Ex Parte Samaranayake et al

Patent Trial and Appeal Board

Feb 15, 2018

13858393 (P.T.A.B. Feb. 15, 2018)

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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/858,393 05/01/2013 Haritha SAMARANAYAKE GB 11.00804.2 1621
22925 7590 02/20/2018
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EXAMINER
WEHBE, ANNE MARIE SABRINA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
02/20/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARITHA SAMARANAYAKE, JERE PIKKARAINEN,
ANN-MARIE MAATTA, and SEPPO YLA-HERTTUALA
Appeal 2017-003 6241
Application 13/858,393
Technology Center 1600
Before RICHARD M. LEBOVITZ, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
This is a decision on Appellant’s Request for Rehearing (“Req.
Reh’g”) under 37 C.F.R. § 41.52(a)(1) of the Decision on Appeal, entered
Nov. 13, 2017 (“DOA”). The appeal involved claims directed to a viral
vector, ganciclovir, and temozolomide for treating malignant glioma.
Appellants request reconsideration of the Decision on Appeal to affirm the
Examiner’s rejection of claims 1—14, 17—25, 27—32, and 34-40 as obvious
view of Medical News, Yla-Herttuala, Wick, and Rainov.
1 The Appeal Brief (“Appeal Br.”) identifies Fin Vector Therapies Ltd, as
the real party in interest. Appeal Br. 2.
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Application 13/858,393
The Request for Rehearing states that the Board erred in finding that
synergy between ganciclovir and temozolomide “is an unnecessary red
herring.” Req. Reh’g 2.
To support this argument, Appellants cite evidence not relied upon in
the Appeal Brief or Reply Brief that temozolomide damages DNA and
causes myelosuppression. Id. at 2—3. It is procedural error to raise new
evidence in a Request for Rehearing absent a qualifying exception:
Arguments not raised, and Evidence not previously relied upon,
pursuant to §§ 41.37, 41.41, or 41.47 are not permitted in the
request for rehearing except as permitted by paragraphs (a)(2)
through (a)(4) of this section.
37 C.F.R. § 41.52(a)(1). Appellants did not establish that any of the
exceptions for new evidence or arguments apply. Consequently, the new
evidence shall not be considered.
Appellants reiterate their argument already addressed in the Decision
on Appeal that Rainov did not show synergy or an added benefit of utilizing
a combination of temozolomide and ganciclovir in vivo. Req. Reh’g 4.
Appellants also argue:
Rainov cogently demonstrates why a physician would avoid
adding Wick’s temozolomide to Yla-Herttuala’s ganciclovir in
vivo.
The Decision on Appeal correctly notes that in contrast to
his in vivo data, Rainov’s in vitro data show synergy. This is
correct, but irrelevant. The instant claims require “a human.”
Rainov may well render obvious claims to an in vitro
diagnostic, but Rainov’s in vivo data clearly and cogently show
why the artisan would avoid adding Wick’s temozolomide to
Yla-Herttuala’s ganciclovir to treat a human patient in vivo.
Req. Reh’g 4.
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Application 13/858,393
To begin, the rejection is not based on “adding Wick’s temozolomide
to Yla-Herttualas’s ganciclovir to treat a human patient in vivo” as stated in
the Request for Rehearing. Id. The Decision on Appeal expressly found
that Medical News disclosed treating patients with both temozolomide and
ganciclovir. DOA 11. Rainov was also cited for teaching “administering
HSV-tk, ganciclovir, and temozolomide on malignant glioma.” Id. Wick
and Yla-Herttuala were cited for teaching specific dosages and regimens of
temozolomide and ganciclovir. Id. Thus, Appellants’ statement about the
basis of the rejection is not correct. Rather, the rejection is based on prior art
teachings that used all three elements of the claim to treat tumors.
The reason the Decision on Appeal described the discussion of
synergy in Rainov as a red herring2 was because Appellants argued, as they
do in this Request for Rehearing, that “Rainov . . . teach[es] avoiding the
combination [of temozolomide and ganciclovir] because it would increase
risk and provide no off-setting benefit.” Appeal Br. 22. However, contrary
to this argument, these two drugs were not only administered together to
treat tumors in Rainov and Medical News, but found to be advantageous in
combination. The following passages from Rainov and Medical News were
cited in the Decision on Appeal to support this conclusion:
Summarizing our data, the demonstration of synergy between
HSV- tk/ GCV [ganciclovir] gene therapy and chemotherapy
with TMZ [temozolomide] suggests a possible enhanced
therapeutic concept for future studies in human malignant
glioma. Despite many still unknown variables, the present
results were clearly defined in a glioma cell culture system and
2 “[Something that distracts attention from the real issue.”
https://www.merriam-webster.com/dictionary/red%20herring (last
accessed January 1, 2018).
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Application 13/858,393
confirmed in animal experiments, and therefore justify further
investigation.
Rainov 667.
On the primary endpoint, the group given Cerepro (R) and
temozolomide showed an improvement of 68% in median
survival time compared with standard care surgery and
radiotherapy controls (350 days vs 208 days). Against the same
controls, treatment with Cerepro (R) alone showed an improved
median survival trend approaching 50%, similar to those given
treatment with temozolomide alone after surgery and
radiotherapy (300 days and 307 days respectively vs 208 days
with standard care). Improvements in the combined Cerepro (R)
[to clarify for Appellants, the use of Cerepro means the viral
vector HSV-tk and GCV because the purpose of the vector is to
convert GCV into an active drug] and temozolomide treatment
group (n= 58) and temozolomide alone group (n=76) were
significant (p<0.05).
Medical News 2.
Thus, each of Rainov and Medical News actually used the same
claimed combination of viral vector, temozolomide and ganciclovir. These
publications did not discourage nor disparage the results obtained with the
combination, but rather stated “further investigation” was justified (Rainov
667) and “[ijmprovements . . . were significant.” Medical News 2.
Despite these clear statements in Rainov and Medical News,
Appellants contend that a skilled worker would have been discouraged from
using the two drugs together because no benefit was observed. Req. Reh’g
3. In other words, Appellants contend that the skilled worker would have
disregarded the plain teachings in Medical News and Rainov. We were not
persuaded by this argument in the Appeal Brief, and still are not by the
Request for Rehearing.
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Application 13/858,393
Specifically, Appellants have not provided persuasive objective
evidence that one of ordinary skill in the art would have ignored Rainov’s
teaching of synergy and Medical News’s teaching of improvement when the
two drugs were utilized to treat humans. Appellants ask us to disregard
these explicit teachings in which all three elements of the claim were utilized
(viral vector, ganciclovir, and temozolomide) without providing objective
evidence to support their argument, such as a declaration by one of ordinary
skill in the art, experimental results, or rebuttal evidence. An argument
made by counsel in a brief does not substitute for evidence lacking in the
record. EsteeLauder, Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir.
1997).
We do not agree that “synergy” is essential in analyzing non­
obviousness as argued by Appellants (Req. Reh’g 3) because Medical News
teaches that the use of the claimed adenoviral vector, ganciclovir, and
temozolomide showed an improvement of 68% in median survival time in
contrast to “approaching 50%” when the vector or drug was used alone:
On the primary endpoint, the group given Cerepro (R) fthe
adenoviral vector and ganciclovir! and temozolomide showed
an improvement of 68% in median survival time compared with
standard care surgery and radiotherapy controls (350 days vs
208 days). Against the same controls, treatment with Cerepro
(R) alone showed an improved median survival trend
approaching 50%, similar to those given treatment with
temozolomide alone after surgery and radiotherapy (300 days
and 307 days respectively vs 208 days with standard care).
Medical News 2 (emphasis added) (quoted from DOA 19). Whether the
improvement is synergistic or simply an additive effect is irrelevant.
Median survival time is better when both therapies are used in combination,
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Application 13/858,393
so why would the medical practitioner avoid the benefits of the combination
as argued by Appellants? Req. Reh’g 4.
Accordingly, while we have considered Appellants’ Request for
Rehearing of the Decision on Appeal, we decline to modify it.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
REHEARING DENIED
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