Ex Parte Pacetti et al

Patent Trial and Appeal Board

Oct 24, 2012

11639512 (P.T.A.B. Oct. 24, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEPHEN D. PACETTI, PAUL M. CONSIGNY, RONALD W.
HEIL JR., FLORIAN NIKLAS LUDWIG, DARIUSH DAVALIAN, LI
ZHAO, IRINA ASTAFIEVA, JINPING WAN, FOZAN EL-NOUNOU,
KATSUYUKI MURASE, SYED F.A. HOSSAINY, RACHEL BRIGHT,
and JEFFREY ELLIS
__________

Appeal 2011-013089
Application 11/639,512
Technology Center 1600
__________

Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a method of treating a vascular disease. The Patent
Examiner rejected the claims for anticipation, obviousness, and obviousness-
type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm the anticipation and obviousness rejections, and reverse the
obviousness-type double patenting rejection.
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STATEMENT OF THE CASE
Claims 1-5, 8-25, and 31-35 are on appeal. Claim 1 is representative
and reads as follows (emphasis added):
1. A method of treating a vascular disease, comprising:
providing a device having a regional delivery interface comprising a
therapeutic agent;
contacting the delivery interface with a surface of a segment of a vessel that
is known to include a region that is afflicted with a vascular disease,
wherein:
the delivery interface contacts the vessel segment surface at the known
afflicted region but also at a non-afflicted region at the periphery of the
afflicted region as well;
and,
delivering the therapeutic agent onto or into the vessel segment surface from
the regional delivery interface in contact with the vessel segment surface.

The Examiner rejected the claims as follows:
 claims 1, 5, 8-14, and 19-21 under 35 U.S.C. § 102(b) as anticipated
by Houser;
1
and
 claims 2-4 under 35 U.S.C. § 103(a) as unpatentable over Houser and
Barasch;
2

 claim 15 under 35 U.S.C. § 103(a) as unpatentable over Houser and
Rosenthal;
3

 claims 16 and 17 under 35 U.S.C. § 103(a) as unpatentable over
Houser and Kokish;
4

1
Russell A. Houser, US 6,632,196 B1, issued Oct. 14, 2003.
2
Eddy Barasch et al., PTCA in Angulated Segments: Effects of Balloon
Material, Balloon Length, and Inflation Sequence on Straightening
Forces in an In Vitro Model, 39 CATHETERIZATION AND CARDIOVASCULAR
DIAGNOSIS 207-212 (1996).
3
Arthur Rosenthal et al., US 2003/0114791 A1, published June 19, 2003.
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 claim 18 under 35 U.S.C. § 103(a) as unpatentable over Houser and
Roy;
5

 claims 22-25, and 31-35 under 35 U.S.C. § 103(a) as unpatentable
over Houser and Golomb;
6

 claims 1, 5, and 8-21 under the doctrine of obviousness-type double
patenting over claims 1-38 of US 7,438,722 B1
7
in view of Houser.

ANTICIPATION
The Issue
The Examiner found that Houser taught balloon catheters for treating
obstructions in blood vessels such as plaque build up. (Ans. 5.) Houser
described inflating balloon compartments to contact an obstruction in a
vessel, and the Examiner found that an obstruction, which Houser also called
a lesion, is an “afflicted region” in Appellants‟ terms. Referring to Houser‟s
Figure 12, the Examiner found that “[o]ne of ordinary skill would
reasonably consider that when the inflated balloon contacts the afflicted
region 178, it necessarily contacts the non-afflicted surfaces (regions) of the
vessel defined by Houser as element 180 in Figure 12.” (Id. at 6.) Referring
to Houser‟s Figure 17, the Examiner found that the inflated balloon would
contact both the occluded (afflicted) and the non-occluded (non-afflicted)
regions illustrated in Figure 17, and the periphery of the afflicted region.
(Id. at 6-7.) Referring to Houser‟s description of a drug delivery balloon

4
Lyudmila Kokish, US 2006/0280858 A1, published Dec. 14, 2006.
5
Shuvo Roy et al., US 6,790,372 B2, issued Sept. 14, 2004.
6
Gershon Golomb et al., US 2002/0187184 A1, published Dec. 12, 2002.
7
Syed F. A. Hossainy, US 7,438,722 B1, issued Oct. 21, 2008.
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(element 260 in Houser‟s Figure 18), the Examiner found that when
positioned and inflated, the drug delivery balloon would contact the blood
vessel at the afflicted region as well as the non-afflicted region at the
periphery of the afflicted region. (Id. at 7-8.)
Appellants contend that “Hauser only addresses the lateral periphery
of the afflicted region since the view in Fig. 12 does not afford any view of
the longitudinal aspect of the afflicted region. The only lateral perspective of
the Hauser's balloon, Fig. 17 does not show or suggest that the balloon in
fact contacts a non-afflicted region of the vessel in a longitudinal direction.”
(App. Br. 4-5.) Appellants also contend that, from a careful reading of
Houser, “it is unequivocal that Hauser only contemplates the actual lesion
site as the site of treatment. There is no other way to interpret the paragraph,
certainly no way to interpret it cover drug delivery to the whole, i.e., lateral
and longitudinal, periphery of the afflicted region.” (Id. at 5.) According to
Appellants, “border,” in light of Specification paragraph 49, “means the
entire periphery of a region, not merely the lateral border.” (Id.)
The Examiner responds that contact in a “longitudinal” direction is
not a limitation of the claims (Ans. 19), and maintains that “as it is clear that
the device of Houser contacts both „afflicted‟ and „non-afflicted‟ regions, the
device is reasonably considered to contact the border (i.e. the periphery)
between said regions” (id. at 20.) The Examiner further responds that
“irrespective of whether, as Appellant alleges, „Houser only contemplates
the actual lesion site [i.e. the afflicted region] as the site of treatment‟, the
actual presence of drug at both afflicted and non-afflicted regions, . . .
clearly illustrates that drug will be delivered at both regions (final step
recited in instant Claim 1) regardless of whether Houser contemplates
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treatment at both regions.” (Id. at 21-22.) The Examiner further explained
why Appellants‟ arguments about “border” and “periphery” were
unpersuasive. (Id. at 22-23.)
Appellants reply:
The examiner relies virtually totally on drawings in the cited
references and how, in some cases, the pictured devices seem to
extend beyond the boundaries of a lesion. There is no verbal
confirmation in Hauser that the drawings are in fact accurate or that
that which might possibly be extrapolated from the drawings was in
fact at all intended by the authors. The examiner cannot simply supply
his own interpretation of the drawing, based entirely on hindsight, , as
a ground for rejection of the instant application absent some support,
however incidental or tangential, in the references themselves. There
simply is not a single word in any of the disclosures that extension of
therapeutic agent coverage is necessary, desirable or even was under
consideration at the time, whereas it is expressly required in the
instant invention. There is absolutely no way the examiner or anyone
skilled in the art, on studying any or all of Houser, Barasch,
Rosenthal, Kokish, Roy, Golomb and Hossainy, could arrive at the
conclusion that extending the treatment area beyond the afflicted
region could or would be beneficial.

(Reply Br. 3.)
The issue with respect to this rejection is whether the evidence
supports finding that Houser‟s method of delivering a drug via balloon
included delivery balloon interface contact with a known afflicted region
and also a non-afflicted region at the periphery of the afflicted region.

Findings of Fact
1. We adopt the Examiner‟s findings concerning the scope and content
of Houser‟s disclosure.
2. The Specification states:
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As used herein, an "afflicted region" of a vessel is a region that
exhibits clinical manifestations of disease, such as macroscopic
evidence in the form of, without limitation, obvious luminal wall
thickening, inflammation, etc. or microscopic evidence in the form of,
again without limitation, an accumulation of monocytes,
macrophages, neutrophiles, smooth muscle cells, inflammatory
cytokines, various lipoproteins, etc.

(Spec. 12-13, [0048].)
3. The Specification states:
As used herein, a "non-afflicted region" of a vessel is a region
that does not exhibit a clinical manifestation of the disease and
appears as healthy tissue. "Non-afflicted regions at the periphery of
the afflicted region" refers to healthy tissue at the border between
afflicted and non-afflicted regions.

(Id. at 13, [0049].)
4. Houser‟s Figure 12 is reproduced here:

FIG. 12 shows “a catheter balloon 168 having four dilatation
compartments 170, 172, 174 and 176 [which] is inserted in the vessel
180 until it reaches the obstructed area. . . . The multiple
compartments of balloon are then inflated to contact the obstruction.”
Element 178 is an obstruction. (Houser, col. 7, ll. 56-65.)

5. Houser‟s Figure 17 is reproduced here:
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“FIG. 17 is an enlarged view of the distal end of a second alternative
embodiment utilizing two balloons. (Id. at col. 4, ll. 20-21.)

6. Houser‟s Figure 18 is reproduced here:

“FIG. 18 is an enlarged view of the distal end of a third alternative
embodiment utilizing two balloons, one for drug delivery.” (Id. at col.
4, ll. 23-25.)

7. Houser explained drug delivery as follows:
When the two balloon embodiment is utilized, a proximal
balloon 260 may be used for drug delivery. The balloon has a reduced
diameter area 262 with a helical or stepped configuration as shown in
FIG. 18. A thin film heater 264 can be bonded to the reduced diameter
area. Perforations 266 in the thin film heater and balloon's surface
provide the means for drug delivery at the lesion site. The drugs are
commonly carried in the fluid which expands the balloon. Such
reduced diameter is not necessary, although it allows the drug to pool
in between balloon 260 and lesion site. Thus, in use, the distal balloon
enlarges the occluded area and then the proximal balloon delivers the
drug at the treatment site.

(Id. at col. 9, ll. 22-33.)

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Principles of Law
“During examination, „claims … are to be given their broadest
reasonable interpretation consistent with the specification, and … claim
language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.‟” In re Am. Acad. of Sci. Tech.
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). “[L]imitations are not to be read
into the claims from the specification.” In re Van Geuns, 988 F.2d 1181,
1184 (Fed. Cir. 1993) (citing In re Zletz, 893 F.2d 319, 321 (Fed. Cir.
1989)).
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.

Id. at 1478, quoting In re Swinehart, 439 F.2d 210, 212 (CCPA 1971).
“Description for the purposes of anticipation can be by drawings alone
as well as by words.” In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972)
(citation omitted); e.g., Karsten Mnf’g Corp. v. Cleveland Golf Co.,
242 F.3d 1376, 1384 (Fed. Cir. 2001) (claims to golf club anticipated by
picture of prior art golf club).

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Analysis
Houser‟s Figures 12 and 17 each show a lesion on a portion of a
vessel lumen. (FF 4 and 5.) The lesion shown does not completely cover
the vessel wall; the lesion defines an afflicted region, and the rest of the
vessel wall is unafflicted. There necessarily is “healthy tissue at the border
between afflicted and non-afflicted regions,” in the Specification‟s terms.
(FF 3.) The evidence shows that Houser described enlarging an occluded
area by using a multi-leaf balloon, and then moving a drug delivery balloon
into the treatment site. (FF 7.) When the treatment site is like those shown
in Figures 12 or 17, the drug delivery balloon will necessarily be between
the afflicted and non-afflicted portions of the vessel lumen. The Examiner
noted that Houser allowed for the drug delivery balloon to have a reduced
diameter, but correctly called attention to Houser‟s explicit teaching that
“[s]uch reduced diameter is not necessary.” (FF 7.) The evidence supports
the Examiner‟s finding that when this embodiment of Houser is used, “the
delivery interface contacts the vessel segment surface at the known afflicted
region but also at a non-afflicted region at the periphery of the afflicted
region as well.” (Claim 1.) This evidence is sufficient “to require the
applicant to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.” Schreiber, 128 F.3d at 1478.
Appellants have not met that burden.
Appellants have also argued that there is no way to interpret Houser‟s
method to “cover drug delivery to the whole, i.e., lateral and longitudinal,
periphery of the afflicted region.” (Appeal Br. 5.) We disagree with that
argument for the reasons explained above. But we also disagree that
appealed claim 1 even requires delivery to the whole periphery of the
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afflicted region. Claim 1 states that the delivery interface contacts the vessel
segment surface at the known afflicted region and at “a” non-afflicted region
at the periphery of the afflicted region. “A” region at the periphery does not
mean “the whole periphery.”
Appellants cite Specification paragraph 49 as supporting their
interpretation of claim 1. (Id.) Paragraph 49 states only that “„[n]on-
afflicted regions at the periphery of the afflicted region‟ refers to healthy
tissue at the border between afflicted and non-afflicted regions.” (FF 3.)
The Specification does not state that contacting the whole periphery is
required. Even if the Specification taught contacting the whole periphery or
border, that teaching would not be properly imported into the claim using the
article “a.”
Appellants fault the rejection for relying “virtually totally on
drawings.” (Reply Br. 3.) Contrary to Appellants‟ suggestions, the
Examiner reasonably explained how Houser words and drawings described
the invention Appellants now claim, and reasonably explained why
Appellants‟ arguments were unpersuasive. (Ans. 19-23.) Although we find
that in this case the Examiner relied on both text and drawings, reliance on
drawings is not an error, as drawings alone may be sufficient to support a
finding of anticipation. Mraz, 455 F.2d at 1072.
Claims 5, 8-14, and 19-21 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
We adopt the Examiner‟s findings and reasoning as our own. For
each of the obviousness rejections, Appellants contend that Houser does not
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teach all the elements of claim 1, and is insufficient to suggest all the
elements of the dependent claims, because none of the additional references
make up for Houser‟s deficiencies. These arguments are unpersuasive
because, as explained in the “Anticipation” section above, we disagree that
Houser is deficient with regard to claim 1.
Appellants additionally contend that “Barasch does not so much as
tangentially allude to drug delivery.” (App. Br. 6.) We conclude the
rejection of claims 2-4 over Houser and Barasch is well founded because
Barasch is pertinent to balloons used to dilate vessel occulsions. See In re
Clay, 966 F.2d 656, 659 (Fed. Cir. 1992) (“A reference is reasonably
pertinent if, even though it may be in a different field from that of the
inventor‟s endeavor, it is one which, because of the matter with which it
deals, logically would have commended itself to an inventor‟s attention in
considering his problem.”).
The obviousness rejections are affirmed for the reasons stated in the
Examiner‟s Answer.

OBVIOUSNESS-TYPE DOUBLE PATENTING
The Issue
The Examiner‟s position is that because Houser taught the method of
appealed claim 1, “the scope of the method [c]laimed by Hossainy falls
within that recited by instant Claim 1.” (Ans. 18.)
Appellants contend that “Hossainy says not a word about what region
of the vasculature is to be treated,” and that the rejection erroneously reads
limitations into the Hossainy claims. (App. Br. 8.)
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Further Findings of Fact
8. Hossainy‟s claim 1 reads, in part:
1. A method for inhibiting restenosis comprising:
(a) implanting a stent at a treatment site in a patient‟s vasculature,
wherein the stent comprises a drug-polymer layer including a first
drug, therapeutic agent, medicine, compound or active agent; and
(b) peri-procedurally delivering a solution comprising a second drug,
therapeutic agent, medicine, compound or active agent to the
treatment site intraluminally,
wherein the peri-procedural deliverance of the second drug,
therapeutic agent medicine, compound or active agent occurs
substantially contemporaneously with, and/or immediately after, the
implantation of the stent,
*****

Principles of Law
Obviousness-type double patenting entails a two-step analysis. First,
the allegedly conflicting claims are construed and, second, the difference(s)
between the claims are considered to determine whether the claims are
patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968
(Fed. Cir. 2001). “A later patent claim is not patentably distinct from an
earlier patent claim if the later claim is obvious over, or anticipated by, the
earlier claim.” (Id.)
To support a finding of inherency, the evidence “must make clear that
the missing descriptive matter is necessarily present in the thing described in
the reference . . . . Inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (citations omitted).
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Analysis
The appealed claims recite that “the delivery interface contacts the
vessel segment surface at the known afflicted region but also at a non-
afflicted region at the periphery of the afflicted region as well.” Hossainy‟s
claim 1 does not recite that limitation. (FF 8.) The rejection appears to use
Houser as an evidentiary reference to show that Hossainy‟s claim anticipates
the appealed claims. However, the rejection does not explain which step in
Hossainy‟s claim is thought to anticipate, and how the missing concept is
necessarily present, and how Houser is relevant. The rejection is reversed
because it does not explain how Hossainy necessarily anticipated the
appealed claims. See Robertson, 169 F.3d at 745.

SUMMARY
We affirm the rejection of claims 1, 5, 8-14, and 19-21 under
35 U.S.C. § 102(b) as anticipated by Houser.
We affirm the rejection of claims 2-4 under 35 U.S.C. § 103(a) as
unpatentable over Houser and Barasch.
We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as
unpatentable over Houser and Rosenthal.
We affirm the rejection of claims 16 and 17 under 35 U.S.C. § 103(a)
as unpatentable over Houser and Kokish.
We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as
unpatentable over Houser and Roy.
We affirm the rejection of claims 22-25, and 31-35 under 35 U.S.C.
§ 103(a) as unpatentable over Houser and Golomb.
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We reverse the rejection of claims 1, 5, and 8-21 under the doctrine of
obviousness-type double patenting over claims 1-38 of US 7,438,722 B1 in
view of Houser.
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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