GENENTECH, INC.

Patent Trials and Appeals Board

Mar 4, 2020

14035811 - (D) (P.T.A.B. Mar. 4, 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.
14/035,811 09/24/2013 Banmeet Anand 00B206.0129 7551
124674 7590 03/04/2020
Baker Botts LLP
30 Rockefeller Plaza
New York, NY 10112-4498
EXAMINER
HADDAD, MAHER M
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
03/04/2020 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):
chang.elaine@gene.com
chang.elaine@gene.com
nycdocket@bakerbotts.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte BANMEET ANAND, ERIC STEFANICH,
MEINA TANG, JENNIFER VISICH, MARNA WILLIAMS,
and SHARON O'BYRNE
_________________

Appeal 2019-001845
Application 14/035,811
Technology Center 1600
_________________

Before ERIC B. GRIMES, DEBORAH KATZ, and MICHAEL A. VALEK,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 13, 17–19, 25, 26, 28–30, 33, 34, 65,
68, 69, and 74–89. We have jurisdiction under 35 U.S.C. § 6(b). We
AFFIRM.

1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party-in-interest as Genentech, Inc. (App. Br. 5.)
2 We consider the Office Action issued March 26, 2018 (“OA”), the Appeal
Brief filed September 26, 2018. (“Appeal Br.”), the Examiner’s Answer
issued on October 26, 2018 (“Ans.”), the Reply Brief filed December 26,
2018 (“Reply Br.”) and the oral argument held on February 2, 2020, in
reaching our decision.
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2
Appellant’s Specification is directed to treating gastrointestinal
inflammatory diseases, such as ulcerative colitis and Crohn’s disease, by
administering antibodies targeting the protein integrin beta7. (Spec. ¶ 3.)
The Examiner rejects all of Appellant’s claims under three separate
grounds of obviousness: (1) as being obvious under 35 U.S.C. § 103(a) over
Fong ’2363 and Fong ’0824 in view of the ’508 publication5; (2) as being
obvious under 35 U.S.C. § 103(a) over both Fong patents in view of the ’508
publication and Fasanmade6 as evidenced by a Declaration by the Tang
Declaration filed May 1, 2017; and (3) under the doctrine of obviousness-
type double-patenting over claims 1–14 of Fong ’082 in view of the ’508
publication and, optionally, Fasanmade. (See Ans. 3.)
Appellant claims a method of treatment using an anti-beta7 antibody
at a flat dose falling within a recited range. Appellant’s claim 13 recites:
A method of treating a gastrointestinal inflammatory disorder in
a human patient, the method comprising administering
subcutaneously to the patient a flat dose of an integrin beta7
antagonist, wherein the flat dose is between about 100 mg and about
220 mg, and wherein the integrin beta7 antagonist is a monoclonal
anti-beta7 antibody or a fragment thereof comprising six
hypervariable regions (HVRs), wherein:
(i) the HVR-L1 comprises amino acid sequence A1-A11,
wherein A1-A11 is RASESVDTYLH (SEQ ID NO:1);

3 U.S. Patent 7,528,236 B2, issued May 5, 2009.
4 U.S. Patent 8,124,082 B2, issued February 28, 2012.
5 Gelzleichter et al., U.S. Patent Application Publication 2010/0255508 A1,
published October 7, 2010.
6 Fasanmade et al., “Population pharmacokinetic analysis of infliximab in
patients with ulcerative colitis,” Eur. J. Clin. Pharmacol., 65:1211–28
(2009).
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RASESVDSLLH (SEQ ID NO:7), RASESVDTLLH (SEQ ID NO:8),
or RASESVDDLLH (SEQ ID NO:9);
(ii) the HVR-L2 comprises amino acid sequence B1-B8,
wherein B1-B8 is KYASQSIS (SEQ ID NO:2), or RYASQSIS (SEQ
ID NO:20);
(iii) the HVR-L3 comprises amino acid sequence C1-C9,
wherein C1-C9 is QQGNSLPNT (SEQ ID NO:3);
(iv) the HVR-H1 comprises amino acid sequence D1-D10
wherein D1-D10 is GFFITNNYWG (SEQ ID NO:4);
(v) the HVR-H2 comprises amino acid sequence E1-E17
wherein E1-E17 is GYISYSGSTSYNPSLKS (SEQ ID NO:5); and
(vi) the HVR-H3 comprises amino acid sequence F2-F11
wherein F2-F11 is MTGSSGYFDF (SEQ ID NO:6) or
RTGSSGYFDF (SEQ ID NO:19); or comprises amino acid sequence
F1-F11, wherein F1-F11 is AMTGSSGYFDF (SEQ ID NO:16),
ARTGSSGYFDF (SEQ ID NO:17), or AQTGSSGYFDF (SEQ ID
NO:18).

(App. Br. 46 (emphasis added).) Appellant does not argue for the separate
patentability of any of the rejected claims, thus our analysis focuses on claim
13 as representative.
Findings of Fact
1. Fong ’082 teaches treating a human for gastrointestinal
inflammatory diseases (inflammatory bowel disease, Crohn’s disease,
ulcerative colitis, etc.), by subcutaneously administering a humanized
antibody that binds integrin beta7. (See Fong ’082, 91:64, 153:47–156:29
(claims 1–14); see Office Act. 3.)
2. Fong ’082 teaches an anti-beta7 antibody that comprises the six
hypervariable regions recited in Appellant’s claim 13. (See Fong ’082,
153:47–155:18 (claim 1); see Final Act. 3.)
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3. Appellant’s Specification defines a “flat dose” as “a particular
amount of anti-beta7 antibody that is administered to every patient
regardless of weight.” (Spec. ¶ 189.)
4. Fong ’082 teaches exemplary ranges of doses expressed as
doses per body weight, for example 0.5 mg/kg to about 10 mg/kg. (See
Final Act. 3, citing Fong ’082 92:43–44.)
5. The ’508 publication teaches methods of determining a dosing
regimen of a humanized anti-integrin beta7 antibody, as recited in claim 13,
for treatment of a gastrointestinal inflammatory disorder, wherein the
method is based on comparisons of the levels of biomarker in a patient
sample. (’508 publication ¶¶ 13, 14, 317 claims 3–25; see Final Act. 4.)
6. The ’508 publication teaches the pharmacokinetic and
pharmacodynamic effects of an anti-beta7 antibody after intravenous
administration. (See ’508 publication ¶ 418, Table 2-1; see Final Act. 4–5.)
7. Fasanmade teaches pharmacokinetic analysis of an antibody in
patients with ulcerative colitis. (Fasanmade abstract.)
8. Fasanmade teaches using population pharmacokinetics with the
program NONMEM to analyze concentration-time data for an antibody
treatment. (Fasanmade abstract.)
9. Fasanmade teaches using models that include the effect of
weight on clearance. (Fasanmade abstract.)
10. Fasanmade teaches that for the antibody infliximab, an antibody
distinct from the antibody recited in claim 13, body weight-adjusted dosing
is necessary to allow equivalent exposure to all patients to mitigate possible
weight-related influences. (Fasanmade 1222–23.)
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11. Inventor Tang testifies that
population pharmacokinetic analysis is necessary to determine
whether flat dosing or weight-based dosing is appropriate for a
target antibody. This is also explained in Bai et al., “A Guide to
Rational Dosing of Monoclonal Antibodies”, Clin
Pharmacokinet. (2012 Feb 1);51 (2): 119-35 (“Bai”), which I
co-authored. In Bai, a population pbarmacokinetic analysis was
used to provide insights into conditions under which either a
flat dose or a weight-based dose “would be superior in reducing
pharmacokinetic variability and exposure differences between
light and heavy subjects across the population. ” See Bai at
Abstract (Conclusions).

(Tang Decl., ¶ 24.)
12. Mould7, which was presented by Appellant, explains that
[t]here are several potential dose regimens that can be
employed for mAbs: (i) a flat dose, where subjects all receive
the same dose; (ii) an individualized dose, which usually
involves a bodyweight or BSA-based dose; and (iii) a Bayesian
individualized dose, where the dose is adjusted using a
nomogram or the subject’s individual concentration or response
measurement.

(Mould 30 (Exhibit G of Appeal Br.).)

13. Mould teaches:
For drug X, where weight was not an important predictor of
clearance, a flat dose provides a uniform drug exposure (AUC=
83.6 mg• day/L) seen by a single curve in figure 5a. When
weight-based dosing was considered for drug X, AUC for
heavier subjects increased, as drug clearance was independent

7 Mould and Green, "Pharmacokinetics and pharmacodynamics of
monoclonal antibodies: concepts and lessons for drug development,"
Biodrugs 24:23–29 (2010).
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of weight (figure 5b). Conversely, for drug Y where weight
does affect clearance, AUC decreased with weight when a flat
dose was used (figure 5c) and can be ‘normalized’ by giving a
weight-based (e.g. 0.5 mg/kg) dose (figure 5d).

