Ex Parte Ogiso

Patent Trial and Appeal Board

Mar 25, 2016

10569556 (P.T.A.B. Mar. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/569,556 0212712006
7055 7590 03/29/2016
GREENBLUM & BERNSTEIN, PLC
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
FIRST NAMED INVENTOR
Makoto Ogiso
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.
P29315 7641
EXAMINER
LOPEZ, LESLIE ANN
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
03/29/2016 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
following e-mail address( es):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MAKOTO OGIS0 1
Appeal2013-008481
Application 10/569,556
Technology Center 3700
Before EDWARD A. BROWN, BRANDON J. WARNER, and
FREDERICK C. LANEY, Administrative Patent Judges.
LANEY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Makoto Ogiso (Appellant) appeals under 35 U.S.C. § 134(a) from the
Examiner's decision to reject claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-
28. Br. 6. Claims 7, 8, 20, and 11 have been canceled. Id. Claims 3, 4, 11-
13, 15, 16, 23, and 24 have been withdrawn. Id. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellant, the Real Party in Interest is Pentax Corporation.
Br. 4.
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Application 10/569,556
CLAIMED SUBJECT MATTER
The subject matter of Appellant's application generally relates to "a
porous or surface roughened structure suitable for artificial bones and dental
roots and its production method, particularly to a porous or surface
roughened structure of a biocompatible material impregnated with fine bone
powder and its production method." Spec. 1:6-10.2 Claims 1 and 17 are
independent. Claim 1 is illustrative of the claimed subject matter, and
recites:
1. A bone-powder-impregnated, porous structure comprising
a porous matrix made of a biocompatible material impregnated
with fine living bone powder obtained by pulverizing living
bones and/or teeth, wherein the fine living bone powder
comprises sub-micron particles.
EVIDENCE
The Examiner relies upon the following evidence:
Takagi
Kagechi
Boyce
Levine
Smith
us 4;654;314
us 5, 134,031
us 5,899,939
US 2003/0220696 Al
US 2004/0253279 Al
REJECTIONS
Mar. 31; 1987
July 28, 1992
May 4, 1999
Nov. 27, 2003
Dec. 16, 2004
The Examiner rejects claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-
28 as follows:
2 Our citations to the Specification herein are in reference to the "Substitute
Specification" received February 27, 2006.
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l. claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28 under 35
U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement;
II. claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28 under 35
U.S.C. § 112, second paragraph, as being indefinite for failing
to particularly point out and distinctly claim the subject matter
Appellant regards as the invention;
III. claims 1, 9, 10, 14, 17, 22, and 25 under 35 U.S.C. § 103(a) as
being unpatentable over Boyce and Kagechi;
IV. claims 1, 2, 5, 6, and 17-19 under 35 U.S.C. § 103(a) as being
unpatentable over Smith, Boyce and Kagechi;
V. claim 26 under 35 U.S.C. § 103(a) as being unpatentable over
Boyce, Kagechi, and Takagi; and
VI. claims 27 and 28 under 35 U.S.C. § 103(a) as being
unpatentable over Boyce, Kagechi, and Levine.
ANALYSIS
Rejection I
The Examiner finds the Specification fails to provide evidence
Appellant incorporated "living bone powder" into the disclosed invention
because the Specification repeatedly uses the phrases "bone powder" and
"fine bone powder" without demonstrating the references to those phrases
apply to "living bone powder." Final Act. 3; Ans. 3-5. According to the
Examiner, the Specification only uses "living bone powder" in one instance
to describe the storage conditions of "living bone powder", but does not tie
"living bone powder" to the discussions of "bone powder" or "fine bone
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powder" associated with the disclosed invention. Final Act. 3. As such, the
Examiner concludes the claimed "living bone powder" constitutes new
matter. Id.
Appellant contends the Specification supports the phrase "living bone
powder" and demonstrates Appellant's possession of the presently claimed
invention. Br. 10-13. We agree. In the "Disclosure of the Invention"
section of the Specification, Appellant describes the "bone-powder-
impregnated, porous structure" as "impregnated with fine bone powder
obtained by pulverizing living bones and/or teeth." Spec. 5:5-8, 6:5---6. In
addition, in "The Best Mode for Carrying out the Invention" section,
Appellant identifies various examples of bones, teeth, and how the bone
powder is prepared. Id. at 12:25-13:27. In the claims, "living bone powder"
is likewise described as being "obtained by pulverizing living bones and/or
teeth." Br. 59 (Claims App.).
