Ex Parte Sengun et al

Patent Trial and Appeal Board

Apr 25, 2018

13242085 (P.T.A.B. Apr. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/242,085 09/23/2011
27777 7590 04/27/2018
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Mehmet Ziya Sengun
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.
MIT5150USNP 9590
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
04/27/2018 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MEHMET ZIY A SENGUN, JUSTIN M. PICCIRILLO,
GEROME MILLER, and ARTHUR G. STEPHEN
Appeal2017-003973
Application 13/242,085 1
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-25 and 29-
31 (Br. 2). Examiner entered rejections under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the real party in interest as "DePuy Mitek, LLC which
is a subsidiary of Johnson & Johnson" (Br. 2).
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Application 13/242,085
STATEMENT OF THE CASE
Appellants' disclosure "relates to tools for inserting implants into
bone and more particularly to drivers for suture anchors" (Spec. i-f 1 ).
Appellants' independent claims 1, 12, and 19 are representative and
reproduced below:
1. An inserter comprising:
a rigid tip portion having a distal end and a proximal end,
and at least the distal end being capable of being placed within
an implant;
an elongated, rigid shaft having a proximal surface which
is capable of receiving a driving force and a distal end
proximate the rigid tip portion; and
a localized compliant region disposed between the tip
portion and the shaft which requires less lateral force to bend
than the tip portion, at least when the tip portion has been
placed within the implant.
(Br. 8.)
12. An inserter comprising:
a rigid tip portion having a distal end and a proximal end,
and at least the distal end capable of being placed within an
implant to provide internal support for the implant during
insertion into bone;
an elongated, rigid shaft having a proximal surface which
is capable of receiving a driving force and a distal end
proximate the rigid tip portion;
a distal-facing shoulder at the proximal end of the tip
portion capable of engaging the proximal end of the implant;
and
a compliant region disposed between the shoulder and
the shaft which requires less lateral force to bend than the tip
portion, at least when the tip portion has been placed within the
implant.
(Id. at9.)
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19. A combination comprising:
a suture anchor having a distal end and a proximal end,
and defining a lumen open at the proximal end;
a rigid tip portion having a distal end and a proximal end,
and at least the distal end being capable of being placed within
the lumen of the suture anchor to provide internal support for
the suture anchor during insertion into bone;
an inserter including an elongated, rigid shaft having a
proximal surface which is capable of receiving a driving force
and a distal end proximate the rigid tip portion;
a distal-facing shoulder at the proximal end of the tip
portion capable of engaging the proximal end of the suture
anchor; and
a compliant region disposed between the shoulder and
the shaft which requires less lateral force to bend than the tip
portion, at least when the tip portion has been placed within the
suture anchor.
(Id. at 10.)
The claims stand rejected as follows:
Claims 1-3, 5-10, 12, 13, 15-17, 19-22, and 24 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination ofHeckele2 and
McGuire. 3
Claims 4, 14, 23, and 29-31 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Heckele, McGuire, and Kozak. 4
Claim 4 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Heckele, McGuire, and Appenzeller. 5
2 Heckele et al., US 6,830,574 B2, issued Dec. 14, 2004.
3 McGuire et al., US 5,797,918, issued Aug. 25, 1998.
4 Kozak, US 6,813,975 B2, issued Nov. 9, 2004.
5 Appenzeller et al., US 2009/0157123 Al, published June 18, 2009.
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Application 13/242,085
Claims 11, 18, and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Heckele, McGuire, and Nicholson. 6
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Heckele discloses an
instrument [that] serves for the application in particular of bone
grafts in the space between two vertebrae and includes a shank,
a handle, and a holder for the implant, which forms the distal
instrument part. The holder is pivotably mounted relative to the
shank and can be fixed in any respective position which is
reached by pivoting.
(Heckele, Abstract.)
FF 2. Heckele's Figure 1 is reproduced below:
Fig.1
11
. .... )
i
9
Heckele's "FIG. 1 is a total view of [Heckele's] instrument according to
[Heckele's disclosure] in a part longitudinal section" (Heckele 2: 37-38
(emphasis omitted); see generally Final Act. 7 4--6).
