Ex Parte Constantz et al

Patent Trial and Appeal Board

Oct 18, 2012

11189555 (P.T.A.B. Oct. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRENT R. CONSTANTZ, DAVID DELANEY, and
DURAN YETKINLER
__________

Appeal 2011-009715
Application 11/189,555
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
The following claim is representative.
1. A method of producing a flowable composition that sets into a
calcium phosphate containing product, said method comprising:
combining:
(a) a setting fluid; and
(b) a dry reactant component comprising a first particulate calcium
and/or phosphate reactant having a mean particle size of about 8 µm or less
and narrow particle size distribution;
in a ratio of (a) to (b) sufficient to produce said flowable material that
has a setting value of about 400 Newtons or more in 6 minutes.

Cited References

Chow et al. US 5,525,148 Jun. 11, 1996
Demian et al. US 5,795,922 Aug. 18. 1998
Chow et al. US 5,976,234 Nov. 2, 1999
Constantz US 6,375,935 B1 Apr. 23, 2002

Grounds of Rejection
Claims 1-19, 23, 33 and 42-52 remain/are rejected under 35 U.S.C. §
103(a) as being unpatentable over Constantz in view of Chow and Demian.
Claims 1, 9, 11, 12, 17, 19, 23, and 33 are rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 6, 7, 16, and 18 of U.S. Patent No. 7,252,833.
Claims 1, 9, 11, 12, 17, 19, 23, and 33 are rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 8, 9, 10, 21, and 22 of U.S. Patent No. 7,306,786.
Claims 1, 9, 11 and 23 are provisionally rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 6, and 9 of US 7,252,841 in view of Chow et al. (US 5,976,234).

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Claims 1, 11, 12, 19, and 22 are provisionally rejected on the ground
of nonstatutory obviousness-type double patenting as being unpatentable
over claims 1-5, 9, 12, and 15-20 of copending Application No. 11/134,051
in view of Chow et al. (US 5,976,234).

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer pages 5-17.
The following additional facts are highlighted.
1. As is well known to those of the skill in the art, mean particle size
and particle size distribution are completely different
characteristics of a particulate composition. The mean particle size
(as determined using the Horiba LA-300 laser diffraction particle
sizer) is the average size of all the particles present. (App. Br. 11.)

2. In contrast, as defined in the specification (page 6, lines 5-9), by
narrow particle size distribution is meant that the standard
deviation of the particles that make up the particular reactant
population (as determined using the Horiba LA-300 laser
diffraction particle sizer) does not exceed about 4.0 µm. (App. Br.
11.)

Discussion
ISSUE
The Examiner finds that
The difference between the instant application and
Constantz et al. is that Constantz et al. do not expressly teach a
mean particle size of about 8 microns or less and narrow
particle size distribution or a mean particle size of about 4
microns or less and standard deviation that does not exceed
about 4 microns or a mean particle size of about 3 microns; a
second particulate calcium and/or phosphate reactant in the dry
reactant or a second calcium and/or phosphate reactant having a
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mean particle size of about 9 microns or greater in a ratio of
setting fluid to dry reactants sufficient to produce a flowable
material that has a setting value of about 400 N or more in 6
minutes or about 200 N or more in 3 minutes. This deficiency
in Constantz et al. is cured by the teachings of Chow et al.

(Ans. 9-10.)

The Examiner concludes that

It would have been obvious to one of ordinary skill in the
art at the time the claimed invention was made to use a mean
particle size of about 8 microns or less and narrow particle size
distribution or a mean particle size of about 4 microns or less
and standard deviation that does not exceed about 4 microns or
a mean particle size of about 3 microns; a second particulate
calcium and/or phosphate reactant in the dry reactant or a
second calcium and/or phosphate reactant having a mean
particle size of about 9 microns or greater in a ratio of setting
fluid to dry reactants sufficient to produce a flowable material
that has a setting value of about 400 N or more in 6 minutes or
about 200 N or more in 3 minutes in the method of Constantz et
al., as suggested by Chow, and produce the instant invention.

(Id. at 10.) The Examiner finds that “[o]ne of ordinary skill in the art of
bone cements would have followed the teachings of Chow et al. and selected
the appropriate particles in a narrow particle size distribution.” (Ans. 11.)
The Examiner finds Appellants’ Declaration evidence of unexpected
results unconvincing as Appellants have failed to test the closest prior art
example of Constantz. (Id. at 21.)
Appellants argue that

the combination of Constantz in view of Chow and Demain
fails to teach or suggest the claimed elements of: 1) a reactant
with narrow particle size distribution; and … even if a prima
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facie case had been established, the Appellants' showing of
unexpected results in the Declaration is sufficient to overcome
such a prima facie case.

(App. Br. 8.)

Appellants argue that

The cited references provide no guidance to one of
ordinary skill in the art to investigate particle size distribution
in the preparation of cement compositions. Further, Constantz
merely teaches that the size of the particles of the composition
typically vary by at least 1 and up to 3 orders of magnitude.
For example, "the particle size of the components of the
particulate composition typically ranges from about 1 to 1000
microns, usually from about 1 to 200 µm and more usually
from about 1 to 40 microns." See column 3, lines 3 to 7.
At best, Constantz's broad disclosure of particle sizes
does not teach or suggest a narrow particle size distribution,
rather a wide particle size distribution.

(Id. at 10.) Appellants assert the Examiner has erred by discounting
the Declaration under 37 C.F.R. 1.132 filed April 2, 2009.
1

The issue is: Has the Examiner provided evidence in the prior art of
a narrow particle size distribution to support a prima facie case of
obviousness?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or

1
Declaration of David Delaney, dated April 1, 2009 and filed April 2, 2009.
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argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).

ANALYSIS
Appellants argue that the combination of Constantz in view of
Chow and Demain fails to teach or suggest the claimed elements of a
reactant with a narrow particle size distribution in a method of producing a
flowable composition, as claimed. (App. Br. 10.)
We find that the Examiner has failed to establish a prima facie case of
obviousness on the evidence before us. The Examiner has failed to point to
any disclosure of Constanz or Chow of a narrow particle size distribution of
a dry reactant component. In fact, the Examiner admitted that Constanz
does not disclose a narrow particle size distribution (Ans. 9-10), and
Constanz would reasonably appear to disclose an actual range of particle
sizes, and not a narrow particle size distribution.
Appellants argue that

As is well known to those of the skill in the art, mean particle size and
particle size distribution are completely different characteristics of a
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particulate composition. The mean particle size … is the average size
of all the particles present. …

In contrast, as defined in the specification (page 6, lines 5-9), by
narrow particle size distribution is meant that the standard deviation of
the particles that make up the particular reactant population (as
determined using the Horiba LA-300 laser diffraction particle sizer)
does not exceed about 4.0 µm.

(App. Br. 11.) Appellants argue that conventional milling techniques lead to
particles with a wide range of particle sizes and that a narrow particle size
distribution is not inherent in prior art milling techniques. (App. Br. 12.)
The Examiner found that
Chow et al. measured the median diameter of the
ingredients and found the size of the alpha tricalcium carbonate
to be 2.91 microns (which is about 4 microns of instant claim 8
and reads on instant claim 16) and the calcium carbonate to be
12.4 microns (which is greater than about 10 microns of instant
claim 4) (Column 8, Table I).

(Ans. 8; emphasis added.) The Examiner concluded from this finding that
“[o]ne of ordinary skill in the art of bone cements would have followed the
teachings of Chow et al. and selected the appropriate particles in a narrow
particle size distribution.” (Ans. 11.) We are not persuaded by the
Examiner’s argument.
The Examiner has failed to address Appellants’ argument that a
median diameter particle size as disclosed in Chow is not a narrow particle
size distribution, as understood by one of ordinary skill in the art reasonably
interpreting the claims in light of the Specification (see App. Br. 11 (citing
Spec. 6:5-9)). The Examiner has provided no evidence to the contrary. The
Examiner has failed to find error with such language or failed to show that
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this terminology would not have been readily understood by one of ordinary
skill in the art; nor has the Examiner adequately explained why an ordinary
artisan would consider selecting a narrow particle size range as defined in
the Specification to be an obvious optimization of either reference.
As the Examiner has failed to provide evidence in the prior art of a
narrow particle size distribution of a dry reactant component, he has failed to
meet the obviousness requirement of a teaching or suggestion of all
limitations in a claim. CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003).
The obviousness rejection is reversed.

Double Patenting Rejections
PRINCIPLES OF LAW
The double patenting doctrine is designed to prevent a patent owner
from extending his exclusive rights to an invention through claims in a later-
filed patent that are not patentably distinct from claims in the earlier filed
patent. Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378
(Cir. 2003.) “Because nonstatutory double patenting compares earlier and
later claims, an earlier patent’s disclosure is not available to show
nonstatutory double patenting. See Gen. Foods Corp. v. Studiengesellschaft
Kohle mbH, 972 F.2d 1272, 1281-82 (Fed. Cir. 1992).
An affirmance should be designated a new ground of rejection if it
does not share the basic thrust of the examiner’s rejection. In re Kronig, 539
F.2d 1300, 1302-03 (CCPA 1976).

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ISSUE
The Examiner argues that
There is nothing in '833, '786 or '841 to exclude using 'a narrow
particle size distribution'. With respect to the setting values, it is
merely measuring the setting value of the composition which is an
intrinsic property. Therefore one of ordinary skill in the art would
have recognized the obvious variation of the instant application over
the copending application. These arguments are not persuasive as
stated by the Examiner above concerning 'result effective parameters'.
No unexpected results have been shown and synergy has not been
argued and therefore the routine optimization argument stands.

(Ans. 25.)
For each of the double patenting rejections, Appellants argue that the
cited patent claims do not disclose the limitation of a setting value of about
400 N or more in 6 minutes and narrow particle size distribution. (App. Br.
p. 23-26.)
FINDINGS OF FACT
Representative Claims

A. 7,252,833 Claim
1. A method of producing a flowable composition that sets
into a calcium phosphate containing product, said method
comprising combining:
(a) a water soluble silicate setting fluid;
(b) dry reactants comprising a calcium source and a phosphate source; and
(c) an osteoclastogenic agent which is a RANK ligand,
in a ratio of (a) to (b) sufficient to produce said flowable
20 composition that goes from a non-solid state to solid calcium
phosphate containing product after setting.

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B. 7,252,841 Claim
1. A method of producing a flowable composition that rapidly sets into a
solid strong calcium phosphate containing
product, said method comprising combining:
(a) a water soluble silicate setting fluid; and
(b) dry reactants comprising:
(i) calcium and a phosphate sources; and
(ii) a monovalent cation dihydrogen phosphate salt
which is NaH2P04 or NaH2P04 H20; in a ratio of (a)
to (b) sufficient to produce said flowable composition
that has a setting value of at least about 50 Newtons
in 3 minutes.

C. 7,306,786 Claim
1. A method of producing a flowable composition that sets into a calcium
phosphate mineral product, said method comprising:
(a) a setting fluid;
(b) dry reactants comprising a calcium source and a phosphate source;
and
(c) a water-soluble contrast agent comprising a radio-opaque
element other than calcium that is incorporated into said calcium phosphate
product wherein said water-soluble contrast agent comprises a salt of a
radio-opaque element;
to produce said flowable material that sets into a calcium phosphate
mineral product that includes atoms of said radio-opaque element
incorporated into said mineral product.

D. App. Ser. No. 11/134,051 (Sept. 2, 2011 Amended Claim)

27. A method of producing a calcium phosphate composition that sets
into a calcium phosphate mineral containing product, said method
comprising:
combining:
(a) a setting fluid;
(b) dry reactants comprising:
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(i) calcium and phosphate sources comprising a first particulate
calcium and/or phosphate reactant having a mean particle size of 8 µm or
less and narrow particle size distribution; and a second calcium and/or
phosphate reactant having a mean particle size that is 10 µm or greater;
and
(ii) a monovalent cation dihydrogen phosphate salt;
in a ratio of (a) to (b) sufficient to produce said calcium phosphate mineral
containing product that is resorbable over time when implanted into a
physiological site.

ANALYSIS
We reverse the obviousness-type double patenting rejections over the
indicated claims of U.S. patents 7,252,833; 7,252,841; and 7,306,786 in
view of Chow. For each of these rejections the Examiner has failed to show
a disclosure in any of the recited patents, or in Chow of a dry reactant
component having a narrow particle size distribution. The Examiner has
failed to provide evidence that such a feature would have been inherent in
the claimed methods of the recited patents or Chow. Therefore, these
obviousness-type double patenting rejections are reversed.
On the other hand, we affirm the provisional obviousness-type double
patenting rejection over claims 1-5, 11, 12, 19, 22, 23, 33, 45 and 46 over
pending claims 27, 29-31, 33, 36-42 and 47-52 (Sept. 2, 2011 amended
claims) of App. Ser. No. 11/134,051 in view of Chow.
2
Both the pending
claims in the present application and those of App. Ser. No. 11/134,051 both
recite:

2
The claims of App. Ser. No. 11/134,051 have been amended since the
Examiner’s Answer. We designate the provisional rejection in view of App.
Ser. No. 11/134,051 as a new ground of rejection for this reason.
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A method of producing a flowable composition that sets into a
calcium phosphate containing product, said method comprising:
combining:
(a) a setting fluid; and
(b) a dry reactant component comprising a first particulate calcium
and/or phosphate reactant having a mean particle size of about 8 µm or less
and narrow particle size distribution with a ratio of (a) to (b). The claimed
setting value would be inherent in such a flowable composition made from a
narrow particle size distribution as claimed.
Because the Appellant has amended the claims of the provisional
rejection and they do not correspond to the original claim numbering set
forth in the Answer, we designate this rejection a new ground of rejection.

CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejection and the obviousness rejection is reversed. The obviousness-type
double patenting rejections over U.S. patent Nos. 7,252,833; 7,252,841; and
7,306,786 in view of Chow are reversed. The provisional double patenting
rejection is affirmed and designated a new ground of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of
rejection . . . shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that 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:
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(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
proceeding will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .

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

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