Ex Parte BHAGAT

Patent Trial and Appeal Board

Dec 4, 2018

13332251 (P.T.A.B. Dec. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/332,251 12/20/2011
36844 7590 12/06/2018
Cermak Nakajima & McGowan LLP
127 S. Peyton Street, Suite 200
ALEXANDRIA, VA 22314
FIRST NAMED INVENTOR
Urvashi BHAGAT
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.
218-001 5463
EXAMINER
HEYER, DENNIS
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/06/2018 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):
CGOODE@cnmiplaw.COM
IP@cnmiplaw.com
ACERMAK@cnmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte URV ASHI BHAGAT
Appeal2019-000388
Application 13/332,251
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
JOHN G. NEW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method of preparing a lipid-containing formulation for a subject. The
Examiner rejected the claims as indefinite, as anticipated, and as lacking
patentable subject matter under 35 U.S.C. § 101. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.
1 Appellant identifies the Real Party in Interest as Asha Nutrition Sciences,
Inc. (App. Br. 3).
2 We have considered and herein refer to the Specification of Dec. 20, 2011
("Spec."); Final Office Action of Dec. 21, 2016 ("Final Act."); Appeal Brief
of May 7, 2018 ("App. Br."); Examiner's Answer of Aug. 16, 2018
("Ans."); and Reply Brief of Oct. 15, 2018 ("Reply Br.").
Appeal2019-000388
Application 13/332,251
Statement of the Case
Background
"Linoleic acid (LA) and Alpha-linolenic Acid (ALA) are the
precursors for all omega-6 and omega-3 fatty acids. It is well established
that LA and ALA are 'essential' fatty acids" (Spec. ,r 4). "Dietary
deficiency or excess of the two essential fatty acids may cause many
illnesses" (id.). "Numerous studies provide evidence for the prophylaxis and
treatment of medical conditions using supplementation with omega-3 fatty
acids and recommendations to reduce omega-6 consumption" (id. ,r 6). "The
traditional emphasis on increasing omega-3 and reducing omega-6
consumption often does not result in satisfactory relieves because of the
uncertainties introduced by dietary and demographic factors" (id. ,r 7).
The Specification teaches "methods for prophylaxis and/ or treatment
of medical conditions linked with an imbalance in one or more lipids within
context of other factors" (Spec. ,r 8). The Specification teaches "methods
that use more advantageous sources of omega-6 fatty acids, in the presence
of nutritionally adequate omega-3 fatty acids" (id.).
The Claims
Claims 94, 95, 101, 108, 116, 119, 122-125, 128-132, 134, 137, 139,
140, 145-150, 153-166, 168, 171, 177, and 178 are on appeal. 3 Claim 94 is
representative and reads as follows:
3 We note that claim 172 is listed as "previously presented" in the Claims
Appendix. However, claim 172, added in the Amendment filed Jan. 4, 2013,
was identified as withdrawn in the Final Action mailed Apr. 16, 2013 (see
Final Act. 4/16/2013 at 2 "Claims 95, 102-104, 107-108, 112-114, 116,
118-119, 121-125, 128-137, 139-140, and 142-172 are withdrawn as being
drawn to nonelected species.").
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Appeal2019-000388
Application 13/332,251
94. A method of preparing a lipid-containing formulation for
a subject, comprising:
combining daily amounts of fatty acids for the subject
based on one or more factors selected from: age of the subject,
gender of the subject, diet of the subject, the body weight of the
subject, physical activity level of the subject, lipid tolerance of
the subject, medical conditions of the subject, family medical
history of the subject, and ambient temperature range of the
subject's living area,
wherein the formulation comprises omega-6 and omega-
3 fatty acids, and wherein the ratio of omega-6 to omega-3 fatty
acids and/or their amounts are controlled based on the one or
more factors; wherein, the formulation provides a dosage of
omega-6 and omega-3 at an omega-6 to omega-3 ratio of:
4: 1 or greater, wherein dosage of omega-6 fatty acids is
not more than 40 grams; or
1: 1 to 10: 1 if the subject has a diet of low antioxidants
and/or low phytochemicals; or
4:1 to 45:1 if the subject has a diet of high antioxidants
and/or high phytochemicals; or
2:1 to 30:1 if the subject has a diet of high seafood; or
1:1 to 45:1 based on lipid tolerance of the subject; or
1: 1 to 50: 1 if the subject has a condition wherein gradual
increase of omega-6 and/or gradual withdrawal of omega-3 is
necessary; or
wherein, the fatty acid content is matched to Table 6;
wherein the formulation produced by the method is not a
specific variety of a fruit, a vegetable, a grain, a legume, a nut,
or a seed.
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Appeal2019-000388
Application 13/332,251
The Rejections
A. The Examiner rejected claims 94, 95, 101, 108, 116, 119, 122-125,
128-132, 134,137,139,140, 145-150, 153-166, 168,171, 177,and 178
under 35 U.S.C. § 112, second paragraph (Ans. 4--5).
B. The Examiner rejected claims 94, 95, 101, 108, 116, 119, 122-125,
128-132, 134,137,139,140,145, 147-149, 153-157, 159-162, 164--166,
168, 171, 177, and 178 under 35 U.S.C. § 101 (Ans. 6-13).
C. The Examiner rejected claims 94, 95, 101, 108, 116, 119, 122-125,
128-132, 134,137,139,140,145, 147-149, 153-157, 159-162, 164--166,
168, 171, 177, and 178 under 35 U.S.C. § 102(b) as anticipated by Olive
Oil4 and Olive Oil Nutritional Profile5 (Ans. 14--20).
A. 35 US.C. § 112, second paragraph
The Examiner finds:
The terms "high" and "low" are relative terms and it is
unclear to the Examiner how high or low the amounts of
antioxidants, phytochemicals and or seafood is required in the
diet of a subject to meet said limitations. The claims do not
recite any amounts of antioxidants, phytochemicals or seafood.
As such, one of ordinary skill would be unable to discern
whether an amount of antioxidants, phytochemicals or seafood
in the diet of a subject as disclosed in the prior art falls within
the scope of "high" or "low."
(Ans. 5.)
4 Olive Oil, http://web.archive.org/web/20070713174214/
http://www.whfoods.com/ genpage. php?pfriendly= 1 &tname=foodspice&dbi
d=132 (2007).
5 Olive Oil Nutritional Profile,
http://web.archive.org/web/20070714054939/http://www.whfoods.com/genp
age.php?pfriendly= 1 &tname=nutrientprofile&dbid= 110 (2007).
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Appeal2019-000388
Application 13/332,251
Appellant contends the Specification "provides guidance for
recognizing high-antioxidant diets, high-phytochemical diets, high seafood
diets. The specification also teaches that omega-6 and omega-3 fatty acid
metabolism and requirements are affected by a number of antioxidants and
phytochemicals, and how to adjust the formulation accordingly" (App. Br.
11 (citing Spec. ,r 33)). Appellant also points to teachings in the art
regarding the use of "high" and "low" (see App. Br. 11-12) as well as a
statement by Dr. Erickson regarding "high" and "low" (see App. Br. 13).
We agree with Appellant. The Supreme Court articulated the test for
indefiniteness as "requir[ing] that a patent's claims, viewed in light of the
specification and prosecution history, inform those skilled in the art about
the scope of the invention with reasonable certainty." Nautilus, Inc. v.
Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). "As long as claim terms
satisfy this test, relative terms and words of degree do not render patent
claims invalid." One-E-Way, Inc. v. International Trade Commission, 859
F.3d 1059, 1063 (Fed. Cir. 2017). "To determine whether a particular term
is indefinite, ' [ o ]ne must bear in mind ... that patents are "not addressed to
lawyers, or even to the public generally," but rather to those skilled in the
relevant art."' Id. ( citing Nautilus, 572 U.S. at 909).
The Examiner provides no evidence that the terms "high" and "low"
in relation to dietary components would have been indefinite to one of
ordinary skill in the art. In contrast, as explained in more detail below,
Appellant provides several references that use the terms "high" and "low"
with respect to dietary compositions and statements by Dr. Erickson
specifically assert that the skilled artisan would have understood the
meaning of these relative terms.
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Appeal2019-000388
Application 13/332,251
The Specification uses the terms "high" and "low" relative to dietary
components, for example teaching "an individual with a low-antioxidant
low-phytochemical herbivorous diet, a low-antioxidant low-phytochemical
ovo-lacto vegetarian diet, a low-antioxidant low-phytochemical vegan diet,
or a low-antioxidant low-phytochemical omnivorous diet may be
administered related compositions" (Spec. ,r 33).
Table 1 of Simopolous, 6 reproduced in part below, shows specific
values given for the terms "high" and "low" in the context of omega 6 and
omega 3 fatty acids, as well as for other dietary elements:
F,~t
High
High (2.3 g/d)
649
(: :l57
High
High
1.'1etier;:te to high
Lo~:v ( 0 ,2. g/d.J
Hlgh {12_G)
1.-~4-.2.0R
(>149-0-205
Dr. Erickson stated, in Applicant's Interview Summary:
The concept of "high" and "low" of nutrients and food types is
well known in the field of nutrition and the terms often appear
in scientific and medical publications in the field. This is
frequently the case in nutritional surveys and nutritional
epidemiology. The relative amounts of "high" and "low" of
various nutrients and food types are well known.
(Applicant's Interview Summary 4/25/17 at 9.)
Thus, the evidence shows that the ordinary artisan in the nutritional
arts would have understood the meaning of "high" and "low" as it relates to
6 Simopoulos, The importance of the ratio of omega-6/omega-3 essential
fatty acids, 56 BIOMED. PHARMACOTHER. 365-79 (2002).
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Application 13/332,251
amounts of nutritional components, and omega fatty acids in particular, with
reasonable certainty. We therefore reverse the indefiniteness rejection.
B. 35 US.C. § 101
The Examiner finds that the claims on appeal are "directed to a
judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract
idea) without significantly more" (Ans. 6). The Examiner finds that the
claims recite a "process of making a lipid-containing formulation (i.e. a
combination of products or elements), wherein the product formed by said
process is a combination of products of nature" (id.). Specifically, the
Examiner finds "[b ]ecause each compound in olive oil is naturally occurring,
and, further, because the recited combination of compounds is known to
occur together in nature (i.e. is present in olive oil), said combination formed
by combining daily amounts of fatty acids is considered a 'product of
nature"' (id. at 10). The Examiner also finds the claim steps basing dosage
on particular factors "is a mental step that merely equates to gathering
information, correlating or making a determination and is thus an abstract
idea which is a judicial exception" (id. at 13).
Appellant contends:
[T]he claims require more than merely providing some quantity
of the recited formulation. The claims require that the
"combining" is done such that "the ratio of omega-6 to omega-
3 fatty acids and/or their amounts are controlled based on the
one or more factors." This amounts to more than an abstract
idea because the abstract idea is applied to the formulation such
that the formulation's composition varies as a function of the
factors considered.
(App. Br. 21.)
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Appeal2019-000388
Application 13/332,251
We apply the test set out in Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 566 U.S. 66 (2012), based on the two-step
Alice framework. Alice Corp. Pty. Ltd. v. CLS Bank Int 'l, 134 S. Ct. 2347,
2355 (2014).
In Alice step one, we ask whether the claims are directed to a patent
ineligible concept, such as natural phenomena or an abstract idea. Alice, 134
S.Ct. at 2355; Mayo, 566 U.S. at 75-77; Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). While method
claims are generally eligible subject matter, method claims that are directed
only to abstract ideas and/or natural phenomena are directed to patent
ineligible concepts. Ariosa, 788 F.3d at 1376. In Alice step two, we
examine the elements of the claims to determine whether they contain an
inventive concept sufficient to transform the claimed naturally occurring
phenomena into a patent-eligible application. Alice, 134 S. Ct. at 2355
(quoting Mayo, 566 U.S. at 71-72).
Alice Step One
Claim 94 is directed to a process of designing a lipid formulation
based on three overlapping types of parameters: (a) personal characteristics
such as age, gender, diet, and weight ( cf Spec. ,r 9); (b) dietary intake such
as amounts of antioxidants, phytochemicals, and seafood (cf Spec. ,r 33);
and (c) climate conditions at the subject's location (cf Spec. ,r,r 43--44).
The claim is directed to a method of preparing a lipid containing
formulation for a subject. Thus, the method, itself, is not a natural
phenomenon or natural law because the claim does not read on only the
composition, itself, but rather is directed to making the composition.
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Appeal2019-000388
Application 13/332,251
Therefore, the method of combining lipids based on these parameters is not
reasonably interpreted as a natural phenomenon.
Moreover, the instant facts differ from those in Mayo, where the
natural correlation between 6-thioguanine levels and therapeutic efficacy
was a relationship that "exists in principle apart from any human action.
The relation is a consequence of the ways in which thiopurine compounds
are metabolized by the body----entirely natural processes." Mayo, 566 U.S.
at 77. Here, even if there is a correlation between a particular amount of
fatty acids and a particular therapeutic effect in a patient, the claim is not
drawn to that correlation, but rather is directed to a method of making such a
composition.
As to patent ineligibility based on abstract ideas, claim 94 is not
directed to an abstract idea but rather to a specific process for combining
omega-6 and omega-3 fatty acids based on the three overlapping types of
parameters relating to specific characteristics of a subject individual. We
can analogize the instant facts to Cellzdirect, where a claim to a process of
producing cryopreserved hepatocytes that survive multiple freeze/thaw
cycles using a particular process was "directed to a new and useful method
of preserving hepatocyte cells." Rapid Litigation Management Ltd. v.
Cellzdirect, Inc., 827 F.3d 1042, 1048 (Fed. Cir. 2016). Cellzdirect noted:
[The] claims are like thousands of others that recite processes to
achieve a desired outcome, e.g., methods of producing things,
or methods of treating disease. That one way of describing the
process is to describe the natural ability of the subject matter to
undergo the process does not make the claim "directed to" that
natural ability.
Id. at 1048-1049.
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Appeal2019-000388
Application 13/332,251
Similarly, the claims as a whole are not abstract. "That a
mathematical equation is required to complete the claimed method and
system does not doom the claims to abstraction." Thales Vision ix Inc. v.
United States, 850 F.3d 1343, 1349 (Fed. Cir. 2017). The instant claims
seek to protect only the process of combining omega-6 and omega-3 fatty
acids for a particular subject based on a number of specific characteristics
that must be considered together including personal characteristics, dietary
intake, and climate conditions at the subject's location. Therefore, rather
than claiming an abstract idea such as merely "gathering information,
correlating or making a determination" (see Ans. 13), the claims specify
forming a particular combination of omega-6 and omega-3 fatty acids based
on the information for preparation of dietary supplements for a particular
subject. See Thales, 850 F.3d at 1349 ("The claims specify a particular
configuration of inertial sensors and a particular method of using the raw
data . . . . Far from claiming the equations [ e.g. abstract idea] themselves,
the claims seek to protect only the application of physics to the
unconventional configuration of sensors as disclosed.").
Because the claims are not directed to either a natural phenomenon or
an abstract idea, we need not tum to the second step of the Alice framework.
We therefore conclude that all of the claims on appeal are directed to
patent-eligible subject matter and reverse the § 101 rejection.
C. 35 us.c. § 102(b)
The Examiner finds "'Olive Oil' teaches that 2 tablespoons a day of
olive oil added to an otherwise unchanged diet in 28 outpatients, ranging in
age from 64 to 71, resulted in significant drops in total- and LD L
cholesterol" (Ans. 14). The Examiner finds:
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Application 13/332,251
[O]ne can clearly envisage that the reference teaches the
amounts of the fatty acids in two tablespoons of olive oil, when
provided by combining two one tablespoon servings, is "based
on" "diet of the subject", "medical conditions of the subject",
"gender of the subject" and "age of the subject". Moreover, the
reference indicates that olive oil is part of a diet from the
Mediterranean region, a region which has a specific climate
( ambient temperature range), and thus qualifies as a method of
combining two one tablespoon servings of olive oil "based on"
the elected factor (the ambient temperature range of a subject's
living area).
(Ans. 19.)
Appellant contends the rejection
erred by not giving patentable weight to the following claim
elements recited in claims 94 and 101; effectively ignoring a
large part of the claim language.
wherein the ratio of omega-6 to omega-3 fatty acids
and/or their amounts are controlled based on the one or
more factors ... ( claim 94)
evaluating the subject on the basis of one or more factors
selected from ... ( Claim 101)
wherein the ratio of omega-6 to omega-3 fatty acids
and/ or their amounts are controlled based on the one or
more factors ... ( Claim 101)
(App. Br. 25.) Appellant contends the prior art fails "to disclose and enable
how to prepare, select, and control omega-6 and omega-3 'based on' 'age',
'gender', 'diet', 'medical condition', or the 'ambient temperature range' of
the subject" (App. Br. 26).
We agree with Appellant that the method of preparing a formulation
as specified in the claim is not anticipated by the so-called "Olive Oil"
publication. As indicated by Appellants, Olive oil does not teach controlling
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Application 13/332,251
the amounts of omega-6 and omega-3 based on one of the recited factors,
but rather teaches the same olive oil composition irrespective of the patient's
diet or other factors.
We agree with Appellant because there is no evidence that the
subjects discussed in the "Olive Oil" reference necessarily were prepared
using fatty acid ratios consistent with the individual correlations between
personal characteristics, dietary intake, and climate conditions as recited in
claim 94.
This reasoning that the patient population in claim 94 may differ from
the patient population in "Olive Oil" is consistent with Perricone, which
distinguished between the topical application of a lotion to skin generally to
prevent sunburn, and the topical application of a lotion to treat sunburned
skin. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005).
Perricone found that the "issue is not ... whether [the prior art] lotion if
applied to skin sunburn would inherently treat that damage, but whether [the
prior art] discloses the application of its composition to skin sunburn. It
does not." Id. at 1378 (emphasis omitted).
The same analysis applies here. There is a general teaching in "Olive
Oil" to provide olive oil that will inherently contain a particular ratio of
omega-6 to omega-3 fatty acids to patients (see Olive Oil 2). If the subjects
in "Olive Oil" also happened to have the particular dosages based on
personal characteristics and dietary intake as shown in tables 9--11 of the
Specification (see Spec. ,r,r 4 7--49), as well as the climate conditions of
Table 6 of the Specification (see Spec. ,r 43), the "Olive Oil" composition
might also necessarily satisfy the three requirements of personal
characteristics, dietary intake, and climate conditions, analogous to the skin
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Application 13/332,251
treatment at issue in Perricone. However, the Examiner has not identified
any teaching or suggestion in "Olive Oil" to modify the composition to
satisfy the three requirements of personal characteristics, dietary intake, and
climate conditions. In the same manner that not everyone who applies lotion
to his or her skin will necessarily have sunburn, not all subjects taking olive
oil have been demonstrated to necessarily satisfy the three requirements of
personal characteristics, dietary intake, and climate conditions recited in the
Specification. Therefore, the evidence of record in "Olive Oil" does not
demonstrate that olive oil will necessarily result in the required subject
specific formulations. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)
("Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient." ( citation omitted)).
This situation is different than the product claims at issue in In re
Bhagat, 726 F. App'x 772 (Fed. Cir. 2018), where the claims were all
directed to formulations and compositions and the prior art disclosed
products that contained "a dosage of lipids within the scope of the claims."
Id. at 776. Here, the claims are drawn to specific methods with specific
steps and required considerations that have not been shown to be necessarily
present in the "Olive Oil" reference.
We therefore reverse the anticipation rejection.
SUMMARY
In summary, we reverse the rejection of claims 94, 95, 101, 108, 116,
119, 122-125, 128-132, 134,137,139,140, 145-150, 153-166, 168,171,
177, and 178 under 35 U.S.C. § 112, second paragraph.
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Application 13/332,251
We reverse the rejection of claims 94, 95, 101, 108, 116, 119, 122-
125, 128-132, 134, 137, 139, 140, 145, 147-149, 153-157, 159-162, 164--
166, 168, 171, 177, and 178 under 35 U.S.C. § 101.
We reverse the rejection of claims 94, 95, 101, 108, 116, 119, 122-
125, 128-132, 134,137,139,140,145, 147-149, 153-157, 159-162, 164--
166, 168, 171, 177, and 178 under 35 U.S.C. § 102(b) as anticipated by
Olive Oil and Olive Oil Nutritional Profile.
REVERSED
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