Ex Parte Churchill et al

Patent Trial and Appeal Board

May 16, 2017

12432675 (P.T.A.B. May. 16, 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.
12/432,675 04/29/2009 William Lucas Churchill 70.008 US CIP2 7584
102261 7590 05/18/2017
Vista IP Law Group - Interlace Medical
Nancy Rushton
21760 Stevens Creek Blvd.
Suite 100
Cupertino, CA 95014
EXAMINER
SHI, KATHERINE MENGLIN
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/18/2017 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):
nnr @ viplawgroup .com
sp @ viplawgroup. com
hologicpatentgroup @ hologic .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM LUCAS CHURCHILL, ROY HEWITT SULLIVAN,
ALBERT CHUN-CHI CHIN, ERIC KARL LITSCHER,
WILLIAM HARWICK GRUBER, and RONALD DAVID ADAMS
Appeal 2016-002428
Application 12/432,6751
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a tissue
removal device, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Hysteroscopic resection is a treatment for removal of uterine fibroids
involving insertion of a scope into the uterus through the vagina, i.e.,
transcervically, and then cutting away the fibroid from the uterus. (Spec.
1 Appellants identify the Real Party in Interest as Hologic, Inc. (Appeal Br.
2.)
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Application 12/432,675
Tflf 4—7.) Electromechanical cutters inserted through a hysteroscope or
“resectoscopes” are devices known for removal of the fibroid tissue. (Id.
6—8.) Appellants’ invention is directed to a device for gynecological
tissue removal. (Id. H 2, 9.)
Claims 1, 3—5, 7—11, 14, and 16—20 are on appeal. Claims 1, 9, 10,
and 11 are representative and read as follows:
1. A tissue removal device, comprising:
a housing;
an outer tube having a proximal end and a distal end, the
proximal end of the outer tube being supported by the housing,
the outer tube configured for transcervical insertion and having
a tissue resection window proximate the distal end of the outer
tube;
an inner tube disposed within the outer tube, the inner tube
configured to be translated and rotated relative to the outer tube
during operation of the tissue removal system, so that a distal
end of the inner tube moves back and forth across the resection
window to sever tissue extending therethrough; and
a motor drive assembly operatively coupled to the inner tube,
wherein actuation of the motor drive assembly causes the inner
tube to rotate at a speed of at least about 3000 rotations per
minute, and to oscillate translationally at a rate of about 1.5 to
about 4 cycles per second.
(Appeal Br. 11.)
9. The tissue removal system of claim 1, wherein actuation of
the motor drive assembly enables the inner tube to remove
tissue at a rate of at least 1.5 gm/min.
10. The tissue removal system of claim 1, wherein the outer
tube comprises an outer diameter of no greater than about 3.0
mm.
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11. A tissue removal device, comprising:
a housing;
an outer tube having a proximal end and a distal end, the
proximal end of the outer tube being supported by the housing,
the outer tube configured for transcervical insertion and having
tissue resection window proximate the distal end of the outer
tube;
an inner tube disposed within the outer tube, the inner tube
configured to be translated and rotated relative to the outer tube
during operation of the tissue removal device, so that a distal
end of the inner tube moves back and forth across the resection
window to sever tissue extending therethrough;
a drive shaft disposed within the housing, the drive shaft
comprising a helical groove;
a carriage engaged with the drive shaft such that the drive shaft
rotates relative to the carriage, and rotation of the drive shaft
causes the carriage to oscillate translationally relative to the
drive shaft, wherein the carriage is coupled to the inner tube
such that the inner tube oscillates translationally with the
carriage, wherein a speed at which the inner tube oscillates
translationally depends on a structure of the helical groove;
a spur gear fixedly coupled to the drive shaft; and
an elongated gear fixedly coupled to the inner tube and engaged
with the spur gear, wherein a speed at which the inner tube
rotates depends on the relative diameters of the spur gear and
the elongated gear,
wherein the structure of the helical groove and the relative
diameters of the spur gear and the elongated gear are configured
such that the device has an advance ratio of no more than about
0.15, the advance ratio being the ratio of the speed at which the
inner tube oscillates translationally to the speed at which the
inner tube rotates.
