Ex Parte Owen et al

Patent Trial and Appeal Board

Mar 18, 2019

11920632 (P.T.A.B. Mar. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/920,632 12/21/2007 Richard Harley Grenville Owen
22428 7590 03/20/2019
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
093840-0102 8592
EXAMINER
EISEMAN, ADAM JARED
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
03/20/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD HARLEY GRENVILLE OWEN,
STEPHEN BLATCHER, STEWART MADDISON FOX, and
MARTIN LAWRENCE HUGHES
Appeal2017-006668
Application 11/920,632
Technology Center 3700
Before BENJAMIN D. M. WOOD, ANNETTE R. REIMERS, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Richard Harley Grenville Owen et al. ("Appellants") 1 appeal under 35
U.S.C. § 134(a) from the Examiner's decision, as set forth in the Final
Office Action mailed March 24, 2016 ("Final Act."), rejecting claims 57-75,
1 The Appeal Brief identifies PlaqueTec Limited as the real party-in-interest.
Appeal Br. 2.
Appeal2017-006668
Application 11/920,632
92-96, 101, and 102 (all pending claims). Appellants' representative
presented oral argument on March 7, 2019. We have jurisdiction over this
appeal under 35 U.S.C. § 6(b). We AFFIRM-IN-PART.
SUMMARY OF THE INVENTION
The claimed subject matter "relates to a catheter for insertion into a
blood vessel allowing blood samples to be taken." Spec. 1. Claims 57, 72,
and 92 are independent. Claims 57 and 92, reproduced below from pages 27
and 31 (Claims Appendix), respectively, of the Appeal Brief, are illustrative
of the claimed subject matter:
57. A catheter device for insertion into a blood vessel,
compnsmg:
a sampling part arranged to collect and preserve a
plurality of spatially separated discrete blood samples from a
plurality of locations along a length of the blood vessel;
wherein the sampling part includes:
an axially elongated sample member having an
axial array of a plurality of openings for receiving blood from
outside of the catheter device at intervals along the length of the
blood vessel; and
an elongated sleeve coaxial with the sample
member, the sleeve defining an axial passage for housing the
sample member and including a plurality of through holes
corresponding to said openings in the sample member, and
wherein movement between the sleeve and the sample
member aligns all the through holes with the openings of the
sample member, to simultaneously expose all the openings to
blood outside the catheter device so as to collect the plurality of
discrete blood samples along the length of the blood vessel, and
wherein the catheter device is flexible so as to be
channeled through the blood vessel, and has a blunt distal end.
92. A method for positioning a catheter in a blood vessel,
compnsmg:
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providing the catheter having a sampling part and a
reference guide sleeve, the catheter being flexible so as to be
channeled through the blood vessel, and having a blunt distal
end·
' introducing said reference guide sleeve into the blood
vessel at a fixed position relative to the blood vessel, wherein
said reference guide sleeve has an axial duct for receiving the
sampling part of said catheter; and
collecting a plurality of spatially separated discrete blood
samples from a plurality of locations along a length of the blood
vessel,
wherein the reference guide sleeve and sampling part
have one or more indexing parts with respect to each other,
which positions the sampling part at a predetermined position
relative to the reference guide.
REFERENCES
The Examiner relies on the following prior art references in rejecting
the claims on appeal:
Kreuzer
Martin
Barbut
Sutton
Brown
us 4,808,158
us 5,472,417
us 6,165,199
US 7,179,232 B2
WO 2004/010874 Al
REJECTIONS
Feb.28, 1989
Dec. 5, 1995
Dec. 26, 2000
Feb.20,2007
Feb. 5,2004
I. Claims 101 and 102 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
II. Claims 57----62, 65-75, and 102 stand rejected under 35 U.S.C.
§ I03(a) as being unpatentable over Brown, Barbut, and Kreuzer.
III. Claims 63 and 64 stand rejected under 35 U.S.C. § I03(a) as being
unpatentable over Brown, Barbut, Kreuzer, and Martin.
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Application 11/920,632
IV. Claims 92-96 and 101 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Brown, Barbut, Kreuzer, and Sutton.
ANALYSIS
Rejection I
The Examiner determines that "[t]he term 'about' in claims 101 and
102 is a relative term which renders the claim indefinite." Final Act. 2.
According to the Examiner, "[t]he [S]pecification does not give any
definition to the term about, and as such it is unclear as to what margin of
error or tolerance is applied to the claimed ranges, thus leaving the claims
indefinite." Id. at 2-3; see also Ans. 13-15.
