Ex Parte Cullmann et al

Patent Trial and Appeal Board

Feb 27, 2018

12578354 (P.T.A.B. Feb. 27, 2018)

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.
12/578,354 10/13/2009 Dieter Cullmann GRUE-007 6182
24353 7590 03/01/2018
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
MARX, IRENE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
03/01/2018 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DIETER CULLMANN and GUNTHER BURGARD
Appeal 2017-004107
Application 12/578,354
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
ELIZABETH A. LaVIER, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
Appeal 2017-004107
Application 12/578,354
STATEMENT OF CASE
The following claim is representative.
17. A method of treating arterial hypertension in a mammalian
individual having chronically elevated blood pressure, the method
comprising administering to the individual hyaluronidase in an
amount of at least 3,000 IU of hyaluronidase per day.
Cited References
Winn
Burgard
US 5,250,548
US 2005/0249717 A1
Oct. 5, 1993
Nov. 10, 2005
J. J. Ryan, The Treatment of Hypertension by Hyaluronidase, Milne Pub.,
132—42 (1954).
O.S. Gilyova et al., The Achievements of Modern Medicine in Systemic
Hirudotherapy, Russian Journal of Biomechanics, Vol. 3, No. 4, 1-10
(1999).
Hana Rauchova et al., The Effect of Chronic L-carnitine Treatment on Blood
Pressure and Plasma Lipids in Spontaneously Hypertensive Rats, European
Journal of Pharm., Vol. 342, 235-39 (1998).
Jorge Martins de Oliveira, et al., Intravenous Injection of Hyaluronidase in
Acute Myocardial Infarction: Preliminary Report of Clinical and
Experimental Observations, Am. Heart J., Vol. 57, No. 5, 712-22 (1959).
Grounds of Rejection
Claims 39, 40, and 42 stand rejected under 35 U.S.C. § 112(a) or 35
U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written
description requirement.
Claims 17-21, 23-27, 31, and 39^46 stand rejected under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Ryan taken with Gilyova, de
Oliviera, and Burgard, and further taken with Rauchova and Winn.
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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
2-7.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“[OJbviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Written Description
The Examiner finds that
no clear basis or support is found in this section of the written
disclosure for the invention as now claimed because there is no
correlation between the material disclosed and the claimed
reduction in blood pressure. The portion of the Specification
cited does not indicate a dosage or regimen of administration of
hyaluronidase with any specificity. The functional limitations
argued are not specific as to any particular reduction in blood
pressure due to particular amounts of hyaluronidase. Similarly,
the cited portions at page 10 to page 11 are not specific as to
results to be obtained.
Ans. 3.
In particular,
regarding the working examples, it is noted that any results
provided in the as-filed specification wherein a reduction in
blood pressure is specifically indicated require the
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administration of at least 4500 IU hyaluronidase. No results are
shown for the range of 3000 to 4500, for example. The
exemplified material does not provide sufficient support for the
new generic recitation of reducing diastolic blood pressure in
the individual by at least 5 mm Hg, respectively at least 10 mm
Hg and/or to reduce systolic blood pressure in the individual by
at least 5 mm Hg, respectively at least 10 mm Hg by
administering at least 3000 IU hyaluronidase per day, for one
day, for example.
Ans. 3.
Appellants state that support for the claims is found at page 10, line 32
to page 11, line 3 of the Specification. App. Br. 5.
We find that the Examiner has not set forth a prima facie case of lack
of written description. Appellants point to pages 10 and 11 of the
Specification, which state in several locations that “[according to a
preferred embodiment, at least about 3,000 IU ... of hyaluronidase are
administered per day.” The Specification also describes “using
hyaluronidase for the prevention and/or treatment of arterial hypertension.”
Spec. 2. Thus, the Specification, on its face, describes the administration of
3,000 IU of hyaluronidase per day to treat arterial hypertension. As the
Federal Circuit has noted:
A claim will not be invalidated on section 112 grounds simply
because the embodiments of the specification do not contain examples
explicitly covering the full scope of the claim language. That is
because the patent specification is written for a person of skill in the
art, and such a person comes to the patent with the knowledge of what
has come before. Placed in that context, it is unnecessary to spell out
every detail of the invention in the specification; only enough must be
included to convince a person of skill in the art that the inventor
possessed the invention and to enable such a person to make and use
the invention without undue experimentation.
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Falknerv. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006) (quoting LizardTech,
Inc. v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336, 1345 (Fed. Cir.
2005)).
The written description rejection is reversed.
Obviousness Rejection
The Examiner finds that Ryan teaches the treatment or prevention of
chronic hypertension, including arterial hypertension and secondary
hypertension by administering an effective amount of hyaluronidase. See,
e.g., Ryan pages 132-39. Final Act. 4.
In addition, the Examiner finds that
Gilyova et al. teach the treatment of hypertension or
“chronically elevated blood pressure” with hyaluronidase, since it
discloses the treatment of hypertension with leeches, which contain
hyaluronidase. See, e.g., Gilyova et al., page 2, paragraph 3 and
Specification, page 8, paragraph 1, the effectiveness of the treatment
of hyaluronidase on hypertension is disclosed at Gilyova et al. page 3,
paragraphs 4 and 7 et seq.
Final Act. 4.
It is also noted that in the process of treatment of Gilyova
et al., while the patients are clearly suffering from hypertension,
other patients having cardiovascular disease are treated in a
similar manner, which strongly suggests that similar or related
mechanisms are involved in hypertension and other
manifestations of cardiovascular disease and the effectiveness
of medicaments, including hyaluronidase, in the treatment of
these related conditions was known in the art at the time the
claimed invention was made.
In addition, De Oliveira et al. teach a method of treating
arterial hypertension by administering to an individual an
effective amount of hyaluronidase. See, e.g., Case Reports on
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patients pages 714, first paragraph and Burgard el al. teach a
method of treating arterial hypertension by administering to an
individual an effective amount of hyaluronidase. See, e.g.,
[0026]. See paragraphs [0026]-[0028] for administration
protocols.
The administration of hyaluronidase in combination with
the antihypertensive agent carnitine is disclosed at [0029] in
Burgard et al. In this regard, Rauchova el al. adequately
demonstrates that carnitine is an antihypertensive agent. See,
e.g., page 237, first full paragraph. In addition, Winn et al.
disclose the administration of various antihypertensive agents
together with agents such as diuretics, vasodilators, adrenergic
blocking agents, calcium channel blockers, angiotensin
converting enzyme inhibitors, renin inhibitors, etc .. See, e.g.,
col. 191, line 19 et. seq.
Final Act. 5.
1) Appellants submit that there is no evidence in Ryan that
hyaluronidase treated hypertension in any of the patients discussed
therein. One cannot conclude, from the disclosure of Ryan, that
hyaluronidase treats hypertension. App. Br. 9.
2) Appellants argue that a close reading of Ryan does not show that
hyaluronidase treated hypertension in any of the patients. App. Br.
9.
3) Appellants submit that Ryan does not provide sufficient guidance
for one of ordinary skill in the art to use an amount of
hyaluronidase administered per day of at least 3,000 IU to treat
arterial hypertension. App. Br. 11.
4) Appellants argue that Gilyova discusses application of leeches to
provide a variety of effects, including anti-thrombal, anti-
aggregative, thrombolytic, anti-inflammatory, anti-ischemic,
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analgesic, vasodilative, and hypotensive effects (Gilyova, page 3,
paragraph 4). However, Appellants submit that there is no
disclosure in Gilyova of the use of hyaluronidase to treat arterial
hypertension. App. Br. 12.
5) Appellants argue that one of ordinary skill in the art would not
attribute to hyaluronidase the antihypertensive effect of
hirudotherapy, and Gilyova fails to disclose or suggest the
treatment of hypertension with hyaluronidase. App. Br. 13.
6) With respect to de Oliveira, Appellants argue that the patient
referred to on page 714 did not suffer from an arterial hypertension
as alleged in the Office Action. Instead, the patient was suffering
from a diaphragmatic infarction as shown and commented in de
Oliveira with Figure 4 (page 715). Figure 4 of de Oliveira reads:
“Acute diaphragmatic infarction extending to the dorsal regions.”
App. Br. 14.
7) Appellants argue that Burgard indicates that the treatment is for
cardiac hypertrophy and fatty disease of the heart, and for reducing
the risk of infarction, and argue that Burgard does not mention
treating arterial hypertension. App. Br. 15.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. In particular, the Examiner has failed to
provide evidence in the prior art of the treatment of hypertension with
hyaluronidase in the dosage claimed.
