Ex Parte Minar et al

Patent Trial and Appeal Board

Apr 3, 2015

11052428 (P.T.A.B. Apr. 3, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHRIS MINAR and BRUCE RITTENOUR
1

____________

Appeal 2012-009370
Application 11/052,428
Technology Center 3700
____________

Before DONALD E. ADAMS, CHRISTOPHER G. PAULRAJ, and
AMANDA F. WIEKER, Administrative Patent Judges.

WIEKER, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a guidewire. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1
According to Appellants, the real party in interest is Lake Region
Manufacturing, Inc. (App. Br. 2).
Appeal 2012-009370
Application 11/052,428

2
STATEMENT OF THE CASE
BACKGROUND
Guidewires are used for navigating the human vasculature, often in
conjunction with a medical device, such as a stent (Spec. 1 ¶ 3). Guidewires
typically include visible markers positioned at intervals, used to determine
the length of portions of the vasculature (id. at 2 ¶ 7).
The Specification discloses that it is difficult to place markers on
guidewires with low-friction coatings, such as those made from
polytetrafluoroethylene (PTFE) (id. at 6 ¶ 28). “The present invention
overcomes this difficulty in the prior art by, in one embodiment, employing
a tetrafluoroethylene-based [(TFE-based)] ink to create visual indicia on the
body of a PTFE-coated guidewire” (id.).
THE CLAIMS
Claims 1–7 and 9–12 are on appeal. Claim 1 is representative:
1. A guidewire comprising:
an elongated core having a proximal section and a distal
section,
one or the other of the proximal or distal sections of the
guidewire having a hydrophobic coating therein,
the hydrophobic coating having thereon indicia
comprising hydrophobic ink,
the coating comprising polytetrafluoroethylene (PTFE),
the indicia comprising cured TFE suspension,
the TFE suspension wetting the hydrophobic coating in
its uncured state and being cured by heating to a temperature in
the range of 600
o
F to 950
o
F to permanently adhere to the
hydrophobic coating.

(App. Br. 14 (formatting added for clarity)).
Appeal 2012-009370
Application 11/052,428

3
THE ISSUES
A. The Examiner rejected claims 1–5, 7, 9, 10, and 12 under 35
U.S.C. § 103(a) as obvious over Clark
2
and Berguer
3
(Ans. 4–6).
B. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as
obvious over Clark, Berguer, and Hall
4
(id. at 6).
C. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as
obvious over Clark, Berguer, Woessner,
5
and Dixon
6
(id. at 6–7).
A. 35 U.S.C. § 103(a) over Clark and Berguer
Regarding claim 1, the Examiner finds that Clark discloses a
guidewire comprising an elongated core with a hydrophobic coating of
PTFE on either the distal or proximal end (Ans. 4–5). The Examiner finds
that the hydrophobic coating has indicia comprising ink thereon (id. at 5).
The Examiner finds that Clark does not disclose that the ink is hydrophobic
ink comprising TFE suspension (id.).
The Examiner finds that Berguer discloses printing indicia with a
hydrophobic ink comprising a cured TFE suspension onto a PTFE surface
(id.). The Examiner concludes that it would have been obvious to one
skilled in the art to “replace the ink as disclosed by Clark et al. with a
hydrophobic ink including TFE suspension as taught by Berguer et al. in
order to form a permanent bond between the ink and the coating” (id.).
The Examiner also finds that the following limitation is a product by
process limitation that is not limited to the manipulations of the recited steps,

2
Clark et al., US 6,613,002 B1, issued Sept. 2, 2003.
3
Berguer et al., US 5,100,422, issued Mar. 31, 1992.
4
Hall, US 5,243,996, issued Sept. 14, 1993.
5
Woessner, US 5,919,170, issued Jul. 6, 1999.
6
Dixon, US 2001/0042315 A1, published Nov. 22, 2001.
Appeal 2012-009370
Application 11/052,428

4
only to the structure implied by those steps: “the TFE suspension wetting
the hydrophobic coating in its uncured state and being cured by heating to a
temperature in the range of 600
o
F to 950
o
F to permanently adhere to the
hydrophobic coating” (Ans. 5). The Examiner finds “the structure implied is
a cured ink to create indicia. Berguer et al. disclose this structure” (id.).
The issue is: Does the evidence of record support the Examiner’s
conclusion that claim 1 would have been obvious over Clark and Berguer?
FINDINGS OF FACT
1. Clark discloses an elongated member such as a wire guide 16
including “distal portion 53 including at least one of the first and second
indicia patterns 12, 13,” “intermediate portion 51, which may include a
portion of the indicia pattern 11 such as the second system of indicia,” and
“proximal portion [40, which] includes a portion of the second system of
indicia 13” (Clark at Abstract; col. 4, ll. 7–23).
2. Clark discloses that wire guide 16 includes “an outer surface coating
42,” which may vary over different portions of the device (id. at col. 3, ll.
58–59; col. 5, ll. 11–13). “For example, the distal portion 53 can have a
PET coating, which is more acceptable of printing, while the intermediate
portion 51 and/or proximal portion 40 can be made of PTFE, which is more
difficult on which to print” (id. at col. 5, ll. 13–17).
3. Clark discloses that indicia 12, 13 “are printed in ink on the outer
coating 42 of the wire guide, which is a polymeric material such as PET, or
another suitable material, although other well-known methods of imprinting
or marking medical devices could be used” (id. at col. 5, ll. 7–11).
4. Berguer discloses a vascular patch comprising a PTFE layer 30, suture
guidelines 28, and an elastomeric coating 36, wherein suture guidelines 28
Appeal 2012-009370
Application 11/052,428

5
are “visible from the ablumenal side . . . . [and] assist a surgeon in properly
and consistently placing the sutures to secure vascular patch 20 to the blood
vessel” (Berguer at col. 5, ll. 29–35; col. 6, ll. 41–47).
5. Berguer specifies that “a plurality of suture guidelines 28, in the form
of a continuous helical stripe, is formed upon the outer cylindrical wall of
PTFE tube 38” with “striping ink [that] is preferably a water-based PTFE
dispersion (TFE series)” (id. at col. 7, ll. 9–10; 17–19).
6. Berguer discloses that, after striping the suture guidelines 28:
[the] striped PTFE tube 38 is loaded onto a sintering rack 40
and is heated at a temperature between 330° C. and 400° C. for
10-100 seconds in a sintering oven (not shown). The specific
temperature and heating period depend upon the dimensions of
the PTFE tube. The sintering operation permanently bonds the
PTFE ink to the PTFE tube 38.
(Id. at col. 7, ll. 37–52).
PRINCIPLES OF LAW
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). As expressly
recognized in KSR, any art recognized need or problem can provide a reason
for combining claim elements. Id.
“Where a product-by-process claim is rejected over a prior art product
that appears to be identical, although produced by a different process, the
burden is upon the applicants to come forward with evidence establishing an
unobvious difference between the claimed product and the prior art
product.” In re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983) (citations
omitted).
Appeal 2012-009370
Application 11/052,428

