Ex Parte Brady et al

Patent Trial and Appeal Board

Aug 29, 2014

12168619 (P.T.A.B. Aug. 29, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/168,619 07/07/2008 Scott P. Brady SCH054 P303 7810
277 7590 08/29/2014
PRICE HENEVELD LLP
695 KENMOOR SE
P O BOX 2567
GRAND RAPIDS, MI 49501
EXAMINER
TRAN, SUSAN T
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
08/29/2014 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 SCOTT P. BRADY and ROBERT C. DOSTER1
________________

Appeal 2012-005402
Application 12/168,619
Technology Center 1600
________________

Before JEFFREY M. FREDMAN, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1-16, 19, 20, 26, and 27. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm, and designate our affirmance as a New Ground of
Rejection under 37 C.F.R. § 41.50(b).
STATEMENT OF CASE
Appellants’ invention is directed to tablet coating compositions
suitable for orally-administered dietary supplements.

1 Appellants identify Enzyme Therapy, Inc. as the Real Party in Interest.
(App. Br. 2).
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Exemplary independent claim 1 recites :
1. A tablet coating composition comprising:
water; and
at least one Certified Organic ingredient dispersed in the
water, the composition being comprised entirely of water,
Certified Organic ingredients, and at least one organic
compliant ingredient.
Independent claims 11 and 27 are further directed to a coated tablet
comprising a tablet core and a coating layer. Claim 27, and the dedependent
claims on appeal variously specify Certified Organic honey solids, Certified
Organic soy lecithin, organic compliant vegetable glycerin, and organic
compliant carrageenan.
Claims 1, 2, 4, 6, 7, 9, 11-13, 15, 20, 26, and 27 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Vitamininformationpress (VIP)2, in
view of Dalziel3 and Roman4.
Claims 1-16, 19, 20, 26, and 27 stand rejected under 35 U.S.C. §
103(a) as unpatentable over VIP, in view of Dalziel, Roman, and Sue5.

FINDINGS OF FACT
The tablet coatings of Appellants’ invention “are made from Certified
Organic ingredients and organic compliant ingredients.” (Spec. ¶ 12.)

2 “New Organic Products,” 9(4) Vitamininformationpress (April 2007).
3 Dalziel et al., US 2006/0068019, published March 30, 2006.
4 Roman et al., US 2008/0299258, published December 4, 2008.
5 Sue et al., US 2002/0192283, published December 19, 2002.
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The Specification defines “Certified Organic ingredients” as
“ingredients that are certified ‘organic’ by the U.S.D.A. Accredited
Certifying Agents for the National Organic Program established in
accordance with the Organic Foods Production Act of 1990 (7 U.S.C. 6501
et seq.).” (Id. ¶ 13.) “Organic compliant” ingredients are “non-agricultural
substances (as listed under 7 U.S.C. §205. 605) that may be used in the
production of products that may be labeled organic pursuant to 21 C.F.R.
01.22.” (Id. ¶ 17.)
The Specification discloses preferred tablet coating compositions
comprising “water, Certified Organic honey solids, and an organic compliant
carrageenan. (Id. ¶ 20.) “Honey solids or honey powder is composed of
sugars (predominantly fructose and glucose, but may also include maltose
and sucrose), dextrins, minerals, diastase enzyme (which converts starch to
maltose units), small amounts of lipids and proteins other than the diastase
enzyme, and beeswax.” (Id. ¶ 21.) The Specification further states that
coating compositions may also include organic compliant vegetable glycerin
as a plasticizer (id. ¶ 24), and Certified Organic soy lecithin “to reduce the
tackiness of the coating on the tablet cores.” (id. ¶ 25).
The Specification states that “[c]oated tablets are well-known in the
art”
and have been employed for over 1,000 years. For example,
it is reported that the mucilage of psyllium seeds was used
to coat pills having an offending taste at least as early as the
9th century. Subsequently, it is reported that gold, silver,
gelatin, and waxes have been employed as tablet coatings.
Id. ¶ 3.

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The Specification discloses that tablet coatings perform a plurality of
functions, stating:
Unquestionably, a significant portion, if not most,
pharmaceutical and/or nutriceutical solid dosage forms are
provided with a coating that typically performs a plurality
of functions. Tablet coatings are used for protecting the
active ingredient in the tablet core from air, moisture and
light to improve stability and extend useful shelf life of the
tablet. Coatings are also used for masking unpleasant taste
and odor; and for making the tablet easier to swallow. In
addition, tablet coatings can be used to improve the
appearance of the tablet, and to improve the mechanical
integrity of the tablet by making it more resistant to
abrasion, attrition and the like.
(Id. ¶ 4.)
Sue is directed to tablet coatings for masking the odor or taste of
pharmaceutical preparations, in particular, dietary supplements derived from
Valarian root extract. (Sue Abstract, ¶¶ 2, 5.) Sue teaches tablet coating
compositions comprising, inter alia, a solvent such as water (id. ¶ 33),
lecithin (id. ¶ 58), a plasticizer such as glycerin (id. ¶ 11), and a coating
layer comprising “a sugar and at least one anti-tackiness agent” (id. ¶ 11).
Sue further discloses that “[s]ugars increase the palatability of the
preparation,” and that suitable sugars “include, but are not limited to,
sucrose, dextrose, dextrin, maltose, glucose, fructose, mannose, sorbitol,
lactose, mannitol, xylose and the like.” (Id. ¶ 25).
Dalziel teaches coating compositions for pharmaceutical or nutritional
supplements in particle form which may contain water as a solvent (Dalziel
¶ 75), along with soy protein (id. ¶ 83); lecithin (id. ¶¶ 74, 83); carrageenan
(id. ¶¶ 83, 95); and a sweetening agent such as fructose, glucose, maltose, or
sucrose (id. ¶¶ 83, 85).
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Roman teaches that raw organic honey as a sweetener. (Roman
¶ 52.)
VIP is directed to “New Organic Products” including an “Organic
Vitamin C 120 mg tablet.” (VIP 1.) VIP states that under USDA’s National
Organic Program, 100% Organic means that “100% of the ingredients are
organic; can use the USDA organic logo” and “Organic” means that “95%
or more of ingredients are organic; can use the USDA organic logo.” (Id. 2).
ANALYSIS
Appellants contend that the Examiner errs in rejecting claims 1-16,
19, 20, 26, and 27 under 35 U.S.C. § 103(a) as unpatentable in view of Sue,
Dalziel, Roman, and VIP. For the reasons set forth below, we are not
persuaded.
“Certified Organic” and “Organic Compliant”
The claims on appeal recite a coating composition or coating layer
“comprised entirely of” water, Certified Organic ingredients, and organic
compliant ingredients. Invoking the language of independent claim 1,
Appellants contend that “[n]one of the coating compositions specifically
disclosed by Dalziel et al. is “comprised entirely of water, certified organic
ingredients, and at least one organic compliant ingredient.” (Reply Br. 1.)
Appellants further contend that the portions of Dalziel relied on by the
Examiner “disclose a huge selection of choices without providing any
teaching that would guide a person having ordinary skill in the art to the
claimed coating composition comprised entirely of water, certified organic
ingredients and at least one organic compliant ingredient.” (Id.)
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The claim terms at issue are, thus, “certified organic” and/or “organic
compliant.” “Only when a claim is properly understood can a determination
be made . . . whether the prior art anticipates and/or renders obvious the
claimed invention.” Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
239 F.3d 1343, 1351 (Fed. Cir. 2001). “[T]he PTO gives a disputed claim
term its “broadest reasonable interpretation consistent with the specification,
and . . . claim language should be read in light of the specification as it
would be interpreted by one of ordinary skill in the art.” In re Bond, 910
F.2d 831, 8333 (Fed. Cir. 1990).
The court recognizes the fairness of reading claims broadly “before a
patent is granted [since] the claims are readily amended as part of the
examination process.” Burlington Indus., Inc. v. Quigg, 822 F.2d 1581,
1583 (Fed. Cir. 1987). “Thus, a patent applicant has the opportunity and
responsibility to remove any ambiguity in claim term meaning by amending
the application.” In re Bigio, 381 F.3d 1320, 1324 (Fed. Cir. 2004).
Applying the broadest reasonable interpretation to claims also “serves the
public interest by reducing the possibility that claims, finally allowed, will
be given broader scope than is justified.” In re Am. Acad. of Sci. Tech. Ctr.,
367 F.3d 1359, 1364 (Fed. Cir. 2004).
As defined in the Specification, “Certified Organic ingredients” are
“ingredients that are certified ‘organic’ by the U.S.D.A. Accredited
Certifying Agents for the National Organic Program established in
accordance with the Organic Foods Production Act of 1990 (7 U.S.C. 6501
et seq.).” (Spec. ¶ 13.) The Specification does not teach, and Appellants
have not argued, that a “Certified Organic” certification results in any
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structural or functional difference as compared to the same material that has
not been certified.
The Specification similarly defines “organic compliant” ingredients as
“non-agricultural substances (as listed under 7 U.S.C. §205.605) that may be
used in the production of products that may be labeled organic pursuant to
21 C.F.R. 01.22.” (Id. ¶ 17.) Again, Appellants have presented no evidence
that the statutory designation of an ingredient as one that may be used in
products that may ultimately be labeled organic provides any structural or
functional distinction over the same ingredient that has not been certified or
identified on a list.
Because there are no structural differences, we find that the “Certified
Organic” and “organic compliant” designations are non-functional
descriptive terms akin to printed matter. “All that the printed matter does is
teach a new use for an existing product.” In re Ngai, 367 F.3d 1366, 1339
(Fed. Cir. 2004). And as our reviewing Court emphasizes, “‘[w]here the
printed matter is not functionally related to the substrate, the printed matter
will not distinguish the invention from the prior art in terms of
patentability.’” Id. (citing In re Gulack, 703 F.2d 1381, 1387 (Fed. Cir.
1983).) Thus, although we consider all claim limitations when determining
patentability, Appellants’ non-functional descriptive designations are not
entitled to weight in the analysis. Cf. In re Lowry, 32 F.3d 1579, 1584 (Fed.
Cir. 1994) (“Lowry’s data structures are physical entities that provide
increased efficiency in computer operation. They are not analogous to
printed matter.”)
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Independent Claims 1 and 11
In light of our construction, Appellants’ claim 1 reduces to a tablet
coating composition comprising at least two ingredients dispersed in water.
Similarly, in claim 11, these at least two ingredients comprise a coating layer
on the surface of a tablet core. Thus construed, we find claims 1 and 11
obvious under 35 U.S.C. § 103(a) in view of the cited references.6
In particular, Sue discloses tablet coating compositions comprising
water as a solvent (id. ¶ 33), and multiple ingredients suitable for coating
compositions, including lecithin (id. ¶ 58), glycerin (id. ¶ 11), and various
sugars (id. ¶ 25). Sue further discloses the application of coatings to
Valerian root tablet cores. Dalziel also discloses coating compositions
comprising water as a solvent, and a selection of ingredients including soy
protein (id. ¶ 83), lecithin (id. ¶¶ 74, 83), carrageenan (id. ¶¶ 83, 95), and
sugars such as fructose, glucose, maltose and sucrose (id. ¶¶ 83, 85). VIP
discloses organically-derived tablets and establishes that there is a market
for such products.
The cited art provides a reason to apply coating compositions to the
surface of uncoated tablets. In particular, Sue teaches the coating of tablet
cores mask odor or taste. (Sue Abstract, ¶¶ 2, 5). In addition, Appellants’
Specification admits that (1) “[c]oated tablets are well-known in the art”
(Spec. ¶ 3), and “a significant portion, if not most, pharmaceutical and/or
nutriceutical solid dosage forms are provided with a coating that typically

6 Although we affirm here the rejection under 35 U.S.C § 103(a), we are
mindful of the well-settled axiom that “‘anticipation is the epitome of
obviousness.’” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002)
(quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
1983)).

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performs a plurality of functions” including “protecting the active ingredient
in the tablet core from air, moisture and light . . . masking unpleasant taste
and odor . . . making the tablet easier to swallow. . . . improve[ing] the
appearance of the tablet, and [improving] the mechanical integrity of the
tablet by making it more resistant to abrasion, attrition and the like.”
In light of the above, one of ordinary skill in the art would have found
it obvious to formulate a composition comprising water as a solvent and at
least two coating ingredients as taught by Sue and/or Dalziel, and to further
apply that composition to the surface of a tablet core with the reasonable
expectation of achieving one or more of the benefits of coating taught by
Sue, or admitted as known in Appellants’ Specification. See KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398, 401 (2007) (the “combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.”).
Further, and to the extent the claim terms “Certified Organic” and
“organic compliant” should be accorded functional weight, one of ordinary
skill in the art would have found it obvious to select “Certified Organic”
certified materials and “organic compliant” listed compounds from among
those set forth in Sue and/or Dalziel in order to market coated tablets with
the USDA logo and “100% Organic” or “Organic” designation as taught by
VIP. (See VIP 2). See KSR at 421 (“When there is a design need or market
pressure to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of innovation but of ordinary
skill and common sense.”)
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Claims 2-10, 12-16, 19, 20, 26, and 27
Claims 2-10, 12-16, 19, 20, 26, and 27 further recite at least one of
Certified Organic honey solids, Certified Organic soy lecithin, organic
compliant vegetable glycerin, and organic compliant carrageenan. As
above, we accord the terms “Certified Organic” and “organic compliant” no
patentable weight. Each of these ingredients is taught or suggested by the
cited references.
Honey Solids
Sue teaches a coating composition comprising “a sugar and at least
one anti-tackiness agent” (id. ¶ 11) and states that “[s]ugars increase the
palatability of the preparation.” Dalzeil similarly teaches sugars as
sweetening agent (id. ¶¶ 83, 85). We agree with the Examiner that one of
ordinary skill in the art would have found it obvious to substitute the sugars
taught by Sue or Dalziel with the raw organic honey taught by Roman.
(Ans. 5 (citing Roman ¶ 52)). Indeed, we note that whereas paragraph 21 of
the Specification discloses that the sugars in honey solids or honey powder
are “predominantly fructose and glucose, but may also include maltose and
sucrose,” these sweeteners are expressly disclosed in Sue paragraph 25, and
Dalziel paragraphs 83 and 85.
Appellants admit that Roman discloses raw organic honey as a
sweetening agent but argue that
the required Certified Organic honey solids are different
from the raw honey disclosed by Roman et al. First, the
raw honey disclosed by Roman et al. is not necessarily
certified organic. Further, raw honey is normally filtered,
and does not contain honey solids, which are comprised
predominantly of sugars, dextrins, minerals, diastase
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enzymes, and small amounts of lipids and proteins, and
bees wax (see paragraph 21 of the specification).
(App. Br. 9.) We are not persuaded.
Again, we accord no patentable distinction to whether the material
disclosed by Roman is “necessarily certified organic.” Nor have Appellants’
pointed to any evidence of record that Roman’s raw honey is functionally
different from the claimed honey solids; that raw honey is “normally
filtered;” or that filtering eliminates honey solids.7 Mere lawyer’s arguments
and conclusory statements, unsupported by factual evidence, are entitled to
little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997);
In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Soy Lecithin
Appellants’ Specification discloses the use of Certified Organic soy
lecithin “to reduce the tackiness of the coating on the tablet cores.” (Spec. ¶
25). Sue discloses a coating layer comprising “a sugar and at least one anti-
tackiness agent.” (Sue ¶ 11.) Both Sue (id. ¶58) and Dalziel (Dalziel ¶¶ 74,
83) disclose lecithin as a coating ingredient. Dalziel also discloses the
inclusion of soy protein (id. ¶ 83), further suggesting the use of soy lecithin
in particular.
Vegetable Glycerin
Appellants’ Specification states that coating compositions may also
include organic compliant vegetable glycerin as a plasticizer. (Spec. ¶ 24).
The use of glycerin as a plasticizer is expressly taught in Sue paragraph 11.

7 Contrary to Appellants’ assertion, we note that a trade group, the “National
Honey Board,” states that “While there is no official definition of “raw”
honey, it generally means honey that has not been heated or filtered.”
http://www.honey.com/faq/ (accessed August 25, 2014).
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Appellants have provided no evidence that glycerin derived from a
vegetables is structurally or functionally different from glycerin derived
from animal fat or chemically synthesized. Consequently we find that one
of ordinary skill in the art would freely substitute one source for the other.
Carrageenan
Dalziel discloses the use of carrageenan in coatings at paragraphs 83
and 95. Appellants contend that the Examiner errs in citing Dalziel because
the reference “does not teach a tablet with a coating” (App. Br. 8), but “is
limited to coating particles that contain a polyunsaturated fatty acid or a
liquid pharmaceutical material” (Reply Br. 3). We do not find this
argument persuasive.
In order for a reference to be proper for use in an obviousness
rejection, it must be analogous art to the claimed invention. In re Bigio, 381
F.3d 1320, 1325 (Fed. Cir. 2004). Analogous art need not be from the same
field of endeavor as the claimed invention because “[w]hen a work is
available in one field of endeavor, design incentives and other market forces
can prompt variations of it, either in the same field or a different one.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
“Two separate tests define the scope of analogous prior art: (1)
whether the art is from the same field of endeavor, regardless of the problem
addressed and, (2) if the reference is not within the field of the inventor’s
endeavor, whether the reference still is reasonably pertinent to the particular
problem with which the inventor is involved.” Bigio, 381 F.3d at 1325
(citations omitted). If Dalziel is analogous art, “any need or problem known
in the field of endeavor at the time of the invention and addressed by
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[Appellant’s disclosure] can provide a reason for combining the elements in
the manner claimed.” KSR, 550 U.S. at 420.
We find that the cited references are analogous art under either test.
First, Appellants’ invention, Dalziel is directed to coating compositions for
pharmaceutical or nutritional supplements, albeit in particle form rather than
larger tablets. As such, Dalziel is within the same general field of the
invention. Second, we find that the coating of pharmaceuticals or nutritional
supplements in particle form is reasonably pertinent to the coating of similar
compositions in tablet format.
Weight Percent
We are mindful that claims 6-10, 12, 19, 20, and 27 recite express
amounts of the various coating ingredients discussed above. Appellants
have not, however, argued patentability on these bases. We, therefore,
sustain the Examiner’s rejection under 35 U.S.C. §103(a) with respect to
these elements. 37 C.F.R. § 41.37(c)(1)(vii). “[T]he Board [has] reasonably
interpreted Rule 41.37 to require more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art.” In re Lovin,
652 F.3d 1349, 1357 (Fed. Cir. July 22, 2011).
DECISION
The rejection of claims 1, 2, 4, 6, 7, 9, 11-13, 15, 20, 26, and 27 under
35 U.S.C. § 103(a) as unpatentable over Dalziel, Roman, and
Vitamininformationpress (VIP) is affirmed.
The rejection of claims 1-16, 19, 20, 26, and 27 as unpatentable under
35 U.S.C. § 103(a) in view of Sue, Dalziel, Roman, and VIP is affirmed.
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However, because our reasoning differs from that of the Examiner, we
designate our affirmance a new ground of rejection under 37 C.F.R.
§ 41.50(b).
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED; 37 C.F.R. § 41.50(b)

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