Ex Parte Stinson

Patent Trial and Appeal Board

Mar 30, 2016

12071061 (P.T.A.B. Mar. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/071,061 02/14/2008
121974 7590 04/01/2016
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Jonathan S. Stinson
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.
S63.2N-14715-US03 7979
EXAMINER
GUPTA, YOGENDRAN
ART UNIT PAPER NUMBER
1744
NOTIFICATION DATE DELIVERY MODE
04/01/2016 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):
kddocketing@cpaglobal.com
bbonneville@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHAN S. STINSON
Appeal2014-005280
Application 12/071,061 1
Technology Center 1700
Before CHUNG K. PAK, TERRY J. OWENS, and N. WHITNEY WILSON,
Administrative Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the Final Action2 of
claims 65, 67 through 73, 75, 76, and 84 through 87. We have jurisdiction
pursuant to 35 U.S.C. § 6. We REVERSE.
1 Application 12/071,061 (Application'061), filed February 14, 2008, which is a
continuation of Application 10/911,650, filed on August 05, 2004, which issued as
U.S. Patent No. 7,354,455, which in tum is a continuation of Application
09/972,054, filed on October 09, 2001, which issued as U.S. Patent No. 6,790,237.
2 Final Action mailed July 03, 2013 ("Final Act"). Remaining co-pending
claims 54 through 62 have been withdrawn from consideration.
Appeal2014-005280
Application 12/071,061
fNTRODUCTION
The appealed subject matter relates to a method for manufacturing a
medical stent having an elastomeric valve, which is "near the distal end portion of
the stent." '061 Specification ("Spec."), i-fi-1 [005] and [008]. The medical stent may
be used as an "esophageal" medical stent for "preventing harmful gastric acid
reflux in a patient." Id. at i-fi-1 [001] and [005]. According to '061 Specification (id.
at ,-r [005]),
[t]he valve is normally closed but configured to open in response to a
predetermined condition. For an esophageal stent, the predetermined
condition may be a pressure difference between the upstream and the
downstream of the valve ... For instance, the passage of food from
the esophagus into the stomach causes the pressure difference across
the valve large enough to open the valve and upon completion of the
food passage, the valve returns to its normal-closed state to prevent
the reflux.
Details of the appealed subject matter are recited in representative independent
claim 65 of Application'061, which is reproduced below from the Claims
Appendix to the Appeal Brief3 (bracketed reference characters of
'061 Specification Fig. 4, reproduced on the following page, indentations, and
emphasis added):
65. A method of manufacturing a medical stent having an
elastomeric valve, comprising:
providing a generally tubular body [2];
positioning a fixture [15] proximate to a distal end [5] of the
tubular body [2];
applying an elastomeric material [18] onto the fixture [15]; and
3 Appeal Brief filed on October 28, 2013 ("App. Br.").
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Application 12/071,061
removing the fixture [15] to form the elastomeric valve [20] at
the distal end [5] of the tubular body [2];
wherein the elastomeric valve [20] is configured to be normally
closed and to be open in response to a predetermined condition,
the elastomeric valve [20] having a circular cross-section when
the elastomeric valve [20] is in the closed configuration; and
wherein the elastomeric valve [20] has a generally dome-
shaped, convex outer surface, is substantially symmetric about a
longitudinal axis of the tubular body [2] when in the normally closed
position, and consists of the elastomeric material.
Fig. 4 is shown below:
FIG.4
Fig. 4 is a schematic diagram of an exemplary method for manufacturing
stent 1' with elastomeric valve 20. Fixture 15 is used for forming the shape
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Application 12/071,061
of elastic valve 20. Protrusion 19 on fixture 15 forms a small opening 21 in
elastomeric valve 20. Fixture 15 is inserted from the proximal end 4 of
tubular body 2 with elongated handle 16, and then fixed in tubular body 2 at
the distal end 5 of tubular body 2. Fixed fixture 15 is then coated with
elastomeric material 18, for example by spraying from nozzle 17 or dip-
coating (not shown). After coating, elastomeric material 18 coated on
fixture 15 is cured. Fixture 15 is then removed from stent 1 '. Valve 20 may
be provided with pleats or slits 22 to "facilitate the opening" of valve 20.
Id. at iii! [034] and [035].
The Examiner maintains the following grounds of rejection in the
Examiner's Answer, 4 which are before us on appeal:
1. Claims 65, 67 through 73, 75, and 76 under 35 U.S.C. § 112, first
paragraph, as failing the written description requirement.
2. Claim 87 under 35 U.S.C. § 112, first paragraph, as failing the
written description requirement.
4 Examiner's Answer mailed on January 24, 2014 ("Ans.") 3 through 10. In
rejections 1 and 3, claim 74 has been omitted because it was cancelled in the
Amendment filed on October 21, 2013 (after the mailing of the Final Act.), which
was entered by the Examiner. In addition, the Examiner has withdrawn the
rejection of claim 74 under 35 U.S.C. § 112, fourth paragraph, set forth in the Final
Action. Ans. 2.
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Application 12/071,061
3. Claims 65, 67 through 73, 75, 76, and 84 through 87 under
35 U.S.C. § 103(a) as being unpatentable over the collective teachings of
Chinn5, Greenhalgh6, and Schulte7 .
4. Claims 68 through 70 under 35 U.S.C. § 103(a) as being
unpatentable over the collective teachings of Chinn, Greenhalgh, Schulte,
and Dua8.
DISCUSSION
Rejections 1 and 2, § 112, first paragraph.
The Examiner holds that the originally filed specification does not provide
an adequate written description as required under 35 U.S.C. § 112, first paragraph
for the limitations "the elastomeric valve ... consists of an elastomeric material"
recited in claim 65 and "a valve consisting of an elastomeric material" recited in
claim 87. The Examiner finds that "[t]here is no disclosure in the original
disclosure ... which supports the position that the valve is made of ONLY
elastomeric material." Ans. 3, 4. The Examiner holds that the language "consists
of' is "essentially a negative limitation which states that the valve is constructed of
nothing else but elastomeric material." Id. The Examiner finds that "[n]o[]where
in applicant's original disclosure does it describe expressly or inherently with
5 United States Patent Application Publication 2001/0025196 Al by Joseph
Andrew Chinn et al., published on September 27, 2001.
6 United States Patent 6,494,909 B2, issued to E. Skott Greenhalgh on December
17, 2002.
7 United States Patent 3,445,916, issued to RudolfR. Schulte on May 27, 1969.
8 PCT Published Application WO 00/32137 by Kulwinder S. Dua et al., published
on June 08, 2000.
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Application 12/071,061
sufficient specificity that the valve is intended to be formed by 100% elastomeric
material." Id. at 11.
Appellant urges that the disclosure in '061 Specification "would have
reasonably conveyed to the skilled artesian that applicant possessed the claimed
subject matter at the time of original filing." App. Br. 8, citing '061 Specification,
i-fi-1 [0034] and [0035]. In particular, according to Appellant, '061 Specification
paragraph [0034], with reference to Fig. 4, "states ... [that] 'the fixture 15 is
coated with an elastomeric material 18 ... The coating can be performed, for
example by, spraying 17 or dip-covering (not shown) the elastomeric material 18
onto the surface of the fixture 15 .. . "'(emphasis added). Id. at 8, 9. As discussed
supra, Fig. 4 is a schematic diagram of an exemplary method for manufacturing
stent 1' with elastomeric valve 20.
The predecessor to our reviewing court has held that "the invention claimed
does not have to be described in ipis verbis in order to satisfy the description
requirement of§ 112." In re Lukach, 442 F.2d 967, 969 (CCPA 1971). The court
has also held that "[i]t is not necessary that the application described the claim
limitations exactly ... but only so clearly that persons of ordinary skill in the art
will recognize from the disclosure that appellants invented processes including
those limitations." In re Wertheim, 541F.2d257, 262 (CCPA 1976).
We find that Appellant's disclosure in paragraph [0034] of
'061 Specification provides an adequate written description for the limitations that
the "elastomeric valve . . . consists of an elastomeric material" recited in claim 65
and the "valve consisting of the elastomeric material" recited in claim 87. The
Examiner has failed to direct us to any credible evidence establishing that the '061
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Specification description for forming an elastomeric valve from an elastomeric
material relates to a different invention than that discussed supra.
Thus, we conclude that the Examiner has failed to establish that claims 65
and 87 fail to comply with the written requirement of§ 112, first paragraph. The
Examiner's rejections of claims 65 and 87 under§ 112 are reversed.
Rejection 3, Obviousness over the collective teachings of
Chinn, Greenhalgh, and Schulte
In rejecting independent claims 65 and 87, the Examiner finds that the
collective teachings of Chinn and Greenhalgh render obvious a method for forming
a medical stent, i.e., a heart valve, as recited in claims 65 and 87, but for making
the stent's elastomeric valve having "a generally dome-shaped, convex outer
surface" as recited in claim 65 or "a convex outer surface" as recited in claim 87.
Ans. 5, 6. To make up for the deficiencies of Chinn and Greenhalgh, the
Examiner finds that Schulte teaches an anatomical (heart) valve comprising an
elastomeric check valve, where "the elastomeric valve is generally dome shaped
(convex) ... " Id., at 7, citing Schulte, col. 1, 11. 23-42, col. 1, 1. 65, to col. 2, 1. 6,
and Figures 1-13. The Examiner (id.) then determines that "[i]t would have been
obvious to utilize a circular cross section for the valve and have a generally
dome/convex valve to ensure uniform one way flow through a valving system."
Appellant urges that collective teachings of Chinn, Greenhalgh, and Schulte
"fail to render obvious the subject matter of' claim 65 and of claim 87. App.
Br. 11, 13. In particular, Appellant urges that, contrary to the Examiner's finding,
"the outer surface of the valve of Schulte is concave, not convex" (emphasis in the
original). App. Br. 12, citing Schulte, col. 2, 11. 3-5, which discloses that in making
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Application 12/071,061
the check valve, the "leaflets [of the valve] are concave inwardly from the outside
of the valve ... " (emphasis in original).
In response to Appellant's arguments, the Examiner reasons that although
"the leaflets [in Schulte' s valve] are "concave individually .... it is the sum and
configuration of the three leaflets which form the convex configuration seen in
[Schulte] figures 1-7 ." Ans. 12. The Examiner holds that the "leaflets which will
be formed will form a bulge at the middle which then forms a convex surface." Id.
at 12, 13, citing Schulte Figs. 11 and 13, reproduced below. The Examiner finds
that "a convex surface is any surface or boundary that curves or bulges outward."
Ans. 13, 14, citing the definition from "freedictionary.com."
f'lG.//
According to Schulte (col. 2, 11. 51-52; col. 3, 11. 41-45), Fig. 11 illustrates a side-
view of the valve, which comprises concave leaflets and a "cuff' attached to the
bottom of the valve. A silicone layer 49 is coated on the cuff and any
discontinuity 50 is filed with silicone rubber "to make a smooth and continuous
device." Fig. 13 illustrates an end-view of the valve, where the tops of the
leaflets 51, 52, and 53 are coated with silicone rubber 55. Schulte, col. 2,
11. 53-55, and col. 3, 1. 62, to col. 4, 1. 2.
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In the Reply Brief~ 9 Appellant urges that claims 65 and 87 recite that the
"outer surface" of the elastomeric valve is "convex," and claim 65 further recites
that the valve's outer surface is "generally dome-shaped." Reply 6. Appellant
(id.) urges the "surfaces of the leaflets of Schulte do not bulge or curve outwardly"
in Schulte' s Fig. 11. Put another way, claims 65 and 87 require that the "outer
surface" of the elastomeric valve, as a whole, be "convex," a condition that is not
satisfied by a single point or line that is formed when the outer ends of two or more
leaflets meet or touch, as illustrated in Schulte Fig. 13.
The preponderance of the evidence of record does not support the
Examiner's determination that the collective teachings of Chinn, Greenhalgh, and
Schulte would have prompted a person having ordinary skill in the art to practice
the necessary steps to manufacture a stent with an elastomeric valve having a
"generally dome-shaped, convex outer surface" as recited in claim 65 or having
"a convex outer surface" as recited in claim 87. As indicated supra, none of the
cited references; in particular Schulte; teaches or suggests making a stent having an
elastomeric valve having a convex outer surface recited in claims 65 and 87, as
well as having a dome-shaped outer surface as recited in claim 65. The Examiner
has not directed out attention to any teachings in Schulte that would have led such
a person to practice the necessary steps to make a stent with an elastomeric valve
having a convex outer surface as recited in claims 65 and 87.
Accordingly, we find that Appellant has shown reversible error in the
Examiner's determination that the collective teachings of Chinn, Greenhalgh, and
Schulte would have prompted a person having ordinary skill in the art to arrive at
9 Reply Brief filed on March 21, 2014 ("Reply").
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Application 12/071,061
the subject matter recited in the claims on appeal within the meaning of 35 U.S.C.
§ 103(a). The Examiner's rejection of claims 65 and 87 is reversed.
Rejection 4, Obviousness over the collective teachings of
Chinn, Greenhalgh, Schulte, and Dua
The additional prior art reference used in rejecting some of the dependent
claims on appeal in rejection 4 was not relied upon by the Examiner to remedy the
deficiencies of Chinn, Greenhalgh, and Schulte, discussed supra. Accordingly,
rejection 4 is also reversed.
ORDER
In view of the foregoing, we REVERSE the rejections of claims 65, 67
through 73, 75, 76, and 87 under 35 U.S.C. § 112, first paragraph, and of
claims 65, 67 through 73, 75, 76, and 84-87 under 35 U.S.C. § 103(a).
REVERSED
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