Michael Hudnall

Patent Trials and Appeals Board

Aug 3, 2021

2020005243 (P.T.A.B. Aug. 3, 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.
15/681,529 08/21/2017 Michael Hudnall 17-103-MH 8430
32118 7590 08/03/2021
LAMBERT SHORTELL & CONNAUGHTON
100 Franklin Street
Suite 903
BOSTON, MA 02110
EXAMINER
GEORGE, PATRICIA ANN
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
08/03/2021 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):
info@lambertpatentlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
_________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL HUDNALL
__________

Appeal 2020-005243
Application 15/681,529
Technology Center 1700
___________

Before ADRIENE LEPIANE HANLON, GEORGE C. BEST, and
JANE E. INGLESE, Administrative Patent Judges.

HANLON, Administrative Patent Judge.

DECISION ON APPEAL

A. STATEMENT OF THE CASE
The Appellant1 filed an appeal under 35 U.S.C. § 134(a) from an
Examiner’s decision finally rejecting claims 1–20. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
Michael Hudnall. Appeal Brief dated March 17, 2020 (“Appeal Br.”), at 2.
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The claimed invention is directed to a method of reversing liver
fibrosis (claims 1–14) and a method of treating a patient having chronic liver
disease (claims 15–20).
Representative claim 1 is reproduced below from the Claims
Appendix to the Appeal Brief.
1. A method of reversing liver fibrosis comprising the steps
of administering a composition to a patient, the composition
comprising:
N-acetyl cysteine in a range of 500–5,000 mg;
polyenylphosphatidylcholine in a range of 500–10,000
mg;
alpha lipoic acid in a range of 200–2,500 mg; and
at least one of: L-lysine in a range of 400–5,000 mg; L-
arginine in a range of 1,000–9,000 mg; vitamin C in a range of
500–10,000 mg; N-acetyl L-carnitine in a range of 250–3,000
mg; betaine HCl in a range of 300–20,000 mg; L-glutamate in a
range of 200–2,000 mg; turmeric in a range of 200–1,500 mg;
proanthocyanidins in a range of 100–1,000 mg; nigella sativa in
a range of 50–400 mg; pantothenic acid in a range of 20–10,000
mg; benfotiamine in a range of 50–400 mg; magnesium in a
range of 50–800 mg; vitamin E in a range of 50–1,000 IU;
cynara scolymus in a range of 25–300 mg; L-glycine in a range
of 50–3000 mg; vitamin B1 in a range of 10–200 mg; vitamin
B2 in a range of 10–200 mg; ubiquinol in a range of 30–1,000
mg; piper cubeba in a range of 10–100 mg; artemisia
absinthium in a range of 10–100 mg; vitamin B3 in a range of
45–3,000 mg; vitamin B6 in a range of 10–200 mg; zinc in a
range of 5–50 mg; vitamin D3 in a range of 400–10,000 IU;
folate in a range of 200–3,000 mcg; vitamin B12 in a range of
200–3,000 mcg; selenium in a range of 100–600 mcg; and
biotin in a range of 50–2,000 mcg;
wherein the step of administering comprises dividing the
composition into three equal doses, a first of the three doses
administered at a first time, a second of the three doses
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administered at a second time, and a third of the three doses
administered at a third time, the three doses administered in a
24 hour period;
wherein the administering is repeated every 24 hours;
and
testing the patient, the step of testing comprising taking a
sample from the patient, analyzing the sample for an indicator
of liver fibrosis, and comparing the analyzed sample to a
previously analyzed sample.
Appeal Br., Claims Appendix (emphasis added).
Claim 15 recites the same composition recited in claim 1. Appeal Br.,
Claims Appendix.
Claims 2 and 16, which depend from claims 1 and 15, respectively,
recite the following same components in the same amounts as recited in
claims 1 and 15. However, in contrast to claims 1 and 15, claims 2 and 16
recite that the composition comprises each of:
L-lysine in a range of 400–5,000 mg; L-arginine in a range of
1,000–9,000 mg; vitamin C in a range of 500–10,000 mg; N-
acetyl L-carnitine in a range of 250–3,000 mg; betaine HCl in a
range of 300–20,000 mg; L-glutamate in a range of 200–2,000
mg; turmeric in a range of 200–1,500 mg; proanthocyanidins in
a range of 100–1,000 mg; nigella sativa in a range of 50–400
mg; pantothenic acid in a range of 20–10,000 mg; benfotiamine
in a range of 50–400 mg; magnesium in a range of 50–800 mg;
vitamin E in a range of 50–1,000 IU; cynara scolymus in a
range of 25–300 mg; L-glycine in a range of 50–3000 mg;
vitamin B1 in a range of 10–200 mg; vitamin B2 in a range of
10–200 mg; ubiquinol in a range of 30–1,000 mg; piper cubeba
in a range of 10–100 mg; artemisia absinthium in a range of
10–100 mg; vitamin B3 in a range of 45–3,000 mg; vitamin B6
in a range of 10–200 mg; zinc in a range of 5–50 mg; vitamin
D3 in a range of 400–10,000 IU; folate in a range of 200–3,000
mcg; vitamin B12 in a range of 200–3,000 mcg; selenium in a
range of 100–600 mcg; and biotin in a range of 50–2,000 mcg.
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Appeal Br., Claims Appendix.
The Examiner maintains the following grounds of rejection on
appeal:2
(1) claims 1, 3, 6, 11–15, and 19 under 35 U.S.C. § 103 as
unpatentable over Liu3 in view of Mazzio,4 PhosChol,5 Challem,6 Thorton,7
CT,8 and Gervais,9 as evidenced by Xing;10

2 The prior art cited in the rejections on appeal is identified below and on
pages 2, 12–14, 24, 26, and 27 of the Final Office Action dated February 20,
2020 (“Final Act.”).
3 Chenghai Liu et al., Effect of Fuzheng Huayu formula and its actions
against liver fibrosis, Chinese Medicine, June 29, 2009,
http://www.cmjournal.org/content/4/1/12 (“Liu”).
4 US 2008/0292607 A1, to Elizabeth Mazzio et al., published November 27,
2008 (“Mazzio”).
5 PhosChol® Put the body on offense,
http://web.archive.org/web/20050308185800/http://www.phoschol.com/abo
ut_phoschol (last visited Nov. 17, 2016) (“PhosChol”).
6 Jack Challem, NAC the Super Nutrient, Jan. 1, 2014,
https://www.betternutrition.com/features-dept/nac-super-nutrient
(“Challem”).
7 Natural Health 365, Alpha lipoic acid reverses liver failure,
http://www.naturalhealth365.com/ala_liver.htm (last visited Nov. 17, 2016)
(“Thornton”).
8 Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C
Patients with Hepatic Fibrosis,
https://clinicaltrials.gov/ct2/show/NCT00854087 (last visited Sept. 12,
2019) (“CT”).
9 US 2005/0031651 A1, to Francine Gervais et al., published February 10,
2005 (“Gervais”).
10 Xinrui Xing et al., The Active Components of Fuzheng Huayu Formula
and Their Potential Mechanism of Action in Inhibiting the Hepatic Stellate
Cells Viability – A Network Pharmacology and Transcriptomics Approach,
Front. Pharmacol., May 24, 2018, https://doi.org/10.3389/fphar.2018.00525
(“Xing”).
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(2) claims 2, 13, and 16 under 35 U.S.C. § 103 as unpatentable
over Liu in view of Mazzio, PhosChol, Challem, Thorton, CT, and Gervais,
as evidenced by Xing, and further in view of WHF B1,11 WHF B2,12 Web
MD,13 WHF B5,14 WHF B6,15 WHF C,16 WHF D,17 WHF E,18

11 The world’s healthiest foods, thiamin-B1, May 2, 2013,
https://web.archive.org/web/20130502120633/http://whfoods.org/genpage/p
hp?tname=nutrient&dbid=100 (“WHF B1”).
12 The world’s healthiest foods, riboflavin-B2, May 2, 2013,
https://web.archive.org/web/21030502104209/http://whfoods.org/genpage/p
hp?tname=nutrient&dbid=93 (“WHF B2”).
13 Web MD, Niacin and Niacinamide (Vitamin B3),
https://www.webmd.com/vitamins/ai/ingredientmono-924/niacin-and-
niacinamide-vitamin-b3 (last visited Nov. 15, 2018) (“Web MD”).
14 The world’s healthiest foods, pantothenic acid-B5, May 2, 2013,
https://web.archive.org/web/20130502122556/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=87 (last visited Nov. 15, 2018) (“WHF B5”).
15 The world’s healthiest foods, vitamin B6, May 2, 2013,
https://web.archive.org/web/20130502121854/http://whfoods.org.genpage.p
hp?tname=nutrient&dbid=108 (last visited Nov. 15, 2018) (“WHF B6”).
16 The world’s healthiest foods, vitamin C, May 2, 2013,
https://web.archive.org/web/20130502111043/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=109 (last visited Nov. 15, 2018) (“WHF C”).
17 The world’s healthiest foods, vitamin D, May 2, 2013,
https://web.archive.org/web/20130502113257/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=110 (last visited Nov. 15, 2018) (“WHF D”).
18 The world’s healthiest foods, vitamin E, June 18, 2013,
https://web.archive.org/web/20130618125302/http://whfoods.com/genpage.
php?tname=nutrient&dbid=111 (last visited Mar. 3, 2017) (“WHF E”).
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WHF Magnesium,19 WHF zinc,20 WHF selenium,21 WHF folate,22 WHF
Biotin,23 Swanson 2,24 Pure Formulas,25 Marshall,26 Cleveland Clinic:

19 The world’s healthiest foods, magnesium, Oct. 31, 2013,
https://web.archive.org/web/20131031235307/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=75 (last visited Nov. 15, 2018) (“WHF
Magnesium”).
20 The world’s healthiest foods, zinc, May 2, 2013,
https://web.archive.org/web/20130502125902/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=115 (last visited Nov. 15, 2018) (“WHF zinc”).
21 The world’s healthiest foods, selenium, May 2, 2013,
https://web.archive.org/web/20130502120638/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=95 (last visited Nov. 15, 2018) (“WHF
selenium”).
22 The world’s healthiest foods, folate, May 2, 2013,
https://web.archive.org/web/20130502115827/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=63 (last visited Nov. 15, 2018) (“WHF folate”).
23 The world’s healthiest foods, biotin, May 2, 2013,
https://web.archive.org/web/20130502124938/http://whfoods.org/genpage.p
hp?tname=nutrient&dbid=42 (last visited Nov. 15, 2018) (“WHF Biotin”).
24 Swanson Health Products, turmeric,
http:web.archive.org/web/20120916005308/http://www.swansonvitamins.co
m/swanson-premium-turmeric-720-mg-240-caps (last visited Nov. 16, 2018)
(“Swanson 2”).
25 N-Acetyl-L-Carnitine,
http://web.archive.org/web/20130116114821/http://pureformulas.com/nacet
yllcarnitine-500-mg-90-capsules-by-montiff.html (last visited Nov. 16,
2018) (“Pure Formulas”).
26 US 6,461,634 B1, to Edward Marshall, issued October 8, 2002
(“Marshall”).
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Ubiquinol,27 Cleveland Clinic: Grape Seed Extract,28 DiMateeo-Leggio,29
Swanson,30 Whitaker,31 Bombardelli,32 Genestra,33 Ayushveda,34 Natural
Remedies,35 IFIC,36 BLT,37 and BM101;38

27 Cleveland Clinic Wellness, CoQ10 Pro Con, Feb. 9, 2013,
http://web.archive.org/web/20130209231445/http://www.clevelandclinicwel
lness.com/Features/Pages/CoQ10.aspx (last visited Nov. 16, 2018)
(“Cleveland Clinic: Ubiquinol”).
28 Cleveland Clinic Wellness, Grape Seed Extract Pro Con, Feb. 9, 2013,
http://web.archive.org/web/20130209213821/http://www.clevelandclinicwel
lness.com/Features/Pages/Grape-Seed-Extract.aspx (last visited Nov. 16,
2018) (“Cleveland Clinic: Grape Seed Extract”).
29 US 2005/0260285 A1, to Giovina DiMateeo-Leggio, published November
24, 2005 (“DiMateeo-Leggio”).
30 Swanson Health Products, Full Spectrum Black Cumin Seed,
http://web.archive.org/web/20121108024119/http://www.swansonvitamins.c
om/swanson-premium-full-spectrum-black-cumin-seed-400-mg-60-caps
(last visited Mar. 7, 2017) (“Swanson”).
31 Whitaker Wellness, Top Three Mistakes in Diabetes Treatment,
http://whitakerwellness.com/2014/08/top-three-mistakes-diabetes-treatment
(last visited Nov. 16, 2018) (“Whitaker”).
32 US 7,887,854 B2, to Ezio Bombardelli et al., issued February 15, 2011
(“Bombardelli”).
33 Genestra Brands Herbal Supplement, https://www.amazon.com/Genestra-
Brands-Dandelion-Calendula-
Supplement/dp/B004BPFZRI#customerReviews (last visited Mar. 8, 2017)
(“Genestra”).
34 Ayushveda.com, Piper cubeba,
http://web.archive.org/web/20080503194528/http://www.ayushveda.com/he
rbs/piper-cubeba.htm (last visited Nov. 16, 2018) (“Ayushveda”).
35 Natural Remedies, Wormwood,
http://web.archive.org/web/20110506160309/http://www.naturalremedies.or
g/wormwood (last visited Nov. 16, 2018) (“Natural Remedies”).
36 IFIC Review, Glutamate and Monosodium Glutamate: Examining the
Myths, Feb. 6, 2011,
https://web.archive.org/web/20110206180122/https://www.foodinsight.org/
Content/76/Gultamate-and-Monosodium-Glutamate.pdf (“IFIC”).
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(3) claims 4, 8–10, 17, 18, and 20 under 35 U.S.C. § 103 as
unpatentable over Liu in view of Mazzio, PhosChol, Challem, Thorton, CT,
and Gervais, as evidenced by Xing, and further in view of Lehmann;39
(4) claim 5 under 35 U.S.C. § 103 as unpatentable over Liu in view
of Mazzio, PhosChol, Challem, Thorton, CT, and Gervais, as evidenced by
Xing, and further in view of Mato;40 and
(5) claim 7 under 35 U.S.C. § 103 as unpatentable over Liu in view
of Mazzio, PhosChol, Challem, Thorton, CT, and Gervais, as evidenced by
Xing, and further in view of Byrne.41
B. DISCUSSION
The Examiner finds Liu discloses administering Fuzheng Huayu
(FZHY) formula to a patient to reverse liver fibrosis.42 Final Act. 3. The
Examiner relies on Xing as evidence of the components of the herbs in

37 British Liver Trust, Pioneering Liver Health, Jan. 12, 2014,
https://web.archive.org/web/20140112222642/https://www.britishlivertrust.o
rg.uk/liver-information/diet-and-liver-disease (“BLT”).
38 Building-Muscle 101, How to Make your Own Supplements, Nov. 22,
2011, http://web.archive.org/web/20111122001329/http://www.building-
muscle101.com/how-to-make-your-own-supplements.html (last visited Nov.
11, 2016) (“BM101”).
39 Rainer Lehmann et al., Circulating Lysophosphatidylcholines Are
Markers of a Metabolically Benign Nonalcoholic Fatty Liver, 36 Diabetes
Care 2331–38 (2013) (“Lehmann”).
40 José Mato et al., S-adenosylmethionine metabolism and liver disease,
https://www.ncbi.nlm/nih.gov/pmc/articles/PMC4027041 (last visited Nov.
16, 2018) (“Mato”).
41 US 6,797,729 B1, to Theresa Byrne et al., issued September 28, 2004
(“Byrne”).
42 Liu discloses that “[l]iver fibrosis is a common histological process to
develop into cirrhosis in various chronic liver diseases including chronic
hepatitis and fatty liver.” Liu, Abstract.
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Fuzheng Huayu formula. Final Act. 3; Ans. 4343 (explaining that Xing is
merely cited as evidence of the ingredients of FZHY formula). In particular,
the Examiner finds Xing discloses that vitamin B12 is a component of C.
Sinensis, which is said to be an herb in Fuzheng Huayu formula. Final Act.
3; Appeal Br. 16 (contending that “Table 1 of Xing shows that vitamin B12 is
present in the FZHY herb Fructus Schisandrae Chinensis”). Thus, the
Examiner relies on Xing to establish that administering Fuzheng Huayu
formula to a patient to reverse liver fibrosis, as disclosed in Liu, inherently
includes the administration of vitamin B12.44 See Ans. 47 (finding that Liu
administers FZHY formula as a whole and thus all of the nutrients in FZHY
formula are administered for the reversal of liver fibrosis); see also
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999) (“Inherency is not necessarily coterminous with the knowledge of
those of ordinary skill in the art. Artisans of ordinary skill may not
recognize the inherent characteristics or functioning of the prior art.”).
The Examiner finds that Liu, as evidenced by Xing, does not disclose
the amount of vitamin B12 in Fuzheng Huayu formula.45 Final Act. 4.
Therefore, the Examiner turns to Mazzio. Mazzio discloses a nutritional
composition for preventing Parkinson’s disease. Mazzio ¶ 3; see also

43 Examiner’s Answer dated May 12, 2020.
44 The Examiner also relies on Xing to show that Fuzheng Huayu formula
includes magnesium. Final Act. 4. In the rejection of claims 1 and 15,
however, the Examiner does not find that Fuzheng Huayu formula includes
magnesium in an amount within the claimed range, i.e., 50 to 800 mg.
45 The Examiner also finds that Liu, as evidenced by Xing, does not disclose
the claimed amount of betaine HCl. Final Act. 4. In the rejection of claims
1 and 15, however, the Examiner does not find that Fuzheng Huayu formula
includes betaine HCl.
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Appeal Br. 17. The Examiner finds Mazzio discloses administering vitamin
B12 to a patient in an amount that encompasses the claimed range. Final
Act. 4; Mazzio Table 1 (disclosing that Mazzio’s nutritional composition
includes 0 to 350 µg of vitamin B12).
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art
to modify the method of making nutritional compositions with
vitamin B12 for administration, as Liu, to include 200– 3,000
mcg of vitamin B12, as claimed, because Mazzio illustrates that
the art finds an encompassing range as being suitable for
similar intended uses, including methods of making nutritional
compositions with vitamin B12 for administration, which
shows that it was known that such a thing was known to have
been done. See MPEP 2144.07.
Final Act. 4 (emphasis added).
The Appellant argues that
Mazzio does not teach or suggest that the neurodegenerative
diseases for which its nutraceutical is formulated have any
relation to liver disease, nor is there any indication in any of the
cited references that the physiological conditions Mazzio seeks
to modulate with B12 are of concern in liver disease patients.
Appeal Br. 17. Therefore, the Appellant argues that “[o]ne of skill in the art,
upon review of Liu and Mazzio, as evidenced by Xing, would not . . . have
been motivated to modify the amount of B12 in the FZHY composition of
Liu.” Appeal Br. 17.
The Appellant’s argument is supported by the record. In that regard,
the Examiner does not direct us to any evidence establishing a correlation
between the use of vitamin B12 in the treatment of neurodegenerative
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diseases, such as Parkinson’s disease, and the use of vitamin B12 in the
treatment of liver fibrosis as disclosed in Liu.
Additionally, the evidence of record establishes that Xing is not prior
art. See Reply Br. 646 (contending that the claims on appeal have a priority
date of April 16, 2015, and Xing was published in May 2018); see also
Appeal Br. 8 (contending that Xing is not available as prior art). Therefore,
the Examiner has failed to establish that Liu’s Fuzheng Huayu formula was
known to include vitamin B12 at the time of the Appellant’s invention. For
that reason, there would have been no reason to modify the amount of
vitamin B12 in Liu’s Fuzheng Huayu formula absent the Appellant’s
disclosure. See Reply Br. 7 (arguing there is no evidence of record that one
of skill in the art would have known what compounds were present in each
herb of FZHY; thus one of ordinary skill in the art would not have been
motivated to modify particular compounds found in any of the FZHY herbs
based on the record evidence).
The Examiner’s reliance on the remaining prior art of record does not
cure the deficiency identified above in the obviousness rejection of claims 1
and 15. In that regard, the Examiner finds that each of the following
components recited in claims 1 and 15 (as well as dependent claims 2 and
16) was known to be used as a nutritional supplement at the time of the
Appellant’s invention:
L-lysine in a range of 400–5,000 mg; L-arginine in a range of
1,000–9,000 mg; vitamin C in a range of 500–10,000 mg; N-
acetyl L-carnitine in a range of 250–3,000 mg; betaine HCl in a
range of 300–20,000 mg; L-glutamate in a range of 200–2,000
mg; turmeric in a range of 200–1,500 mg; proanthocyanidins in

46 Reply Brief dated June 30, 2020.
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a range of 100–1,000 mg; nigella sativa in a range of 50–400
mg; pantothenic acid in a range of 20–10,000 mg; benfotiamine
in a range of 50–400 mg; magnesium in a range of 50–800 mg;
vitamin E in a range of 50–1,000 IU; cynara scolymus in a
range of 25–300 mg; L-glycine in a range of 50–3000 mg;
vitamin B1 in a range of 10–200 mg; vitamin B2 in a range of
10–200 mg; ubiquinol in a range of 30–1,000 mg; piper cubeba
in a range of 10–100 mg; artemisia absinthium in a range of
10–100 mg; vitamin B3 in a range of 45–3,000 mg; vitamin B6
in a range of 10–200 mg; zinc in a range of 5–50 mg; vitamin
D3 in a range of 400–10,000 IU; folate in a range of 200–3,000
mcg; vitamin B12 in a range of 200–3,000 mcg; selenium in a
range of 100–600 mcg; and biotin in a range of 50–2,000 mcg.
Appeal Br., Claims Appendix; see Final Act. 14–21 (finding that WHF B1,
WHF B2, Web MD, WHF B5, WHF B6, WHF C, WHF D, WHF E, WHF
Magnesium, WHF zinc, WHF selenium, WHF folate, WHF Biotin, Swanson
2, Pure Formulas, Marshall, Cleveland Clinic: Ubiquinol, Cleveland Clinic:
Grape Seed Extract, DiMateeo-Leggio, Swanson, Whitaker, Bombardelli,
Genestra, Ayushveda, Natural Remedies, and IFIC each disclose a
component recited in dependent claims 2 and 16).
The Examiner finds “BLT teaches that good nutrition will help
support liver function.” Final Act. 23. Therefore, the Examiner concludes
that it would have been obvious to one of ordinary skill in the art to “modify
the method of making nutritional supplements, as the modified teaching of
Liu” to include the components identified above to help support liver
function. Final Act. 23 (emphasis added).
Significantly, the Examiner does not find that Liu generally discloses
a method of making nutritional supplements but rather finds that Liu
discloses a method of making compositions “for the reversal of live [sic,
liver] fibrosis.” Final Act. 3. On this record, the Examiner does not explain,
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in any detail, why one of ordinary skill in the art would have used any of the
components identified above in the claimed amounts to treat liver fibrosis as
disclosed in Liu. The Examiner finds that each of the components identified
above has various benefits in certain amounts. However, the Examiner has
failed to establish that one of ordinary skill in the art would have understood
that those benefits have any relationship to treating liver fibrosis as disclosed
in Liu. See Appeal Br. 21 (arguing that “[n]one of the cited references [in
the obviousness rejection of claims 2, 13, and 16] teach or suggest that the
compounds recited therein are beneficial to the treatment of liver disease”).
To illustrate, BLT discloses that “[g]ood nutrition can help to support
your liver to function.” BLT (emphasis added); see also Appeal Br. 23
(arguing that BLT “does not teach or suggest that supplements are useful in
the treatment of liver disease” (emphasis added)). However, BLT discloses
that “[i]f you have a liver condition, there are some special considerations
you may need to make in your diet to stay nutritionally well and to help to
manage your condition. Some of these are specific to certain liver diseases,
others relate to how advanced your liver disease is.” BLT (emphasis added).
The Examiner does not direct us to any evidence identifying the “special
considerations” needed in the diet of a patient who has liver fibrosis.
Based on the foregoing, we find the Examiner has failed to establish
that one of ordinary skill in the art would have modified Liu’s Fuzheng
Huayu formula to include any of the components identified above in an
amount within the claimed range to treat liver fibrosis.
Claims 1 and 15 also recite that the composition comprises 500–5,000
mg N-acetyl cysteine, 500–10,000 mg polyenylphosphatidylcholine, and
200–2,500 mg alpha lipoic acid. Appeal Br., Claims Appendix. The
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Examiner finds that Challem, PhosChol, and Thorton, respectively, disclose
each of those components in amounts that “encompass” the claimed ranges.
Final Act. 5–6. Challem, PhosChol, and Thorton, however, do not disclose
that N-acetyl cysteine, polyenylphosphatidylcholine, and alpha lipoic acid,
respectively, are used in amounts within the claimed ranges to treat liver
fibrosis as disclosed in Liu.
More specifically, Challem discloses that N-acetyl cysteine helps heal
liver damage caused by acetaminophen but does not disclose the amount of
N-acetyl cysteine necessary to promote such healing. PhosChol discloses
that polyenylphosphatidylcholine (PPC) protects hepatocytes. “PhosChol”
is said to be a dietary supplement that delivers “900 mg of purified PPC per
softgel capsule, and 3 grams of purified PPC per measured teaspoon of
liquid concentrate” (emphasis added). PhosChol, however, does not
disclose the dosage necessary to protect hepatocytes in a patient with liver
fibrosis. Finally, Thorton discloses that alpha lipoic acid reverses liver
damage but only discloses a dosage of 200–300 mg or more to treat diabetic
neuropathy.
In sum, we find the Examiner has failed to show, in the first instance,
that the method recited in claims 1–20 would have been obvious to one of
ordinary skill in the art based on the prior art of record. See In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992) (examiner bears the initial burden of
presenting a prima facie case of unpatentability). For that reason, the
obviousness rejections on appeal are not sustained.
C. CONCLUSION
The Examiner’s decision is reversed.
In summary:
Appeal 2020-005243
Application 15/681,529

15

Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 6, 11–
15, 19
103 Liu, Mazzio,
PhosChol,
Challem, Thorton,
CT, Gervais, Xing
1, 3, 6, 11–
15, 19
2, 13, 16 103 Liu, Mazzio,
PhosChol,
Challem, Thorton,
CT, and Gervais,
Xing, WHF B1,
WHF B2, Web
MD, WHF B5,
WHF B6, WHF C,
WHF D, WHF E,
WHF Magnesium,
WHF zinc, WHF
selenium, WHF
folate, WHF
Biotin, Swanson 2,
Pure Formulas,
Marshall,
Cleveland Clinic:
Ubiquinol,
Cleveland Clinic:
Grape Seed
Extract, DiMateeo-
Leggio, Swanson,
Whitaker,
Bombardelli,
Genestra,
Ayushveda,
Natural Remedies,
IFIC, BLT,
BM101
2, 13, 16
4, 8–10, 17,
18, 20
103 Liu, Mazzio,
PhosChol,
4, 8–10, 17,
18, 20
Appeal 2020-005243
Application 15/681,529

16

Challem, Thorton,
CT, Gervais, Xing,
Lehmann
5 103 Liu, Mazzio,
PhosChol,
Challem, Thorton,
CT, Gervais, Xing,
Mato
5
7 103 Liu, Mazzio,
PhosChol,
Challem, Thorton,
CT, Gervais, Xing,
Byrne
7
Overall
Outcome
1–20

REVERSED