Ex Parte Ketkar et al

Patent Trial and Appeal Board

Jul 24, 2018

12440160 (P.T.A.B. Jul. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/440,160 06/15/2010 Rajendra D. Ketkar
73905 7590 07/26/2018
DENTONS US LLP
P.O. BOX 061080
CHICAGO, IL 60606-1080
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.
MONS:177US 1605
EXAMINER
KOV ALENKO, MYKOLA V
ART UNIT PAPER NUMBER
1662
NOTIFICATION DATE DELIVERY MODE
07/26/2018 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):
patents.us@dentons.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJENDRA D. KETKAR, JAY CARTMELL PERSHING, and
MICHAEL A. STEPHENS 1
Appeal2017-008056
Application 12/ 440, 160
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for producing hybrid com, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
"Production of hybrid com seed is an expensive process due to
manual or mechanical detasseling and input costs of herbicides, insecticides,
1 Appellants identify the Real Party in Interest as Monsanto Company.
Appeal Br. 2.
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Application 12/ 440, 160
fungicides, nutrients, and irrigation. The yield of hybrid seed tends to be
lower resulting in lower revenues." Spec. 1.
Id.
[T]he cost of producing homozygous inbreds with multiple
traits for creating hybrids is quite high and becomes higher with
the introduction of each additional trait as breeders need to
ensure a right combination of traits, right position of these traits
in the genome, and integration of these traits in the right
germp lasm.
"Although, hybrid com seeds with up to three traits are known in the
market place and different methods of introducing the multiple traits are
known, the current state of the art lacks a systematic method for delivering
at least four transgenic traits in hybrid com seed." Spec. 2. The
Specification describes a method for "identifying at least four transgenic
traits having a low impact on decreasing cost of production, wherein the
traits are introduced into germplasm of the male parent and/or the female
parent." Spec. 3.
Claims 28, 30-37 and 40 are on appeal. Claim 28 is the sole
independent claim and reads as follows:
28. A method for producing hybrid com seed with at
least four transgenic traits, comprising:
a) providing a female parent comprising at least two
transgenic events each conferring a different herbicide tolerance
trait that provides tolerance to a different herbicide selected
from the group consisting of glyphosate, glufosinate, dicamba,
and 2,4-D and a male parent comprising at least two transgenic
events that confer at least two transgenic traits selected from the
group consisting of an insect resistance trait, a drought
tolerance trait, a nutrient use efficiency trait, a cold tolerance
trait, an intrinsic yield trait, a herbicide tolerance trait, and a
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Application 12/ 440, 160
combination thereof, wherein the number of transgenic events
is balanced on the female and male parents;
b) pollinating said female parent with pollen only from
the male parent; and
c) allowing the female parent to produce hybrid seeds.
The claims have been rejected under 35 U.S.C. § I03(a) as
unpatentable over Poehlman2 in view of Lundquist3, Johnson 4, and Pallett. 5
DISCUSSION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the claims would have been obvious over Poehlman combined with
Lundquist, Johnson and Pallett.
The Examiner finds that Poehlman teaches
a method for producing hybrid com seed comprising providing
a female parent and a male parent; pollinating the female parent
with pollen only from the male parent; and allowing the female
parent to produce hybrid seed (instant claims 28 and 40;
Poehlman et al, page 334, Figure 17.9). Poehlman et al teach
that such traits as insect resistance, drought resistance and cold
tolerance are important breeding objectives for developing
hybrid com plants (instant claims 28 and 40; Poehlman et al,
pages 338-341).
Final Act. 4.
2 John M. Poehlman and David A. Sleper, Breeding Field Crops, (4th ed.
1995) ("Poehlman").
3 Lundquist et al., US 5,990,390, issued Nov. 23, 1999 ("Lundquist").
4 Johnson, US 6,852,915 B2, issued Feb. 8, 2005 ("Johnson").
5 Pallett et al., US 7,250,561 Bl, issued July, 31, 2007 ("Pallett").
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Appeal2017-008056
Application 12/ 440, 160
The Examiner finds that while Poehlman does not teach a female
parent having two herbicide tolerance traits and a male having traits selected
from the group consisting of an insect resistance trait, a drought tolerance
trait, a nutrient efficiency trait, a cold tolerance trait, and a combination
thereof, these traits are taught by the other references. Final Act. 5.
The Examiner finds that Johnson teaches an inbred com line having
one or more transgenes introduced into the com. The Examiner finds that
the trait introduced includes herbicide tolerance including tolerance to
glyphosates, sulfonylurea and triazine. Final Act. 5
The Examiner finds that Lundquist teaches com having two or more
transgenes including those conferring herbicide, insect, disease, or drought
resistance. Final Act. 6. The Examiner finds that Pallett teaches stacking
transgene for resistance to two or more herbicides including HPPD-
inhibitors and glyphosate. Id.
The Examiner concludes
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
modify the methods of Poehlman et al using the teachings of
Johnson et al, Lindquist et al, and Pallett et al and combine, in a
hybrid com plant, two or more transgenic events ( on either
parent), wherein at least two events on one parent confer
resistance to two different herbicides ( as taught by Pallett et al),
and the two transgenic events on the other parent confer
resistance to insects and drought, for example ( as taught by
Lindquist et al), thus arriving at the method of the claimed
invention. It would have been obvious to combine transgenes
conferring resistance to different herbicides in one of the
parents, because doing so is expressly suggested by Pallet et al,
and is also standard industry practice. It would have been
obvious to combine two transgenes conferring resistance to, for
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Application 12/ 440, 160
example, insects and drought, because doing so is taught by
Lindquist et al and Johnson et al, and is standard industry
practice as well. A hybrid com plant thus obtained would
comprise at least four transgenic traits.
One of ordinary skill in the art would have been
motivated to combine these teachings to produce the claimed
invention because Poehlman et al teach that "[c]hoice of proper
objectives is necessary for the com breeder to develop hybrids
that will be adapted to the area in which they are to be grown
and superior to those already in use" (page 337, 2nd paragraph).
Thus, one of ordinary skill in the art would have been
motivated to produce hybrid com seed by crossing parents with
different desirable traits. One of ordinary skill in the art would
have reasonable expectation of success given the teachings of
Poehlman et al, Lindquist et al, and Pallett et al.
Final Act. 6-7.
Appellants contend that none of the references teach all of the
limitations of the claims. Appeal Br. 3. Appellants argue that none of the
references teach a female parent having two transgenic events each of which
confers herbicide resistance nor do they teach a male parent with the
specified traits. Id. at 3--4. Appellants contend that the Examiner
improperly resorted to common sense or basic knowledge to establish the
presence of a claim element. Id. at 4--5. Appellants argue that there is
nothing in the references which would have motivated one skilled in the art
to combine the teachings of the references nor has the Examiner shown that
one skilled in the art would have had a reasonable expectation of success.
Appeal Br. 6-9. Appellants argue that even if the Examiner has established
a prima facie case of obviousness, there is evidence of unexpected results
sufficient to demonstrate non-obviousness. Appeal Br. 11-13.
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Application 12/ 440, 160
Findings of Fact
We adopt the Examiner's findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FPL As shown in Figure 17.9 below, Poehlman teaches production of
a com hybrid by providing a male and female parent, pollinating the female
parent with pollen only from the male parent; and allowing the female parent
to produce the hybrid seed. Poehlman 333--4.
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Appeal2017-008056
Application 12/ 440, 160
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Figure 17.9 from Poehlman showing a production of a single cross seed.
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Appeal2017-008056
Application 12/ 440, 160
FF2. Poehlman teaches "[a] double cross is the hybrid progeny from
a cross between four unrelated inbreds. The inbreds are crossed in pairs to
produce two single-crosses, which are then crossed to produce the double
cross. The pedigree of the double cross made with inbreds A, B, C, and D is
written (AxB) x (CxD)." Poehlman 332.
FF3. Poehlman teaches that traits such as insect resistance, drought
resistance, and cold tolerance are important breeding objectives for
developing hybrid com. Poehlman 338--41.
FF4. Johnson discloses a method for "producing a com plant
containing in its genetic material one or more transgenes." Johnson
Abstract.
FF5. Johnson teaches
The development of commercial com hybrids requires
the development of homozygous inbred lines, the crossing of
these lines, and the evaluation of the crosses. Pedigree breeding
and recurrent selection breeding methods are used to develop
inbred lines from breeding populations. Breeding programs
combined desirable traits from two or more inbred lines or
various broad-based sources into breeding pools from which
inbred lines are developed by selfing and selection of desired
phenotypes. The new inbreds are crossed with other inbred
lines and the hybrids from these crosses are evaluated to
determine which have commercial potential.
Johnson col. 2, 11. 30--41.
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Application 12/ 440, 160
FF6. Johnson teaches that the transgenes introduced into the com can
include those which confer resistance to pests or disease, and resistance to
herbicides. Johnson col. 13, 1. 58- col. 17, 1. 4.
FF7. Johnson teaches conferring resistance to sulfonylurea,
glyphosate, and triazine. Johnson col. 15, 1. 60 - col. 16, 1. 38.
FF8. Lundquist relates to genetically transforming maize plants.
Lundquist Abstract.
FF9. Lundquist teaches
In certain embodiments, the present invention
contemplates the transformation of a recipient cell with more
than on advantageous transgene. Two or more transgenes can
be supplied in a single transformation event using either distinct
trans gene encoding vectors of using a single vector
incorporating two or more gene coding sequences. For
example, plasmids bearing the bar or aroA expression units in
either convergent, divergent or collinear orientation, are
considered to be particularly useful. Further preferred
combinations are those of an insect resistance gene such as a Bt
gene, or the use of bar with a protease inhibitor gene such as
pinII, or the use of bar in combination with either of the above
genes. Of course, any two or more transgenes of any
description such as those conferring herbicide, insect, disease
( viral, bacterial, fungal, nematode) or drought resistance, male
sterility, drydown, standability, prolificacy, starch properties,
oil quality and quantity, or those increasing yield or nutritional
quality may be employed as desired.
Lundquist col. 16, 11. 33--49.
FFlO. Lundquist teaches performing crosses using either a male or
female parent as the transformant. Lundquist col. 105, 11. 30-39.
FF 11. Pallett discloses a method for conferring resistance to multiple
herbicides on a plant. Pallett col. 1, 11. 48--49.
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Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prim a f acie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
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. In
that instance the fact that a combination was obvious to try
might show that it was obvious under § 103.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007).
"To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention." Bristol-Myers
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
"[I]t is well settled that unexpected results must be established by
factual evidence. 'Mere argument or conclusory statements in the
specification does not suffice."' In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
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Application 12/ 440, 160
Analysis
We find the Examiner has established that the subject matter of the
claims would have been obvious to one of ordinary skill in the art at the time
the invention was made over Poehlman combined with Johnson, Lundquist
and Pallett. Appellants have not produced evidence showing, or
persuasively argued, that the Examiner's determinations on obviousness are
incorrect. Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim
28 as representative; therefore, all claims fall with claim 28. We address
Appellants' arguments below.
Appellants contend that the references fail to teach or suggest all of
the limitations of the claims and that the Examiner improperly relied on
common knowledge in finding certain limitations present. Appeal Br. 3---6.
We are not persuaded.
Poehlman teaches crossing a male parent having a specific trait with a
female parent having tow related traits. FF 1. Poehlman also teaches
crossing one parent with two distinct traits with another parent having two
different traits. FF2. Poehlman, Johnson and Lundquist teach the traits
which can be added to com include disease resistance, herbicide resistance,
drought resistance, cold resistance. FF2, FF6, FF9. Lundquist and Pallett
teach conferring resistance to two or more herbicides on a plant. FF9, FF 11.
Lundquist teaches that herbicide resistance can be conferred on either a male
or female parent. FF 10. Production of hybrids having four trans genes is
also known in the art. FF2.
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The art in this case presents one skilled in the art with a finite number
of known possibilities for crossing com plants to produce the desired results.
As such the claimed method would have been obvious to one skilled in the
art for the reasons given by the Examiner (see, e.g., Final Act. 7).
We do not agree with Appellants that the Examiner improperly relied
on common knowledge to support the rejection. As demonstrated above,
each of the claim elements is taught or suggested by the prior art.
Appellants next contend that the Examiner has failed to provide a
motivation to combine the references nor has the Examiner shown that one
skilled in the art would have a reasonable expectation of success of arriving
at the claimed invention. Appeal Br. 6-11. Appellants' arguments are
unpersuasive.
Poehlman teaches the desirability to modify com to adapt the com to
the environment in which they are to be grown. Poehlman 337. Pallett
teaches that farmers like to use combinations of herbicides making it
desirable to develop plants with resistance to tow or more herbicides. Pallett
col. 1, 11. 39--49. Each of the references teaches methods which successfully
confer two or more traits on a plant. See, e.g., FF2, FF5, FF9, FFl 1. The
combined teachings of the reference provide the motivation to develop the
claimed method and demonstrate a reasonable expectation that the claimed
method would be successful. In particular, the Examiner explains that the
ordinary artisan would have had reason to perform the modification of com
to obtain adapted hybrid plants that are superior to those already in use (see
Final Act. 7).
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Appellants contend that there is evidence of unexpected results which
support a conclusion of non-obviousness. Appeal Br. 11. In support of this
argument, Appellants point to the Specification where is shows that
conferring herbicide resistance on the female parent reduces the production
rate failure to a greater extent that when the traits are conferred on the male
parent. Appeal Br. 12. We are not persuaded. Appellants have presented
no objective evidence that such a result was unexpected but rely on attorney
argument. We also note the Specification does not identify this result as
unexpected or surprising in any way. Attorney argument is insufficient to
establish that the result are unexpected. In re Geisler, 116 F.3d at 1470.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 28 would have been
obvious over Poehlman combined with Johnson, Lundquist and Pallett.
Claims 30-37 and 40 have not been argued separately and therefore
fall with claim 28. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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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