Ex Parte Lindquist et al

Patent Trial and Appeal Board

Nov 28, 2012

11775324 (P.T.A.B. Nov. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JEFFREY S. LINDQUIST and PETER EDELMAN
__________

Appeal 2011-008593
Application 11/775,324
Technology Center 3700
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
protector for a medical device, such as a stent. The Examiner has rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.

Appeal 2011-008593
Application 11/775,324

2
STATEMENT OF THE CASE
The Specification describes stent protectors used to protect stent and
stent coatings, where such a protector comprises, for example, at least one
scavenger for moisture (Spec. 5, ll. 9-23).
Claims 1-24 are on appeal. Independent claims 1 and 24 are
representative, and read as follows:
1. A protector for an intraluminal medical device, the protector
having a distal end and a proximal end, the protector comprising a
tubular member, said tubular member having a layer, said layer
comprising a polymer composition, the polymer composition
comprising a polymer matrix material and at least one scavenger for
moisture-dispersed in said polymer matrix material.
24. A method of protecting a stent from moisture, oxygen or
radiation, the method comprising:
providing a protector, the protector comprising at least one
polymer layer, the polymer layer comprising a scavenger for moisture
and
disposing said protector about said stent.
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
(I) claims 1-12, 14-17, 20, 23, and 24 as obvious over Yan1;
(II) claims 4, 5, 18, and 19 as obvious over Yan in view of Taylor2;
and
(III) claims 13, 21, and 22 as obvious over Yan in view of
Mandrusov.
3

1
Yan, US 2005/0268573 A1, published Dec. 8, 2005.
2
Taylor, US 2005/0039743 A1, published Feb. 24, 2005.
3
Mandrusov et al., US 7,008,411 B1, issued Mar. 2006 .
Appeal 2011-008593
Application 11/775,324

3
I.
Issue
Does the Examiner establish by a preponderance of the evidence that
independent claims 1, 14, 23 and 24 are obvious over Yan?
Findings of Fact
1. The instant Specification describes a stent protector, such as the
embodiment shown in Figures 1 and 3.

Figure 1 depicts stent protector (10) as “a simple tubular member formed
with a polymer layer 4 including a polymer matrix material and a scavenger
6 for moisture, oxygen or combination thereof, dispersed therein” (Spec. 7,
ll. 15-19). Figure 3 depicts a “radial cross section taken at section 3-3” in
Figure 1 (id. at ll. 22-23).
2. The Specification discloses that:
The protector, which may also be referred to as a
protective sheath or sleeve, is generally provided for covering a
device on the distal end of a catheter system prior to use such as
during packaging, shipping and storage. The protector can be
added to any delivery system prior to use and is intended to
protect a deliverable device, such as an intravascular stent,
Appeal 2011-008593
Application 11/775,324

4
stent-graft, etc. from being dislodged prematurely from the
catheter system or moved with respect thereto.
Furthermore, the protector also works to prevent physical
damage or contamination due to the transfer of unwanted
material, and to protect any coating from being damaged prior
to deployment of the stent.
(Spec. 7, ll. 6-14.)
3. The Specification also discloses that a “stent protector protects the
stent from physical damage or contamination due to the transfer of unwanted
material and is removed at the time of use …” (id. at 2, ll. 11-12). The
Specification states “[i]t would be desirable to have an improved stent
protector which reduces the exposure of the stent to environmental moisture,
oxygen and light” (id. at ll. 17-18). The Summary of the Invention in the
Specification immediately thereafter states that “[t]he present invention
relates to an improved protector for a medical device including at least one
scavenger for moisture, oxygen, ultraviolet (UV) radiation, or a combination
thereof” (id. at ll. 20-23). The Specification also teaches that “ʻ scavenger
for moisture’ shall be used interchangeably with desiccant” (id. at 5, ll. 6-9).
4. Yan discloses packaging of sterilized devices, such as stents and
catheters (Yan [0004]), where the packaging is in the form of a tube, for
example (id. at [0003]). The packaging acts as “a barrier to bacteria, viruses,
and other larger substances” as well as “a barrier to water and other fluids
which might detrimentally affect the sterilized contents” (id.).
5. Figures 4A - 4E in Yan depict a catheter (40) carrying a stent (42)
placed within a container for packaging (10) (id. at [0034]). Yan describes a
package having a container (e.g., “container 10” as shown in Figure 4A) that
Appeal 2011-008593
Application 11/775,324

5
includes a wall portion (e.g., “portion 14”) that is gas permeable, and a wall
portion (e.g., “portion 12” in Figure 4A) that is gas impermeable (id. at
[0007]; [0034]).
6. Yan teaches that it may be “desirable to provide desiccant materials in
or over a portion of the impermeable enclosure in order to sequester any
moisture which may remain within the pouch after final sealing” (id. at
[0020]). In addition, Yan teaches that the “desiccant may be coated over or
laminated within the polymer or metal film which comprises the gas
impermeable enclosure” (id.).
7. When discussing Figure 4B of the reference, Yan discloses that “a
desiccant may be placed within the interior of the container and/or a portion
of the container, typically the impermeable portion, may contain or be
formed of a laminated or otherwise coupled oxygen absorbers or scavenger
and/or moisture desiccants” (id. at [0035]).
8. When discussing Figures 6A-C of the reference, Yan discloses that
the permeable portion 14 of container 10 can be made from a
material incorporated with oxygen absorbers or scavengers 50
as well as being coated partially or fully on the interior or
exterior surface with a layer (or matrix of oxygen absorbers,
scavenger, and/or permeable polymers) 50 or 52 of suitable
oxygen absorbers or scavengers.
(Id. at [0038]; see also [0014] – [0016]). Figure 6A of Yan depicts oxygen
absorbers or scavengers (50) dispersed in a permeable portion (14) of
packaging container (10).
Appeal 2011-008593
Application 11/775,324

6
Analysis
In relation to independent claims 1, 14, 23, and 24, the Examiner
notes that “Yan does not disclose the polymer matrix material has at least
one scavenger for moisture dispersed in it” (Ans. 4). The Examiner further
states, however, that “Yan discloses a desiccant that can be incorporated in
the package in combination with an oxygen scavenger dispersed within the
polymer matrix (Fig. 6A, Para [0038])” (id.; see also id. at 7). Based on
cited teachings, i.e., paragraphs [0020], [0035], [0038] of Yan (id. at 3-4),
the Examiner concludes that it “would have been obvious to one having
ordinary skill in the art at the time the invention was made to disperse the
moisture scavengers in the matrix along with the oxygen scavengers, in
order to decrease the profile of the package while maintaining both moisture
and oxygen absorbing characteristics” (id. at 4, 7).
Both claims 1 and 14 recite a protector comprising a tubular member
“comprising a polymer matrix material and at least one scavenger for
moisture dispersed in said polymer matrix material” (emphasis added).
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). We interpret the phrase “dispersed in” in
these claims to mean that “at least one scavenger for moisture” is mixed in a
“polymer matrix material” in a protector, such as shown in Figures 1 and 3
of the Specification (FF 1). In other words, scavenger is located inside of
and throughout, not simply layered on or placed next to, the polymer matrix.
Appeal 2011-008593
Application 11/775,324

