Ex Parte Moya et al

Board of Patent Appeals and Interferences

Aug 31, 2012

11542834 (B.P.A.I. Aug. 31, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/542,834 10/04/2006 Wilson Moya MCA-746 US 6480
25182 7590 09/04/2012
EMD Millipore Corporation
290 CONCORD ROAD
BILLERICA, MA 01821
EXAMINER
MENON, KRISHNAN S
ART UNIT PAPER NUMBER
1777
MAIL DATE DELIVERY MODE
09/04/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________

Ex parte WILSON MOYA and MIKHAIL KOZLOV
________________

Appeal 2011-008238
Application 11/542,834
Technology Center 1700
________________

Before JEFFREY T. SMITH, LINDA M. GAUDETTE, and
DONNA M. PRAISS, Administrative Patent Judges.

PRAISS, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1, 3-9 and 33-36. We have jurisdiction under 35 U.S.C. § 6.
Appellants’ claimed invention relates to ultrafiltration membranes
having a modified hydrophilic surface for use to remove viruses from a
biomolecular solution and their method of making. Spec. 1. Claim 1 is
illustrative:
1. A virus retentive ultrafiltration membrane having a surface and an
initial log retention value (LRV) of at least 4.0 for PhiX174,
wherein the membrane is made using the following process:
(i) adsorbing a hydroxyalkyl cellulose onto the membrane surface,
thereby to render the surface hydrophilic;
(ii) treating the hydrophilic surface to a step selected from the
group consisting of (a) autoclaving in the presence of steam or
water; and (b) submerging in boiling water; and
(iii) comparing the flux of the membrane before and after step (ii),
such that the ultrafiltration membrane comprises an increase in
flux after the treatment compared to before the treatment.

The Examiner relied on the following references in rejecting the
appealed subject matter:
Wrasidlo US 4,413,074 Nov. 1, 1983
Henis US 5,139,881 Aug. 18, 1992
Wang US 6,579,342 B2 June 17, 2003
Kidd US 6,770,202 B1 Aug. 3, 2004

The Examiner maintains, and Appellants appeal, the rejection of
claims 1, 3, and 33-36 under 35 U.S.C. § 102 and, alternatively, § 103(a) as
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anticipated and/or unpatentable over Henis or Wrasidlo. The Examiner also
maintains, and Appellants appeal, the rejection of claims 1, 3-9, 11, and 33-
36 under 35 U.S.C. § 112, second paragraph, as indefinite and under
35 U.S.C. § 103(a) as unpatentable over Henis or Wrasidlo in further view
of Wang and Kidd.1

OPINION2
The dispositive issues for the rejections on appeal are:
Did the Examiner err in determining that “an increase in flux” recited
in claim 1 is indefinite?
Did the Examiner err in determining that Henis and Wrasidlo
individually disclose a hydrophilic ultrafiltration membrane as described by
the subject matter of claim 1?
Did the Examiner err in determining that the combination of Henis or
Wrasidlo with further evidence from Wang and Kidd would have suggested
to a person of ordinary skill in the art a single or multi-layered ultrafiltration
membrane as described by the subject matter of independent claim 1?
After review of the arguments and evidence presented by both
Appellants and the Examiner, we affirm- the prior art rejections and reverse
the §112, 2nd paragraph rejection.

1 The rejection of claims 33-36 for double patenting over claim 1 or 3 stands
withdrawn by the Examiner and, therefore, is no longer an issue in this
appeal. Ans. 4.
2 Appellants have not presented separate substantive arguments addressing
claims 1, 3-9, 11, 33-36. In accordance with 37 C.F.R. § 41.37(c)(1)(vii),
we select claim 1 as representative for deciding the issue on appeal.
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35 U.S.C. § 112, Second Paragraph Rejection
The Examiner found that “an increase in flux” is indefinite claim
language because “[t]he end user will not be able to determine if the
membrane had undergone such a process step from a flux measurement
alone, and would not be able to make such a determination by making a flux
measurement after conducting a steam or hot water treatment either . . . .”
Ans. 5. We understand the Examiner’s argument to be that one cannot
determine whether a membrane has been subjected to the claimed process
steps of a steam or hot water treatment by testing a membrane before and
after subjecting it to a steam or hot water treatment.
Appellants contend that “one of ordinary skill in the art would
necessarily need to measure the flux of membrane before and after the
claimed treatment in order to discern whether or not such a membrane falls
within the scope of the instant claims, as recited in the claims.” App. Br. 8
(emphasis omitted). Appellants also assert that the Declaration evidence
submitted “provides a simple wettability test, known in the art, that may be
used to distinguish between the claimed membranes and those that do not
fall within the scope of the instant claims (e.g., the membranes described in
Wrasidlo).” Id.
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). We agree with
Appellants that one skilled in the art would understand from the claim and
the specification that the claimed increase in flux is determined by a
comparison of the flux of the membrane before and after treating it by
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“autoclaving in the presence of steam or water” or “submerging in boiling
water” as recited in claim 1, step (ii).
For the above reasons, we reverse the Examiner’s rejection of claims
1, 3-9, 11, and 33-36 under 35 U.S.C. § 112, second paragraph, as indefinite.

Prior Art Rejections
The appealed claims are drafted in product-by-process format. It is
well settled that if the product in a product-by-process claim is the same as
or obvious from a product of the prior art, the claim is unpatentable even
though the prior art product was made by a different process. In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche
Ltd., 580 F.3d 1340, 1366 (Fed. Cir. 2009) (“It has long been the case that an
old product is not patentable even if it is made by a new process.”) The
initial burden is upon the Examiner to establish that the claimed product is
essentially the same or an obvious variant over the prior art product. One
way of fulfilling this burden is to demonstrate a close correspondence
between the recited process and the process of the prior art. Then the burden
shifts to the applicant to show a patentable distinction between the claimed
and prior art products.
The claimed characteristics of the ultrafiltration membrane which
must be shown by the Examiner to be the same or obvious from prior art
membranes are (1) an initial log retention value (LRV) of at least 4.0 for
PhiX174, and (2) a hydrophilic surface.

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35 U.S.C. §§ 102 and 103 Rejections over Henis
The Examiner found that Henis teaches “the same type of membrane
with the same treatment – polysulfone ultrafiltration membrane with
hydroxyalkyl cellulose treatment to make the membrane hydrophilic.” Ans.
6. The Examiner further found, and Appellants do not contend otherwise,
that “[t]he retention of PhiX174 to LRV of at least 4 would be an inherent
property of the [Henis] membrane . . . .” Id.
Appellants’ arguments in rebuttal to the rejection are directed to the
process limitations. Appellants contend that “Henis simply discusses drying
the membrane at 70°-80° C in an oven or at room temperature, which entails
dry heat (i.e., not in the presence of water or steam).” App. Br. 9 (emphasis
omitted). Appellants further contend that “Henis also does not teach or
suggest the claimed limitation of comparing the flux of membrane before
and after the treatment recited in the instant claims or membranes having an
increased flux.” Id. (emphasis omitted).
Appellants have not directed us to any evidence to rebut the
Examiner’s position that the membrane of Henis has the same structure as
the claimed ultrafiltration membrane.3 Appellants have not established that
the ultrafiltration membrane of Henis does not have a hydrophilic coating or
LVR as required by the claimed invention. Appellants’ attorney argument is
insufficient and unpersuasive because it distinguishes Henis based on the
claimed process steps. (App. Br. 9-10). Consequently, Appellants have not
particularly shown error in the Examiner’s rejection over Henis. See 37
C.F.R. § 41.37(c)(1)(vii)(noting that an argument that merely points out

3 Appellants submitted the declarations of Wilson Moya and Mikhail Kozlov
in support of this appeal, but do not rely on that declaration evidence to
distinguish Henis. See, generally, App. Br.; Reply Br.
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what a claim recites is unpersuasive.) Accord In re Lovin, 652 F.3d 1349,
1357 (Fed. Cir. 2011)(“[T]he Board reasonably interpreted Rule 41.37 to
require more substantive arguments in an appeal brief than a mere recitation
of the claim elements and a naked assertion that the corresponding elements
were not found in the prior art.”).
Because anticipation is the epitome of obviousness, we also sustain
the Examiner’s rejection as obvious in view of Henis. See In re Baxter
Travenol Labs., 952 F.2d 388, 391 (Fed. Cir. 1991); In re Fracalossi, 681
F.2d 792, 794 (CCPA 1982).
For the foregoing reasons, we affirm the rejections of claims 1, 3, 33-
36 under 35 U.S.C. §§ 102 and 103(a) as being anticipated and unpatentable
over Henis.

35 U.S.C. §§ 102 and 103 Rejections over Wrasidlo
The Examiner found that Wrasidlo teaches “soak[ing] the polysulfone
membrane in hydroxyalkyl cellulose solution” and heating to cross-link at
“temperature range – 110-190C.” Ans. 7.
The Examiner also found, and Appellants do not contest otherwise,
that “[v]irus retention in the ultrafiltration membrane [of Wrasidlo] and the
throughput would be inherent . . . .” Id.
Appellants argue that declaration evidence submitted demonstrates
that “the membrane of Wrasidlo fails to show an increased flux following
the claimed treatment of autoclaving in the presence of water or steam or
submerging in boiling water, when the flux was compared before and after
the treatment.” App. Br. 11 (emphasis omitted). Appellants also argue that
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Wrasidlo “fails to teach or suggest the claimed limitation of ‘comparing the
flux before and after the treatment’ as set forth in the claims.” Id. at 12.
The Examiner contends that the declaration evidence is insufficient to
establish patentability because Wrasidlo’s process of forming the membrane
was not adequately reproduced. According to the Examiner, the declaration
evidence “does not match the disclosed process details” and therefore the
comparison was not to Wrasidlo’s membrane, but instead to “a membrane
produced by additional process steps and conditions superimposed to
Wrasidlo’s process.” Ans. 10, 11. For example, Wrasidlo discloses that
heat treatment at 190°C is for a period of 30 seconds, not 10 minutes as used
in the declaration. Ans. 10-11; Wrasidlo, col. 7, ll. 14-25. The declaration
describes autoclaving the membrane at 120°C for about an hour, which is
not a process step in Wrasidlo. Ans. 11. Additionally, the washing step of
Wrasidlo is not included in the declaration. Ans. 11; Wrasidlo, col. 7, ll. 37-
49.
Thus, the Examiner has met the initial burden of establishing a close
correspondence between the claimed process and the process of Wrasidlo,
while Appellants have not persuasively demonstrated that the membrane of
Wrasidlo was duplicated and distinguished from the claimed product.
Because anticipation is the epitome of obviousness, we also sustain
the Examiner’s rejection as obvious in view of Wrasidlo. See In re Baxter
Travenol Labs., 952 F.2d at 391; In re Fracalossi, 681 F.2d at 794.
For the foregoing reasons, we affirm the rejection of claims 1, 3, 33-
36 under 35 U.S.C. §§ 102 and 103(a) as being anticipated and unpatentable
over Wrasidlo.

Appeal 2011-008238
Application 11/542,834

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35 U.S.C. § 103 Rejections over Henis, Wrasidlo, Wang and Kidd
The Examiner provided a sufficient rationale for combining the
references relied upon because each relates to providing a coating of
hydroxyalkyl cellulose to improve the hydrophilicity of single or
multilayered membranes and hydrophilicity is a desirable characteristic for a
membrane. Ans. 9. Appellants have not addressed any of the secondary
references nor asserted any additional arguments evidencing error by the
Examiner in rejecting all of the pending claims as obvious. App. Br. 13.
Accordingly, absent any argument from Appellants as to specific, technical
reasons why the membranes disclosed by the references are structurally
different from the claimed membrane, we are unpersuaded the Examiner is
in error.
For the foregoing reasons, we affirm the rejection of claims 1, 3-9, 11,
33-36 under 35 U.S.C. § 103(a) as being unpatentable over Henis or
Wrasidlo in view of Wang and Kidd.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(v).
AFFIRMED-IN-PART

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