Although the Specification uses the phrase "fine bone powder"
instead of "living bone powder", this can demonstrate to a skilled artisan that
Appellant had invented what is now claimed. Simply because the same
words are not used in both the Specification and the claims does not, in and
of itself, demonstrate a failure to satisfy the "written description"
requirement. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995) ("In
order to determine whether a prior application meets the 'written
description' requirement with respect to later-filed claims, the prior
application need not describe the claimed subject matter in exactly the same
terms as used in the claims; it must simply indicate to persons skilled in the
art that as of the earlier date the applicant had invented what is now
claimed.").
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In the Answer, the Examiner "notes any tissue once removed from the
body of the donor immediately starts dying" and "[t]he only point at which
all bone implants can be considered living, under the ordinary meaning of
the word living, is while they remain in a living donor." Ans. 4 (emphasis
added). Furthermore, according to the Examiner, "the process of freezing
kills cellular tissue." Id. As a result, the Examiner concludes "any bone
powder used after a freezing process would be considered without living
tissue to an artisan of ordinary skill in the art." Id. There are several issues
with the above analysis.
First, with respect to core factual findings in a determination of
patentability, an Examiner cannot establish a prima facie case based on
conclusions simply deemed to be basic knowledge or common sense. In re
Zurko, 258 F.3d 1379, 1385-86 (Fed. Cir. 2001). Rather, the Examiner
"must point to some concrete evidence in the record in support of those
findings." Id. The above findings by the Examiner are not based on any
evidence in the record and, therefore, lack evidentiary support and have
little, if any, probative value.
Second, the Examiner's analysis appears directed to enablement rather
than written description. Written description and enablement are separate
requirements under 35 U.S.C. § 112, first paragraph. Ariad Pharms., Inc. v.
Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). As such, they
require different evaluations. See id. at 1352. Written description requires
an evaluation of whether the Specification "clearly allows persons of
ordinary skill in the art to recognize that [the inventor] invented what is
claimed." Id. at 1351. Enablement requires an evaluation of whether the
Specification allows a skilled artisan to make and use the claimed invention
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without undue experimentation. See id. at 1352; see also United States v.
Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988) (The enablement test
evaluates "whether one reasonably skilled in the art could make or use the
invention from the disclosures in the patent [application] coupled with
information known in the art without undue experimentation.").
The Examiner's rejection is limited to "written description." See
Final Act. 3. The Examiner's analysis, however, is directed to whether a
skilled artisan can make or use "living bone powder" from bone that has
been removed from its host and/or frozen, which is an enablement analysis.
Setting aside whether, after being excised and frozen, "living bone" can
remain "living" to make "living bone powder," because enablement is not
before us, the Examiner notably does not explain why the Specification's
description of "fine bone powder" as being "obtained by pulverizing living
bones and/or teeth" is not sufficiently clear to evidence the inventor invented
what is claimed- i.e., "living bone powder," which is bone powder obtained
by pulverizing living bones and/or teeth.
Therefore, because a preponderance of the evidence does not support
the Examiner's written description rejection, we do not sustain that rejection
of claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and25-28.
Rejection II
The Examiner finds "living bone powder" is indefinite because "[i]t is
unclear what constitutes living bone powder." Final Act. 4. As support, the
Examiner offers the following analysis:
All bone powder must be from some type of bone via a donor.
As it is unclear what is meant by "living" in this case, it is also
unclear at what point during processing bone powder is no longer
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considered "living". Lacking any evidence or reference that
states a distinction and/ or differences between what is considered
"living bone powder" and demineralized bone powder, it is the
Examiner's position that "living bone powder" limitation is met
[by] demineralized bone powder.
Id. Further, regarding the claim language "obtained by pulverizing living
bones and/or teeth," the Examiner notes that clause "does not provide a
definition of what is meant by 'living bone powder', but rather provides a
process by which 'living bone powder' is made." Ans. 6.
Appellant asserts "living bone powder" is a structure defined by the
process for making it. Br. 14. Regarding demineralized bone powder,
Appellant maintains that the Specification never suggests "living bone
powder" and "demineralized bone powder" are equivalent or
interchangeable. Id. at 15. Appellant further points to the fact that the
claims, as originally filed, made a clear distinction between the two by
separately identifying "living bone powder" and "demineralized bone
powder" in completely separate claims - e.g., original claims 7, 8, 20 and
21. Id. As such, Appellant asserts "bone powder obtained by pulverizing
living bones and/or teeth was specifically contemplated and disclosed as a
distinct embodiment from demineralized bone powder." Id.
A claim satisfies the definiteness requirement of 35 U.S.C. § 112,
second paragraph, when one skilled in the art understands the claim
parameters as read in light of the specification. BJ Servs. Co. v. Halliburton
Energy Servs., 338 F.3d 1368, 1372 (Fed. Cir. 2003) (quoting Union Pac.
Res. Co. v. Chesapeake Energy Corp., 236 F.2d 684, 692 (Fed. Cir. 2001)
("The definiteness inquiry focuses on whether those skilled in the art would
understand the scope of the claim when the claim is read in light of the rest
of the specification.")). Defining a product in terms of the process used to
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make it does not necessarily make the identified product indefinite. Jn re
Hughes, 496 F.2d 1216, 1218 (CCPA 1974). "[I]t is well established that
product claims may include process steps to wholly or partially define the
claimed product." In re Luck, 476 F.2d 650, 653 (CCPA 1973).
Consistent with the Specification and plain meaning of the term, we
are persuaded that a skilled artisan, in this case, would readily recognize the
meaning of "living bone powder" as the resulting product derived from
"pulverizing living bone and/or teeth." The Specification describes the
"Preparation of bone powder" as taking bone pieces and/or teeth and
breaking them down into a powder using a mortar and pulverizer. Spec.
13: 19-14: 15. In addition, the Specification provides an example in which,
"Bone pieces were taken from the tibia of an adult dog by a trepan bar
mounted to an electric dental engine, and pulverized in a physiological
saline solution in an alumina mortar in a sterile environment." Id. at 23: 11-
13. The solution with the fine bone powder was then put into a centrifugal
separator to separate the powder from the saline solution. Id. at 23: 13-20.
Neither the Specification nor the claim language demonstrates ambiguity in
the understanding of "living bone powder."
The Examiner suggests there is some ambiguity about whether "living
bone powder" excludes "demineralized bone powder." Ans. 6. The
Examiner, however, does not offer any evidence, nor provide an explanation
with a rational underpinning, demonstrating a skilled artisan would consider
"living bone" and "demineralized bone" as equivalents or interchangeable.
We note the Reddi et al., Proceeding of the National Academy of Sciences of
the United States of America 69, pp. 1601-1605 (1972), paper does
evidence, however, that a skilled artisan would recognize demineralized
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bone powder results from employing an acid solution to the bone to remove
the mineralized organic matrix within a bone. See Br. 61 (Evidence App.)
(hereinafter "the Reddi paper"). As such, the described process of
"demineralizing" bone supports Appellant's contention that a skilled artisan
understands living bone and demineralized bone are distinctly different
because the mineralized organic matrix is obviously necessary for "living
bone" and completely removing it would effectively remove (or kill) the
living cells embedded in the mineralized organic matrix. Br. 21-22.
The Examiner has also not established "living bone powder" is
unclear simply because bone "starts dying" immediately after it has been
removed from the donor. We note the Examiner has not asserted the term
"living bone" used in the claims is indefinite. We note further the Reddi
paper evidences the term "living bone" is a term used and understood by
those skilled in the art. See Br. 64---65 (Evidence App.). Because the
Examiner does not assert "living bone" is unclear and because the Reddi
paper indicates "living bone" is an art-recognized term, the evidence shows
a skilled artisan would know what is or is not "living bone."
Opining that bone starts dying after being removed from the donor
does not evidence ambiguity as to the meaning of "living bone powder."
Ans. 6. To the contrary, it suggests the skilled artisan recognizes the bone is
still "living" because it is not yet "dead." Also, to state the skilled artisan
recognizes when bone is dying, presupposes the skilled artisan is also
capable of determining the extremes at both ends of the process- i.e., living
bone at one end and dead bone at the other. To the extent the Examiner is
suggesting that it is basic knowledge or common sense to a skilled artisan
that "living bone" cannot exist for any period of time outside its donor or
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after being frozen, the Examiner has not identified any evidence in the
record to support such a finding and, therefore, it has little, if any, probative
value. In re Zurko, 258 F.3d at 1385-86.
Because "living bone powder" is the product of pulverized living bone
and/ or teeth and because the Examiner has not demonstrated by evidence, or
by articulating a reason with rational underpinnings, that a skilled artisan
cannot identify living bone, the evidence in this record supports a
determination that a skilled artisan understands the claim parameters.
Therefore, we do not sustain the Examiner's indefiniteness rejection of
claims 1, 2, 5, 6, 9, 10, 14, 17-19, 22, and 25-28.
Rejection III
Appellant raises two dispositive issues regarding the Examiner's
obviousness rejection of independent claim 1. First, Appellant asserts the
Examiner erred by relying on Boyce's disclosure of "demineralized bone
powder" to satisfy the claimed "living bone powder" element. Br. 17-22.
Second, Appellant asserts the Examiner erred by relying on Kagechi because
it is non-analogous art. Br. 23-25. We agree with Appellant in both
instances.
Relying on Boyce to disclose "living bone powder," the Examiner
"notes that demineralized bone powder is considered to meet the claim
limitation because, lacking any definition of 'living' ... , the bone was living
at the time it was still within the living source of the bone (the only known
point at which all bone implants can be considered living under the ordinary
meaning of the word living)." Ans. 8. Other than the demineralized bone
powder, the Examiner does not identify any other bone composition from
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Boyce to purportedly satisfy the "living bone powder" limitation. As
discussed above (see supra, Rejection II), "living bone powder" is the
product of "living bone" pulverized into a powder and the evidence
demonstrates a recognized difference between "living bone" and
"demineralized bone." Consistent with this fact, Boyce also recognizes
there are distinctions between fully mineralized bone and demineralized
bone (partially and fully). See Boyce 3:41-57. As a result, simply pointing
out that Boyce discloses demineralized bone powder, without something
more, does not establish by a preponderance of the evidence that it was
known to impregnate a porous structure with living bone powder.
In addition, the Examiner's reliance on Kagechi was error. The
Examiner finds Kagechi is "concerned with the same field of endeavor,
namely pulverizing bone into powder." Final Act. 6; Ans. 11. According to
the Examiner, "one skilled in bone powders would consider sources using
bone powders and processes for making them." Although the Examiner
references the test for determining whether a reference is outside the field of
endeavor, no such analysis is performed. Ans. 11. Instead, the Examiner
simply concludes Kagechi is analogous because it is in the "field of bone
powders." Id.
Determining whether prior art is analogous requires consideration of
"(1) whether the art is from the same field of endeavor, regardless of the
problem addressed, and (2) if the reference is not within the field of the
inventor's endeavor, whether the reference still is reasonably pertinent to the
particular problem with which the inventor is involved." In re Clay, 966
F.2d 656, 658-59 (Fed. Cir. 1992). As the above criteria instructs, if the
reference is within the same field of endeavor, then the problem being
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addressed by the inventor is irrelevant; however, if the reference is not
within the same field of endeavor, then the reference must be "reasonably
pertinent" to a problem facing the inventor. Precedent provides guidance as
to when a reference is reasonably pertinent to the problem:
A reference is reasonably pertinent if ... it is one which, because
of the matter with which it deals, logically would have
commended itself to an inventor's attention in considering his
problem. If a reference disclosure has the same purpose as the
claimed invention, the reference relates to the same problem, and
that fact supports use of that reference in an obviousness
rejection.
Innovention Toys, LLC v. MGA Entm 't, Inc., 637 F.3d 1314, 1321 (Fed. Cir.
2011) (quoting Clay, 966 F .2d at 659). "The pertinence of the reference as a
source of solution to the inventor's problem must be recognizable with the
foresight of a person of ordinary skill, not with the hindsight of the
inventor's successful achievement." Scientific Plastic Products, Inc. v.
Biotage AB, 766 F.3d 1355, 1359 (Fed. Cir. 2014).
Broadly stated, the field of endeavor for Appellant's invention is
medical devices and, more specifically, medical devices related to inducing
bone growth. Spec. 1:7-11, 4:26-5:2. Broadly stated, Kagechi's field of
endeavor is textiles, and, more specifically, animal protein fiber composites.
Kagechi 1:5-10.
No explanation is provided about how or why the Examiner finds
Kagechi' s "field of endeavor" is "bone powders" or "pulverizing bone into
powder." Nor does the Examiner provide a reference to any supporting
evidence within Kagechi to support such a finding. Although Kagechi
discusses using animal protein powders, only one example of which includes
pulverizing bones into very fine powder, it does so in the context of using
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the powder as an additive to further develop a fiber composite. Kagechi
1 :48-3:35. As such, rather than defining the field of endeavor, the
pulverized bone is simply one example of an additive used within the field
of textile materials. Textiles and medical devices are different fields of
endeavor.
Because Kagechi is in a different field of endeavor than the claimed
invention, we next focus on the problems facing the inventor to determine
whether a problem was of a nature that the attention of a skilled artisan
facing such a problem would have been logically directed to Kagechi.
Appellant describes the problems addressed as follows:
[T]he technique of medically repairing large bone defects has not
been established yet. In the case of using artificial dental roots
in patients with advanced absorption and shrinkage of jawbone,
too, a bone regeneration technique needing no living bone in a
large amount is desired. Further, in the implantation of artificial
bones and dental roots such as outer heads, etc. in the bone, they
are required to be strongly integrated with the surrounding bone
as soon as possible after the implantation.
Spec. 4: 17-23. Put more succinctly, the problem facing the inventor was
how to minimize the amount of living bone needed and still enable an
implanted medical device to strongly integrate with the surrounding bone as
soon as possible after the implantation.
Kagechi describes the problems it addresses as follows:
[M]ixing and kneading of natural leather powder with synthetic
fiber material led to the poor spinning performance due to the
adverse influence exerted on the spinning machine such as
occurrence of clogging because the synthetic fiber becomes
lacking in flexibility, poorer in elongation characteristics and
thus liable to break. Moreover, the natural leather powder to be
mixed and kneaded with the synthetic fiber material has a particle
size only enough to pass through the 50 to 250 mesh sieve, the
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fiber must be designed to be considerably thick as compared with
general fibers, thus resulting in "thick, hard and fragile" one.
Furthermore, such composite fiber material was not applicable to
actual textile products and was thus of little practical use because
it is slow in moisture absorbing and desorbing speed, though its
water-holding performance is improved.
Kagechi 1 :29--45. Put another way, the problem facing Kagechi was how to
create animal protein fiber composites with improved moisture absorptivity
and permeability characteristics, capable of being freely knitted or woven,
and good touch and feel qualities. Id. at 1:5-10, 48---64. What is noticeably
absent from both Kagechi and Appellant's Specification is any discussion
about a need or problem specific to bone powder or creating bone powder.
In addition, the purposes for using the bone powder are completely
different. Appellant uses bone powder to facilitate bone growth; whereas,
Kagechi uses bone powder to improve the mechanical and physical
characteristics of composite fibers. There is not enough evidence to support
a finding that Kagechi is reasonably pertinent to the problems facing
Appellant leading to the claimed invention. Therefore, the Examiner erred
by relying on Kagechi as analogous art.
Because we find identifying "demineralized bone powder" alone,
without more, is insufficient to establish a prima facie case Boyce discloses
"living bone powder," and because we find Kagechi is not analogous art, we
do not sustain the Examiner's obviousness rejection of claim 1. Independent
claim 1 7 has similar limitations as claim 1 and the Examiner relies on the
same analysis to determine obviousness. As a result, and for the same
reasons, we also do not sustain the Examiner's rejection of claims 9, 10, 14,
17, 22, and 25.
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Rejection IV
The Examiner's rejection of claims 1, 2, 5, 6, and 17-19 as
unpatentable over Smith, Boyce, and Kagechi also relies on the erroneous
determination that Boyce and Kagechi disclose a porous structure
"impregnated with fine living bone powder obtained by pulverizing living
bones and/or teeth, wherein the fine living bone powder comprises sub-
micron particles," which is a limitation in both independent claims 1 and 17.
Final Act. 7-9. The Examiner's application of Smith in this rejection does
not cure the deficiencies of the rejection discussed above (see supra
Rejection III) for claim 1. Thus, we do not sustain the rejection of claims 1,
2, 5, 6, and 17-19 as unpatentable over Smith, Boyce, and Kagechi.
Rejection V
Claim 26 depends from claim 1. Br. 60 (Claims App.). The
Examiner's rejection of claim 26 as unpatentable over Boyce, Kagechi, and
Takagi is based on the erroneous determination that Boyce and Kagechi
disclose a porous structure "impregnated with fine living bone powder
obtained by pulverizing living bones and/or teeth, wherein the fine living
bone powder comprises sub-micron particles," which is a limitation in
independent claim 1. Final Act. 9. The Examiner's application of Takagi in
this rejection does not cure the deficiencies of the rejection discussed above
(see supra Rejection III) for claim 1. Thus, we do not sustain the rejection
of claim 26 as unpatentable over Smith, Boyce, and Takagi.
Rejection VI
Claim 27 depends from claim 1 and claim 28 depends from claim 17.
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Br. 60 (Claims App.). The Examiner's rejection of claims 27 and 28 as
unpatentable over Boyce, Kagechi, and Levine is based on the erroneous
determination that Boyce and Kagechi disclose a porous structure
"impregnated with fine living bone powder obtained by pulverizing living
bones and/or teeth, wherein the fine living bone powder comprises sub-
micron particles," which is a limitation in both independent claims 1 and 17.
Final Act. 10. The Examiner's application of Levine in this rejection does
not cure the deficiencies of the rejection discussed above (see supra
Rejection III) for claim 1. Thus, we do not sustain the rejection of claim 26
as unpatentable over Smith, Boyce, and Levine.
DECISION
We reverse the decision of the Examiner to reject claims 1, 2, 5, 6, 9,
10, 14, 17-19, 22, and 25-28.
REVERSED
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