(Mould 30.)

14. Mould states:
Wang et al. [citation omitted] compared flat dosing to body
size-based dosing for several approved mAbs. This work
suggests that the choice between a flat or body size-based dose
is dependent on the pharmacokinetic behavior of each mAb and
the pharmacokinetic variability.

(Mould 30–31.)
16. Mould presents Table I, which indicates that eleven of the
twenty-six listed monoclonal antibodies have been used with flat dosing.
(Mould 25–26.)

Analysis
The Supreme Court instructs that

[w]hen 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'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Thus, the
availability of a finite number of identified, predictable solutions that are
within the skill of the ordinary artisan may indicate that a solution to a
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problem would have been obvious to try and, thus, unpatentable under 35
U.S.C. § 103.
Appellant does not contest that an anti-beta7 antibody with the
hypervariable regions recited in claim 13 was known in the prior art or that it
was known to be useful for subcutaneous administration in treating
gastrointestinal inflammatory disorders in a human patient. (See Fong ’082,
91:64, 153:47–155:29 (claims 1–14); see Office Act. 3.) Appellant does not
contest that such treatment was previously known to involve dosing at
specific concentrations based on the weight of the patient. (See Fong ’082
92:43–44; see Office Act. 3.) Nor does Appellant contest that flat dosing
(that is, using dosing that is the same for all patients regardless of weight
(see Spec. ¶ 189)) was a known option for a dosing regimen that would be
more convenient and would avoid potential dose calculation mistakes. (See
Office Act. 6.)
Instead, Appellant argues that the prior art does not teach
administration of a flat dose of beta7 antibody of between about 100 mg and
about 220 mg and that the Examiner erred in performing a series of
extrapolations to determine that doing so would have been obvious. (See
Appeal Br. 11–12.)
Rejection over the Fong patents and the ’508 publication
In the first rejection under 35 U.S.C. § 103, the Examiner determines
that it would have been obvious to those of ordinary skill in the art to use a
flat dose of the claimed anti-beta7 antibody because the ’508 publication
teaches a method of determining dosing regimens for the claimed antibody
(which the ’508 publication called “rhuMAb β7”), albeit in consideration of
the effects of the antibody on a biomarker. (See Office Act. 4; see ’508
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publication ¶¶ 13, 14, 317, claims 3–25.) The Examiner finds that the ’508
publication teaches evaluating pharmacokinetic and pharmacodynamic
effects of a claimed anti-beta7 antibody, which, according to the Examiner,
demonstrate a biphasic serum concentration with a fast initial distribution
phase followed by a slower elimination phase. (See Office Act. 4.) The
Examiner finds further that the data presented in the ’508 publication
indicates several other characteristics of the claimed anti-beta7 antibody,
including dose-proportional pharmacokinetics in cynomolgus monkeys and
full saturation of the beta7 receptors on peripheral blood T cell subsets. (See
Office Act. 4–5.)
The Examiner concludes:
That is the rate of elimination is first order kinetic in regard to
rhuMAB β7 (i.e., proportional pk) concentration, the circulating
level of drug decreases exponentially with time irrespective of
the body weight. That is the effect of patient weight on rhuMAb
β7 clearance and exposure was not considered clinically
relevant. Accordingly, the rhuMAb β7 is a first order kinetic
which qualifies the rhuMAb β7 for flat dose at a regular time
interval base[d] on the rhuMAb β7 half-life of 14.5 days (~70
day to reach complete (97%) elimination). That is at steady
state, the amount of drug lost in each interval equals the amount
gained, that is the dose multiplied by the bioavailability.