6
ANALYSIS
Clark discloses a vascular guidewire comprising an elongated core
with a proximal section and a distal section (FF1). Clark discloses that one
or the other of the proximal and distal sections has a PTFE coating (FF2),
which is inherently hydrophobic. Clark also discloses that the PTFE coating
has indicia thereon (FF1–FF3), the indicia comprising ink (FF3).
Berguer discloses a vascular patch comprising a layer of PTFE with
indicia thereon (FF4). Berguer discloses that the indicia are formed with an
ink, specifically a cured TFE suspension, which is inherently hydrophobic,
such that a permanent bond between the ink and PTFE is created (FF5–FF6).
In light of these disclosures, we agree with the Examiner’s conclusion
that it would have been obvious to a person of ordinary skill in the art at the
time the invention was made to have utilized a hydrophobic, cured TFE
suspension as the ink for Clark’s printed indicia, based on Berguer’s
disclosure that cured TFE ink forms a permanent bond with PTFE. We
address Appellants’ arguments below.
First, we understand Appellants to contend that Clark and Berguer are
non-analogous art (App. Br. 6, 11). We are unpersuaded.
“In order to rely on a reference as a basis for rejection of the
applicant’s invention, the reference must either be in the field of the
applicant’s endeavor or, if not, then be reasonably pertinent to the particular
problem with which the inventor was concerned.” In re Oetiker, 977 F.2d
1443, 1447 (Fed. Cir. 1992). Here, Clark is directly within Appellants’ field
of endeavor, as it concerns a guidewire with a PTFE coating and visible
indicia (FF1). Although Berguer discloses a vascular patch, not a vascular
guidewire, Berguer’s disclosure is “reasonably pertinent to the particular
Appeal 2012-009370
Application 11/052,428

7
problem with which [Appellants’] were concerned,” namely, providing
visible indicia on a PTFE vascular device (FF4). Clark and Berguer,
therefore, are analogous references.
Appellants also argue that Clark “does not suggest any technique for
applying ‘indicia’ to a hydrophobic guidewire surface because the Clark et
al. invention is a ‘System of Indicia...’ not a method for applying indicia”
(App. Br. 8); that Berguer’s PTFE material is unique and “vastly different”
from that claimed (id. at 11); and that Berguer’s indicia are “sandwiched”
between the PTFE material and an elastomeric coating (id.). We are
unpersuaded.
Claim 1 does not recite “a method for applying indicia.” Rather, it
recites a guidewire with a hydrophobic coating and indicia thereon (App. Br.
14). Similarly, Appellants’ arguments do not identify any claimed features
that are lacking in the Clark and Berguer combination. It is well established
that limitations not appearing in the claims cannot be relied upon for
patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
Appellants also contend that Clark discloses applying ink to a PET
surface, which is not a hydrophobic PTFE surface (App. Br. 8). We
disagree.
Clark discloses that indicia 12, 13 “are printed in ink on the outer
coating 42 of the wire guide, which is a polymeric material such as PET, or
another suitable material” (FF3 (emphasis added)). Clark also specifies that
the outer coating 42 may include PET in the distal portion and PTFE in the
intermediate and proximal portions (FF2). Clark discloses, therefore, a
hydrophobic PTFE coating (in at least the intermediate and proximal
portions) having indicia comprising ink thereon (FF2–FF3).
Appeal 2012-009370
Application 11/052,428

8
Appellants also contend that the Examiner’s rejection of claim 1 is
“conclusory” and “devoid of any ‘articulated reasoning’” (App. Br. 6).
Specifically, Appellants contend that the “Examiner merely assumed the
obviousness conclusion with no articulated basis,” providing a “content-free,
conclusory obviousness rejection” (id.). We are not persuaded.
We find that the Examiner provides clear findings of fact regarding
the disclosures of Clark and Berguer, along with ample citations to the
relevant portions of the references (Ans. 4–5). The Examiner also provides
an articulated reasoning with a rational underpinning to support the legal
conclusion of obviousness, as required by KSR. Specifically, the Examiner
concludes that it would have been obvious to one skilled in the art to
“replace the ink as disclosed by Clark et al. with a hydrophobic ink
including TFE suspension as taught by Berguer et al. in order to form a
permanent bond between the ink and the coating” (id. at 5). This clearly
articulated conclusion is supported by ample citations to the record and is
well-founded (FF6).
We understand Appellants to contend that because Clark discloses the
difficulty of printing on PTFE, Clark altogether teaches away from such
printing (App. Br. 8–9, 11). Additionally, Appellants argue that “Clark et al.
suggests that no ‘indicia’ need be placed on hydrophobic surfaces because
they are simply away from, and not part of, the Clark et al. invention” (id. at
9). We disagree.
Although Clark states that PTFE is “more difficult on which to print,”
Clark also clearly discloses that indicia are indeed placed on the PTFE
portions of the guidewire (FF1–2). This disclosure does not constitute a
teaching away. Rather, Clark provides an affirmative teaching of a
Appeal 2012-009370
Application 11/052,428

9
hydrophobic PTFE guidewire with indicia thereon. Syntex (U.S.A.) LLC v.
Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations omitted) (“A
statement that a particular combination is not a preferred embodiment does
not teach away absent clear discouragement of that combination.”). Further,
Clark’s disclosure that printing on PTFE is difficult (FF2) identifies a known
problem associated with printing indicia on a PTFE guidewire. Berguer
identifies a solution to this problem, by disclosing indicia comprising a
cured TFE suspension that permanently bonds with a PTFE material (FF6).
The evidence of record supports the Examiner’s conclusion (Ans. 5, 8).
Appellants contend that the Examiner engaged in hindsight reasoning,
because the Examiner “focus[ed]” on “hydrophobicity/hydrophilicity,” terms
that do not appear in Clark or Berguer (Reply Br. 3). We are not persuaded.
The claims themselves recite that the coating and indicia are
“hydrophobic,” and the Examiner appropriately finds that the PTFE coating
taught by Clark and the TFE ink taught by Berguer are hydrophobic. The
Examiner’s obviousness rationale does not turn on the hydrophobicity of
these materials, but rather difficulty of printing on PTFE, which is expressly
recognized in the art (Ans. 8).
The Examiner found the following limitation to be a product-by-
process limitation: “the TFE suspension wetting the hydrophobic coating in
its uncured state and being cured by heating to a temperature in the range of
600
o
F to 950
o
F to permanently adhere to the hydrophobic coating” (Ans.
5). Appellants make several arguments about this limitation, which we
address below (App. Br. 14).
Appellants contend that the product-by-process doctrine reflected in
MPEP § 2113 only applies to “Product-By-Process claims,” not to “product-
Appeal 2012-009370
Application 11/052,428

10
by-process limitations” (App. Br. 7 (emphasis added); Reply Br. 2 (“A
process limitation in what is otherwise an apparatus or article claim certainly
does not make the entire claim into a product-by-process claim contemplated
by MPEP §2113.”)). We disagree.
We find Appellants’ distinction between product-by-process claims
and product-by-process limitations arbitrary and unsupported. A product
claim containing a single process limitation is still a product-by-process
claim. While it is true that “a new product may be patented by reciting
source or process limitations so long as the product is new and unobvious,”
it is equally well established that “a patentee who does not distinguish his
product from what is old except by reference, express or constructive, to the
process by which he produced it, cannot secure a monopoly on the product
by whatever means produced.” Amgen Inc. v. F. Hoffmann-La Roche Ltd.,
580 F. 3d 1340, 1366 (Fed. Cir. 2009), quoting Gen. Elec. Co. v. Wabash
Appliance Corp., 304 U.S. 364, 373 (1938).
Appellants also contend that for MPEP § 2113 to apply, “Applicants
would have to be claiming a ‘substantially identical’ prior art guidewire
made by a new process,” and that the lack of any pending anticipation
rejections demonstrates that the claimed guidewire is not substantially
identical to the prior art (Reply Br. 2 (citation omitted)). We disagree.
The remainder of the MPEP portion quoted by Appellants states that
“once a product appearing to be substantially identical is found and a 35
U.S.C. § 102/103 rejection is made, the burden shifts to the applicant to
show an unobvious difference.” See MPEP § 2113 (emphasis added). That
the claims are not anticipated, therefore, is irrelevant because the Examiner
made an obviousness rejection under 35 U.S.C. § 103(a) over the prior art.
Appeal 2012-009370
Application 11/052,428

11
See In re Marosi, 710 F.2d at 803 (affirming obviousness rejection of
product-by-process claim).
Appellants are correct, however, in noting that the limitation must be
afforded some patentable weight (Reply Br. 3). Specifically, as the
Examiner stated, the product-by-process language limits the claim to the
structure implied by the recited steps (Ans. 5). See MPEP § 2113 (“The
structure implied by the process steps should be considered when assessing
the patentability of product-by-process claims over the prior art, especially
where . . . the manufacturing process steps would be expected to impart
distinctive structural characteristics to the final product.”). We agree with
the Examiner that this limitation implies some structure to the claim,
specifically, “a cured ink to create indicia” (id.). Appellants failed to
identify any additional structural requirements imposed by the process
limitation.
We find that Clark and Berguer render obvious an identical product,
although produced by a different process (e.g., cured at a lower temperature)
(FF3–FF6). Appellants have not come forward with evidence establishing
an unobvious difference between the claimed product and the prior art
product. See In re Marosi, 710 F.2d at 803.
Appellants also argue that the disputed language was added to avoid
the Examiner’s rejection under 35 U.S.C. § 101, rendering the Examiner’s
current position “internally inconsistent” (App. Br. 7; Reply Br. 2).
That the disputed claim language was added to avoid a prior rejection
is immaterial. All claim language, whether original or added by amendment,
must satisfy several statutory requirements. The addition of language to
Appeal 2012-009370
Application 11/052,428

12
avoid a rejection on one statutory basis does not permit the amended claim
to violate another.
Because Appellants failed to rebut the Examiner’s prima facie case of
obviousness by a preponderance of the evidence, the rejection of claim 1 is
affirmed.
CONCLUSION OF LAW
The evidence of record supports the Examiner’s conclusion that claim
1 would have been obvious over Clark and Berguer at the time the invention
was made.
Claims 2–5, 7, 9, 10, and 12 are not separately argued and, therefore,
fall with claim 1 (App. Br. 9). 37 C.F.R. § 41.37(c).
B. 35 U.S.C. § 103(a) over Clark, Berguer, and Hall
Appellants do not provide any specific argument regarding the
rejection of claim 6 (App. Br. 9). Accordingly, Appellants waived any
additional argument to claim 6. 37 C.F.R. § 41.37(c)(1)(vii).
C. 35 U.S.C. § 103(a) over Clark, Berguer, Woessner, and Dixon
The Examiner finds that Clark and Berguer render obvious a
fluoropolymer coat with contrasting indicia, but fail to disclose that the
fluoropolymer coat is green and the indicia is white (Ans. 7). The Examiner
finds that Woessner teaches a device for use inside the body with indicia that
may be any desired color that is readily apparent and provides visible
contrast to the tube on which the indicia are placed (id.). The Examiner
finds that green and white are well known contrasting colors, as
demonstrated by Dixon (id.). The Examiner concludes that it would have
been obvious to one skilled in the art to use a “contrasting color scheme,
such as white indicia on a green surface as taught by Dixon, for the
Appeal 2012-009370
Application 11/052,428

13
fluoropolymer coat and the indicia as disclosed by Clark et al. in view of
Berguer et al. for the predictable results of allowing a user to visualize the
indicia against a contrasting color” (id.).
The issue is: Does the evidence of record support the Examiner’s
conclusion that claim 11 would have been obvious at the time the invention
was made, over Clark, Berguer, Woessner, and Dixon?
FINDINGS OF FACT
7. Clark discloses an embodiment of the second system of indicia 13 in
which the guidewire’s outer coating includes “helical striping” with “first
and second contrasting colors 74, 55 . . . to add another visual cue to help
distinguish relative movement of the device” (Clark at col. 6, ll. 20–33).
Clark specifies that this “indicia pattern also can be used with the first
system of indicia 12 . . . or a different type of the second system of indicia
13, e.g., printed diagonal markings 15” (id. at col. 6, ll. 25–28).
8. Woessner discloses a urinary catheter with a “printed stripe or
demarcation or series of marks to determine the alignment of a tip end of the
catheter relative to the striped or marked portion of the catheter outside the
body” (Woessner at Abstract).
9. Woessner discloses that “the stripe could be printed or marked or
could even be a series of marks. Typically the visible stripe is of contrasting
color with the polymer tubing so as to be readily apparent to an operator”
(Woessner at col. 3, ll. 64–67).
10. Dixon discloses a tape measure with a “writing stripe 80 [that] is
preferably of a contrasting color . . . . While the tape 5 may be typically a
yellow or green color, the writing stripe 80 is a distinct color such as white,
thereby providing a good contrast” (Dixon ¶ 43).
Appeal 2012-009370
Application 11/052,428

14
PRINCIPLES OF LAW
“The criterion [for determining obviousness], however, is not the
number of references, but what they would have meant to a person of
ordinary skill in the field of the invention.” In re Gorman, 933 F.2d 982,
986 (Fed. Cir. 1991).
ANALYSIS
Appellants contend the Examiner fails to explain “how anyone would
combine the 4 references (especially given that it took 4 references?)” (App.
Br. 12). Appellants also argue that “the Examiner restates his devoid-of-
analysis rejection and then assumes the conclusion” (id.).
We are unpersuaded by Appellants’ argument concerning the number
of references. The Examiner’s reliance on four references in rejecting claim
11 is irrelevant. See In re Gorman, 933 F.2d at 986.
We also disagree with Appellants’ characterization of the Examiner’s
rejection as “devoid-of-analysis” (App. Br. 12). Rather, the Examiner made
explicit findings regarding the subject matter of claim 11. Specifically, the
Examiner finds that Clark and Berguer disclose a guidewire with indicia in
contrasting colors (Ans. 7); that Woessner discloses that contrasting colors
make indicia readily apparent to a user of a medical device (id.); and that
Dixon discloses green and white to be a well-known contrasting color
combination (id.). Sufficient evidence supports these findings (FF7–10).
The Examiner also provides articulated reasoning with a rational
underpinning, citing ample portions of the record, to support the conclusion
of obviousness. Specifically, the Examiner concludes that it would have
been obvious to provide a green and white color scheme for the coating and
indicia “for the predictable results of allowing a user to visualize the indicia
Appeal 2012-009370
Application 11/052,428

15
against a contrasting color” (Ans. 7). We note that this rationale is explicitly
provided by the prior art (FF7, FF9, FF10). Consequently, we agree with
the Examiner’s conclusion of obviousness.
Furthermore, we note that where the difference between a claimed
invention and the prior art is only the content of printed matter, e.g., color,
the printed matter must create a “new and unobvious functional relationship”
to patentably distinguish over the art. See, e.g., In re Ngai, 367 F.3d 1336,
1338 (Fed. Cir. 2004). Appellants do not suggest any new and unobvious
functional relationship associated with the claimed color scheme.
Because Appellants failed to rebut the Examiner’s prima facie case of
obviousness by a preponderance of the evidence, the rejection of claim 11 is
affirmed.
CONCLUSION OF LAW
The evidence of record supports the Examiner’s conclusion that claim
11 obvious would have been obvious over Clark, Berguer, Woessner, and
Dixon at the time the invention was made.

SUMMARY
In summary:
the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over
Clark and Berguer is AFFIRMED, and claims 2–5, 7, 9, 10, and 12 fall with
claim 1;
the rejection of claim 6 under 35 U.S.C. § 103(a) as obvious over
Clark, Berguer, and Hall is AFFIRMED;
the rejection of claim 11 under 35 U.S.C. § 103(a) as obvious over
Clark, Berguer, Woessner, and Dixon is AFFIRMED.
Appeal 2012-009370
Application 11/052,428

16

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED
rvb