Appellants traverse, arguing that "the term 'about' as recited in claims
101 and 102 should be afforded its plain and ordinary meaning of
'approximately"' and that "those of ordinary skill in the art would have
known the approximate volume of a sample needed for a diagnostic
chemistry process." Appeal Br. 7, 8 (citing MPEP§ 2173.05(b)(III)).
Appellants note that "[t]he term 'about' is routinely used in patent claims,
and the courts routinely construe it as plain meaning [sic], accordingly to
how 'a person having ordinary skill in the art' would understand it." Reply
Br. 3.
"[T]he word 'about' does not have a universal meaning in patent
claims, and [its] meaning depends on the technological facts of the particular
case." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir.
1995). Use of the word about as part of a numeric range avoids a strict
numerical boundary to the specified parameter. Cohesive Techs. Inc. v.
Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008). In determining the
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Application 11/920,632
range encompassed by the term about, one must consider the context of the
term as it is used in the specification and claims of the application. Pall, 66
F.3d at 1217.
Here, the Specification discusses the sample volume as follows:
"Many diagnostic chemistry processes require samples of approximately
50 µ1 and, hence, for many embodiments each discrete sampk is
substantialzy of this value. Hmvever, the discrete samples may be behveen
0. 1 µland 100 µl, more preferably behveen 20 J.tl and 50 ~tL~' Spec. 6
(emphases added} Thus, the Specification supports Appellants' assertion
that the tenn about as used in the claims means "approximately.'' See
Appeal Br. 7; see also Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d
1364, 1369 (Fed. Cir. 2005) (recognizing the ordinary meaning of about to
be approximately).
The Examiner appears to apply a per se rule that because the claims
include the word about, the claims are indefinite. Such an approach is
improper, as it is well established that the use of relative terminology in
claim language does not automatically render the claim indefinite. See, e.g.,
Seattle Box Co., Inc. v. Indus. Crating & Packaging, Inc., 731 F .2d 818, 826
(Fed. Cir. 1984). Rather, the correct test is whether one of ordinary skill in
the art would understand what is claimed when the claim is read in light of
the specification. Id. As set forth above, one of skill in the art would
understand that a "volume ... between about lO~tl and 50j.tl" means a
volume between approximately 10 µ1 and 50 µ1; in other words, Appellants'
"use of the term 'about' shows that [Appellants] did not intend to limit the
claimed ranges to their exact end-points." In re Harris, 409 F.3d 1339, 1343
(Fed. Cir. 2005).
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Accordingly, we do not sustain the rejection of claims 101 and 102 as
being indefinite.
Rejection II
Independent claim 57 recites a catheter device "wherein movement
between the sleeve and the sample member aligns all the through holes with
the openings of the sample member ... so as to collect the plurality of
discrete blood samples along the length of the blood vessel." Appeal Br. 27
(Claims App.). Independent claim 72 recites a catheter system "wherein
movement between the sleeve and the sample member aligns all the through
holes with the openings of the sample member ... so as to collect the
plurality of discrete blood samples along the length of the blood vessel." Id.
at 29-30. The Examiner relies on Barbut to teach this feature, finding:
Barbut teaches a tissue extraction device comprising an
elongate extraction member having a plurality of openings for
receiving blood from outside the device and an elongate sleeve
coaxial with the sample member including a plurality of
through holes corresponding to said openings in the
extraction/perfusion member and wherein movement between
the sleeve and extraction/perfusion member aligns all the
through holes with the openings of the sample member, to
simultaneously expose all the openings or simultaneously close
all openings.
Final Act. 4--5 (citing Barbut, 7:23-37, Figs. 6-8).
Barbut discloses medical devices for use in treating patients with
acute stroke or occlusive cerebrovascular disease. Barbut, 1:7-9. In one
embodiment, a catheter includes a lumen having a balloon occluder and an
aspiration port at the distal end of the lumen. Id. at 5:66-6:9, Fig. 3. A
chopping mechanism is closely associated with the aspiration port. Id. at
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6:9-12. The catheter is inserted into the patient's artery such that the
balloon occluder is positioned proximate an occlusion in the artery. Id. at
6:23-35, Fig. 4A. The balloon is inflated to create a closed chamber
between the balloon and the occlusion, blood is aspirated from the chamber,
and the occluding material is removed through application of negative
pressure and the chopping mechanism positioned adjacent an aspiration port
at the distal end of the catheter. Id. at 6:35---65.
In another embodiment of the device, the catheter also includes a
perfusion lumen having two concentric cylindrical members, each having
perfusion ports therein. Id. at 7:23-35. The perfusion ports are located
proximal to the balloon occluder. Id. at 7:23-24, Fig. 6. "The second
member can be rotated relative to the first member so that the perfusion
ports on the first member align with the perfusion ports on the second
member." Id. at 7:35-37. The catheter is inserted into the patient's artery
and the balloon occluder is inflated as in the previously discussed
embodiment. Id. at 7:38--47. The second member is then rotated relative to
the first member to align the perfusion ports, and high pressure flow is
released through the perfusion ports. Id. at 7:47-52, 8:7-19. This high
pressure flow is directed through collateral arteries to provide improved
perfusion to the restricted area. Id. at 7:52-57. As illustrated in Figure 8B,
the inflated balloon occluder separates the opposing perfusion and aspiration
flows.
Thus, as correctly noted by Appellants, Barbut's perfusion ports are
not used to collect samples therein. Appeal Br. 17. The Examiner does not
rely on Brown or Kreuzer in any manner that would remedy the deficiency
noted above with respect to Barbut. The rejection of claims 57 and 72 is,
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thus, based on an erroneous factual finding, and the conclusion of
obviousness cannot stand. See In re Warner, 379 F.2d 1011, 1017 (CCPA
1967).
Accordingly, we do not sustain the rejection of claims 57 and 72, or of
their dependent claims 58---62, 65-71, 73-75, and 102, as being unpatentable
over Brown, Barbut, and Kreuzer.
Rejection III
Claims 63 and 64 depend from claim 57. Appeal Br. 28. The
Examiner does not rely on Martin in any manner that would remedy the
deficiency noted above with respect to claim 57. Therefore, for the same
reasons as explained above, we do not sustain the rejection of claims 63 and
64 as being unpatentable over Brown, Barbut, Kreuzer, and Martin.
Rejection IV
The Examiner finds that Brown discloses a method as substantially
recited in independent claim 92, including, inter alia, collecting a plurality
of blood samples from a plurality of locations along the length of a catheter,
the catheter having a sampling part and a reference guide sleeve, but does
not "explicitly disclose that the catheter is flexible so as to be channeled
through the blood vessel and has a blunt distal end." Final Act. 3-5, 10
(incorporating the findings and determinations made with respect to
Rejection II). The Examiner finds that Kreuzer "teaches a catheter for
sampling blood from a blood vessel wherein the catheter is flexible so as to
be channeled through the blood vessel and has a blunt distal end," and
reasons that it would have been obvious to modify Brown's device to have
these features "to allow the catheter to be channeled into the blood vessel
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and avoid puncturing the vessel unnecessarily." Id. at 5---6. The Examiner
finds that the combination of references as applied in Rejection II
does not specifically disclose the reference guide sleeve which
receives the sampling part is inserted into the body first; or that
the reference guide sleeve and the sampling part have one or
more indexing parts with respect to each other, which positions
the sampling part at a predetermined position relative to the
reference guide.
Id. at 10. The Examiner relies on Sutton to teach these features. Id. at
10-11.
Appellants traverse the rejection of claim 92 by incorporating
arguments made with respect to claim 57 and by asserting that Sutton does
not cure the deficiencies alleged in such arguments. Appeal Br. 24--25. We
note that some of the arguments made with respect to claim 57-including
the argument relied upon above regarding Rejection II-are not applicable
because claim 92 does not include the relevant recitations.
First, Appellants argue that Brown is non-analogous and, therefore,
cannot properly be used in an obviousness rejection. Id. at 8-15. Appellants
cite extensively to the Declaration of Dr. Stephen Blatcher ("Blatcher
Deel."), one of the inventors. Id. A reference qualifies as prior art for a
determination under § 103 when it is analogous to the claimed invention. In
re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992).
Two separate tests define the scope of analogous prior art:
(1) whether the art is from the same field of endeavor,
regardless of the problem addressed, and (2) if the reference is
not within the field of the inventor's endeavor, whether the
reference still is reasonably pertinent to the particular problem
with which the inventor is involved.
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In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski,
796 F.2d 436,442 (Fed. Cir. 1986)). The field of endeavor is determined
"by reference to explanations of the invention's subject matter in the patent
application, including the embodiments, function, and structure of the
claimed invention." Id.; see also Deminski, 796 F.2d at 442 (finding that if a
prior art reference discloses essentially the same structure and function as
the invention, it is likely in the same field of endeavor).
Appellants argue that Brown is from a different field of endeavor
because "[t ]he claimed invention is directed to collecting blood samples,"
and "Brown is directed to collection of tissue biopsies." Appeal Br. 9; see
also Blatcher Deel. ,r,r 5-8. Appellants argue that Brown's device "includes
a sharp tip 52 ... [that] is completely unsuitable for the claimed invention,
which is channeled through a blood vessel for sampling the blood." Appeal
Br. 9 ( citing Brown, 7: 1 O); see also Blatcher Deel. ,r,r 9-12. Appellants
argue that "the device in Brown allows for portions that 'deliberately break
off during use', which is completely incompatible with being located in a
blood vessel." Appeal Br. 9 ( citing Brown, 8: 14--19); see also Blatcher
Deel. ,r 12. Appellants argue that "Brown discloses a preferred sampling
volume of less than 1.2 cubic millimeters," which "is far too small for the
types of diagnostic chemistry analysis facilitated by the present invention."
Appeal Br. 10 (citing Brown, 2:13, 5:26-27); see also Blatcher Deel. ,r 14.
Appellants reproduce several portions of the Blatcher Declaration. Appeal
Br. 10-13.
We are not persuaded by Appellants' arguments, which
mischaracterize Brown's catheter. Contrary to Appellants' assertion that
Brown is "directed to collection of tissue biopsies" (id. at 9; see also
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Blatcher Deel. ,r 8), Brown repeatedly discloses collection of fluid samples.
For example, Brown discloses that the internal vacuum of its vacuum
sampling device embodiment "draws either tissue or fluid from the exterior
of the chamber 3 into the chamber 3." Brown, 9: 15-16 ( emphasis added);
see also id. at 12: 19-21 ("mechanisms for collecting samples of tissue or
fluids" ( emphasis added)), 13: 5 ( contrasting biopsy and sampling). Contrary
to the assertions of Appellants' declarant (see Blatcher Deel. ,r 9), this
embodiment does not "need" material to be cut or include a blade; rather,
Brown discloses that the covering material can be contoured to cut through
material drawn into the cavity (Brown, 9 :24--26), which would be
unnecessary for collecting fluid samples, and the referenced blade pertains to
"[a]n additional embodiment" (id. at 9:31). Brown also refers to its device
as "a biopsy and/or fluid sampling device." Id. at 1 :30 (emphasis added).
Thus, like Appellants' device, Brown discloses a catheter for collecting fluid
samples.
Regarding the "sharp tip 52" cited by Appellants, Brown discloses:
"The catheter 50 includes a distal insertion end 52 and sampling devices 54.
The distal end 52 is a sharp or pointed end that is inserted into the subject
requiring removal of tissue or fluid samples." Id. at 7:9-11. That Brown
uses a sharp or pointed tip does not differentiate Brown's field of endeavor
from that of Appellants' claimed invention. Rather, like Appellants' device,
Brown discloses a medical catheter for insertion into a patient for biopsy or
other purposes. See id. at 7: 8-9.
Regarding Appellants' assertion that Brown allows for portions to
deliberately break off, Brown discloses that its sampling devices are
fabricated with biodegradable polymers, and that the use of such polymers
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"allows implementations of this invention with portions that deliberately
break off during use, are left within the body, and cause no harm." Brown,
8:14--16. Continuing, Brown discloses that "[t]he sampling devices 54 need
not be fabricated with biodegradable materials; however, use of
biodegradable materials removes the danger associated with portions that
break or fail during use." Id. at 8: 17-19. Thus, Brown contemplates
implementations of its device that have portions that deliberately break off,
but does not require such implementations as suggested by Appellants. A
skilled artisan would not use such a frangible implementation where it would
be undesired or dangerous to the patient. See KSR Int 'l Co. v. Teleflex Inc.,
550 U.S. 398,421 (2007) ("A person of ordinary skill is also a person of
ordinary creativity, not an automaton.").
Regarding the volume of Brown's sampling chambers, Appellants
focus on the preferred volume to the exclusion of Brown's full disclosure.
As correctly noted by the Examiner (see Final Act. 7-8, 14; Ans. 23-24),
Brown discloses that "[ v ]olumes of such sampling chambers range from as
small as about a picoliter or less and as large as about a few hundred
microliters [(µl)] or more." Brown, 10:5---6. Thus, Brown discloses a
volume ranging from 1x10-12 liter to at least 1x10-4 liter, which encompasses
the volume range recited by Appellants.
The additional assertions made by Appellants' declarant similarly fail
to persuade us that Brown is not analogous to the claimed invention. For
example, the declarant' s characterizations of Brown's catheter as being
"stiff' and "inflexible" (see Blatcher Deel. ,r,r 10, 12) are unsupported by
evidence or persuasive technical reasoning, and the Examiner does not
suggest reusing Brown's catheter (see id. ,r 13). We additionally note that
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Dr. Blatcher is also an Inventor/ Appellant and, as such, the Declaration is
less persuasive than that of a disinterested person. See In re McKenna, 203
F.2d 717, 720 (CCPA 1953) ("[A]n affidavit by an applicant or co-applicant
as to the advantages of his invention is less persuasive than one made by a
disinterested person.").
In view of the foregoing, we determine that a preponderance of the
evidence supports the Examiner's determination that Brown is analogous to
the claimed invention. See Ans. 15-16. Because both Appellants' method
and Brown's device are directed to medical catheters for insertion into a
patient for obtaining fluid samples, Brown is in the same field of endeavor
as the claimed subject matter.
Appellants next argue that Brown does not disclose obtaining a
plurality of blood samples. Appeal Br. 15-16; see also Reply Br. 12-14.
According to Appellants, "Brown is directed to removing solid tissue or
fluid using 'scrapping or cutting using a jaw or knife mechanism,"' and
"[t]he use of sharp or cutting edges is completely unsuitable for the claimed
invention." Appeal Br. 15 (citing Brown, 3:5---6).
We are not persuaded by Appellants' arguments. As noted above,
Brown discloses a vacuum sampling device embodiment that draws fluid
into its chambers and that does not use a jaw or knife mechanism.
Additionally, as correctly noted by the Examiner (see Final Act. 3--4; Ans.
20), Brown discloses that "[t]he multiple sampling devices are positioned
along the outer diameter of the shaft portion of a single catheter or other
device, and samples are collected and stored in respective chambers of the
sampling devices." Brown, 1:33-2:2; see also id. at Fig. 1.
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Finally, Appellants argue that "there is no disclosure in Brown of the
need or desire to collect blood samples" and "[Kreuzer] contains no
disclosure or teaching regarding sampling of any kind." Appeal Br. 19.
According to Appellants, "one of ordinary skill in the art would not have
been motivated by the disclosure of Kreuzer to modify the catheter of Brown
to be flexible for intravascular use." Id. Continuing, Appellants argue that
because "[t]he catheter of Brown was suitable for its purpose (e.g.,
collecting fluid samples from diseased areas) ... there would have been no
reason for one of ordinary skill in the art to modify the catheter of Brown to
collect blood samples." Id. Appellants argue that "neither Kreuzer nor
Brown disclose how to use the microminature manufacturing technologies
(Brown at p. 1) to make a catheter having the necessary dimensions to be
inserted into a blood vessel." Id. ( citing Blatcher Deel. ,r 12).
We are not persuaded by Appellants' arguments. As correctly noted
by the Examiner, and as discussed above, Brown discloses the collection of
fluid samples from a patient. Appellants fail to apprise us of error in the
Examiner's determination that blood qualifies as such a fluid. See, e.g.,
Final Act. 13-14. For the same reasons, Appellants' arguments against the
application of Kreuzer's teaching to Brown's device are unpersuasive.
Given that Brown contemplates collecting samples of body fluid, such as
blood, Appellant fails to apprise us of error in the Examiner's determination
that a skilled artisan would have formed Brown's device of a flexible
material and provided a blunt distal end as taught by Kreuzer.
Regarding Appellants' arguments regarding the manufacturing of
Brown's modified device, Brown does not require any specific
manufacturing method. The assertion that Brown's device would require
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"significant re-engineering" is premised on Dr. Blatcher' s characterization
of the Brown catheter as being inflexible. Appeal Br. 19-20 ( citing Blatcher
Dec. ,r,r 12-13). However, as noted above, the declarant does not provide an
evidentiary basis for this conclusory assertion. Moreover, as flexible
vascular catheters are well known, as evidenced, for example, by Kreuzer,
Appellants fail to persuade us that forming Brown's device of a flexible
material would be beyond the skill set of a person of ordinary skill in the art.
Accordingly, for the foregoing reasons, we sustain the rejection of
claims 92-96 and 101 as being unpatentable over Brown, Barbut, Kreuzer,
and Sutton.
DECISION
The Examiner's decision to reject claims 101 and 102 as being
indefinite is reversed.
The Examiner's decision to reject claims 57----62, 65-75, and 102 as
being unpatentable over Brown, Barbut, and Kreuzer is reversed.
The Examiner's decision to reject claims 63 and 64 as being
unpatentable over Brown, Barbut, Kreuzer, and Martin is reversed.
The Examiner's decision to reject claims 92-96 and 101 as being
unpatentable over Brown, Barbut, Kreuzer, and Sutton 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-IN-PART
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