Ex Parte Szeto

Patent Trial and Appeal Board

Mar 19, 2018

12854551 (P.T.A.B. Mar. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/854,551 08/11/2010 Hazel H. Szeto
23524 7590 03/21/2018
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
093873-0208 8026
EXAMINER
HELLMAN, KRISTINA M
ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
03/21/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HAZEL H. SZETO
Appeal 2016-004646 1
Application 12/854,551
Technology Center 1600
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal2 under 35 U.S.C. § 134 involves claims directed to a
method of treating metabolic syndrome comprising administering one of two
known peptides. The Examiner rejected the claims as unpatentable under
35 U.S.C. § 103 and on the grounds of obviousness-type double-patenting.
We have jurisdiction under 35 U.S.C. § 6(b ). The rejections are affirmed.
1 The Appeal Brief ("Appeal Br.") 2 identifies Cornell University and
Stealth Peptides International as the real-parties-in-interest. The application
is referred to herein as "the '551 Application."
2 This appeal was heard on February 1, 2017. A transcript of the hearing
will be entered into the record in due course.
Appeal 2016-004646
Application 12/854,551
STATEMENT OF THE CASE
Appellant appeals from the Examiner's final rejection of Claims 1, 3-
5, 7, 8, and 11-15. As summarized in the Reply Brief ("Reply Br."), the
claims are rejected by the Examiner under 17 grounds of rejection. Reply
Br. 3-5. Rejections 1-14 are based on prior art; rejections 15-17 are
obvious-type double-patenting rejections citing the same prior art cited in
rejection 1-14. There is one independent claim on appeal, Claim 1, and
claims 3-5, 7, 8, and 11-15 depend from it.
Prior art rejections
The primary prior art publication in each rejection is a patent or
published patent application ("patent publications") that either has
overlapping or the same inventorship with the application involved in this
appeal. The Examiner cited each individual patent or published patent
application in separate rejections. However, several of the patents are
related to each other, e.g., as being continuations of each other with the same
disclosures. The Examiner also numbered the patents with arbitrary
numbering, rather than using the patent number as an identifier. For ease of
identity, we have used the last three digits of the patent/publication number
as an identifier and have grouped the patents/ publications (issued patent or
published patent application) according to whether they are continuations of
each other with common disclosures. The groupings are as follows:
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Application 12/854,551
1. Sz606, 3 Sz711 4
2. Sz306, 5 Sz57 l, 6 Sz9877
3. Ne638, 8 Ne727 9
Each group discloses the same peptides as the appealed claims,
identified as SS-31 (D-Arg-2'6'-DmtLys-Phe-NH2) and SS-20 (Phe-D-Arg-
Phe-Lys-NH2). Appellant does not dispute that the claimed peptides are the
same as those described in the cited patents and published patent
applications.
Each of the rejections are based on a Szeto ("Sz") or Neufer ("Ne")
patent publication combined with Duncan, 10 Virsik, 11 and Pi-Sunyer. 12
Appellant does not argue the dependent claims separately. Consequently,
dependent claims 3-5 and 11-13 fall with claim 1. 37 C.F.R. § 41.37(c)(l).
A second publication by Austen 13 is cited in certain rejections to reach
dependent claims. Reply Br. 3-5. However, Appellant does not provide
separate reasons for the patentability of these claims, but rather reiterated the
same arguments for claim 1. See, e.g., Appeal Br. 18. Consequently, claims
3 Szeto, US 2006/0084606 Al, publ. Apr. 20, 2006.
4 Szeto, US 2007/0015711 Al, publ. Jan. 18, 2007.
5 Szeto, Liu, and Cho, US 2007/0129306 Al, publ. June 7, 2007.
6 Szeto, Liu, and Cho, US 2010/0317571 Al, publ. Dec. 16, 2010.
7 Szeto, Liu, and Cho, US 7,811,987 B2, issued Oct. 12, 2010.
8 Neufer, Anderson, Szeto, US 2012/0149638 Al, publ. June 14, 2012.
9 Neufer, Anderson, Szeto, US 8,088,727 B2, issued Jan. 3, 2012.
10 Duncan et al., Chronic activation of the innate immune system may
underlie the metabolic syndrome, 119 SAO p AULO MED. J. REV. p AUL MED.
122-127 (2001).
11 Virsik et al., WO 2008/052044 A2, publ. May 2, 2008.
12 Pi-Sunyer et al., The Metabolic Syndrome: How to Approach Differing
Definitions, 91 MED. CLIN. N. AM. 1025-1040 (2007).
13 Austen et al., US Publ. Pat. Appl. 2007/0110728 Al, publ. May 17, 2007.
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Application 12/854,551
7, 8, 14, and 15 involved in these rejections fall with claim 1. 37 C.F.R. §
41.37( c )(1 ).
Double-patenting rejections
The arguments over the obviousness-type double-patenting rejections
and the subject matter of the claims of the cited art are the same as those
made over the obviousness prior art rejections. Appeal Br. 21-24.
Consequently, the double-patenting rejections stand or fall with the prior art
rejections. 37 C.F.R. § 41.37(c)(l).
Claim 1
Claim 1, the only independent claim on appeal, is representative and
reads as follows:
1. A method of treating metabo lie syndrome in a mammalian
subject in need thereof, comprising administering to the
mammalian subject in need thereof a therapeutically effective
amount of the peptide D-Arg-2'6'-Dmt-Lys-Phe-NH2 [SS-31] or
Phe-D-Arg-Phe-Lys-NH2 [SS-20].
wherein treatment comprises one or more effects selected
from the group consisting of: reducing glucose intolerance,
reducing blood LDL cholesterol levels, reducing blood VLDL
cholesterol levels, reducing blood triglyceride levels, increasing
blood HDL cholesterol levels, and reducing blood plasminogen
activator inhibitor-I (P AI-1) levels.
METABOLIC SYNDROME
Claim 1 is directed to a method of treating metabolic syndrome in a
mammal in need of treatment. The method comprises administering
therapeutically effective amounts of peptide SS-31 or SS-20.
The '5 51 Application describes metabolic syndrome as follows:
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FPL
Metabolic syndrome is a collection of health disorders or risks
that increase the chance of developing heart disease, stroke, and
diabetes. . . . Metabolic syndrome may include any of a variety
of underlying metabolic phenotypes, including insulin
resistance and/or obesity predisposition phenotypes.
'551 Application i-f 4.
FF2.
Metabolic syndrome is often characterized by any of a number
of metabolic disorders or risk/actors, which are generally
considered to most typify metabolic syndrome when more than
one of these factors are present in a single individual. The
factors include: central obesity (disproportionate fat tissue in
and around the abdomen), atherogenic dyslipidemia (these
include a family of blood fat disorders including, e.g., high
triglycerides, low HDL cholesterol, and high LDL cholesterol
that can foster plaque buildups in the vascular system, including
artery walls), high blood pressure, insulin resistance or glucose
intolerance (the inability to properly use insulin or blood sugar),
a chronic prothrombotic state (e.g., characterized by high
fibrinogen or plasminogen activator inhibitor levels in the
blood), and a chronic proinflammatory state (e.g., characterized
by higher than normal levels of high-sensitivity C-reactive
protein in the blood). People with metabolic syndrome are at
increased risk of coronary heart disease, other diseases related
to plaque buildups in artery walls (e.g., stroke and peripheral
vascular disease) and type 2 diabetes.
Id. i-f 5 (emphasis added).
FF3. Pi-Sunyer discloses that "in all definitions [of metabolic
syndrome], insulin resistance is an underlying central component of the
MetS [metabolic syndrome]." Pi-Sunyer 1025.
FF4. The WHO definition of metabolic syndrome includes (a)
diabetes or insulin resistance; and two of, inter alia (b) a specific waist-to-
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hip ratio as an indicator of obesity; ( c) abnormal blood lipids; and ( d) high
blood pressure. Pi-Sunyer 1027.
