Ex Parte Pietrzkowski

Patent Trial and Appeal Board

May 11, 2017

14118865 (P.T.A.B. May. 11, 2017)

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.
14/118,865 05/14/2014 Zbigniew Pietrzkowski 100700.0067US 5570
24392 7590
FISH & TS ANG LLP
ROBERT D. FISH
2603 Main Street
Suite 1000
Irvine, CA 92614-6232
05/15/2017 EXAMINER
MAIER, LEIGH C
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
05/15/2017 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):
rfish @ fishiplaw. com
patents @ fishiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZBIGNIEW PIETRZKOWSKI
Appeal 2016-006477
Application 14/118,8651
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of modulating the concentration of a protein associated with metabolic
syndrome, which have been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
“Metabolic syndrome, also known as insulin resistance syndrome, is a
collection of disorders that, in combination, greatly increase an individual’s
chances of developing diabetes and cardiovascular disease.” (Spec. 13.)
1 Appellant identifies the Real Party in Interest as VDF FutureCeuticals, Inc.
(Appeal Br. 2.)
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Application 14/118,665
“[AJspects of the syndrome, [include] for example, inflammation that is
associated with atherosclerosis and cardiovascular disease.” {Id. 14.)
Generally speaking, metabolic syndrome is characterized by
obesity, difficulty in regulating glucose levels, elevated blood
pressure, high serum triglyceride levels, and decreased HDL
levels. Difficulties in regulating the body’s glucose levels
include type II diabetes, which is characterized by a decrease in
the body’s response to insulin. Biological markers for
inflammation, such as C-reactive protein and YLK-40, may be
present at elevated levels in affected individuals and are often
associated with the development of atherosclerosis.
(Id. f 3.) According to Appellant, “there remains a growing need for
inexpensive and conveniently administered compounds that are effective in
modulating endogenous substances related to metabolic syndrome.” {Id. 1
8.) Appellant’s invention is directed at “a method . . . that modulates the
concentration and/or activity of an endogenous substance that is associated
with metabolic syndrome (or related conditions) by administration of a boro-
carbohydrate complex to a mammal, typically at an effective dosage and
schedule.” {Id. 110.)
Claims 1—20 are on appeal. Claims 1, 8, and 15 are representative and
read as follows:
1. A method of modulating the concentration of a protein associated
with metabolic syndrome comprising:
identifying an individual as having a condition associated with
metabolic syndrome; and
administering to the individual a boro-carbohydrate complex at a
dosage and schedule effective to reduce the concentration of under-
carboxylated osteocalcin in blood.
(Appeal Br. 18.)
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8. A method comprising:
identifying an individual as having a condition associated with
metabolic syndrome; and
administering to the individual a boron-carbohydrate complex at a
dosage and schedule effective to increase the concentration of adiponectin in
blood.
(Appeal Br. 18—19.)
15. A method comprising:
identifying an individual as having a condition associated with
metabolic syndrome; and
administering to the individual a boro-carbohydrate complex at a
dosage and schedule effective to reduce the concentration of YKL-40 in
blood.
(Appeal Br. 19.)
The following ground of rejection by the Examiner is before us on
review:
Claims 1—20 under 35 U.S.C. § 103 as unpatentable over Miljkovic,2
Gottlieb3 and Lopez Mas4.
DISCUSSION
The Examiner finds that “Gottlieb teaches that metabolic syndrome is
an inflammatory state as evidenced by markers such as C-reactive protein
and fibrinogen,” as well as including dyslipidemia. (Final Action 3.) The
Examiner further finds that Gottlieb teaches treatment that mitigates chronic
inflammation. (Id.)
2 Miljkovic et al., Calcium Fructoborate: Plant-Based Dietary Boron for
Human Nutrition, 6 J. Dietary Supplements 211 (2009).
3 Gottlieb, M., US 2004/0186059 Al, published Sept. 23, 2004.
4 Lopez Mas et al., WO 2009/013596 A2, published Jan. 29, 2009.
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The Examiner finds that “Lopez Mas teaches that metabolic syndrome
comprises a cluster of risk factors, including dyslipidemia” and that patients
with this syndrome have an increased risk of cardiovascular disease. (Id.)
The Examiner further finds that Lopez Mas teaches treatment with products
having antioxidant functionality.
The Examiner finds that Miljkovic teaches that a diet enriched with
calcium fructoborate “has a positive effect on lipid metabolism, causing a
decrease in cholesterol levels.” (Id.) The Examiner further finds that
Miljkovic teaches calcium fructoborate “is anti-inflammatory, causing a
decrease in C-reactive protein and fibrinogen,” as well as having “value as
an antioxidant.” (Id.) The Examiner additionally finds that Miljkovic
“suggests the use of calcium fructoborate in metabolic disorders, generally.”
(Id.) The Examiner also notes that Miljkovic discloses “the administration
of 6 or 12 mg/day of [calcium fructoborate] to patients for 8 weeks in a
method relying on the anti-inflammatory effect.” (Id. at 4.)
In summary, the Examiner finds that it is known from Gottlieb and
Lopez Mas that anti-inflammatory, antioxidant, and anti-dyslipidemic agents
are useful in the treatment of metabolic syndrome and from Miljkovic that
calcium fructoborate has anti-inflammatory, antioxidant, and anti-
dyslipidemic effects, which are physiological activities shown to be
beneficial in the treatment of metabolic syndrome. (Ans. 5, 8.) In light of
these teachings of the prior art, the Examiner finds that it would have been
obvious to one of ordinary skill in the art to administer calcium fructoborate
to a person having metabolic syndrome, in the amounts taught to be
administered by Miljkovic, with a reasonable expectation of success, and
that, in so doing, one would reduce the concentration in the blood of the
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patient of under-carboxylated osteocalcin and YKL-40, and increase the
concentration in the blood of the patient of adiponectin as recited in the
claims. (Final Action 4; Ans. 8.) The Examiner notes that it would be
expected that one would reduce the concentration in the blood of the patient
of under-carboxylated osteocalcin and YKL-40, and increase the
concentration in the blood of the patient of adiponectin as recited in the
claims because the dosage range taught for administration by Miljkovic
overlaps with dosages recited in the claims (Ans. 6, 8), and that “it would be
within the scope of the artisan to optimize the dosage for the treatment based
on the antiinflammation and antioxidant effect through routine
experimentation” (Final Action 4).
We agree with the Examiner’s factual findings, which properly
ascertained the scope and content of the prior art and the differences
between the claimed invention and that prior art, contrary to Appellant’s
allegation (Appeal Br. 7—10), and conclusion that the method of modulating
the concentration of a protein associated with metabolic syndrome as recited
in claims 1, 8, and 15 is rendered obvious by the art cited by the Examiner.
Each of these claimed methods has two steps. One step is to identify an
individual as having a condition associated with metabolic syndrome, and
the other is to administer a “boro[n]-carbohydrate” complex to that
individual. It is true that the administration has to effect a reduction or an
increase in the concentration of a particular recited protein, however, it is the
Examiner’s position that such a result is inherent in the obvious combination
of Miljkovic, Gottlieb, and Lopez Mas for treating patients with metabolic
syndrome with calcium fructoborate.
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The Examiner provided well-founded reasons, premised on the level
of ordinary skill in the art, which although not specifically delineated, was in
evidence by the prior art (Appeal Br. 10—11), for combining the teachings of
Miljkovic, Gottlieb, and Lopez Mas for treating patients with metabolic
syndrome with calcium fructoborate. Gottlieb teaches that chronic
inflammation, as evidenced by elevated C-reactive protein and serum
fibrinogen, and dyslipidemia are components of metabolic syndrome, which
is a syndrome that can progress to coronary artery disease and/or diabetes
mellitus. (Gottlieb ]Hf 3, 5, 50, 51.) Gottlieb teaches controlling
inflammation to defer progression of metabolic syndrome to diabetes
mellitus and coronary heart disease. (Gottlieb Abs.) Lopez Mas also
teaches that metabolic syndrome is associated with an increased risk of
cardiovascular disease. (Lopez Mas 2.) And Lopez Mas teaches preventing
or treating cardiovascular diseases and metabolic syndrome with the
antioxidant phenolic compound, hydroxytyrosol. (Lopez Mas 9—10.)
