Ex Parte Frohberg et al

Patent Trials and Appeals Board

Jul 3, 2019

13585675 - (D) (P.T.A.B. Jul. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/585,675 08/14/2012 Claus Frohberg
4372 7590 07/08/2019
ARENT FOX LLP
1717 K Street, NW
WASHINGTON, DC 20006-5344
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.
040128.00006 2391
EXAMINER
MAIER, LEIGH C
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
07/08/2019 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):
patentdocket@arentfox.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLAUS FROHBERG and RALF-CHRISTIAN SCHMIDT
Appeal2018-002288
Application 13/585,675
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134(a) involving claims to a
modified starch. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm, but designate our affirmance
as a new ground of rejection.
1 Appellants identify the Real Party in Interest as Bayer Intellectual Property
GmbH (see App. Br. 1 ).
2 We have considered and refer to the Specification of Aug. 14, 2012
("Spec."); Final Office Action of May 10, 2017 ("Final Action"); Appeal
Brief of Aug. 10, 2017 ("App. Br."); Examiner's Answer of Oct. 30, 2017
("Ans."); and Reply Brief of Dec. 27, 2017 ("Reply Br."). An oral hearing
was held on June 25, 2019.
Appeal2018-002288
Application 13/585,675
Statement of the Case
Background
"[S]tarch is a nutritionally essential component of human and animal
food" (Spec. 1: 16-17).
The structural features of the starch which is present in
foodstuffs may have an effect on the functional properties (for
example water-binding capacity, swelling power), the
nutritional characteristics (for example digestibility, effect of
the foodstuff on the glycemic index) or the structural
characteristics (for example sliceability, texture, stickiness,
processability) of a very wide range of foodstuffs
(Id. at 1: 17-21 ). "The object of the present invention is to provide modified
waxy starches with altered functional characteristics ... In particular, the
altered functional characteristics consist in the fact that the modified starches
have an increased hot-water swelling power" (Id. at 10:7-12).
The Claims
Claims 12, 17, 20-25, 27-29, and 32--40 are on appeal. Claims 12 is
representative and reads as follows:
12. A modified starch comprising an apparent amylose
content of below 5% by weight and a hot water swelling power
between 60-100 gig, wherein the hot water swelling power is
determined using a temperature of 92.5°C.
The Re} ection 3
The Examiner rejected claims 12, 17, 20-25, 27-29, and 32--40 under
35 U.S.C. § I03(a) as obvious over Lanahan4 and Hu5 (Ans. 4--5).
3 The Examiner withdrew anticipation and obviousness rejections (Ans. 3).
4 Lanahan et al., US 2006/0282917 Al, published Dec. 14, 2006.
5 Hu et al., Starch digestibility and the estimated glycemic score of different
types of rice differing in amylase contents, 40 J. CEREAL SCI. 231-7 (2004).
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Appeal2018-002288
Application 13/585,675
The Examiner finds that "Lanahan teaches modified starch, having
modified phosphate content ... obtained from oats, barley, com or rice"
(Ans. 4). The Examiner finds Lanahan teaches "[c]ovalent derivatization of
starch with ionic functional group(s) increases its solubility and swelling
capacity in any ionic medium, making the modified starch molecules more
accessible to other molecules" (id.). The Examiner finds Lanahan teaches
the "modified starch allows for improved starch solubility and swelling
power, and increased starch digestibility when used as feed, food or as a
fermentable substrate" (id.).
The Examiner acknowledges that Lanahan "does not exemplify the
production of a rice starch or flour or exemplify one with the recited
swelling power" (Ans. 5). The Examiner finds "Hu teaches that rice starch
with low amylose content is more digestible than that with a higher amylose
content" (id.).
The Examiner finds it would have been obvious "to modify the
invention of Lanahan by selecting a low amylose rice plant" because "low
amylose rice ... is known to be more digestible" (Ans. 5). The Examiner
finds the swelling power obvious for two reasons: first, because "Lanahan
specifically teaches that increased phosphorylation leads increased swelling
power"; and second, because "particular value of the swelling power appears
to be another advantage which would flow naturally from following the
suggestion of the prior art" (Ans. 5).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Lanahan and
Hu render claim 12 obvious?
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Appeal2018-002288
Application 13/585,675
Findings of Fact
1. Lanahan teaches "modified starch, as well as production and
uses thereof. The starch has modified properties of viscosity and a modified
phosphate content" (Lanahan ,r 1 ).
2. Lanahan teaches:
Covalent derivatization of starch with ionic functional
group(s) increases its solubility and swelling capacity ... For
example, covalently modifying glucose residues of starch with
an ionic phosphate group can increase the affinity of the starch
molecules for water or any polar solvent. This derivatization
can also assist[] the swelling of the starch .... The swelled and
hydrated phosphorylated starch is more susceptible to attack by
a[]modifying agent.
(Lanahan ,r 18).
3. Lanahan teaches "[p]referably, the plant and plant cells utilized
in the invention are transgenic maize or transgenic rice" (Lanahan ,r 15).
4. Lanahan teaches "the starch, derivatized with ionic functional
group( s) ( e.g. phosphate) may not only increase the proportion of starch
available for hydrolysis, but may also increase the rate of starch hydrolysis
and/or decrease the enzyme requirement to achieve complete hydrolysis"
(Lanahan ,r 20).
5. Lanahan teaches "a starch that can be more easily (in less time
and/or by using of lower enzyme dose) hydrolyzed by amylase and/or
glucoamylase may serve as a better starting substrate for the fermentation
process" (Lanahan ,r 24).
6. Lanahan teaches a "plant or plant part comprising starch
granules under conditions which activate the RI polypeptide thereby
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Appeal2018-002288
Application 13/585,675
processing the starch granules to form an aqueous solution comprising
hydrolyzed starch product" (Lanahan ,r 29).
7. Hu teaches "[ s ]tarch hydrolysis tends to be more quick and
complete for the waxy and low amylose rice than for the intermediate and
high amylose rice" (Hu, abstract).
8. Table 1 of Hu is reproduced, in part, below:
Typ;;s Cultivars AC
(?d)\V
E,rrly 7.F20l 26.8
indica
Late
.liayu'.!93 21.3
Zhefo504 15.2
Yumm Ned LI
ZF20l
Jiayi.C93
Zhefu504
Yumw NoJ
17.5
0.8
Japo- JIN:\ 25.8
il!CQ
Ximilud I 20.l
Jl.'.'.U 13 i)
Shm:rnuo 0
Hyhtid Uyou:3027 26.5
Xii')'OU ,ff, 21.6
Fenyoux- 14.3
iang7..an
Zt,m10 (L7
Table 1 shows four cultivars of rice with low amylose content; specifically
Yunuo No. 1 at 1.1 % or 0.8%, Shaonuo at 0%, and Zanuo at 0.7% (Hu 234,
Table 1).
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Appeal2018-002288
Application 13/585,675
Principles of Law
"[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art." In re Boesch, 617
F.2d 272,276 (CCPA 1980).
Analysis
Appellants contend that "the PTO's obviousness rejection, like its
anticipation rejections, is based on inherency-a 'high standard' to meet"
(citing Par Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir.
2014)) 6 (App. Br. 11). Appellants contend
the PTO has not shown that the combination of Lanahan and
Hu would necessarily result in a starch having the claimed
swelling power. Indeed, while the PTO asserts that "increased
phosphorylation leads to increased swelling power," there is no
evidence showing that a particular phosphate content leads to
the claimed swelling power.
(App. Br. 11).
While we agree with Appellants as to inherency, 7 we are not
persuaded that the claims are nonobvious over the cited prior art because
6 We note that Par deals with an issued patent, not a patent application,
where the Examiner must simply provide evidence sufficient to show
inherency in order to shift the burden of production to Appellant consistent
with MPEP § 2112 and In re Best, 562 F.2d 1252 (CCPA 1977).
7 The evidence in Table 6 of Appellants Specification shows that even a rice
starch from a plant like 738-104/6 with 2.3% amylose only has a swelling
power of 47.3 gig (see Spec. 81 :7-12). Thus, the Examiner has not provided
evidence sufficient to demonstrate that any of the particular embodiments
shown by Lanahan or Hu necessarily have a swelling power within the scope
of the claim. "Inherency ... may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
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Appeal2018-002288
Application 13/585,675
Lanahan specifically suggests swelling capacity is a optimizable variable of
interest by teaching that " [ c] ovalent deri vatization of starch ... increases its
solubility and swelling capacity ... This derivatization can also assist[] the
swelling of the starch" (FF 2). Lanahan explains that the "swelled and
hydrated phosphorylated starch is more susceptible to attack by
a[]modifying agent" (FF 2) and therefore may "increase the proportion of
starch available for hydrolysis" and "increase the rate of starch hydrolysis"
(FF 4).
Thus, the ordinary artisan, starting with one of the four low amylose
rice plants of Hu with amylose content well below 5% (FF 8), would have
had reason to optimize the swelling power as disclosed by Lanahan (FF 2)
because Lanahan recognizes that swelling capacity is an optimizable
variable that may be improved by covalent derivatization of the starch with
ionic phosphate groups (FF 2, 4). Indeed, Lanahan explains that "a starch
that can be more easily (in less time and/or by using of lower enzyme dose)
hydrolyzed by amylase and/or glucoamylase may serve as a better starting
substrate for the fermentation process" (FF 5).
Thus, the ordinary artisan would have expected that optimizing
swelling time by applying the derivatization of Lanahan to the rice plants of
Hu would result in more easily, more rapidly, and more inexpensively
prepared starch for use as a fermentation substrate (FF 5). That Appellants
have claimed an optimized range does not render the range unobvious,
because the ordinary artisan would have had reason to routinely experiment
with Lanahan's derivatization conditions and Ru's rice plants to obtain those
optimal values. "[W]here the general conditions of a claim are disclosed in
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Application 13/585,675
the prior art, it is not inventive to discover the optimum or workable ranges
by routine experimentation." In re Aller, 220 F.2d 454,456 (CCPA 1955).
Because our reasoning differs from that of the Examiner, in that we
rely upon an optimization rationale rather than an inherency rationale, we
will designate this affirmance as a new ground of rejection, to allow
Appellants a fair opportunity for response.
Appellants next contend that
one of ordinary skill in the art would not, based on Lanahan,
have a reasonable expectation of what effect, if any, the
introduction an RI nucleic acid molecule would have on a
waxy mutant rice plant. At best, the PTO's rejection amounts to
adding different starches having unknown swelling powers in
an attempt to arrive at the claimed starches.
(App. Br. 11-12).
We find this argument unpersuasive, as it relates to the optimization
rationale, because this is precisely the point of optimizing a results-effective
variable. "Obviousness does not require absolute predictability of success ..
. all that is required is a reasonable expectation of success." In re Kubin,
561 F.3d 1351, 1360 (Fed. Cir. 2009). Here, given the evidence in
Appellants' own Specification that an untreated rice plant of 738-104/6 with
2.3% amylose resulted in a swelling power of 47.4 gig (see Spec. 81, table
6), the ordinary artisan would have reasonably expected to be able to use the
0%, 0.7%, 0.8%, or 1.1 % amylose rice plants of Hu, by optimizing their
swelling power using the covalent derivatization procedure of Lanahan, to
obtain rice starches with swelling powers falling within the claimed range.
The current record does not include evidence showing that a low amylose
rice of Hu, treated with Lanahan's covalent derivatization procedure, would
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Appeal2018-002288
Application 13/585,675
not be routinely optimizable to yield a rice starch with a hot water swelling
power of 60-100 g/ g or higher as required by the claims.
Appellants contend that "if one of ordinary skill in the art had a reason
to combine Lanahan and Hu and had a reasonable expectation of success,
which they would not, this hypothetical combination would not result in a
genetically modified plant having increased SSII, and thus would not
produce the claimed starches" (App. Br. 12).
We find this argument unpersuasive because the claim is not drawn to
a genetically modified plant, but rather to a "modified starch." None of the
instant claims require a genetically modified plant, but rather recite either a
"modified starch" or a "flour." Therefore, "appellant's arguments fail from
the outset because ... they are not based on limitations appearing in the
claims." In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
Appellants point to data regarding increased swelling power over wild
type rice (see App. Br. 13) and contend the "data presented above
demonstrates that the claimed starches are significantly different than a
hypothetical starch derived from plants having reduced GBSSI activity,
increased SSII activity, and increased GWD ( or RI) activity. Indeed, the
data shows that there is a synergistic effect when all three genetic
modifications are made" (App. Br. 14).
We find this argument unpersuasive for two reasons. First, the data is
not compared to the closest prior art, the 0% amylose rice plant of Hu (FF
8). See In re Baxter Travenol Labs., 952 F.2d 388,392 (Fed. Cir. 1991)
("[W]hen unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior
art.").
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Appeal2018-002288
Application 13/585,675
Second, the data is not commensurate in scope with claim 12. Claim
12 broadly encompasses any starch, derivatized or not, from any cultivar of
any plant used for flour or starch including "maize, rice, wheat or potato,"
(Spec. 2:2) as well as "tapioca ... sweet potato ... [and] arrow root" (Spec.
4:4--5). Indeed, as Hu demonstrates, different rice cultivars have different
amylose content (FF 8). The data identified by Appellants relates solely to a
particular rice plant cultivar with three genetic alterations and a particular
amylose content, and is not commensurate with the scope of all rice
cultivars, much less with the much broader scope of claim 12. Unexpected
results must be "commensurate in scope with the degree of protection sought
by the claimed subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005).
Conclusion of Law
A preponderance of the evidence of record support the Examiner's
conclusion that Lanahan and Hu render claim 12 obvious.
SUMMARY
We affirm the rejection of claims 12, 17, 20-25, 27-29, and 32--40
under 35 U.S.C. § 103(a) as obvious over Lanahan and Hu.
Because we rely on an optimization rationale that was not relied upon
by the Examiner, we designate our affirmance as a new ground pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
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Appeal2018-002288
Application 13/585,675
When the Board enters such a non-final decision, the
appellant, 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 prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
AFFIRMED; 37 C.F.R. § 4I.50(b)
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