(Appeal Br. 12.)
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The following grounds of rejection by the Examiner are before us on
review:
1. Claims 1, 3, 4, 7, 8, 11, 17, and 18 under 35 U.S.C. § 103(a) as
unpatentable over Hibner,2 Drucker,3 and Sussman.4
2. Claim 9 under 35 U.S.C. § 103(a) as unpatentable over Hibner,
Drucker, Sussman, and Hakky.5
3. Claims 10 and 14 under 35 U.S.C. § 103(a) as unpatentable
over Hibner, Drucker, Sussman, and Stine.6
4. Claim 16 under 35 U.S.C. § 103(a) as unpatentable over
Hibner, Drucker, Sussman, and Takasu.7
5. Claim 5 under 35 U.S.C. 103(a) as unpatentable over Hibner,
Drucker, Sussman, and Johnson.8
6. Claims 19 and 20 under 35 U.S.C. § 103(a) as unpatentable
over Hibner, Drucker, Sussman, and Cesarini.9
DISCUSSION
Claim 1 is obvious over Hibner, Drucker, and Sussman
The Examiner finds that Hibner teaches a tissue removal system as
claimed where, during operation of the tissue removal system, the inner tube
is configured to be translated and rotated relative to an outer tube so that the
distal end of the inner tube moves back and forth across the resection
window to sever tissue that extends through the window. (Final Action 2—
3.) The Examiner notes that while Hibner discloses that the motor drive
2 Hibner et al., US 7,611,474 B2, issued Nov. 3, 2009.
3 Drucker et al., US 6,387,110 Bl, issued May 14, 2002.
4 Sussman et al., US 5,284,472, issued Feb. 8, 1994.
5 Hakky et al., US 5,312,399, issued May 17, 1994.
6 Stine et al., US 6,027,514, issued Feb. 22, 2000.
7 Takasu, US 5,190,518, issued Mar. 2, 1993.
8 Johnson et al., US 4,842,578, issued June 27, 1989.
9 Cesarini et al., US 2004/0092980 Al, published May 13, 2004.
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assembly of the device causes the rotation and oscillation of the inner tube at
various speeds, Hibner does not specifically teach rotating it at “at least
about 3000 rotations per minute” or oscillating it translationally at a rate of
about 1.5 to about 4 cycles per second. (Id. at 3 4.) The Examiner finds,
however, that these speeds for rotation and translational oscillation would
have been obvious from Drucker and Sussman. (Id. ) In particular, the
Examiner finds that Drucker is directed to a tissue removing device in which
the motor can be operated to drive an inner tube to rotate at a speed
anywhere between 1,000 to 10,000 rotations per minute to cut tissue through
a resection window. (Id. at 3.) The Examiner finds that Sussman teaches a
tissue removal device where an inner tube is operated to cut tissue through a
resection window anywhere from 1 to 600 cycles per minute, which is 0.017
to 10 cycles per second. (Id. at 4.) The Examiner concludes that because
Drucker and Sussman teach that it was known to operate an inner tube of a
tissue removal device at the rotational speeds and translational oscillation
cycles claimed in processes for cutting tissue through a resection window, it
would be a matter of routine skill in the art to determine the optimum or
workable ranges with only routine skill and arrive at the claimed range. (Id.
at 3-4.)
We agree with the Examiner’s factual findings and conclusion that the
claimed device would have been obvious to one of ordinary skill in the art.
The Examiner has factually determined that claim 1 is directed to a
device whose structural elements are taught by Hibner including a motor
drive assembly that is operatively coupled to the inner tube that causes
rotation and reciprocation of the inner tube. (Hibner 3:5—20, 5:34—67, and
claim 9.) Regarding the device of Hibner, what is deemed obvious, is that in
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light of Sussman and Dracker’s teachings, the structure of Hibner is a motor
drive that either does achieve the speeds claimed in “actuation of the motor
drive assembly,” or was obvious to modify in such a way as to achieve those
speeds.
