Ex Parte Kramer et al

Patent Trial and Appeal Board

Feb 27, 2013

10032659 (P.T.A.B. Feb. 27, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PAMELA A. KRAMER and JOHN WILLIAM MORRIS, JR.
__________

Appeal 2011-011859
Application 10/032,659
Technology Center 3700
__________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1, 3-10, 14-16, 22-24, 26-29, and 41-45 are pending and
rejected (App. Br. 3). However, Appellants only appeal the rejections of
claims 1, 9, 14-16, 22, 26-29, and 41-45 (id.). Thus, the Examiner should
cancel claims 3-8, 10, 23, and 24. See Ex parte Ghuman, 88 USPQ2d 1478,
1480 (BPAI 2008) (citing MPEP § 1215.03).
Appeal 2011-011859
Application 10/032,659

2
We will focus on claims 1, 22, and 41, which are the only independent
claims on appeal and read as follows:
1. A medical device for use in treating a human patient, comprising:
a metal alloy substrate having an average grain size in the range of
one to ten microns.
22. An intravascular stent for use in a body lumen, comprising:
a plurality of cylindrical rings interconnected to form the stent, each
cylindrical ring having a first delivery diameter and a second expanded
diameter; and
each cylindrical ring being formed from a fine grained material having
an average grain size of one to ten microns.
41. A stent comprising a substrate having an average grain size in the
range of one to ten microns.
Claims 1, 9, 14-16, and 41-45 stand rejected under 35 U.S.C. § 103(a)
as obvious over Davidson (US 5,954,724, Sep. 21, 1999) (Ans. 3).
Claims 22 and 26-29 stand rejected under 35 U.S.C. § 103(a) as
obvious over Frantzen (US 5,843,175, Dec. 1, 1998) in view of Davidson
(Ans. 4).
With regard to claims 1 and 41, the Examiner relies on Davidson for
disclosing “a medical device or stent (10) including a metal alloy substrate
having a fine grain size, where the substrate is a titanium based alloy” (id. at
3). The Examiner finds that “Davidson does not disclose that the average
grain size is in the range of one to ten microns” (id.). However, the
Examiner finds that “Davidson discloses that the alloy substrate can be
mechanically worked „to optimize grain size‟” (id.). Relying on In re Aller,
220 F.2d 454, 456 (CCPA 1955), the Examiner concludes that it would have
been obvious “to size . . . the grains in the substrate as claimed, since it has
been held that where the general conditions of a claim are disclosed in the
Appeal 2011-011859
Application 10/032,659

3
prior art, discovering the optimum or workable ranges . . . involves only
routine skill in the art” (id. at 4).
With regard to claim 22, the Examiner relies on Frantzen for
disclosing “an intravascular stent comprising a metal alloy substrate,”
wherein “the stent includes a plurality of interconnected cylindrical rings or
a plurality of struts or elongate elements (e.g. 20 or 120) and straight links
(e.g., 50 or 150) or undulating links (e.g., 180)” (id.). The Examiner
acknowledges that “Frantzen does not disclose that the substrate has an
average grain size in the range of one to ten microns” (id.). However, the
Examiner relies on Davidson as discussed above (id.). As with claims 1 and
41, the Examiner concludes that it would have been obvious “to size . . . the
grains in the substrate as claimed, since it has been held that where the
general conditions of a claim are disclosed in the prior art, discovering the
optimum or workable ranges (of grain size) involves only routine skill in the
art” (id. at 4-5).
ISSUE
With regard to each ground of rejection, the issue is: Has the
Examiner set forth a prima facie case that Davidson suggests a material
having an average grain size in the range of one to ten microns?
FINDINGS OF FACT
1. Davidson “relates to titanium alloys suitable for use in the
construction of medical implants and devices” (Davidson, col. 1, ll. 6-8).
2. Davidson discloses that “[a]lloy strength is achieved by aging
to precipitate the alpha phase or by cold working” (id. at col. 1, ll. 47-49).
Appeal 2011-011859
Application 10/032,659

4
3. Davidson also discloses that the “method[s] for titanium alloy
production, such as casting, powder metallurgy, etc. are well known to those
of ordinary skill in the art of metallurgy and the production of the alloy
requires no special skills or precautions beyond the materials, proportions
and techniques described below” (id. at col. 6, ll. 47-52).
4. In addition, Davidson discloses that “the alloy can be hot or
cold mechanically worked to optimize grain size, strength, elastic modulus,
and toughness” (id. at col. 8, ll. 21-23).
5. Davidson also discloses that the “small size ( 25 angstroms) of
the omega phase . . . can provide strengthening and hardening” (id. at col. 9,
ll. 31-33)
ANALYSIS
Davidson discloses that the “small size ( 25 angstroms) of the omega
phase . . . can provide strengthening and hardening” (Finding of Fact (FF)
5). As noted by Appellants, 25 Angstroms “is four hundred to four thousand
times smaller than the claimed range” (Reply Br. 3).
The Examiner notes that Davidson also discloses the alpha phase
(Ans. 5). However, the Examiner has not provided any evidence indicating
the grain size of the alpha phase. Thus, the only grain size that has been
pointed to in this record is the 25 angstroms of the omega phase.
We recognize that Davidson discloses that “the alloy can be hot or
cold mechanically worked to optimize grain size” (FF 4) and that “method[s]
for titanium alloy production . . . are well known to those of ordinary skill in
the art of metallurgy and the production of the alloy requires no special skills
or precautions beyond the materials, proportions and techniques described
Appeal 2011-011859
Application 10/032,659

5
below” (FF 3). However, given that the only disclosure of grain size is 25
angstroms, we agree with Appellants that the Examiner has not set forth a
prima facie case that an average grain size of one to ten microns would have
been obvious.
CONCLUSION
The Examiner has not set forth a prima facie case that Davidson
suggests a material having an average grain size in the range of one to ten
microns. We therefore reverse the obviousness rejection of claims 1, 22, and
41, and of claims 9, 14-16, 26-29, and 42-45, which depend from claims 1,
22, or 41.

REVERSED

cdc