Indrajit Ghosh et al.

Patent Trials and Appeals Board

Jul 25, 2019

15017084 - (D) (P.T.A.B. Jul. 25, 2019)

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.
15/017,084 02/05/2016 Indrajit Ghosh 298046-18 4436
3705 7590 07/25/2019
ECKERT SEAMANS CHERIN & MELLOTT LLC
U.S. Steel Tower
600 Grant Street, 44th Floor
Pittsburgh, PA 15219
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
07/25/2019 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):
ipmail@eckertseamans.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte INDRAJIT GHOSH and JIA-AI ZHANG
____________

Appeal 2018-009026
Application 15/017,0841
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 37–39 and 41–
46 (App. Br. 4). Examiner entered rejections under 35 U.S.C. § 112(b),
35 U.S.C. § 103(a) and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellants identify “Novartis AG” as the real party in interest (Appellants’
June 4, 2018 Appeal Brief (App. Br.) 3).
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STATEMENT OF THE CASE
Appellants’ disclosure “describes formulated compositions and the
corresponding technology of manufacturing tablets for ExjadeTM
(deferasirox) to prevent gastrointestinal irritation, having no food effect and
improve patient compliance” (Spec. 2). Claims 37, 41, and 44 are
representative and reproduced below:
37. A method of treatment of chronic iron overload in a patient
comprising directly orally administering 90 mg deferasirox or a
pharmaceutically acceptable salt thereof in a solid swallowable
dosage form wherein the dosage form is a whole and intact
tablet.
(App. Br. 31.)
41. A method according to claim 37 wherein,
(i) deferasirox or a pharmaceutically acceptable salt thereof is
present in an amount 45% to 60% by weight based on the total
weight of the tablet,
(ii) at least one filler is present in an amount of 10% to 40% by
weight based on total weight of the tablet,
(iii) at least one disintegrant is present in an amount of 1% to
10% by weight based on the total weight of the tablet,
(iv) at least one binder is present in an amount of 1% to 5% by
weight based on the total weight of the tablet; and,
(v) optionally, separate from the total weight of the tablet, a
coating.
(Id.)
44. A method according to claim 41 wherein,
(i) filler is selected from the group consisting essentially of
microcrystalline cellulose, and ethylcellulose;
(ii) disintegrant is selected from the group consisting essentially
of cross-linked polyvinylpyrrolidone (crospovidone), starch,
CMC-Ca, CMC-Na, microcrystalline cellulose, alginic acid,
sodium alginate, and guar gum; and,
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(iii) binder is selected from the group consisting essentially of
polyvinylpyrrolidone (PVP), hydroxypropylmethyl cellulose,
hydroxypropyl cellulose, hydroxyethyl cellulose,
microcrystalline cellulose, hypromellose, and starch.
(Id. at 32.)

Grounds of rejection before this Panel for review:
Claims 44–46 stand rejected under 35 U.S.C. § 112(b).
Claims 37–39 and 41–46 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Zadok.2
Claims 37–39 and 41–46 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
the claim of Ghosh.3

DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that a Markush grouping that recites the phrase “selected from the group
consisting essentially of” is indefinite?
ANALYSIS
Appellants’ claim 44 depends from and further limits the method set
forth in Appellants’ claim 41 to require, inter alia, that the “filler is selected
from the group consisting essentially of microcrystalline cellulose[] and
ethylcellulose” (App. Br. 32 (emphasis added)). Appellants’ claims 45 and
46 comprise similar language.

2 Zadok et al., US 2009/0142395 A1, published June 4, 2009.
3 Ghosh et al., US 9,283,209 B2, issued Mar. 15, 2016.
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According to Examiner, the phrase “selected from the group
consisting essentially of” renders the Markush grouping of Appellants’
claimed invention indefinite (see Ans. 3). We agree.
A Markush grouping is a closed group of alternatives, i.e., the
selection is made from a group “consisting of” (rather than
“comprising” or “including”) the alternative members. Abbott
Labs [v. Baxter Pharmaceutical Products, Inc., 334 F.3d 1274,
1280 (Fed. Cir. 2003)]. If a Markush grouping requires a
material selected from an open list of alternatives (e.g., selected
from the group “comprising” or “consisting essentially of” the
recited alternatives), the claim should generally be rejected
under 35 U.S.C. [§] 112(b) as indefinite because it is unclear
what other alternatives are intended to be encompassed by the
claim.
Manual of Patent Examining Procedure (MPEP) § 2173.05(h)(I) (emphasis
added).
For the foregoing reasons, we are not persuaded by Appellants’
contention that
the term “consisting essentially of” is not indefinite because a
skilled artisan is able to have reasonable certainty about what
the basic and novel properties of the invention are, and thus the
skilled artisan would have reasonable certainty about whether
another component would materially alter the basic and novel
properties of the claimed invention.
(App. Br. 30.)
CONCLUSION
The preponderance of evidence support Examiner’s conclusion that a
Markush grouping that recites the phrase “selected from the group consisting
essentially of” is indefinite.
The rejection of claims 44–46 under 35 U.S.C. § 112(b) is affirmed.

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OBVIOUSNESS:
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 3–5), and provide the following findings for emphasis.
FF 1. Zadok “relates to a pharmaceutical composition comprising a dry co-
milled composition comprising a poorly water soluble active pharmaceutical
ingredient (API) and at least two pharmaceutically acceptable excipients”
(Zadok ¶ 2; see generally Ans. 3).
FF 2. Zadok discloses that its API is “preferably deferasirox or a
pharmaceutically acceptable salt thereof” (Zadok ¶ 43; see also id. ¶ 4
(Zadok discloses that “[d]eferasirox is an orally active iron chelator,
currently marketed under the trade name EXJADE® for the treatment of
iron overload in transfusion dependent anemias”); see generally Ans. 3).
FF 3. Zadok discloses:
Deferasirox is typically administered at an initial dose of
about 20 mg/kg body weight, and the dose is adjusted up to a
maximum of 30 mg/kg body weight. Thus for an average adult
patient weighing about 70 kg, the recommended daily dose is
between 1.4 and 2.1 g of deferasirox.
(Zadok ¶ 11; see generally Ans. 3 and 7.)
FF 4. Zadok discloses:
[A] high-dose pharmaceutical composition comprising about
20% to about 80% by weight of a poorly water soluble active
pharmaceutical ingredient (API), preferably deferasirox or a
pharmaceutically acceptable salt thereof, wherein said API is
co-milled in a dry process with at least two pharmaceutically
acceptable excipient[s], to obtain a co-milled composition[.]
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Preferably, the pharmaceutical composition is in a unit dosage
form.
(Zadok ¶ 23; see generally Ans. 3.)
FF 5. Zadok’s “unit dosage form is preferably in the form of a tablet. The
tablet may be in the form of an oral dosage form, or in the form of a
dispersible tablet[4]” (Zadok ¶ 23 (emphasis added); see also id. ¶ 59 (Zadok
discloses that “[t]he tablet may be in the form of an oral dosage form, or in
the form of a dispersible tablet”); id. ¶ 64 (same); id. ¶ 23 (Zadok claims a
pharmaceutical composition comprising a poorly water soluble active
pharmaceutical ingredient (API), i.e., deferasirox, “in the form of a tablet”
and separately claims such a pharmaceutical composition in the form of “a
dispersible tablet”); see Ans. 3).
FF 6. Zadok discloses that “pharmaceutical composition further comprises
at least one pharmaceutically acceptable excipient selected from the group
comprising: glidant, lubricant, disintegrant, fillers and binders” (Zadok
¶ 77).
FF 7. Zadok discloses that a “disintegrant (such as crospovidone) is
present in an amount of about 2% to about 20%” (Zadok ¶ 76; see generally
Ans. 4).
FF 8. Zadok discloses that “[s]uitable fillers for the formulation include,
but are not limited to, [microcrystalline] cellulose” (Zadok ¶ 83; see
generally Ans. 4).
FF 9. Zadok discloses that a “binder is present in an amount greater than
about 10%” (Zadok ¶ 79; see generally Ans. 4, 7).

4 Zadok discloses that “[a]s used herein the term ‘a dispersible tablet’ refers
to a tablet which has to be dispersed in an aqueous phase, e.g. water, prior to
ingestion” (Zadok ¶ 29).
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FF 10. Zadok discloses:
Suitable binders for the formulation include, but are not limited
to, acacia, alginic acid, carbomer copolymer, carbomer
interpolymer, copovidone, microcrystalline cellulose, dextrin,
ethylcellulose, gelatin, glucose (liquid), guar gum,
hydroxypropyl cellulose, maltose, methylcellulose,
polyethylene oxide, polyvinylpyrrolidone, povidone, starch, or
sodium carboxymethylcellulose.
(Zadok ¶ 82 (emphasis added); see generally Ans. 4.)
FF 11. Zadok discloses a dispersible tablet formulation comprising 2.8% of
povidone, as a binder, and 12% microcrystalline cellulose, which according
to Zadok serves as both a binder and a filler (see generally Zadok ¶ 101
(Example 25); cf. FF 8, FF 10; see Ans. 7).
FF 12. Zadok discloses:
a method for treating a medical condition by administering [a]
high-dose composition[, within the scope of its disclosure,] to a
patient in need thereof. Examples of the medical conditions
that may be treated include treatment of iron overload in
transfusion dependent anemias (transfusion hemosiderosis), in
particular thalassemia major, thalassemia intermediate and in
sickle cell disease to reduce iron-related morbidity and
mortality, in patients 2 years and older.
(Zadok ¶ 86; see generally Ans. 3.)

ANALYSIS
Claims 37–39:
Zadok discloses a method of treating chronic iron overload in a
patient comprising directly orally administering deferasirox or a
pharmaceutically acceptable salt thereof in a solid swallowable dosage form
wherein the dosage form is a whole and intact tablet (FFs 1–3, 5, 12). Zadok
further discloses that “the recommended daily dose[, of deferasirox,] is
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between 1.4 and 2.1 g” (FF 3). Although Zadok does not expressly teach
formulations comprising 90, 180, and 360 mg of deferasirox, the amounts
recited in claim 37 and certain dependent claims, “where[, as here,] the
general conditions of a claim are disclosed in 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). Therefore, we find no error in
Examiner’s conclusion that, at the time of Appellants’ claimed invention, it
would have been prima facie obvious to a person of ordinary skill in this art
to determine the optimum or workable amount of deferasirox in Zadok’s
orally administrable tablet for the treatment of chronic iron overload in a
patient (see generally Ans. 4; cf. App. Br. 31). For the foregoing reasons,
we are not persuaded by Appellants’ contention that a person of ordinary
skill in this art would not have found it prima facie obvious to practice a
method, within the scope of Appellants’ claimed invention, which comprises
the direct oral administration of tablets comprising 90, 180, or 360 mg of
deferasirox (see App. Br. 12, 16, 17).
A reference disclosure is not limited only to its preferred
embodiments, but is available for all that it discloses and suggests to one of
ordinary skill in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976).
Therefore, we are not persuaded by Appellants’ contention that because
Zadok does not exemplify an orally administrable tablet it does not disclose
such a tablet (App. Br. 10; see id. at 12–13; Reply Br. 5–6, 9–10; cf. FF 5).
For the foregoing reasons, we are not persuaded by Appellants’ contention
that Zadok’s disclosure is limited to “EXJADE® which is administered as a
dispersible tablet that requires dispersing in an aqueous medium prior to
administration” (App. Br. 12; see also id. at 17–19).
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Claims 41–43:
Zadok discloses a tablet as an oral dosage form, comprising
deferasirox, at least one filler, at least on disintegrant, and at least one binder
(FFs 1–6). Zadok discloses that deferasirox or a pharmaceutically
acceptable salt thereof is present in the tablet in an amount of “about 20% to
about 80% by weight” of the tablet (FF 4). Zadok further discloses that at
least one disintegrant is present in the tablet “in an amount of about 2% to
about 20%” by weight of the tablet (FF 7). In addition, Zadok exemplifies
the use of at least one binder (povidone) in an amount of 2.8% and at least
one filler (microcrystalline cellulose) in an amount of 12% (see FF 11).
Therefore, we find no error in Examiner’s conclusion that, at the time of
Appellants’ claimed invention, it would have been prima facie obvious to a
person of ordinary skill in this art to formulate a solid swallowable dosage
form in the form of a whole and intact tablet comprising deferasirox, filler,
disintegrant, and binder in the foregoing weight % ranges, which fall within
or overlap the ranges set forth in Appellants’ claims 41–43 (see generally
Ans. 4). “[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness.”
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004); see also In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997)
(Overlapping ranges support a prima facie case of obviousness.).
Although Zadok discloses the use of a binder in an amount greater
than about 10% (FF 9); Zadok exemplifies a table comprising at least one
binder in an amount of 2.8% of the weight of the tablet and, thus, meets the
requirements of Appellants’ claimed invention (FF 11). As Examiner
explains, although “the total amount of binder taught by [Zadok] is
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preferably greater than 10%,” Zadok exemplifies “combinations of binders
wherein one of the binders is present at 1-5%” (Ans. 7 (citing Zadok ¶ 101)).
Thus, we are not persuaded by Appellants’ contention that Zadok “does not
teach ‘at least one binder is present in an amount of 1% to 5% by weight
based on total weight of the tablet,’ as recited by each of [Appellants’]
claims 41-43” (App. Br. 11 (emphasis added)). For the foregoing reasons,
we are not persuaded by Appellants’ contention that Examiner
“mischaracterized” Zadok’s disclosure as it relates to “about 10% binder”
(App. Br. 15; see also id. at 16, 20–21). For the same reasons, we are not
persuaded by Appellants’ contentions regarding Zadok’s disclosure as it
relates to the amount of filler (id. at 15; cf. FF 11 (Zadok exemplifies a
composition comprising 12% microcrystalline cellulose filler, which meets
the requirements of Appellants claimed invention requiring at least one filler
in an amount of 10% and 40% by weight based on the total weight of the
tablet)).

Claims 44–46:
Zadok discloses a tablet in the form of an oral dosage form,
comprising a filler (microcrystalline cellulose), disintegrant (crospovidone),
and binder (polyvinylpyrrolidone) (see FFs 7–10), the same components
which are recited in claim 44. Therefore, we find no error in Examiner’s
conclusion that, at the time of Appellants’ claimed invention, it would have
been prima facie obvious to a person of ordinary skill in this art to formulate
a solid swallowable dosage form in the form of a whole and intact tablet
comprising the foregoing filler, disintegrant, and binder (see generally Ans.
3–4).
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For the reasons set forth above, we are not persuaded by Appellants’
contention that “Examiner has failed to meet the standards for a proper
factual inquiry that precedes the legal conclusion of obviousness” (see App.
Br. 15–16; see generally id. at 11–12, 16, 21).
For the same reasons, we are not persuaded by Appellants’ contention
that “Examiner improperly relied on hindsight, conjecture, and conclusory
statements to find that one of ordinary skill would have had a reasonable
expectation of success” because the same recited ingredients are disclosed in
Zadok (App. Br. 17).

Unexpected Results:
Appellants contend that “studies as described in the Kumar
Declaration[5] and the Specification have shown that the dissolution profile
and bioavailability profile of the conventional tablets recited in the claims do
not correlate according to Zadok” (App. Br. 23; see also Reply Br. 6–8, 12–
17). We are not persuaded.
As Examiner explains, Appellants’ Specification discloses three
formulations: Variants A–C, which appear to be the same as those discussed
by Kumar (Ans. 8–9; cf. Spec. 18–19; Kumar Decl. ¶¶ 12–13). The specific
formulations for Variants A–C are reproduced below:

5 Declaration of Saran Kumar, submitted Sept. 26, 2017
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(Spec. 18.) Examiner finds that the specific formulations of Variants A–C
are not commensurate in scope with Appellants’ claims 37–39 and 41–46
(see Ans. 9–10). In order to be persuasive of non-obviousness, “[e]vidence
of secondary considerations must be reasonably commensurate with the
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scope of the claims.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir.
2011). We agree with Appellants’ contention that they are not
required to test every embodiment within the scope of [their] . .
. claims . . . [i]f an applicant demonstrates that an embodiment
has an unexpected result and provides an adequate basis to
support the conclusion that other embodiments falling within
the claim will behave in the same manner.
(App. Br. 25.) On this record, however, Appellants fail to meet their
evidentiary burden. For example, the scope of Appellants’ claim 37,
reproduced above, drawn to a method of treatment comprising directly orally
administering 90 mg deferasirox or a pharmaceutically acceptable salt
thereof in a solid swallowable dosage form wherein the dosage form is a
whole or intact tablet, is not commensurate in scope with the specific
formulations of Variants A–C (see App. Br. 31; cf. Spec. 18) because the
claim is not restricted to the specific fillers, disintegrants, binders, etc. used
in A–C. In addition, the requirements of Appellants’ claims 41 and 44,
reproduced above, describe broad ranges of ingredients, which again, are not
commensurate in scope with the specific formulations of Variants A–C
relied upon in support of Appellants’ asserted unexpected results. For
example, Appellants’ claim 41 requires the presence of at least one
disintegrant, such as crospovidone, in an amount of 1% to 10% by weight
based on the total weight of the tablet, but the formulations of Variants A–C
exemplify only a range of 6.81–7.00%, which is in the upper half of the
range provided by Appellants’ claim 41. Similarly, Appellants’ claim 41
requires the presence of at least one binder, such as polyvinylpyrrolidone, in
an amount of 1% to 5% by weight based on the total weight of the tablet, but
the formulations of Variants A–C exemplify only a range of 2.19–2.25%,
which falls in the lower half of Appellants’ claimed range. The disintegrant
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and binder are expected to affect disintegration time and dissolution of
tablets. As Appellants explain, “[t]he characteristics of the [] swallowable
. . . tablets, such as its disintegration time and dissolution are uniquely
needed to reach the intended exposure levels” (Spec. 9). Thus, although
Appellants may have established an unexpected property with respect to the
specific formulations set forth in Variants A–C, this evidence is not
commensurate with the full scope of Appellants’ claimed invention.
Further, we are not persuaded by Appellants’, and Declarants’, narrow
interpretation of Zadok’s disclosure, which fails to account for Zadok’s
broader disclosure that fairly suggests a solid swallowable dosage form
wherein the dosage form is a whole or intact tablet (App. Br. 18, 22–29;
Kumar Decl. ¶¶ 12–29; Danko Decl.6 ¶¶ 11–28; cf. FFs 1–3, 5, 12).
Therefore, we are not persuaded by Appellants’, and Declarants’, assertion
that their claimed invention, which is encompassed by a first embodiment of
Zadok’s disclosure, is distinguishable from Zadok because a second
embodiment of Zadok encompasses a dispersible tablet (App. Br. 18, 22–29;
Kumar Decl. ¶¶ 12–29; Danko Decl. ¶¶ 11–28). Thus, in addition to
providing evidence that is not commensurate in scope with their claimed
invention, it also does not appear that Appellants have compared their
claimed invention to the closest prior art on this record, specifically, an
orally administrable tablet that falls within the scope of Zadok’s disclosure
of a solid swallowable dosage form wherein the dosage form is a whole or
intact tablet. “[W]hen unexpected results are used as evidence of

6 Declaration of Laszlo Danko, submitted Sept. 27, 2017. We note that
Appellants refer to this declaration alternatively as the Danko Declaration
(see, e.g., App. Br. 22) and Laszlo Declaration (see, e.g., id. at 26–27).
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nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991).
Although Danko states that “[d]irect oral administration of the
compound, deferasirox . . . yields substantially more bioavailability than
aqueous suspension of the compound,” such an observation is no more than
the discovery of a new benefit of an old process, which cannot render the old
process patentable (Danko Decl. ¶ 16; see generally Kumar Decl. ¶ 15
(“Direct administration of the conventional solid oral dosage forms of
deferasirox were . . . found to exhibit suprabioavailability compared to the
aqueous dispersion”); see also Reply Br. 2–4 (“Appellants simply
discovered that a 30% reduced amount of deferasirox could be directly
administered orally as a conventional tablet to yield the same therapeutic
effect as the FDA-approved dispersible tablet, EXJADE®”); Reply Br. 10–
12). See Kao, 639 F.3d at 1071; In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990); see also Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347
(Fed. Cir. 1999) (“[T]he discovery of a previously unappreciated property of
a prior art composition, or of a scientific explanation for the prior art’s
functioning, does not render the old composition patentably new to the
discoverer.”).
For the foregoing reasons, we are not persuaded by Appellants’
contentions regarding unexpected results.

Commercial Success:
According to Appellants, Example 5 of their Specification “is the
JADENU® composition now on the market (also Variant A of the instant
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disclosure as well as the Kumar [D]eclaration)” (Reply Br. 7). For the
reasons set forth above, however, Variant A of Appellants’ Disclosure, as
discussed in the Kumar Declaration, is not commensurate in scope with
Appellants’ claimed invention (cf. id. at 18–19). “Evidence of secondary
considerations must be reasonably commensurate with the scope of the
claims.” Kao, 639 F.3d at 1068.
Appellants contend that “[u]sers of the solid dosage form for direct
oral administration . . . tend to be highly positive toward the medication, and
consider it easy to take with minimal side effects, while reporting strong
levels of compliance” (App. Br. 28; see Danko Decl. ¶ 21; see also Danko
Decl. ¶¶ 21–28). Stated differently, Appellants assert that a directly orally
administrable tablet is easier to take than a formulation that must be
dissolved in solution prior to administration and, therefore, strong
compliance levels are reported. Appellants, however, failed to establish that
these observations would not also be true of the directly orally administrable
tablet disclosed by Zadok.
For the foregoing reasons, we are not persuaded by Appellants’
contentions regarding commercial success.
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claims 37–39 and 41–46 under
35 U.S.C. § 103(a) as unpatentable over Zadok is affirmed.

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OBVIOUSNESS-TYPE DOUBLE PATENTING:
Examiner rejected Appellants claims 37–39 and 41–46 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claim of Ghosh (see Final Act. 5; Ans. 5).
Appellants do not contest this rejection (see Ans. 11 (“Appellants
provide no arguments against the obviousness[-]type double patenting
rejection”)).
“If a ground of rejection stated by . . . [Examiner] is not addressed in .
. . [Appellants’] brief, [Appellants] ha[ve] waived any challenge to that
ground of rejection and the Board may summarily sustain it”. MPEP
§ 1205.02.
Therefore, the rejection of claims 37–39 and 41–46 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claim of Ghosh is affirmed.

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