Ex Parte Hennen

Patent Trial and Appeal Board

May 10, 2017

12906883 (P.T.A.B. May. 10, 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.
12/906,883 10/18/2010 William J. Hennen 27047-5474USC1 1952
128128 7590 05/12/2017
Durham Jones & Pinegar, P.C.
Intellectual Property Law Group
3301 North Thanksgiving Way, Suite 400
Lehi, UT 84043
EXAMINER
KIM, TAEYOON
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
05/12/2017 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):
ipmail@djplaw.com
ckoy@djplaw.com
jpitt@djplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM J. HENNEN
Appeal 2016-002575
Application 12/906,883
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
nutritional supplement. The Examiner rejected the claims as not directed to
patent eligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
Statement of the Case
Background
“The present invention relates generally to compositions, including
nutritional supplements, for use in improving cardiovascular health and,
1 Appellant identifies the Real Party in Interest as 4LIFE RESEARCH, LC
(see App. Br. 2).
Appeal 2016-002575
Application 12/906,883
more specifically, to compositions that may be useful for preventing
arteriosclerosis” (Spec. 12).
The Claims
Claims 1, 4, 11, 12, 14—16, 18, 50, 53, and 59—83 are on appeal.
Claim 1 is representative and reads as follows:
1. A nutritional supplement, comprising:
at least one vitamin;
at least one mineral;
at least one herb or plant extract selected from the group
comprising Butcher's Broom, Ginkgo biloba, hawthorn, garlic,
red rice yeast extract, resveratrol and ginger; and a
cardiovascular support component, consisting of:
an inflammation-reducing component for
decreasing an amount of inflammation in blood vessels
of a subject, comprising transfer factor;
at least one low density lipoprotein (LDL)
receptor binding component;
at least one blood cholesterol reduction
component;
at least one blood flow enhancing component;
and
at least one antioxidant.
The issue
The Examiner rejected claims 1, 4, 11, 12, 14—16, 18, 50, 53, and 59—
83 under 35 U.S.C. § 101 as directed to a judicial exception (i.e., a law of
nature, a natural phenomenon, or an abstract idea) without significantly
more (Ans. 2—3).
The Examiner finds:
Because the claims are directed to a composition comprising
vitamins, mineral, herb or plant extract, transfer factor, a low
density lipoprotein receptor-binding component (lysine,
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Appeal 2016-002575
Application 12/906,883
magnesium lysinate), a blood cholesterol reduction component,
a blood flow-enhancing component (niacinamide), and an
antioxidant (beta-carotene, vitamin E, coenzyme Q10), and the
ingredients of the composition are nature-based products, the
nature-based product is analyzed to determine whether it has
markedly different characteristics.
(Ans. 2—3). The Examiner finds “[tjhere is no indication in the specification
that the claimed mixture/combination of naturally occurring products has
any characteristics (structural, functional or otherwise) that are significantly
different from naturally occurring counterparts” (id. at 3).
The Examiner concludes “[b]ecause the claims do not include
additional elements that are sufficient to amount to significantly more than
the judicial exception ... the claims do not qualify as eligible subject
matter” (id.).
The issue with respect to these rejection is: Does the evidence of
record support the Examiner’s conclusion that the nutritional supplement of
claim 1 is not directed to patent eligible subject matter?
Findings of Fact
1. The Specification teaches “a component of mammalian, avian,
and other immune systems known as ‘transfer factor’” (Spec. 112).
2. The Specification teaches:
Due to the presence of transfer factor in the composition, the
composition enlists the immune system of a treated subject
against pathogens that may cause inflammation or lesions that
may lead to cardiovascular disease. Other components of such
a composition may act to prevent Lp(a) from binding to LDL
receptors on the walls of blood vessels, prevent and/or repair
damage to the blood vessels, reduce inflammation, improve
blood flow, reduce blood cholesterol levels, and/or prevent fats
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Appeal 2016-002575
Application 12/906,883
from oxidizing and, thus, from sticking to the walls of blood
vessels.
(Spec. 114).
3. The Specification teaches “transfer factor increase[s] the
activity of natural kill[er] cells, reducing levels of C. pneumoniae, H. pylori,
HSV-1 and HSV-2. It follows that the role that each of these pathogens
plays in cardiovascular disease would also be reduced or eliminated by
therapy with . . . transfer factor” (Spec. 122).
4. The Specification teaches ten anecdotal examples of treatment
with the exemplary composition, including a
fifty-four (54) year old male suffering from angina had three
coronary arteries that were occluded by about 75% to about
80%. He began therapy with four capsules of the
EXEMPLARY COMPOSITION twice daily (i.e., eight
capsules per day), along with three capsules of TRANSFER
FACTOR™ each day. Within four months, the occlusion or
blockage of the same three arteries had reduced to about 30% to
about 40%.
(Spec. 149).
Principles of Law
On issues of patent eligibility, we “first determine whether the claims
at issue are directed to a patent-ineligible concept,” such as laws of nature,
natural phenomena, and abstract ideas. Alice Corp. Pty Ltd. v. CIS Bank
Int’l, 134 S.Ct. 2347, 2355 (2014).
If this threshold is met, we move to the second step of the inquiry and
“consider the elements of each claim both individually and ‘as an ordered
combination’ to determine whether the additional elements ‘transform the
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Appeal 2016-002575