Appellants do not point to any distinction between the structure set
forth in claim 1 and that of Hibner. A recitation with respect to the manner
in which a claimed apparatus is intended to be employed, as is the limitation
“wherein actuation of the motor drive assembly causes the inner tube to
rotate at a speed of at least about 3000 rotations per minute, and to oscillate
translationally at a rate of about 1.5 to about 4 cycles per second,” does not
differentiate the claimed apparatus from a prior art apparatus satisfying
the structural limitations claimed. See, e.g., In re Yarush, All F.3d 958, 959
(CCPA 1973) (“Appellant’s use limitation does not impart a structural
feature different from those of the prior art. . . . Whether a vibrator is
operated gently to settle materials in a mold or more forcefully to ‘hammer’
them is a process limitation which does not limit or define the claimed
apparatus.”); In re Casey, 370 F.2d 576, 579—80 (CCPA 1967).
A device claim “cannot properly be allowed unless [it] include[s]
structural limitations defining invention over the prior art.” In re Twomey,
218 F.2d 593, 1596 (CCPA 1955). The fact that the structural components
necessary to achieve the claimed reciprocation rate of the inner tube are
present in Hibner suggests that it would be able, without invention, to
produce the reciprocation rate claimed, regardless of whether one skilled in
the art would operate it at those speeds.
Appellants do not contend there is some technical incompatibility that
would prevent the motor of Hibner from operating at the claimed
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reciprocating range. Rather, Appellants disagree with the Examiner’s
conclusion of obviousness because (1) Drucker’s disclosed rotational range
“is not co-extensive with the claimed range” (2) Sussman “does not in any
way indicate an advantage or reason to employ a much narrower range” for
translational oscillation, (3) selecting an optimum reciprocation rate for a
high speed rotational cutter is not addressed by Sussman, and (4) Sussman’s
cutter does not rotate. (Appeal Br. 5—6.) Appellants contend that a person
of ordinary skill in the art “would have no rationale or scientific reason or
motivation to look to Sussman’s vitreous tissue cutter for teaching how to
identify the respective rotational and reciprocation rates of a transcervical
tissue removal device consistent with Appellants’ objective of maximizing
the overall resection rate of intrauterine tissue (i.e., in grams/minute).” (Id.
at 6.) Moreover, Appellants contend that Hibner does not provide “any
reason to impose a reciprocating rate limitation on [its] biopsy device,”
because it is “concerned only with maintaining a minimum number of cutter
rotations through the aperture.” (Id.) Appellants note that a “biopsy device
of the type taught by Hibner is designed to capture a discrete tissue sample
using [a] single reciprocating stroke” and that if another sample is to be
obtained, there must be a pause of several seconds before the next sample is
obtained “to allow the attending medical technician to reposition the tissue
receiving window at a new orientation and/or position.” (Reply Br. 1—2.)
We do not find Appellants’ arguments persuasive.
Regarding Drucker’s disclosed range of operation, to the extent that it
even matters structurally to the claimed motor drive assembly, we note that
“even a slight overlap in range establishes a prima facie case of
obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Here,
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there is a significant overlap of the claimed “at least 3000 rotations per
minute” and Dracker’s disclosed 1000 to 10,000 rotations per minute
(Drucker 3:55—60).
The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims. These cases have consistently held
that in such a situation, the applicant must show that the
particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior
art range.
In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990) (citations omitted).
Appellants have not pointed us to any such showing on this record, much
less one that relates to the structure of the motor assembly of Appellants’
claimed tissue removal device.
Regarding the fact that Sussman does not teach rotation of its inner
tube, we note that “[n]on-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). The reference “must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole.” Id. As the
Examiner explained, Hibner teaches that an inner tube of a resection
assembly can be operated to both rotate and oscillate translationally, i.e.,
reciprocate, to cut tissue in a resection window. (Ans. 14.) Moreover,
Hibner discloses the cutter can rotate and translate at “any speed” with a
fixed relationship. (Hibner 3:5—9.) Sussman was relied upon by the
Examiner for demonstrating that the reciprocation rate range recited in the
claims was not unknown or unconventional for tissue removal devices, and
thus the Hibner device motor assembly was structurally capable of operating
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in this range, or it would have been obvious to modify the structure in such a
way as to be able to operate in that range. (Final Action 16; Ans. 15.)
