den Hoed, Robert

Patent Trials and Appeals Board

Apr 10, 2020

15234712 - (D) (P.T.A.B. Apr. 10, 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.
15/234,712 08/11/2016 Robert den Hoed P07738US2 1647
34082 7590 04/10/2020
ZARLEY LAW FIRM P.L.C.
CAPITAL SQUARE
400 LOCUST, SUITE 200
DES MOINES, IA 50309-2350
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
04/10/2020 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):
crasmussen@zarleylaw.com
emarty@zarleylaw.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROBERT DEN HOED
__________

Appeal 2019-004985
Application 15/234,7121
Technology Center 1600
__________

Before ERIC B. GRIMES, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of making hydrolyzed marine Type I collagen, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Collagen is a natural substance that has shown “positive beneficial
results for treating degenerative diseases” and has been “found to block a
tumor’s angiogenesis.” (Spec. 1.) Appellant’s invention is concerned with a
method of making hydrolyzed Type I collagen from marine skin. (Id.)

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42.
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Claims 1–4 and 6–13 are on appeal. Claim 1 is representative and
reads as follows:
1. A method of making hydrolyzed marine Type I collagen,
comprising the steps of:
combining water, marine skin, and sodium hydroxide to form a
mixture in a tank;
mixing the tank for approximately 40 minutes;
rinsing the mixture;
adding water and sulfuric acid to the tank and mixing for
approximately 40 minutes;
draining liquid from the tank while retaining the marine skin;
adding citric acid and water to the tank and mixing for
approximately 40 minutes; and
draining the citric acid and water, and thereafter adding water
and draining the water until the pH of the mixture is between
2.8 and 3.4.
(Appeal Br. 12.)

The prior art relied upon by the Examiner is:
Name Reference Date
Grossman US 5,093,474 Mar. 3, 1992
Summers US 2013/0035473 A1 Feb. 7, 2013
P. Kittiphattanabawon et al., Characterisation of acid-soluble
collagen from skin and bone of bigeye snapper (Priacanthus
tayenus), 89 Food Chemistry 363–372 (2005) (“2005
Kittiphattanabawon”)
S. Brier et al., Purification and characterization of pepsins A1 and
A2 from the Antarctic rock cod Trematomus bernacchii, 274 FEBS
Journal, 6152–6166 (2007)
T. Potaros et al., Characteristics of Collagen from Nile Tilapia
(Oreochromis niloticus) Skin Isolated by Two Different Methods, 43
Kasetsart J. (Nat. Sci.), 584–593 (2009)
P. Kittiphattanabawon et al., Isolation and Characterisation of
collagen from the skin of brownbanded bamboo shark (Chiloscyllium
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punctatum) 119 Food Chemistry 1519–1526 (2010) (“2010
Kittiphattanabawon”)
Sietz® K Series Depth Filter Sheets, Pall Food and Beverage, (2011),
available at
W. Feng, et al. Optimization of enzyme-assisted extraction and
characterization of collagen from Chinese sturgeon (Acipenser
sturio Linnaeus) skin, 9(Suppl 1) Pharmacogn Mag., S32–S37 (2013)
G. Aguirre-Alvarez et al., The effect of drying temperature on
mechanical properties of pig skin gelatin films, 9(3), CyTA - Journal
of Food, 243–249 (2011)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 4, and 62 under 35 U.S.C. § 103(a) as unpatentable over
Grossman, Potaros, and 2005 Kittiphattanabawon.
Claims 2, 3, and 7–13 under 35 U.S.C. § 103(a) as unpatentable over
Grossman, Potaros, 2005 Kittiphattanabawon, Pall, Feng, Aguirre-Alvarez,
2010 Kittiphattanabawon, Brier, and Summers.

DISCUSSION
Regarding independent claims 1 and 4, the Examiner finds that
Grossman teaches a method of producing gelatin from fish skins that
involves soaking those skins in aqueous sodium hydroxide, washing the
soaked skins with water until a pH of about 7 is reached, then washing the
material in aqueous sulfuric acid, washing that material in water until a pH
of about 7 is reached, then soaking that processed material with aqueous

2 Appellant filed an Amendment after the final rejection, which combined
claim 5 with claim 4 and canceled claim 5, which amendment was entered
by the Examiner. (See Advisory Action dated Sept. 28, 2018.)
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citric acid solution, then washing that soaked material until a pH of about 7
is reached. (Final Action 4–5.) Next the material so treated is washed in
distilled water to remove residual salt in overnight extraction. (Id. at 5.)
Afterward the mixture is filtered, centrifuged, and then lyophilized. (Id.)
The Examiner notes that Grossman does not identify what pH is
reached with the washing in distilled water to remove residual salts after the
citric acid treatment. (Final Action 9.)
The Examiner relies on 2005 Kittiphattanabawon to conclude that the
washing step with distilled water to remove residual salts, would have been
obvious to carry out by one of ordinary skill in the art until an acidic pH
within the claimed range was reached. (Final Action 9.) In particular, the
Examiner finds that 2005 Kittiphattanabawon teaches that type I collagen
from fish skins has a high solubility at pH range from 2–5. (Id.) From this,
the Examiner concludes that one of ordinary skill in the art would have been
motivated to modify the method of Grossman to wash the residual salts from
citric-acid treated and washed material in water until a pH of from 2–5 is
reached so as to “maximize the solubility of the type I collagen” of
Grossman. (Id.)
Furthermore, the Examiner notes that “Grossman teaches the final pH
is 3.77 (col. 4, line 32), thus it is reasonable to consider the distilled water
for overnight extraction was of an acidic pH.” (Ans. 18.) And, the
Examiner determines that, in conjunction with the solubility teaching of
2005 Kittiphattanabawon, “one of ordinary skill, wanting to obtain a
collagen product, would be motivated to employ a pH range that provides
optimum solubility.” (Id.)
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The Examiner relies on Potaros for teaching that tilapia skin, the fish
skin treated in Grossman, comprises type I collagen. (Final Action 4.) The
Examiner concludes, therefore, that “Grossman’s method of producing
gelatin (hydrolyzed collagen) from fish skins necessarily produces
hydrolyzed marine Type I collagen.” (Id.)
The Examiner’s rejection of independent claim 12 relies on the same
teachings discussed above. (See Final Action 11.) The additional references
the Examiner relies on are to address additional limitations not present in
claims 1, 4, and 6.
We disagree with the Examiner’s conclusion that it would have been
obvious to modify the washing step of Grossman to remove salts to achieve
a pH within the range claimed of independent claims 1, 4, and 12.
First, we note that it appears that with respect to Grossman the
Examiner improperly treats the “final wash with distilled water to remove
any residual salts” as the same step as the overnight extraction in distilled
water controlled at a temperature within the range of 40–50 °C. In
particular, the Examiner states:
The citric acid-treated skins were washed with water until the
washings had pH about 7, and were then subjected to a final
wash with distilled water to remove any residual salts by
placing the treated skins in a vessel containing distilled water
controlled at a temperature within the range of 40°– 50° C.
(Final Action 5.) However, Grossman teaches washing in distilled water to
remove residual salts and then placing the “thus-treated skins . . . in a vessel
containing distilled water controlled at a temperature within the range of
40°–50°C” for overnight extraction. (Grossman 4:9–16.) These are two
separate steps that involve the use of distilled water.
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It is true that the pH of the final product of Grossman was determined
to be pH 3.77 (Ans. 18). However, that was the pH after the residual salts
from the citric acid treated material were washed in distilled water and also
then subjected to an overnight extraction in distilled water at a temperature
within the range of 40°–50°C, then filtered, centrifuged, and lyophilized.
(Grossman 4:9–33.) While it may be that the overnight extraction in
distilled water contributed to the final acidic pH of the product—which
product was not arrived at until after the material that was extracted in
distilled water overnight, filtered, centrifuged, and then lyophilized—the
final pH does not provide any information as to the pH resulting from the
washing of the citric acid treated material with distilled water to remove any
residual salts from the citric acid treatment, a step which occurs before
extraction in distilled water and filtering of the extracted product, which
could affect pH of the final product.
Furthermore, we disagree with the Examiner’s conclusion that 2005
Kittiphattanabawon’s determination that its extracted collagen final product
has a high solubility in a pH range from 2–5 (Final Action 9) and can be
completely solubilized in 0.5 M acetic acid (Ans. 18) would suggest to one
of ordinary skill in the art anything regarding at what pH one step during the
treatment process to extract collagen from marine skin in the first instance
should be carried out. Indeed, we agree with Appellant that the solubility of
an extracted collagen at a particular pH does not speak to what pH any
particular intermediate step in the method of making (extracting) collagen
should be carried out or was likely carried out. (Appeal Br. 5.)
Additionally, that 2005 Kittiphattanabawon “employ[s] acidic
treatment of the fish skins” and that “the obtained collagen pellet was
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solubilized in 0.5 M acetic acid” (Ans. 20) does not provide a relevant
teaching as to why one of ordinary skill in the art would have modified the
Grossman process of washing the citric acid treated material with distilled
water in a manner that this washing would be carried out to an acidic pH
within the claimed range. In particular, the 2005 Kittiphattanabawon
process does not teach using distilled water washing to achieve an acidic pH
during its process. Rather, to the extent an acidic pH is desirable and
achieved during the extraction process in 2005 Kittiphattanabawon, it is by
soaking skins that were defatted in 10% butyl alcohol in an acetic acid
solution for 24 hours after being washed with cold water. (2005
Kittiphattanabawon 364 (2.4. Preparation of collagen from skin and bone).)
Thus, we do not find that 2005 Kittiphattanabawon would have provided any
motivation to one of ordinary skill in the art regarding the pH to be achieved
when washing the citric acid treated material with distilled water to remove
salts during the Grossman process, prior to overnight extraction in distilled
water.
In light of the foregoing, we conclude that the Examiner has failed to
meet the initial burden of presenting a prima facie case of obviousness. In re
Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (citations omitted).
And we therefore, reverse the rejection of claims 1, 4, and 6 under 35 U.S.C.
§ 103(a) as unpatentable over Grossman, Potaros, and 2005
Kittiphattanabawon, as well as claims 2, 3, and 7–13 under 35 U.S.C.
§ 103(a) as unpatentable over Grossman, Potaros, 2005 Kittiphattanabawon,
Pall, Feng, Aguirre-Alvarez, 2010 Kittiphattanabawon, Brier, and Summers.

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CONCLUSION
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 4, 6 103 Grossman, Potaros,
2005
Kittiphattanabawon
1, 4, 6
2, 3, 7–
13
103 Grossman, Potaros,
2005
Kittiphattanabawon,
Pall, Feng, Aguirre-
Alvarez, 2010
Kittiphattanabawon,
Brier, Summers
2, 3, 7–13
Overall
Outcome
1–13

REVERSED