7
Figures in the Specification, as well as the general meaning of the word
“dispersed,”
4
are consistent with this interpretation.
Method claim 23 requires “mixing at least one polymer material with
at least one scavenger for moisture” (emphasis added). Such “mixing”
likewise leads to dispersing “at least one scavenger for moisture” in the
polymer material of the protector. In other words, the method of claim 23
makes a protector having at least one scavenger for moisture dispersed in
polymer material, similarly to what is recited in claims 1 and 14.
Looking at Yan, and specifically paragraphs [0020], [0035], [0038] of
Yan cited by the Examiner (Ans. 3-4), we conclude that the Examiner fails
to establish a prima facie case of obviousness of claims 1, 14, and 23 over
this reference. Specifically, the only teaching in Yan that suggests
dispersing a scavenger in a polymer matrix material in a layer of a protector
is Figure 6A, as well as the reference’s discussion of this embodiment in
paragraph [0038] (FF 8). In relation to Figure 6A, however, Yan only
describes “oxygen absorbers or scavengers 50,” and does not mention
“moisture desiccants” (id.).
Elsewhere in the reference, Yan discusses “moisture desiccants”
where it teaches providing “desiccant materials in or over a portion of the
impermeable enclosure,” such as discussed in [0020] (FF 6). This paragraph
in Yan does not describe or suggest dispersing a desiccant within a portion
of the container/packaging. Rather, it teaches placing desiccant inside the

4
See, e.g., See RANDOM HOUSE WEBSTER’S COLLEGE DICTIONARY, 387
(1995) (defining “disperse” to mean “to cause (particles) to separate
uniformly throughout a solid, liquid, or gas”).
Appeal 2011-008593
Application 11/775,324

8
packaging or over a portion of it. Likewise, in paragraph [0035], Yan
discloses that a desiccant may be placed inside the container “and/or a
portion of the container … may contain or be formed of a laminated or
otherwise coupled oxygen absorbers or scavenger and/or moisture
desiccants” (FF 7) (emphasis added). Disclosure of a “laminated or
otherwise coupled” scavenger, such as a desiccant, does not describe or
suggest dispersing the scavenger within a polymer, i.e., inside the wall of the
container itself. Rather, such teaching suggests placing a scavenger next to
the container wall, where the scavenger is connected to the wall either by
lamination or coupling.
The Examiner does not adequately explain where, how or why Yan
suggests dispersing a moisture desiccant inside a polymer matrix material
that may comprise a wall of a container. Stated differently, the Examiner
does not provide evidence or scientific reasoning as to why Yan’s teaching
in paragraph [0038] and shown in Figure 6A of Yan, that oxygen absorber or
scavenger may be dispersed in a polymer matrix, teaches or suggests
dispersing a moisture desiccant in the polymer matrix. The Examiner’s
reference to Yan’s teachings regarding lamination or coupling of “oxygen
absorbers or scavenger and/or moisture desiccants” to a container in
paragraph [0035] is insufficient to establish a prima facie case of
obviousness of claims 1, 14 and 23, which require that a scavenger for
moisture be dispersed in, or mixed in, the polymer material of the protector
itself.
If an examiner fails to establish a prima facie case of unpatentability
in the first instance, the rejection is improper and must be reversed. In re
Appeal 2011-008593
Application 11/775,324

9
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In re Rijckaert, 9 F.3d 1531,
1532 (Fed. Cir. 1993). For the reasons discussed above, we reverse the
obviousness rejection of independent claims 1, 14, and 23, over Yan.
Because the Examiner does not provide additional reasoning or evidence
regarding dependent claims 2, 3, 6-12, 15-17, and 20, we reverse the
obviousness rejection of these claims over Yan as well.
We note, however, that claim 24 differs from other independent
claims in that it recites a protector comprising “at least one polymer layer,
the polymer layer comprising a scavenger for moisture.” Claim 24 lacks the
“dispersed in” or “mixing” language of claims 1, 14, and/or 23. As such, the
protector of claim 24 encompasses a packaging container comprising a
desiccant “coated over or laminated within the polymer” as described in
paragraphs [0020] and [0035] of Yan. Thus, the Examiner establishes a
prima facie case of obviousness of claim 24 over Yan.
We are not persuaded by Appellants’ arguments regarding the term
“protector” (App. Br. 11-13; Reply Br. 2-6). Appellants assert that “Yan
does not teach or suggest a protector,” arguing that the packaging container
in Yan is not a “protector” as claimed and described in the Specification.
Appellants cite to teachings in the Specification, including one sentence
stating that a protector can protect a device, such as a stent, “from being
dislodged prematurely from the catheter system or moved with respect
thereto” (FF 2; App. Br. 10 n.1; 12 n. 6). As noted by the Examiner,
however, such features are not recited in claim 24 (Ans. 6).
Claim 24 recites a “method of protecting a stent from moisture,
oxygen or radiation,” where the method provides a protector comprising a
Appeal 2011-008593
Application 11/775,324

10
“scavenger for moisture.” The Specification discloses, for example, that a
“stent protector protects the stent from physical damage or contamination
due to the transfer of unwanted material and is removed at the time of use to
permit delivery and deployment of the stent in the body of a patient” (FF 3).
In addition, after noting that “[i]t would be desirable to have an improved
stent protector which reduces the exposure of the stent to environmental
moisture, oxygen and light,” the Specification emphasizes that the “present
invention relates to an improved protector for a medical device including at
least one scavenger for moisture, oxygen, ultraviolet (UV) radiation, or a
combination thereof” (id.) Yan discloses such a “protector” when it
discloses a packaging container that protects a stent from contamination of
unwanted material, such as moisture, before use (FF 4).
Conclusion of Law
We conclude that the Examiner fails to establish by a preponderance
of the evidence that independent claims 1, 14 and 23 are obvious over Yan,
but does establish that independent claim 24 is obvious over Yan.
II.
Issue
Does the Examiner establish by a preponderance of the evidence that
claims 4, 5, 18, and 19 are obvious over Yan in view of Taylor?
Analysis
Claims 4 and 5 depend on claim 1, and claims 18 and 19 depend on
claim 14. In relation to Taylor, the Examiner states that this reference
“discloses the use of anhydrous calcium sulphate to absorb moisture
Appeal 2011-008593
Application 11/775,324

11
(paragraph [0092])” (Ans. 5). Because the Examiner does not establish that
Taylor remedies the deficiency in Yan regarding the “at least one scavenger
for moisture dispersed in said polymer matrix material” required in claims 1
and 14 as discussed above, the Examiner fails to establish a prima facie case
of obviousness of claims 4, 5, 18, and 19.
Conclusion of Law
We conclude that the Examiner fails to establish by a preponderance
of the evidence that claims 4, 5, 18, and 19 are obvious over Yan in view of
Taylor.
III.
Issue
Does the Examiner establish by a preponderance of the evidence that
claims 13, 21, and 22 are obvious over Yan in view of Mandrusov?
Analysis
Claim 13 depends indirectly on claim 1, and claims 21 and 22 depend
indirectly on claim 14. In relation to Mandrusov, the Examiner states that
this reference discloses “a drug eluting stent that is coated L-lactic acid (Col.
9, lines 50-55)” (Ans. 5). Because the Examiner does not establish that
Mandrusov remedies the deficiency in Yan regarding the “at least one
scavenger for moisture dispersed in said polymer matrix material” required
in claims 1 and 14 as discussed above, the Examiner fails to establish a
prima facie case of obviousness of claims 13, 21, and 22.
Appeal 2011-008593
Application 11/775,324

12
Conclusion of Law
We conclude that the Examiner fails to establish by a preponderance
of the evidence that claims 13, 21, and 22 are obvious over Yan in view of
Mandrusov.
SUMMARY
We reverse the rejection of claims 1-12, 14-17, 20, and 23 as obvious
over Yan, but affirm the rejection of claim 24 as obvious over Yan. We
reverse the rejections of claims 4, 5, 18, and 19 as obvious over Yan in view
of Taylor, and claims 13, 21, and 22 as obvious over Yan in view of
Mandrusov.

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-IN-PART

cdc