Application 12/906,883
nature of the claim’ into a patent-eligible application.” Id. See also Ass n
for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117
(2013) (holding isolated genomic DNA to be unpatentable under § 101
where, in contrast to bacteria that had been engineered to include additional
plasmids and to degrade oil, “markedly different characteristics from any
found in nature,” the genomic DNA had only been separated from its
surrounding genetic material, citing Diamond v. Charkarbarty, 447 U.S.
303,310 (1980)).
Analysis
Appellant acknowledges that “the ingredients of the various
compositions recited by the claims of the ’883 application are themselves
naturally occurring” but contends “independent claim 1 recites at least eight
different elements . . . This complex combination . . . was created by man,
not by nature, and cannot be found in combination in any natural
environment” (App. Br. 5). Appellant contends “the claimed combinations
of ingredients includes additional elements . . . that are sufficient to amount
to significantly more than the judicial exception” (Reply Br. 3 4).
The Examiner responds
the claimed combination as a whole does not add significantly
more to each naturally occurring ingredient. The specification
does not indicate that the claimed combination of naturally
occurring products provide any markedly different
characteristics compared to the naturally occurring counterpart
products in nature. Therefore, the claimed combination is
merely a list of naturally occurring products without any
improvement or change in their characteristics significantly
different from what occurs in nature.
(Ans. 4).
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Appeal 2016-002575
Application 12/906,883
We begin our analysis with the first step of the Mayo analysis, and we
agree with both the Examiner and Appellant that the individual components
that compose the nutritional supplement of claim 1 represent naturally
occurring products. Just as “separating [a] gene from its surrounding genetic
material is not an act of invention” in Myriad, there is no principled
distinction why the individual isolations of a vitamin, a mineral, a plant
extract, transfer factor, or the other components that together comprise the
nutritional supplement represent anything other than naturally occurring
products.
We next address whether the combination of these naturally occurring
products into the claimed nutritional supplement results in a markedly
different characteristic necessary to transform the nature of the claim into a
patent-eligible application. Here, the USPTO Subject Matter Eligibility
Guidelines (May 2016) (“Guidelines”) are instructive, and in particular,
Example 30, which relates to dietary compositions.2 Example 30 provides
several claims, including claim 1 to a novel sweetener and water, and claim
3 to the novel sweetener with a compound N that improves taste (see
Guidelines 18). The Guidelines find claim 1 ineligible because the
combination with water does not result in anything “significantly more” but
find claim 3 patent eligible because the combination with compound N
“results in the claimed mixture being distinct from its natural counterparts in
a way that is relevant to the nature of the invention as a dietary sweetener”
(Guidelines 21).
2 USPTO Subject Matter Eligibility Guidelines, https://www.uspto.gov/sites/
default/files/documents/ieg-may-2016-ex.pdf 1—31(May 2016).
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Application 12/906,883
While any of these components alone may be naturally occurring, the
combination of all the claimed elements does not occur naturally, as transfer
factor derived from animal sources would not be found naturally with herb
or plant extracts. Moreover, the Specification teaches that the combination
of these components results in a composition for treatment and prevention of
arteriosclerosis (FF 2) and provides examples of such treatment (FF 4). Just
as the combination of the sweetener with compound N yielded a new result
of reduced bitter aftertaste in Example 30, so too, the Specification asserts
that the combination of claim 1 is results in improved treatment of
arteriosclerosis (FF 2), resulting in a composition that is “significantly more”
than the natural products alone and markedly different than the natural
products. We note that the Examiner has presented no evidence rebutting
the Specification’s disclosure in this regard.
The instant facts also differ from Funk, which determined that the use
of six species of root-nodule bacteria “in combination does not improve in
any way their natural functioning. They serve the ends nature originally
provided and act quite independently of any effort of the patentee.” Funk
Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). The
Specification states that the natural function of transfer factor is to antigen-
specifically engage the immune system while other components directly act
on cholesterol reduction or function as antioxidants (FF 2). The
Specification teaches that the combination results in reduced arteriosclerosis
(FF 4), something different than the natural functioning of either transfer
factor, the herb or plant extracts, or the antioxidants, among other
components. Therefore, unlike the situation in Funk, the nutritional
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Appeal 2016-002575
Application 12/906,883
supplement of claim 1 is “significantly more” than the natural products alone
and markedly different than the natural products alone.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the nutritional supplement of claim 1 is not directed to patent eligible
subject matter.
SUMMARY
In summary, we reverse the rejection of claims 1,4, 11, 12, 14—16, 18,
50, 53, and 59-83 under 35 U.S.C. § 101.
REVERSED
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