6 Nicholson et al., US 5,968,044, issued Oct. 19, 1999.
7 Office Action mailed November 12, 2015.
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Application 13/242,085
FF 3. Heckele' s Figure 6 is reproduced below:
flg,6
Heckele's "FIG. 6 shows the instrument according to [Heckele's] invention
in an application as a bone graft applicator" (Heckele 2: 47--48).
FF 4. Examiner finds that Heckele's instrument comprises:
[A] rigid tip portion (3) having a distal end (at 14) and a
proximal end (at 12/13), and at least the distal end being
capable of being placed within an implant (21) (as shown in
[Heckele's] Fig. 6) an elongated, rigid shaft (4) having a
proximal surface which is capable of receiving a driving force
(via handle 2/head 9) and a distal end (7) proximate the rigid tip
portion (3) (as shown in [Heckele's] Figs. 1-2); and a localized
compliant region (pivotal interface of 8 and 12, [Heckele' s]
Figs. 1-2) disposed between the tip portion (3) and the shaft ( 4)
which requires less lateral force to articulate than the tip portion
(force required to articulate spherical bearing body 12 within
recess 8 is fully adjustable and allows for free articulation when
fully released; [see Heckele,] col. 3, lines 40-43), at least when
the tip portion (3) has been placed within the implant (21) (as
shown in [Heckele's] Fig. 6).
(Final Act. 4--5; see also Heckele 3: 31-39.)
FF 5. Examiner finds that Hecke le teaches Appellants' claimed invention,
but for a "compliant region being bendable and more malleable than the tip
portion" (Final Act. 6; see id. at 5---6).
FF 6. McGuire relates "to surgical screwdrivers for inserting bone screws
and, more particularly, to surgical screwdrivers for inserting interference
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Application 13/242,085
bone fixation screws in bone tunnels and to methods of performing
arthroscopic cruciate ligament reconstruction of the knee" (McGuire 1: 19-
23).
FF 7. McGuire's Figures 9 and 16 are reproduced below:
F1G.9 FIG.16
McGuire's "FIG. 9 is an isometric view of a cannulated flexible
screwdriver," within the scope of McGuire's disclosure (McGuire 4: 59---60
(emphasis omitted)). McGuire's FIG. 16 illustrates a cannulated flexible
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Application 13/242,085
screwdriver, within the scope of McGuire's disclosure, in a flexed position
(id. 5: 9-13 (emphasis omitted)).
FF 8. Examiner finds that "McGuire teaches ... a surgical screwdriver
comprising a compliant/articulating region that is either in the form of a
malleable/bendable wire coil (212) ([see McGuire's] Fig. 9) or one or more
articulating pivotal linkage members (311) ([see McGuire's] Fig. 16)"
FF 9. Examiner finds that McGuire "teaches that a flexible shaft in the
form of a bendable wire coil ... is an equivalent alternative, that is known in
the art, to a flexible shaft in the form of one or more articulating pivotal
linkage members" (Final Act. 6).
FF 10. Examiner finds that the combination of Heckele and McGuire
teaches Appellants' claimed invention but for "a compliant region [that] is
[a] bellows-type structure consisting of a notch at a distal end of the shaft
adjacent the tip portion with the notch being 2 millimeters in length" and
relies on Kozak to make up for this deficiency in the combination of Heckele
and McGuire (see Final Act. 7-9).
FF 11. Examiner finds that the combination of Heckele and McGuire
teaches Appellants' claimed invention but for a "compliant region [that has]
bellows" and relies on Appenzeller to make up for this deficiency in the
combination of Heckele and McGuire (see Final Act. 9).
FF 12. Examiner finds that the combination of Heckele and McGuire
teaches Appellants' claimed invention "except for the device being sterile
and being provided within a sterility maintaining package" and relies on
Nicholson to make up for this deficiency in the combination ofHeckele and
McGuire (Final Act. 10).
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ANALYSIS
The combination of Heckele and McGuire:
Based on the combination of Heckele and McGuire, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie "obvious to substitute a malleable/bendable wire coil
section of the device of McGuire for the articulating pivotal linkage of the
device of Heckele, as they are taught to be art known equivalents by
McGuire" (Final Act. 7).
Claims 1 and 12:
Appellants' independent claims 1 and 12 are reproduced above.
Appellants contend that, notwithstanding Examiner's assertion to the
contrary, the combination of Heckele and McGuire would, "[a]t best ... lead
to an instrument in which the entire shaft was flexible, rather than a
localized compliant region" (Br. 4). In this regard, Appellants contend that
"when McGuire ... desire[ d] a local articulation they disclose only a
mechanical joint, and do[ es] not teach that the flexing shaft is useful for
localized articulation but rather only for a tool in which the entire shaft is
flexible" (id.). We are not persuaded.
As Examiner explains, "the test for obviousness is not whether the
features of a secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed invention must
be expressly suggested in any one or all of the references. Rather, the test is
what the combined teachings of the references would have suggested to
those of ordinary skill in the art" (Ans. 2). See In re Keller, 642 F.2d 413,
425 (CCP A 1981 ). On this record, Examiner relied upon Heckele to
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Application 13/242,085
disclose a driving tool comprising a localized region of mechanical
articulation in the form of a pivotal interface and McGuire to disclose "that it
was well-known in the art of driving tools that a mechanical articulation
point in the form of a bendable coil wire ... is equivalent to a mechanical
articulation point in the form of a pivotal interface" (Ans. 2-3). We agree
and discern no error in Examiner's conclusion that "[i]nterchanging a
bendable wire coil for the articulating joint of Heckle ... provides a
localized compliant region (i.e. a bendable coil in place of the articulating
joint) between the rigid shaft (4) and the tip portion (3) of [Heckel's] device"
(id. at 3).
With respect to Appellants' claim 12, Appellants contend that "[t]he
failing of the rejection of claim 1 apply to claim 12. The alleged
combination of references would at best provide a fully flexible shaft" (Br.
5). For the reasons set forth above, with respect to Appellants' claim 1, we
are not persuaded.
Claim 2:
Appellants' claim 2 depends from and further limits Appellants' claim
1 to require that "the tip portion is capable of providing internal support for
the implant during insertion into bone" (Br. 8).
Examiner finds that Heckele's "tip portion (3) is capable of providing
internal support for the implant (21) during insertion into bone" (Final Act.
5; see FF 3--4). In this regard, Examiner finds "that Fig. 6 and col. 3, lines
36-39 of Heckele expressly disclose the tip portion of the device of Heckele
inserted into and supporting an implant as the implant is inserted into a
vertebral body" (Ans. 3--4; see FF 3--4).
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For the foregoing reasons, we are not persuaded by Appellants'
unsupported assertion that Heckele's tip is the "kind of shape [that] would
not really provide support" (Br. 5). See also, In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of
evidence").
Claims 3 and 13:
Appellants' claim 3 depends from and further limits Appellants' claim
1 to require that "the compliant region is formed of a material that is more
malleable than that of the tip portion" (Br. 8 (emphasis added)). Similarly,
Appellants' claim 13 depends from and further limits Appellants' claim 12
to require that "the compliant region is formed of a material that is more
malleable than that of the tip portion" (Br. 9 (emphasis added)).
Examiner's Final Rejection does not address claims 3 or 13. As
Appellants' explain, Examiner failed to establish that either of Heckele or
McGuire, alone or in combination, teach this requirement of Appellants'
claimed invention (see Br. 5).
We are not persuaded by Examiner's assertion that McGuire's "coiled
wire ... is more easily bent into different shapes than the tip 3 and threaded
spike 14 of Heckle" (Ans. 4). As Appellants' explain, McGuire's "coiled
wire [] relies on the physical arrangement of the coils for flexure, and is
silent as to the relative malleability of the materials" (Br. 5 (emphasis
added)). Appellants' claims 3 and 13 require that the material used to form
the compliant region is more malleable than that of the tip portion (see Br. 8
and 9). Because Examiner failed to address the requirements of Appellants'
claims 3 and 13, the rejection of these claims is reversed.
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Claim 10:
Appellants' claim 10 depends ultimately from and requires the
inserter of Appellants' claim 1 to "further includ[ e] an implant retention
element carried by the tip portion," "wherein the retention element includes
a laterally-extending projection formed on the tip portion," and "wherein the
projection has a smooth distal leading edge and a sharply-defined transition
at a trailing edge" (Br. 8-9).
Examiner finds that Hecke le' s
implant retention element (threads; [see Heckele,] col. 3, lines
36-39) carried by the tip portion (14); ... include[] a laterally-
extending projection (threads extend laterally from tip) formed
on the tip portion (14); ... wherein the projection (threads)
[have] a smooth distal leading edge (distal-facing thread
surface) and a sharply-defined transition (sharp V-shaped
transition between distal and proximal facing thread surfaces) at
a trailing edge (proximal-facing thread surface).
(Final Act. 5-6.) In this regard, Examiner provides the following annotated
illustration of "conventional screw threads"
smooth
distal
leading
edge
lateral projection . ?. sl>arply-d<>flned transition to traillng edg•
Examiner's illustration of "conventional screw threads" annotates what
Examiner finds are "a smooth distal surface and a sharply defined transition
at a trailing edge" of a lateral projection (see Ans. 4--5).
In response, Appellants simply assert that a "screw thread [] fails to
meet" the requirements of Appellants' claimed invention (Br. 5).
Appellants, however, fail to explain why Examiner's rationale is incorrect.
Therefore, we are not persuaded by Appellants' unsupported contention.
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See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (37 C.F.R. § 41.37
requires "more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art").
The combination of Heckele, McGuire, and Kozak:
Based on the combination of Heckele, McGuire, and Kozak,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious
to modify the device ... [suggested by the combination of
Heckele and McGuire] to have the compliant region comprise a
bellows-type structure consisting of a notch at a distal end of
the shaft adjacent the tip portion in order to prevent a user's
fingers from being pinched while allowing the shaft to be
manipulated from a straight to a bent position and further
preventing dirt and other foreign substances from entering the
flexible joint portion, as taught by Kozak.
(Final Act. 8 (emphasis added); see Kozak 7: 42--45 and 53-54 ("bulges[,
such as those forming a bellows configuration,] prevent a user's fingers from
being pinched while allowing the shaft [] to be manipulated from a straight
to a bent position" and "prevent[ s] dirt and other foreign substances from
entering via the first end portion").) Examiner further finds that "[a] change
in size is generally recognized as being within the level of ordinary skill in
the art," and, therefore, "[i]t would have been an obvious matter of design
choice to form the notch" in the device suggested by the combination of
Heckele, McGuire, and Kozak, to have "a length of 2 millimeters," because
"such a modification would have involved a mere change in the size of a
component" (Final Act. 8-9).
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Claims 4, 14, and 23:
Appellants' claims 4, 14, and 23 depend from and further limit
Appellants' claims 1, 12, and 19, respectively, to require that the "compliant
region is a bellows" (Br. 8 (emphasis added)).
Appellants contend that Examiner "misinterpreted the claims as
employing [the transitional term] 'comprising' instead of 'is' in defining the
compliant region" (Br. 5). We agree. Examiner's rationale is based on a
construction of Appellants' compliant region as comprising a bellows-type
structure (see Final Act. 8 ("Claim 4 is interpreted as lacking any
express negative limitations and further utilizes the open-ended transitional
phrase 'comprising' thereby allowing for additional structure in the
compliant region as opposed to an interpretation requiring a 'bellows-only'
compliant region"); see also Ans. 5). As Appellants' correctly explain,
Examiner's claim interpretation is incorrect. According to Appellants'
claimed invention the compliant region is a bellows, thus, it is improperly to
interpret Appellants' claims as comprising bellows. Because, Examiner
misinterpreted Appellants' claimed invention, we reverse the rejection of
Appellants' claims 4, 14, and 23.
Claims 29-31:
Appellants' claim 29 depends from and further limits Appellants'
claim 1 to require that the "compliant region consists of a notch at a distal
end of the shaft adjacent the tip portion" (Br. 11 ). Appellants' claim 30
depends from and further limits Appellants' claim 29 to require that the
"notch has a length of about 2 millimeters" (Br. 11 ). Appellants' claim 31
depends from and further limits the "compliant region" of Appellants' claim
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19 to "consist[] of a notch at a distal end of the shaft adjacent the tip
portion" (Br. 11 ).
Appellants contend that "it makes no logical sense how a notch is
going to protect a user's fingers" and "Examiner is just clearly throwing
elements together to make a rejection with little or no regard to how they
might motivate one of skill in the art" (Br. 6). Appellants' contention lacks
an evidentiary basis on this record and is, thus, not persuasive.
For clarity, we reproduce Examiner's annotation of Kozak's Figure 11
below:
Fig 11
Kozak describes its Fig. 11 as "yet another alternative device for protecting
a user's fingers when operating [a] prior art [flexible extension shaft]
device" (Kozak 3: 39--40 and 51-52 (emphasis added)). Examiner annotated
Kozak's Fig. 11 to identify a bellows region and a notch. Notwithstanding
Appellants' unsupported assertion to the contrary, Kozak expressly states
that such a configuration will, inter alia, "prevent a user's fingers from
being pinched while allowing the shaft [] to be manipulated from a straight
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to a bent position" (Kozak 7: 42--45). Appellants' contentions regarding
their claims 30 and 31 are equally unsupported and, therefore, not
persuasive. Accordingly, we are not persuaded by Appellants' unsupported
assertion regarding the rejection of Appellants' claims 29-31 (see Br. 6).
The combination of Heckele, McGuire, and Appenzeller:
Based on the combination of Heckele, McGuire, and Appenzeller,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to substitute the flexible tubular neck
or wall of the device of Heckele in view of McGuire for the localized
compliant region in the form of a hollow bellows of the device of
Appenzeller, as they are taught to be art known equivalents by Appenzeller"
(Final Act. 9).
Having found no deficiency with respect to the rejection of
Appellants' claim 1, we are not persuaded by Appellants' contention that
"[t]his rejection suffers from the same failings as the rejection of claim 1
discussed above" (Br. 6).
Appellants' further contend that "there is no suggestion for putting
this compliancy into the [claimed] inserter" (id.). We are not persuaded. As
Examiner explains, the combination of Heckele and McGuire "teaches an
articulating surgical instrument having a compliant and flexible articulating
region or neck" and "Appenzeller is cited for its express teachings that a
hollow bellows ... is a well-known equivalent alternative to a flexible
tubular neck," thus, "it would have been obvious to substitute a bellows
structure for a flexible articulating structure as set forth in the pending
rejection" (Ans. 7). Appellants failed to address Examiner's reason for
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making the proposed modification. Therefore, we are not persuaded by
Appellants' unsupported assertions. In re Pearson, 494 F.2d at 1405.
The combination of Heckele, McGuire, and Nicholson:
Based on the combination of Heckele, McGuire, and Nicholson,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious
to modify the device of Heckele in view of McGuire to be
sterile and to be provided within a sterility maintaining package
in order to provide a sterile, ready-to-use kit to a surgeon that
facilitates the procedure, reduces operation time, and minimizes
a patient's risk of infection/ contamination, as taught by
Nicholson.
(Final Act. 10.) Having found no deficiency in Examiner's rejection of
Appellants' claims 1, 12, and 19, we are not persuaded by Appellants'
contention that "[t]his rejection suffers the same failings as put forward with
respect to [Appellants'] claims 1, 12 and 19 respectively" (Br. 7).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness as it relates to the rejection of Appellants':
claims 1, 2, 5-10, 12, 15-17, 19-22, and 24 over the combination of
Heckele and McGuire; claim 4 over the combination of Heckele, McGuire,
and Appenzeller; claims 11, 18, and 25 over the combination of Heckele,
McGuire, and Nicholson; and claims 29-31 over the combination of
Heckele, McGuire, and Kozak.
The rejection of claims 1, 2, 10, and 12 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Heckele and McGuire is affirmed.
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Claims 5-9, 19-22, and 24 are not separately argued and fall with claim 1.
Claims 15-17 are not separately argued and fall with claim 12.
The rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Heckele, McGuire, and Appenzeller is affirmed.
The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Heckele, McGuire, and Nicholson is affirmed.
Claims 18 and 25 are not separately argued and fall with claim 11.
The rejection of claims 29-31under35 U.S.C. § 103(a) as
unpatentable over the combination of Heckele, McGuire, and Kozak is
affirmed.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness as it relates to the rejection of
Appellants' claims 3 and 13 over the combination of Heckele and McGuire
and Appellants' claims 4, 13, 14, and 23 over the combination of Heckele,
McGuire, and Kozak.
The rejection of claims 3 and 13 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Heckele and McGuire is reversed.
The rejection of claims 4, 14, and 23 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Heckele, McGuire, and Kozak is
reversed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a).
AFFIRMED-IN-PART
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