Ex Parte Buck et al

Patent Trial and Appeal Board

Nov 15, 2018

12453821 (P.T.A.B. Nov. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/453,821 05/22/2009 Reinhold Buck
23643 7590 11/19/2018
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
UNITED ST A TES OF AMERICA
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.
52759-222336 4134
EXAMINER
KEYWORTH, PETER
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
11/19/2018 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REINHOLD BUCK, JENNY DEIBERT,
and ARND WOCHNER
Appeal 2018-001 719
Application 12/453,821 1
Technology Center 1700
Before KAREN M. HASTINGS, JAMES C. HOUSEL, and
JEFFREY R. SNAY, Administrative Patent Judges.
HASTINGS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's decision rejecting claims 1-7 and 10-142 under 35 U.S.C.
§ 103(a) over Buck (US 2006/0144782 Al, published July 6, 2006)
("Buck") in view of Krause et al. (WO 2006/106133 Al, published Oct. 12,
2006) ("Krause").
We have jurisdiction over the appeal under 35 U.S.C. § 6(b). 3
1 Appellants identify the real party in interest as Gambro Lundia AB (Appeal
Br. 2).
2 Claims 8 and 9 have been withdrawn from consideration. Final Act. Office
Action Summary.
3 We refer to the Specification, filed May 22, 2009 ("Spec."); the Appeal
Brief, filed May 22, 2017 ("Appeal Br."); the Examiner's Answer, mailed
Oct. 12, 2017 ("Ans."), and the Reply Brief filed Dec. 7, 2017 ("Reply Br.").
Appeal 2018-001719
Application 12/453,821
We AFFIRM.
Independent claim 1 below is illustrative of the subject matter on
appeal ( emphasis added):
1. A semipermeable asymmetric hollow fiber membrane
comprising a polyethersulfone and a polyvinylpyrrolidone
(PVP), said polyvinylpyrrolidone having a low molecular
weight component having a molecular weight of below 100 kD,
and a high molecular weight component having a molecular
weight of 100 kD or more, wherein the membrane has a sieving
coefficient for myoglobin in aqueous solution of between 86%
and 90% and a sieving coefficient for albumin in aqueous
solution of 9% or less.
Appeal Br. 22 (Claims Appendix).
ANALYSIS
Appellants group the claims as follows: claims 1, 4, 5, 7, and 10-13;
claims 2 and 14; claims 3 and 14; and claim 6 (Appeal Br. 3). We address
these groups below.
Claims 1, 4, 5, 7, and 10-13
Appellants' principle argument on appeal is the combination of Buck
and Krause does not disclose or suggest a membrane having the sieving
coefficients recited in claim 1 for myoglobin and albumin in an aqueous
solution (Appeal Br. 3-9; Reply Br. 2-3). Specifically, Appellants assert
Buck discloses sieving coefficients for substances in whole blood, not in
aqueous solution, and measurements in whole blood provide different results
than those for aqueous solutions, as indicated by Figure 3b of Buck (Appeal
Br. 4--8).
Appellants' arguments are unpersuasive. First, the broadest
reasonable interpretation of "aqueous solution" in view of Appellants'
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Application 12/453,821
Specification does not exclude blood. Specifically, the Examiner determines
that blood contains water and other components and "[ t ]hus, blood could be
an aqueous solution in the broadest reasonable interpretation of the term"
(Ans. 4). In response, Appellants assert the Examiner's interpretation is
mistaken because the Specification states sieving coefficients are measured
in aqueous solutions, particularly phosphate buffered saline (PBS) (Reply
Br. 3---6).
"[T]he PTO must give claims their broadest reasonable construction
consistent with the specification. . . . Therefore, we look to the specification
to see if it provides a definition for claim terms, but otherwise apply a broad
interpretation" (In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379
(Fed. Cir. 2007)). "[A]s applicants may amend claims to narrow their scope,
a broad construction during prosecution creates no unfairness to the
applicant or patentee" (id.). Furthermore, an applicant "may demonstrate an
intent to deviate from the ordinary and accustomed meaning of a claim term
by including in the specification expressions of manifest exclusion or
restriction, representing a clear disavowal of claim scope" (In re Am. Acad.
of Sci. Tech. Ctr., 367 F.3d 1359, 1365 (Fed. Cir. 2004)).
Here, Appellants cite to passages in the Specification discussing the
use of PBS as an aqueous solution. However, Appellants do not direct us to
any passages that demonstrate an intent to limit aqueous solutions to PBS or
to exclude blood from aqueous solutions. Nor do Appellants dispute that
blood contains water, as stated by the Examiner (Ans. 5). Therefore, we
agree with the Examiner that the broadest reasonable interpretation of
"aqueous solution" encompasses blood, such as whole blood.
We therefore tum to whether Buck's membrane would possess the
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Appeal 2018-001719
Application 12/453,821
sieving coefficients of claim 1 in which blood is an aqueous solution. To
address this, we provide an annotated copy of Buck's Figure 3b:
Sieving CMffici.;;mts of High Cut Off Mllmbran&
100asured io who!e blood and buffsr (water) • solutlon
-----------·------·--------------- -----..,.......--- -----------------·····-·---,
I
r:.:.:.:.:.:: whole t,;,:,od I I
--------- ·····------------ ---- -~-==-~-t-~:.~,·. ___________ /
:
D,3
0.2
0 ,, ..
MW {Dalton}
8(;i}()G Pig. 3h
Annotated copy of Buck's Figure 3b
Appellants disclose that the molecular weight (MW) for myoglobin is
17,053 Dalton and the molecular weight for albumin is 66,248 Dalton (Spec.
6:2-4). In the copy above, Buck's Figure 3b has been annotated to label the
marks for 60,000 Da, 70,000 Da, 80,000 Da, and 90,000 Da (due to their low
visibility) and to show the approximate locations for myoglobin and albumin
on the horizontal axis, which represents molecular weight (MW). 4 The
4 Appellants provide an annotated copy of Buck's Fig. 3b at page 7 of the
Appeal Brief. We decline to use that copy because the location for
albumin's molecular weight does not appear to be correctly labeled.
Specifically, Appellants appear to have labeled the molecular weight for
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Appeal 2018-001719
Application 12/453,821
vertical axis indicates the sieving coefficient (S) in decimal form rather than
a percentage for a substance of a particular molecular weight. As shown
above, myoglobin would have a sieving coefficient of 1 (i.e., 100%) in
whole blood ( the curve in the left hand part of Figure 3b) and albumin would
have a sieving coefficient of less than 0.09 (i.e., 9%). Therefore, although
Buck does not explicitly disclose a sieving coefficient for myoglobin, Figure
3b suggests Buck's membrane would possess the claimed sieving
coefficients for myoglobin and albumin in whole blood ( e.g., an "aqueous
solution" under its broadest reasonable interpretation).
Second, regardless of whether "aqueous solution" encompasses blood,
the Examiner explains why it would have been obvious to optimize the pore
structure of Buck's membrane and result in a membrane having the sieving
coefficients of claim 1. "[D]iscovery of an optimum value of a result
effective variable in a known process is ordinarily within the skill of the art."
In re Boesch, 617 F.2d 272,276 (CCPA 1980).
In particular, the Examiner finds pore size is a result-effective variable
affecting sieving coefficients, citing the results presented in paragraph 7 4 of
Buck (Final Act. 3--4). We agree that the table included in paragraph 74 of
Buck demonstrates that changes in a membrane's pore size affect the sieving
coefficient for a substance. For example, when the pore size of a membrane
is greatly increased from 10-15 nm and 20--40 nm to greater than 100 nm,
the sieving coefficient for albumin (having a relatively high MW of 66,248
Da) greatly increases from 0.002 and 0.011 to 0.146 (Buck ,r 74).
Conversely, when pore size is decreased to 10-15 nm, the sieving
albumin at or near the mark for 60,000 Dalton instead of the approximate
location for 66,248 Dalton.
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Appeal 2018-001719
Application 12/453,821
coefficients for B-2-microglobulin and interleukin6 (which have relatively
low MWs of 11,800 Da and 26,000 Da, respectively) decrease (id.).
Moreover, Buck teaches that a proper pore structure optimizes various types
of permeability and "sieving properties" (id. ,r 60).
As a result, it would have been obvious to modify Buck's membrane
by determining workable or optimal pore sizes to achieve optimal sieving
properties and permeability as a matter of routine experimentation and
design within the level of the ordinary skill, thus arriving at an arrangement
or configuration within the scope of claim 1. As noted by the Examiner
(Ans. 3), such an arrangement provides a structure encompassed by claim 1
and thus would inherently possess the claimed sieving coefficients.
Appellants do not direct us to any evidence or persuasive technical reasoning
that Buck's membrane, as modified in view of its teachings regarding the
effect of pore size upon sieving properties, would not possess the claimed
sieving coefficients.
In addition, Appellants contend there would have been no motivation
to modify Buck to include the PVP mixture disclosed by Krause because the
claimed membrane does not require additional components disclosed by
Buck and Krause, which would have indicated the proposed modification
was not as simple or predictable as the Examiner would think and one of
ordinary skill would have had to consider (Appeal Br. 9-11). Appellants
further argue the Examiner has improperly used the benefit of hindsight in
making the rejection over Buck and Krause (id. 11-13).
These arguments are also unpersuasive. The Examiner finds Krause
discloses a membrane including polyethersulfone and PVP having a low
molecular weight component of less than 100 kD and a high molecular
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Application 12/453,821
weight component of 100 kD or more (Final Act. 4 ). The Examiner
concludes it would have been obvious to modify Buck's membrane in view
of Krause's teachings because Krause discloses that two component PVP
mixtures provide the possibility to tune the hydrophobic/hydrophilic
properties of a membrane in a very fine manner and within a wide range
(id.).
Krause's disclosure at page 4, lines 12-21, and page 6, lines 20-24,
supports the Examiner's findings and conclusion. As a result, the Examiner
has articulated a rationale with rational underpinnings in the applied
references why it would have been obvious to modify Buck in view of
Krause. Appellants' arguments regarding additional factors one of ordinary
skill in the art would have needed to consider and the possible
unpredictability associated therewith are merely that; arguments without
evidence or persuasive technical reasoning explaining why the combination
would have been too unpredictable or why one of ordinary skill in the art
would have lacked a reason to combine or a reasonable expectation of
success. For the latter we note that"[ o ]bviousness does not require absolute
predictability of success .... all that is required is a reasonable expectation
of success" (In re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)).
Furthermore, to the extent the combination of Buck and Krause would
include components not recited in claim 1, the latter uses "comprising"
language, which permits the inclusion of additional elements.
In view of the above, Appellants' arguments do not identify a
reversible error in the Examiner's rejection of claim 1. Appellants do not
argue claims 4, 5, 7, and 10-13 separately from claim 1 (Appeal Br. 3-13).
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Application 12/453,821
Claims 2, 3, 6, and 14
As noted above, Appellants argue claims 2 and 14, claims 3 and 14,
and claim 6 as separate groups. We address these groups together for
purposes of efficiency.
For claims 2, 3, 6, and 14, Appellants reiterate Buck and Krause do
not disclose the sieving coefficients recited in claim 1 and further argue the
Examiner has not shown where the combination of Buck and Krause does
not disclose the recitations of claims 2, 3, 6, and 14, the applied references
do not provide a motivation to provide the recitations of those claims, and
the Examiner has relied upon impermissible hindsight (id. 13-20).
In order to overcome the Examiner's rejection, Appellants must
identify with sufficient particularity what the Examiner did wrong, i.e.,
identify a reversible error in the Examiner's rejection. In re Jung, 637 F.3d
1356, 1365---66 (Fed. Cir. 2011); ExparteFrye, 94 USPQ2d 1072 (BPAI
2010). Here, the Examiner has set forth findings and conclusions to support
a prima facie case of obviousness (Final Act. 4--7). Appellants' arguments,
which are general in nature and lacking in any degree of specificity by
merely alleging claim recitations are missing in the applied references and
asserting the Examiner has not set forth a proper rationale, do not identify a
reversible error in the Examiner's rejections of claims 2, 3, 6, and 14.
For the reasons discussed above and those set forth in the Examiner's
Answer, we sustain the Examiner's§ 103(a) rejection of claims 1-7 and 10-
14.
DECISION
The Examiner's rejection of claims 1-7 and 10-14 is affirmed.
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Application 12/453,821
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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