Miljkovic suggests that calcium fructoborate would be beneficial to treat
metabolic disorders, such as dislipidemy, that result in an abnormal amount
of lipids or fats in the blood. (Miljkovic 221—22.) Miljkovic also teaches
that calcium fructoborate is an anti-inflammatory, including activity to
reduce C reactive protein and fibrinogen, as well as having antioxidant
properties, and would also be beneficial in treating cardiovascular disorders.
(Miljkovic 218-220, 221-222.)
Consequently, we agree with the Examiner, that Miljkovic teaches
that calcium fructoborate has “physiological activities shown to be beneficial
[in Gottlieb and Lopez Mas] in the treatment of metabolic syndrome.” (Ans.
5.) That is so regardless of Appellant’s point that “inflammation may be
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related to hundreds of other conditions, diseases, or syndromes” besides
metabolic syndrome (Reply Br. 6). The prior art (Gottlieb) links elevated C
reactive protein and fibrinogen levels to chronic inflammation and a
component of metabolic syndrome. And the prior art (Miljkovic 221—222)
links calcium fructoborate with the ability to lower C reactive protein and
fibrinogen levels and to that being anti-inflammatory activity.
While it is true that the claims are not directed to treating metabolic
syndrome (Reply Br. 4—5), they are directed at the patient population that
has a “condition associated with metabolic syndrome,” which the prior art
teaches includes cardiovascular disease, and/or diabetes (Lopez Mas 2, 9),
and/or atherogenic dyslipidemia (Gottlieb 1 50, Lopez Mas 2). And,
Miljkovic suggests that provision of calcium fructoborate will be beneficial
to that patient population, as just discussed.
In light of the combined teachings of the prior art, we also agree with
the Examiner that there was ample reason from the prior art to treat a patient
that has metabolic syndrome (including a condition associated with
metabolic syndrome) with anywhere between 6 and 12 mg of calcium
fructoborate, a dosage shown in Miljkovic to result in anti-inflammatory
activity (Miljkovic 218), with a reasonable expectation of achieving
therapeutic activity. “Obviousness does not require absolute predictability
of success ... all that is required is a reasonable expectation of success.” In
re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). The prior art teaches a
number of physiological activities that could be targeted to ameliorate
metabolic syndrome and resultant progression to other diseases such as
cardiovascular disease, and dyslipidemia, and Miljkovic teaches calcium
fructoborate has a number of those relevant activities (antioxidant, anti-
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inflammatory, and lowering cholesterol levels), and even suggests use in
“the diet of patients with cardiovascular and dislipidemy disorders.”
(Miljkovic 222).
We disagree with Appellant that the Examiner did not provide a
factual finding “that modulation of under-carboxylated osteocalcin,
adiponectin, or YKL-40 naturally or even necessarily flows from anti­
inflammatory effect of any drugs or treatment methods” (Reply Br. 6—7; see
also Appeal Br. 7). The Examiner found that the effective result claimed
would have inherently been achieved. (Ans. 8; See also Final Action 4.)
We agree.
“[Ijnherency may supply a missing claim limitation in an obviousness
analysis . . . when the limitation at issue is the ‘natural result’ of the
combination of prior art elements.” Par Pharm. v. TWI Pharms., Inc., 773
F.3d 1186, 1194 (Fed. Cir. 2014); see also Santarus, Inc. v. Par Pharm.,
Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012) (finding method of treating
claims obvious from the prior art even though the claimed achievement of
specific blood semm concentration levels was not disclosed in the prior art).
Given that Miljkovic teaches a dosage range of calcium fructoborate
to administer to achieve a beneficial effect for treating a condition associated
with metabolic syndrome (6 mg to 12 mg) overlaps with the claimed
amounts that are indicated to “reduce the concentration of under-
carboxylated osteocalcin in blood,” i.e., at least 10 mg (claim 4), “to increase
the concentration of adiponectin in blood,” i.e., at least 10 mg (claim 11),
and “to reduce the concentration of YKF-40 in blood,” i.e., at least 0.01 mg
(claim 18), whether or not recognized by the prior art, we agree with the
Examiner that the effective result claimed would have inherently been
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achieved. That is so because Appellant’s dependent claims instruct that the
result of the dosage taught to be administered by Miljkovic is a result
necessarily achieved by the administered amount; as such, it is both inherent
and not an additional requirement imposed by the claims. See Alcon
Research, Ltd. v. ApotexInc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (“As in
In re Kubin, this claim language does not impose any additional requirement
because the ’805 patent itself defines mast cell stabilization as a property
that is necessarily present at those concentrations.”); In re Kubin, 561 F.3d
1351, 1357—58 (Fed. Cir. 2009) (“Even if no prior art of record explicitly
discusses the [limitation], the ... application itself instructs that [the
limitation] is not an additional requirement imposed by the claims on the
[claimed invention], but rather a property necessarily present in the [claimed
invention].”)
For the foregoing reasons, we disagree with Appellant that the
Examiner’s rejection “fail[s] to provide any logical link and explicit analysis
in support of the combination rationale to combine the cited references”
(Reply Br. 6; see also Appeal Br. 12—15).
That the purpose for combining the references is different from
Appellant’s (Reply Br. 4—5), does not render the Examiner’s rejection
improper. Prima facie obviousness does not require prior art references to
recognize or even suggest the problem that applicant attempted to solve. In
re Beattie, 91A F.2d 1309, 1312 (Fed. Cir. 1992.) (“As long as some
[reason,] motivation or suggestion to combine the references is provided by
the prior art taken as a whole, the law does not require that the references be
combined for the reasons contemplated by the inventor.”); In re Kemps, 97
F.3d 1427, 1430 (Fed. Cir. 1996) (“Although the motivation to combine here
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differs from that of the applicant, the motivation in the prior art to combine
the references does not have to be identical to that of the applicant to
establish obviousness.”) In other words, “[i]n determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls.” KSR Int 7 Co. v. Teleflex
/«c., 550 U.S. 398,419 (2007).
Appellant’s argument that “none of the references cited by the
Examiner discloses any of [the] three proteins recited” and that “[wjithout
teaching [the] modulation [of the proteins recited] in the cited art, the
claimed subject matter cannot be taught or obvious” (Reply Br. 5) is also not
persuasive. That Appellant recites the use of a boro-carbohydrate complex
in the same patient population but for a different purpose to achieve a result
not discussed in the prior art (Appeal Br. 16) does not render the claimed
method nonobvious. SeeAlcon, 687 F.3d at 1369.
The district court’s fact finding that the prior art did not teach
that olopatadine would stabilize human conjunctival mast cells,
and indeed taught away from using olopatadine for this
purpose, is not clearly erroneous. It is, however, not the only
motivation to arrive at the claimed invention. A person of
ordinary skill in the art at the time of invention would have
been motivated to use olopatadine to treat human eye allergies
as claimed for its established antihistaminic efficacy. Given that
the patent defines, and expressly claims, olopatadine
concentrations that are “therapeutically effective” to stabilize
conjunctival mast cells, Kamei’s disclosure of overlapping
concentrations, even if for a different purpose, meets these
claim limitations.);
In reLintner, 458 F.2d 1013, 1016 (CCPA 1972) (“The fact that appellant
uses sugar for a different purpose does not alter the conclusion that its use in
a prior art composition would be prima facie obvious from the purpose
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disclosed in the references.”) As just discussed, the Examiner provided the
requisite motivation to establish prima facie obviousness of administering a
boro-hydrate complex to an individual having a condition associated with
metabolic syndrome, which we conclude would inherently result in the
claimed reduction or increase of the specified proteins of the claims, given
that the administration dosage suggested by the prior art overlaps with the
specifically claimed amount recited in Appellant’s claims to achieve that
purpose. Thus, the positive steps recited in Appellant’s claimed processes
are rendered obvious by the prior art cited by the Examiner and would
inherently achieve the claimed result.
Claims 2—7, 11—14, and 16—20 have not been argued separately and
therefore fall with claims 1, 8, and 15. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1—20 under 35 U.S.C. § 103 as
unpatentable over Miljkovic, Gottlieb and Lopez Mas.
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).
AFFIRMED
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