As the Examiner explained (Final Action 4), ‘“it is not inventive to
discover the optimum or workable ranges by routine experimentation’” of
known results effective variables. In reAller, 220 F.2d 454, 456 (CCPA
1955). Hibner teaches these rates are results effective variables. Hibner
teaches that changes in the density of the tissue encountered by the tube that
moves both rotationally and reciprocally may affect the speeds of both
rotation and reciprocation, and thus, Hibner indicates that the speeds of
rotation and translational oscillation are results effective variables in cutting
efficacy. (Ans. 15; Hibner 2:24—39, 2:64—3:20.)
That Sussman does not indicate an advantage to the claimed range
(Appeal Br. 6) also is of no import to the Examiner’s obviousness position
for the reasons just discussed. The general conditions are disclosed in the
prior art and “where the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable ranges by
routine experimentation.” In re Applied Materials, Inc., 692 F.3d 1289,
1295—96 (Fed. Cir. 2012). The motivation to optimize comes from the
natural desire of those skilled in the art to experiment with, and improve
upon, known conditions taught in the prior art. In re Peterson, 315 F.3d
1325, 1330 (Fed. Cir. 2003).
Sussman and Drucker are relied upon for teaching the claimed
reciprocation rate and rotational rates are ranges that are known in the prior
art for operation of cutter tubes for tissue removal. (Ans. 18.) “If a person
of ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
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Appellants do not argue that achieving a motor assembly that could operate
to have rotational speeds of the inner tube of at least 3000 rpm and
reciprocating motion of about 1.5 to about 4 cycles per second was
unpredictable.
Appellants further argue that because Hibner is directed to a biopsy
device, one of ordinary skill in the art would not “have rationally or
reasonably considered operating Hibner’s tissue biopsy device with the
claimed reciprocation rate range of about 1.5 cycles per second to about 4.0
cycles per second.” (Reply Br. 1.) This argument is similarly unpersuasive
because “[w]hat matters in the § 103 nonobviousness determination is
whether a person of ordinary skill in the art, having all of the teachings of
the references before him, is able to produce the structure defined by the
claim.” Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013 (Fed.
Cir. 1983). Appellants’ argument is inapposite on that point.
Appellants’ argument that “it would have been. . . counter-intuitive to
one of ordinary skill in the art at the time of the Appellants’ claimed
invention to limit the reciprocation rate of the inner cutter despite increasing
its rotational rate” is also unpersuasive for the reasons discussed above, i.e.,
these limitations are directed to the use of the device and not its structure.
(Appeal Br. 6.) What is more, Appellants appear to base this argument on
the fact “Appellants expected that limiting the reciprocation rate, and
consequently resecting fewer tissue samples per minute, would seem to
decrease - not increase — the overall tissue resection rate (in grams per
minute).” {Id.) Claim 1 is not, however, limited to resecting a particular
number of tissue samples. Moreover, a person of ordinary skill in the art is
not the inventor. Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d
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1437, 1454 (Fed. Cir. 1984) (“[C]ourts never have judged patentability by
what the real inventor/applicant/patentee could or would do. Real inventors,
as a class, vary in their capacities from ignorant geniuses to Nobel laureates;
the courts have always applied a standard based on an imaginary worker of
their own devising whom they have equated with the inventor.”)
Consequently, what Appellants would have found to be expected or not by
limiting the reciprocation rate is not probative of what one of ordinary skill
in the art would have expected.
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claim 1 for obviousness over Hibner, Drucker,
and Sussman.
Claims 3, 4, 5, 7, 8, and 16 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 11 and 18 are obvious over Hibner, Drucker, and Sussman
The Examiner finds that Hibner does not disclose an “advance ratio of
no more than about 0.15, the advance ratio being the ratio of the speed at
which the inner tube oscillates translationally to the speed at which the inner
tube rotates” as recited in claims 11 and 18. (Final Action 6, 8.) The
Examiner, however, concludes that the teachings of Drucker and Sussman
regarding rotational speed and reciprocating speeds of inner tubes of tissue
removal devices, see supra, renders the limitation obvious as discovering
“the optimum or workable ranges involves only routine skill in the art.” (Id.
at 7, 9.)
We agree with the Examiner’s conclusion of obviousness regarding
independent claims 11 and 18. Similar to claim 1, Appellants do not argue
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that there are any structural differences in Hibner and the claimed device
that would prevent the advance ratio claimed from being achieved.
Hibner teaches that the cutter drive assembly maintains a fixed
relationship between the cutter rotation speed and translation speed at any
speed. (Hibner 3:5—8 (emphasis added).) And Appellants even
acknowledge that it is possible the combination of speeds taught by Drucker
and Sussman, which Appellants do not contend the structural assembly of
Hibner would not be able to achieve, could result in a ratio of 0.15 or less.
(Appeal Br. 8.) Thus, to the extent that the structure of Hibner would have
to be modified at all to achieve the rotational and reciprocal speeds in the
ranges taught by Drucker and Sussman, which Appellants’ do not contend to
be the case, Appellants concede the structure would be capable of operating
with the claimed advance ratio.
Moreover, as with claim 1, Appellants do not contend there is some
technical incompatibility that would prevent the Hibner device from
operating at the claimed advance ratio range. Rather, Appellants disagree
with the Examiner’s conclusion of obviousness because the combination of
Sussman and Drucker with Hibner results in advance ratios outside of the
claimed range. To the extent that this argument has any relevance to the
structural elements recited in claims 11 or 18, we note that “even a slight
overlap in range establishes a prima facie case of obviousness.” Peterson,
315 F.3d at 1329. Determining workable ranges of the advance ratio, i.e.,
“the ratio of the speed at which the inner tube oscillates translationally to the
speed at which the inner tube rotates,” in view of the fact that Drucker and
Sussman teach the speeds for moving the inner tube rotationally and
reciprocally were known, would be an obvious matter of optimization. The
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motivation to optimize comes from the natural desire of those skilled in the
art to experiment with, and improve upon, known conditions taught in the
prior art. Peterson, 315 F.3d at 1330. And as with claim 1, Appellants have
not established with factual evidence any unexpected properties related to
the structure of the devices recited by claims 11 and 18 to rebut that prima
facie case.
We find Appellants’ arguments regarding unexpectedness as related to
the operation of the devices recited in claims 11 and 18 at the claimed ratio
unpersuasive. Appellants contend that they were unsuccessful in designing a
uterine fibroid treatment device that increased uterine fibroid tissue removal
when they “first attempted conventional device design and operating
parameters that were thought to be routine to those skilled in the art.”
(Appeal Br. 8.) This argument is not persuasive in light of the fact that
claims 11 and 18 are not limited to uterine fibroid tissue removal, nor are
they limited to a device that effects a particular amount of fibroid tissue
removal. Moreover, Appellants’ argument as to what they found to be
unexpected is not probative of what one of ordinary skill in the art would
have expected for the claimed invention for two reasons. First, “[o]ne way
for a patent applicant to rebut a prima facie case of obviousness is to make a
showing of ‘unexpected results,’ i.e., to show that the claimed invention
exhibits some superior property or advantage that a person of ordinary skill
in the relevant art would have found surprising or unexpected.” In re Soni,
54 F.3d 746, 750 (Fed. Cir. 1995) (underlining added); see also, Pfizer, Inc.
v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (“Pfizer’s evidence
must fail because the record is devoid of any evidence of what the skilled
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artisan would have expected.”) Appellants are not the person of ordinary
skill in the art. Kimberly-Clark, 745 F.2d at 1454.
Second, “it is well settled that unexpected results must be established
by factual evidence.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Attorney argument is not such factual evidence. Id.
Appellants’ additional argument that they “discovered that limiting
the advance ratio of their tissue removal device . . . achieved ‘particularly
good results’” (Appeal Br. 8) is also unpersuasive. “[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.” In re Baxter Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Appellants have provided no
comparison, asserting, instead, their subjective viewpoint. Moreover, the
claims recite an advance ratio of no more than 0.15, whereas Appellants’
Specification indicates that “particularly good results have been achieved
under the following conditions .. . advance ratio of preferably less than
0.25.” (Spec. 195.) Thus, there is reason to believe that the advance ratio
of 0.15 is not critical to achieving particularly good results.
