Ex Parte Berry et al

Patent Trial and Appeal Board

Aug 30, 2016

13396318 (P.T.A.B. Aug. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/396,318 02/14/2012 Elizabeth Jane BERRY
28510 7590 09/01/2016
MICHAEL P, MORRIS
BOEHRINGER INGELHEIM USA CORPORATION
900 RIDGEBURY ROAD
PO BOX 368
RIDGEFIELD, CT 06877-0368
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.
10-0138-US-2 5721
EXAMINER
VISONE, THOMAS J
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/01/2016 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):
USPTO.e-Office.rdg@boehringer-ingelheim.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ELIZABETH JANE BERRY, FUAD TAWFIQ HADDADIN,
ALI KHAZRAEINAZMPOUR, JEREMY KROLL,
SONIA REGINA CANTISANO MALBURG,
EDGAR ARNULFO SANDOVAL BASURTO, and
STEPHEN SCHEERER
Appeal2014-008208
Application 13/396,318
Technology Center 1600
Before JEFFREY N. FREDMAN, JACQUELINE WRIGHT BONILLA,
and DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON REHEARING
In a Decision entered July 28, 2016 ("Decision") in relation to the
above-captioned application, we: (1) reversed the Examiner's rejection of
claims 1---6, 8-14, and 19 under 35 U.S.C. § 103(a) as obvious over Fanget1
and further in view of Sanderson2; (2) reversed the Examiner's rejection of
claim 7 under§ 103(a) as obvious over Fanget and Sanderson as applied to
1 U.S. Patent No. 6,149,917, issued Nov. 21, 2000.
2 U.S. Patent No. 5,510,258, issued Apr. 23, 1996.
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claims 1---6, 8-14, and 19, and further in view of Tree3 and Fox4; (3) set forth
a new ground of rejection of claims 1---6, 8-14, and 19 under§ 103(a) as
obvious over Fanget in view of Sanderson and in further view ofMcAleer5;
and (4) set forth a new ground of rejection of claim 7 under§ 103(a) as
obvious over Fanget, Sanderson, and McAleer as applied to claims 1---6, 8-
14, and 19, and in further view of Tree and Fox. Appellants have requested
rehearing of our Decision in relation to the new grounds of rejection.
We have granted Appellants' request to the extent we have
reconsidered our original Decision in light of Appellants' points, but we
decline to modify the Decision.
DISCUSSION
Appellants urge that "the deference normally given to a Board
Decision, when the Board is affirming an existing rejection, should not apply
in the instant case wherein new rejections are made relying on a newly cited
reference." (Req. Reh'g 2). We acknowledge that our issue of new grounds
of rejection entitles Appellants to request a rehearing pursuant to 37 C.F.R.
§ 41.52 and confirm that our duty to review is as set forth in 37 C.F.R.
§ 41.52(a)(l):
3 Julia A. Tree, et al., Comparison of large-scale mammalian cell culture
systems with egg culture for the production of influenza virus A vaccine
strains, 19 Vaccine, 3444--50 (2001) ("Tree").
4 Stephen R. Fox, et al., Maximizing Interferon-y Production by Chinese
Hamster Ovary Cells Through Temperature Shift Optimization:
Experimental and Modeling, 85(2) Biotech. and Bioeng' g, 177-84 (Jan. 20,
2004) ("Fox").
5 U.S. Patent No. 3,965,258, issued June 22, 1976.
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When a request for rehearing is made, the Board shall render a
decision on the request for rehearing. The decision on the
request for rehearing is deemed to incorporate the earlier
opinion reflecting its decision for appeal, except for those
portions specifically withdrawn on rehearing, and is final for
the purpose of judicial review, except when noted otherwise in
the decision on rehearing.
We address the Appellants' arguments regarding the new grounds of
rejection below.
First New Ground of Rejection
Appellants urge that our Decision erred in issuing new grounds of
rejection of claims 1---6, 8-14, and 19 under 35 U.S.C. § 103(a) as obvious
over Fanget in view of Sanderson and in further view of McAleer because
these claims "are not obvious to one of ordinary skill in the art" over the
cited references. (Req. Reh'g 2).
Appellants begin by arguing the scope of the teachings of Fanget and
Sanderson. (Id. at 2-3). Because Appellants raise no new arguments
regarding these references, we see no reason to alter our Findings of Fact 1-
3 and 5 or our conclusions regarding the teachings of these references, and
adopt them here pursuant to 37 C.F.R. § 41.52.
With regard to McAleer, Appellants argue that while "McAleer does
teach that the cells, growth medium and virus are added to the culturing
apparatus as a mixture ... it does not disclose that the ... advantages are
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due to the simultaneous addition of the cells and virus." (Id. at 4). Rather,
Appellants argue
(Id.)
McAleer states such an advantage only for the simultaneous
addition of the virus and growth medium. It does not mention
the presence of the cells in this statement. McAleer does not
indicate any particular advantage to the simultaneous addition
of the cells. Accordingly, the reasons for motivating the
combination of McAleer with Fanget and Sanderson do not
appear to be supported by the references' teachings.
Appellants further argue that even if it could be implied from
McAleer that the advantage was conferred by simultaneous addition of virus
to growth medium containing the cells, "there is no basis for one of ordinary
skill in the art to reasonably expect that the advantage for simultaneous
addition in the McAleer process would also be seen in the Fanget/Sanderson
process." (Id.) Appellants argue that because there are differences in the
vaccine production methods, the viruses themselves and the cell lines to be
infected,
[n]o nexus is provided or apparent on the record as to why the
simultaneous addition method for the distinct virus in distinct
cell lines in McAleer would reasonably be expected to be
successful to prepare a very different type of virus in very
different cell lines.
(Id. at 5).
Appellants argue the record instead "directs one of ordinary skill in
the art away from a reasonable expectation of success" in using the claimed
method because McAleer was published is "decades earlier" than the Fanget
and Sanderson references. (Id.) According to Appellants, one of ordinary
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skill would believe the disclosures of Appellants' Specification along with
those of more recent references Fanget and Sanderson that the "conventional
method of producing PRRSV from a mammalian cell line required advance
seeding and growth of the cell line before infecting with the virus." (Id.)
Thus, Appellants argue, the record has no basis from which the ordinarily
skilled artisan could have predicted "how the very different virus and very
different cell line of Fanget/Sanderson would react when subject to the
method as modified by McAleer" and that the age of the McAleer reference
"belies that the outcome of such a modification would be predictable." (Id.
at 5---6).
We do not find Appellants' arguments persuasive. It is well
established that prior art references need not disclose an express motivation
to combine the teachings that is identical to that stated by a patent applicant
in order to motivate the combination. See In re Kemps, 97 F.3d 1427, 1430
(Fed. Cir. 1996) ("[T]he motivation in the prior art to combine the references
does not have to be identical to that of the applicant to establish
obviousness."). McAleer discloses a decreased possibility of contamination
and increased efficiency of process as two reasons for simultaneous or
substantially simultaneous addition of the virus with the growth medium (FF
1 O; Dec. 9). In addition, our reviewing court has held that improvement-
related factors may motivate a combination:
[A Jn implicit motivation to combine exists not only when a
suggestion may be gleaned from the prior art as a whole, but
when the "improvement" is technology-independent and the
combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient.
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Because the desire to enhance commercial opportunities by
improving a product or process is universal-and even
common-sensical- ... there exists in these situations a
motivation to combine prior art references even absent any hint
of suggestion in the references themselves. In such situations,
the proper question is whether the ordinary artisan possesses
knowledge and skills rendering him capable of combining the
prior art references.
DyStar Textilfarben GmbH & Co. Deutsch/and KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006) (bold emphasis added).
We find one of skill in the art familiar with the teachings of McAleer
"as a whole" would have recognized that McAleer' s process teaches
addition of cells concurrently with the virus in the growth medium. We
further find the benefits of the alternate and more efficient process disclosed
in McAleer would have motivated one of skill in the art to combine its
teachings with those of Fanget and Sanderson. As noted in DyStar above, an
issue may exist whether the ordinary article "possesses knowledge and skills
rendering him capable of combining the prior art references." (Id.) But
Appellants have provided no evidence or other reasons to believe one of
ordinary skill in the art would be incapable of combining the teachings of
McAleer, Fanget, and Sanderson. We are therefore persuaded by the
reasoning in In re Burhans, 154 F .2d 690 ( CCP A 1946), that a reference
may establish obviousness where, in the absence of a secondary
consideration, the selection of any order of known process steps would have
been obvious:
Appellant contends that the references taken singly or together
do not teach his characteristic four steps .... There is no merit
in the point here in the absence of any proof in the record that
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the order of performing the steps produces any new and
unexpected results.
(Id. at 692).
Because Appellants have not provided any evidence of secondary
considerations leading us to believe that one of ordinary skill would have
avoided adding the cells at the same time as the medium and the virus, or
have been unsuccessful in doing so - particularly where McAleer
demonstrated success and increased efficiency with this method - we are not
persuaded by this attorney argument. See In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of
evidence.").
We further note that the age of the McAleer reference is not a
persuasive reason to believe its teachings do not apply: "[t]he mere age of
the references is not persuasive of the unobviousness of the combination of
their teachings, absent evidence that, notwithstanding knowledge of the
references, the art tried and failed to solve the problem." In re Wright, 569
F.2d 1124, 1127 (CCPA 1977). Appellants have provided no evidence of
failure by one of skill in the art to use the methods of McAleer in PRRSV.
Rather, we find one of skill in the art would have recognized that the
components could be added together or separately, as desired, because
McAleer teaches that adding the components together is an obvious
equivalent method to initiate infection. The obviousness analysis "can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007). "A person of ordinary skill is also a person of ordinary creativity,
not an automaton." Id. at 4 21.
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With regard to Appellants' final argument that no nexus has been
provided as to why McAleer's method would reasonably be expected to
succeed when used "to prepare a very different type of virus in very different
cell lines" (Req. Reh'g 5), we note that "[o]bviousness does not require
absolute predictability of success .... For obviousness under § 103, all that
is required is a reasonable expectation of success." In re 0 'Farrell, 853
F.2d 894, 903---04 (Fed. Cir. 1988). In the absence of any contrary evidence
from Appellants, we find a reasonable expectation of success is provided
here where the cited references all pertain to viral culture methods and
McAleer has disclosed success in applying the identical order of steps used
in the claimed methods.
Second New Ground of Rejection
Appellants incorporate their arguments regarding the first new ground
of rejection in reference to the second new ground of rejection and raise no
separate argument pertaining to the rejection of independent claim 7.
Accordingly, we find claim 7 falls with claims 1---6, 8-14, and 19. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We are not persuaded that our Decision issuing a New Grounds for
rejection of claims 1-6, 8-14, and 19 under 35 U.S.C. § 103(a) as obvious
over Fanget, Sanderson, and McAleer and of claim 7 under 35 U.S.C.
§ 103(a) as obvious over Fanget, Sanderson, and McAleer in view of Tree
and Fox misapprehended or overlooked any point of fact or law advanced by
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Appellants. We therefore decline to modify our original Decision entered
July 28, 2016.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
DENIED
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