Ex Parte Yonak et al

Patent Trial and Appeal Board

May 31, 2016

13905197 (P.T.A.B. May. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/905, 197 05/30/2013
93599 7590
Eric P, Mirabel, JD, LLM
3783 Darcus Street
Houston, TX 77005
06/03/2016
FIRST NAMED INVENTOR
Sonja Lea Y onak
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.
THER-5RNDR-Con 3775
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/03/2016 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):
emirabel@comcast.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SONJA LEA YONAK and RANDOLPH S. PORUBCAN1
Appeal2014-005953
Application 13/905,197
Technology Center 1600
Before LORA M. GREEN, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating certain ailments with a pro biotic formulation. The Examiner has
rejected the claims as indefinite and/or obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Probiotic formulations are believed useful in treating a number of
conditions, including diarrhea, vaginal yeast infections, constipation,
1 Appellants identify the Real Party in Interest as Master Supplements, Inc.
(Appeal Br. 3.)
Appeal2014-005953
Application 13/905,197
heartburn, bloating, indigestion, flatulence and poor nutrient absorption.
(Spec. 5.) "Conditions leading to indigestion and lack of nutrient absorption
by the intestine are also treated by probiotics." (Id.) Polysorbate 80 has
been used in order to enhance the growth of probiotics. (Id. at 1-2.)
However, polysorbate 80 reacts with and degrades freeze-dried probiotic
strains when mixed directly with them. (Id. at 2.) In addition, many
consumers object to inclusion of polysorbate 80 in pro biotic formulations
because polysorbate 80 is not a natural product. (Id.) The claims are
directed to the method of treating conditions with a pro biotic formulation
that includes a natural product to enhance growth of the pro biotic rather than
polysorbate 80.
Claims 24, 25, 27, 38, 47, and 482 are on appeal. Claim 24 and 47 are
illustrative and read as follows:
24. A method of treating diarrhea, vaginal yeast infections,
constipation, heartburn, bloating, indigestion, flatulence or poor
nutrient absorption, comprising the step of: administering a
formulation consisting essentially of: a dry powdered form of
Lactobacillus or Bifidobacterium; and dry powdered sunflower
lecithin and oleic acid.
4 7. The method of claim 24 wherein 10 to 100 mg of the lecithin and
oleic acid, are administered for each dose of the Lactobacillus and/or
Bifidobacterium.
(Appeal Br. 20.)
2 Claims 28-37 and 39--46 are also pending, but stand withdrawn from
consideration. (Appeal Br. 5.)
2
Appeal2014-005953
Application 13/905,197
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 47 and 48 under 35 U.S.C. § 112, second paragraph as
indefinite. (Adv. Action 2.)
2. Claims 24, 25, 27, 38, 47, and 48 under 35 U.S.C. § 103(a) as
unpatentable over Porubcan3 and Garbolino.4 (Id.)
DISCUSSION
Ground 1. Indefiniteness
The Examiner concludes that claims 4 7 and 48 are indefinite because
"the lecithin" lacks sufficient antecedent basis in claim 24 and the term
could refer to soy lecithin in light of the specification. (Ans. 5---6.) We
disagree with the Examiner's conclusion.
The statute requires that claims "particularly point [ ] out and
distinctly claim []the subject matter" of the invention. 35 U.S.C. § 112,
second paragraph. Notwithstanding Appellants' disclosure that soy lecithin
may function in the same manner as sunflower lecithin in a formulation
including a probiotic (Spec. 3:9-10), claims 47 and 48 leave little doubt as to
what is intended regarding "the lecithin" to which they refer. Claim 24
requires "administering a formulation consisting essentially of' three
ingredients: "a dry powdered form of Lactobacillus or Bifidobacterium; and
dry powdered sunflower lecithin and oleic acid" to treat one or more of the
identified conditions. (Appeal Br. 20.) Claims 47 and 48 depend directly
3 Porubcan, US 2005/0106132 Al, published May 19, 2005.
4 Garbolino et al., US 2009/0017163 Al, published Jan. 15, 2009.
3
Appeal2014-005953
Application 13/905,197
from claim 24 and recite that in the treatment method, a particular amount
"of the lecithin and oleic acid, are administered .... " (Id. (emphasis
added).) When read in context of claim 24, claims 47 and 48 apprise one of
ordinary skill in the art with reasonable certainty that the amount "of the
lecithin and oleic acid" to be "administered" is the sunflower lecithin and
oleic acid referenced in claim 24 that are essential elements of the three
ingredient formulation to be administered.
Accordingly, we reverse the Examiner's rejection of claims 47 and 48
as being indefinite.
Ground 2. Obviousness
The Examiner takes the position that it would have been obvious to
one of ordinary skill in the art "to substitute" lecithin for polysorbate 80
("PSM") in the Porubcan composition, because Garbolino teaches that
"lecithin (like PS~'v1) ... stimulates probiotic bacterial grmvtrJviability" but
unlike PSM, lecithin is "stable under higher water conditions." (Ans. 4.)
According to the Examiner, "one of ordinary skill in the art would be
motivated to substitute lecithin for PSM in the composition employed in the
method of Porubcan, with the reasonable expectation that the resulting
composition will. .. enhance the growth/viability of pro biotic bacteria not
only when dry, but also in situations where the water activity increases."
(Id.)
Appellants contend that Garbolino teaches lecithin increases probiotic
bacteria shelf-life, i.e., survival, not that it enhances probiotic growth.
(Appeal Br. 18.) Appellants argue that modifying Porubcan as proposed by
4
Appeal2014-005953
Application 13/905,197
the Examiner would lose the advantage of obtaining enhanced growth of the
probiotic that is effected by the PSM in Porubcan's formulation. (Id.)
A rejection based on § 103 must rest on a factual basis, and these facts
must be interpreted without hindsight reconstruction of the invention. In re
Warner, 379 F.2d 1011, 1017 (CCPA 1967). The Examiner's conclusion of
obviousness rests on the position that growth and viability are equivalent, or
that lecithin is known to both increase growth and viability of pro biotic
bacteria. The art relied upon by the Examiner does not teach either
proposition. Nor does the Examiner provide sufficient evidence that there is
a problem of poor viability of pro biotic bacteria in powder formulations.
Porubcan discloses that "[t]ypical human diets are not well suited for
probiotic[ growth]" and [t]o help correct this problem, manufacturers of
probiotic dietary supplements have started to include prebiotics[, i.e.,
nutrient substances that encourage the growth of probiotics in vivo,] in their
formulations." (Id. at i-fi-13--4.) According to Porubcan, carbohydrate
prebiotics, however, have at least two drawbacks: 1) they are needed in
quantities that are too large to be practical for capsule or tablet probiotic
formulations and 2) they can cause flatulence and abdominal pain and/or
allergic reactions. (Id. i15.) Porubcan teaches to add PSM in a dry form
instead of carbohydrate prebiotics, and that this compound "dramatically
stimulates the growth" of Lactobacillus pro biotic bacteria. (Porubcan i-fi-1 7,
23, 25.)
Garbo lino discloses that "[p ]robiotic bacteria are widely used in
chilled dairy products such as yoghurt ... [and] while attempts have been
made to produce spreads [that have a longer shelf life than chilled dairy
5
Appeal2014-005953
Application 13/905,197
products], such as margarine, ... contain[ing] probiotics, problems have
been encountered with bacterial viability and/or product quality."
(Garbolino i-f 3.) Garbolino teaches that lecithin increases "the survival rate"
of pro biotic bacteria in food products having a moist environment and that
are stored for several weeks prior to consumption. (Garbolino i-fi-116, 32, 40-
42.)
