Ex Parte Shipp

Patent Trial and Appeal Board

Aug 27, 2018

11161702 (P.T.A.B. Aug. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/161,702 08/12/2005
50855 7590
Covidien LP
60 Middletown A venue
Mailstop 54, Legal Dept.
North Haven, CT 06473
08/29/2018
FIRST NAMED INVENTOR
John Isbell Shipp
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.
H-US-01162 (203-6225) 2701
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/29/2018 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):
rs. patents. two@medtronic.com
mail@cdfslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN ISBELL SHIPP
Appeal2017-006255
Application 11/161, 702
Technology Center 3700
Before EDWARD A. BROWN, BRANDON J. WARNER, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
John Isbell Shipp ("Appellant") 1 appeals under 35 U.S.C. § 134(a)
from the Examiner's decision, as set forth in the Final Office Action dated
June 13, 2016 ("Final Act."), rejecting claims 1-17, 37, 38, and 42--45. We
have jurisdiction over this appeal under 35 U.S.C. § 6(b ).
1 The Appeal Brief identifies Covidien LP, whose ultimate parent company
is Medtronic, plc, as the real party in interest. Appeal Br. 2.
Appeal2017-006255
Application 11/161,702
SUMMARY OF THE DECISION
We AFFIRM-IN-PART.
SUMMARY OF THE INVENTION
Appellant's claimed invention is directed to surgical fasteners. Spec.
,r 2. Claims 1 and 10 are independent. Claim 1, reproduced below from
page 36 (Claims Appendix) of the Appeal Brief, is illustrative of the claimed
subject matter:
1. A mesh fastener for penetrating tissue and fixating mesh
having a longitudinal axis comprising:
a head section with a distal surface and a proximal
surface perpendicular to the longitudinal axis, the head section
having an outer wall defining an outer diameter, the outer wall
having a pair of spaced apart tool engaging flanges defining a
pair of open sections and a pair of threaded sections, each open
section of the pair of open sections extending from the proximal
surface to the distal surface of the head section, the pair of
threaded sections being located about 180° from each other,
each flange of the pair of spaced apart tool engaging flanges
including a single thread having a first pitch formed on an outer
surface of a respective one of the pair of spaced apart tool
engaging flanges, each thread extending radially to a single
peak;
a threaded, truncated tissue snaring section, having a
distal and a proximal end, the proximal end of which is formed
on the distal surface of the head section,
the threads of the tissue snaring section, having a
diameter and root diameter, and extending from the proximal
end of the tissue snaring section to the distal end of the tissue
snaring section, the threads of the tissue snaring section having
a second pitch that is different from the first pitch; and
a sharpened tip extending distally from the tissue snaring
section.
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Application 11/161,702
REFERENCES
The Examiner relies on the following prior art references in rejecting
the claims on appeal:
Jarrett us 5,080,665 Jan. 14, 1992
Yuan us 5,681,310 Oct. 28, 1997
Grafton US 6,319,270 Bl Nov. 20, 2001
Gogolewski US 6,747,121 B2 June 8, 2004
Criscuolo WO 03/103507 A2 Dec. 18, 2003
Zergiebel CA 2 527 778 Al June 14, 2004
REJECTI0NS 2
I. Claims 1--4 and 44 stand rejected under 35 U.S.C. § I03(a) as being
unpatentable over Zergiebel and Criscuolo.
II. Claims 5, 6, and 8 stand rejected under 35 U.S.C. § I03(a) as being
unpatentable over Zergiebel, Criscuolo, and Jarett.
III. Claim 7 stands rejected under 35 U.S.C. § I03(a) as being
unpatentable over Zergiebel, Criscuolo, and Gogolewski.
IV. Claim 9 stands rejected under 35 U.S.C. § I03(a) as being
unpatentable over Zergiebel, Criscuolo, and Grafton.
V. Claims 1--4, 10-12, 37, 38, and 42--45 stand rejected under 35 U.S.C.
§ I03(a) as being unpatentable over Yuan, Zergiebel, and Criscuolo.
VI. Claims 13-14 and 16 stand rejected under 35 U.S.C. § I03(a) as being
unpatentable over Yuan, Zergiebel, Criscuolo, and Jarett.
VII. Claim 15 stands rejected under 35 U.S.C. § I03(a) as being
unpatentable over Yuan, Zergiebel, Criscuolo, and Gogolewski.
2 Rejections under 35 U.S.C. § I03(a) based in part on Lewis (US
2004/0243139 Al, published Dec. 2, 2004) of claims 10-14, 16, 17, 37, 38,
42, and 45 have been withdrawn. Ans. 3--4.
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Application 11/161,702
VIII. Claim 17 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Yuan, Zergiebel, Criscuolo, and Grafton.
ANALYSIS
Rejection I
The Examiner finds that Zergiebel discloses a mesh fastener
substantially as recited in independent claim 1, but relies on Criscuolo to
teach a head section including a single thread. Final Act. 2-5. Regarding
the recited sharpened tip, the Examiner finds that features in Zergiebel
identified by reference characters "140a, 220 or 240 can be interpreted as a
piercing geometry at the distal end of the snaring section." Id. at 3.
Appellant traverses, arguing that the portions of Zergiebel relied upon
by the Examiner as corresponding to the recited sharpened tip "are part of
the fastener applier 100 of Zergiebel, not the screw fasteners 10 or 200."
Appeal Br. 9. We agree with Appellant.
Zergiebel discloses an absorbable surgical fastener with two main
components: a body portion and a head portion. Zergiebel 5:27-29. The
fastener is inserted into a patient via an applier. Id. at 8:13-14. The applier
includes an elongated tubular portion housing a cylindrical driver, which
includes a longitudinally extending pilot having a sharpened tip. Id. at 8:20-
22, 9:4--6, 9:29-30. In use, the sharpened tip of the pilot is used to tap the
mesh and underlying tissue, and the fastener is thereafter inserted through
the tapped hole. Id. at 9:29-30, 11 :7-9, 11 :28-29.
Thus, as correctly noted by Appellant, the Examiner has not identified
adequately what disclosed structure of the cited references corresponds to
the recited sharpened tip of the mesh fastener. Nor do we agree with the
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Application 11/161,702
Examiner's determination that the claim language "does not preclude the
sharpened tip that extends distally from being a different part of the system
as long as the structure of the fastener can include a sharpened tip extending
distally from the snaring section." Ans. 4--5. Claim 1 expressly requires the
sharpened tip to be a part of the mesh fastener. The Examiner has not
identified where this requirement is disclosed in the cited references.
Accordingly, we do not sustain the rejection of claim 1, or its
dependent claims 2--4 and 44, as being unpatentable over Zergiebel and
Criscuolo.
Rejections II-IV
Claims 5-9 depend from claim 1. The Examiner does not rely on
Jarret, Gogolewski, or Grafton in any manner that would remedy the
deficiencies noted above with respect to the rejection of claim 1. Therefore,
the rejections of claims 5-9 as being unpatentable over Zergiebel, Criscuolo,
and one of Jarrett, Gogolewski, and Grafton are not sustained.
Rejection V
Appellant addresses the rejection of independent claims 1 and 10
collectively. Appeal Br. 20-29, 31-34. We select claim 1 as representative.
See 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that Yuan discloses a mesh fastener substantially
as recited in independent claim 1, but relies on Zergiebel to teach a head
with spaced apart tool engaging flanges defining a pair of open sections.
Final Act. 17-20. The Examiner determines that it would have been obvious
to one of ordinary skill in the art "to modify the head section of Yuan to
include the pair of spaced apart flanges and pair of spaced apart openings as
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suggested by Zergiebel, since such a modification allows the head to better
engage with a driver and helps facilitate driving of the fastener." Id. at 19--
20. The Examiner also relies on Criscuolo to teach a head portion including
a single thread. Id. at 20-21.
Appellant traverses, first arguing that "nowhere does Yuan point to
holding of the fastener or driver engagement of the fastener as an issue" and,
because the Examiner states that "the hexagonal wrench and the tool holes
of Yuan would not be effected at all, ... it is unclear to Appellant how the
addition of the flanges could improve the engagement between the
hexagonal wrench of Yuan with the modified fasteners of Yuan as asserted
by the Examiner." Appeal Br. 21-22.
Appellant's arguments are unpersuasive because they do not
characterize accurately the Examiner's rejection. The rejection does not
indicate that the added flanges and openings would improve the engagement
with Yuan's hexagonal wrench, as stated by Appellant; rather, the rejection
states that the flanges and openings would "allow[] the head to better engage
with a driver and help[] facilitate driving of the fastener." Final Act. 20
(emphasis added). As explained by the Examiner (see Ans. 6-7),
Zergiebel's openings (slots 28) are "used to transmit both linear and
rotational forces in order to drive the absorbable screw fastener" and
"allow[] for torque and linear drive thus allowing for considerably less
insertion force into the body tissue." Zergiebel 2:9--12, 2:24--26, 6:24--26.
Zergiebel additionally discloses that "[ s ]lots 28 are configured to transmit
torque to screw fastener 1 O" and may be tapered "to facilitate[] rotation and
driving of screw fastener 10." Id. at 6:24--30. Thus, the Examiner's
conclusion that incorporating Zergiebel's flanges and openings into Yuan's
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fastening screw would provide for better engagement with a driver and
facilitate driving of the fastener is based on a rational underpinning and
supported by the evidence.
Appellant next argues that, because
adding the slot/flange arrangement of Zergiebel to the fastener
of Yuan would require removing material from the head of the
fastener of Yuan, one skilled in the art would readily appreciate
that this removal of material would decrease surface contact
area between the modified fastener and bone, and therefore,
decrease the frictional securement of the modified fastener to
bone contrary to the objectives of Yuan.
Final Act. 22; see also id. at 28; Reply Br. 5---6. Appellant's argument is
unpersuasive because the assertion of a decrease in "frictional securement"
is unsupported by any evidence or declaration. It is well settled that
arguments of counsel cannot take the place of factually supported objective
evidence. See, e.g., In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Additionally, we note that Zergiebel's slots do not appear to extend to the
bottom surface of head portion 14 (see, e.g., Zergiebel Fig. 1), and, thus,
their incorporation into Yuan's fastener would not require removal of
material from the surface of head 21 that engages mat 10.
Appellant next argues that the Examiner's modification is improper
because in order to use Zergiebel's fastener applier 100, Yuan's fasteners
would have to be cannulated, which would require elimination of their
pointed tips. Appeal Br. 23-24.
This argument is unpersuasive because "modifying the fastener head
to include a pair of spaced openings and a pair of spaced flanges ... does
not require the fastener of Yuan to be cannulated." Ans. 9. The Examiner
does not propose to use Zergiebel' s specifically disclosed fastener applier in
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the combination. We note that Zergiebel explains that tips 143a of resilient
fingers 144a are seatable in respective slots 28, thereby holding the fastener
in position ready for application. Zergiebel 9: 14--21. Appellant does not
explain persuasively why use of such fingers within the added head slots
would require cannulation of the fastener.
Appellant next reproduces paragraphs 8 and 26 of the Specification
and argues that, because "all the bone fasteners of Yuan are 1) formed of
metal and 2) have the sharp pointed tips for insertion into bone and that
3) such structure was clearly identified as problematic in Appellant's
Specification," "one of ordinary skill in the art would not be motivated to
select Yuan as a primary reference since the structure of Yuan is clearly
wholly contradictory to the needs of one of ordinary skill in the art." Appeal
Br. 27; see also Reply Br. 6-9.
Appellant's arguments regarding the contents of the Specification,
rather than the language of the claims, fail to apprise us of error in the
Examiner's use of Yuan. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
("Many of appellant's arguments fail from the outset because ... they are
not based on limitations appearing in the claims."); In re Am. A cad. of Sci.
Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (citations omitted)
( cautioning against reading limitations into the claims from the
specification). Furthermore, we note that although Yuan discloses metallic
fasteners, Yuan also discloses that its fasteners can be made of a
biocompatible material such that they "will be absorbed and incorporated
gradually and completely into the body of a patient receiving the treatment."
Yuan 2:22--41.
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Finally, Appellant argues that Yuan is not analogous art. Appeal Br.
31-34. In support, Appellant relies on a Declaration of Dr. B. Todd
Heniford (the Heniford Declaration). 3 Id. at 32.
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.
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). Regarding the
scope of analogous art:
The Supreme Court's decision in KSR International Co. v.
Teleflex, Inc., 550 U.S. 398 (2007), directs us to construe the
scope of analogous art broadly, stating that ''familiar items may
have obvious uses beyond their primary purposes, and a person
of ordinary skill often will be able to fit the teachings of
multiple patents together like pieces of a puzzle." Id. at 402
( emphasis added).
3 Although Appellant notes that the Heniford Declaration was filed during
prosecution of a related patent application (see Appeal Br. 32 n.2), it does
not appear that the Heniford Declaration is of record in this case.
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Application 11/161,702
Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010).
Appellant's Specification describes surgical fasteners for fastening
material to tissue, such a fastener having a head section, a mesh retention
section, and a threaded tissue-snaring section. Spec. ,r,r 2, 48-50, Fig. 1.
Indeed, the preamble of claim 1 recites "[a] mesh fastener for penetrating
tissue and fixating mesh." Appeal Br. 36 (Claims App.). We, thus, define
the field of endeavor as surgical fasteners for fastening material to tissue.
Similarly, Yuan describes a surgical fastener for fastening material
(holding mat) to tissue (bone) (see, e.g., Yuan 1:52-60, Fig. 1). Therefore,
Yuan is analogous art at least because it is from the same field of endeavor
as Appellant's claimed invention. 4
Accordingly, we sustain the rejection of claims 1 and 10, as well as
their dependent claims 2--4, 11, 12, 37, 38, and 42--45, which are not argued
separately, as being unpatentable over Yuan, Zergiebel, and Criscuolo.
Rejections VI-VIII
Appellant does not make any other substantive argument regarding
the rejection of claims 13-17, each of which depends from claim 10. See
Appeal Br. 29-30. Therefore, we likewise sustain the rejections of
dependent claims 13-1 7.
4 We note that the Heniford Declaration discusses the particular problem
with which Appellant is involved (namely, fastening mesh to soft tissue for
hernia repair), but does not address the field of endeavor.
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DECISION
The Examiner's decision to reject claims 1-9 and 44 as unpatentable
over Zergiebel and Criscuolo alone, or in varying combinations with Jarrett,
Gogolewski, and Grafton, is reversed.
The Examiner's decision to reject claims 1--4, 10-17, 37, 38, and 42-
45 over Yuan, Zergiebel, and Criscuolo alone, or in varying combinations
with Jarrett, Gogolewski, and Grafton, 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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