HYGIA PHARMACEUTICALS, LLC

Patent Trials and Appeals Board

Dec 8, 2020

2020002209 (P.T.A.B. Dec. 8, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/775,621 09/11/2015 Barbara Brooke Jennings 832-3SC 7306
24336 7590 12/08/2020
TUTUNJIAN & BITETTO, P.C.
401 Broadhollow Road, Suite 402
Melville, NY 11747
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
12/08/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@tb-iplaw.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 2020-002209
Application 14/775,621
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 appeal under 35 U.S.C. § 134(a) involving
claims to a method of reducing the risk of, preventing, or treating damage to
cells or tissues due to reactive oxygen species (ROS) free radicals that were
rejected for lack of written description under 35 U.S.C. § 112(a) and for
obviousness under 35 U.S.C. § 103. We have jurisdiction under
35 U.S.C. § 6(b).

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. 4. Herein, we refer to the Final Office
Action mailed May 5, 2019 (“Final Act.”); Appellant’s Appeal Brief filed
November 1, 2019 (“Appeal Br.”); Examiner’s Answer mailed November
26, 2019 (“Ans.”); and Appellant’s Reply Brief filed January 24, 2020
(“Reply Br.”).
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We AFFIRM.

STATEMENT OF THE CASE
Claims 50–54, 56–58, 61, 63, and 64 are on appeal and can be found
in the Claims Appendix of the Appeal Brief. Claim 50 is the only
independent claim and reads as follows:
50. A method of reducing the risk of, preventing, or treating
damage to cells or tissues due to reactive oxygen species (ROB)
free radicals in a subject in need thereof comprising orally
administering an effective amount of a composition comprising:
water;
a phosphorylated myoinositol and/or orally acceptable
salt thereof, wherein the phosphorylated myoinositol has
between 1 and 9 phosphate groups of which any two phosphate
groups can exist as a pyrophosphate group; and
Genistein.
Appeal Br. 42.2 Claim 56 depends from claim 50 and additionally recites
that the composition further comprises “Ubiquinol.” Id. at 43. Claim 57
depends from claim 56 and recites that the “Ubiquinol comprises Qunol
Liquid Co Q10.” Id.
Appellant seeks review of the following rejections:
I. Claims 50–54, 56–58, 61, 63, and 64 under 35 U.S.C. § 112(a), for
failure to meet the written description requirement (“Written
Description Rejection”);

2 Appellant’s claims recite “ROB” as an acronym for reactive oxygen
species, whereas Appellant’s Specification uses the acronym “ROS” to refer
to such. See, e.g., Spec. ¶¶ 3, 31. For clarity, we use “ROS” to refer to
reactive oxygen species in this decision.
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II. Claims 50–54, 56, 58, 61, 63, and 64 under 35 U.S.C. § 103 as
unpatentable over Shamsuddin,3 Medical Net,4 Turner,5 and
Shapiro;6
III. Claim 57 under 35 U.S.C. § 103 as unpatentable over Shamsuddin,
Medical Net, Turner, Shapiro, and Peters;7
IV. Claims 50–53, 61, 63, and 64 under 35 U.S.C. § 103 as unpatentable
over Traynor-Kaplan,8 Bowen,9 and Thornthwaite;10
V. Claims 56 and 57 under 35 U.S.C. § 103 as unpatentable over
Traynor-Kaplan, Bowen, Thornthwaite, and Peters;
VI. Claims 50–53, 58, and 61 under 35 U.S.C. § 103 as unpatentable over
Lam,11 Kalra,12 and Thornthwaite;

3 US 2007/0293458 A1, published Dec. 20, 2007 (“Shamsuddin”).
4 “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”).
5 Benjamin L. Turner et al., Determination of Neo- and D-chiro-Inositol
Hexakisphosphate in Soils by Solution 31P NMR Spectroscopy, 46 Environ.
Sci. Technol. 4994–5002 (2012) (“Turner”).
6 US 2002/0001565 A1, published Jan. 3, 2002 (“Shapiro”).
7 US 6,455,072 B1, issued Sept. 24, 2002 (“Peters”).
8 US 6,221,856 B1, issued April 24, 2001 (“Traynor-Kaplan”).
9 R. Bowen, “Free Radicals and Reactive Oxygen,” Aug. 16, 2003, available
at http://www.vivo.colostate.edu/hbooks/pathphys/misc_topics/radicals.html
(“Bowen”).
10 US 2010/0209497 A1, published Aug. 19, 2010 (“Thornthwaite”).
11 Stephen Lam et al., A Phase I Study of myo-Inositol for Lung Cancer
Chemoprevention, 15 Cancer Epidemiol Biomarkers Prev 1526–1531 (2006)
(“Lam”).
12 Kalra et al., Increased production of oxygen free radicals in cigarette
smokers, 72 Int. J. Exp. Path. 1–7 (1991) (“Karla”).
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VII. Claims 56 and 57 under 35 U.S.C. § 103 as unpatentable over Lam,
Kalra, Thornthwaite, and Peters;
VIII. Claims 50–53, 58, 61, 63, and 64 under 35 U.S.C. § 103 as
unpatentable over Sabin13 and Thornthwaite; and
IX. Claims 56 and 57 under 35 U.S.C. § 103 as unpatentable over Sabin,
Thornthwaite, and Peters.
See Appeal Br. 8–40. For purposes of our analysis, we group the
obviousness rejections according to the first reference in each of Examiner’s
combinations, e.g., Rejections II and III above are the “obviousness
rejections involving Shamsuddin.”
I. WRITTEN DESCRIPTION REJECTION
Issue
The issue for this rejection is whether a preponderance of the evidence
supports Examiner’s finding that claims 50–54, 56–58, 61, 63, and 64 fail to
comply with the written description requirement.
Analysis
Examiner first finds that the written description requirement is not met
because
Appellants[] do not provide support to administration of any of
the myo-inositol pyrophosphate compounds with genistein in a
method as claimed. There is no data or single example to
substantiate the claimed invention of administration of
phosphorylated myo-inositol, of which any two phosphate
groups can exist as a pyrophosphate group.
Ans. 6. For this reason, Examiner concludes the Specification “does not
reasonably convey to one skilled in the relevant art that the inventors had

13 US 5,112,814, issued May 12, 1992 (“Sabin”).
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possession of the entire scope of the claimed invention.” Id. at 8.
We disagree with Examiner’s finding. The Specification expressly
describes compositions containing “pyrophosphated inositol isomers” in
combination with water and Genistein. Spec. ¶ 22. Indeed, as Appellant
points out, the Specification describes a number of specific phosphorylated
myoinositol compounds containing pyrophosphate groups for use in the
recited method. See Appeal Br. 14 (citing Spec. ¶ 31 (describing
pyrophosphated inositols having “1–4 pyrophosphate groups”)). We agree
with Appellant that this description is sufficient to demonstrate possession of
the genus of phosphorylated myoinositol, including those in which two or
more of the phosphate groups exist as pyrophosphate groups, as recited in
Appellant’s claims.
Examiner further determines that Appellant’s claims lack written
description because “there is no data to support the effects of preventing any
damage to cells or tissues due to reactive oxygen species (ROS) free radicals
. . . to determine that the damage is completely preventable” by oral
administration of the recited composition. Ans. 7. In particular, Examiner
notes that there are “no working examples [that] support administration of
phosphorylated myo-inositol or its isomers or salts as claimed to improve the
clinical outcome.” Id.
Appellant responds, urging that data and working examples
evidencing an actual reduction to practice are not necessary to meet the
written description requirement under 35 U.S.C. § 112(a). Appeal Br. at 15–
16. According to Appellant, the Specification shows by citation to “multiple
references and in multiple paragraphs that there is a credible basis for
asserting the claimed composition is useful for the recited treatment.” Id. at
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18. In particular, Appellant asserts that the Specification provides support
for these features in “paragraphs [0010] and [0031] which describe the
efficacy of myoinositol in reducing the effects of reactive oxygen species on
cells, and the relationship of various sources and insults to the production of
such reactive oxygen species.” Id. at 21.
Again, we determine that Appellant has the better argument. Our
reviewing court has made clear that neither examples, nor data obtained
through an actual reduction to practice are necessary to meet the written
description requirement. Falko-Gunter Falkner v. Inglis, 448 F.3d 1357,
1366–67 (Fed. Cir. 2006). Rather, the Specification may disclose a
constructive reduction to practice that is sufficient to demonstrate possession
of the claimed invention. Id. Here, the portions of the Specification that
Appellant relies upon explain that myoinositol hexaphosphate, i.e., a type of
phosphorylated myoinositol, “has been shown to be a free radical scavenger”
in studies (Spec ¶ 10) and describe administering such compounds in an
“effective amount” to reduce “the risk of damage to cells caused by reactive
oxygen species” (Id. ¶ 31). We agree with Appellant that this description
read in conjunction with other portions of the Specification further
describing the composition administered according to the claimed method
(see, e.g., Spec. ¶¶ 1, 22, 36, 123, 125) is sufficient to demonstrate
possession of the method recited in Appellant’s claims.
For these reasons, the Written Description Rejection is not supported
by the preponderance of the evidence. We, therefore, reverse that rejection.
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II. OBVIOUSNESS REJECTIONS INVOLVING SHAMSUDDIN
Issue
The issue for these rejections is whether the preponderance of
evidence of record supports Examiner’s conclusion that Shamsuddin in
combination with the other cited prior art renders Appellant’s claims
obvious.
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
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
organism with acute symptoms and eventual high risk of many cancers.” Id.
Shamsuddin further teaches that “IP-6 and/or inositol” and their
pharmaceutically acceptable salts and derivatives, including pyrophosphate
derivatives, “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 and its
derivatives “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.”).
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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.
FF3. Shamsuddin teaches that it is also advantageous to add “customary
antioxidants” such as “ubiquinone and ubiquinol and their derivatives” to its
IP6 compositions. Shamsuddin ¶¶ 167, 168.
FF4. Shamsuddin teaches that the IP-6 in its compositions may be present
in various “isomers” thereof. Shamsuddin ¶ 27. Turner teaches that there are
four stereoisomers of inositol hexakisphosphate and that, at least in soil,
myoinositol hexakisphosphate is the most abundant. Turner 4994.
FF5. Medical Net describes studies by “Shamsuddin and his colleagues”
showing that “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).
FF6. Shapiro teaches that certain “isoflavones, in particular genistein” can
be orally administered “to prevent or treat damage from acute or chronic
exposure to radiation” and to protect “normal tissues during diagnostic and
therapeutic radiation exposure.” Shapiro ¶ 2; see id., Abstr. (teaching that
such an “isoflavone radioprotective agent” can be “administered orally”).
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FF7. Shapiro further describes experiments in mice demonstrating “that
single or multiple oral doses of genistein protect mice from a lethal dose of
ionizing radiation” when administered before or both before and after
irradiation. Shapiro ¶¶ 54–55 (Ex. 1).
FF8. Peters teaches a “stable aqueous dispersion of nutrients” including “a
Coenzyme Qn where n is an integer of 1 to 12” and other ingredients such as
an isoflavone that “can reduce free-radical damage to cells.” Peters, Abstr.,
1:17–30. Peters teaches that its formulations are desirable because
“Coenzyme Q’s are not ordinarily dispersable in aqueous systems because
they are only slightly water or oil soluble.” Id. at 1:20–23.
FF9. Appellant’s Specification cites Peters as describing “Ubiquinol(Qunol
Liquid CoQ10).” Spec. ¶¶ 127, 129.
Analysis
Examiner finds that Shamsuddin teaches the oral administration of
aqueous solutions containing IP-6 to prevent damage to cells and tissue
resulting from ROS free radicals created by ionizing radiation regardless of
the source of that radiation. See Final Act. 17–18. Examiner further finds
that Shapiro teaches the oral administration of genistein for the “same
purpose” and, therefore, that “it is prima facie obvious” to combine genistein
with “the formulation of Shamsuddin comprising an isomer of IP-6, myo-
inositol phosphate to reduce the adverse effects of diagnostic radiation
treatment (e.g. free radicals, ROS).”14 Id. at 19–20 (citing, inter alia, In re

14 Examiner relies on Turner for its teaching that myo-IP-6 is a stereoisomer
of IP-6, which is abundant in naturally-occurring IP-6 and, therefore, that it
would have been obvious to administer IP-6 comprising the myo
stereoisomer. See Final Act. 19–20. Appellant does not dispute this finding
in its Appeal Brief.
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Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)).
Regarding claims 56 and 57, Examiner determines that Shamsuddin
teaches the use of antioxidants such as ubiquinol in its IP-6 compositions.
Final Act 18, 22 (citing Shamsuddin ¶ 168). Examiner concludes that it
would have been obvious to use the Qunol Liquid CoQ10 composition
taught in Peters as the ubiquinol in such compositions because Peters teaches
that its “composition is stable, and is in aqueous dispersion that can be added
to other drugs or adjuvants in the form of a liquid.” Id. at 23.
After considering the record and arguments in the Appeal Brief, we
adopt Examiner’s findings and reasoning regarding the scope and content of
the prior art (Final Act. 17–23; FF1–FF9) and agree that Appellant’s claims
would have been obvious over Shamsuddin in combination with the other
cited references. We address Appellant’s arguments below.
Appellant argues that “there is no motivation to combine Shapiro with
Shamsuddin, Medical Net, and Turner . . . since Shapiro does not mention
genistein is effective against reactive oxygen species.” Appeal Br. 24.
Specifically, Appellant points to differences between the radiation doses
administered in the tests in Shamsuddin and Shapiro to urge that
[t]he testing, treatments and results described in Shamsuddin
are distinctly different from those described by Shapiro and a
person of ordinary skill in the art would not be motivated to
combine the references based on such unrelated results at least
because there is no predictability of results or expectation of
success for combining the genistein from Shapiro with the IP-6
of Shamsuddin to treat reactive oxygen species.
Id. at 24–25. For this reason, Appellant contends Examiner has not shown
that “the compounds are useful for the same purpose” based on the teachings
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in the prior art and, therefore, has not presented a sufficient prima face
showing. See id. at 26–28.
Appellant’s arguments are not persuasive. Shamsuddin and Shapiro
teach the administration of IP-6 and genistein respectively for preventing
damage caused by radiation of varying intensity from a wide variety of
sources. FF1, FF6. Thus, we agree with Examiner that the prior art teaches
the administration of IP6 and genistein for the same purpose, i.e., treating or
preventing damage to cells and tissue from radiation exposure. This
showing is sufficient to meet Examiner’s burden to present a prima facie
case for the rejection. 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 Kerkhoven, 626 F.2d at 850).
Appellant’s argument that Shapiro additionally describes experiments in
mice involving a lethal dose of radiation (see FF7), whereas at least some of
Shamsuddin’s examples involve lower doses of radiation, does not
undermine Examiner’s prima facie showing, which is premised on the
references’ broader teachings that their respective compositions are useful
for protecting against damage from a wide variety of types and intensities of
radiation.
Appellant’s separate arguments for claims 56 and 57 are similarly
unavailing. Regarding the additional requirement for ubiquinol in claim 56,
Appellant asserts that Examiner’s finding that Shamsuddin teaches that
requirement is “conclusory” because “Shamsuddin . . . does not appear to
mention ubiquinol with[in] its 28 pages.” Appeal Br. 29. Appellant is
incorrect. Shamsuddin expressly teaches the addition of both “ubiquionone
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and ubiquinol.” FF3. Indeed, Examiner expressly cited this teaching in both
the Final Action and again in the Answer. See Final Act. 18; Ans. 11, 42
(citing the addition of ubiquinol as an antioxidant in Shamsuddin ¶ 168).15

Appellant’s argument for claim 57 is similarly premised on the
incorrect assertion that “Shamsuddin fails to teach, mention, or suggest
ubiquinol.” Appeal Br. 30. As explained above, Appellant is mistaken.
Shamsuddin provides an express rationale for adding ubiquinol to its
aqueous IP-6 compositions. FF3. And we agree with Examiner that a
skilled artisan would be motivated to use the type of ubiquinol, i.e., Qunol
Liquid Co Q10, taught in Peters in Shamsuddin’s compositions because
Peters teaches it forms a stable aqueous dispersion. Final Act. 23; FF8–FF9.
For these reasons, we determine that Examiner’s rejection of claims
50, 56, and 57 as obvious over Shamsuddin in combination with the other
cited references is supported by a preponderance of the evidence. Appellant
does not argue any of the other claims separately from claim 50.
Accordingly, we affirm the rejection of those claims for the same reasons
discussed above.

15 Appellant continues to ignore Examiner’s express reliance on Shamsuddin
paragraph 168 in its Reply Brief, arguing that “Examiner’s statement that ‘it
is well known that ubiquinol is an antioxidant,’ is a form of Official Notice
[] that does not provide the necessary notice to Appellant.” Reply Br. 20.
Appellant is incorrect. Examiner’s statement is premised on an express
teaching in Shamsuddin to which Appellant has failed to respond.
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III. OBVIOUSNESS REJECTIONS INVOLVING TRAYNOR-
KAPLAN
Issue
The issue for these rejections is whether the preponderance of
evidence of record supports Examiner’s conclusion that Traynor-Kaplan in
combination with the other cited prior art renders Appellant’s claims
obvious.
Findings of Fact
FF10. Traynor-Kaplan describes “methods for using compositions
comprising inositol derivatives as agents for inhibiting superoxide anion
production.” Traynor-Kaplan, Abstr. According to Traynor-Kaplan,
“[e]xposure of tissues to superoxide anion radical can lead to oxidative stress
and tissue damage.” Id. at 2:28–30. For example, Traynor-Kaplan teaches
that “[s]uperoxide anion can act as a carcinogen causing oxidant-induced
DNA sequence changes” and “production of superoxide anion and other free
radicals can lead to demyelination or neuronal death and conditions such as
multiple sclerosis, the deterioration of cognitive function with aging,
dementia, amyotropic lateral sclerosis (‘ALS’), Alzheimer’s disease,
Parkinson’s disease, and other degenerative neuropathies.” Id. at 2:30–32,
35–40. Traynor-Kaplan further teaches that the inositol derivatives it
describes can be administered “for inhibiting superoxide anion production
and for reducing consequent tissue damage, as well as for treating or
preventing” the above-noted pathological conditions. Id. at 16:8–17.
FF11. Traynor-Kaplan teaches that a particularly preferred inositol
derivative for preventing and treating damage caused by superoxide anion
production is “D-myo-inositol 1,4,5,6-tetrakisphosphate,” i.e., a
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phosphorylated myoinositol with four phosphate groups. Traynor-Kaplan
17:46–47. Traynor-Kaplan recites a method for inhibiting superoxide anion
production comprising “administering to a mammal” a “therapeutically
effective amount” of D-myo-inositol 1,4,5,6-tetrakisphosphate as well as
other types of phosphorylated myoinositols. Id. at claims 1, 33.
FF12. Traynor-Kaplan teaches that its inositol derivatives may be
administered orally in solutions containing water. Traynor-Kaplan 18:10–29.
Traynor-Kaplan further teaches that the inositol derivative in such solutions
may be combined with an anti-inflammatory compound. Id. at 17:54–58.
FF13. Bowen teaches that superoxide anion is a type of free radical referred
to as a reactive oxygen species. Bowen 1. Bowen explains that such free
radicals are of concern because, inter alia, they have “extremely high
chemical reactivity” and “inflict damage on cells.” Id. Bowen teaches that
antioxidants protect against damage from reactive oxygen species. Id. at 3–4.
FF14. Thornthwaite teaches that antioxidants such as “[c]oenyzme Q10
(CoQ10, ubiquinone)” and “genistein” are “emerging as prophylactic and
therapeutic agents” because they “scavenge free radicals otherwise reactive
oxygen species.” Thornthwaite ¶ 104. According to Thornithwaite, “[f]ree
radicals have been associated with pathogenesis of various disorders like
cancer, diabetes, cardiovascular diseases, autoimmune diseases,
neurodegenerative disorders and are implicated in aging.” Id. Thornthwaite
teaches that ubiquinone and genistein are antioxidants that “have been found
to be pharmacologically active as prophylactic and therapeutic agents for the
above mentioned diseases.” Thornthwaite ¶¶ 103, 104; see also id. ¶¶ 23–44
(describing studies involving administration of genistein); ¶¶ 105–123
(describing studies involving administration of CoQ10/ubiquinone).
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Analysis
Examiner finds that Traynor-Kaplan teaches a method for preventing
or reducing damage caused by superoxide anions, i.e., a type of reactive
oxygen species free radical as evidenced by Bowen, through the oral
administration of a solution containing water and a therapeutically effective
amount of a phosphorylated myoinositol such as D-myo-inositol 1,4,5,6-
tetrakisphosphate. See Final Act. 24–25. Examiner further finds that
Thornthwaite teaches the administration of antioxidants, including genistein
and coenzyme Q10, as prophylactic and therapeutic agents that likewise
scavenge free radicals and prevent damage caused by reactive oxygen
species. Id. at 26. Examiner concludes that it would have been “obvious to
add genistein and coenzyme Q10 in the formulation of Traynor-Kaplan
comprising a myo-inositol phosphate compound to reduce the adverse
effects of reactive oxygen species (free radicals)” because the prior art
teaches that these compounds are useful for the same purpose and, therefore,
it would have been prima facie obvious to combine them “in order to form a
third composition useful for the same purpose.” Id. at 26–27 (citing, inter
alia, Kerkhoven, 626 F.2d at 850).
Regarding claims 56 and 57, Examiner finds that Thornthwaite
teaches that coenzyme Q10 is converted to ubiquinol during or after
administration. Final Act. 26 (citing Thornthwaite ¶¶ 111, 113). Examiner
concludes it would have, therefore, been obvious to administer ubiquinol in
the articulated combination of Traynor-Kaplan and Thornthwaite. See id. at
29. Regarding claim 57, Examiner concludes it would have been obvious to
use the Qunol Liquid CoQ10 composition taught in Peters as the ubiquinol
in such compositions because Peters teaches that its “composition is stable,
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and is in aqueous dispersion that can be added to other drugs or adjuvants in
the form of a liquid.” Id.
After considering the record and arguments in the Appeal Brief, we
adopt Examiner’s findings and reasoning regarding the scope and content of
the prior art (Final Act. 24–29; FF8–FF14) and agree that Appellant’s claims
would have been obvious over Traynor-Kaplan in combination with the
other cited references. We address Appellant’s arguments below.
Appellant contends that Thornthwaite “fails to describe the use of
ubiquinol [and genistein] for ‘reducing the risk of, preventing, or treating
damage to cells or tissues due to reactive oxygen species [] free radicals,’ as
claimed.” Appeal Br. 32. According to Appellant, Thornthwaite “only
describes an association between various disorders like cancer, diabetes,
cardiovascular diseases, autoimmune diseases, neurodegenerative disorders”
and such antioxidants, but “fails to present a direct link between the reactive
oxygen species and these illnesses, but instead presents other medical
explanations.” Id. at 33. Thus, urges Appellant, Thornthwaite “does not
provide a teaching that the efficacy of genistein is due specifically to treating
damage to cells or tissues due to reactive oxygen species” and “there is no
reason, other than hindsight reconstruction, to combine the material
described in the reference for the claimed treatment.” Id. at 34.
Appellant’s argument is unpersuasive. The record evidences, and
indeed Appellant does not dispute that, superoxide anion and other ROS are
free radicals (FF13) and Thornthwaite specifically teaches that such “free
radicals are associated with pathogenesis” of the various disorders it lists
(FF14). Thus, contrary to Appellant’s argument, Thornthwaite does link
ROS to the same diseases against which it teaches genistein and coenzyme
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Q10 “have been found to be pharmacologically active as prophylactic and
therapeutic agents.” Id. In addition, Thornthwaite teaches that genistein and
coenzyme Q10 are antioxidants, “which scavenge free radicals . . . and
prevent the damage caused by them.” Thornthwaite ¶ 104 (emphasis
added). Accordingly, Thornthwaite does, in fact, provide an express
teaching that genistein and coenzyme Q10 prevent damage caused by ROS
free radicals. For these reasons, the rejection is not premised on improper
hindsight, as Appellant contends, but rather on the references’ express
teachings the compounds they teach are useful for the same purpose.
Appellant’s additional arguments regarding claims 56 and 57 are
likewise unpersuasive. See Appeal Br. 35. As explained above,
Thornthwaite teaches the use of coenzyme Q10 to prevent damage caused by
ROS free radicals. See FF14. Thus, we agree with Examiner that
Thornthwaite teaches the use of coenzyme Q10 and genistein compositions
for the same purpose as the phosphorylated myoinositol compositions taught
in Traynor-Kaplan. In addition, Thornthwaite evidences that coenzyme Q10
is converted to ubiquinol upon administration. See Thornthwaite ¶ 113.
Accordingly, the record supports Examiner’s finding that it would have been
obvious to add ubiquinol based on Thornthwaite’s teaching regarding
coenzyme Q10. Appellant’s argument that Peters does not itself “describe
the use of ubiquinol for ‘reducing the risk of, preventing, or treating damage
to cells or tissues due to reactive oxygen species [] free radicals’” (see
Appeal Br. 35) does not distinguish Examiner’s articulated combination of
references, which relies upon Thornthwaite’s teachings to provide the
motivation for adding ubiquinol to the composition administered in Traynor-
Kaplan’s method. See Soft Gel Techs., Inc. v. Jarrow Formulas, Inc., 864
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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 on the
teachings of a combination of references.”).
For these reasons, we determine that Examiner’s rejection of claims
50, 56, and 57 as obvious over Traynor-Kaplan in combination with the
other cited references is supported by a preponderance of the evidence.
Appellant does not argue any of the other claims separately from claim 50.
Accordingly, we affirm the rejection of those claims for the same reasons
discussed above.
IV. OBVIOUSNESS REJECTIONS INVOLVING LAM
Issue
The issue for these rejections is whether the preponderance of
evidence of record supports Examiner’s conclusion that Lam in combination
with the other cited prior art renders Appellant’s claims obvious.
Analysis
Examiner finds that Lam describes “a multiple dose clinical study of
administration of myo-inositol (18 g/d mixed with juice or water) in smokers
with bronchial dysplasia” and “teaches that myo-inositol to be an effective
agent in lung cancer prevention.” Final Act. 29–30. Examiner relies on
teachings in the other cited references, i.e., Kalra and Thornthwaite, for the
limitations relating to ROS free radicals and genistein. Id. at 30. Examiner
then concludes it would have been obvious to add genistein and coenzyme
Q10 “in the method of Lam to reduce the adverse effects of free radicals.”
Id.
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While we agree with Examiner that it would have been obvious to
combine these references for the reasons articulated in the Final Action,
there remains a deficiency in the prima facie showing. That deficiency is the
fact that Lam teaches administration of myo-inositol (see Lam, Abstr.) and
not a “phosphorylated myoinositol” having “between 1 and 9 phosphate
groups of which any two phosphate groups can exist as a pyrophosphate
group,” as recited in independent claim 50. Examiner has not offered
evidence demonstrating, or otherwise articulated a rationale for why, it
would have been obvious to administer a phosphorylated form of myo-
inositol based on the teachings in Lam.
For this reason, Examiner has not met the “initial burden, on review of
the prior art . . ., of presenting a prima facie case” that claim 50 would have
been obvious over Lam, Kalra, and Thornthwaite. In re Oetiker, 977 F.2d
1443, 1446 (Fed. Cir. 1992). The rejections of the other claims involving
Lam suffer from the same deficiency and, therefore, Examiner has failed to
meet this burden for those claims as well. Accordingly, we reverse the
obviousness rejections involving Lam.
V. OBVIOUSNESS REJECTIONS INVOLVING SABIN
Issue
The issue for these rejections is whether the preponderance of
evidence of record supports Examiner’s conclusion that Sabin in
combination with the other cited prior art renders Appellant’s claims
obvious.
Findings of Fact
FF15. Sabin teaches a method of orally administering phytic acid and salts
and isomers thereof to treat Parkinson’s disease. Sabin, Abstr. Phytic acid is
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“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). Sabin also teaches that hydrolysates of phytic
acid, i.e., metabolites wherein “one or more of the phosphate groups on the
cyclohexane ring” have been removed, may be administered. Id. at 4:49–57.
According to Sabin, such compositions may be orally administered “in liquid
. . . form.” Id. at 5:15.
FF16. Sabin describes various mechanisms by which “phytic acid will
operate through and directly affect Parkinsonism.” Sabin 2:5–7. In
particular, Sabin teaches:
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.
Analysis
Examiner finds that Sabin teaches a method of orally administering
phytic acid, i.e., hexakisphosphate myo-inositol, and related phosphorylated
myoinositols in liquid form. Final Act. 33. Examiner further determines
that Sabin teaches phytic acid acts by “block[ing] iron mediated free radical
formation” thereby protecting healthy tissue from damage caused by such
free radicals. Id. Examiner concludes that a skilled artisan “would have
found it obvious to add genistein and coenzyme Q10 [as taught in
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Thornthwaite] in the method of Sabin to reduce the adverse effects of free
radicals” because “it is prima facie obvious to combine two or more
ingredients each of which is taught by the prior art to be useful for the same
purpose in order to form a third composition which is useful for the same
purpose.” Id. at 34 (citations omitted). In addition, Examiner concludes that
Sabin teaches Vitamin C and Vitamin E as antioxidants and
hence a person of ordinary skill in the art before the effective
filing date of the invention would have found it obvious to add
additional antioxidant (in addition to phytic acid) in the
composition to derive synergistic or additive therapeutic
benefits in treating damages caused by free radicals.
Id. at 35.
Regarding claim 56 and 57, Examiner relies on the same findings
regarding Thornthwaite and Peters discussed above with respect to the
rejections involving Traynor–Kaplan and concludes it would have been
obvious to use the Qunol Liquid CoQ10 because Peters teaches that
“composition is stable, and is in aqueous dispersion that can be added to
other drugs or adjuvants in the form of a liquid.” Final Act. 36.
After considering the record and arguments in the Appeal Brief, we
adopt Examiner’s findings and reasoning regarding the scope and content of
the prior art (Final Act. 33–36; FF8–FF9, FF14–FF16) and agree that claims
50–53, 56–58, 61, 63, and 64 would have been obvious over Sabin in
combination with the other cited references. We address Appellant’s
arguments below.
Appellant argues that Sabin “fails to describe genistein” and that “a
person of ordinary skill in the art would not combine Thornthwaite with
Sabin” for the same reasons it argues to dispute the combination of
Thornthwaite with Traynor–Kaplan and Lam. Appeal Br. 39–40. Appellant
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additionally contends that the “rejections are cumulative and contrary to the
requirements of compact prosecution.” Id. at 40.
Appellant’s arguments are unpersuasive. The record supports
Examiner’s finding that Sabin teaches the administration of phytic acid, i.e.,
a “phosphorylated myoinositol” as recited in claim 50, for the same purpose,
i.e., as an antioxidant to reduce adverse effects caused by free radicals, as the
genistein and coenzyme Q10 compositions taught in Thornthwaite. FF14–
FF16. Accordingly, Examiner has met the burden to establish a prima facie
showing for these rejections.
Appellant has not offered sufficient evidence or argument to
overcome Examiner’s prima facie showing. We are likewise unpersuaded
by Appellant’s argument that the rejections involving Sabin are
“cumulative” of Examiner’s other rejections. See Appeal Br. 40. While it is
true that Examiner’s rationale for combining Sabin with Thornthwaite and
Peters is similar to that articulated for some of the other rejections, each of
Examiner’s obviousness rejections is distinct from the others because each is
based on a different prior art combination. In any event, the fact that
Examiner has presented multiple prior art combinations supporting a
conclusion that Appellant’s claims are obvious does not provide a basis for
reversing those rejections involving Sabin.
For these reasons, we determine that Examiner’s rejection of claims
50, 56, and 57 as obvious over Sabin in combination with the other cited
references is supported by a preponderance of the evidence. Appellant does
not argue any of the other claims separately from claim 50. Accordingly, we
affirm the rejection of those claims for the same reasons discussed above.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
50–54, 56–
58, 61, 63,
64
112(a) Written
Description
50–54, 56–
58, 61, 63,
64
50–54, 56,
58, 61, 63,
64
103 Shamsuddin,
Medical Net,
Turner, Shapiro
50–54, 56,
58, 61, 63,
64

57 103 Shamsuddin,
Medical Net,
Turner, Shapiro,
Peters
57
50–53, 61,
63, 64
103 Traynor-Kaplan,
Bowen,
Thornthwaite
50–53, 61,
63, 64

56, 57 103 Traynor-Kaplan,
Bowen,
Thornthwaite,
Peters
56, 57
50–53, 58,
61
103 Lam, Kalra,
Thornthwaite
50–53, 58,
61
56, 57 103 Lam, Kalra,
Thornthwaite,
Peters
56, 57
50–53, 58,
61, 63, 64
103 Sabin,
Thornthwaite
50–53, 58,
61, 63, 64

56, 57 103 Sabin,
Thornthwaite,
Peters
56, 57
Overall
Outcome
50–54, 56–
58, 61, 63,
64

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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