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claims 11 and 18 for obviousness over Hibner,
Drucker, and Sussman.
Claim 17 has not been argued separately and therefore falls with claim
11. 37C.F.R. §41.37(c)(l)(iv).
Claims 19 and 20 have not been argued separately and therefore fall
with claim 18. 37 C.F.R. § 41.37(c)(l)(iv).
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Claim 9 is obvious over Hibner, Drucker, Sussman and Hakky
Claim 9 requires the actuation of the motor drive assembly enable
tissue removal at a rate of at least 1.5 gm/min. The Examiner finds that
Appellants’ Specification at paragraph 95 teaches that the claimed removal
rate is achievable by operating the drive assembly at certain rotational and
reciprocating speeds. In light of that, and because Drucker and Sussman
indicate that such speeds are known to be achievable, and the speeds would
have been obvious speeds for the drive motor assembly structure taught by
Hibner to be capable of operating at, the Examiner concludes the claimed
rate of removal would have been capable of being achieved with the Hibner
device. (Ans. 18—19.) The Examiner further finds that Hakky teaches rates
of removal of between 6 and 8 gm/min are known “for safely removing
tissue.” {Id. at 19.) Appellants contend that “just because Hakky may teach
a system for extracting tissue at a rate of at least 1.5 grams per minute, does
not mean that Hibner’s tissue biopsy device can be operated to do so.”
(Appeal Br. 9.)
We do not find Appellants’ argument persuasive. The claim 9
limitation regarding actuation of the motor assembly is a recitation of the
manner in which the claimed tissue removal device is intended to be
employed, i.e., so as to remove tissue at the recited rate, and as such it does
not differentiate the claimed apparatus from a prior art apparatus satisfying
the structural limitations claimed. Yarush, All F.3d at 959. As with claim
1, Appellants do not argue any structural differences with regard to Hibner.
Thus, we agree with the Examiner that the motor assembly of Hibner, which
Appellants do not argue is structurally incapable of operating at the
rotational speeds taught by Drucker and the reciprocating rates taught by
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Sussman, is also capable of operating to remove the recited minimum
amount of tissue per minute (Ans. 19), a removal rate that Appellants do not
contend is unknown or unexpected. Appellants’ further argument that “there
is no . . . reason for using the Hibner biopsy device to remove at least 1.5
gm/min of tissue” (Appeal Br. 9) is similarly unpersuasive. “[T]he test [for
obviousness] is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413,
425 (CCPA 1981). Hibner is a tissue removal device, even though it is to be
used for biopsying tissue. Drucker, Sussman, and Hakky teach that tissue
removal devices that have an inner tube can operate rotationally, in a
reciprocating motion, at the rates identified in Appellants’ claims, and to
remove resected tissue at greater than the minimum rate recited in the claim.
Hibner’s device has a motor assembly that causes the inner tube to move
rotationally and in a reciprocating motion, and Appellants have not argued
that the assembly is structurally incapable of operating at the claimed rates
or to remove the tissue at the rates claimed. Thus, we find the fact that
Hibner teaches the device to be used for biopsying tissue immaterial to
whether it is capable of being used as a tissue removal device having the
ability to function at rates that are known in the art, which are claimed. “It is
well settled that the recitation of a new intended use for an old product does
not make a claim to that old product patentable.” In re Schreiber, 128 F.3d
1473, 1477 (Fed. Cir. 1997).
For the reasons discussed, Appellants do no persuade us that the
Examiner erred in rejecting claim 9 for obviousness over Hibner, Drucker,
Sussman, and Hakky.
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Claim 10 and 14 are obvious over Hibner, Drucker, Sussman and Stine
Claims 10 and 14 require the outer tube diameter to be no greater than
about 3.0 mm. The Examiner finds that while Hibner does not teach the
diameter of the outer tube claimed, such would be obvious in light of the
teachings of Stine. (Final Action 10—11.) The Examiner finds that “Stine et
al teaches a tissue removal device comprising an inner tube (22) disposed
within an outer tube (20) (Figure 4C).” (Id. at 10.) The Examiner finds that
Stine teaches use of small outer diameter tubes is advantageous because the
device will be flexible. (Id.) The Examiner further finds that “Stine . . .
teaches . . . the outer tube comprises an outer diameter ranging from 1
French to 12 French, preferably 3 French (= 1 mm) (column 5, lines 31-35).”
(Id. at 10-11.)
The Examiner notes that “[tjumors are known for growing almost
anywhere in the human body and thus a smaller device would
advantageously allow the cutter to reach harder to access tumors.” (Ans.
20.) Moreover, the Examiner notes that “it is known in the art that the
smaller the incision/tissue removed, the less trauma that is applied to the
body.” (Id.)
According to the Examiner, it would have been obvious to modify the
outer tube of Hibner to the smaller size taught by Stine to “advantageously
allow[] the device to be more flexible and access harder to reach sites.”
(Ans. 20.) The Examiner further finds that “modifying the diameter of the
outer tube to the claimed range would not destroy Hibner for its intended
purpose.” (Id. at 19.)
We agree with the Examiner that modifying the outer tube of Hibner
to be no greater than 3 mm, a size that Stine teaches was known in the art,
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Appeal 2016-002428
Application 12/432,675
would have been obvious to one of ordinary skill in the art. “If a person of
ordinary skill can implement a predictable variation [of a known work],
§103 likely bars its patentability.” KSR, 550 U.S. at 417. Appellants do not
contend the change in the outer tube is an unpredictable variation for biopsy
devices. Indeed, Stine indicates that variation of the outer tube diameter size
of tissue removal devices is not unpredictable, but rather a matter of design
choice. (Stine 5 (teaching that outer diameters from 1 French to 12 French
for intravascular use is within the skill of the art and typical).) While Stine’s
device is used intravascularly and not percutaneously is a distinction without
a difference regarding whether or not the structure of the outer diameter
would be an unpredictable change. That is because the device, though used
intravascularly, is still used to remove tissue, which is the purpose of
Hibner’s device. As the Examiner noted, and Appellants do not contest,
changing the size to a smaller one “would not destroy Hibner for its intended
purpose.” (Ans. 19.)
Appellants argue that “just because the Stine device may have an
outer diameter of only 1.0 mm, does not mean that a POSITA would have
any scientific reasoning or other objective rationale to modify the Hibner
tissue biopsy device in this fashion.” (Reply Br. 4.) We do not find this
argument persuasive. The Examiner provided several reasons why one of
ordinary skill in the art would have a reason to modify the outer diameter of
the Hibner biopsy device. It would allow the device the flexibility to reach a
tumor in smaller areas and would result in less trauma to the body.
For the reasons discussed, Appellants do not persuade us that the
Examiner erred in rejecting claims 10 and 14 for obviousness over Hibner,
Drucker, Sussman, and Stine.
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Appeal 2016-002428
Application 12/432,675
SUMMARY
We affirm the rejection of claims 1, 3, 4, 7, 8, 11, 17, and 18 under 35
U.S.C. § 103(a) as unpatentable over Hibner, Drucker, and Sussman.
We affirm the rejection of claim 9 under 35 U.S.C. § 103(a) as
unpatentable over Hibner, Drucker, Sussman, and Hakky.
We affirm the rejection of claims 10 and 14 under 35 U.S.C. § 103(a)
as unpatentable over Hibner, Drucker, Sussman, and Stine.
We affirm the rejection of claim 16 under 35 U.S.C. § 103(a) as
unpatentable over Hibner, Drucker, Sussman, and Takasu.
We affirm the rejection of claim 5 under 35 U.S.C. § 103(a) as
unpatentable over Hibner, Drucker, Sussman, Takasu, and Johnson.
We affirm the rejection of claims 19 and 20 under 35 U.S.C. § 103(a)
as unpatentable over Hibner, Drucker, Sussman, and Cesarini.
TIME PERIOD FOR RESPONSE
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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