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We begin with claim interpretation. Appellants’ Specification states
that:
hyaluronidase is used for the treatment of an arterial
hypertension selected from the group consisting of endocrine
hypertension, essential hypertension, arteriosclerotic hypertension,
cardiovascular hypertension, renal hypertension, labile hypertension,
neurogenic hypertension, paroxysmal hypertension, portal
hypertension, pulmonary hypertension, and secondary hypertension.
Also encompassed by “arterial hypertension” as used herein is a
hypertension caused by monogenic defects such as glucocorticoid-
remediable aldosteronism and Liddle's syndrome, hypertension caused
by hypertension-susceptilibity [sic] genes such as angiotensinogen
and alpha-adducin genes. “Arterial hypertension” according to the
invention may as well be caused by environmental factors such as salt
intake, preferably sodium intake, obesity, occupation, and alcohol
intake, all of which forms of hypertension are also contemplated as
being encompassed by the present invention. Moreover, hypertension
in the sense of the present application also includes hypertension
caused by obstructive sleep apnea, by aortic coarctation, by
preeclampsia, by drugs such as combined oral contraceptive pill,
cyclosporin, steroids, and by CNS disturbances.
Spec. 5 (emphases added). Appellants’ Specification also states that, “there
is no correlation between the amount of plaques or sclerotified vessels and
the occurrence of hypertension.” Spec. 2. Appellants note that, “[t]his is
also consistent with the finding that as a result of the Hyaluronidase
treatment the present inventors observed a sustained and significant
reduction in arterial hypertension in hypertensive patients who displayed no
significant arteriosclerotic plaques before and after commencement of the
Hyaluronidase treatment.” Spec. 3.
While claim 17 describes treatment of arterial hypertension, claim 18
further defines arterial hypertension to include, “endocrine hypertension,
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essential hypertension, arteriosclerotic hypertension, cardiovascular
hypertension, renal hypertension, labile hypertension, neurogenic
hypertension, paroxysmal hypertension, portal hypertension, pulmonary
hypertension, or secondary hypertension.” Thus, by the doctrine of claim
differentiation, claim 17 encompasses the conditions of claim 18. In other
words, “arterial hypertension” includes renal hypertension and secondary
hypertension.
As to Ryan, we agree with Appellants that Ryan does not teach the
claimed dosage of hyaluronidase. While Ryan arguably teaches treatment of
secondary hypertension associated with a kidney infection, or pregnancy
preeclampsia hypertension within the scope of the pending claims, we agree
with Appellants that the evidence of the effectiveness of hyaluronidase in
treating hypertension in Ryan may have been inconclusive to one of ordinary
skill in the art at the time of the invention. Several treatment groups in
Ryan’s studies, Group IV in particular, did not respond to the treatment or
were made worse by the hyaluronidase treatment. App. Br. 9-10.
We agree with Appellants that Gilyova is inconclusive with respect to
hyaluronidase effectiveness in treating hypertension, because hyaluronidase
is but one of many substances present in leech saliva that could be
responsible for the hypertension reduction effects. App. Br. 12.
The patients discussed in de Oliveira are restricted to those exhibiting
acute myocardial infarction. App. Br. 14. The Examiner has failed to point
to any specific disclosure in de Oliveira that its treatment protocol had any
effect on blood pressure. Id. We further note that there is no evidence that
the de Oliveira patient with atherosclerosis is an individual within the scope
of the pending claims (i.e., an “individual having chronically elevated blood
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pressure”), as Appellants’ Specification establishes that “there is no
correlation between the amount of plaques or sclerotified vessels and the
occurrence of hypertension.” Spec. 2.
With respect to Burgard, the Examiner argues generally that Burgard
treats a form of heart disease which includes hypertension. Ans. 5.
However, the claim scope is limited to treating arterial hypertension in a
mammal with a specific dosage of hyaluronidase. We find that the
Examiner has failed to establish that the forms of heart disease mentioned in
Burgard encompass arterial hypertension.
We do not reach Appellants’ proffered evidence of unexpected results
because we find that, in the first instance, the Examiner has failed to
establish a prima facie case of obviousness on the evidence before us.
The obviousness rejection is reversed.
CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejection, which is reversed. The written description rejection is also
reversed.
REVERSED
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