The Examiner has not provided sufficient evidence as to why one of
ordinary skill in the art would have substituted sunflower lecithin, which
Garbolino uses in high water content formulations, such as spreads, to
improve long-term survivability of probiotics included in those formulations
(see Garbo lino i-fi-1 39--42), in place of PSM in the dry powder dietary
supplement of Porubcan, which is provided to stimulate growth of the
probiotic when ingested (see Porubcan i-fi-125-27). The Examiner only
provides a conclusory statement "that the resulting composition will be
stable and enhance the growth/viability of pro biotic bacteria not only when
dry, but also in situations where the water activity increases (as moisture
settles into the product during storage, for example, as often happens in the
typical bathroom medicine cabinet or in a refrigerator), and the composition
will exhibit a long shelf life, even if higher water activity conditions develop
during storage, so that probiotic growth/viability remains satisfactory at the
time of administration" (Ans. 4). Absent from the Examiner's explanation is
some factual basis to establish the desirability of replacing Porubcan's PSM
with sunflower lecithin. In determining obviousness, the relevant inquiry is
"[would] an artisan of ordinary skill in the art at the time of the invention,
confronted by the same problems as the inventor and with no knowledge of
6
Appeal2014-005953
Application 13/905,197
the claimed invention, [ ] have selected the various elements from the prior
art and combined them in the manner claimed." See Princeton Biochemicals,
Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1337 (Fed. Cir. 2005). To
establish a prima facie case of obviousness, the Examiner must identify
some objective teaching in the prior art or show that knowledge generally
available to one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.
There is insufficient evidence provided by the Examiner that the dry
powder probiotic-PSM formulation of Porubcan is not shelf-stable such that
the viability of the pro biotic is impaired over time. Moreover, there is
insufficient evidence in this record that promoting survivability of pro biotic
bacteria is the same thing as promoting growth of that bacteria such that
sunflower lecithin would be an equivalent prebiotic to PSM in the Porubcan
composition.
Indeed, Porubcan and Garbolino suggest they are not equivalent. In
particular, Porubcan states regarding probiotic growth:
When probiotics are ingested they must grow and multiply in
the intestinal tract without the benefit of microbiological
growth media. . . . Typical human diets are not well suited for
probiotics and, given the abundance of and competition from
many less fastidious intestinal bacteria, it can be difficult for
probiotics to effectively multiply in vivo. To help correct this
problem, manufacturers of pro biotic dietary supplements have
started to include prebiotics in their formulations.
Prebiotics are nutrient substances that encourage the growth of
probiotics in vivo.
7
Appeal2014-005953
Application 13/905,197
(Porubcan i-fi-13--4.) Garbolino, on the other hand, states regarding probiotic
viability:
Whilst attempts have been made to produce spreads, such as
margarine, which contain probiotics, problems have been
encountered with bacterial viability and/or product quality.
Since, unlike yoghurt which is purchased and consumed within
a relatively short period after manufacture, margarine is stored
much longer, sometimes even for many months after sale, while
being consumed. The long term survival of probiotics in
products with a longer shelf-life is a consideration since the
product needs to deliver a sufficient dose of live bacteria at the
point of consumption. Consequently, significant losses of
viable bacteria over several weeks or months need to be
avoided.
(Garbolino i13.)
The mere fact that references can be combined or modified does not
render the resultant combination obvious unless the prior art, the nature of
the problem, or common sense also suggests the desirability of the
combination. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 401 (2007) ("[A]
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results .... [I]f a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill."); In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir.
1992). An examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case ofunpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (1992). If the examiner fails to establish a
prima facie case of unpatentability in the first instance, the rejection is
8
Appeal2014-005953
Application 13/905,197
improper and must be reversed. Id.; In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993). After reviewing the evidence, we disagree with the Examiner's
conclusion that the teachings of Porubcan and Garbo lino render it obvious to
substitute lecithin for PSM in the Porubcan composition. Thus, we agree
with Appellants that the Examiner has not set out a prima facie case.
Accordingly, we reverse the rejection of claims 24, 25, 27, 38, 47, and
48 as being obvious over Porubcan and Garbolino.
SUMMARY
We reverse the rejection of claims 47 and 48 under 35 U.S.C. § 112,
second paragraph as indefinite.
We reverse the rejection of claims 24, 25, 27, 38, 47, and 48 under 35
U.S.C. § 103(a) as unpatentable over Porubcan and Garbolino.
REVERSED
sl
9