FF5. The IDF definition of metabolic syndrome includes (a) obesity;
and two of a list that includes (b) abnormal blood lipids; ( c) raised blood
pressure; and (d) raised fasting glucose or diagnosed diabetes. Pi-Sunyer
1027.
FF6. The NCEP definition of metabolic syndrome includes three of
(a) obesity; (b) serum glycerides levels of a certain level; (c) HDL
cholesterol of a certain level (abnormal blood lipids); and (d) high serum
glucose. Pi-Sunyer 1026.
FF7. Pi-Sunyer teaches "MetS is characterized by the development of
a highly atherogenic lipid profile known as atherogenic dyslipidemia." Pi-
Sunyer 1029.
REJECTIONS BASED ON SZ606 & SZ711
The Examiner found that each of Sz606 and Sz711 (collectively,
"Sz606" because the disclosures of Sz606 and Sz711 are the same) describes
treating oxidative damage with peptides SS-31 and SS-20. Final Act. i-fi-18,
39. Sz606 discloses the following diseases and condition as treatable with
the recited peptides:
FF8. "Examples of acute conditions include heart attack, stroke and
traumatic injury. Traumatic injury may include traumatic brain and spinal
cord injury." Sz606 i177.
FF9. "Examples of chronic diseases or conditions include coronary
artery disease and any neurodegenerative disorders, such as those described
below." Sz606 i178.
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FF 10. "Reducing oxidative damage associated with atherosclerosis is
important since atherosclerosis is implicated in, for example, heart attacks
and coronary artery disease." Sz606 i-f 103.
FF 11. "Other conditions which can be treated in accordance with the
present invention include ... diabetes." Sz606 i-f 111.
FF 12. Inflammation associated with oxidative stress. Sz606 i-fi-1 102,
104, 107, 108; claim 41.
The Examiner stated that, while SZ606 describes treating oxidative
damage with peptides SS-31 and SS-20, Sz606 does not teach administration
of the peptides to treat metabolic syndrome as claimed. Final Act. i-f 9.
However, the Examiner cited Virsik for its teaching that metabolic diseases,
including diabetes, metabolic syndrome, hypertension, obesity, and
dyslipidemia, are associated with oxidative damage. Id. i-f 10. Thus, the
Examiner determined it would have been obvious to one of ordinary skill in
the art to treat metabolic syndrome with peptides SS-31 and SS-20 because
these peptides are known to treat oxidative damage and Virsik teaches the
association between oxidative damage and metabolic syndrome. Id. at 14.
The Examiner stated:
One of ordinary skill in the art would have been motivated to
use peptides SS-31 and SS-20 to treat metabolic syndrome
because it was known [as taught by Virsik] that oxidative
damage was associated with metabolic diseases which include
prediabetes, diabetes mellitus type I, diabetes mellitus type II,
metabolic syndrome, hypertension, obesity, and dyslipidemia
(Virsik et al. at abstract; p. 3, II. 12-33; p. 40, II. 13-14). Thus,
a treatment for oxidative damage in diabetes would be
indicative of the usefulness of treating oxidative damage in
patients with metabolic syndrome, hypertension, obesity, and
dyslipidemia.
Id. (page 7 of Final Act.)
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Appellant contends:
Virsik states only that persons having metabolic syndrome,
"may therefore benefit from improved antioxidant therapies."
Id. (emphasis added). The reference does not teach or suggest
the use of antioxidants for the treatment of metabolic syndrome
generally, and does not exemplify the use of propofol, or any
agent, in the treatment of metabolic syndrome.
Appeal Br. 9.
This argument does not persuade us that the Examiner erred. First,
the fact that Virsik stated "may" does not diminish its teaching because
Virsik' s disclosure constitutes a direction to try antioxidant therapy for
metabolic syndrome. Absolute predictability is unnecessary to establish
obviousness and the fact that Virsik made this suggestion indicates a belief
that it would work or would have at least been obvious to try with a
reasonable expectation of success.
To render a claim obvious, prior art cannot be "vague" and
must collectively, although not explicitly, guide an artisan of
ordinary skill towards a particular solution. Bayer Schering,
575 F.3d at 1347. Indeed, "most inventions that are obvious
were also obvious to try," id., and a combination is only
obvious to try if a person of ordinary skill has "a good reason to
pursue the known options." KSR, 550 U.S. at 421 [].When a
field is "unreduced by direction of the prior art," and when prior
art gives "no indication of which parameters were critical or no
direction as to which of many possible choices is likely to be
successful," an invention is not obvious to try. Bayer Schering,
575 F.3d at 1347 (citing In re O'Farrell, 853 F.2d 894, 903
(Fed. Cir. 1988)); see also Ortho-McNeil, 520 F.3d at 1364
(stating the number of options must be "small or easily
traversed").
Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1361 (Fed. Cir. 2011),
There is no evidence in this record that it would have required
additional direction or experimentation to have administered peptides SS-31
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Application 12/854,551
and SS-20 to successfully treat metabolic syndrome. Rather, it is
unchallenged that Sz606 teach administering the peptides to treat diseases
with oxidative damage. The only difference is that Sz606 doesn't explicitly
tell the skilled worker to do so for treating metabolic syndrome. However,
this missing information is supplied by Virsik because Virsik teaches
treating the oxidative damage associated metabolic syndrome, including
diabetes. Appellant did not dispute the latter teachings in Virsik. Appellant
has not established that using the peptides for treating metabolic syndrome
would require any more guidance than what is disclosed in Sz606 for
treating a subject for oxidative damage.
Appellant contends that one of ordinary skill in the art would not have
been motivated to have substituted the claimed peptides for propofol, the
chemical described in Virsik, given their chemical and structural
dissimilarity. 14 Appeal Br. 9.
However, as indicated by the Examiner (Final Act. i-fi-125-26), the
rejection is not based on the substitution of propofol for peptides SS-31 or
SS-20, but rather is based on the teachings in Virsik that metabolic
syndrome is "associated with oxidative stress and may therefore benefit
from improved antioxidant therapies." Virsik 42: 15-17. There is overlap in
the conditions described by Sz606 and Virsik as being caused by oxidative
damage (e.g., diabetes as in Sz606 i-f 111 and Virsik at 42: 15-17).
14 We note that in making this argument Appellant has also cited post-filing
date publications without establishing the information contained within the
publications was available on the filing date of the application. Thus, this
evidence has not been established to be pertinent to the obviousness issue
which is determined on the date when the application was filed, not years
later.
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Therefore, one of ordinary skill in the art would have had reason to believe
that a patient with metabolic syndrome would benefit from the peptide
treatment.
REJECTIONS BASED ON SZ306, SZ571, AND SZ987
The Examiner found that Sz306, Sz571, and Sz982 (collectively
"Sz306" since it is only necessary to reference the disclosure of Sz306 since
the other two patent publications have the same disclosure) describe treating
abnormal expression of the CD36 protein with the SS-31 and SS-20
peptides. Final Act. i-f 47. The Examiner acknowledged that the Sz306
patent does not disclose treating metabolic syndrome as claimed. Id.
However, the Examiner found it would have been obvious to one of ordinary
skill in the art to have utilized peptides SS-31 or SS-20 to treat metabolic
syndrome because abnormal expression of the CD36 protein is associated
with a number of the same diseases and conditions characteristic of
metabolic syndrome. Ans. 19. These diseases and conditions are disclosed
in the Sz306 patents as follows:
FF13.
Mammals in need of reducing CD36 expression include,
for example, mammals that have increased CD3 6 expression.
The increased expression of CD3 6 is associated with various
diseases and conditions. Examples of diseases and conditions
characterized by increased CD36 expression include, but are
not limited to atherosclerosis, inflammation, abnormal
angiogenesis, abnormal lipid metabolism, abnormal removal of
apoptotic cells, ischemia such as cerebral ischemia and
myocardial ischemia, ischemia-reperfusion, ureteral
obstruction, stroke, Alzheimer's Disease, diabetes, diabetic
nephropathy and obesity.
Sz306 i-f 119 (emphasis added).
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FF14.
Mammals in need of reducing CD36 expression also
include mammals suffering from complications of diabetes.
Some complications of diabetes include, in addition to
nephropathy, neuropathy, retinopathy, coronary artery disease,
and peripheral vascular disease associated with diabetes.
Sz306 i-f 120 (emphasis added).
As indicated by the Examiner, diabetes (FF4), abnormal lipid
metabolism (FF2, FF4, FF5, FF6, FF7), and obesity (FF2, FF4, FF5, FF6)
are among the diagnostic factors for metabolic syndrome. Ans. 18.
Consequently, one of ordinary skill in the art would have had reason to
administer SS-31 or SS-21 to patients with metabolic syndrome because the
peptides are known to treat the same conditions associated with the
syndrome. Ans. 44. In other words, since the peptides are known to treat at
least three of the diagnostic factors for metabolic syndrome, the skilled
worker would have recognized that they would be useful to treat a patient
diagnosed with metabolic syndrome.
In regard to the expectation of success, because the peptides are
known to treat at least three of the diagnostic factors for metabolic
syndrome, the skilled worker would have reasonably expected that they
would effectively treat a syndrome with the same symptoms. Ans. 44. In
addition, to the teaching in Sz306 that the peptide treat three of the
diagnostic factors for metabolic syndrome, the Examiner also found that
Sz306 also teaches that the peptides treat stroke (id.) which patients having
metabolic syndrome are at increased risk for (FFl, FF2), establishing that
the peptide are effective for treating the diseases which arise from metabolic
syndrome.
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REJECTIONS BASED ON NE638 & NE727
The Examiner found (Ans. 25) that Ne638 and Ne727 (collectively
"Ne638" since it is only necessary to reference the disclosure ofNe638 since
Ne727 has the same disclosure) describe treating insulin resistance and
"diabetes, pre-diabetes, related metabolic diseases, and complications arising
therefrom." Ne638 i-fi-16, 54, 59. Ne638 also discloses:
FF15.
The aromatic-cationic peptides of the present invention are
useful to prevent or treat disease. Specifically, the invention
provides for both prophylactic and therapeutic methods of
treating a subject at risk of (or susceptible to) a disorder or
having a disorder associated with insulin resistance. Insulin
resistance is generally associated with type II diabetes,
coronary artery disease, renal dysfunction, atherosclerosis,
obesity, hyperlipidemia, and essential hypertension.
Ne638 i-f 100 (emphasis added).
FF16.
In one aspect, the invention provides a method for preventing,
in a subject, a disease or condition associated with insulin
resistance in skeletal muscle tissues, by administering to the
subject an aromatic cationic peptide that modulates one or more
signs or markers of insulin resistance, e.g., body weight, fasting
glucose/insulin/free fatty acid, glucose tolerance (OGTT), in
vitro muscle insulin sensitivity."
Ne638 i-f 102.
The Examiner acknowledged that Ne638 does not specifically
disclose treating metabolic syndrome as claimed. Ans. 26. However, the
Examiner found it would have been obvious to one of ordinary skill in the
art to have utilized peptides SS-31 or SS-20 to treat metabolic syndrome
because several of the same conditions and diseases that Ne638 used to treat
are characteristic of metabolic syndrome. Id. at 44.
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As indicated by the Examiner and taught or suggested by the passages
reproduced above, N e63 8 teaches that the peptides are useful to treat insulin
resistance (FF2, FF3, FF4, FF5), obesity (FF2, FF4, FF5, FF6),
hyperlipidemia (FF2, FF4, FF5, FF6, FF7), and essential hypertension (FF2,
FF4), which are diagnostic factors for metabolic syndrome. Ans. 25.
Consequently, one of ordinary skill in the art would have had reason to
administer peptides SS-31 or SS-20 to patients with metabolic syndrome
because the peptides are known to treat the same diseases and conditions
associated with the syndrome. Ans. 44. In other words, because the
peptides are known to treat several of the diagnostic factors for metabolic
syndrome, the skilled would have recognized that they would be useful to
treat a patient diagnosed with metabolic syndrome. Significantly, insulin
resistance is characterized by Pi-Sunyer as "an underlying central
component of' metabolic syndrome and Ne638 teaches that peptides SS-31
and SS-20 can be used to treat insulin resistance. FF3, FF15, FF16. Ne638
also expressly teaches its peptides are useful for treating metabolic disease.
Ne638 i-f 59. Thus, the disclosure in Ne638 of treating insulin resistance and
metabolic disease suggest treating metabolic syndrome because metabolic
syndrome is a metabolic disease and insulin resistance is a central
component of the syndrome.
In regard to the expectation of success, because the peptides are
known to treat at least several diagnostic factors for metabolic syndrome,
particularly insulin resistance and metabolic diseases, the skilled worker
would have reasonably expected that they treat a syndrome with the same
symptoms. Ans. 44.
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CLAIM PREAMBLE
Appellant contends that the Examiner did not give weight to the claim
preamble requiring treatment of metabolic syndrome. Reply Br. 9; Appeal
Br. 7. Appellant asserts that the Examiner found "that the population of
diabetic patients described by a subset of cited references falls entirely
within the population of patients having metabolic syndrome, and equates
the treatment of metabolic syndrome with treatment of diabetes." Reply Br.
9--10.
Appellant's arguments might be applicable if the Examiner had made
an anticipation rejection based solely on inherency, i.e., that treating one of
the conditions in the Szeto or Neufer patent publications would also
"inherently" have treated metabolic syndrome. However, the rejection is
based on § 103. The Examiner made a clear statement in the Final Action
that linkages between the conditions disclosed in the Szeto and Neufer
publications (e.g., "cardiovascular system, diabetes," "complications related
to insulin resistance including hyperinsulinemia, type II diabetes,
hypertension, cardiovascular disease, and coronary artery disease") and
metabolic syndrome "were known in the prior art," providing "a motivation
and expectation ... that the claimed peptides would be useful in treating
metabolic syndrome." Final Act. 12; see also page 13. Thus,
notwithstanding whether the Examiner made the type of inherency
statements cited by Appellant, in the Final Office Action and the Answer, in
response to Appellant's arguments, the Examiner stated that the linkages
between the conditions in the cited prior art and metabolic syndrome,
suggested the use the peptides to treat metabolic syndrome.
Appellant also states:
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The use of aromatic-cationic peptides to treat conditions
associated with metabolic syndrome, as disclosed in the Szeto
and Neufer references, does not suggest that the peptides would
be effective in treating metabolic syndrome itself, which is a
complex, multifaceted disorder.
Reply Br 13.
Appellant's argument has not taken the full disclosures of the Szeto
and Neufer publications, combined, into consideration. The Neufer patent
publications, as explained above, teach treatment of insulin resistance which
is a central component of metabolic syndrome and the treatment of
metabolic disease; the Szeto patent publications describe treatment of
several of the diagnostic criteria for metabolic disease. These disclosures,
along with Virsik, would have made it obvious at the time of the invention to
have used the peptides to treat metabolic syndrome.
SUMMARY
For the foregoing reasons, we affirm:
Each of the Examiner's rejections based on Sz606 and Sz711 of
claims 1, 3-5, 7, 8, and 11-15.
Each of the Examiner's rejections based on Sz306, Sz571, and Sz987
of claims 1, 3-5, 7, 8, and 11-15.
Each of the Examiner's rejections based on Sz606 and Sz711 of
claims 1, 3-5, 7, 8, and 11-15.
Each of the Examiner's obviousness-type double patenting rejections.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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