Ex Parte Robb et al

Patent Trial and Appeal Board

Dec 13, 2016

13558037 (P.T.A.B. Dec. 13, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/558,037 07/25/2012 T. Tait Robb 5394.C80US2 7747
104326 7590 12/15/2016
Schwegman Lundberg & Woessner / Zimmer
P.O. Box 2938
Minneapolis, MN 55402
EXAMINER
LEWIS, RALPH A
ART UNIT PAPER NUMBER
3732
NOTIFICATION DATE DELIVERY MODE
12/15/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte T. TAIT ROBB, BRUCE BERCKMANS III,
ROSS W. TOWSE, and ROBERT L. MAYFIELD
Appeal 2015-000454
Application 13/558,037
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and
EDWARD A. BROWN, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
T. Tait Robb et al. (Appellants)1 seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision, as set forth in the Final Office Action,
dated July 31, 2013 (“Final Act.”), rejecting claims 41-53.2 We have
jurisdiction under 35 U.S.C. § 6(b).
1 Appellants identify the real party in interest as Biomet 3i, LLC. Appeal
Br. 2.
2 Appellants canceled claims 21-27 in an amendment filed after the Final
Action; the Examiner entered this amendment in an Advisory Action dated
July 24, 2014.
Appeal 2015-000454
Application 13/558,037
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to our authority under 37 CE.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Appellants’ claimed subject matter “relates to roughened surfaces
provided on dental implants to improve the osseointegration of the implant
surface with the bone, thereby shortening the time between initial insertion
of the implant and the installation of a prosthetic tooth.” Spec. 2,11. 15-18.
Claims 41 and 48 are independent. Claim 41 is reproduced below.
41. A method of producing a uniformly roughened
surface on Ti 6/4 alloy for contact with living bone comprising:
treating least a portion of the implant surface for a suitable
period of time to create a first surface; and
contacting the first surface with a first aqueous solution
including hydrofluoric acid and hydrochloric acid for a suitable
period of time to create a second surface having a topography for
osseointegration of the implant with living bone.
Independent claim 48 also is directed to a method of producing a
uniformly roughened surface on a Ti 6/4 alloy implant and recites the same
“contacting” step as claim 41. Appeal Br. A2 (Claims App.).
REJECTIONS
The Final Action includes the following grounds of rejection:
1. Claims 41 and 44^17 under 35 U.S.C. § 103(a) as unpatentable
over Leitao (US 6,069,295, issued May 30, 2000).
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Application 13/558,037
2. Claims 42, 43, and 48-53 under 35 U.S.C. § 103(a) as
unpatentable over Leitao and Lazzara (US 5,863,201, issued
January 26, 1999).
RELATED PROCEEDING
The application presently on appeal claims priority under 35 U.S.C.
§ 120 to Application 10/843,916, filed May 12, 2004 (“the ’916 application).
The ’916 application came before the Board of Patent Appeals and
Interferences in an appeal from an adverse Examiner’s decision, and the
Board issued a decision reversing the Examiner’s decision. Ex parte Robb,
Appeal 2010-001525 (BPAI January 24, 2012) (attached to Appeal Brief as
Exhibit A). The claims on appeal in the related application were of different
scope than the claims before us in the present appeal, and the Examiner
relied on several prior art references in the rejection in the related
application that differ from the prior art references relied upon in the
Examiner’s rejections in the present appeal. See id. at 1-2. In the appeal in
the related application, Appellants relied on the Declaration of Keith D.
Beaty Under 37 C.F.R. § 1.132 (“Beaty Decl.”) and the Declaration of
Richard J. Lazzara Under 37 C.F.R. § 1.132 (“Lazzara Decl.”) to show
patentability of the appealed claims over the prior art. See id. at 4 (FF 2, 3).
Appellants submitted these same declarations in the present application to
rebut the Examiner’s obviousness determinations of the presently appealed
claims. Appeal Br., Exhibits B and C.
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Application 13/558,037
ANALYSIS
First Ground of Rejection
The Examiner found that Leitao discloses a process for surface
roughening of an implant comprised of Ti 6/4 alloy including etching the
implant first surface with acid to produce surface roughening. Final Act. 5
(citing Leitao, col. 1,11. 60-64, col. 2,11. 66-67, col. 7,11. 44, 51). In
particular, the Examiner relied on Example 3 of Leitao, which discloses the
use of hydrochloric acid (HC1) and sulphuric acid (H2SO4) to etch the
surface of a Ti 6/4 alloy. Id. The Examiner found, “however, Leitao
explicitly states that ‘[t]he chemical surface treatment may e.g. be a
treatment with a strong, preferably mineral, acid solution, such as
hydrofluoric, hydrochloric, sulphuric, nitric, perchloric acid or
combinations thereof’ (column 2, lines 49-52, emphasis added).” Id. The
Examiner determined “[t]o have etched the Leiteo [sic] [Ti 6/4 alloy]
implant [of Example 3] with a combination of hydrofluoric and hydrochloric
acid as is explicitly suggested by Leiteo [sic] would have been obvious to
one of ordinary skill in the art.” Id. at 5-6.
Appellants argue that Leitao does not suggest etching a Ti 6/4 alloy
using hydrofluoric (HF) and hydrochloric (HC1) acids (Appeal Br. 6-7), and
that one skilled in the art would be led away from the inclusion of
hydrofluoric acid in an etching solution for Ti 6/4 alloy. Appeal Br. 6-7,
12-13 (Appellants arguing Leitao’s specific teaching of etching Ti 6/4 alloy
excludes the use of hydrofluoric acid).
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Appeal 2015-000454
Application 13/558,037
Leitao discloses generally that the substrate of the implant can be of
various materials, including metals, organic natural and synthetic polymers,
and ceramic materials. Leitao, col. 1,1. 66 - col. 2,1. 9. Leitao discloses
that the invention provides a process of subjecting the solid implant substrate
material to a mechanical or chemical surface treatment until a desired
surface roughness is obtained. Id., col. 2,11. 36-40. Leitao describes “[t]he
chemical surface treatment may e.g. be a treatment with a strong, preferably
mineral, acid solution, such as hydrofluoric, hydrochloric, sulphuric, nitric,
perchloric acid or combinations thereof.” Id., col. 2,11. 49-52. Leitao’s
disclosure of a list of possible substrate materials and a list of possible
chemical surface treatment materials does not provide any specific guidance
in this portion of the disclosure in column 2 as to which chemical surface
treatment materials would work with the various substrate materials.
In Example 3, Leitao discloses a “new two-step chemical treatment
for preparing an implant with a specific surface roughness, resulting in a
metallic surface that allows fast precipitation of biomimetic calcium
phosphate (Ca-P) coatings from in vitro super-saturated calcification
solutions (SCS).” Id., col. 7,11. 28-33. Leitao discloses that that the two-
step chemical treatment “was performed on the metallic implant materials,
i.e. commercially pure titanium (cp.Ti), annealed Ti6A14V and porous
tantalum (Ta).” Id., col. 7,11. 42 45. Leitao teaches that the pure titanium
and annealed titanium alloy samples were treated with a mixture of HC1 and
H2SO4, and the tantalum implant samples were treated with a mixture of
HC1, H2SO4 and HF. Id., col. 7,11. 50-54. Notably, Leitao does not suggest
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Application 13/558,037
using hydrofluoric acid in the treatment mixture for the titanium samples.
Further, Leitao discloses that “[t]he procedure of the treatments for titanium
implants and tantalum could not be exchanged, otherwise no CA-P coating
was acquired.” Id., col. 8,11. 32-34. We find that Leitao’s omission of
hydrofluoric acid from the treatment mixture used with the Ti 6/4 alloy
implant, and Leitao’s disclosure that the tantalum treatment mixture which
included hydrofluoric acid would not work on the Ti 6/4 alloy implant to
achieve the CA-P coating, would have led one having ordinary skill in the
art away from using hydrofluoric acid to treat the Ti 6/4 alloy implant. For
this reason, we do not sustain the rejection of claim 41, and its dependent
claims 44^47, under 35 U.S.C. § 103(a) as unpatentable over Leitao.
Second Ground of Rejection
The second ground of rejection relies on the same determination of
obviousness regarding use of hydrofluoric acid in the treatment mixture for
the Ti 6/4 alloy based on Leitao that we found deficient in the first ground of
rejection. Final Act. 7-8 (relying on Lazzara for teaching surface
roughening on a threaded portion of an implant and for the initial step of
removing native oxide with hydrofluoric acid prior to etching). For the
reasons provided supra in our analysis of the first ground of rejection, we
likewise do not sustain the rejection of claims 42 and 43, which depend from
claim 41, and independent claim 48, and its dependent claims 49-53, under
35 U.S.C. § 103(a) as unpatentable over Leitao and Lazzara.
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Application 13/558,037
NEW GROUND OF REJECTION
As noted by the Examiner (Ans. 6), independent claim 41 is broad and
does not limit the claimed method to producing the Osseotite® surface
described in the Specification. Spec. 6,11. 21-27 (describing the Osseotite®
surface as having a “generally uniform set of sharp peaks with a maximum
peak-to-valley height of 10 pm or less” and an “average peak-to-peak
distance is about 1-3 pm” and which is “clinically demonstrated to achieve
enhanced osseointegration” (emphasis added)). Rather, claim 41 simply
calls for contacting the first surface of the implant with an aqueous solution
including HF and HC1 “for a suitable period of time to create a second
surface having a topography for osseointegration of the implant with living
bone.” Appeal Br. A1 (Claims App.). We understand the Specification to
describe that application of the specific two-step treatment method discussed
on page 9, line 29 through page 10, line 18 of the Specification to a Ti 6/4
alloy implant resulted in improved osseointegration of the implant to the
bone. We further understand the Specification to describe that implants
having roughened surfaces other than the Osseotite® surface still achieve
osseointegration of the implant with the bone, but not as quickly as achieved
with an implant having the Osseotite® surface. Spec. 3,11. 20-22
(describing the Osseotite® surface as “having reduced the time required for
osseointegration of the titanium implant with bone”). Further, we
understand the claim, as written, to require only that the contacting step
produce a roughened surface having a topography capable of
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osseointegration of the implant with living bone, as the claim is directed to a
method of producing the implant and not a method of using the implant.
Based on the scope of claim 41, we enter a new ground of rejection of
claim 41 under 35 U.S.C. § 102(b) as anticipated by Hama (U.S. Patent
Number 4,818,559, issued April 4, 1989). Hama discloses “[a] method of
producing a uniformly roughened surface on Ti 6/4 alloy for contact with
living bone,” as recited in the preamble of claim 41. In particular, Hama
discloses using Ti 6/4 alloy material as artificial material for tooth roots.
Hama, col. 2,1. 64 - col. 3,1. 7. Hama further discloses the surface of the
metallic core material is made rough to a specific maximum surface
roughness in the range of 15 pm to 100 pm. Id., col. 3,11. 28-32.
Hama discloses “treating [at] least a portion of the implant surface for
a suitable period of time to create a first surface,” as recited in the first step
of claim 41. In particular, Hama discloses “[t]he metallic material is formed
into the desired shape by conventional methods, such as cutting, casting,
forging, punching, electro arc machining, laser-processing, and powdered
metal techniques.” Hama, col. 3,11. 25-28. As noted by the Examiner in the
Final Action, “whether the implant is machined, cast or made in some other
way[,] it would necessarily have had a surface that was shaped (i.e. [,]
treated) over a period of time to have a first surface.” Final Act. 5. We find
that the methods for shaping the metallic implant material disclosed in
Hama, such as cutting, forging, punching, and machining, constitute treating
a portion of the implant surface for a suitable period of time to create a “first
surface.”
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Application 13/558,037
Hama further discloses “contacting the first surface with a first
aqueous solution including hydrofluoric acid and hydrochloric acid for a
suitable period of time to create a second surface having a topography for
osseointegration of the implant with living bone,” as recited in the second
step of claim 41. In particular, Hama describes that in order to make the
surface rough, the metallic core material is subjected to chemical etching,
which is “carried out by using mineral acid, such as sulfuric acid,
hydrochloric acid, hydrofluoric acid, which are used alone or in a
combination of two or more thereof.” Hama, col. 3,11. 41^15, 51-55. Thus,
Hama discloses, to achieve the desired surface roughness of 15 pm to
100 pm, the metallic core material, which is preferably made of Ti 6/4 alloy,
is subjected to chemical etching by contact with an aqueous solution that
includes sulfuric acid, hydrochloric acid, and hydrofluoric acid.3 We note
that Hama is not concerned with the acid being too aggressive because it is
not trying to achieve a surface roughness of less than 10 pm. See, e.g.,
Beaty Deck, para. 8 and Lazzara Deck, para. 9 (stating that Hama teaches
using hydrochloric acid and hydrofluoric acid to etch an implant surface to
obtain a surface topography of up to 100 pm). While such a roughened
surface may not be capable of the improved osseointegration achieved by
Appellants’ Osseotite® surface described in the Specification, this
roughened surface nonetheless provides a topography capable of
osseointegration of the implant with living bone, as called for in claim 41.
3 Claim 41 does not exclude sulfuric acid in the claimed solution.
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Finally, we find it of no moment that Hama additionally teaches
spraying the roughened surface with a ceramic material because the claim
uses the transitional term “comprising” and is thus broad enough to include
additional steps. For these reasons, we enter a new ground of rejection of
claim 41 under 35 U.S.C. § 102(b) as anticipated by Hama.
DECISION
The decision of the Examiner to reject claims 41-53 is REVERSED.
We enter a NEW GROUND OF REJECTION of claim 41 under
35 U.S.C. § 102(b) as anticipated by Hama.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
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(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be found in
the Manual of Patent Examining Procedure § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
REVERSED; 37 C.F.R, $ 41.50(b)
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