Kenny Koay et al.

Patent Trials and Appeals Board

Sep 4, 2019

14193317 - (D) (P.T.A.B. Sep. 4, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/193,317 02/28/2014 Kenny KOAY 10139/28802 4307
76960 7590 09/04/2019
Fay Kaplun & Marcin, LLP
150 Broadway, suite 702
New York, NY 10038
EXAMINER
WAGGLE, JR, LARRY E
ART UNIT PAPER NUMBER
3775
MAIL DATE DELIVERY MODE
09/04/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KENNY KOAY, ROD MCMILLAN, and RENE HAAG
__________

Appeal 2019-000161
Application 14/193,317
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and
WILLIAM A. CAPP, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final decision rejecting claims 1–9, 20, and 22. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 DePuy Synthes Products, Inc. (“Appellant”) is the applicant, as provided
for under 37 C.F.R. § 1.46, and is also identified as the sole real party in
interest. Appeal Br. 2. Appellant further notes that Appellant is owned by
Johnson & Johnson, Inc. Id.
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STATEMENT OF THE CASE
The Specification
The “Background” portion of the Specification explains:
Bone fixation devices such as drills, reamers, chisels and
needles are typically formed of metal to permit the devices to
withstand forces applied thereto as they are applied in bone
fixation procedures. Generally, such bone fixation devices are
not constructed out of implant-grade metal since implant-grade
metal is not strong enough to withstand the forces repeatedly
applied during use. Thus, the use of drills and reamers
constructed out of implant-grade metal would result in damage
to the device and require frequent replacement.
Typically, tools used in bone fixation such as drill and
reamers are constructed of non-implant-grade metal. However,
if such bone fixation devices fracture of break during surgical
use, fragments may be dislodged into the body. The time
required to locate and remove such non-implant-grade metal
fragments is lengthy and may exceed the time required to
perform a target bone fixation procedure.
Spec. ¶¶1–2. Thus, the Specification discloses a bone fixation device
“formed of implant-grade material and having a carburized or nitrided outer
surface configured to increase a surface hardness thereof to a desired level.”
Id. ¶5 (3:14–16).
The Rejected Claims
Claims 1–9, 20, and 22 are rejected. Final Act. 1.2 Claim 1, the sole
independent claim, is representative and reproduced below.

2 Claims 10–19 are withdrawn from consideration, claim 21 is canceled, and
no other claims are pending. Final Act. 1–2; Appeal Br. 13–14.
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1. A bone cutting device extending from a proximal
end to a distal end and having a sharpened cutting surface
adjacent the distal end, the cutting surface being dimensioned to
permit cutting of bone, the bone cutting device being formed of
an implant grade material and an outer surface of the bone
cutting device is one of carburized and nitrided.
Appeal Br. 13.
The Examiner’s Rejections
The following rejections, under 35 U.S.C. § 103, are before us for
review:
1. claims 1, 2 and 4–9 as being unpatentable over Kumar,3
Sander,4 Karapetian,5 and Total Materia6 (Final Act. 2); and
2. claims 3, 20, and 22 as being unpatentable over Kumar, Sander,
Karapetian, Total Materia, and Henthorne7 (id. at 5).
DISCUSSION
Rejection 1
Appellant argues the rejection of claims 1, 2, and 4–9 together.
Appeal Br. 3–10. We select claim 1 as representative. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Kumar discloses a dental drill with a bit for cutting into a jawbone.
Kumar 2:46–57. Kumar teaches that the bit may be fabricated of “stainless
steel,” “UNS S45500 (ASTM-A564),” or “a variety of other materials, such

3 US 6,641,395 B2, issued Nov. 4, 2003 (“Kumar”).
4 US 5,522,817, issued June 4, 1996 (“Sander”).
5 US 9,198,649 B2, issued Dec. 1, 2015 (“Karapetian”).
6 https://www.totalmateria.com/page.aspx?ID=CheckArticle&LN=
EN&site=kts&NM=117 (Nov. 2003) (“Total Materia”).
7 US 4,371,394, issued Feb. 1, 1983 (“Henthorne”).
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as metals, alloys, ceramics, [or] plastics.” Id. at 13:42–50 (cited at Final
Act. 3). Thus, the Examiner found that Kumar discloses the subject matter
of claim 1 except for “the bone cutting device being formed of an implant
grade material and an outer surface of the bone cutting device is one of
carburized and nitride,” as recited in claim 1. Final Act. 3.
Sander discloses “the attachment of bone penetrating elements to
bioabsorbable polymer implant devices, such as fasteners, thereby enabling
the implant devices to be drilled or driven directly into bone or other hard
tissue.” Sander 2:58–62. Sander states:
Unlike prior art fasteners, the fastening body portion 101 of the
present surgical fastener 100 has one or more bone penetrating
elements such as tips 104 attached to the distal ends of legs 102,
for penetrating bone or hard tissue. The tips 104 must have a
hardness sufficient for such penetration. Thus, tips 104 are
preferably made of a metal, such as stainless steel, titanium and
its alloys, cobalt-chromium-molybdenum alloys, or other
implant grade metal alloys.
Id. at 3:49–56 (emphasis added) (cited at Final Act. 4); see also id. at 6:26–
32 (“The tips 301 and 401 are fabricated from material which has hardness
and strength suitable for its purpose of drilling bone. Such materials have
been mentioned above and include ceramics and implant grade metal
elements and alloys.” (emphasis added) (also cited at Final Act. 4)).
The Examiner determined:
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to construct the invention of
Kumar et al. with the bone cutting device being formed of an
implant grade material in view of Sander et al. in order to provide
a known, alternative and effective material having the hardness
and strength suitable for cutting bone.
Final Act. 4.
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The Examiner found (as relevant to claim 2, in particular8) that
Karapetian teaches the use of an anchor, for anchoring soft tissue to bone,
which has a cutting tip “fabricated of 316L stainless steel (i.e., an implant
grade/quality austenitic material).” Final Act. 4; see also id. at 7 (repeating
same finding and citing Karapetian 8:55–57).
The Examiner found that Total Materia teaches “gas nitriding
austenitic stainless steels of the 300 series (see actual pages 2–3).” Final
Act. 4.
The Examiner concluded:
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to construct the invention of
Kumar et al. in view of Sander et al. with an outer surface of the
bone cutting device being nitrided, wherein the bone cutting
device is formed of implant quality austenitic stainless steel in
view of Karapetian et al. and Total Materia in order to provide a
bone cutting device fabricated from a material capable of being
nitrided in order to obtain a high surface hardness, to increase
wear resistance, and to improve fatigue life of the cutting device.
Final Act. 4.
Appellant’s arguments against this rejection are not persuasive.
First, some of Appellant’s arguments are simply inapposite. For
example, Section I.B. of the Appeal Brief is titled: “Kumar and Sanders Do
Not Teach or Suggest a Bone Cutting Device Formed of Implant Grade
Material Having a Carburized or Nitrided Outer Surface Carburized as

8 Claim 2 recites: “The device of claim 1, wherein the bone cutting device is
formed of one of implant quality austenitic stainless steel, cobalt alloys,
CCM (Co-28Cr-6Mo Alloy), MP35N, L605, ASTM-F-1058, elgiloy,
titanium, titanium alloys, Ti-6Al-4V, Ti-6Al-7Nb and Ti-15Mo.” (Emphasis
added).
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Claimed.” Appeal Br. 3. However, the rejection is based, not on these two
references alone, but on four references. Final Act. 4; Ans. 7; cf. In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references. . . .
[The reference] must be read, not in isolation, but for what it fairly teaches
in combination with the prior art as a whole.”). In fact, Appellant concludes
Section I.B. of the Appeal Brief by conceding that the Examiner’s rejection
is not based on merely Kumar and Sander, stating:
Indeed, the Examiner acknowledges in the Final Office Action
that Kumar in combination with Sanders does not teach or
suggest an outer surface of a bone cutting device “is one of
carburized and nitrided,” as recited in claim 1, nor do they teach
or suggest a bone cutting device formed of implant quality
austenitic stainless steel. See Final Office Action, 4.
Appeal Br. 4. Appellant’s Section I.B. arguments (and others like them9) are
unpersuasive.
As much of Appellant’s arguments are inapposite, the Examiner has
repeatedly reminded Appellant for what the references are relied on, stating:

9 In a different section of the Appeal Brief, Appellant argues that
“Karapetian does not teach or suggest any bone cutting device formed of ‘an
implant grade material’ where ‘an outer surface of the bone cutting device
is one of carburized and nitride,’ as recited in claim 1.” Appeal Br. 5.
However, the Examiner did not rely exclusively on Karapetian for teaching
the latter recitation of claim 1. See Final Act. 4 (“Karapetian et al. teach the
use of an anchor (10) capable of being formed with a tissue cutting tip (32),
wherein the tissue cutting tip is fabricated from 316L stainless steel (i.e. an
implant grade/quality austenitic material). . . . Total Materia teach gas
nitriding austenitic stainless steels of the 300 series.”).
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Kumar et al. was relied upon for disclosing the majority of the
claimed limitations regarding the “bone cutting device.” Sander
et al. was relied upon for teaching the implant grade material.
Karapetian et al. and Total Materia were relied upon
[collectively] for teaching nitriding an implant grade, not an
industrial grade, 316L stainless steel.
Ans. 7; Advisory Action 2 (mailed April 9, 2018).
One of Appellant’s further arguments is that “Karapetian includes no
suggestion of implant grade material beyond the fact that the device is to be
implanted.” Appeal Br. 5–6. The Examiner points out, however, that
Sander was relied on for teaching the general concept of using implant grade
material. Ans. 7; see also Final Act. 3–4 (“Sander et al. teach the use of a
device (301 /401) capable of being used as a cutting device (i.e. drill) for
cutting bone formed of an implant grade material (e.g. metal element or
alloy).” (citing Sander, Figs. 6–7, 3:49–64, 6:12–32)). Karapetian was relied
on for teaching the specific implant grade material 316L stainless steel.
Final Act. 4. More specifically, Karapetian teaches a bone anchor for
implantation, which is implanted by virtue of a tip of the anchor cutting into
bone. Karapetian 8:53–57. That Karapetian does not focus on the cutting
tip being implantable (as opposed to the entire anchor of which it is a part)
does not undermine the Examiner’s rejection.
Appellant next argues that “nothing in Karapetian suggests applying
such material [i.e., implant grade 316L stainless steel] to a non-implantable
item, such as the dental drill described by Kumar, or the bone cutting device
of the present application.” Appeal Br. 6. We disagree. Karapetian
explicitly discloses that implant grade 316L stainless steel is sufficient for
cutting into bone. Karapetian 8:53–57. Additionally, the rejection is not
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limited to what Karapetian alone suggests or teaches. As found by the
Examiner, Sander teaches the skilled artisan that “implant grade metal
alloys” generally may be used for “bone penetrating elements.” Sander
3:49–56 (cited at Final Act. 3–4).
Appellant asserts that the Examiner does not “point to anything in the
cited references that would have lead one of skill in the art to make the
proposed combination.” Appeal Br. 9. This is a blanket statement that is
belied readily by the record, including Examiner’s findings and
determinations quoted and cited above.
The only specific argument presented in support of Appellant’s
assertion is the following:
In particular, the cited references do not provide any basis for
modifying the material of the drill of Kumar (that is not
implanted), with any material used in devices designed to remain
within the body of a patient - such as, metal from a tip of a self-
inserting absorbable orthopedic fixation device as described in
Sander or 316L stainless steel from a suture anchor as described
in Karapetian.
Id. This argument is not persuasive, at least in view of Sander’s teaching
that “bone penetrating elements such as tips 104 . . . are preferably made of a
metal, such as stainless steel, titanium and its alloys, cobalt-chromium-
molybdenum alloys, or other implant grade metal alloys.” Sander 3:49–56;
see also Karapetian 8:53–57 (disclosing that implant grade 316L stainless
steel is a sufficient material for cutting bone); see also Final Act. 4
(employing implant grade material in Kumar is obvious because such
material is “a known, alternative and effective material having the hardness
and strength suitable for cutting bone”).
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We have considered all of Appellant’s arguments but none apprises us
of error in the Examiner’s rejection of claim 1 over Kumar, Sander,
Karapetian, and Total Materia. Accordingly, we affirm the rejection of
claim 1, as well as that of claims 2 and 4–9, which fall therewith. See 37
C.F.R. § 41.37(c)(1)(iv).
Rejection 2
Claims 3, 20 and 22 depend from claim 1. Appellant argues that
“Henthorne does not teach or suggest a bone cutting device ‘formed of an
implant grade material,’ as recited in claim 1” and, therefore, “Henthorne
does not remedy the deficiencies of Kumar, Sander, Karapetian, and Total
Materia.” Appeal Br. 11. Because Appellant does not apprise of error in the
Examiner’s rejection of claim 1 over Kumar, Sander, Karapetian, and Total
Materia, Appellant also does not apprise us of error in the Examiner’s
rejection of claims 3, 20, and 22 over the same art further in view of
Henthorne.
Accordingly, for similar reasons as discussed above, we affirm the
rejection of claims 3, 20, and 22 as being unpatentable over Kumar, Sander,
Karapetian, Total Materia, and Henthorne.
SUMMARY
The Examiner’s rejection of claims 1, 2, and 4–9 as unpatentable over
Kumar, Sander, Karapetian, and Total Materia is affirmed.
The Examiner’s rejection of claims 3, 20, and 22 as being
unpatentable over Kumar, Sander, Karapetian, Total Materia, and Henthorne
is affirmed.

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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED