HYGIA PHARMACEUTICALS, LLC

Patent Trials and Appeals Board

Mar 23, 2021

2020004709 (P.T.A.B. Mar. 23, 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.
13/803,716 03/14/2013 Barbara Brooke Jennings 200307.404 7979
500 7590 03/23/2021
SEED INTELLECTUAL PROPERTY LAW GROUP LLP
701 FIFTH AVE
SUITE 5400
SEATTLE, WA 98104
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/23/2021 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):
USPTOeAction@SeedIP.com
pairlinkdktg@seedip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BARBARA BROOKE JENNINGS
____________

Appeal 2020-004709
Application 13/803,716
Technology Center 1600
____________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal2 under 35 U.S.C. § 134(a) involving
claims to a method of reducing adverse effects of reactive oxygen species
(ROS) on cells in a patient that were rejected for obviousness under 35
U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42(a). Appellant identifies Hygia Pharmaceuticals, LLC as the
real party in interest. Appeal Br. 3. Herein, we refer to the Final Office
Action mailed Oct. 2, 2019 (“Final Act.”); Appellant’s Appeal Brief filed
Feb. 28, 2020 (“Appeal Br.”); Examiner’s Answer mailed April 7, 2020
(“Ans.”); and Appellant’s Reply Brief filed June 5, 2020 (“Reply Br.”).
2 This Appeal is related to Appeal 2020-002209 (Application 14/775,621),
Decision entered Dec. 8, 2020.
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STATEMENT OF THE CASE
Claims 8 and 14–20 are on appeal and can be found in the Claims
Appendix of the Appeal Brief. Appellant does not separately address the
claims. We therefore select claim 8 as representative for our analysis. See
37 C.F.R. § 41.37(c)(1)(iv). Claim 8 reads as follows:
8. A method of reducing adverse effects of reactive oxygen
species on cells in a patient in need thereof comprising orally
administering to the patient, an aqueous liquid formulation,
comprising:
water;
myoinositol hexaphosphate and/or an orally acceptable
salt thereof; and
ascorbic acid.
Appeal Br. 33.
Appellant seeks review of the following rejections:3
I. Claims 8 and 14–20 under 35 U.S.C. § 103 as unpatentable over
Shamsuddin,4 Medical Net,5 and IHM;6
II. Claims 17 and 19 under 35 U.S.C. § 103 as unpatentable over
Shamsuddin, Medical Net, IHM, and Okunieff;7

3 Examiner’s written description rejection under 35 U.S.C. § 112(a) was
withdrawn. Ans. 3.
4 US 2007/0293458 A1, published Dec. 20, 2007 (“Shamsuddin”).
5 “Antioxidants Inositol and Inositol Hexaphosphate Could Provide All-
purpose Radiation Protection,” Nov. 6, 2007, available at http://www.news-
medical.net/news/2007/11/06/32212.aspx (“Medical Net”).
6 Inositol Hexaphosphate Monograph, 7 Alternative Medicine Review 244–
48 (2001) (“IHM”).
7 P. Okunieff et al., Antioxidants Reduce Consequences of Radiation
Exposure, 614 Adv. Exp. Med. Biol. 165–178 (2008) (“Okunieff”).
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III. Claims 8 and 14–20 under 35 U.S.C. § 103 as unpatentable over
Shamsuddin, Medical Net, IHM, and Dey;8
IV. Claims 8 and 17–19 under 35 U.S.C. § 103 as unpatentable over
Sabin9 and Nikolova;10 and
V. Claims 8 and 16–19 under 35 U.S.C. § 103 as unpatentable over
Shamsuddin II,11 IHM, and Abdollahi.12
See Appeal Br. 22–32.
The issue for each of these rejections is whether the preponderance of
the evidence supports Examiner’s conclusion that Appellant’s claims are
obvious over the cited prior art. We set forth our findings and analysis for
each of these rejections below.
I. OBVIOUSNESS REJECTION OVER SHAMSUDDIN,
MEDICAL NET, AND IHM
Findings of Fact
FF1. Shamsuddin teaches that “inositol hexaphosphate (IP-6),” i.e., a
phosphorylated inositol with 6 phosphate groups, has “potent antioxidant
activity to prevent active oxygen species-mediated mutagenesis, cell injury
and carcinogenesis.” Shamsuddin, Abstr. Shamsuddin explains that
“[s]ublethal radiation causes DNA damage through the formation of free

8 N. Dey et al., Molecular Mechanisms of Cigarette Smoke-Induced
Proliferation of Lung Cells and Prevention by Vitamin C, J. of Oncology
561862, 1–16 (2011) (“Dey”).
9 US 5,112,814, issued May 12, 1992 (“Sabin”).
10 G. Nikolova, Oxidative Stress and Parkinson Disease, 10 Trakia Journal
of Sciences 92–100 (2012) (“Nikolova”).
11 US 2007/0212449 A1, published Sept. 13, 2007 (“Shamsuddin II”).
12 M. Abdollahi et al., Role of Oxidative Stress in Osteoporosis, 2 Therapy
787–96 (2005) (“Abdollahi”).
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radicals, reactive oxygen species, and pyrimidine crosslinks” and that
exposure to ionizing radiation whether from war-time nuclear blasts or
cosmic radiation “causes the same spectrum of damage to the cells and the
organisms with acute symptoms and eventual high risk of many cancers.” Id.
Shamsuddin teaches that “IP-6 and/or inositol” and their pharmaceutically
acceptable salts “significantly counteract the harmful effects of radiation,
affecting cell cycle progression in a protective manner” and are, therefore,
“effective agents for protection against nuclear, solar and other radiation
injuries.” Id.; see also Id. ¶ 1 (teaching the administration of IP-6 “prior to,
during, or after exposure to radiation” to prevent or treat damage to tissues
and cells “from exposure to solar, nuclear, cosmic, and other forms of
electromagnetic or particulate radiation; including radiation exposure such as
occurs during anticancer radiotherapy.”).
FF2. Shamsuddin teaches that IP-6 compositions can be dissolved in water
and administered orally prior to radiation exposure to provide a prophylactic
effect. Shamsuddin ¶ 85; see also id. ¶ 113 (describing administration of IP-
6 to mice in drinking water as a radioprotectant). Shamsuddin likewise
teaches that IP-6 “can be provided as a flavored or unflavored oral solution”
for systemic administration. Id. ¶ 190.
FF3. Shamsuddin teaches that, in addition to IP-6, the pharmaceutical
compositions administered in its methods “may also contain an antioxidant.”
Shamsuddin ¶ 28. Shamsuddin describes vitamin C (ascorbic acid) and
tocopherol (vitamin E) as a “customary antioxidants” that may be
“advantageously” combined with IP-6. Id. ¶¶ 167–68.
FF4. Medical Net teaches that inositol and IP-6 are “potent antioxidants”
and describes studies by “Shamsuddin and his colleagues” showing that
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“Inositol and inositol hexaphosphate (IP6) protected both human skin cells
and a skin cancer-prone mouse from exposure to ultraviolet B (UVB)
radiation.” Medical Net 1. Medical Net teaches that these “studies confirm
the degree to which these molecules protect against the DNA-damaging
effects of ionizing radiation” and that “[r]adiation damage is radiation
damage, regardless of source, so there could also be protective role for IP6 in
any form of radiation exposure, whether it is from a therapeutic dose or from
solar, cosmic or nuclear sources.” Id. (internal quotations omitted).
FF5. IHM teaches that IP-6 is “also known as myo-inositol hexaphosphate
and phytic acid.” IHM 244. According to IHM, IP-6 “functions as an
antioxidant by chelating divalent cations such as copper and iron, preventing
the generation of reactive oxygen species responsible for cell injury and
carcinogenesis.” Id.
Analysis
Examiner finds that Shamsuddin teaches that IP-6 is a potent
antioxidant, which can be orally administered in an aqueous solution to
prevent damage to cells and tissue resulting from ROS free radicals created
by ionizing radiation from diagnostic X-rays and other sources. See Ans. 5–
6. Examiner further relies on Medical Net’s teaching that IP-6 is a
“protective agent from ionizing radiation.13 Id. at 6–7.
Regarding the ascorbic acid limitation, Examiner finds that
Shamsuddin teaches adding other “antioxidants including vitamin C and
derivatives (e.g. ascorbyl palmitate).” Ans. 6. Examiner determines it would

13 Examiner relies on IHM for its teaching that IP-6 is “also known as myo-
inositol hexaphosphate.” Ans. 7. Appellant does not dispute this finding in
its Appeal Brief.
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have been “obvious to add another anti-oxidant, e.g. vitamin C (ascorbic
acid) in the composition . . . to provide the dosage form as single
formulation for convenience to the subject” and that a skilled artisan would
expect “additive or synergistic benefits” from the combination “as both IP6
and ascorbic acid are anti-oxidants.” Id. at 7–8.
We agree with and adopt Examiner’s findings and reasoning
regarding the scope and content of the prior art (Ans. 5–9, 18–21; FF1–FF5)
and agree with Examiner’s conclusion that claim 8 would have been obvious
over Shamsuddin in combination with the other cited references. We
address Appellant’s arguments below.
Appellant argues that “Shamsuddin does not describe ascorbic acid or
combining ascorbic acid with myoinositol hexaphosphate for an oral liquid
formulation.” Appeal Br. 23. According to Appellant, Shamsuddin
describes the use of ascorbic acid as an additional antioxidant, but only in
parenteral solutions and non-oral cosmetic or dermatological preparations.
Id. at 23–25. For this reason, Appellant urges that Examiner has failed to
show that one of ordinary skill in the art would have been motivated to
combine ascorbic acid and IP-6 in an orally-administered liquid formulation,
as recited in claim 8. Id. at 25.
Appellant’s argument is not persuasive for several reasons. First, we
agree with Examiner that the teaching in Shamsuddin paragraph 28,
describing the use of other antioxidants in addition to IP-6, refers to “a
general embodiment that is applicable to oral administration.” Ans. 19.
Thus, contrary to Appellant’s argument, Shamsuddin’s teaching of other
antioxidants is not strictly limited to non-oral dosage forms. Second,
Shamsuddin describes ascorbic acid as a “customary antioxidant” that is
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compatible with IP-6. FF3. The fact that this description occurs in a
passage describing preferred antioxidants for use in “cosmetic and/or
dermatological applications” does not suggest that ascorbic acid should only
be used in such applications. Third, the cited references support Examiner’s
finding that both IP-6 and ascorbic acid were known antioxidants (FF1,
FF3–FF4) and therefore it was prima facie obvious to combine the two to
achieve an antioxidant effect, thereby reducing the adverse effects of ROS.
See MPEP § 2144.06 (“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.”) (quoting In re Kerkhoven, 626 F.2d 846, 850 (CCPA
1980)).
Finally, Appellant’s suggestion that the prima facie showing is
premised on Examiner taking “official notice” of the above-noted facts is
incorrect. See Appeal Br. 25; Reply Br. 9–10. Examiner’s prima facie
showing is premised on the teachings in the cited references––not on official
notice under MPEP § 2144.03. See generally Ans. 5–9 (citing references).
And we agree that the cited references support Examiner’s findings. See
FF1–FF5.
For these reasons, we determine that Examiner’s rejection of claim 8
is supported by a preponderance of the evidence. Appellant does not argue
claims 14–20 separately from claim 8. Accordingly, we affirm the rejection
of those claims for the same reasons discussed above.
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II. OBVIOUSNESS REJECTION OVER SHAMSUDDIN,
MEDICAL NET, IHM, AND OKUNIEFF
Findings of Fact
FF6. Okunieff teaches that antioxidants “have been studied for their
capacity to prevent radiation toxicity both with regard to reduction of
radiation-related cytotoxicity and for reduction of indirect radiation effects
including long-term oxidative damage.” Okunieff, Abstr. In particular,
Okunieff explains that “[r]eactive oxygen species play a pivotal role in the
initiation of apoptosis” and “scavenging of ROS by antioxidants interferes
with the initiation of apoptosis by depleting ROS levels in cells and
maintaining membrane integrity.” Id. at 5. To this end, Okunieff teaches
that the combination of vitamin E and vitamin C “provide[s] both an effective
protection of membranes and increased radioresistance in cells.” Id. at 3; see
also id. at 7 (teaching that “regeneration of vitamin E and other antioxidants
by vitamin C” in a “combined antioxidant treatment[]” provides an
“enhanced radioprotective effect” through “regulation and response to
ROS”).
Analysis
Examiner relies on the same teachings in Shamsuddin, Medical Net,
and IHM discussed above, noting that Shamsuddin teaches administration of
an oral solution comprising IP-6, electrolytes,14 and other antioxidants such
as vitamin C (i.e., ascorbic acid) and vitamin E, but does “not explicitly

14 Appellant does not dispute Examiner’s finding that Shamsuddin teaches
the addition of an electrolyte to its oral solution in its Appeal Brief, nor does
Appellant argue claim 19 separately from claim 17. Accordingly, any
argument that claim 19 is separately patentable over this combination of
references has been waived. See 37 C.F.R. § 41.37(c)(iv).
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teach them as free radical scavengers.” Ans. 9. Examiner determines that
Okunieff teaches that vitamin E is a free radical scavenger and that the
combination of vitamins E and C provides “an effective protection of
membranes and increased radioresistance in cells.” Id. Thus, Examiner
concludes that it would have been obvious to include vitamins E and C along
with IP-6 in an aqueous, orally-administered solution to reduce “adverse
effects associated with free radicals during radiation exposure.” Id. at 10.
We agree with and adopt Examiner’s findings and reasoning
regarding the scope and content of the prior art (Ans. 5–10, 18–22; FF1–
FF6) and agree that claims 17 and 19 would have been obvious over the
cited references. We address Appellant’s arguments below.
Appellant argues that “[t]he addition of Okunieff fails to remedy the
deficiencies of Shamsuddin, Medical Net, and IHM, at least because
Okunieff relates to thiol-based anti-oxidants, not ascorbic acid.”15 Appeal
Br. 27. According to Appellant, Okunieff teaches that “the combination of
vitamin E and ascorbic acid provides an effective protection of membranes,
but fails to describe ascorbic acid being beneficial alone or with myoinositol
hexaphosphate.” Id.; see also Reply Br. 12 (arguing that “Okunieff fails to
teach the use of ascorbic acid/vitamin C alone for aqueous liquid
formulation for oral administration”).
Appellant’s argument is not persuasive. Examiner’s rejection is
premised on the combination of both vitamin E (i.e., a free-radical

15 Claims 17 and 19 were also rejected based on the first obviousness
rejection. To the extent Appellant relies on the same arguments it makes for
the first rejection, we are not persuaded for the same reasons discussed
above.
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scavenger) with vitamin C and IP-6. Nor do Appellant’s claims exclude the
presence of multiple antioxidants in addition to IP-6. Thus, it is of no
moment that Okunieff does not describe ascorbic acid as being “beneficial
alone.” See Appeal Br. 27. “[A]ppellant’s arguments fail from the outset
because . . . they are not based on limitations appearing in the claims.” In re
Self, 671 F.2d 1344, 1348 (CCPA 1982).
Moreover, Examiner has provided ample support in the record to
show that it would have been obvious to administer the combination of IP-6
and vitamins C and E in an oral solution. As explained above, Shamsuddin
teaches that other antioxidants, including both ascorbic acid and vitamin E,
can be included in its IP-6 compositions. FF3. Moreover, in addition to the
teachings in Shamsuddin, Okunieff provides an express motivation to
administer vitamins E and C as antioxidants to reduce adverse effects of
ROS. FF6. Accordingly, we agree that Examiner’s rejection of claims 17
and 19 is supported by a preponderance of the evidence and therefore affirm.
III. OBVIOUSNESS REJECTION OVER SHAMSUDDIN,
MEDICAL NET, IHM, AND DEY
Findings of Fact
FF7. Dey teaches that ROS are related to lung cancer and that cells treated
with vitamin C exhibit a lower concentration of ROS in assays designed to
test efficacy in preventing formation of lung cancer. See Dey, Abstr., 3, Fig.
3, 7 (Fig. 4), 9. According to Dey, “[v]itamin C prevents cell death
apparently by preventing oxidative stress (Figure 4) and apoptosis (Figure
5).” Id. at 9.
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Analysis
Examiner relies on the same teachings in Shamsuddin, Medical Net,
and IHM discussed above, but notes that these references do not explicitly
teach that ROS may be generated by cigarette smoke, as recited in dependent
claim 20. Ans. 11. Examiner finds that Dey links cigarette smoke to high
concentrations of ROS and oxidative stress and further teaches the
“beneficial effects of Vitamin C in . . . preventing oxidative stress.” Id.
Examiner determines it would have been obvious to “add Vitamin C as an
anti-oxidant to the formulation comprising . . . myoinositol hexaphosphate to
prevent cell death and . . . oxidative stress” related to ROS and cigarette
smoking. Id. at 11–12.
We agree with and adopt Examiner’s findings and reasoning
regarding the scope and content of the prior art (Ans. 5–8, 11–12, 18–23;
FF1–FF5, FF7) and agree that claim 8 would have been obvious over the
cited references. We address Appellant’s arguments below.
Appellant argues that “Dey fails to remedy the issues discussed above
for the other cited references, since Dey fails to describe the combination of
claimed features.” Appeal Br. 28. Specifically, Appellant contends “Dey
discusses the adverse effects of cigarette smoking, but fails to teach,
mention, or suggest an aqueous liquid formulation including ascorbic acid
and myoinositol hexaphosphate for oral administration.” Id.
Appellant’s argument is unpersuasive. As explained above, Examiner
has presented a sufficient prima facie showing that claim 8 is obvious over
the articulated combination of Shamsuddin, Medical Net, and IHM. Dey
provides additional support for the rejection through its teaching that vitamin
C reduces ROS levels and prevents oxidative stress arising from cigarette
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smoke. FF7. As such, Dey evidences a further motivation for including
ascorbic acid in Shamsuddin’s orally-administered aqueous solution
containing IP-6. Appellant’s argument that Dey alone does not teach all of
the limitations of claim 8 does not overcome the rejection because the
rejection is premised on the combination of references articulated by
Examiner. See Soft Gel Techs., Inc. v. Jarrow Formulas, Inc., 864 F.3d
1334, 1341 (Fed. Cir. 2017) (quoting In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986)) (“[N]on-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references.”).
For these reasons, we determine that Examiner’s rejection of claim 8
is supported by a preponderance of the evidence. Appellant does not argue
claims 14–20 separately from claim 8. Accordingly, we affirm the rejection
of those claims for the same reasons discussed above.
IV. OBVIOUSNESS REJECTION OVER SABIN AND NIKOLOVA
Findings of Fact
FF8. Sabin teaches a method of orally administering phytic acid and salts
and isomers thereof to treat Parkinson’s disease. Sabin, Abstr. Phytic acid
is “myo-inositol-hexakis (dihydrogen phosphate).” Id. at 2:64–65; see also
id. at claim 5 (reciting administration of “hexakisphosphate myo-inositol” to
treat Parkinson’s disease). According to Sabin, such compositions may be
orally administered “in liquid . . . form.” Id. at 5:15.
FF9. Sabin describes various mechanisms by which “phytic acid will
operate through and directly affect Parkinsonism.” Sabin 2:5–7. In
particular, Sabin teaches:
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Parkinsonism may result from toxic iron in the brain. Iron,
besides being highly toxic in the brain, stimulates production of
free radicals. Free radicals, because of their unpaired electrons
and instability and propensity to combine with other biological
molecules, are thought to be in excess, damaging to healthy
tissue and are being implicated in chronic degenerative diseases
such as cancer, arthritis and aging. Phytic acid may thus block
iron mediated free radical formation. Like Vitamin C and
Vitamin E, phytic acid and its hydrolysates are antioxidants.
Id. at 2:8–18. Sabin further teaches that “[v]itamins C and E have
achieved some success in the treatment of Parkinson’s disease so it is
thought that antioxidants, like Vitamin C and Vitamin E and others,
have a role in Parkinsonism.” Id. at 1:62–65.
FF10. Nikolova teaches that “oxidative stress and reactive oxygen species
(ROS) play an important role in the aetiology and/or progression of a number
of human diseases,” including Parkinson’s disease. Nikolova, 92; see also id.
at 98 (“[S]trong evidence has implicated oxidative stress in the pathogenesis
of Parkinson disease.”). In particular, Nikolova explains that:
Oxidative stress defined as an imbalance between biochemical
processes leading to production of reactive oxygen species
(ROS) and the cellular antioxidant cascade, causes molecular
damage that can lead to a critical failure of biological functions
and ultimately cell death. In Parkinson disease, oxidative stress
induced by free radicals damages neuronal membrane lipids,
proteins and other components of brain tissue.
Id. at 94.
Analysis
Examiner finds that Sabin teaches a method of orally administering
phytic acid, i.e., myoinositol hexaphosphate, in liquid form to treat
Parkinson’s disease. Ans. 12–13. Examiner determines that both Sabin and
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Nikolova teach that free radicals cause cellular damage that is linked to
Parkinson’s disease and that Sabin teaches that antioxidants such as
myoinositol hexaphosphate, vitamin C and vitamin E may be useful for
treating Parkinson’s disease by blocking free radical formation. Id.
Accordingly, Examiner concludes that it would have been “obvious to add
Vitamins C and E in the composition comprising myo-inositol
hexaphosphate in the method of Sabin because Sabin explicitly teaches the
vitamins as anti-oxidants” and a skilled artisan would expect to achieve
“synergistic or additive therapeutic benefits” by combining the same. Id. at
14.
We agree with and adopt Examiner’s findings and reasoning
regarding the scope and content of the prior art (Ans. 12–14, 23–25; FF8–
FF10) and agree that claim 8 would have been obvious over the cited
references. We address Appellant’s arguments below.
Appellant argues that “Sabin hypothesiz[es] that Parkinsonism results
from toxic iron and free radicals, but provides no other support or teaching
that such basis is true, or would lead a person of ordinary skill in the art to
use myoinositol hexaphosphate . . . and ascorbic acid for reducing adverse
effects of reactive oxygen species.” Appeal Br. 29. We disagree. Sabin
teaches that there is a link between damage from free radicals and
Parkinson’s disease. FF9. Nikolova further explains that ROS are a type of
free radical that causes oxidative stress, which in turn is implicated in the
pathogenesis of Parkinson’s disease. FF10. In addition, Sabin teaches that
phytic acid, vitamin C (i.e., ascorbic acid) and vitamin E are all antioxidants
and therefore may be useful for treating Parkinson’s disease by reducing
damage from free radicals. FF9. Thus, Sabin teaches the administration of
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myoinositol hexaphosphate and ascorbic acid for the same purpose, i.e., as
antioxidants to treat Parkison’s disease by preventing damage from free
radicals. Accordingly, we find that Examiner has presented a sufficient
prima facie showing that it would have been obvious to combine the two as
recited in claim 8. See Kerkhoven, 626 F.2d at 850.
Appellant’s argument that “[t]he rejection also fails to identify where
Sabin allegedly describes an aqueous liquid formulation for oral
administration” is unpersuasive. Appeal Br. 30. Sabin makes clear that
“[t]he preferred method of administration . . . is through oral administration
in liquid or tablet form.” Sabin 5:13–15. Therefore, the record supports
Examiner’s finding that it would have been prima facie obvious to
administer the recited combination of myoinositol hexaphosphate and
ascorbic acid in an oral solution. Appellant has not offered sufficient
evidence or argument to overcome Examiner’s prima facie showing.
Finally, Appellant’s argument that Nikolova fails to teach various
“features of claim 8” is not persuasive because Examiner has shown that
those features are taught by the articulated combination of Sabin and
Nikolova. Therefore Appellant cannot overcome Examiner’s rejection by
attacking Nikolova individually. See Soft Gel, 864 F.3d at 1341.
For these reasons, we determine that Examiner’s rejection of claim 8
is supported by a preponderance of the evidence. Appellant does not argue
claims 17–19 separately from claim 8. Accordingly, we affirm the rejection
of those claims for the same reasons discussed above.
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V. OBVIOUSNESS REJECTION OVER SHAMSUDDIN II, IHM,
AND ABDOLLAHI
Findings of Fact
FF11. Shamsuddin II teaches that a method of preventing or slowing the
progression of osteoporosis by administering “a pharmaceutical composition
comprising inositol hexaphosphate [i.e., IP-6] with or without inositol in an
amount sufficient to prevent, slow the progression or inhibit osteoporosis.”
Shamsuddin II ¶ 17; see also id. ¶ 47 (teaching that osteoblast cells treated
with IP-6 have “better ability to lay new bone” and that IP-6 “suppresses the
proliferation of bone destroying osteoclast cells”).
FF12. Shamsuddin II teaches that IP-6 may be administered by adding it to
beverages such as water, fruit or vegetable juices, soft drinks, or nutrient-
enriched drinks. Shamsuddin II ¶ 28.
FF13. Shamsuddin II teaches that both inositol and IP-6 are antioxidants.
Shamsuddin ¶ 16.
FF14. Abdollahi teaches that one factor “significantly influencing bone
mass is oxidative stress” and therefore “[u]se of antioxidants can be helpful
in the management of osteoporosis.” Abdollahi, Abstr.
FF15. Abdollahi explains that osteoporosis “is due to a change in the
balance between activities of osteoblasts and osteoclasts,” i.e., the
“specialized cells . . . responsible for bone formation and resorption.”
Abdollahi, 787. Abdollahi teaches that the activities of these cells may be
influenced by “[f]ree radical products of oxygen metabolism.” Id. “These
reactive oxygen species (ROS) are neutralized by the antioxidant system in
the body,” which includes “agents such as vitamins E and C.” Id. According
to Abdollahi, “[o]xidative stress occurs when there is an imbalance between
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free radical production and antioxidant capacity” and that this imbalance may
cause osteoporosis. Id.
FF16. Abdollahi teaches that “[v]itamin C is a key antioxidant vitamin” as
well as “the antioxidant with the most significant evidence for possible effect
on bone formation/bone loss.” Abdollahi, 792. Abdollahi describes results
from a number of studies suggesting that vitamin C is beneficial for treating
various aspects of osteoporosis. Id.
Analysis
Examiner finds that Shamsuddin II teaches a method comprising the
oral administration of IP-616 in an aqueous solution to prevent or slow the
progression of osteoporosis, but “does not teach that osteoporosis is an
adverse effect associated with ROS or [that] the composition comprises
ascorbic acid.” Ans. 15. For these aspects of claim 8, Examiner relies on
Abdollahi’s teaching that oxidative stress caused by ROS is a factor that
influences bone mass and leads to osteoporosis. Id. Examiner further
determines that Abdollahi teaches the use of antioxidants, including vitamin
C, to treat osteoporosis. Id. at 15–16. In view of these teachings, Examiner
concludes that it would have been obvious “to add vitamins including
Vitamin C (ascorbic acid) in the liquid composition of Shamsuddin [II] in
treating osteoporosis . . . which is an adverse effect associated with ROS” in
order to “provide therapeutic benefits.” Id. at 16.
We agree with and adopt Examiner’s findings and reasoning
regarding the scope and content of the prior art (Ans. 14–17, 25–26; FF5,

16 Examiner’s rejection again relies on IHM for its teaching that IP-6 is also
known as myoinositol hexaphosphate. Ans. 15. As before, Appellant does
not dispute this finding.
Appeal 2020-004709
Application 13/803,716

18
FF11–FF16) and agree that claim 8 would have been obvious over the cited
references. We address Appellant’s arguments below.
Appellant contends that Abdollahi is “non-analogous art relating to”
osteoporosis, which “is not in the same field of endeavor and does not
address problems of reactive oxygen species.” Appeal Br. 31. We disagree.
Abdollahi specifically teaches that oxidative stress caused by ROS is a factor
that causes osteoporosis and bone loss. FF14–FF15. Abdollahi further
teaches that antioxidants such as vitamin C may be helpful to treat
osteoporosis. FF16. Shamsuddin II teaches that IP-6 is an antioxidant
(FF13) and teaches the oral administration of IP-6 in an aqueous solution to
treat or prevent osteoporosis. FF11–FF12. Thus, not only are Abdollahi and
Shamsuddin II in the same field of endeavor, these references are pertinent
to and teach the administration of ascorbic acid and IP-6 for the same
purpose, i.e., treating or preventing osteoporosis.
Accordingly, Examiner has established that it would have been prima
facie obvious to combine the two ingredients in an oral solution, as recited in
claim 8. See Kerkhoven, 626 F.2d at 850. Appellant has not offered
sufficient evidence or argument to overcome Examiner’s prima facie
showing.17

17 Appellant also asserts that “Shamsuddin and Inositol hexaphosphate
Monograph fail to render claim 8 and the claims depending therefrom
obvious for at least all the reasons discussed above,” apparently referring to
its arguments concerning the other rejections. Appeal Br. 31; Reply Br. 16.
But those arguments relate to the teachings in Shamsuddin, not Shamsuddin
II, and therefore are not germane to this rejection. To the extent any of
Appellant’s arguments concerning the other rejections are relevant here, we
are not persuaded for the same reasons discussed above.
Appeal 2020-004709
Application 13/803,716

19
For these reasons, we determine that Examiner’s rejection of claim 8
is supported by a preponderance of the evidence. Appellant does not argue
claims 16–19 separately from claim 8. Accordingly, we affirm the rejection
of those claims for the same reasons discussed above.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
8, 14–20 103 Shamsuddin,
Medical Net, IHM
8, 14–20
17, 19 103 Shamsuddin,
Medical Net, IHM,
Okunieff
17, 19
8, 14–20 103 Shamsuddin,
Medical Net, IHM,
Dey
8, 14–20
8, 17–19 103 Sabin, Nikolova 8, 17–19
8, 16–19 103 Shamsuddin II,
IHM, Abdollahi
8, 16–19
Overall
Outcome
8, 14–20

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

AFFIRMED