ALTERA INTERNATIONAL, LTD.

Patent Trials and Appeals Board

Sep 14, 2021

2021000503 (P.T.A.B. Sep. 14, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/897,794 12/11/2015 Jay A. Altman 074408-509235 6179
27148 7590 09/14/2021
POLSINELLI PC
PO Box 140310
KANSAS CITY, MO 64114-0310
EXAMINER
CONIGLIO, AUDREA JUNE BUCKLEY
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
09/14/2021 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):
patentdocketing@polsinelli.com
rendsley@polsinelli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAY A. ALTMAN
Appeal 2021-000503
Application 14/897,794
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims directed to a method for reducing
chronic respiratory disease in an equid as being indefinite and as being
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM the indefiniteness rejection but REVERSE the
obviousness rejection.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Altera
International, LTD. (Appeal Br. 1.)
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Application 14/897,794

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STATEMENT OF THE CASE
Appellant’s Specification indicates that “[c]hronic lower airway
inflammatory diseases commonly occur in horses.” (Spec. ¶ 6.) When
horses are afflicted with such disease they need long term or even lifelong
management. (Id. ¶ 7.) Appellant’s Specification indicates that “there is a
need in the art for methods of ameliorating chronic lower airway
inflammatory disease.” (Id.) Appellant’s invention is directed to such a
method. (Id. ¶ 50.)
Claims 11, 12, 14, 17, and 18, are on appeal. Claim 11, reproduced
below, is illustrative of the claimed subject matter:
11. A method for reducing chronic respiratory disease in an
equid, the method comprising administering 2-4g per 110 lbs
body weight for at least two weeks of a composition, wherein the
composition comprises an all-vegetarian, fish oil-free source of
DHA, methylsulfonylmethane (MSM), and between about 1000
and about 3000 mg per 30 g dose of a combination of Pleurotus
eryngii mushrooms, Cordyceps militaris mushrooms, and
Ganoderma lucidum mushrooms, wherein a portion of
neutrophils in the lung mucus of the equid is reduced relative to
the lung mucus of the equid prior to administration of the
composition.
(Appeal Br. iii–iv (“V. CLAIMS APPENDIX”).)

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The prior art relied upon by the Examiner is:
Name Reference Date
Chevis WO 2004/032918 A1 Apr. 22, 2004
Perrin et al. US 8,545896 B2 Oct. 1, 2013
Kim US 2009/0304827 A1 Dec. 10,
2009
Kevin G. Keegan et al.2 Effects of an Oral Nutraceutical
on Clinical
Aspects of Joint Disease in a
Blinded, Controlled
Clinical Trial: 39 Horses, 53
AAEP Proceedings, 252–55
2007
Nair US 2001/0206721 Aug. 25,
2011
Stamets US 2006/0171958 A1 Aug. 3, 2006
Ra WO 2007/126221 A1 Nov. 8, 2007
Lowell Observations on heaves. An
asthma-like syndrome in the
horse, 35 (4) J. Allergy, 322–30
1984

The following grounds of rejection by the Examiner are before us on
review:
Claims 11, 12, 14, 17, and 18 under 35 U.S.C. § 112(b) as being
indefinite.
Claims 11, 14, 17, and 18 under 35 U.S.C. § 103 as unpatentable over
Chevis, Perrin, Kim, Downer, Nair, Stamets, and Ra.
Claim 12 under 35 U.S.C. § 103 as unpatentable over Chevis, Perrin,
Kim, Downer, Nair, Stamets, Ra, and Lowell.

2 The Examiner refers to this reference by the last named author, Judy
Downer, rather than the first named author. We do the same to avoid
confusion.
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DISCUSSION
INDEFINITENESS
The Examiner rejected claims 11, 12, 14, 17, and 18 as being
indefinite because there is insufficient antecedent basis in claim 11 for the
limitation “a portion of neutrophils in the lung mucus . . . relative to the
lung mucus.” (Final Rejection 3.) In addition, the Examiner stated:
It has not been stated what portion or neutrophils are under
consideration in what lung mucus is being considered? What is
the "portion" being claimed, and what "lung mucus" is
considered a standard or control? Appropriate clarification is
required.
(Id.) Appellant did not respond to this rejection.
We agree in part with the Examiner’s rejection. In particular, we
agree that there is insufficient antecedent basis for “the lung mucus” in the
phrase “a portion of neutrophils in the lung mucus.” However, we do not
otherwise find the phrase the Examiner points to gives rise to uncertainty.
We conclude that the claim limitation can be met where any portion of
neutrophils in lung mucus of the equid administered the claimed
composition is reduced as compared to the lung mucus of the equid prior to
being administered the composition. Breadth does not equate to
indefiniteness. In re Miller, 441 F.2d 689, 693 (CCPA 1971).

OBVIOUSNESS
In finding the method of claim 11 obvious, the Examiner relied on
Chevis for its teaching of treating inflammation of the respiratory tract in a
mammal through the administration of tuna fish oil, which oil has at least
one omega-3 polyunsaturated fatty acid, e.g., docosahexanoic acid. (Final
Action 4.) The Examiner relied on Kim for its teachings of using anti-
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inflammatory compositions of fish oil with edible mushrooms and other
beta-glucan sources to treat “undesired respiratory and other inflammatory
conditions in mammals.” (Id. at 6.) The Examiner relied on Downer for its
teaching of treating osteoarthritis in horses using the product “Myristol,”
which includes methylsulfonylmethane, glucosamine, hydrolyzed collagen,
and cetyl myristoleate. (Id. at 7.) The Examiner found that from the
foregoing, it would have been obvious to one of ordinary skill in the art “to
add edible mushroom and other beta-glucan sources, a mushroom blend as
taught by Kim” (id. at 6) and “to add methylsulfonylmethane as taught by
Downer” (id. at 7) to the composition of Chevis with a reasonable
expectation of success because “Chevis, Kim, and Downer are directed to
anti-inflammatory compositions and methods including orally administered
formulations” (id). The Examiner further explained that one of ordinary
skill in the art would have been motivated to do so (1) because Kim teaches
“dried powder of edible mushrooms and other beta-glucan sources and fish
oil may be used in various combinations against inflammation disorders (see
[0095])” (id. at 6) and (2) “to reduce known inflammatory and/or
osteoarthritis conditions in horses based on Downer’s teaching” (id. at 7).
The Examiner relied on Perrin for teaching that algae oil and fish oil
are equivalently useful sources of DHA in nutritional supplements (id. at 5)
and thus it would have been obvious to substitute algae oil DHA for Chevis’
tuna oil DHA (id. at 6).
The Examiner relied on Nair, Stamets, and Ra to find that the claimed
mushroom species would have been obvious to use together in the
composition of Chevis as modified by Kim and Downer. (Final Action 7–
9.) In particular, the Examiner found that Nair teaches the use of various
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known medicinal mushrooms, including Ganoderma lucidum, in dietary
formulations and in ranges of from 100 mg to 15000 mg (id. at 7–8), and
that mushrooms are generally “included in dietary supplements for various
purposes including inhibition of cancer, lowering lipids in serum, enhancing
immunity to disease, inhibiting the aging processes, and preventing
diseases.” (Ans. 4). The Examiner found that Stamets teaches Ganoderma
lucidum and Plurotus eryngii “to be desirably included in mushroom blends
giving desired benefits not limited to known antiviral and additional known
nutraceutical benefits” (Final Action 8), whether as mycelium, extracts or
derivatives (Ans. 3). The Examiner found that “Ra teaches anti-
inflammatory drugs desirably further including Cordyceps Militaris extract
(see abstract; page 9, line 8 and lines 12-15 in particular) for its known
‘health functional food’ effects having anti-inflammatory benefits (page 12,
lines 1-12).” (Final Action 8.) The Examiner stated: “[i]n other words,
Stamets and Ra provide teachings of particular mushroom components
which may be used in combination in place of Kim and Nair’s generally
disclosed mushroom component.” (Id. at 9.) According to the Examiner,
it would have been prima facie obvious and one reasonably
would have expected success from selecting the aforementioned
mushrooms or mushroom components in particular for inclusion
in a single benefit composition, with each reference above
providing a specific rationale associated with each specific
mushroom (i.e., anti-inflammatory benefit, anti-viral benefit,
anti-cancer, anti-aging, anti-disease benefit).
(Ans. 4.)
In summary the Examiner’s position of obviousness is
that it would have been obvious to combine Chevis and Perrin
where both are directed to nutritional supplements including
DHA; it is maintained that it would have been obvious to
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combine Chevis and Kim where both are directed to anti-
inflammatory compositions and methods for treating undesired
respiratory and other inflammatory conditions in mammals. It is
maintained that it would have been obvious to combine Downer's
MSM in an oral formulation for treating inflammatory conditions
with the products and methods of Chevis and Kim. It is
maintained that it would have been obvious to combine Kim and
Nair and Ra where these are directed to the use of mushroom
components in anti-inflammatory nutritional or dietary
formulations, and further that one would have been motivated to
do so based on Ra and Stamets' teaching of benefits of
mushrooms.
(Ans. 5.)
The Examiner also found that the neutrophil limitation would have
necessarily resulted when the composition of Chevis as modified by Kim,
Downer, Perrin, Nair, Stamets and Ra was administered to equids “since the
results of a method cannot be separated from performance of the method.”
(Final Action 9.)
We do not agree with the Examiner’s conclusion of obviousness.
Appellant’s claim is directed a method of treatment by applying a particular
composition. The rejection must establish a reason to combine all of the
claimed ingredients of the composition and to administer that composition to
equids with a reasonable expectation of treating chronic respiratory disease.
We conclude that the Examiner has not set forth a persuasive reason that one
of ordinary skill in the art would have found it obvious to include MSM in
the composition of Chevis. Downer teaches that Myristol, which includes
MSM, is a nutraceutical that can alleviate clinical signs of osteoarthritis in
horses. (See, e.g., Downer abstr.) The Examiner has not provided any
evidence that a horse that is suffering from inflammation of the lower
respiratory tract or the gastrointestinal tract would also likely be suffering
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from osteoarthritis. Thus, there is insufficient evidence in the cited
references to support inclusion of Myristol, much less MSM itself in the
composition of Chevis for use in treating a horse with inflammation of the
lower respiratory tract or gastrointestinal tract.
Furthermore, we conclude, for similar reasons, that the Examiner has
not set forth a persuasive reason that one of ordinary skill in the art would
have found it obvious to include the three specific mushroom types set forth
in Appellant’s claim 11 in the composition of Chevis as modified by Kim. It
is true that Kim generally suggests that mushrooms which include beta
glucan can be combined with fish oil which has omega-3 fatty acids such as
DHA in a composition to treat inflammation-associated disorders. (Kim
¶¶ 45, 46, 73, 74, 95.) However, the Examiner has not provided sufficient
evidence to establish that one of ordinary skill in the art would have selected
the three specific mushrooms claimed for use in the composition to treat a
horse that is suffering from inflammation of the lower respiratory tract or the
gastrointestinal tract, because the Examiner has not established that such a
horse would also likely be suffering from a proliferation of cancer cells,
hypertension or peroxidized lipid, or a virus.
Nair teaches that “the polysaccharide protein complex included in
Ganoderma lucidum extract exhibits the inhibition of the proliferation of
cancer cells, treatment of essential hypertension, inhibition of the formation
of peroxidized lipid, etc.” (Nair ¶ 19.) Stamets teaches Ganoderma lucidum
and Pleurotus eryngii mushrooms, among others, may be added to “[t]he
mycelium, extracts and derivatives of Fomitopsis officinalis, Piptoporus
betulinus and/or Ganoderma resinaceum.” (Stamets ¶ 45.) And Stamets
teaches that the Fomitopsis, Piptoporus and Ganoderma resinaceum have
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antiviral activity. (Id. ¶ 37.) Stamets also states that “[t]he invention
includes the combination of products from multiple mushroom species in a
form to have the accumulated effect of restricting the growth, spread and
survivability of viruses in animals.” (Id. ¶ 47.) It further states that “[s]uch
forms may have the additional advantages of functioning as antibacterials,
antiprotozoals, immunomodulators, nutraceuticals and/or probiotics as well
as enhancing innate immunity defense mechanisms and host immune
response.” (Stamets ¶ 47.) However, the foregoing does not indicate that
Ganoderma lucidum and Pleurotus eryngii mushrooms are known to treat
inflammation or that mammals suffering from inflammation of the lower
respiratory tract or the gastrointestinal tract also have a viral infection, or a
bacterial or protozoal infection. On the other hand, even if one were to
consider that it would have been obvious to add Ganoderma lucidum and
Pleurotus eryngii to the composition of Chevis as a general nutraceutical or
probiotic or to enhance innate immunity defense mechanisms or host
immune response as Stamets suggest certain forms of multiple mushroom
species may function as,3 one must still find from the prior art, a reason to
also include Cordyceps Militaris.
Ra does not teach Cordyceps Militaris is known to treat inflammation
or indicate any other benefit that is derived from the ingestion of Cordyceps
Militaris. Ra teaches that Oldenlandia diffusa extract which includes ursolic
acid and oleanolic acid “shows anti-inflammatory and analgesic effects.”
(Ra 7, 8.) Ra further teaches that such an extract composition can also

3 In such a composition, according to Chevis, the DHA and EPA would
treat the inflammation of the respiratory tract or gastrointestinal tract of the
mammal.
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include an herbal extract of Cordyceps Militaris, among other mushrooms.
(Id. at 9.) However, Ra does not indicate that any of the listed herbal extract
components much less Cordyceps Militaris were known to have anti-
inflammatory properties. Thus, we conclude that there is insufficient
evidence in the cited references to support inclusion of Cordyceps Militaris
in the composition of Chevis as modified by Kim and Stamets for use in
treating a horse with inflammation of the lower respiratory tract or
gastrointestinal tract.
Moreover, the Examiner has not provided sufficient evidence that it
would have been obvious to include the combination of Ganoderma
lucidum, Pleurotus eryngii, and Cordyceps Militaris in an amount of about
1000 to 3000 mg per 30 g dose. The Examiner notes that Nair teaches a 20
gram powder total dosage and teaches embodiments of mushroom ranging
from 100 mg to 150000 mg. (Final Action 8.) The Examiner then scales
those teachings to a 30 gram dosage. (Id.) Even assuming such calculations
were correct, Nair does not teach or suggest the combination of mushrooms
claimed. Moreover, because we conclude that Nair does not provide a
reason to include Ganoderma lucidum in the composition of Chevis, the
teachings regarding that amount of mushroom to be included in the Nair
composition does not provide one of ordinary skill in the art with a reason to
include such an amount of even Ganoderma lucidum in the composition of
Chevis much less a combination of Ganoderma lucidum, Pleurotus eryngii,
and Cordyceps Militaris in such an amount.
Thus, for the foregoing reasons we do not affirm the Examiner’s
rejection of claims 11, 14, 17, and 18 as being obvious over Chevis, Perrin,
Kim, Downer, Nair, Stamets, and Ra.
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The Examiner’s rejection of claim 12 incorporating the teachings of
Lowell does not cure the defects noted above. Thus, we also do not affirm
the Examiner’s rejection of claim 12 as being obvious over Chevis, Perrin,
Kim, Downer, Nair, Stamets, Ra, and Lowell.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
11, 12, 14,
17, 18
112 Indefiniteness 11, 12, 14,
17, 18

11, 14, 17,
18
103 Chevis, Perrin,
Kim, Downer,
Nair, Stamets, Ra
11, 14, 17,
18
12 103 Chevis, Perrin,
Kim, Downer,
Nair, Stamets, Ra,
Lowell
12
Overall
Outcome
11, 12, 14,
17, 18

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