Ex Parte Hickle

Patent Trial and Appeal Board

Sep 29, 2016

12927590 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/927,590
7590
Dorsey L Baker
2804 N. Loop 289
Lubbock, TX 79415
FILING DATE FIRST NAMED INVENTOR
11/18/2010 Randall Scott Hickle
09/29/2016
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.
0063 6409
EXAMINER
PRAKASH, SUBBALAKSHMI
ART UNIT PAPER NUMBER
1793
MAILDATE DELIVERY MODE
09/29/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RANDALL SCOTT HICKLE
Appeal2015-004838
Application 12/927,590
Technology Center 1700
Before KAREN M. HASTINGS, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner's
April 24, 2014 decision finally rejecting claims 1, 2, and 4--19. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We affirm-in-part.
CLAIMED SUBJECT MATTER
Appellant's invention is directed to a dietary composition and method
for assisting in personal weight loss and weight gain prevention (Spec. 1 :5-
1 Appellant identifies the real party in interest as Alexander Laboratories,
LLC (Appeal Br. 3).
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Application 12/927,590
7). Claims 1, 6, and 9 are representative and are reproduced below from the
Claims Appendix of the Appeal Brief (key claim limitations shown in
italics):
1. A dietary composition for enabling safe, effective,
convenient and low cost weight loss and/or management
by an individual, with satiety and without imposing
complex dietary decisions or calorie counting upon the
individual, said composition comprising:
a) a daily dietary composition of nutrients in which
approximately 60[]% of the calories are derived from
unsaturated fats and 30% are derived from protein;
b) said composition being packaged to facilitate
consumption in regular intervals throughout the day to
continuously maintain nutrients in the gastrointestinal
tract and to cause the formation of peptide YY,
cholecystokinin and/or GLP-1 in the intestinal track of
said individual to slow the digestive process and to
generate satiety.
6. A method of providing safe, effective, convenient and low
cost weight loss and[/]or management, without imposing
complex dietary decisions or calorie counting upon the
individual, said method comprising the steps of
a) providing a dietary composition of macronutrients
pre-packaged for consumption at regular times throughout
the day to continuously maintain the presence of
macronutrients in the gastrointestinal tract, said
composition being pre-packaged in from 7 to 16 equal
doses; and
b) said dietary composition comprising primarily
unsaturated fats and protein to induce satiety and to
diminish the production of Ghrelin.
9. A medical food to be prescribed by a physician for the
treatment of a patient's weight and/or undesirable health
conditions including low lipid profiles, undesirable
vascular inflammation, and Type II diabetes:
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a) said medical food comprising primarily unsaturated
fat, and/or fatty acids of EPA and DHA and protein and
being packaged for consumption in a package selected
from the following: a capsule, a health food bar, a plastic
container, a time release container;
b) said medical food further including vitamins and
hormones selected from the group of Q-10, niacin, B
vitamins and antioxidants to be prescribed by said
physician for treatment of said weight and/or health
condition.
Appeal Br. 15-16 (Claims App.).
REJECTIONS
I. Claims 1 and 9 are rejected under 35 U.S.C. § 112, i-f 2 as
indefinite. 2
II. Claims 1, 2, 4--8, and 12-17 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Bialek3 in view of Myers. 4
III. Claims 9-11, 18, and 19 rejected under 35 U.S.C. § 103(a) as
unpatentable over Bialek in view of Myers, and evidence in
Behnam.5
DISCUSSION
Rejection under§ 112, iJ 2 as indefinite
During prosecution, "the PTO applies to the verbiage of the proposed
claims the broadest reasonable meaning of the words in their ordinary usage
2 The Examiner's rejection of claims 2 and 6 under 35 U.S.C. § 112, i-f 2 as
indefinite is withdrawn (Ans. 2).
3 Bialek et al., US 2006/0105093 Al, published May 18, 2006.
4 Myers et al., US 2008/0081840 Al, published Apr. 3, 2008.
5 Behnam, US 2006/0287384 Al, published Dec. 21, 2006.
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Application 12/927,590
as they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant's
specification." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Claims
are definite if they
set out and circumscribe a particular area with a reasonable
degree of precision and particularity. It is here where the
definiteness of the language employed must be analyzed-not
in a vacuum, but always in light of the teachings of the prior art
and of the particular application disclosure as it would be
interpreted by one possessing the ordinary level of skill in the
pertinent art.
In re Moore, 439 F.2d 1232, 1235 (CCPA 1971).
The Examiner has rejected claims 1 and 9 under 35 U.S.C. § 112, i-f 2.
With respect to claim 1 's recitation of "daily dietary composition of
nutrients," the Examiner's asserts that "[i]t is unclear ... as to whether the
entire daily dietary needs of an individual are satisfied by the composition of
the invention" (Final Act. 2). The Examiner further asserts that the
recitation requiring that "60% of the calories are derived from unsaturated
fats and 30% are derived from protein" is indefinite because "[i]t is unclear
what the remaining 10% of the calories in the composition are comprised of'
(id. at 2-3).
With respect to claim 9' s recitation of a "medical food ... being
packaged for consumption in a package selected from the following: a
capsule, a health food bar, a plastic container, a time release container," the
Examiner asserts that "the composition of the delivery systems [as] a
capsule, a health food bar and the characteristics of 'a time release container'
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are not defined ... [nor would the ordinary skilled artisan] be reasonably
apprised of the scope of a 'time release container'" (id. at 3).6
Upon consideration of the Examiner's findings, the evidence on this
record and the arguments advanced by Appellant, the preponderance of
evidence weighs in favor of a conclusion that the claims comply with the
requirement to particularly point out and distinctly claim the subject matter.
With respect to claim 1, Appellant's arguments are persuasive that the
skilled artisan would clearly understand this claim simply recites a
composition of nutrients in which approximately 60 % of the calories are
derived from unsaturated fats and 30% are derived from protein. As noted
by Appellants (Appeal Br. 6), the language ("comprising") is not limited to a
composition which cannot be supplemented by additional foodstuffs. Thus,
we find that a person of ordinary skill in the art would understand that the
claims require a composition in which "60% of the calories are derived from
unsaturated fats and 3 0% are derived from protein."
Likewise, Appellant's arguments are persuasive that the skilled artisan
would clearly understand claim 9 because the Examiner admits that the
claimed package forms are disclosed in the applied prior art (Appeal Br. 8-
9; see also Final Act. 7; 9 ("Each of the delivery systems recited in the
claims 9 and 18 is known in the art .... ")).
Accordingly, we reverse the rejection of claims 1 and 9 under
35 U.S.C. § 112, ii 2.
6 As further grounds for the rejection of claim 9, the Examiner refers to the
recitation of "a composition of a dietary composition" (Final Act. 3). This
limitation, however, is no longer recited in the claim (see Amendment filed
June 24, 2014).
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Rejections under§ 103(a)
Rejection II
The Examiner finds Bialek teaches a dietary composition that
"comprises the same ingredients providing the same function" as the
composition of independent claims 1 and 6, but acknowledges that Bialek
"does not specifically disclose feeding the composition ... at regular
intervals" (Final Act. 4). The Examiner finds, however, that Myers teaches
"a weight control program wherein a composition comprising protein and fat
... is consumed at regular intervals during waking hours by a subject in
need of weight control" (id. at 4, citing Myers i-f 8; Example 2). The
Examiner determines that it would have been obvious to the ordinary skilled
artisan to prepare Bialek's dietary composition for weight loss and/or weight
management by using elements from Myers' weight management control
program, "whereby the individual would consume a pre-determined amount
of a meal replacing, satiety effecting food composition, at regular
intervals .... " (Final Act. at 5).
Appellant, inter alia, makes the following principal arguments urging
reversal of Rejection II: (1) the Examiner erroneously construes the prior art
because "there is no information in []Bialek stating the relative percentages
of fat and protein of the resulting unidentified food and beverage products
into which he incorporates the emulsion .... " (Appeal Br. 10), (2) the
claims recite limitations requiring the composition components in caloric
percentages, not by weight percentage (Reply Br. 3) and, therefore, the
claimed percentages "differ substantially" from the applied prior art (id.),
and (3) "[t]he [claim] terms 'daily dietary composition' and '60[]% of the
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calories are derived from ... fats and 30% ... from protein['] are not given
effect in the rejection" (Appeal Br. 11 ).
The Examiner responds by finding that Bialek suggests the inclusion
of unsaturated fats in an oil and protein composition because Bialek
discloses that "' [i]t is preferred that the oil has a monounsaturated fatty acid
content of at least 20% wt., more preferably of at least 30% wt . ... [and]
that the oil has a polyunsaturated fatty acid content of at least 5% wt.'"
((emphasis added) Ans. 10-11, citing Bialek i-f 27).
It is well understood that "rejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) (quoting In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006)). The
fact that a reference may be modified to reflect features of the claimed
invention does not make the modification, and hence the claimed invention,
obvious unless the prior art suggested the desirability of such modification.
In re Mills, 916 F.2d 680, 682 (Fed. Cir. 1990).
Appellant's arguments are persuasive because the Examiner has not
provided adequate reasoning to explain why a person of skill in the art
would have modified the teachings of Bialek to include an amount in which
approximately 60% of the calories are derived from unsaturated fats based
on the disclosed at least 30% wt. in Bialek. Even if 60% by calories and
30% by weight were considered to be sufficiently close, the Examiner has
not adequately explained why a person of skill in the art would have
produced a composition having 60% of the calories derived from
unsaturated fats. The Examiner's application of Myers does not cure this
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deficiency. Although ivlyers discloses the administration of 1100 mg of
DHA per day in a diet comprising up to 1200 calories (Myers i-f 6), the
Examiner has not provided any reasoning as to why this suggests to the
ordinary skilled artisan a composition having 60% of the calories derived
from unsaturated fats. While it is well known that a gram of any fat has
more calories than a gram of protein 7, the Examiner has not based the
rejection on this fact or provided any analysis based on the relative number
of calories in fat or protein but instead states "as the scope of the invention is
not defined, it is not possible to differentiate the instant invention from the
art" (Ans. 11 ).
Accordingly, we reverse the rejection of independent claim 1 under
35 U.S.C. § 103(a) over Bialek in view of Myers. Similarly, we reverse the
obviousness rejection of the claims dependent from claim 1 (i.e., claims 2, 4,
5, and 12-16).
With respect to claim 6, however, Appellant's arguments set forth
above are not persuasive. Unlike claim 1, claim 6 does not recite requisite
caloric percentages of fat and protein. Rather, claim 6 recites the limitation
"a dietary composition of macronutrients ... comprising primarily
unsaturated fats and protein" (emphasis added). Regardless of the applied
prior art's disclosed composition component units, Appellant's arguments
have not identified reversible error in the Examiner's determination that the
combination of Bialek and Myers suggest a dietary composition comprised
primarily of unsaturated fats and proteins.
7 A gram of fat has 9 calories, while a gram of protein has 4 calories; see
https://fnic.nal. usda. gov /how-many-calories-are-one-gram-fat-carbohydrate-
or-protein
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Appellant also argues that the Examiner's proposed combination
"changes the principal of operation and the fundamental concepts of the
prior art references" (Appeal Br. 11).8 In other words, Appellant argues that
the Examiner's proposed modification attempts to convert "mere additive[ s]
to a 'daily composition of nutrients in which 60[]% of the calories are
derived from unsaturated fats and 30% are derived from protein."' (Appeal
Br. 11 ). Therefore, according to Appellant, the Examiner's "rejection results
in a destruction of the inventions of the references" (id. at 9).
We are unpersuaded by this argument. The Supreme Court has made
clear that an obviousness analysis "need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." KSR Int'! Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007). That is because "[a] person of ordinary skill is also a
person of ordinary creativity, not an automaton." Id. at 4 21. It is also well
established that a reference is good for all it fairly teaches a person having
ordinary skill in the art, even when the teaching is a cursory mention. E.g.,
In re Mills, 4 70 F .2d 649, 651 (CCP A 1972). As pointed out by the
Examiner, Bialek specifically suggests that the composition of that invention
may be included in meal replacement products to provide satiety benefits
(Ans. 11, citing Bialek i-f 86).
8 We note that Appellant presents an argument for the first time in the Reply
Brief filed March 18, 2015, asserting that Bialek teaches away from the
present invention of a pre-packaged product ready for consumption as a
meal replacement (Reply Br. 4). It is generally improper for Appellant to
discuss for the first time in the Reply Brief matters that could have been
raised in the Appeal Brief. 37 CPR§ 41.41(b)(2) (2013).
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Accordingly, we affirm the rejection of independent claim 6 under
35 U.S.C. § 103(a) over Bialek in view of Myers. In the absence of
arguments specific to their patentability, dependent claims 7, 8, and 17 fall
with claim 6. 37 C.F.R. § 41.37(c)(l)(iv).
Rejection III
With the exception of the Examiner's reliance on Behnam as extrinsic
evidence, the Examiner's grounds for rejecting independent claim 9 in
Rejection III are substantially similar to the Examiner's grounds for
rejecting claims 1 and 6 in Rejection II (Final Act. 8-9). With respect to the
limitation "medical food" as recited in claim 9, the Examiner determines that
"no specific novel or non-obvious medical food composition is described in
the instant invention" (id. at 9).
Appellant's arguments urging reversal of Rejection III rely, inter alia,
on the same arguments set forth above urging reversal of Rejection II (see
Appeal Br. 12). Appellant further argues that the Examiner's findings are
silent as to any teaching or suggestion of a "medical food" as defined by the
Orphan Drug Act (id. at 12, citing 21 U.S.C. § 360ee(b)(3)).
For the reasons set forth above, Appellant has not identified any
deficiencies in the Examiner's combination of Bialek's and Myers'
teachings with respect to claim 6 and its dependent claims. Similar to claim
6, claim 9 does not include limitations reciting requisite composition
component percentages. Rather, claim 9 recites the limitation "[a] medical
food ... comprising primarily unsaturated fat, and/ or fatty acids of EPA and
DHA and protein ... "(emphasis added). Appellant's arguments have not
identified reversible error in the Examiner's determination that the
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combination of Bialek and ivlyers suggest a dietary composition comprised
primarily of unsaturated fats and proteins.
We are likewise not persuaded by Appellant's arguments based on an
attempted incorporation of the Orphan Drug Act's definition of a "medical
food." "[I]n order for one document to incorporate another document by
reference, the incorporating document must identify the incorporated
document with detailed particularity, clearly indicating the specific material
for incorporation." Kyocera Wireless Corp. v. Int 'l Trade Comm 'n, 545
F.3d 1340, 1352 (Fed. Cir. 2008) (citing Advanced Display Sys., Inc. v. Kent
State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000)).
In the instant case, an express identification of the Orphan Drug Act's
definition of "medical food" is absent from the Specification. The
Specification, furthermore, does not provide a definition for the claim term
at issue. "[T]he PTO must give claims their broadest reasonable
construction consistent with the specification . . . . Therefore, we look to the
specification to see if it provides a definition for claim terms, but otherwise
apply a broad interpretation." In re ICON Health & Fitness, Inc., 496 F.3d
1374, 1379 (Fed. Cir. 2007). Appellant's argument, therefore, fails to
identify reversible error in the Examiner's determination that the
Specification is essentially directed to a composition and a method of
packaging the composition, and the cited references in combination render
the claimed composition and method of packaging obvious.
Accordingly, we affirm the Examiner's§ 103(a) rejection of claim 9
under Rejection III. In the absence of arguments specific to their
patentability, dependent claims 10, 11, 18, and 19 fall with claim 9.
37 C.F.R. § 41.37(c)(l)(iv).
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CONCLUSION
We REVERSE the rejection of claims 1 and 9 under 35 U.S.C. § 112,
second paragraph, as indefinite.
We REVERSE the rejection of claims 1, 2, 4, 5, and 12-16 under
35 U.S.C. § 103(a) over Bialek in view of Myers.
We AFFIRM the rejection of claims 6-8, and 17 under
35 U.S.C. § 103(a) over Bialek in view of Myers.
We AFFIRM the rejection of claims 9-11, 18, and 19 under
35 U.S.C. § 103(a) over Bialek, Myers, and further in view of Behnam.
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-IN-PART
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