sizes greater than 300 µm2 inasmuch as the purpose of the filter
material is to block particulate, and having pore sizes larger than 300 µm2
would, by passing relatively large particles, frustrate the blocking effect of
having pores with sizes inside the recited range. Consequently, the
Examiner's finding that Greenberg's disclosure of pores having diameters of
at least 10 µm (areas of at least 78.5 µm2) satisfies the pore size requirement
in claim 18 is based on an unreasonably broad interpretation of claim 18.
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(b)
The Examiner provides an alternate basis for rejecting claim 18,
namely, that in light of the teachings of Yodfat and Greenberg, a person of
ordinary skill in the art would have recognized the size of pores in a filter
material as a result-effective variable. Final Act. 11. Specifically, the
Examiner finds Greenberg teaches open pore sizes may be in the recited
range "for the purpose of preventing the passage of clots and emboli." Id.
( citing Greenberg ,r 5). From this, the Examiner determines that it would
have been obvious to a person of ordinary skill in the art, as a matter of
routine optimization, "to provide the openings of a size no smaller than
about 80 µm2 and no larger than about 300 µm2, for the purpose of
preventing the passage of clots and emboli." Id. (citing In re Aller, 220 F.2d
454 (CCPA 1955)).
Appellant does not specifically discuss the Examiner's alternate basis
for rejecting claim 18. See Appeal Br. 7-9; Reply Br. 1-3. However,
Appellant asserts that Greenberg teaches away from providing an upper limit
of 300 µm2 by disclosing that a pore diameter of at least 20 µm (an area of
314 µm2) is preferred. Appeal Br. 8. Appellant contends that this disclosure
in Greenberg encourages the use of pore sizes of 314 µm2 and above, and,
therefore, discourages the use of pore sizes of less than 314 µm2. Reply Br.
2-3.
The Examiner's finding that Greenberg teaches that the size of pores
in filter material is recognized as a result-effective variable for blood
filtering (Final Act. 11) is supported by a preponderance of the evidence.
See Greenberg, Abstract, ,r 5. Further, Appellant's argument that Greenberg
teaches away from the pore size range recited in claim 18 is unavailing. See
In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) ("[A] finding that the
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Application 14/178,780
prior art as a whole suggests the desirability of a particular combination need
not be supported by a finding that the prior art suggests that the combination
claimed ... is the preferred, or most desirable, combination."). The
statement in Greenberg that a pore diameter of at least 20 µm ( area of at
least 314 µm2) is preferred, but also indicating that pore diameters of at least
10 µm (areas of at least 78.5 µm2) function to filter blood (Greenberg ,r 5),
does not amount to teaching away from the use of pore diameters sizes
limited to a range of 80 µm2 to 300 µm2 as recited. Accordingly, we sustain
the Examiner's rejection of claim 18, and claim 19 depending therefrom, as
unpatentable over Y odfat and Greenberg.
Rejections 111-V
The Examiner relies on the same findings of fact and reasoning
regarding modifications based on Greenberg in Rejections III-Vas
discussed above for Rejection II. See Final Act. 13-16, 20-22. Appellant
contends that the arguments discussed above apply to each of Rejections HI-
V and makes no separate arguments contesting any of these rejections. See
Appeal Br. 7-9. Accordingly, for the same reasons discussed regarding
Rejection II, we sustain Rejections III-V.
DECISION
The Examiner's decision rejecting claims 1-6, 8, 9, 13, and 16-19 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).
AFFIRMED
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