Ex Parte Beyar et al

Patent Trial and Appeal Board

Apr 4, 2017

11461072 (P.T.A.B. Apr. 4, 2017)

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.
11/461,072 07/31/2006 Mordechay Beyar 101896-911(DEP6101USCIP4) 3078
21125 7590 04/06/2017
NUTTER MCCLENNEN & FISH LLP
SEAPORT WEST
155 SEAPORT BOULEVARD
BOSTON, MA 02210-2604
EXAMINER
HELM, CARALYNNE E
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
04/06/2017 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):
docket @ nutter.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MORDECHAY BEYAR and OREN GLOBERMAN
Appeal 2014-008171
Application 11/461,072
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a bone
cement comprising an acrylic polymer mixture. The Examiner rejected the
claims as indefinite, as failing to further limit, as anticipated, and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“In general, polymeric cements become more viscous as the polymer
chain grows by reacting directly with the double bond of a monomer” (Spec.
2:12—13). “Examples of commercially available viscous bone cements
include, but are not limited to . . . Simplex™ -P and -RO . . . These cements
1 Appellants identify the Real Party in Interest as DePuy Synthes Products,
LLC (see App. Br. 2).
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Application 11/461,072
are characterized by a liquid phase after mixing and prior to achieving a
viscosity of 500 Pascal-second” (Spec. 2:25—28).
The Claims
Claims 1, 5—11, 18—24, 26, and 29-33 are on appeal. Claim 1 is
representative and reads as follows:
1. A bone cement comprising an acrylic polymer mixture,
the cement characterized in that it achieves a viscosity of at
least 500 Pascal-second within 180 seconds following initiation
of mixing of a monomer component and a polymerizable
polymer component and characterized by sufficient
biocompatibility to permit in-vivo use, the polymer component
comprising: (i) a main sub-population of polymethyl
methacrylate beads characterized by a molecular weight in a
range between about 150,000 Dalton and about 500,000 Dalton,
and (ii) a high molecular weight sub-population of polymethyl
methacrylate beads characterized by a molecular weight in a
range between about 600,000 Dalton to about 5,000,000
Dalton.
The issues
A. The Examiner rejected claims 1, 5—11, 18—24, 26, and 29-33 under 35
U.S.C. § 112, second paragraph, as indefinite (Ans. 2—3).
B. The Examiner rejected claim 7 under 35 U.S.C. § 112, fourth
paragraph, as failing to further limit claim 1 (Ans. 3).
C. The Examiner rejected claims 1,5,7, 10, 18—23, 32, and 33 under 35
U.S.C. § 102(b) as anticipated by Arroyo2 as evidenced by Krause3 and
Farrar4 (Ans. 4—6).
2 Arroyo, US 4,837,279, issued June 6, 1989 (“Arroyo”).
3 Krause et al., The viscosity of acrylic bone cements, 16 J. Biomedical
Materials Res. 219-243 (1982) (“Krause”).
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D. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as obvious
over Arroyo, Krause, and Farrar (Ans. 6—7).
E. The Examiner rejected claims 1, 7—9, 11, 24, and 29-31 under 35
U.S.C. § 103(a) as obvious over Farrar, Arroyo, Lu,4 5 and Krause (Ans. 7—
11).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds:
Each of the claims include the recitation of various
viscosity values for the recited bone cement composition.
Given the nature of the bone cement, its viscosity is not a static
parameter. The viscosity of the bone cement is dependent upon
a number of parameters including the temperature, the shear
rate employed for measurement and even the technique
employed for mixing the components (e.g. hand mixing vs.
vacuum mixing). As a result, a single composition can be
assessed to have different viscosity values with one inside and
another outside the claim limitations. As a result the
description of the claimed composition based upon its viscosity
in the absence of defined values for the parameters that
influence this measurement is indefinite.
(Ans. 3).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the claims are indefinite?
4 Farrar et al., Rheological properties of PMMA bone cements during curing,
22 Biomaterials 3005—3013 (2001) (“Farrar”).
5 Lu, Orthopedic Bone Cements, Biomechanics and Biomaterials in
Orthopedics, 86-88 (2004) (“Lu”).
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Findings of Fact
1. The Specification teaches that:
mixture of polymer and monomer produces a high viscosity
mixture with substantially no intervening liquid phase within
180, optionally within 120, optionally within 100, optionally
within 60, optionally within 30, optionally within 15 seconds or
greater or intermediate times from onset of mixing. . . .
These desired reaction kinetics can be achieved by
adjusting one or more of average polymer MW, polymer MW
distribution, polymer to monomer ratio and polymer bead size
and/or size distribution.
(Spec. 19:25 to 20:3).
2. The Specification teaches in a first “test (Average temperature:
22.3°C; Relative Humidity: app. 48%) the cement was mixed for 30-60
seconds, then manipulated by hand and placed inside the injector” (Spec.
14:18—19) and in a second test “(Average 21.1°C; Relative Humidity: app.
43%) the cement was mixed for approximately 45 seconds, then manipulated
by hand and placed inside the injector” (Spec. 15:1—2).
3. The Specification discloses: “Differences between the two
experiments may reflect the influence of temperature and humidity on
reaction kinetics” (Spec. 15:24—25).
4. Krause teaches
Seven types of acrylic bone cements were characterized
for their rheological behavior and are listed in Table I. For all
cements, the ratio of monomer to powder was kept to the
manufacturer’s specifications, 20 cm3 of liquid monomer to 40
g of polymer powder (a monomer to powder ratio of 0.5 cm3/
g). For all test procedures, a stopwatch was started
immediately when the monomer was added to the powder. The
cement was mixed at a constant rate of approximately 60 beats
per minute for the first minute to ensure complete saturation of
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Application 11/461,072
the powder with the monomer. The cement was then allowed
to remain in the mixing bowl for another 30 s after which time
the cement was placed in the appropriate rheometer, at 2 min
after mixing.
The Surgical Simplex P-RO, Zimmer LVC, and Zimmer
Bone Cement were characterized using both the rotational and
capillary extrusion rheometers according to the test parameters
given in Table II.
(Krause 227).
5. Figure 10 of Krause is reproduced, in part, below:
1 SUR&CAt -SfMlM;* Ift©
“Figure 10. Log false apparent viscosity: elapsed time from mixing” (Krause
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6. Figure 3, panel B of Farrar is reproduced below:
“Fig. 3. Dynamic Viscosity-time profiles over a range of temperatures: . . .
(b) Simplex P” (Farrar 3010).
Principles of Law
“[I]f a claim is amenable to two or more plausible claim constructions,
the USPTO is justified in requiring the applicant to more precisely define the
metes and bounds of the claimed invention by holding the claim
unpatentable under 35 U.S.C. § 112, second paragraph.” Ex Parte Miyazaki
89 USPQ2d 1207, 1211-12 (BPAI 2008).
Analysis
Appellants contend a “person of ordinary skill in the art, especially
having the Krause paper which is incorporated by reference for this purpose,
would be able to calculate the viscosity in Pascal* seconds (which
corresponds to Newton*seconds/meter squared) from the many
measurements and dimensions provided in the specification” (App. Br. 19).
Appellants contend “there is no need for Appellants to include each and
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every measuring condition in the claim because a person of ordinary skill in
the art will interpret the claims in view of the specification” {id. at 20).
Appellants contend:
The present application describes the particular methodology
used to characterize the cement's viscosity over time, including
mixing time, rheometer dimensions, temperature, and humidity,
See. e.g., present published application at paragraphs [0110]-
[0126]. A person of ordinary skill in the art could use this
information to determine the viscosity of cement at these
measuring conditions and within the claimed time period
following initiation/onset of mixing.
{id.).
The Examiner responds “[a]s discussed in detail by Krause et al. and
Farrar et al., the exact same composition of bone cement when measured at
different temperatures and at different shear rates displays a different
viscosity. Even the mixing methodology influences the viscosity” (Ans. 12).
The Examiner concludes “the claimed viscosity is a subjective parameter
since a single composition of bone cement in accordance with the
components as detailed in the claims can display a myriad of different
viscosities at a given time. This collection of viscosities can be both inside
and outside the claimed ranges” {id.).
We find the Examiner has the more persuasive position because the
requirement that the cement “achieves a viscosity of at least 500 Pascal-
second within 180 seconds following initiation” does not inform the skilled
artisan as to whether any particular formulation necessarily falls inside or
outside the scope of claim 1.
