BIOMET 3I, LLC

Patent Trials and Appeals Board

Oct 22, 2020

2020000760 (P.T.A.B. Oct. 22, 2020)

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.
15/401,740 01/09/2017 Bruce Berckmans III 5394.C64US5 3509
104326 7590 10/22/2020
Schwegman Lundberg & Woessner / Zimmer
P.O. Box 2938
Minneapolis, MN 55402
EXAMINER
APONTE, MIRAYDA ARLENE
ART UNIT PAPER NUMBER
3772
NOTIFICATION DATE DELIVERY MODE
10/22/2020 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):
SLW@blackhillsip.com
USPTO@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRUCE BERCKMANS III, ROSS W. TOWSE, and
ROBERT L. MAYFIELD
Appeal 2020-000760
Application 15/401,740
Technology Center 3700
Before MICHAEL L. HOELTER, MICHAEL L. WOODS, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 36–56. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm in part.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies BIOMET 3I, LLC as the real party in interest.
Appeal Br. 3.
Appeal 2020-000760
Application 15/401,740
2
CLAIMED SUBJECT MATTER
Appellant’s invention relates to dental implants having discrete
monocrystalline particles deposited thereon. Spec. ¶ 2.
Claim 36, 44, and 52, reproduced below with emphasis added, are the
only pending independent claims.
36. A dental implant, comprising:
a head portion;
a lowermost end opposing the head portion; and
a threaded bottom portion for engaging bone between the
head portion and the lowermost end, the threaded bottom portion
including:
a microscale roughened surface;
a first nanotopography on the microscale roughened
surface; and
a second nanotopography in contact with a first
portion of the microscale roughened surface and a first
portion of the first nanotopography.

44. A dental implant, comprising:
a head portion;
a lowermost end opposing the head portion; and
a threaded bottom portion for engaging bone between the
head portion and the lowermost end, the threaded bottom portion
including:
a microscale roughened surface;
a nanoscale roughened surface formed on the
microscale roughened surface; and
a plurality of discrete nanoparticles deposited on
and in contact with a first portion of the microscale
roughened surface and a first portion of the nanoscale
roughened surface.

52. A dental implant, comprising:
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Application 15/401,740
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a head portion;
a lowermost end opposing the head portion; and
a threaded bottom portion for engaging bone between the
head portion and the lowermost end, the threaded bottom portion
including:
a roughened surface including an array of microscale
irregularities and a plurality of permanent nanostructures formed
on the microscale irregularities; and
a plurality of discrete nanoparticles deposited on the
roughened surface, wherein a portion of the roughened surface
is exposed between at least some of the discrete nanoparticles
such that the exposed roughened portion between the discrete
nanoparticles is for contacting bone.
Appeal Br. 19, 20, 21 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Dinkelacker US 2004/0153154 A1 Aug. 5, 2004
Beaty US 2005/0263491 A1 Dec. 1, 2005
Berckmans III US 8,647,118 B2 Feb. 11, 2014
Wen2 EP1449544 A1 Aug. 25, 2004
Gintaras Gintaras Juodzbalys et. al., New Acid Etched
Titanium Dental Implant Surface,
Stomatologija, Baltic Dental and
Maxillofacial Journal, 5:101–105
(2003)

2 The Examiner refers to this reference as “Smith.” Final Act. 12.
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Application 15/401,740
4
REJECTIONS3
I. Claims 36–56 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Dinkelacker and Beaty.
II. Claims 41, 42, 45, and 53 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Dinkelacker, Beaty, and Gintaras.
III. Claims 36–39, 41, and 43 are rejected on the ground of
nonstatutory double-patenting over claims 1 and 7 of Berckmans III.
IV. Claims 44–46 and 49 are rejected on the ground of nonstatutory
double-patenting over claims 1, 8, and 9 of Berckmans III.
V. Claims 52 and 53 are rejected on the ground of nonstatutory
double-patenting over claim 1 of Berckmans III.

OPINION
Rejection I–Dinkelacker and Beaty
Claims 36–51
The Examiner finds that Dinkelacker discloses many of the elements
recited in independent claims 36 and 44, but does not disclose a second
nanotopography in contact with a first portion of a microscale roughened
surface and a first portion of a first nanotopography as recited in claim 36 or
a plurality of discrete nanoparticles as recited in claim 44. Final Act. 3–4.
To address these deficiencies in the teachings of Dinkelacker, the Examiner
turns to Beaty. Id. at 4. Specifically, the Examiner finds Beaty discloses
submicron projections and cone-like topography and “discrete fine particles

3 The Examiner withdrew a rejection of claims 52–56 as unpatentable over
Dinkelacker and Wen. Ans. 3.
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[of] bone-growth enhancing material . . . entrapped on and between the small
cone-like structures.” Id. (citing Beaty ¶¶ 43–44). The Examiner
acknowledges that Beaty does not explicitly disclose that the fine particles
have a size that creates a nanotopography, but infers that these particles must
be of such a size “to be able to enter and be entangle[d] in the bigger
structure of the etched surface.” Id. The Examiner reasons it would have
been obvious to apply fine particles as disclosed in Beaty on the surface
disclosed by Dinkelacker “in order to have a uniformed surface that
includes[,] in all the topographies[,] bone-growth-enhancing materials to
promote the bonding of the surface to adjacent bone through all the different
structures.” Id. The Examiner determines that the result of this proposed
combination of the teachings of Dinkelacker and Beaty would meet all the
requirements of claims 36 and 44 because the particles from Beaty would
amount to the recited second nanotopography (claim 36) and plurality of
nanoparticles (claim 44). See id.
Nanotopography and Nanoparticles
Appellant argues that the Examiner erred in finding that the fine
particles disclosed by Beaty are of a size that creates a nanotopography (or
nanoparticles). Appeal Br. 12. Specifically, Appellant contends that the
cone-shaped elements disclosed by Beaty have base diameters of 0.3 to 1.2
microns, and, therefore, particles that may become trapped between these
elements need not be small enough to create a nanotopography. Id.
Appellant further contends that Beaty is silent regarding the size or shape of
the disclosed fine particles. Id. at 12–13.
In response, the Examiner finds that Beaty’s disclosure of the sizes
and spacing of its cone-shaped elements uses the term “about” before setting
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forth any numerical ranges, thus allowing for some variation from the stated
ranges. Ans. 6. The Examiner then states:
It is also applicable that when Beaty describes that the surface
topography is in the submicron size range, it is also included in
the term “about” values of at least 0.1 micron in such range,
where taking in consideration that 0.1 microns it is also read as
100 nano, therefore it is considered to represent the
nanotopography. Therefore, the etched surface of Beaty is
considered to be the claimed first nanotopography.
Id. The Examiner further finds:
it is understood that the fine particles should be in the nano size
range if at least one of the material suggested is hydroxyapatite,
which it is well known in the art since many years before the
priority date of the present application was even submitted, this
hydroxyapatite material can be obtained in the nano size
particles, in the form of monocrystalline apatite.
Id. at 7 (emphasis added). Thus, the Examiner points out that one of the
materials used by Beaty is hydroxyapatite, and the Examiner determines this
material can be used in the form of “nano size particles.”
In reply, Appellant contends that there is no reason that the “about”
0.3 to 1.2 micron range of diameters for Beaty’s cone-shaped elements
(spaced apart by about 0.3 to 0.75 microns) implies that particles disposed
between them are nanoparticles. Reply Br. 5. In support of this argument,
Appellant asserts that, based on these size/spacing ranges, the spacing
between tips of cones could be 1.275 microns. Id. Appellant further states,
“[a]dditionally, the only example of a preferred particle is one that is
commercially available under the registered trademark ‘Bio-Oss,” and “it
appears that the Bio-Oss® is available in small granules (0.25 – 1
millimeters), which is 250 microns to 1000 microns, and large granules (1-2
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millimeters), which is 1000 microns to 2000 microns.” Id. (citing
https://dental.geistlich-na.com/en-us/professionals/bone-substitutes/bio-
oss/product-range/)4; see also Beaty ¶ 46.
For the reasons discussed below, a preponderance of the evidence
supports the Examiner’s finding that a person of ordinary skill in the art
would understand the fine particles disclosed by Beaty to include particles of
a size that produces a nanotopography as recited in claim 36.
Appellant’s Specification describes the effect of the pH of the solution
in which the fine particles are immersed during deposition, stating that, for
low pH solution, “the particles deposited on the surface are generally smaller
(about 20 nanometers) and more uniform[, and at] an elevated pH (i.e.,
greater than 9), the size of the HA nanocrystals deposited is generally
greater, ranging from about 20 nanometers to about 150 nanometers.” Spec.
¶ 45. The Specification also sets the lower limit for structure that is
considered to be “microscale” at 1 micron (1000 nanometers). Id. ¶ 38. The
Specification also provides an example using nanocrystalline calcium
phosphate (“HA”). See id. ¶¶ 8, 40. Specifically, the Specification states,
“[i]n preparing a solution of HA nanocrystals, raw HA nanocrystal material
may be refined to achieve a stock solution with limited agglomeration of
crystals” and “[a]n appropriate particle size distribution (volume) as
indicated by the Nanotrac 150 . . . has a D10 (tenth percentile distribution) of
less than 150 nanometers, a D50 (fiftieth percentile distribution) of less than
300 nanometers, and a D90 (ninetieth percentile distribution)) of less than
900 nanometers.” Id. ¶ 40. Thus, the Specification considers crystals

4 Appellant does not identify where, in the record, this website has been
entered as evidence.
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having a size of 900 nanometers5 to be nanostructures, namely,
“nanocrystals.”
Appellant’s Specification discusses another filed patent application,
PCT/US2006/010281 (hereinafter “PCT ’281”), when describing
nanostructures. See Spec. ¶ 89. Specifically, the Specification states:
Controllable, generally permanent nanostructures are then
applied to the implant surface prior to depositing the discrete
nanoparticles on the implant surface. The controllable
permanent nanostructures may be applied using techniques
described in PCT/US2006/010281, entitled “Controllable
Nanostructuring On Micro-Structured Surfaces,” which is
incorporated by reference in its entirety. The nanostructures are
formed by depositing a vapor of nanostructuring material on the
implant surface and forming nanostructures from the
nanostructuring material.
Id.6 PCT ’281 relates to a process for creating nano-sphere structures on
microstructured surfaces. PCT ’281, 1:10–11. In disclosing what sizes may
be considered nanostructures, PCT ’281 states:
The nanostructure on the substrate can be in any physical
appearance. In one embodiment, the nanostructure is a nano-
sphere or a plurality of nano-spheres. The nanostructure
generally has a size in the range from about 1 nm to over 1000
nm, e.g., about 5 nm, about 10 nm, about 20 nm, about 50 nm,
about 80 nm, about 90 nm, about 95 nm, about 100 nm, about
200 nm, about 500 nm, about 800 nm, about 900 nm, about 1000
nm or about 1500 nm.

5 The disclosed distribution has a cut-off for the ninetieth percentile at 900
nanometers, allowing for some of the particles to have a size even greater
than 900 nanometers.
6 Appellant quotes this paragraph in its entirety on page 4 of the Reply Brief.
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Id. at 8:16–21. Thus, a document that is incorporated by reference in
Appellant’s Specification considers “nanostructure” to have dimensions
ranging from about 1 nm to about 1500 nm.
Furthermore, Dinkelacker gives an indication of what sizes may be
considered “nanoscale,” stating, “[t]he depth of the lacunae of the
nanostructure may be in the range of 10-500 nm, e.g., 250 nm, and the
distance between the elevations may be in the range of 100 to 500 nm, e.g.,
250 nm.” Dinkelacker ¶ 36; see also id. at claims 8, 24. Thus, Dinkelacker
gives an example of nanostructure as large as 500 nm.
In light of Appellant’s Specification, the broadest reasonable
interpretation of the term “nanostructure,” and, accordingly, of
“nanotopography” and “nanoparticle” in the claims, includes structures
having sizes from 1 nm to at least 1000 nm. It is unnecessary for us to
determine the exact upper bound of broadest reasonable interpretation of
these terms because Appellant’s relevant arguments can be addressed based
on the understanding that the acceptable range for nanostructure extends
from 1 nm to at least 1000 nm.
Beaty describes its cone-shaped elements as follows:
Substantial numbers of the irregularities are substantially cone-
shaped elements having base-to-peak heights in the range from
about 0.3 microns to about 1.5 microns. The bases of these cone-
shaped elements are substantially round with diameters in the
range from about 0.3 microns to about 1.2 microns, and spaced
from each other by about 0.3 microns to about 0.75 microns.
Beaty ¶ 43. Beaty next describes the materials applied to the cone-shaped
elements, stating “[e]xamples of such materials are bone-growth-enhancing
materials such as bone minerals, bone morphogenic proteins,
hydroxyapatite, whitlockite, and medicaments,” and “[t]hese materials are
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preferably applied to the etched surface in the form of fine particles which
become entrapped on and between the small cone-like structures.” Id. ¶ 44
(emphasis added). Paragraphs 43 and 44 of Beaty describe the size and
spacing of the “cone-like” projections in which fine particles become
trapped, but these paragraphs do not explicitly describe the size or spacing of
the trapped particles. As the spacing between the cone-like structures may
be as small as about 300 nanometers (well within the 1–1000 nanometer
range discussed above), we agree with the Examiner that a person of
ordinary skill in the art would understand particles entrapped between the
cone-like structures would have nano-scale dimensions, i.e., dimensions of
no more than 1000 nanometers. Accordingly, we find unavailing
Appellant’s argument alleging the Examiner erred in finding that the fine
particles disclosed by Beaty are of a size that creates a nanotopography.
Teaching Away
Appellant next argues that Dinkelacker intends to avoid using sharp
edges on its topography, and, therefore, “Dinkelacker teaches away from
using cone-shaped projections as disclosed in Beaty.” Appeal Br. 13
(emphasis omitted).
In response, the Examiner explains that Dinkelacker is relied upon to
provide the first nanotopography recited in claim 36, stating:
It would be obvious for a person skill in the art to
combine[] the at least microscale roughened surface and the first
nanotopography on the microscale roughened surface disclosed
by Dinkelacker, with the nano particles that are in between of the
nanotopography of Beaty, in order to promote the bonding of the
implant surface to the adjacent bone through all the different
structures in the surface.
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Ans. 8 (emphasis added). The Examiner rephrases this statement of the
proposed combination as follows, “if Beaty’s second nanotopography can be
attached in between another nanotopography, the same particles can be used
in between the first nanotopography of Dinkelacker’s, in this way forming a
second nanotopography including a portion contacting the first
nanotopography and a portion contacting the microstructure.” Id. Thus, the
Examiner proposes to include only the fine particles disclosed by Beaty in
the nanostructure already disclosed by Dinkelacker.7 In other words,
Appellant’s argument that Dinkelacker teaches away from incorporating
Beaty’s cone-like projections is an attack on a combination of the teachings
of Dinkelacker and Beaty that is not proposed by the Examiner.
Accordingly, Appellant’s argument that Dinkelacker teaches away from the
proposed modification does not identify Examiner error.
Apparently in response to the Examiner’s reiteration that the rejection
relies on Dinkelacker, not Beaty, to teach the first nanotopography recited in
claim 36, Appellant argues the rounded domes of the microscale surface of
Dinkelacker facilitate the cell movements into the lacunae. Reply Br. 6.
According to Appellant, “one would not deposit particles onto the surface in
Dinkelacker as doing so would alter the rounded domes and lacunae of the
micro scale surface and the nanostructures to have projections, etc.” Id.
This argument amounts to unsupported speculation as to the technical
effects of the addition of the fine particles disclosed by Beaty. Appellant
provides no persuasive technical reasoning and no evidence as to why the
addition of these particles, which Beaty considers to be beneficial, would not

7 Appellant makes no argument that this combination is beyond the level of
ordinary skill in the art.
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provide the same type of benefit when incorporated in the first
nanotopography of Dinkelacker. Nor does Appellant provide such evidence
that the addition of these particles would be detrimental.
Requirement to be “in contact with”
Appellant next argues “Appellant[’s] claims require that the
nanoparticles are deposited onto both a portion of the microscale portion and
the first nanotopography,” and the Examiner’s proposed combination of the
teachings of Dinkelacker and Beaty fails to meet this requirement. Appeal
Br. 13.
In response, the Examiner states that
describing that the second nanotopography is in contact with a
portion of the microscale roughened surface, and another portion
is in contact with the first nanotopography, indicates that not all
of the threaded bottom portion includes all three layers as argued.
Some portion of the threaded bottom portion have all three
layers, and other portion only has two, e.g. the microscale
roughened surface and the second nanotopography layers.
Therefore, for purposes of analysis, the Office is
concentrating on the three “layers” portion. In other words, by
the second nanotopography being on the first nanotopography,
and due to the first nanotopography roughness is incorporated
onto the microscale roughened surface, not by adding a material
layer, but by creating a second roughness on top of the initial
surface, the second nanotopography is in contact with the first
nanotopography, and it is also in contact with the surface having
the microstructure.
Ans. 5. Thus, the Examiner finds that once the second nanotopography
(from Beaty) is added to the first nanotopography (from Dinkelacker), the
second nanotopography will automatically be in contact with the microscale
roughened surface.
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Appellant has the better argument because the broadest reasonable
interpretation of claims 36 and 44 requires two distinct surfaces to contact
the second nanotopography (or nanoparticles). For example, claim 36
recites, in part “a second nanotopography in contact with a first portion of
the microscale roughened surface and a first portion of the first
nanotopography.” Appeal Br. 19 (Claims App.) (emphasis added). By
using the word “and” between reciting contact with the first portion of the
microscale roughened surface and contact with the first portion of the first
nanotopography, claim 36 implies that these two surfaces are not the same
surface. Furthermore, the Examiner’s reading of claim 36 renders
superfluous the recitation in claim 36 that the second nanotopography is “in
contact with a first portion of the microscale roughened surface.” See
Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007)
(denouncing claim constructions which render phrases in claims
superfluous). This is so because, according to the Examiner, mere contact
with the first portion of the first nanotopography also qualifies as contact
with a first portion of the microscale roughened surface.
The Examiner’s unreasonably broad interpretation of claim 36 led to
the unsupported conclusion that adding the fine particles disclosed by Beaty
to the surfaces disclosed by Dinkelacker would meet all the requirements of
claim 36. Accordingly, we do not sustain the rejection of claim 36, and
claims 37–43 depending therefrom, as unpatentable over Dinkelacker and
Beaty. For substantially similar reasons, we do not sustain the rejection of
claim 44, and claims 45–51, depending therefrom, as unpatentable over
these references.
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Claims 52–56
Unlike claims 36 and 44, independent claim 52 does not recite a
second nanotopography (or a plurality of discrete nanoparticles) in contact
with two other distinct surfaces. See Appeal Br. 21 (Claims App.). Thus,
Appellant’s argument regarding this claim limitation does not apply to claim
52. Appellant makes no argument in support of the patentability of claims
52–56 aside from the arguments discussed above. See Appeal Br. 10–18.
Accordingly, as none of those arguments apprises us of Examiner error with
respect to the rejection of claim 52, we sustain the rejection of claims 52–56
as unpatentable over Dinkelacker and Beaty.
Rejection II–Dinkelacker, Beaty, and Gintaras
In addition to rejecting claims 41, 42, 45, and 53 as unpatentable over
Dinkelacker and Beaty, the Examiner rejects these claims based on a
combination of Dinkelacker, Beaty, and Gintaras. See Final Act. 11–12.
The Examiner’s use of the disclosure in Gintaras does not remedy the
deficiency in Rejection I discussed above. Appellant makes no separate
arguments for the patentability of claim 53. See Appeal Br. 10–18. We
sustain Rejection II with respect to claim 53, but do not sustain this rejection
with respect to claims 41, 42, and 45.

Rejections III–V Obviousness Double-Patenting
Appellant does not traverse Rejections III–V. See Appeal Br. 7–18.
Accordingly, we summarily sustain these rejections.

CONCLUSION
The Examiner’s rejections are affirmed in part.

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DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
36–56 103(a) Dinkelacker, Beaty 52–56 36–51
41, 42, 45,
53
103(a) Dinkelacker, Beaty,
Gintaras
53 41, 42, 45
36–39, 41,
43
Nonstatutory Double
Patenting
36–39, 41,
43

44–46, 49 Nonstatutory Double
Patenting
44–46, 49
52, 53 Nonstatutory Double
Patenting
52, 53
Overall
Outcome
36–39, 41,
43–46, 49,
52–56
40, 42, 47,
48, 50, 51,

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 IN PART