Ex Parte HOFFMANN et al

Patent Trial and Appeal Board

Jan 31, 2019

14293418 (P.T.A.B. Jan. 31, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/293,418 06/02/2014
38263 7590 01/31/2019
ProPat, LLC
1794 Deer Park Lake Road
Spruce Pine, NC 28777
FIRST NAMED INVENTOR
Hans-Rainer HOFFMANN
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.
06/065 LTS C 1 5312
EXAMINER
DEES, NIKKI H
ART UNIT PAPER NUMBER
1791
MAIL DATE DELIVERY MODE
01/31/2019 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 HANS-RAINER HOFFMANN,
BODO ASMUSSEN, HOLGER PIOTROWSKI,
and MARKUS MULLER
Appeal2018-002254
Application 14/293,418
Technology Center 1700
Before MICHAEL P. COLAIANNI, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the decision of the
Examiner finally rejecting claims 1 and 3-14. We have jurisdiction over the
appeal under 35 U.S.C. § 6(b ).
We affirm.
1 The real party in interest is said to be LTS Lohmann Therapie-Systeme AG
(Appeal Br. 3).
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Application 14/293,418
BACKGROUND
Appellants' invention is directed to edible, film-shaped preparations
with cola flavor which, on contact with moisture, are said to disintegrate
quickly without leaving any residue (Spec. 1: 19-20).
Independent claims 1, 4, and 11 are representative of the claims on
appeal and are reproduced below from the Claims Appendix to the Appeal
Brief ( emphasis added):
1. An edible, water-soluble, wafer containing cola
flavouring, wherein said preparation dissolves quickly upon
contact with moisture, does not leave a residue, and has a
pleasant mouthfeel and wherein said preparation contains a
film-forming polymer being a hydroxypropylated starch
derivative selected from the group consisting of
hydroxylpropylated pea starch and hydroxypropylated tapioca
starch in combination with further film-forming polymers,
said cola flavo[u]ring present in said preparation in an
amount ranging from 5 to 20 %-wt[.],
said hydroxypropylated starch derivative present in an
amount rangingfrom[J55 to 65 %-wt[.],
said one or more further film-forming polymers present
in an amount ranging from 0.01 to 10[]%-wt[.J, all %-wts[.]
relative to dry matter,
from 2 to 5 %-wt[.] acidifier,
and said one or more further film-forming polymers selected
from the group consisting of cellulose derivatives, partially
hydrolysed polyvinyl alcohols, polyvinyl pyrrolidone, and
polyethylene glycols.
4. The preparation according to Claim 1, wherein the film-
forming polymer mixture comprises
a) 55 to 65%-wt. of a hydroxypropylated starch
derivative, and
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b) 4. 7 to 10%-wt. of further film-forming polymer
consisting of partially hydrolysed polyvinyl alcohols
c) 5 to 18%-wt[.] glycerine
d) 0[]%-wt. filler(s), and
e) 2 to 5 %-wt[.] acidifier and
stabilizer is not required.
11. An edible, water-soluble, film-shaped preparation
containing 5 to 20 %-wt[.] cola flavouring, wherein said
preparation dissolves quickly upon contact with moisture, does
not leave a residue, and has a pleasant mouthfeel, and wherein
said preparation contains a film-forming polymer being a
hydroxypropylated starch derivative in an amount in the range
of about 55 - 65[]%-wt[.J selected from the group consisting of
hydroxypropylated pea starch and hydroxypropylated tapioca
starch in combination with a further film-forming polymer
consisting essentially of partially hydrolysed polyvinyl alcohol
in an amount of 4. 7 -10[]%-wt[.J and 2 to 5 %-wt[.] acidifier,
all relative to dry matter, and stabilizer is not required.
(App. A 1, 2, 4--5).
REJECTIONS
(1) Claim 4 is rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement. 2
(2) Claim 4 is rejected under 35 U.S.C. § 112, second paragraph, as
indefinite.
2 The Examiner has withdrawn the rejection of claims 9-12 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement (Ans. 14).
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(3) Claims 1, 3-8, and 11-14 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Corriveau3 in view ofFadden, 4 as evidenced by Saxena. 5
(4) Claim 9 is rejected under 35 U.S.C. § I03(a) as unpatentable over
Corriveau in view of Fadden, as evidenced by Saxena, and in further view of
Heath. 6
(5) Claim 10 is rejected under 35 U.S.C. § I03(a) as unpatentable over
Corriveau in view of Fadden, as evidenced by Saxena, in view of Heath, and
in further view of Pearce. 7
DISCUSSION
Rejection (1) under 35 U.S.C. § 112, ,r 1
The Examiner finds that the limitations of claim 4 reciting "O %[-wt.]
filler( s )" and "stabilizer is not required" were not described in the
Specification as filed within the meaning of§ 112 (Ans. 3).
To satisfy the written description requirement of§ 112, the
Specification must allow a person of ordinary skill in the art to recognize
that the inventor invented what is claimed. In re Gosteli, 872 F .2d 1008,
1012 (Fed. Cir. 1989). The Specification must reasonably convey to a
person of ordinary skill in the art that the inventor had possession of the
3 Corriveau et al., US 2004/0043134 Al, published March 4, 2004.
4 Fadden et al., US 2004/0247648 Al, published December 9, 2004.
5 Saxena, S.K., POLYVINYL ALCOHOL (PVA), Chemical and Technical
Assessment, 6l8t JECFA 1-3 (2004).
6 Heath, Henry B., Source Book of Flavors, The A VI Publishing Co., Inc.
779-92 (1981 ).
7 Pearce et al., US 2003/0224090 Al, published December 4, 2003.
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claimed subject matter as of the filing date. Ralston Purina Co. v. Far-Mar-
Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985); see also Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The Specification,
however, need not describe the claimed subject matter word-for-word. In re
Wertheim, 541 F.2d 257,262 (CCPA 1976).
The Examiner notes that the Specification "states that fillers are
'thickeners, disintegration enhancers, or stabilizers"' (Ans. 3). The
Examiner finds that because claim 4 "has already excluded fillers,"
Appellants are "not considered to have support to 'not require' stabilizers
(id.). According to the Examiner, "'not requiring' a stabilizer does not
exclude the presence of a stabilizer" (id.).
However, we agree with Appellants that the disputed limitations are
supported by the Specification (Appeal Br. 10). We note that the
Specification discloses that "20[]%-wt. of one or more fillers, e.g.[,] ...
stabilisers, ... may be contained in the wafers" (Spec. 13 :20-26) ( emphasis
added). The Specification further discloses that a preferred embodiment of
the described wafers includes 0-20 %-wt. filler(s) (id. at 14:1-8) (emphasis
added). Thus, the Specification describes instances in which the claimed
composition may not require stabilizers and excludes filler( s ). Based on this
disclosure, we find that the Specification describes, within the meaning of
§ 112, the claimed composition containing "O %-wt. filler(s)" and a
"stabilizer," which "is not required."
Accordingly, we reverse the rejection of claim 4 under 35 U.S.C.
§ 112, first paragraph.
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Rejection (2) under 35 U.S.C. § 112, ,:r 2
In the examination context, the relevant inquiry under 35 U.S.C.
§ 112, second paragraph, "is to determine whether the claims do, in fact, set
out and circumscribe a particular area with a reasonable degree of precision
and particularity." In re Moore, 439 F.2d 1232, 1235 (CCPA 1971)
(emphasis added); see also In re Packard, 751 F.3d 1307, 1310 (Fed. Cir.
2014) ("[a] claim is indefinite when it contains words or phrases whose
meaning is unclear"). "[T]he 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." Moore, 439
F.2d at 1235.
In this instance, the Examiner determines that the limitation "stabilizer
is not required" as recited in claim 4 is construed to mean that the "stabilizer
is optionally present" (Ans. 4). The Examiner further determines that "if
[A]ppellant[s] ha[ve] already claimed the preparation comprising 0[]%[-wt.]
filler, [then] it is unclear what [ A Jppellant[ s] intended the 'not required'
stabilizer to encompass" (id.).
In response, Appellants argue that because the Specification describes
"stabilizers" as an example of "fillers," "a person having ordinary skill in the
art would understand that the recitation '0[]%-wt. fillers(s)' limits the scope
of Claim 4 to recite that the preparation as claimed includes 0[]%-wt. of
stabilizer" (Appeal Br. 15). Appellants further argue that "contrary to the
Examiner's urgings, the recitations of Claim 4 cannot be read as 'a stabilizer
is optionally present"' (Reply Br. 5).
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This argument is insufficient to show error in the rejection as
Appellants do not explain the meaning of the claim language "stabilizer is
not required." The disputed language is particularly unclear if, as Appellants
assert, it cannot mean that the claimed stabilizer is optionally present.
Accordingly, we affirm the rejection of claim 4 under 35 U.S.C.
§ 112, second paragraph.
Rejections (3), (4), and (5) under 35 U.S.C. § 103(a)
Upon consideration of the evidence of record and each of Appellants'
contentions as set forth in the Appeal and Reply Briefs, we determine that
Appellants have not demonstrated reversible error in any of the Examiner's
rejections under 35 U.S.C § 103(a) in the Final Office Action and Answer.
We sustain the rejections under 35 U.S.C. § 103(a) as obvious over the
applied prior art, essentially for the reasons expressed by the Examiner in the
Final Office Action and the Answer (Final Act. 2-15; Ans. 3-26). We add
the following for emphasis.
Rejection (3)
The Examiner finds that Corriveau's rolled, edible, rapidly dissolving
thin film products teach each of the limitations of independent claims 1 and
11, with the exception that, inter alia, Corriveau is silent with respect to the
claimed hydroxypropylated starch types (Ans. 6). However, the Examiner
relies on Fadden for "teach[ing] that hydroxypropylated tapioca starch is
known to be utilized in fast dissolving orally consumable films" (id. ( citing
Fadden ,r 14)). The Examiner concludes that "it would have been obvious to
have selected [Fadden's] hydroxypropylated tapioca starch where
hydroxypropylated starches, generally, are taught as suitable for use in the
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invention of Corriveau[] as hydroxypropylated tapioca starches were known
in the art to be included in oral films" (Ans. 6).
Appellants make the following arguments urging reversal of the
rejection of claims 1, 3, 4, and 11: (1) "Corriveau's alleged ... 52.6% by
weight ofhydroxypropylated starch in Example 6 is still less than the
claimed range of 55% to 65% by weight as claimed" and the film of
Example 6 actually teaches 47.35 % by wt. ofhydroxypropylated starch of
the finished film (Appeal Br. 21 ); (2) the Examiner does not provide a
rationale why the ordinarily skilled artisan would have randomly combined
the hydroxypropylated starch of Corriveau's Example 6 with the polyvinyl
alcohol ingredient of Example 13, which does not include any
hydroxypropylated starch (id. at 19--20; Reply Br. 12); (3) Corriveau fails to
teach that its dissolved composition does not leave a residue and Fadden's
moisture resistant modified starches would have dissolved more slowly
(Appeal Br. 24, 28; Reply Br. 13-14); (4) Saxena's disclosure that polyvinyl
alcohol imparts barrier film properties teaches away from the claimed
combination of polyvinyl alcohol with hydroxypropylated starch (Appeal Br.
29--30; Reply Br. 14); and (5) Examples 1-3 of the Specification provide
evidence that "the present invention is significant ( and thus unexpected)"
(Appeal Br. 33) and the Rule 132 Declaration of Dr. Muller provides
"comparisons with the closest prior art and the invention" (Reply Br. 12-13
(citing Rule 132 Declaration ,r,r 13-16; 17-21)).
Appellants' arguments are not persuasive.
With respect to arguments (1) and (2), the claims at issue each require
that the recitations of %-wts. are "relative to dry matter." Thus, Appellants
have not identified error in the Examiner's subtraction of the 10 %-wt.
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contributed by water to derive the 52.6 %-wt. ofhydroxypropylated starch
relative to the dry film of Example 6 (see Ans. 7). Furthermore, Corriveau
explicitly discloses that "[ s ]uitable film-formers include but are not limited
to ... modified starches such as those that have been acid modified,
bleached, oxidized, esterified, etherified, crosslinked, and treated
enzymatically" (Corriveau ,r 82; see also In re Fritch, 972 F.2d 1260, 1264
(Fed. Cir. 1992) (explaining that "[i]t is well settled that a prior art reference
is relevant for all that it teaches to those of ordinary skill in the art")). Thus,
we are not persuaded that the claimed hydroxypropylated starch derivative,
which is a modified starch, is not disclosed as a suitable film-former in
Corriveau's list of modified starches.
Corriveau further teaches that "[i]n an embodiment, the concentration
of the film-forming agent constitutes between 5% to about 60% by dry
weight" (Corriveau ,r 82). Therefore, the claimed hydroxypropylated starch
derivative ranges are prima facie obvious over the teachings of Corriveau.
In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("[a]primafacie case
of obviousness typically exists when the ranges of ... [the] claimed
composition overlap the ranges disclosed in the prior art"); see also In re
Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (concluding that a claimed
invention was rendered prima facie obvious by a prior art reference whose
disclosed range (0.020--0.035% carbon) overlapped the claimed range
(0.030--0.070% carbon)).
With regard to argument (2), we are not persuaded because Corriveau
is relevant for all that it teaches to those of ordinary skill in the art. See
Fritch, 972 F.2d at 1264. As the Examiner finds, Corriveau teaches
"combinations of film forming polymers, including all of the claimed film-
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forming polymers, as suitable for inclusion in their invention ... , as well as
specific examples with amounts of hydroxypropylated starch in combination
with smaller amounts of additional film-forming polymers including gelatin"
and polyvinyl alcohol (Ans. 5 ( citing Corriveau ,r 82; Example 6); see also
Ans. 7 (citing Corriveau Example 13)). Based on these teachings,
Appellants' arguments have not identified reversible error in the Examiner's
conclusion that it would have been obvious for the ordinary skilled artisan
"to have utilized a large amount of a hydroxypropylated starch in
combination with a smaller amount of an additional film-forming polymer as
claimed with the reasonable expectation that a suitable water-soluble wafer
would [have] be[ en] provided" (Ans. 5).
We are not persuaded by Appellants' argument (3) because the cited
prior art, which is directed to quick-dissolving oral film, discloses each
limitation recited in claims 1 and 11 (see id. at 18, 20). It is well established
that when claimed and prior art products are produced by identical or
substantially identical processes, the PTO can require an applicant to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. In re Best, 562 F.2d 1252, 1255
(CCPA 1977). This is true whether the rejection is under 35 U.S.C. § 102
(anticipation) or 35 U.S.C. § 103 (obviousness), and is based on the fact that
the PTO is not in a position to manufacture products or to obtain and
compare prior art products. Id.
In this instance, Appellants have not met their burden in
demonstrating that the edible, water-soluble wafer composition resulting
from the Examiner's proposed combination does not possess the claimed
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capability to dissolve quickly upon contact with moisture and does not leave
a residue.
Appellants' argument ( 4) is not persuasive because the Examiner
relies on Saxena only as evidence that teaches that Corriveau's polyvinyl
alcohol would have been inherently partially hydrolyzed (see Ans. 7, 21 ).
Argument ( 5) is not persuasive because Appellants have failed to
establish that the ordinary skilled artisan would not have expected that the
claimed wafer provides quick dissolution properties. See In re Freeman,
474 F.2d 1318, 1324 (CCPA 1973) (holding that to establish the existence of
unexpected results, Appellants must establish: (1) that there actually is a
difference between the results obtained through the claimed invention and
those of the closest prior art and (2) that the difference actually obtained
would not have been expected by a person of ordinary skill in the art at the
time of the invention.).
Appellants have not shown error in the Examiner's finding that both
the applied prior art and the instant claims are similarly directed to fast
dissolving orally consumable films (see Ans. 18, 20). Furthermore, our
review of Examples 1-3 of the Specification and paragraphs 13-16 and 17-
21 of the Rule 132 Declaration of Dr. Muller finds that Appellants have not
made any comparisons with the closest prior art.
Accordingly, we affirm the rejection of claims 1, 3, 4, and 11 for the
reasons set forth above and explained in the Examiner's Final Action and the
Answer. Dependent claims 5-8 and 12-14 fall with each of their respective
independent claims. 37 C.F.R. § 4I.37(c)(l)(iv).
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Rejection (4)
The Examiner finds that the combination of Corriveau and Fadden "is
silent as to the edible films comprising caramel coloring, caffeine or lime
flavoring" (Ans. 11 ). However, the Examiner finds that Heath teaches a
variety of cola syrup formulations (id.). The Examiner concludes that
because "all of the claimed ingredients are known to be used in edible films
and to provide cola flavors it is considered obvious to combine the claimed
ingredients to provide a cola-flavored edible film" (id. at 12).
Appellants make the following arguments urging reversal of the
rejection of claim 9: ( 1) Heath does not teach or suggest the claimed wafer
containing sucralose cola flavoring because Heath requires the combination
of saccharin and calcium cyclamate (Appeal Br. 33-34); and (2) the
Examiner's proposed combination does not teach the required amounts of
sucralose and the optional sorbitol syrup (id. at 35-36).
Appellants' arguments are not persuasive. We agree with the
Examiner that the ordinary skilled artisan would have gleaned from
Corriveau that an edible, water-soluble, wafer may include any known
flavor, including Heath's cola flavoring (see Ans. 23, citing Corriveau ,r 88
( disclosing that "[ a ]ny suitable amount and type of artificial and/ or natural
flavoring agents can be used in any sensorially acceptable fashion.")).
Furthermore, Corriveau teaches a number of high intensity sweeteners for
inclusion in oral films, including sucralose, saccharin, and cyclamate
(Corriveau ,r 92; Example 6 ( disclosing sucralose at 1.4 %-wt.)). Therefore,
in the absence of any showing of unexpected results, Appellants have not
identified reversible error in the Examiner's determination that it would have
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been obvious to combine the claimed ingredients to provide a cola-flavored
edible film.
Accordingly, we affirm the rejection of claim 9 for the reasons set
forth above and explained in the Examiner's Final Action and the Answer.
Rejection (5)
The Examiner finds that the combination of Corriveau, Fadden, and
Heath "is silent as to the edible films comprising polyoxyethylene sorbitan
monooleate[ and] macrogol glycerol hydroxystearate" (Ans. 13). However,
the Examiner finds that Pearce "teach[ es] plasticizers for edible films
including polyoxyethylene sorbitan monooleate (i.e.[,] polysorbate) and
macrogol glycerol hydroxystearate (i.e.[,] polyoxyethylene castor oil
derivative) in a mixture in an amount ranging from 0.1 to 5 % total by
weight" (id. (citing Pearce ,r 50)). The Examiner concludes that because "all
of the claimed ingredients are known to be used in edible films and to
provide cola flavors it is considered obvious to combine the claimed
ingredients to provide a cola-flavored edible film" (Ans. 14).
Appellants urge reversal of the rejection of claim 10 by arguing that
Pearce: (1) teaches that film-forming agents other than pullulan, such as
those presently claimed, give rise to a slimy filler (Appeal Br. 37-38); and
(2) cautions against the addition of the claimed glycerin or sorbitol to avoid
producing an overly moist film (id.).
These arguments are not persuasive because Appellants do not point
to anything in Pearce that criticizes, discredits, or discourages employing
either non-pullalan film-forming agents, glycerin, or sorbitol. Without such
an express teaching, it cannot be said that the art teaches away from the
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necessary modification. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004).
With regard to argument (1 ), the Examiner finds that Pearce's
exemplary Base Film Formulation A does not comprise pullulan (Ans. 25,
citing Pearce ,r 197). Furthermore, Pearce provides a list of film-forming
agents which are essentially the same as those of Corriveau ( compare Pearce
,r 28 with Corriveau ,r 82).
Appellants' argument (2) is not persuasive because we agree with the
Examiner that Pearce only teaches that "it may be useful" to avoid
substantial amounts of sorbitol and/or glycerin (Ans. 25 ( citing Pearce ,r
33)). In other words, Pearce does not teach that these compounds cannot be
included in oral films.
Accordingly, we affirm the rejection of claim 10 for the reasons set
forth above and explained in the Examiner's Final Action and the Answer.
CONCLUSION
We REVERSE the rejection of claim 4 under 35 U.S.C. § 112, ,r 1, for
failing to comply with the written description requirement.
We AFFIRM the rejection of claim 4 under 35 U.S.C. § 112, ,r 2, as
indefinite.
We AFFIRM the rejection of claims 1, 3-8, and 11-14 under 35 U.S.C.
§ 103(a) as unpatentable over Corriveau in view of Fadden, as evidenced by
Saxena.
We AFFIRM the rejection of claim 9 under 35 U.S.C. § 103(a) as
unpatentable over Corriveau in view of Fadden, as evidenced by Saxena, and
in further view of Heath.
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We AFFIRM the rejection of claim 10 under 35 U.S.C. § 103(a) as
unpatentable over Corriveau in view of Fadden, as evidenced by Saxena, in
view of Heath, and in further view of Pearce.
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
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