The Specification, while teaching the optimization of the reaction
conditions (FF 1) and teaching a process for obtaining viscosity information
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(FF 2), expressly recognizes that “[differences between the two experiments
may reflect the influence of temperature and humidity on reaction kinetics”
(FF 3). That is, the Specification recognizes that a viscosity measurement
made on the same sample, at slightly different conditions, may result in
different reaction kinetics (see FF 3).
This variability in viscosity based on reaction conditions is consistent
with Krause, who teaches that even when identical materials are used,
differences in the shear rate result in different viscosities at 180 seconds for
a particular bone cement, surgical simplex RO (FF 5). In Figure 10, Krause
shows that at shear rates of 0.4 and 1.0 sec'1, surgical simplex RO appears to
satisfy the requirements of claim 1 for a viscosity exceeding 500 pascal-
seconds within 180 seconds of initiation, while at shear rates of 10.0 and
97.4 sec'1, the same exact bone cement, surgical simplex RO, does not
satisfy the claim requirements (see FF 5).
Similarly, Farrar demonstrates the temperature dependence of
viscosity for the prior art bone cement, Simplex P (FF 6). Farrar
demonstrates that as the temperature increases from 19 to 25 °C, the
viscosity increases to almost attain 500 pascal-seconds within 180 seconds
of initiation (see FF 6). While Farrar does not test further increases in
temperature, following the ordinary rule of thumb that reaction rates double
as temperatures increase 10 degrees suggests that increases above the 25 °C
tested by Farrar would result in viscosities for Simplex P that satisfy the
requirements of claim 1. Farrar’s evidence therefore also supports the
Examiner’s position that “the claimed viscosity is a subjective parameter
since a single composition of bone cement in accordance with the
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components as detailed in the claims can display a myriad of different
viscosities” (Ans. 12).
Appellants, in addressing the prior art, contend that “Krause tested at
these low levels of shear rate (which would not be used in the practice of
injecting cement) for the purpose of investigating the effect of shear rate on
the cement” (App. Br. 11). However, neither the Specification nor the
claim specify the shear rate used for the bone cement tests, nor does the
claim exclude “low” levels of shear rate as in Krause. Consequently, the
evidence of record does not support Appellants’ contention that a “person of
ordinary skill in the art could use this information to determine the viscosity
of cement” (App. Br. 20). Instead, the evidence on this record suggests that
the ordinary artisan given the limited information required by claim 1, would
find some bone cement compositions that fall both within and outside the
scope of claim 1 depending upon the conditions selected and be unable to
determine whether the bone cements were within the scope of the claim.
Appellants also contend that “it cannot be said that a further increase
in temperature above 25° C (77° F) would necessarily result in cement that
achieves at least 500 Pa-s within 180 seconds from initiation of mixing”
(App. Br. 10). Appellants argument, however, fails to recognize or account
for the trend line established by Farrar, which supports the Examiner’s
indefmiteness position that the temperature of testing for any particular bone
cement composition may determine whether the bone cement falls inside or
outside the 500 Pascal-second within 180 second requirement of claim 1 (see
FF 6).
Appellants contend that “[ujnder the Examiner’s reasoning,
Appellants’ claim must recite a seemingly endless number of experimental
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parameters. In accordance with E.I du Pont de Nemours & Co. v. Phillips
Petroleum Co., the claimed viscosity ranges should not be interpreted in
isolation, but in view of the parameters set forth in the specification” (Reply
Br. 4). More recently, the Federal Circuit stated
neither the claim language nor the specification indicates a
temperature for the final viscosity measurement. But room
temperature is the only temperature mentioned at all in the ’956
patent in connection with a viscosity measurement. . . .
Accordingly, we affirm the court’s conclusion that the
expression “viscosity below 10 Pa.s” does not render claims 1—
8 indefinite.
Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811 F.3d 1334, 1344 (Fed.
Cir. 2016).
We are not persuaded these decisions demonstrate error in the
Examiner’s determination of indefmiteness here with respect to claims still
undergoing prosecution and entitled to no presumption of validity. Instead,
under these circumstances, “the patent drafter is in the best position to
resolve the ambiguity in the patent claims, [and] it is highly desirable that
patent examiners demand that applicants do so in appropriate circumstances
so that the patent can be amended during prosecution rather than attempting
to resolve the ambiguity in litigation.” Halliburton Energy Servs., Inc. v. M—
ILLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008).
Consistent with the goal of claim clarity, “it is a reasonable
implementation of the examination responsibility, as applied to § 112(b), for
the USPTO, upon providing the applicant a well-grounded identification of
clarity problems, to demand persuasive responses.” In re Packard, 751 F.3d
1307, 1313 (Fed. Cir. 2014).
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Balancing the evidence of the Specification, Krause, and Farrar,
Appellants have not provided a persuasive response to the Examiner’s
reasoning regarding indefiniteness of the phrase “a viscosity of at least 500
Pascal-second within 180 seconds” in the claims. In particular, this
functional recitation does not provide definite limits that allow the ordinary
artisan to identify whether bone cements with the same methyl methacrylate
components as those recited in Arroyo (see Arroyo col. 4,1. 58, Example 1)
fall within the scope of the claims or not. Indeed, the evidence suggests that
depending on, for example, the shear, temperature, and polymer composition
conditions, a particular bone cement may fall both inside and outside the
scope of the claim (see FF 5—6).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
claims are indefinite.
B. 35 U.S.C. § 112, fourth paragraph
The Examiner finds, regarding claim 7, that “the claim fails to add
further limitations since its parent claim already recites that the polymer
component is polymethylmethacrylate that has at least two populations
which inherently are characterized by their own average molecular weights”
(Ans. 3).
Appellants contend “Claim 7 is necessarily different from and
narrower than independent claim 1 because it specifies that the claimed
molecular weight ranges refer to the average molecular weight of each
respective sub-population of PMMA beads” (App. Br. 22).
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We find the Examiner has the better position. The only distinction
between claim 7 and claim 1 is that claim 7 recites that “each sub-population
characterized by an average molecular weight.” However, as the Examiner
points out, the main and high molecular weight sub-populations recited in
claim 1 inherently have an average molecular weight, whether determined or
not and whether recited or not. Appellants’ argument that claim 7 limits
claim 1 by specifying that the ranges refer to “average molecular weight” is
not supported by the language of claim 7, which does not refer to the range
element of claim 1 at all. Moreover, Appellants do not explain how this
would impart any structural or functional difference to the sub-populations
of claim 7 relative to those of claim 1. That is, even if the term “average”
applied to the “range” recited in claim 1, Appellants do not explain how that
limits the sub-population of claim 1.
C.-E. 35 U.S.C. § 102(b) and 103(a)
Because we affirm the rejection of claims 1, 5—11, 18—24, 26, and 29-
33 as indefinite, we reverse, pro forma, the Examiner’s prior art rejections
because the claims are not sufficiently definite to allow determination of
whether Arroyo’s disclosed or obvious compositions anticipate or render
obvious the claims.
In particular, Arroyo teaches two particular bone cement compositions
(see Arroyo 4:57 to 5:10) that the Examiner might ordinarily find anticipate
under the burden shifting rationale of In re Best, 562 F.2d 1252, 1254—55
(CCPA 1977). However, in light of the indefmiteness of the claims, it is not
clear what conditions would be used “to require the applicant to prove that
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the subject matter shown to be in the prior art does not possess the
characteristic relied on.” Best, 562 F.2d at 1255.
Therefore, we reverse these rejections consistent with Steele because
“substantial confusion exists in the record at all levels of the prosecution as
to the proper interpretation to be given to the appealed claims. We believe
that this confusion arose and has continued because the claims do not
particularly point out and distinctly claim the invention as required by 35
U.S.C. § 112.” In re Steele, 305 F.2d 859, 863 (CCPA 1962). “Our
decision is not to be construed as meaning that we consider the claims on
appeal to be patentable as presently drawn.” Id.
SUMMARY
In summary, we affirm the rejection of claims 1, 5—11, 18—24, 26, and
29-33 under 35 U.S.C. § 112, second paragraph, as indefinite.
We affirm the rejection of claim 7 under 35 U.S.C. § 112, fourth
paragraph, as failing to further limit claim 1.
We reverse the rejection of claims 1, 5, 7, 10, 18—23, 32, and 33 under
35 U.S.C. § 102(b) as anticipated by Arroyo as evidenced by Krause and
Farrar.
We reverse the rejection of claim 11 under 35 U.S.C. § 103(a) as
obvious over Arroyo, Krause, and Farrar.
We reverse the rejection of claims 1, 7—9, 11, 24, and 29-31 under 35
U.S.C. § 103(a) as obvious over Farrar, Arroyo, Lu, and Krause.
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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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