HB BIOTECHNOLOGIES CORPORATION

Patent Trials and Appeals Board

May 5, 2021

2020005076 (P.T.A.B. May. 5, 2021)

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.
14/236,828 02/05/2014 Danielle Berger 041069.00007 9232
4372 7590 05/05/2021
ARENT FOX LLP
1717 K STREET, NW
WASHINGTON, DC 20006-5344
EXAMINER
AL-AWADI, DANAH J
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/05/2021 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 DANIELLE BERGER
____________

Appeal 2020-005076
Application 14/236,8281
Technology Center 1600
____________

Before JEFFERY N. FREDMAN, DEBORAH KATZ, and
DAVID COTTA, Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to an orally
consumable medical product comprising a water-insoluble fluid absorbing
material filled into a substantially nitrogen-free capsule. The Examiner
rejected the claims on appeal on under 35 U.S.C. § 103 as obvious and under
35 U.S.C. § 112 for failure to comply with the written description
requirement. An oral hearing was held on February 2, 2021, a transcript
from which has been entered into the record. We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is HB
Biotechnologies Corporation. Appeal Br. 1.
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STATEMENT OF THE CASE
The Specification discloses that “[i]n certain diseases, particularly in
kidney diseases, fluid retention within an animal’s body presents serious
difficulties.” Spec. 1. According to the Specification “[t]he conventional
treatment for diseases of this nature is periodic hemodialysis, where artificial
kidney machines eliminate water and toxins from the body.” Id.
Unfortunately, “[t]he cost of dialysis is exceedingly high and the availability
of dialysis machines is not nearly as great as is convenient for both the
practitioner and the patient involved.” Id. Additionally, dialysis may cause
“significant physiological and mental discomfort.” Id. Thus, according to
the Specification, “it is highly desirable to limit the frequency of dialysis to
the minimum number of treatments necessary to preserve health” and “if a
product and/or method were provided for removal of water from the body,
then frequency of dialysis could be substantially reduced.” Id. at 1, 2. The
Specification discloses “a product, system, or means for delivering a fluid
absorbing material to a subject suffering from excess fluid retention,
whereby the product, system, or means reduces the retention of fluid in said
subject.” Id. at 2.
Claims 65 and 67–74 are on appeal. Claim 65 is representative and
reads as follows:
65. An orally consumable medical product comprising a
water-insoluble fluid absorbing material filled into a
substantially nitrogen-free capsule, wherein the fluid absorbing
material exhibits a water regain in the range of about 1 to about
100 grams/gram dry weight, and wherein the fluid absorbing
material is non-ionic cross-linked polysaccharide.
App. Br. 16.

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The claims stand rejected as follows:
I. Claims 65 and 67–74 were rejected under 35 U.S.C. § 112 for
failure to comply with the written description requirement.
II. Claims 65 and 68–74 were rejected under 35 U.S.C. § 103 as
obvious over the combination of Alon,2 Nagahara,3 and Berger.4
III. Claims 65, 67, and 71–74 were rejected under 35 U.S.C. § 103
as obvious over the combination of Alon, Nagahara, Berger, and Patel.5
IV. Claims 65, 68–74 were rejected under 35 U.S.C. § 103 as
obvious over the combination of Alon, Nagata, Narasimhan,6 and Berger.
V. Claims 65, 67, and 71–74 were rejected under 35 U.S.C. § 103
as obvious over the combination of Alon, Nagata, Narasimhan, Berger, and
Patel.
REJECTION I
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must ‘clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration
in original). “[T]he test for sufficiency is whether the disclosure of the