(Office Act. 6.)
Appellant argues that the Examiner erred in concluding that the ’508
publication provides the necessary information to determine that the claimed
antibody would be appropriate for flat dose administration. (See Appeal Br.
21–39.) According to Appellant, one of ordinary skill would not derive a
flat dose from a weight-based dose without knowing how body weight
affects the pharmacokinetics, for example the clearance of the claimed
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antibody. (See id.) Appellant points to the teachings of Mould in support of
this argument. (See Appeal Br. 22–24.)
Mould, referring to Figure 5, explains that where weight is not an
important predictor of clearance, a flat dose provides a uniform drug
exposure, but that where weight affects clearance, flat dosing results in
decreased drug concentrations and weight-based dosing is required to
normalize drug concentrations. (See Mould 30; see FF 13.) Thus, the record
supports Appellant’s argument that the effect of weight on clearance is an
important factor in deciding to use a flat dosing regimen. (See also Tang
Declaration ¶ 8.)
We agree with Appellant that the Examiner’s rejection under 35
U.S.C. § 103(a) based on only the Fong patents and the ’508 publication
does not provide a teaching that the effect of weight on clearance of an
antibody is determinative of whether an antibody can be used at a flat dose.
(See Appeal Br. 24.) Although the ’508 publication provides
pharmacokinetic and pharmacodynamic data for anti-β7 antibodies as
claimed, the Examiner does not point to specific data indicating the effect of
weight on clearance. We are not persuaded that the Examiner’s findings
about a biphasic profile, dose-proportionality, or saturation would have
suggested flat dosing of an anti-beta7 antibody. (See Office Act. 4–5; see
Ans. 22–23.)
We are also not persuaded that the term “repeated administration” in
the ’082 patent refers to administration at a fixed dose, as the Examiner
finds. (See Office Act. 3.) The ’082 patent states that “[f]or repeated
administrations over several days or longer, depending on the condition, the
treatment is sustained until a desired suppression of disease symptoms
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occurs.” (’082 patent 92:40–43.) The rest of this portion of the ’082 patent
provides only weight-adjusted doses. The Examiner does not explain how
repeated administration of a weight-adjusted dose would become a fixed
dose. Rather, a dose dependent on the patient’s weight could be
administered repeatedly. Accordingly, the record does not support the
Examiner’s finding that this language in the ’082 patent teaches a fixed dose.
Because we are not persuaded that the prior art cited by the Examiner
in the rejection under 35 U.S.C. § 103 over the Fong ’236 patent, the Fong
’082 patent and the ’508 patent suggests a method of treatment comprising
administering an anti-β7 antibody at a flat dose, we reverse the rejection.
Rejection over the Fong patents, the ’508 publication, and Fasanmade
The Examiner entered a separate rejection under 35 U.S.C. § 103 over
the Fong ’236 patent, the Fong ’082 patent and the ’508 patent, as well as
Fasanmade. (See Office Act. 21–31.) Fasanmade teaches the use of a
program, NONMEM, to analyze data from clinical trials for the
determination of pharmacokinetic characteristics of a monoclonal antibody
(infliximab) that is different from the anti-beta7 antibody claimed. (See
Fasanmade abstract; see Office Act. 21.) Fasanmade teaches modeling the
effect of weight on antibody clearance. (See Fasanmade 1220, Table 4; see
Office Act. 21.) The recommendation of Fasanmade is that infliximab
should be administered according to body weight, not as a flat dose. (See
Fasanmade 1227.)
The Examiner finds that it would have been obvious to use a fixed
dose of an anti-beta7 antibody as claimed because it was known in the art to
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perform modeling as taught in Fasanmade. (See Office Act. 22–23.)
Specifically, the Examiner states:
Determining the fixed dose formulation of a drug such as
rhuMAb β7 is based on a pharmacokinetic and computer
modeling analysis such as the one disclosed by Fasanmade et
al. Both pharmacokinetic and computer modeling simulations
are known in the art at the time the invention was made. Those
skilled in the art would apply the know[n] methods of
determin[ing] fixed dose formulation of rhuMAb β7/
etrolizumab, and [their] result would have been expected.

(Office Act. 23.)
The Examiner finds further that selection of a specific dose range
could have been achieved through routine optimization because the
concentration (i.e., dose) of antibody is a result effective variable. (See
Office Act. 22–23.)
We are persuaded by the teachings in the prior art that the Examiner
did not err. Even though, as Appellant argues, Fasanmade fails to disclose a
flat dose of an anti-beta7 antibody, we are persuaded that it would have been
obvious for a person of ordinary skill in the art to try a flat dose of anti-beta7
antibody as claimed with a reasonable expectation of success because the
prior art teaches how to determine whether flat dosing is appropriate with
several other monoclonal antibodies. (See Fasanmade abstract, 1220, Table
4.)
Appellant argues that conducting a population pharmacokinetic
clinical trial is not routine optimization because there would not have been a
reasonable expectation of success from such experimentation. (See Appeal
Br. 40–43; see Reply Br. 18–19.) According to Appellant, the unpredictable
nature of how body weight affects antibody exposure is demonstrated by the
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choice of body weight-adjusted dosing for infliximab. (See Appeal Br. 41–
42.) Appellant argues that the results taught in Fasanmade show that it is not
possible to simply convert from a body weight dose to a flat dose. (See id.
42.)
We are not persuaded by this argument because the issue in the
Examiner’s second obviousness rejection is not whether the Examiner
properly converted the body weight doses reported in the Fong patents and
the ’508 publication, but whether a method of treating gastrointestinal
inflammation with the flat doses recited in claim 13 would have been
obvious over those references in combination with Fasanmade. The
Examiner’s second obviousness rejection is not based solely on the
conversion of a weight-based dose to a flat dose. Rather, it is based on the
knowledge in the art of the pharmacokinetic and computer modeling
techniques taught in Fasanmade. (See Office Act. 23.)
Despite the recommendation in Fasanmade of a body weight dose for
infliximab, we are not persuaded by Appellant’s arguments that there would
not have been a reasonable expectation of success in treating a patient using
a flat dose with the claimed anti-beta7 antibody. (See Appeal Br. 41–42; see
Reply Br. 19.) Fasanmade concludes that “a body weight-adjusted dosing
(as is approved for infliximab) is necessary to allow equivalent exposure
among all patients to mitigate a possible weight-related influence of
infliximab exposure.” (Fasanmade 1223.) Thus, Fasanmade demonstrates
that those of ordinary skill in the art were aware of the criteria that determine
success with a flat dose — the effect of weight on antibody clearance.
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The teaching of Fasanmade is reflected in Mould, which states:
Wang et al. [citation dated 2009 omitted] compared flat dosing
to body size-based dosing for several approved mAbs. This
work suggests that the choice between a flat or body size-based
dose is dependent on the pharmacokinetic behavior of each
mAb and the pharmacokinetic variability.

(Mould 30–31.) Mould also provides a table of antibodies and their
corresponding dosing means, with flat dosing for eleven out of the twenty-
six listed antibodies. (See Mould 25–26, Table I.) Thus, Mould, along with
Fasanmade, demonstrates that not only were the criteria for flat dosing
known in the art, it was known that these criteria had been met for several
other antibodies. The claimed anti-beta7 antibody was not the first antibody
to be found appropriate for flat dosing. We find that in light of these other
antibodies those of ordinary skill would have had a reasonable expectation
that flat dosing of the claimed anti-beta7 antibody would have been
successful.
The case law tells us that a “reasonable” expectation of success does
not require absolute certainty of success. See Medichem, S.A. v. Rolabo,
S.L., 437 F.3d 1157, 1165–66 (Fed. Cir. 2006), citing In re O'Farrell, 853
F.2d 894, 903–04 (Fed.Cir.1988) (“Obviousness does not require absolute
predictability of success . . .[A]ll that is required is a reasonable expectation
of success.”). The question of whether there would have been a reasonable
expectation of success depends on the facts of the situation. See Par
Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014).
When other methods similar to a claimed method have been
successful, the court has determined there would have been a reasonable
expectation of success. For example, in Velander v. Garner, 348 F.3d 1359,
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1379 (Fed. Cir. 2003), a reasonable expectation of success was found for a
method of producing a particular protein when several other proteins had
been produced in a similar way.
The court has also determined that the availability of specific
instructions to achieve the claimed subject matter can form the basis for a
reasonable expectation of success. In Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1367–68 (Fed. Cir. 2007), a reasonable expectation of success was
found where the prior art included several references with directions for
narrowing the possible salts previously approved and the result could be
verified by routine trial-and-error procedures.
In contrast, where a method or product was the first of its kind, the
case law has indicated there would not have been a reasonable expectation
of success in achieving the result. See Amgen, Inc. v. Chugai Pharm. Co.,
927 F.2d 1200, 1207–08 (Fed. Cir. 1991) (holding that there was not a
reasonable expectation of success in isolating a gene encoding a specific
protein where none of the prior art references suggested that screening a
human genomic library would be likely to succeed in pulling out the gene of
interest and no one else had successfully used the technique for that
purpose).
Both Fasanmade and Mould indicate that flat dosing had previously
been considered, and used, with antibody therapies and Fasanmade provides
a framework for determining whether antibody clearance is affected by body
weight. Thus, we are not persuaded that those of ordinary skill in the art
would not have had a reasonable expectation of success in using the claimed
anti-beta7 antibody at a flat dose.
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Furthermore, Mould explains that there were three known dosing
regimens at the time: (1) flat dosing, (2) body-weight dosing, and (3)
Bayesian individualized dosing in response to a measurement. (See Mould
30.) Accordingly, there were a finite number of solutions to the problem of
drug dosing.
Appellant presents the declaration of inventor Meina Tao Tang in
support of its arguments. (See Declaration Under 37 C.F.R. § 1.132,
submitted May 1, 2017 (Exhibit H) (“Tang Declaration”).) Dr. Tang does
not address Fasanmade or the knowledge in the art of determining whether
weight affects clearance of antibodies. Accordingly, the Tang Declaration
does not persuade us that the Examiner erred.
Appellant also argues that there would not have been a reasonable
expectation of success in the claimed method because the success rate in
developing large molecule drugs is extremely low. (See Appeal Br. 42.)
This argument is unpersuasive because the Fong patents demonstrate it was
known the claimed anti-beta7 antibody could be used to treat gastrointestinal
inflammatory diseases. (See, e.g., Fong ’082, 153:47–156:29, claims 1–14.)
The issue of this appeal is not whether it would have been expected that the
claimed antibody would work, but rather whether the claimed anti-beta7
antibody could successfully be used in a flat dose. Appellant fails to
persuade us that success would not have been reasonably expected.
The Examiner finds further that the specific flat dose recited in claim
13, “between about 100 mg and about 220 mg” would have been obvious
because concentration is an art-recognized result-effective variable, which
can be routinely determined and optimized in the pharmaceutical arts. (See
Office Act. 22–23.) Although we agree with Appellant that the Examiner’s
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conversion of the weight-based doses taught in the prior art to flat doses
does not prove by itself that the flat dose range recited in claim 13 would
have been obvious, we are persuaded that optimization to achieve the recited
range would have been obvious.
As the Examiner notes, a change in concentration is normally not a
patentable modification. See In re Aller, 220 F.2d 454, 456 (CCPA 1955).
The Examiner’s calculations do not provide the reason why one of ordinary
skill would have chosen the claimed doses, but the calculations demonstrate
that the claimed doses are not significantly different from the ranges of
doses known in the art. That is, the Exmainer’s calculations demonstrate
that the claimed range of about 100 mg to about 220 mg is not drastically
different from, but rather overlaps, the range of about 0.05 mg/kg to about
10 mg/kg taught in the Fong ’082 patent for an average man of 70 kg
(calculated to be 3.5 to 700 mg). (See Office Act. 3.)
Appellant argues that the Examiner inappropriately shifts the burden
of presenting evidence that optimization of the doses reported in the prior art
would not have been routine. (See Reply Br. 20.) Because we are persuaded
that the prior art provides the reason, means, and expectation of success in
choosing a flat dose for the claimed anti-beta7 antibody, and the claimed flat
doses are not dramatically different from the doses taught in the prior art if
they were administered as a flat dose, we are not persuaded that the
Examiner erred.
Appellant does not present any separate arguments against the
rejection of independent claims 74 or 77 or the claims that depend on claims
13, 74, and 77. Accordingly, we are not persuaded that the Examiner erred
in rejecting these claims either.
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Obviousness-type double-patenting
The Examiner rejected all of Appellant’s claims under the doctrine of
obviousness-type double-patenting over claims 1–14 of the Fong ’082 patent
in view of the ’508 publication and optionally in view of Fasanmade. (See
Office Act. 31–32.)
Appellant argues that the Examiner erred in theses rejections for the
same reasons cited against the rejections under 35 U.S.C. § 103(a). As
explained above, we are not persuaded that the Examiner erred in the
§103(a) rejection over the Fong patents, the ’508 publication, and
Fasanmade. Accordingly, we are not persuaded that the Examiner erred in
rejecting the claims under the doctrine of obviousness-type double-patenting
either.
Conclusion
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejection of Appellant’s claims.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89
103(a) Fong ’236,
Fong ’082,
’508
publication
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89
103(a) Fong ’236,
Fong ’082,
’508
publication,
Fasanmade
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89

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13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89
Obviousness-
type Double
Patenting
Fong ’082,
’508
publication,
optionally
Fasanmade
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89

Overall
Outcome
13, 17–19,
25, 26, 28–
30, 33, 34,
65, 68, 69,
74–89

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED