Exeltis USA, Inc.

Patent Trials and Appeals Board

Sep 18, 2020

14792452 - (D) (P.T.A.B. Sep. 18, 2020)

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.
14/792,452 07/06/2015 Eduardo Fernandez 519902US 7369
68850 7590 09/18/2020
DON J. PELTO
Sheppard, Mullin, Richter & Hampton LLP
333 South Hope Street
43rd Floor
Los Angeles, CA 90071
EXAMINER
GEORGE, PATRICIA ANN
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
09/18/2020 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):
DCPAT@SHEPPARDMULLIN.COM
DPELTO@SHEPPARDMULLIN.COM
SheppardMullin_Pair@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDUARDO FERNANDEZ and CHARLES BALZER

Appeal 2019-005857
Application 14/792,452
Technology Center 1700
Before LINDA M. GAUDETTE, N. WHITNEY WILSON, and
BRIAN D. RANGE, Administrative Patent Judges.
RANGE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 5–8, 14–17, 19–24, and 30. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Exeltis
USA, Inc. Appeal Br. 2.
Appeal 2019-005857
Application 14/792,452

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CLAIMED SUBJECT MATTER2
Appellant describes the invention as relating to a gummy composition
for a nutritional supplement. Spec. ¶ 2. Claim 1 is illustrative:
1. A method for treating a prenatal, pregnant or
breastfeeding patient for a disease, condition or disorder that is
associated with a nutritional deficiency in the patient, the method
comprising:
administering one or more gummy compositions to a
patient, wherein the one or more gummy compositions consists
of:
a total dosing amount of about 1000 IU to about 2000 IU
of vitamin A,
a total dosing amount of about 1 mg to about 4 mg of
vitamin B6,
a total dosing amount of about 4 μg to about 15 μg of
vitamin B12,
a total dosing amount of about 0.5 mg to about 2.0 mg of
encapsulated vitamin B9,
a total dosing amount of about 5 mg to about 90 mg of
vitamin C,
a total dosing amount of about 500 IU to about 2000 IU
of vitamin D,
a total dosing amount of about 7.5 IU to about 22.5 IU of
vitamin E,
a total dosing amount of about 7 mg to about 23 mg of
vitamin B3,
a total dosing amount of about 75 μg to about 225 μg of
iodine,

2 In this Decision, we refer to the Final Office Action dated March 8, 2018
(“Final Act.”), the Appeal Brief filed May 6, 2019 (“Appeal Br.”), the
Examiner’s Answer dated May 31, 2019 (“Ans.”), and the Reply Brief filed
July 31, 2019 (“Reply Br.”).
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a total dosing amount of about 5 mg to about 15 mg of
choline,
a total dosing amount of about 1 mg to about 25 mg of
encapsulated iron,
a total dosing amount of about 50 mg to about 500 mg of
at least one omega-3 fatty acid,
water, and
one or more inactive ingredients selected from the group
consisting of: sucrose, glucose, syrup, gelatin, lactic acid, citric
acid, flavorants, colorants, and propylene glycol
to treat a disease, condition or disorder in the patient that is
associated with a nutritional deficiency in the patient,
wherein the vitamins, minerals and omega-3 fatty acids in each
of the one or more gummy compositions is provided in a single
homogenous layer which is elastic and continuous.
Appeal Br. 22–23 (Claims App.).

REFERENCES
The Examiner relies upon the prior art below in rejecting the claims
on appeal:
Name Reference Date
Geuns et al.
(“Geuns”)
US 2010/0099640 A1 Apr. 22, 2010
Rifkin US 2013/0287899 A1 Oct. 31, 2013
Dietary Reference Intskaes for Thiamin, Riboflavin, Niacin, Vitamin B6,
Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline, 1998 (“DRI”)
Integrative Medicine Communications, Vitamin B9 (Folic Acid), Syrian
Clinic, 2000 (“IMC”)
Micronutrient Information Center: Vitamins, Oregon State University
Linus Pauling Institute, April 15, 2003, lpi.oregonstate.edu/mic/vitamins
(“OSU”).
H. Madziva et al, Alginate-pectin microcapsules as a potential for folic
acid delivery in foods, 22 J. Microencapsulation 343 (2005) (“Madziva”).
J. Cox et al., Prenatal Nutrition: Special Considerations, 61 MINERVA
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GINECOLOGICA 373 (2009) (“Cox”).
Jaclyn M. Coletta et al., Omega-3 Fatty Acids and Pregnancy, 3(4) Rev.
Obstretics Gynecology 163, 163–71, 2010 (“Coletta”)
Michael B. Zimmermann & Erich J. Windhab, Encapsulation of Iron and
Other Micronutrients for Food Fortification, Encapsulation Technologies
for Active Food Ingredient and Food Processing (N.J. Zuidam & Victor
Nedovic eds., 2010) (“Zimmermann”).
Spring Valley Prenatal Multivitamin/Multimineral with Folic Acid,
www.amazon.com/Spring-Valley_Prenatal-Multivitamin-
Multimineral/dp/B001QRRI88, March 5, 2010 (“Spring Valley”).3
Vitafusion Prenatal Gummy Vitamins, 90 count, May 6, 2010
(“Vitafusion”).4
Susan Enfield, ISO: A high-quality multivitamin my kids will actually
eat!, deliciousliving.com/blog/iso-high-quality-multivitamin-my-kids-will-
actually-eat, March 8, 2011 (“Enfield”).
Blake, How to Make Your Own Supplements, Building Muscle 101, Nov.
2, 2011, www.building-muscle101.com (“Blake”)5
Elaine Laskowski, Homemade Gummy Vitamins,
www.justapinch.com/recipes/non-edible/beauty-recipe/homemade-
gummy-vitamins.html?p=1, Jan. 14, 2013 (last visited January 11, 2017)
(“Laskowski”).6

REJECTIONS
The Examiner maintains the following rejections on appeal:
A. Claims 5–8, 14–17, and 30 under 35 U.S.C. § 112 as indefinite. Ans.
4–5.

3 The Examiner relies on web.archive.org (i.e., The Wayback Machine) as
archiving this reference. Ans. 6.
4 The Examiner finds that this reference was online by at least May 6, 2010,
as evidenced by an Amazon.com review by D. Won. Ans. 5.
5 The Examiner relies on web.archive.org (i.e., The Wayback Machine) as
archiving this reference. Ans. 6.
6 The Examiner finds that this reference was published online on January 14,
2013. Ans. 5.
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B. Claims 1, 5–8, 10, 14–17, 19–24, 29, and 30 under 35 U.S.C. § 103 as
obvious over Laskowski, Rifkin, Vitafusion, Enfield, Spring Valley,
Cox, Geuns, Appellant’s Admitted Prior Art (“AAPA”), Madziva,
Zimmerman, OSU, DRI, IMC, Coletta, and Blake. Id. at 5.

OPINION
Rejection A, Indefiniteness. The Examiner rejects claims 5–8, 14–17,
and 30 as indefinite. Ans. 4–5. During prosecution, “‘[a] claim is indefinite
when it contains words or phrases whose meaning is unclear.’” Ex parte
McAward, Appeal No. 2015-006416, slip op. at 11 (quoting In re Packard,
751 F.3d 1307, 1314 (Fed. Cir. 2014) (per curiam)). Here, the Examiner
asserts three different bases for rejecting claims as indefinite, and we address
each basis below.
First, the Examiner rejects claims 5–8 and 14–17 as reciting broad
ranges along with narrow ranges. Ans. 4. Claim 5 depends from claim 1 and
recites, for example, “an individual dosing amount of vitamin A ranging
from 275 IU [international units] to about 825 IU” and also recites “wherein
the total dosing amount is two to four individual gummies.” Appeal Br. 23–
24 (Claims App.). Claim 1 recites, for example, “a total dosing amount of
about 1000 IU to about 2000 IU of vitamin A.” Id. at 22. In view of these
recitations, the Examiner states, “[w]hen the claimed amount of gummies is
multiplied by the individual dosages the total dosage does not equal to the
total dosages of the independent claims.” Ans. 4.
Appellant argues that the rejection does not establish that the claims
are unclear. Appeal Br. 10–11. Appellant explains that the Specification
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explains what the claims mean by “total dosing amount” and “individual
dosing amount as follows:
The gummy dosage forms and kits disclosed herein may also
comprise multiple gummy compositions that provide a total dosing
amount of each of the active ingredients. In these embodiments, each
gummy composition is an “individual dosage form” that comprises an
“individual dosing amount” of each of the active ingredients, and
the sum of the multiple individual dosing amounts approximately
equals the total dosing amount.
Spec. ¶ 55 (emphases added). In view of the Specification’s disclosure
above, “total dosing amount” refers to the amount of an ingredient a person
ingests at one relatively discrete moment in time. “Individual dosing
amount” refers to the amount in one individual gummy composition.
The Examiner’s understanding of the claims is correct inasmuch as
the individual dosing amount for an ingredient multiplied by the total
number of gummies the person takes at one point in time will necessarily
equal a total dosing amount. Ans. 4, 28–29. This, however, does not present
any lack of clarity with respect to, for example, claim 5. Rather, claim 5’s
scope only encompasses methods that satisfy both claim 1’s recited
conditions and claim 5’s recited conditions. For example, treating with one
gummy of 275 IU vitamin A is outside the scope of claim 5 because it does
not meet claim 1’s criteria that the total dosing amount be at least 1000 IUs.
Treating with four gummies of 275 IU vitamin A each in one dose, however,
would meet both claim 5 and claim 1’s criteria. We, therefore, do not sustain
the Examiner’s rejection on this basis.
As a second basis of indefiniteness, the Examiner determines that
claims including claim 5 are unclear because they recite, for example, “the
total dosing amount is two to four individual gummies.” Ans. 4–5, 30.
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Appellant argues the recitation is not unclear. Appeal Br. 11. Appellant’s
position is persuasive. The disputed phrase, in the context of claim 1, claim
5, and the Specification, means that the treated person ingests, at the time of
dosing, two to four individual gummy compositions in total. The sum total
dosing amount of each ingredient must be within the ranges recited in claim
1, and the individual dosing amount for each individual gummy composition
must be within the range of claim 5. We also do not sustain the Examiner’s
rejection on this second basis.
Third, the Examiner determines that claim 30 is unclear because claim
30’s recited “the single layer” lacks an antecedent basis. Ans. 5. Appellant
argues the claim is clear. Appeal Br. 11–12. Appellant’s argument is again
persuasive. Claim 30 depends from independent claim 10. Claim 10 recites
the term “layer” only one time: “wherein the vitamins, minerals and omega-
3 fatty acids in each of the one or more gummy compositions is provided in
a single homogenous layer.” Appeal Br. 28 (Claims App.) (emphasis
added). Because this is the only layer recited by claims 10 and 30 and
because both claims 10 and 30 refer to the layer as being “single,” claim
30’s “the single layer” refers back to claim 10’s only single layer. Because
the Examiner does not establish a lack of clarity, we do not sustain this
rejection.
Rejection B, obviousness. The Examiner rejects claims 1, 5–8, 10,
14–17, 19–24, 29, and 30 under 35 U.S.C. § 103 as obvious over Laskowski,
Rifkin, Vitafusion, Enfield, Spring Valley, Cox, Geuns, AAPA, Madziva,
Zimmerman, OSU, DRI, IMC, Coletta, and Blake. Ans. 5. We focus only on
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the Appellant’s identification of error in the rejection and the Examiner’s
related determinations.7
The Examiner finds that Laskowski teaches gummy vitamins for
adults. Ans. 6. The Examiner finds that Laskowski does not teach ranges for
claim 1 and claim 10’s recited nutrients. Id. at 14. The Examiner finds that
OSU teaches that tolerable upper level of intake for vitamin A is “result
dependent based on the consumer’s age.” Ans. 14, 39. The Examiner finds
that OSU’s various tables teach a range that overlaps claim 1 and claim 10’s
recited vitamin A range of 1000 IU to 2000 IU. Id.
Appellant argues that OSU does not teach a total dosing amount of
about 1000 IU to about 2000 IU as claims 1 and 10 recite. Appeal Br. 15.
We agree. The OSU table entitled “Recommended Dietary Allowance
(RDA) for Vitamin A as Preformed Vitamin A (Retinol)” only provides
information about recommended dosage of Vitamin A per day. The table
does not provide any information about what dosage is appropriate for a
total dosing amount (i.e., amount of the ingredient a person should ingest at
one time) or an individual dosing amount (i.e., amount of the ingredient that
should be put in one dosing form).8

7 Appellant presents additional arguments as to why the Examiner’s
rejection is in error. We decline to address the additional arguments because
resolution of error in one aspect of the Examiner’s rejection is sufficient to
reverse.
8 Moreover, as Appellant’s argue, this OSU table teaches 750–770 µg/day
(equivalent to about 2500 IU per day) for pregnant females. That number is
outside of claim 1’s range. We note, however, that this issue may be less
relevant for claim 10 because claim 10 is directed to a composition rather
than a method.
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Indeed, even if the evidence established that a “tolerable upper level
of intake of vitamin A is result dependent, based on the consumer’s age”
(Ans.14) sufficiently to establish that “tolerable upper level of intake” is a
result effective variable (see, e.g., In re Boesch, 617 F.2d 272, 276 (CCPA
1980) (“[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.”)), this would not help
the Examiner’s position. Tolerable upper level of intake per day is not the
same as total dosing amount. The Examiner, therefore, has not cited
evidence to establish that “total dosing amount,” as claims 1 and 10 recite, is
a known result effective variable.
Similarly, the OSU table entitled “Tolerable Upper Level of Intake
(UL) for Preformed Vitamin A (Retinol)” indicates toxicity in adults at
10,000 IU per day. The table again does not address how much Vitamin A
should be provided in one total dose or in one dosing form.
We further note that OSU suggests that “toxicity may result acutely
from high-dose exposure over a short period of time” and that “some
populations may be more susceptible to toxicity at lower doses.” See OSU
SAFETY. Based on these teachings, we do not agree with the Examiner that
OSU establishes that a person of skill in the art would have considered any
total dosing amount below 10,000 IU appropriate. Ans. 38 (“using only the
disclosure in OSU that daily amounts of ingested preformed vitamin A
should not exceed 10,000 IU, the Examiner concludes that OSU teaches the
claimed vitamin A ranges”). Rather, a person of skill in the art would have
sought more specific guidance on dosing amounts while ensuring that the
10,000 IU per day maximum is not exceeded.
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Because the Examiner has not adequately established that a person of
skill in the art would have reached claim 1 or claim 10’s total dosing amount
of vitamin A, we do not sustain the Examiner’s rejection of those claims or
of the claims depending from claims 1 or 10.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
5–8, 14–17,
30
112 Indefiniteness 5–8, 14–
17, 30
1, 5–8, 10,
14–17, 19–
24, 29, 30
103 Laskowski, Rifkin,
Vitafusion, Enfield,
Spring Valley, Cox,
Geuns, AAPA,
Madziva, Zimmerman,
OSU, DRI, IMC,
Coletta, and Blake
1, 5–8, 10,
14–17, 19–
24, 29, 30
Overall
Outcome
1, 5–8, 10,
14–17, 19–
24, 29, 30

REVERSED