2 Alon et al., US Patent Publication No. 2008/0089933 A1, published Apr.
17, 2003 (“Alon”).
3 Nagahara et al., US Patent Publication No. 2007/0141137 A1, published
June 21, 2007 (“Nagahara”).
4 Berger et al., US Patent No. 4,470,975, issued Sep. 11, 1984 (“Berger”).
5 Patel, et al., Developing a Modified Pulsincap System, 21(11)
Pharmaceutical Technology Europe, Nov. 1, 2009 (“Patel”).
6 Narasimhan et al., Correlation of Breath Ammonia with Blood Urea
Nitrogen and Creatinine during Hemodialysis, 98(8) PNAS 4617–21, Apr.
10, 2001 (“Narasimhan”).
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application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id.
“Sufficient description of a genus . . . requires the disclosure of either
a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill
in the art can ‘visualize or recognize’ the members of the genus.” Ariad,
598 F.3d at 1350. The Federal Circuit has identified a number of factors to
be considered in evaluating the adequacy of disclosures supporting generic
claims, including “the existing knowledge in the particular field, the extent
and content of the prior art, the maturity of the science or technology, [and]
the predictability of the aspect at issue.” Id. at 1351.
Claim 65 requires a “water-insoluble fluid absorbing material” that is
a “non-ionic cross-linked polysaccharide” and that “exhibits a water regain
in the range of about 1 to about 100 grams/gram dry weight.” Claim 72
depends from claim 65 and further specifies that the claimed polysaccharide
is: “dextran; modified starches; dextrin; cellulose; polyglucose; hydroxyl
group containing uncharged derivatives; or product obtained by partial
depolymerization; or combinations thereof.” Claim 73 also depends from
claim 65. It further specifies that the claimed fluid absorbing material is a
“copolymer in the form of a gel grain comprising a three dimensional
network of dextran substances.”
In rejecting claims 65 and 67–74 for failure to comply with the written
description requirement, the Examiner found that the claimed fluid
absorbing material encompassed a “very large genus of potential polymers.”
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Final Act. 8.7 The Examiner acknowledged that “polymers in the art are
well known” but found that it was not known “which would perform the
[claimed] functions.” Id. at 9. The Examiner found that “[a]lthough the
claims may recite some structural characteristics, the claims lack written
description because there is no disclosure of a correlation between
function and structure of the compounds beyond those compounds
specifically disclosed in the examples in the specification” and because “the
specification lacks sufficient variety of species to reflect this variance in the
genus.” Id. at 9–10.
Appellant argues that “paragraphs 61–68 of the specification (page 16,
line 21 to page 20, line 17) . . . contain a voluminous list of suitable fluid-
absorbing non-ionic cross-linked polysaccharides, including reference to at
least a dozen U.S. and foreign patents describing such materials and mention
of two manufacturers with lengthy catalogues of suitable materials.” Appeal
Br. 5–6. According to Appellant, “[t]he materials described in these
paragraphs and their structures are well known to those skilled in the art”
and thus the guidance provide by the Specification is “more than adequate to
meet the written description requirement.” Id. at 6.
We agree with Appellant that the Specification supports claim 73, the
narrowest of the pending claims. However, we agree with the Examiner that
the Specification does not support the genus of water-insoluble fluid
absorbing material recited in claims 65, 67–72, and 74. We address our
reasons for agreeing with the Appellant as to claim 73, and agreeing with the
Examiner as to claims 65, 67–72, and 74, below.

7 Office Action mailed November 20, 2018 (“Final Act.”).
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We begin by considering claim 73. Claim 73 depends from claim 65
and further requires that “the fluid absorbing material is a copolymer in the
form of a gel grain comprising a three dimensional network of dextran
substance.” Claim 73 thus comprises a genus of dextran substances. The
Specification provides guidance on the structure of the claimed dextrans,
stating:
The preferred insoluble hydrophilic, cross-linked
polysaccharides used in the present invention are
copolymerization products in the form of gel grains comprising
a three dimensional macroscopic network of dextran
substances, built up of chains of mainly alpha-1,6-
glucosidically bonded glucose residues, bonded together by
ether bridges of the general type –R--O--X--O--R--, wherein R
represents the dextran substances and X is an aliphatic
radical containing from 3 to 10 carbon atoms, the
copolymerization product being water-insoluble but being
capable of absorbing water with swelling, the water regain of
the product being within the range of about 1 to 50 grams per
gram of the dry gel product.
Spec. 18–19 (emphasis added). The Specification also teaches that “[t]he
preferred insoluble, hydrophilic, cross-linked dextrans of the present
invention” are sold “under the trademark Sephadex” and “available . . . in
most countries of the world.” Id. at 20. In addition, the Specification
provides a description of the “typical process for preparing the preferred
insoluble hydrophilic, cross-linked dextrans used in the present invention.”
Id. at 19. We agree with Appellant that these disclosures provide written
description support for the genus of dextran fluid-absorbing materials recited
in claim 73.
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We next consider claim 65, which is substantially broader than claim
73.8 Claim 65 does not limit the claimed fluid-absorbing material to
dextrans, instead encompassing any non-ionic cross-linked polysaccharide
having the claimed water-regain properties. The Specification discloses that,
“[i]n addition to dextrans, other hydroxyl-group containing insoluble
hydrophilic cross-linked polysaccharides which are useful in the present
invention include modified starches, dextrin, cellulose, and polyglucose, and
hydroxyl-group containing charged or uncharged derivatives of these
substances or products obtained by a partial depolymerization of the same,
as well as fractions thereof.” Id. at 17. The Specification teaches that the
claimed fluid-absorbing materials may be “fibrous, particulate, powder,
crystalline, gel, or granular,” “may be derived from natural or synthetic
polymers,” and may include, “amine containing, carboxylate-containing,
sulfonate-containing, polyacrylic, polyvinyl, and/or polysacchrides polymers
. . . or any derivative thereof.” Id. at 15. In sum, the scope of the claimed
genus of fluid-absorbing materials is vast.
In support of this vast genus of fluid-absorbing materials, the
Specification discloses non-dextran fluid absorbing materials only at a high
level of generality, reciting broad categories of polymers with little or no
detail as to their structure or as to specific species of polymers that have the
claimed water regain properties. Spec. 15–20.
Appellant does not argue or direct us to persuasive evidence that the
Specification discloses a representative number of species falling within the
scope of the genus. App. Br. 5–6. Nor does Appellant argue or direct us to

8 Appellant argues claims 65, 67–71, and 74 together. Appeal Br. 5–6. We
designate claim 65 as representative of these claims.
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persuasive evidence that the Specification discloses structural features
common to the members of the genus so that one of skill in the art can
“visualize or recognize” the members of the genus. Id. Instead, Appellant
argues that “[t]hese well-known materials do not need to be described again
in the present specification, because a person of skill in the art is familiar
with these material[s] as well as their water regain properties.” Reply 2;
Appeal Br. 6 (arguing that “[t]he materials described in [the Specification]
and their structures are well known to those skilled in this art”). We
recognize that information that is well known in the art need not be
disclosed. Hybritech, Inc., v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1384 (Fed. Cir. 1986). However, Appellant has not provided persuasive
evidence that the materials broadly described in the Specification were well
known. See, Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989)
(“Attorneys’ argument is no substitute for evidence.”); In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974). Accordingly, we affirm the Examiner’s
rejection of claim 65. Claims 67–71 and 74 were not argued separately and
fall with claim 65.
Claim 72 depends from claim 65 and further requires that the
“insoluble, cross-linked polysaccharide is dextran; modified starches;
dextrin; cellulose; polyglucose; hydroxyl group containing uncharged
derivatives; or product obtained by partial depolymerization; or
combinations thereof.” As Appellant concedes, claim 72 does little to
narrow the genus recited in claim 65. Tr. 12 (“I think Claim 72, for instance,
is not that much narrower than Claim 65 in that it covers most of the
polysaccharide, nonionic polysaccharide materials that would be
encompassed within 65, but, you know, specifically lists a variety of the
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classes that are appropriate.”) We affirm the Examiner’s rejection of claim
72 for the reasons discussed in connection with claim 65.
REJECTION II
Appellant argues claims 65 and 68–74 together. Appeal Br. 6–10.
We designate claim 65 as representative.
In rejecting claim 65 as obvious over the combination of Alon,
Nagahara, and Berger, the Examiner found that Alon disclosed “fluid
absorbing materials filled into capsules.” Final Act. 11. More specifically,
the Examiner found that Alon disclosed gelatin capsules filled with “super
absorbent . . . , cross-linked polymers” that were “non toxic,” “non
digestible,” and “capable of absorbing fluids at a ratio of at least 5:1
(W/W).” Id. The Examiner acknowledged, however, that Alon did not
teach using a nitrogen-free material as its capsule or using cross-linked
polysaccharides as its fluid absorbing materials. Id. at 11, 12.
To address the requirement of claim 65 for a nitrogen-free capsule
material, the Examiner relied on Nagahara. The Examiner found that
Nagahara disclosed that hard gelatin capsules have weak mechanical
strength in a low moisture state and are apt to be broken, and that these
issues could be addressed by using pullulan or PEG-gelatin capsules. Id. at
12. The Examiner found that Nagahara taught that pullulan and PEG-gelatin
capsules were “excellent in mechanical strength in low moisture state,”
“excellent in solubility at low pH,” and “quickly dissolve[] in the stomach.”
Id. The Examiner thus concluded:
[I]t would have been prima facie obvious to one of ordinary
skill in the art to select the capsule shells of Nagahara for use in
Alon such as using pullulan (e.g., nitrogen free) for the stated
benefits disclosed in Nagahara. While it is acknowledged that
Nagahara does not focus on “nitrogen-free,” it would have been
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obvious to pick any of the shells disclosed including the
nitrogen free pullulan for the stated benefits.
Ans. 7.
To address the requirement of claim 65 for cross-linked
polysaccharides as fluid absorbing materials, the Examiner relied on Berger.
The Examiner found that Berger taught “oral compositions that contain
fluid-absorbing materials [including a] cross-linked polysaccharide, dextran,
Sephadex, or a three-dimensional network of dextran substances as recited in
claims 71- 73.” Final Act. 12. According to the Examiner, Berger taught
that these materials have water regain in the range of 1 to 50 grams per gram
of the dry gel product. Id. at 13. The Examiner concluded that it would
have been obvious to use Berger’s water-insoluble, fluid-absorbing materials
in Alon’s capsule because they were known to be suitable for oral
administration. Id.
We agree with the Examiner that claim 65 would have been obvious
over the cited art. We address Appellant’s arguments below.
Appellant argues that “[n]one of the cited references provide any
reason to select substantially nitrogen-free capsule material.” Appeal Br. 7.
According to Appellant, “Alon does not suggest any capsule material other
than gelatin.” Id. at 8. Similarly, Appellant argues that Nagahara “does not
provide any reason or suggestion to select a capsule constructed of a
nitrogen-free material” and that “Nagahara even criticizes a capsule made of
a nitrogen-free material HPMC [hydroxypropyl methylcellulose], stating
that such a HPMC capsule preparation has a problem that its solubility is
lower than that of a hard gelatin capsule at low pH.” Id. We are not
persuaded.
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Alon discloses a pill comprising an outer capsule made of gelatin and
filled with cross-linked super-absorbent polymer beads. Alon ¶ 47. After
the pill is ingested, the capsule “dissolves at a temporal preset,” releasing the
beads in the stomach. Id. ¶¶ 48, 53. Nagahara teaches that “generally used
hard gelatin capsule[s] ha[ve] weak mechanical strength in a low moisture
state and [are] apt to be broken.” Nagahara ¶ 4. Nagahara teaches that
capsules made of pullulan or of a PEG-containing gelatin are “excellent in
mechanical strength in a low moisture state and hardly broken.” Id. ¶ 35. In
addition, Nagahara teaches that “the PEG-containing gelatin capsule [and]
the pullulan capsule . . . are excellent in solubility at low pH, [and] will be
quickly dissolved in the stomach.” Id. We agree with the Examiner that,
based on these disclosures, it would have been obvious to replace Alon’s
gelatin capsule with a pullulan capsule “for the stated benefits disclosed in
Nagahara.” Ans. 7. Both capsules dissolve in the stomach (Alon ¶¶ 48, 53;
Nagahara ¶ 35) and Nagahara teaches that a pullulan capsule has superior
mechanical strength (Nagahara ¶ 35).
We acknowledge that in adopting a pullulan capsule as suggested by
Nagahara, the ordinary artisan may not have recognized the additional
benefit identified by the inventor – i.e., that pullulan is nitrogen-free. It is,
however, of no moment that the Examiner’s rationale for arriving at the
claimed subject matter is different than the inventor’s. KSR Intl., Co. v.
Teleflex Inc., 550 U.S. 398, 419 (2007) (“In determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective reach
of the claim. If the claim extends to what is obvious, it is invalid under
§ 103.”); see also In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992)
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(“[T]he law does not require that the references be combined for the reasons
contemplated by the inventor”); Catalina Mktg. Intl., Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he
patentability of . . . composition claims depends on the claimed structure, not
on the use or purpose of that structure”).
Appellant argues that “Berger does not teach or suggest placing the
compounds in a capsule, much less the use of a substantially nitrogen-free
capsule.” Id. at 8–9. Appellant further argues that Alon “discloses that its
system may be comprised of liquid, food bars or a capsule system” and that
the Examiner “has not provided any reason for selecting capsules over other
dosage forms.” Id. at 9. According to Appellant, “[n]othing in the cited
references or in general common knowledge provides an impetus to combine
Berger (which is totally silent on capsule technique) with other references
cited for allegedly disclosing techniques relating to capsules.” Id.
To the extent Appellant is arguing that Berger does not suggest using
a nitrogen-free material in Alon’s capsule, we are not persuaded because the
Examiner does not rely on Berger for that teaching. Instead, the Examiner
relies on Nagahara’s disclosure of pullulan for that teaching. Final Act. 12.
To the extent Appellant is arguing that the ordinary artisan would not
have incorporated Berger’s three-dimensional network of dextran substances
as the super-absorbent polymer in Alon’s capsule, we are not persuaded
because the combination of Berger and Alon fairly suggests this
modification. Alon discloses a “device and method for substantially
reducing the caloric efficiency of the digestive tract by capturing food being
digested in the stomach and/or anywhere else in the GI tract.” Alon ¶ 2.
Alon does this using a capsule filled with cross-linked super-absorbent
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polymer beads “capable of absorbing fluids at a ratio of at least 5:1 (W/W).”
Id. ¶ 47. Alon teaches that its beads may be cross-linked polydextran. Id.
Berger, like Alon, discloses a method of reducing caloric intake by
introducing cross-linked polysaccharides to the gastrointestinal tract. Berger
2:1–19. Berger’s method uses oral compositions comprising cross-linked
polysaccharides. Id. Berger’s preferred cross-linked polysaccharides are,
like those described in the Specification, “gel grains comprising a three-
dimensional macroscopic network of dextran substances” and having a water
regain “of about 1 to 50 grams per gram of the dry gel.” Id. at 4:34–47;
compare to Spec. 18–19. We agree with the Examiner that, based on these
disclosures, it would have been obvious to use Berger’s “gel grains
comprising a three-dimensional macroscopic network of dextran substances”
in Alon’s capsule because Berger’s gel grains are taught to be suitable for
oral administration and because they have suitable water regain properties.
Final Act. 13.
Appellant argues that there were “many known materials for
constructing capsules” and that “it would have been impossible to aim to
select ‘a nitrogen-free material’ as a material for constructing capsules.”
Appeal Br. 9. We are not persuaded because, absent evidence of unexpected
results, the existence of other materials for constructing capsules does not
render the use of capsules made of pullulan any less obvious. Merck & Co.
v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the
’813 patent discloses a multitude of effective combinations does not render
any particular formulation less obvious.”); In re Corkill, 771 F.2d 1496,
1500 (Fed. Cir. 1985) (affirming obviousness rejection over prior art
teachings that “hydrated zeolites will work” in detergent formulations, even
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though “the inventors selected the zeolites of the claims from among
‘thousands’ of compounds.”); see also, Perricone v. Medicis Pharm. Corp.,
432 F.3d 1368, 1376 (Fed. Cir. 2005) (rejecting the notion that an ingredient
“cannot anticipate because it appears without special emphasis in a longer
list”).
Appellant argues that “[t]he remarkably advantageous effect of the
present invention is beyond expectations.” Appeal Br. 10. To the extent
Appellant offers this “remarkably advantageous effect” as objective indicia
of non-obviousness, we do not find it persuasive because Appellant does not
provide evidence that the advantages allegedly attained were, in fact,
unexpected. “[A]ttorney argument [is] not the kind of factual evidence that
is required to rebut a prima facie case of obviousness.” In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997); Johnston, 885 F.2d at 1581; In re
Pearson, 494 F.2d at 1405. Nor does Appellant compare the alleged
advantageous properties achieved by the claimed composition to the closest
prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392 (Fed. Cir. 1991)
(“when unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior
art”). Accordingly, even if we credit the claimed orally consumable medical
product as providing a remarkably advantageous effect, the record before us
does not support reliance on such effect as objective indicia of
nonobviousness.
Accordingly, we affirm the Examiner’s rejection of claim 65 as
obvious over the combination of Alon, Nagahara, and Berger. Because they
were not argued separately, claims 68–74 fall with claim 65.
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REJECTION III
The Examiner rejected claims 65, 67, and 71–74 over the combination
of Alon, Nagahara, Berger, and Patel. Appellant argues that “[t]his rejection
should be reversed for the reasons discussed above with respect to the
rejection over Alon, Nagahara, and Berger.” Appeal Br. 10. According to
Appellant, “Patel . . . does not remedy the deficiencies of the other
references” and “[t]herefore, Appellant respectfully requests that this
rejection be reversed.” Id. We are not persuaded for the reasons discussed in
connection with the rejection of claims 65 and 68–74 over the combination
of Alon, Nagahara, and Berger. Accordingly we affirm the Examiner’s
rejection.
REJECTION IV
Appellant argues claims 65 and 68–74 together. Appeal Br. 10–14.
We designate claim 65 as representative.
Rejection IV is similar to Rejection II with the principal difference
being that the Examiner relied upon Nagata and Narasimhan rather than
Nagahara to address the requirement of claim 65 for a nitrogen-free capsule
material. Thus, in Rejection IV, as in Rejection II, the Examiner found that
found that Alon disclosed “fluid absorbing materials filled into capsules.”
Final Act. 14. More specifically, the Examiner found that Alon disclosed
gelatin capsules filled with “super absorbent . . . , cross-linked polymers”
that were “non toxic,” “non digestible,” and “capable of absorbing fluids at a
ratio of at least 5:1 (W/W).” Id. The Examiner acknowledged, however,
that Alon did not teach using a nitrogen-free material in its capsule. Id.
To address the requirement of claim 65 for a nitrogen-free capsule
material, the Examiner relied on Nagata. The Examiner found that Nagata
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disclosed that “HPMC has become a successful alternative . . . material to
gelatin . . . for two-piece capsules.” Id. The Examiner concluded that it
would have been obvious to the ordinary artisan “to use [the]
hydroxypropylmethyl cellulose [materials] that are taught by Nagata as the
capsule material in place of Alon.” Id. at 15. The Examiner explained that
“Nagata provides motivation to use HPMC (e.g., nitrogen free capsules) in
place of gelatin taught in Alon” because “Nagata explicitly recognizes that
HPMC is a successful alternative to gelatin . . . for two-piece capsules” and
because Nagata teaches that HPMC capsules have benefits including that
“they are made from non-animal materials, chemically stable, low moisture
content, less brittle in low humidity, [and] fast dissolution.” Ans. 12.
The Examiner additionally found that Narasimhan teaches a
“[c]orrelation of breath ammonia with blood urea nitrogen and creatine
during hemodialysis.” Final Act. 15. The Examiner found that “in kidney
failure, nephrons, the filtering agents that remove nitrogen-bearing wastes
from the blood, are damaged.” Id. From this, the Examiner derived a
“motivation to provide nitrogen free ingredients for treatment in renal
failure.” Id. The Examiner concluded that the ordinary artisan would
“know to avoid adding nitrogen-bearing compounds to renal patients with
already elevated nitrogen-bearing compounds in the blood.” Id.
We agree with the Examiner that claim 65 would have been obvious
over the cited art. Because we do not consider it necessary to our analysis,
we do not consider whether Narasimhan supports the Examiner’s conclusion
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that claims 65 and 68–74 would have been obvious.9 We address
Appellant’s arguments below.
Appellant argues that “Alon does not teach or suggest the need to use
a substantially-free nitrogen material.” Appeal Br. 11. Appellant then
argues that Nagata does not remedy this deficiency because “Nagata
describes benefits of HPMC capsules that are specific to the filled
ingredient.” Id. According to Appellant:
Nagata describes that HPMC is “chemically stable,” has “low
moisture content,” and [is] fast degrading. Nagata at p. 1. All of
these “benefits” are important considerations that depend
critically on the filled ingredient. For example, a low moisture
capsule may be important for the drugs described in Nagata,
which are chemically unstable to water, but this feature is
unimportant for drugs such as the fluid-absorbing material of
Alon or the present invention.
Id. at 11–12. Appellant further argues that HPMC is “just one of many
‘non-animal’ capsule options that are discussed in the art.” Id. at 12. We
are not persuaded.
Nagata teaches:
Several materials have been examined as a substitute for gelatin
in two-piece hard capsules. Hydroxypropylmethyl cellulose
(HPMC) has become a successful alternative material for two-
piece capsules and is actually on the market in the world. . . .
HPMC capsules have been developed for both pharmaceutical
products and dietary supplements.
Nagata 1. Based on this disclosure, we agree with the Examiner that it
would have been obvious to substitute HPMC capsules for the gelatin

9 In affirming a multiple reference rejection under 35 U.S.C. § 103, the
Board may rely on fewer than all of the references relied on by the Examiner
in an obviousness rationale without designating it as a new ground of
rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961).
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capsules disclosed in Alon. In re Kerkhoven, 626 F.2d 846, 850 (CCPA
1980) (“It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same purpose, in order to
form a third composition to be used for the very same purpose . . . . [T]he
idea of combining them flows logically from their having been individually
taught in the prior art.”).
In addition, we agree with the Examiner that Nagata provides reason
to use HPMC capsules by teaching that they have benefits including that
they are made from non-animal materials, chemically stable, have low
moisture content, are less brittle in low humidity, and allow for fast
dissolution. Ans. 12; see also, Nagata 1 (Table 1) (listing these benefits as
well as the benefit that the capsules do not require crosslinking and are
“suited to automatic capsule filling machines”). We recognize that low
moisture content may not be a benefit in capsules filled with super-absorbent
polymers, but Appellant does not direct us to persuasive evidence that low
moisture content would be a detriment. Moreover, the other benefits
identified by the Examiner and by Nagata provide sufficient reason to use
HPMC capsules even without considering the low moisture content that
HPMC capsules provide.
Appellant argues that another feature of HPMC capsules – their fast
degradation – “may be contra-indicated for the capsules of Alon, where the
function of the capsule includes delaying release until at least partial
digestion of the food has occurred.” Appeal Br. at 12. We are not
persuaded because Alon teaches that its capsules dissolve in the stomach and
thus also provide fast degradation. Alon ¶¶ 48, 53. Appellant has not
directed us to persuasive evidence that HPMC would dissolve too quickly to
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19
work in Alon’s capsules. Moreover, Nagata teaches that the “dissolution
profiles of QUALI-V [HMPC capsules developed by Shionogi Qualicaps for
use in pharmaceutical products (Nagata 1)] can be controlled minutely by
adjusting the thickness of capsule shell and so on.” Nagata 4.
Appellant argues that “Berger does not teach or suggest placing the
compounds in a capsule, nor the use of a substantially nitrogen-free
capsule.” Appeal Br. 13. This argument, and Appellant’s other arguments
related to Berger in connection with Rejection IV are similar to Appellant’s
Berger-related arguments made in connection with Rejection II. We do not
find them persuasive for the reasons discussed above. See supra pp. 11–13.
Appellant argues that Narasimhan’s broad teachings regarding kidney
failure and its relationship with nitrogenous compounds is insufficient to
motivate the ordinary artisan to use a nitrogen-free capsule. Appeal Br. 13–
14. As noted above, we do not consider Narasimhan necessary to this
rejection and thus do not consider Appellant’s arguments regarding whether
Narasimhan supports the Examiner’s rejection.
Accordingly, we affirm the Examiner’s rejection of claim 65.
Because they were not argued separately, claims 68–74 fall with claim 65.
REJECTION V
The Examiner rejected claims 65, 67, and 71–74 over the combination
of Alon, Nagata, Narasimhan, Berger, and Patel. Appellant argues that
“[t]his rejection should be reversed for each of the reasons discussed above
with respect to the rejection over Alon, Nagata, Berger, and Narasimhan.”
Appeal Br. 14. According to Appellant, “Patel . . . does not remedy the
deficiencies of the other references” and “[t]herefore, Appellant respectfully
requests that this rejection be reversed.” Id. at 14–15. We are not persuaded
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20
for the reasons discussed in connection with the rejection of claims 65 and
68–74 over the combination of Alon, Nagata, Narasimhan, and Berger.
Accordingly we affirm the Examiner’s rejection.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
65, 67–
74
112 Written description

65, 67-
72, 74
73
65, 68–
74
103(a) Alon, Nagahara, Berger 65, 68–
74

65, 67,
71–74
103(a) Alon, Nagahara, Berger,
Patel
65, 67,
71–74

65, 68–
74
103(a) Alon, Nagata,
Narasimhan, Berger
65, 68–
74

65, 67,
71–74
103(a) Alon, Nagata,
Narasimhan, Berger,
Patel
65, 67,
71–74

Overall
Outcome
65, 67–
74

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED