Ex Parte 7,777,074 et al

Patent Trial and Appeal Board

May 21, 2018

90011394 (P.T.A.B. May. 21, 2018)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
90/011,394 12/17/2010 7,777,074 GASP-004-501 8722
54434 7590 05/21/2018
BOOTH UDALL FULLER, PLC
1255 W. Rio Salado Pkwy.
Suite 215
Tempe, AZ 85281
EXAMINER
KUNZ, GARY L
ART UNIT PAPER NUMBER
MAIL DATE DELIVERY MODE
05/21/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEALS BOARD
____________________

Ex parte THERMOLIFE INTERNATIONAL, LLC.
Appellant
____________________

Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2
Technology Center 3900
____________________

Before TONI M. SCHEINER, RICHARD M. LEBOVITZ, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

2

I. STATEMENT OF CASE
ThermoLife International, LLC (hereinafter “Patent Owner”), the real party
in interest1 of Patent 7,777,074 B2 (hereinafter the “’074 patent”), appeals under
35 U.S.C. §§ 134(b) and 306 from the new grounds of rejection, maintained by the
Examiner, of claim 62 under 35 U.S.C. § 102(b) as anticipated by Barger,3 as
evidenced by Dessaignes4 and Gmelin,5 or as anticipated by Dessaignes or Gmelin.
App. Br. 1; Decision, mailed February 1, 2016 (“Decision”); Examiner’s Final
Rejection, mailed September 28, 2016 (“Fin. Rej.”); Examiner’s Answer, mailed
August 29, 2017 ( “Ans.”). We have jurisdiction under 35 U.S.C. §§ 134(b) and
306.
The ’074 patent relates to various amino acid compounds, in particular,
nitrates or nitrites of amino acid compounds. (’074 patent, col. 1, ll. 26–28).
Claim 6 is the only claim on appeal. Claim 6 was not an original claim of
the ’074 patent, but was added during reexamination, and reads as follows:

1 See Patent Owner’s Appeal Brief filed May 9, 2017 (hereinafter “App. Br.”) at 2.
2 Claim 6 is the only remaining claim on appeal. Claims 1 and 2 have been
cancelled, and claims 3, 4, 5, and 7–10 have been confirmed as patentable by the
Examiner. App. Br. 2; Advisory Action mailed July 23, 2014; Ans. 1.
3 Barger, G., “Monographs on Biochemistry,” THE SIMPLER NATURAL BASES, R. H.
A. 157–163, Plimmer & F. G. Hopkins (eds.) Longmans, Green & Co., London
(1914) (“Barger”).
4 M. Dessaignes, “Scientific and Medicinal Chemistry: Examination of some
Products of the Transformation of Creatine,” 12 (279) THE CHEMICAL GAZETTE OR
JOURNAL OF PRACTICAL CHEMISTRY, 201–204, (June 1, 1854) (“Dessaignes”)
5 Leopold Gmelin, “Creatine,” Hand-Book of Chemistry, 10 ORGANIC COMPOUNDS
CONTAINING EIGHT AND TEN ATOM OF CARBON, 249–255, Henry Watts, trs.,
Harrison and Sons for the Cavendish Society, London (1856) (“Gmelin”).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

3
6. A Compound having the structure of:

wherein Y is selected from the group consisting of a Nitrate and a Nitrite.
Claims App’x, App. Br. 46.
It is undisputed that claim 6 is directed to a creatine nitrate or a creatine
nitrite compound.
The ’074 patent states that, when ingested, creatine nitrate provides
enhanced nitric oxide production while providing improved vasodilation effects for
better circulation and distribution of creatine in the body. Id., col. 17, ll. 54–57.

II. BACKGROUND OF CASE ON APPEAL
This reexamination proceeding is based on two third-party requests for ex
parte reexamination, one filed by Mr. Bruce W. Kneller and Mr. Richard Gaspari
(Request for Ex Parte Reexamination, filed December 17, 2010) and one filed by
Mr. Daniel Pierce and Mr. Richard Gaspari (Request for Ex Parte Reexamination,
filed August 18, 2011). The two requests were merged into a single ex parte
reexamination on March 30, 2012, retaining both of the reexamination control
numbers for identification. A first Decision on Appeal (“Decision”) was issued on
February 1, 2016, with a new ground of rejection including additional evidence
that further supported the Examiner’s initial finding of anticipation.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

4
In our earlier Decision, we addressed Patent Owner’s arguments that the sole
applied prior art reference, Barger, which expressly teaches a “nitrate of creatine”
is ambiguous and did not enable one skilled in the art to make creatine nitrate.
Decision 3. In setting forth this argument, Patent Owner relied on three
declarations of Dr. Chamberlin6 and the testimony of Dr. Wolff.7 Decision 4.
Without agreeing that Barger is ambiguous or not enabling (see Decision 6
(“We are not persuaded that Barger is ambiguous or not enabled.”)), the Decision
included further evidence, Dessaignes and Gmelin, showing that Barger is enabling
because substantially the same method used in the ’074 patent to make creatine
nitrate was known and thus need not have been expressly described in Barger. See
Decision 9. A new ground of rejection was entered because new evidence was
relied upon to address the specific arguments presented by Patent Owner. See
Honeywell Int’l. Inc. v. Mexichem Amanco Holding S.A. DE C.V., 865 F.3d 1348,
1358 (Fed. Cir. 2017) (“[a] new ground of rejection is not negated by the fact that
the Board is responding to [a party's] argument.”) (quoting In re Biedermann, 733
F.3d 329, 338 (Fed. Cir. 2013)). We did not reverse the Examiner’s rejection, but
agreed that, in light of the additionally applied evidence, the Examiner’s rejection

6 The Declaration of Richard Chamberlin under 37 C.F.R. § 1.132, dated
November 9, 2013, and entered into the record on November 12, 2013 (hereinafter
“First Chamberlin Declaration” or “1st Chamberlin Decl.”). The Supplemental
Declaration of Richard Chamberlin, dated May 30, 2014, and entered into the
record on June 2, 2014 (hereinafter “Second Chamberlin Declaration” or “2nd
Chamberlin Decl.”) (10 pages). The Second Supplemental Declaration of Richard
Chamberlin, also dated May 30, 2014, and entered into the record on June 2, 2014
(11 pages) (hereinafter “Third Chamberlin Declaration” or “3rd Chamberlin
Decl.”).
7 The Declaration of Dr. Manfred Wolff, dated November 8, 2013, and entered into
the record on November 12, 2013 (hereinafter “Wolff Decl.”).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

5
was sound. Because Dessaignes and Gmelin also expressly teach creatine nitrate
and a process for making creatine nitrate that is substantially the same as that of the
’074 patent, additional new anticipation grounds of rejection were entered based on
these publications. Decision. 11.
Patent Owner reopened prosecution and submitted additional testimony by
Dr. Chamberlin8 and new testimony of Dr. Levere.9 The Examiner was not
persuaded by Patent Owner’s arguments and evidence and maintained the
Decision’s new grounds of rejection. Final Rej.; Ans.
An oral hearing was held on March 7, 2018. A transcript of the hearing will
be entered into the record in due course.
Accordingly, the issue before us is: based on a preponderance of the
evidence, has Patent Owner shown that the Examiner erred in maintaining the new
grounds of rejection in light of further arguments and evidence of record, namely
the Fourth and Fifth Chamberlin Declarations and the Levere Declaration?
We answer this question in the negative and maintain the new grounds of
rejection set forth in the Decision.

8 The Declaration of Richard Chamberlin under 37 C.F.R. § 1.132, dated March
30, 2016, and entered into the record on April 1, 2016 (hereinafter “Fourth
Chamberlin Declaration” or “4th Chamberlin Decl.”). The Declaration of Richard
Chamberlin under 37 C.F.R. § 1.132, dated November 14, 2016, and entered into
the record on November 28, 2016 (hereinafter “Fifth Chamberlin Declaration” or
“5th Chamberlin Decl.”).
9 The Declaration of Trevor H. Levere under 37 C.F.R. § 1.132, dated March 29,
2016, and entered into the record on April 1, 2016 (hereinafter “Levere
Declaration” or “Levere Decl.”).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

6
III. FINDINGS OF FACT
Dessaignes, 185410
D1. Dessaignes teaches that, in combining creatine with nitrous acid gas,
“beautiful crystalline compounds with a strongly acid reaction” are formed that
“consist of nitrate of creatine.” Dessaignes 203.
D2. Dessaignes describes two methods for making a “nitrate of creatine.”
The first is:
If a rapid current of nitrous acid gas be passed into water containing an
excess of undissolved creatine, the latter is quickly dissolved, and a
large quantity of small brilliant crystals afterwards make their
appearance. These crystals, which may readily be obtained in thick
short prisms by solution in warm water and cooling, consist of nitrate
of creatine. Their solution, which has a very acid taste, is abundantly
precipitated by ammonia. The precipitate, dissolved in hot water,
furnishes on cooling small prisms, which effloresce at 212° F., and the
solution of which is neutral with paper, and does not produce
precipitates with chloride of mercury, chloride of zinc or nitrate of
silver. These prisms, dried at 212° F. and analysed, furnished in 100
parts –

I also determined the quantity of nitric acid in the nitrate of creatine,
and found it to contain 32.36 per cent. of monohydrated nitric acid. The
formula C8H18N6O4, N2H2O6 requires 32.47 per cent. of N2H2O6.

10 We refer to Dessaignes as reported in William Francis, 12 THE CHEMICAL
GAZETTE OR JOURNAL OF PRACTICAL CHEMISTRY, No. 279, pp. 201–204 (June 1,
1854). Dessaignes, which was originally printed in German, is also of record in
English as reported in John and Charles Watt, 1 THE CHEMIST, pp. 594–597
(1854).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

7
Dessaignes, 203.
D3. In the second method, “[t]he same compound was produced by
dissolving 1.057 gr. of crystallized creatine in nitric acid containing 0.447 gr. of
N2H2O6, and evaporating at 86° F. The crystals were homogeneous, and weighed
1.373 gr. From calculation they should weigh 1.376 gr.” Dessaignes, 203.

Gmelin, 185611
G1. Gmelin describes the properties of creatine as follows: “White opaque
mass. (Liebig.) Inodorous, without perceptible taste. (Chevreul.) Has a somewhat
bitter taste, and scratches in the throat. (Liebig.) Neutral to vegetable colours.
(Chevreul.)” and having the formula C8N3H9O4. Gmelin, 252.
G2. Gmelin states that
– 3. Creatine dissolved in strong nitric, sulphuric, phosphoric, or
hydrochloric acid, is converted into cratinine by abstraction of 2HO,
the cratinine then combining with the acid. (Liebig.) — But if these
acids are dilute, the creatine remains unaltered, even after long
boiling, and the solution in cold hydrochloric acid leaves, by
spontaneous evaporation, crystals of pure creatine. (Liebig.)
Gmelin 252–253.
G3. Gmelin teaches
The colourless solution of creatine in nitric acid of sp. gr. 1.34 gives off
nitrous fumes when heated in the water-bath, and leaves on evaporation
a colourless residue [of nitrate of cratinine?], which dissolves in water,
separates out therefrom in small granules, and does not precipitate
bichloride of platinum. (Chevreul.)
Gmelin 253 (emphasis added; brackets in original).
G4. Gmelin also repeats the teachings of Dessaignes as follows:

11 Watts, published in 1882, has substantially the same teachings as Gmelin.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

8
Nitrate of Creatine. — 1. Obtained by dissolving crystallized
creatine in the requisite quantity of nitric acid, and evaporating the
solution at 30°. — 2. By passing a rapid stream of nitrous gas through
water containing an excess of creatine in suspension. The creatine
dissolves with tolerable rapidity, and a considerable quantity of small
shining crystals of the nitrate are formed, which, when recrystallized
by dissolving them in lukewarm water and cooling, form thick short
prisms. This salt is less soluble in water than the sulphate or
hydrochlorate. The solution has a very sour taste, and is decomposed
by ammonia with precipitation of creatine. (Dessaignes.)”
Gmelin 254.
G5. Gmelin states that creatine “does not neutralize the weakest acid, even
when added in vary large quantity. (Liebig.)” Gmelin 254.

Wislicenus12, 1881
Wi1. Wislicenus states:
Creatine crystalises in large, colourless, brilliant, short
monoclinic prisms of the formula C4H9N3O2, H2O, becoming cloudy at
100deg.C, with loss of the water of crystallization. It is soluble in 74
parts of cold, and considerably less boiling, water. It is insoluble in
absolute alcohol and ether.
With the mineral acids creatine yields salts of acid reaction
corresponding to those of glycocyamine, whose solutions can only be
brought to unchanged crystallization at ordinary temperatures, being
converted on heating into salts of creatinine.
Creatine nitrate, C4H9N3O2, HNO3, crystalises in large colourless
prisms.
Wislicenus, 423.

12 JohannesWislicenus, “Adolph Strecker's Short Text-Book of Organic
Chemistry”, 423 KEGAN PAUL, TRENCH & CO., LONDON (1881).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

9
Wi2. Wislicenus further states that “Creatinine . . . is readily formed from
creatine, with removal of water, by heating with dilute mineral acids; e.g. on
evaporating a solution of creatine sulphate on the water bath, creatinine sulphate is
left.” Wislicenus, 423.

Bloxam, 1895
B1. Creatine forms prismatic crystals easily soluble in hot water, but very
sparingly in alcohol and ether. The crystals are C4H9N3O2, Aq. Creatine is neutral
in reaction, but plays the part of a weak monacid base. Creatine nitrate,
C4H9N3O2, HNO3 crystallises in prisms. When the solutions of its salts are heated
above 30° C., they are converted into salts of creatinine, a stronger base containing
H2 and O less than creatine. Bloxam 656.

Barger, 1914
Ba1. Barger is a compendium of bases that can be derived from natural
sources and is entitled “The Simpler Natural Bases.” Barger Title, 5.
Ba2. Barger identifies that “Many substances of physiological importance
are at the same time acids and bases; those in which the basic character
predominates have been included in this monograph.” Barger 5. Creatine is
included in the monograph. Barger, vii (Table of Contents), 69–78, 157–163.
Ba3. Barger states that “[f]or our purposes a better practical definition is to
describe a base as a substance which is precipitated by phosphotungstic acid.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

10
Adopting this criterion we consider creatinine to be a base but creatine not.”
Barger 6.
Ba4. Barger teaches that, in 1844, Liebig prepared creatine from the flesh
of various animals, analyzed it and converted it into its anhydride which he named
creatinine. Barger 69.
Ba5. Barger teaches that “Creatine and creatinine are interconvertible. The
change from the former to the latter substance can be brought about quantitatively
by heating with acid or even without a solvent (see appendix).” Barger 70.
Ba6. Barger provides a chemical structure for creatine as follows. Barger
78.

Ba7. Barger teaches forming creatinine from creatine by heating a dilute
creatine solution containing 6–7 percent hydrochloric acid in a autoclave to 117°
for forty-five minutes, by warming a 0.1 percent creatine solution for 3-4 hours on
the water bath with 2.44 percent hydrochloric acid (twice its volume of normal
hydrochloric acid), by adding an equal volume of normal hydrochloric acid and
heating on the water bath for 3 hours or in the autoclave to 117–120° for 25
minutes, or by heating without a solvent in an autoclave for three hours at 4.5
atmospheres. Barger 158. Thus, Barger teaches all methods of forming creatinine
from creatine require heating to at least 117°, even in the presence of acid.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

11
Ba8. Barger describes the physical and chemical properties of both creatine
and creatinine. Barger 158–159.
Ba9. Barger teaches that “The aqueous solution is neutral. The basic
properties of creatine are very feeble (dissociation constant 1.81 x 10-11 at 40.2°,
Wood [1903]) and its salts with mineral acids are hydrolysed by water.” Barger
158. Thus, Barger teaches that, although it is a feeble base, creatine forms salts
with mineral acids.
Ba10. Barger explains that when creatine is “heated with dilute mineral
acids, with water or by itself, creatinine is formed.” Barger 159.
Ba11. Barger teaches
Compounds of creatine.-The nitrate, C4H9O2N3·HNO3, is less
soluble than the hydrochloride or the sulphate. The compounds
C4H9O2N3·ZnCl2 and C4H9O2N3·CdCl2·2H2O are crystalline
(Neubauer [1862, 2]). All these salts are hydrolysed by water.
Barger 160, first full ¶.
IV. ANALYSIS
There are multiple express teachings in the prior art of a nitrate of creatine
(D1–D3, G4, Wi1, B1, Ba11) and that a nitrate of creatine was formed by mixing
nitric acid and creatine and evaporating the water at 30° C, or 86° F. D3, G4.
Express teachings in the prior art are initially presumed to be enabled. In re Antor
Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012) (“[D]uring patent prosecution,
an examiner is entitled to reject claims as anticipated by a prior art publication or
patent without conducting an inquiry into whether or not that prior art reference is
enabling. As long as an examiner makes a proper prima facie case of anticipation
by giving adequate notice under § 132, the burden shifts to the applicant to submit
rebuttal evidence of nonenablement.”).
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

12
We have considered all of the evidence provided by Patent Owner
purporting to show that these references are either ambiguous or not enabled.
However, for the reasons discussed below, we are not persuaded that Patent Owner
has overcome the new grounds of rejection set forth in the Decision.

Ambiguity
Patent Owner still contends that Barger is ambiguous and that Dessaignes
and Gmelin create more ambiguity rather than clarify the ambiguity in Barger.
App. Br. 9; Reply Br. 10. In particular, Patent Owner contends that Dessaignes or
Gmelin do not establish that creatine nitrate salt is “the only possible resulting
compound described by Barger.” App. Br. 11.
From at least the citations provided by Patent Owner, it has been held that an
ambiguous reference does not, as a matter of law, anticipate a claim. See,
e.g., W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1554 (Fed. Cir.
1983) (refusing to find claims anticipated when the prior art references were
“unacceptably vague”); see also In re Hughes, 345 F.2d 184, 188 (CCPA 1965); In
re Turlay, 304 F.2d 893, 899 (CCPA 1962) (“It is well established that an
anticipation rejection cannot be predicated on an ambiguous reference.”).” Wasica
Fin. GmbH v. Cont’l. Automotive Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017).
None of the cases cited by Patent Owner that describe the prior art as
“ambiguous” involve a clear and express teaching in the reference that anticipates
on its face. For example, in Gore, a claim directed to a paste-extruded PTFE
product, having certain characteristics, was said not to be anticipated by two prior
art references that teach paste-extrusion processes. Gore, 721 F.2d at 1554. The
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

13
teachings of the references are silent as to, and thus do not expressly teach, the
particular characteristics of products produced from the processes taught. Id.
In Hughes, the claim to “pieced, interleaved-spiral core strips” was found
not be anticipated by a prior art reference that described the core only as having the
“identical position” or “relationship” as an original “wound core.” Hughes, 354
F.2d at 186. In other words, what was recited in the claims, i.e., a spiral core, was
not expressly taught by the prior art in Hughes. Id. See also Wasica, 853 F.3d at
1284 (claim to “constant frequency” was not anticipated by prior art, where there
was no express teaching in the art of a “constant frequency” as recited in the claims
and evidence that the term “common frequency” might be an average frequency
and not constant).
Similarly, In re Brink, 419 F.2d 914 (CCPA 1970), a claim reciting a fiber
bed compressed to a bulk density within a recited range was found not to be
anticipated by a prior art reference that did not expressly teach a bulk density for
the fiber bed taught therein. Brink, 419 F.2d at 862–863. In Turlay, a claim to a
cylinder block having “a single,” interpreted as one and only one, exhaust port was
determined to not be anticipated because the reference’s figures in cross section
could have equally conveyed one or two exhaust ports and there was no planar
figure expressly showing the presence of only one exhaust port. Turlay, 304 F.2d
at 899.
However, in the present case, Barger, Dessaignes, and Gmelin expressly
teach a “nitrate of creatine” (Ba11, D2, G4), and these express teachings
unambiguously anticipate the claimed composition, a nitrate of creatine, on their
face. The express teaching is not vague or ambiguous, but clear and exact as to not
only the name of the compound claimed, but also citing the chemical formula and
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

14
other physical properties for both the starting creatine material and the nitrate of
creatine. D1, D2, G1, G3, G4, Wi1, B1, Ba5, Ba6, Ba8, Ba9, Ba10, and Ba11.
Patent Owner asserts that the ambiguity is found not in what is expressly
taught by Barger, but in whether or not what is expressly taught is accurate. In
particular, Patent Owner argues that “Barger may be disclosing alternative
compounds” to creatine nitrate, and that the phrase “nitrate of creatine” is “just a
name, without any substantive support in Barger that the claimed salt was ever
actually or constructively reduced to practice.” App. Br. 11; see App. Br. 9, 15,
26, 27, 31, 32, 35, 37, 40, 41, and 44. Patent Owner relies on evidence that
purports to show that Barger “describes a multitude of possible compounds” by the
single express phrase “the nitrate of creatine” because there are “credible possible
alternative compounds that might have been made.” App. Br. 12-15 (emphasis
added) (citing various portions of Dr. Chamberlin’s First, Second and Third
Declarations and Dr. Wolff’s Declaration). Yet, Barger describes only one
compound expressly by the phrase “the nitrate of creatine,” (Ba11), as does
Dessaignes and Gmelin. D2, G4. Patent Owner has not established that the name,
itself, is ambiguous.
Patent Owner argues that the references are ambiguous because, although
Dessaignes and Gmelin teach that creatine nitrate can be formed by combining
creatine and nitric acid and evaporating at 30° C (D3, G4), Gmelin (and Watts)
also teach that creatine dissolved in “strong” nitric acid is converted to creatinine
then combined with the acid, and if dissolved in “dilute” acids “creatine remains
unaltered” such that the solution retains “crystals of pure creatine.” PO App. Br.
15–18; Reply Br. 16–18; G2. According to Patent Owner, creatine nitrate is not a
possible product with either “strong” or “dilute” acids, and, thus, a nitrate of
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

15
creatine is not possible by mere combination at all. PO App. Br. 18; Reply Br. 16–
18.
We do not find these discrete teachings contradict or render ambiguous
Dessaignes’ mixing process. Gmelin’s discussion of strong and dilute acids does
not address specifically or disparage Dessaignes’ particular process of making
creatine nitrate by combining creatine and nitric acid and does not undermine the
finding that the compound is anticipated. The teaching of creatine nitrate in
Barger, Dessaignes, or Gmelin and the mixing process taught in Dessaignes and
Gmelin are not ambiguous teachings, but clear on their face.
Regarding temperature, Patent Owner argues that the references are
ambiguous because Gmelin (and Watts) teach that heating creatine results in
converting creatine to creatinine. PO App. Br. 19; Reply Br. 15; G3. Patent
Owner contends that evaporating at 30° C (86° F) would require heating the
creatine and nitric acid solution and thus concludes that creatinine and the nitrate
thereof are the only compounds that Dessaignes could have formed. Id. See also
Fifth Chamberlin Decl. ¶ 15.
Again, we do not find these discrete teachings either contradictory or
ambiguous. While they may show that the temperature at which creatine and nitric
acid are combined is a result-effective parameter when making creatine nitrate, the
parameters disclosed in the art do not teach or even suggest that that creatine
nitrate cannot be made by combining creatine and nitric acid at 86° F, as taught by
Dessaignes, and do not undermine the finding that the compound is anticipated.
Indeed, nothing in the literature of record specifically indicates that creatine nitrate
cannot be formed by mixing creatine and nitric acid and evaporating at 30° C.
Rather, a preponderance of the evidence of record suggests that a much higher
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

16
temperature is necessary to convert creatine to creatinine. Wi1 (100 °C); B1
(“above 30 °C”); Ba7 (autoclave temperatures of at least 117 °C). In other words,
a temperature requirement that is specifically taught in the prior art does not render
the teaching of creatine nitrate in Barger, Dessaignes, or Gmelin ambiguous.
Patent Owner further contends that the references are ambiguous because
not all of the references recite the correct formula for creatine nitrate, C4H9N3O2,
HNO3, or they contain other errors. PO App. Br. 17, 30–38; Reply Br. 21–27.
However, it appears that only Gmelin reports the formula for creatine nitrate
incorrectly (G1 (C8N3H9O4, with 4 extra carbon atoms), while the other references,
including Dessaignes report the formula correctly.13 D2 (C8H18N6O4, N2H2O6,
which converts to C4H9O2N3·HNO3); Wi1 (C4H9N3O2, HNO3); B1 (C4H9N3O2,
HNO3); and Ba11 (C4H9O2N3·HNO3). We are not persuaded that Gmelin’s error in
reproducing the formula stated in Dessaignes reflects ambiguity in the art, which
expressly teaches creatine nitrate and a method for making creatine nitrate. The
issue here is not whether a formula is correct or not, but whether the cited
publications unambiguously teach creatine nitrate. Patent Owner attempts to
undermine an express teaching with no more than conjecture. Patent Owner has
failed to introduce adequate evidence that the claimed compound was not made,
i.e., that the prior art on its face is factually incorrect. Without sufficient evidence

13 Patent Owner cites to other errors in the references cited by Barger, namely
Neubauer, Liebig, and Volhard as evidence of unreliability of the formula in
Barger. PO App. Br. 21, 23, and 30 (citing Lever Decl. ¶ 25). While indicating
that it was difficult to get to the formula correct via elemental analysis available at
the time of publication of these earlier references, errors in these references do not
show ambiguity or error in the prior art teachings of creatine nitrate so relied upon.
Moreover, Barger states the correct formula.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

17
to support a finding of clear error, we are unwilling to find the express teaching of
a nitrate of creatine in four separate references to be ambiguous.14 The teaching of
an incorrect formula in Gmelin is not evidence of ambiguity, particularly when
Gmelin unambiguously names the compound that was produced and a process for
making the claimed compound.
Patent Owner also argues that the references are ambiguous because Barger
suggest that creatine is not a base (Ba3) and Gmelin teaches that creatine cannot
neutralize the weakest acid even in large quantities (G5), and thus cannot
disassociate in nitric acid to form creatine nitrate. PO App. Br. 13, 16–17; Reply
Br. 19–21. We addressed the basic nature of creatine in our prior Decision on
Appeal. Decision 6–7. We have nothing to add to these findings but note that
Barger provides a dissociation constant indicating that creatine does dissociate in
water. Ba9. We are not persuaded as to any ambiguity in the teachings of Barger
or Gmelin regarding the weak basic nature of creatine.
Finally, Patent Owner contends that the references are ambiguous because
they teach making the “same compound” or “same combination” using two
different methods, and Patent Owner contends that because the gas bubbling
method is ambiguous, the method for making the “same compound” or “same
combination” must also be ambiguous. PO App. Br. 17–18, 30, and 32–35 (block
quoting Fourth Chamberlin Decl. ¶¶ 12–24); Reply Br. 21, 23–24. In particular,
the gas bubbling method taught by the prior art is said to be performed with

14 Even if the identification of the compound as “nitrate of creatine” is incorrect
and Dessaignes never made creatine nitrate, the reference is not ambiguous; it is
just wrong. An invention is anticipated if it “was ... described in a printed
publication... more than one year prior to the date of application for patent in the
United States.” 35 U.S.C. § 102(b) (2007). An error would still anticipate if the
reference is sufficiently enabled to make what was described.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

18
“nitrous acid gas,” which Patent Owner argues is an ambiguous term, as it could
mean several different gases. PO App. Br. 34 (quoting Fourth Chamberlin Decl. ¶¶
16–17). Patent Owner further states that “a very skilled chemist” could not make
creatine nitrate using the gas bubbling method taught by Dessaignes. Reply Br. 21
(Fourth Chamberlin Decl. ¶ 19), 32.
The rejection we set forth in the Decision does not rely on the bubbling
method taught by Dessaignes and Gmelin. Decision 11. Rather, we rely on the
second mixing method, which is expressly taught by Dessaignes (D3, G4) as
teaching creatine nitrate. Decision 11 (comparing the mixing method to that of the
’074 patent). It is of no moment if the gas bubbling method is unclear in its
teaching or if “a very skilled artisan” could not achieve creatine nitrate using the
gas bubbling method. We give little weight to the actions of unnamed
experimenters who have not testified on the record of their own first-hand
knowledge of the steps taken during the alleged experiment. Rohm and Haas Co.
v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997); In re Michalek, 162 F.2d
229, 231–232 (CCPA 1947) (“With respect to the experiments described in the
affidavits it must be said that in a patent it is to be presumed that a process, if used
by one skilled in the art, will produce the product alleged by the patentee and such
presumption is not overcome by a mere showing that it is possible to operate
within the disclosure without obtaining the alleged product”). See also In re Reid,
179 F.2d 998, 1002 (CCPA 1950) (“[T]he failures of experimenters who have no
interest in succeeding should not be accorded great weight”).
Dessaignes’ second method was determined to be substantially identical to
that described in the ’074 patent. Decision 11. Dessaignes expressly teaches
making a nitrate of creatine by dissolving creatine in nitric acid and evaporating at
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

19
86° F (30° C). The description is clear on its face. We discuss in detail below why
this description, even if dependent upon the nitric acid concentration, is an
enabling teaching in the art.

Enablement
Patent Owner previously argued that Barger was not enabling because it did
not teach a method of making creatine nitrate, only the existence thereof (which
Patent Owner also disputed, as discussed below). Decision 3. However, in the
Decision, we stated that which is known to those skilled in the art need not be
expressly taught in a reference for it to be enabling. Decision 11 (citing Motorola,
Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 (Fed. Cir. 1997)). Thus, in
the new ground of rejection, Dessaignes and Gmelin were relied upon as evidence
that a process for making creatine nitrate was known in the art, establishing that
Barger’s teaching of the same compound was enabled. Decision 11. Patent
Owners do not dispute that that which is known to those skilled in the art need not
be expressly taught in a reference for it to be enabling. See PO App. Br. generally.
Rather, Patent Owner contends that Dessaignes and Gmelin do not enable a skilled
artisan to make creatine nitrate by the processes expressly taught therein, and thus,
none of the references are enabled. PO App. Br. 15, 20–21.
“[A] prior art printed publication cited by an examiner is presumptively
enabling barring any showing to the contrary by a patent applicant or patentee.” In
re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). The burden thus
shifts to Patent Owner to show that the reference is not enabling. Id. (“[I]t is
procedurally convenient to place the burden on an applicant who is in a better
position to show, by experiment or argument, why the disclosure in question is not
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

20
enabling or operative. It would be overly cumbersome, perhaps even impossible,
to impose on the PTO the burden of showing that a cited piece of prior art is
enabling. The PTO does not have laboratories for testing disclosures for
enablement.”).
Initially, Patent Owner argues the express teaching of creatine nitrate is not
“reliable” (i.e., what was made by Dessaignes might not be creatine nitrate as
reported). PO App. Br. 18. Patent Owner’s argues that Dessaignes or Gmelin do
not establish that creatine nitrate salt is “the only possible resulting compound
described by Barger.” App. Br. 11.
However, in determining enablement, the product described in a prior art
publication need not have actually been made to satisfy enablement. Novo Nordisk
Pharm., Inc. v. Bio–Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); In re
Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). The actual results may be prophetic
or even not achievable at all by the writer at the time of the published document,
provided that what is taught may be used by the skilled artisan to make the
disclosed product at the time of claimed invention without undue experimentation.
See Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368,
1379 (Fed. Cir. 2001) (“[A]dditional references used solely to show enablement of
an anticipatory reference need not antedate that reference, but must show that the
claimed subject matter was in possession of the public more than one year prior to
the applicant’s filing date.”). Thus, Patent Owner’s argument that Dessaignes did
not actually make, or is not conclusively shown to have made, creatine nitrate is
not probative to the legal question of enablement.
Nor is a presumption of enablement overcome by a mere showing that it is
possible to operate within the disclosure without obtaining the alleged product. In
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

21
re Weber, 405 F.2d 1403, 1407 (CCPA 1969) (“We do not think that appellants’
mere showing that it is possible to operate within [the prior art’s] disclosure
without obtaining his results is sufficient to overcome the strong presumption that
the process of a patent if used by one skilled in the art will produce the results
alleged by the patentee.”).
Rather, we consider whether a skilled artisan in 2007 could have made
creatine nitrate from Dessaignes’ teaching (as repeated by Gmelin) without undue
experimentation. “Enablement of prior art requires that the reference teach a
skilled artisan—at the time of filing—to make or carry out what it discloses in
relation to the claimed invention without undue experimentation.” In re Morsa,
803 F.3d 1374, 1377 (Fed. Cir. 2015).
Determination of whether the requisite amount of experimentation is undue
may include consideration of:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior art,
(6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Regarding the nature of the invention, the invention is directed to a nitrate or
nitrite compound of creatine. Claim 6.
Regarding the amount of direction provided, Gmelin and Dessaignes teach
substantially identical methods of making creatine nitrate. They describe a method
of “dissolving” crystallized creatine in “the requisite quantity” (G4) or “0.447 gr.”
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

22
(D3) of “nitric acid” and evaporating at 86° F (30° C). D3, G4.15 Dessaignes is
reporting the result of his personal experience, and thus Dessaignes’ teaching
constitutes a working example.
We find the amount of guidance provided in the prior art to be substantial,
particularly as the process described appears to be substantially identical to the
method taught by the ’074 patent, which states that “[a]pplicants have cost-
effectively synthesized Creatine Nitrate by combining nitric acid and Creatine,
mixing with water, and leaving to crystallize.” ’074 patent, col. 9, ll. 19–21. In re
Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994) (lack of diagrams, flow charts, and
other details in the prior art references did not render them nonenabling in view of
the fact that applicant’s own specification failed to provide such detailed
information, and that one skilled in the art would have known how to implement
the features of the references).
Patent Owner further points out the differences between the process taught
by the prior art and the process described in the ’074 patent, in that the ’074 patent
mixes creatine and nitric acid then dilutes with water. PO App. Br. 17, 29–30;
Oral Hearing Transcript 10:24–11:25, 28:1–8. However, Dessaignes teaches
mixing creatine and aqueous nitric acid (D3, “dissolving”) and there is no evidence
to suggest the order of adding water is critical. Indeed, the ’074 patent expressly
states that the order of mixing materials is not critical. See ’074 patent, col. 15, ll.
49–59 (“[I]t will be understood that such manufacture is not limited to the specific
order of steps or forms as disclosed. Any steps or sequences of steps of
manufacture of implementations of an Amino Acid Compound in any form are

15 As noted above, we do not rely on the bubbling method described in these
references. D2, G4. Thus, whether or not this method is enabling is not relevant to
our analysis.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

23
given as examples of possible steps or sequences of steps or potential forms and
not as limitations, since many possible manufacturing processes and sequences of
steps may be used to manufacture Amino Acid Compound implementations in a
wide variety of forms.”). Patent Owner asserts that the skilled artisan could only
make creatine nitrate using knowledge gleaned from the ’074 patent (Reply Br.
10–11, 28, and 33) but have not demonstrated why the order of diluting with water
is critical to the invention.
Regarding the state of the art, Patent Owner points out that the state of the
art was “ancient.” PO App. Br. 22–23. Patent Owner cites extensively to the
testimony of Dr. Levere, who is a historian with a specialty in history of chemistry,
who provides a lengthy discussion of the limitations of mid-nineteenth century
chemists and technology of the time, and where errors might be present in the 19th-
century references. App. Br. 22–23 (citing Levere Decl. ¶¶ 10–29).
A reference is enabled if a skilled artisan would have been able to arrive at
the claimed invention without undue experimentation at the time of the invention,
not at the time of the references. While Dr. Levere describes where some errors
may have existed in the prior art references, Dr. Levere states without clear
explanation or evidence, that a skilled artisan in 2007 would not be capable of
performing the process of mixing crystallized creatine with nitric acid and allowing
it to evaporate at 86° F. Levere Decl. ¶¶ 9, 13, 22, and 33. We decline to give Dr.
Levere’s testimony as to what a modern-day chemist would have been capable of
making from the teachings in the references significant weight because Dr. Levere
is not a modern-day chemist, but a historian. Levere Decl. ¶ 33 (“I am today a
historian of chemistry, not a chemist.”). Dr. Levere has not provided any evidence
as to the particular skills of a modern-day chemist, but only discusses what is
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

24
presented in the nineteenth century references in relation to the time period in
which they were written. This evidence is not probative of whether a skilled
artisan in 2007 would have be capable of preforming Dessianges’ mixing method
to make the claimed compound without undue experimentation.
At the time of the invention, in 2007, the art of salt formation from acids and
bases was well-known and quite extensive. See e.g., Fourth Chamberlin Decl.
¶¶ 16–20, 34–35 (describing what a modern-day chemist knows about oxidizing
agents and nitration/nitrosation agents like nitric/nitrous acids and the knowledge
and assumptions a skilled artisan would use in forming a salt with strong nitric
acid). In fact, Dessaignes discloses specific amounts of each of creatine and nitric
acid utilized to make the nitrate of creatine, as well as an evaporation temperature
(D3). Patent Owner has not provided adequate evidence that following this
specific guidance would not result in creatine nitrate, even if it were necessary to
select a volume of acid in which to perform the mixing. Mixing crystallized
creatine and nitric acid the in manner described in Dessaignes would require no
more than routine experimentation by a skilled artisan.
Even if the chemical formula was wrong in 1854, the skilled artisan today
would have at their disposal many methods for confirming the structure of the
product produced by Dessaignes process. See Fourth Chamberlin Decl. ¶ 57
(discussing known ways to confirm identity “(which today would include melting
point, elemental analysis, chromatographic analysis, NMR, IR, MS, X-ray
crystallography). These rigorous standards have evolved into their present form
over time as each technique listed became available.”). Patent Owner did not
utilize such tools to prove Dessaignes was wrong, but merely attempts to
undermine its express teaching with conjecture.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

25
Regarding predictability in the art, Patent Owner points to the testimony of
Dr. Chamberlin to support its contention that chemical reactions are unpredictable.
App. Br. 24–25. Dr. Chamberlin testifies that “if the experimental parameters in
the original publication are not carefully and completely specified” the result
described therein is “profoundly unreliable.” Id. (citing First Chamberlin Decl.
¶ 16). However, Dr. Chamberlin has not explained how Dessaignes’ instructions
for making creatine nitrate are not “carefully and completely specified.” Dr.
Chamberlin describes “not knowing which of the many forms of a given salt was
used in the original experiment can result in a misleading or completely erroneous
conclusion.” Id. But Dessaignes does not use a salt as a reactant, and Dr.
Chamberlin does not identify any lack of specificity in Dessaignes reagents
(crystallized creatine and nitric acid). D3. As discussed above, a modern-day
chemist would be capable of confirming the salt obtained by mixing crystallized
creatine and nitric acid without undue experimentation. Dr. Chamberlin further
testifies as to the unpredictability of solubility of a given crystal or crystallization
behavior of compounds. PO App. Br. 25 (citing First Chamberlin Decl. ¶ 22).16
Again, Dr. Chamberlin does not speak to any lack of specificity in the process for
making the compound or explain why a skilled artisan could not arrive at the
compound taught by the prior art using the method steps specifically recited in the
prior art.
As for the relative level of skilled artisan, Patent Owner asserts that
the skilled artisan would not only need to be an organic chemist familiar
with reactions of amino acids with mineral acids but also
knowledgeable about the state of organic chemistry at the time of the

16 There is an express teaching in the art that creatine easily dissolves in water (D2,
G4), and thus the prior art would inform the skilled artisan as to the predictable
solubility of creatine in water.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

26
references so that she would be able to properly understand and judge
the disclosures of the references.
PO App. Br. 23. However, salt formation from combining acid and bases in a
simple titration is generally the subject of high school chemistry. Dessaignes’
teaching of a single step of mixing one material with another is not complex
organic chemistry – it’s a mixing step, which can be performed without
exceptional skill. Dessaignes teaches, in plain and clear language, a basic chemical
concept not requiring significant chemical knowledge. While confirming the
identity of a resulting salt indeed may be slightly more difficult, techniques used to
confirm chemical compounds are well-known in the art and are taught at an
undergraduate skill level. Moreover, Dessianges describes numerous physical
properties for the substance that he created, which would be observable without
significant expertise. D2 (“thick short prisms,” “very acid taste,” “precipitated by
ammonia,” and further properties of the precipitate), G4 (“small shining crystals”
that recrystallize to “thick short prisms,” “less soluble that the sulphate or
hydrochlorate,” “very sour taste,” “decomposed by ammonia”), Wi1 (“large
colourless prisms”).
Patent Owner does not address the quantity of experimentation necessary to
arrive at the claimed invention, but only points out that “a very experienced
chemist” could not perform the bubble method described by Dessaignes. PO App.
Br. 24 (citing Fourth Chamberlin Decl. ¶ 19). As discussed above, it is the mixing
method, not the bubbling method, that was cited in the Decision as being
substantially identical to the method described in the ’074 patent. Decision 11.
Patent Owner also argues that both the first and second methods are not
enabled because the references suggest that creatine nitrate cannot be made with
either a “strong” or “weak” acid. PO App. Br. 16–18, 30, and 43; Reply Br. 11;
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

27
G2. Indeed, Dessianges speaks to the grams of nitric acid and creatine, but not the
volume of water in which they are dissolved to determine a final acid
concentration. Even if concentration of nitric acid is a result-effective variable, we
find no reason to conclude that varying nitric acid concentration for a skilled
artisan in 2007 would constitute more than routine experimentation and does not
undermine the finding that the compound is anticipated. In fact, varying
concentrations is also a high school chemistry technique and would be routine for
an ordinary artisan. A reference is not precluded from being enabled merely
because the skilled artisan would have had to perform some experimentation,
provided that the experimentation is not undue. In re Morsa, 803 F.3d at 1377.
Moreover, “[s]killed workers would as a matter of course, in our opinion, if they
do not immediately obtain desired results, make certain experiments and
adaptations.” In re Michalek, 162 F.2d 229, 232 (CCPA 1947). In other words, a
skilled artisan would have more than one opportunity to make adaptations within
the instructions provided to arrive at creatine nitrate.
Thus, considering the above analysis of the Wands factors, we determine
that the evidence supports a conclusion that the skilled artisan would have been
capable of using the teachings of Dessaignes, even with routine variation in nitric
acid concentration, to make creatine nitrate, as taught by the references. In other
words, the skilled artisan would have had possession of the claimed creatine nitrate
compound, as of the time of the invention. We determine based on a
preponderance of the evidence that the prior art is enabling.

Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

28
What if Dessaignes did not, in fact, make creatine nitrate?
As noted above, in order to be enabling, the compound need not have been
made to satisfy enablement. Novo Nordisk Pharm., Inc. v. Bio–Tech. Gen. Corp.,
424 F.3d 1347, 1355 (Fed. Cir. 2005); In re Donohue, 766 F.2d 531, 533 (Fed. Cir.
1985). Indeed, In re Donohue, has a fact pattern similar to the one at issue in this
case: the examiner had made an anticipation rejection over a publication, which
disclosed the claimed compound, in combination with two patents teaching a
general process of making the particular class of compounds.17 Donohue, 766
F.2d at 532. Even though the authors of the publication in Donohue testified that
had not actually synthesized the compound,18 the court held that the fact that the
publication’s author did not synthesize the disclosed compound was immaterial to
the question of reference operability. Id. at 533–534. The method patents were
evidence that the named subject matter of the primary reference, which disclosed
every element of the invention (as does Barger) indeed “was in the public’s
possession” at the time of the invention. Id. at 534. The court distinguished the
case where a showing was made that all attempts to make the compounds using the
prior art methods were unsuccessful. Id. at 533. We have no credible evidence of

17 The generic method patents relied on in Donohue are akin to the Examiner’s
reliance on Rajkumar, Petrosyan, Terzyan, and Mostad, which teach generally how
to make amino-acid nitrate salts from mixing the amino acid with nitric acid, even
dilute nitric acid. Ans. 9–10. As the court in Donohue found the related general
process sufficiently enabling a claim for a specific compound, Donohue, 766 F.2d
at 534, we too could find the teachings of Rajkumar, Petrosyan, Terzyan, and
Mostad sufficient. However, we need not turn to the more general class of amino
acid nitrates cited by the Examiner because Dessianges expressly and clearly
provides a method to make the exact compound claimed.
18 We have no similar testimony from now long-dead Dessaignes to conclude that
he did not actually perform what he asserts to have performed.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

29
record of a modern chemist’s failed attempts to make creatine nitrate by the mixing
method taught in Dessaignes.
Yet, Patent Owner contends that its evidence “cannot be dismissed by
merely referencing In re Donohue and In re Gleave [, 560 F.3d 1331, 1338 (Fed.
Cir. 2009) (“it is not ‘necessary that an invention disclosed in a publication shall
have actually been made in order to satisfy the enablement requirement.’” (quoting
Donohue, 766 F2d at 533)].” Rather, Patent Owner argues that the credibility of
the disclosed methods were not questioned in Donohue as they are here and that
salt formation chemistry and the process taught by Dessaignes is less predictable
than the preparation of antisense oligonucleotides from a sense sequence based on
repeated cycles of phosphoramidite chemistry which was the known technology in
In re Gleave. PO App. Br. 27–29. This argument dismisses the law requiring only
that the product be taught and the procedure be enabling, and not that the product
actually be made. Concerns about credibility of the method being capable of
producing what is taught in the prior art are addressed through the above provided
enablement analysis. If Patent Owner can establish, by preponderance of the
evidence of record, that the skilled artisan cannot make what is alleged in the prior
art using the steps taught in the prior art, only then is a presumed reliable prior art
reference deemed to be unreliable and ineligible as an anticipatory reference as a
matter of law. Patent Owner, despite any concerns about reliability of the resulting
product, has not established based on a preponderance of the evidence that the
skilled artisan is not enabled to make creatine nitrate using the mixing method
described in Dessaignes without undue experimentation.
Moreover, we are not persuaded that Dessaignes is not reliable on its face or
that Dessaignes did not make creatine nitrate. Patent Owner has identified every
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

30
possible error, possible idiosyncrasy, and possible incongruity in the prior art and
in some art not even of record. Yet, Patent Owner still has not conclusively shown
Dessaignes’ mixing process does not produce creatine nitrate. On this record,
Patent Owner has not attempted to reproduce Dessaignes’ mixing process, which
as discussed above can routinely be performed at various concentrations, to show
an error in the process itself.19 Rather, Patent Owner contends that the burden has
not properly shifted to require them to do so.
We disagree that the burden is not properly shifted to Patent Owner. We
find the process taught by Dessaignes and that described in the ’074 patent to be
substantially identical. See Decision 11. The minimal difference between
Dessianges’ method of mixing creatine and nitric acid and that of the ’074 patent,
namely the order of adding water, has not been shown to be substantially different.
Patent Owner has not shown that the order of adding water is a critical to making
creatine nitrate. Rather, the ’074 patent indicates that the order of mixing is not
critical. ’074 patent, col. 15, ll. 49–59.
Because Dessaignes’ mixing process on its face is simple and routine, we
find the burden on Patent Owners to show that creatine nitrate cannot be made by
mixing creatine with nitric acids of any concentration at 30° C, as described by
Dessaignes, to be minimal and not overly burdensome. Yet, no such confirmation
has been done on this record. The burden shift is appropriate because we do not
have the resources of Patent Owner to confirm what the prior art expressly says is
true. In re Antor Media Corp., 689 F.3d at 1288.

19 Yet, Patent Owner allegedly attempted the likely more complicated bubbling
experiment. Fourth Chamberlin Decl. ¶ 19.
Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

31
Because of the age of the prior art, some inaccuracies might be present due
to the lack of sophisticated equipment at the time, but we are not persuaded that the
findings of Dessaignes are necessarily inaccurate. Supposition of error is not
enough for Patent Owner to meet their burden to show lack of enablement or
ambiguity in an otherwise express teaching in the prior art. In re Weber, 405 F.2d
at 1407.

V. CONCLUSION
We conclude that Patent Owner has not overcome the new grounds of
rejection of claim 6.
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this Decision becomes final and appealable
under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice
on the Director of the United States Patent and Trademark Office. See 37 C.F.R.
§§ 90.1, 1.983.

AFFIRMED: 37 C.F.R. § 41.77(f)

Appeal 2018-001029
Merged Reexamination Control 90/011,394 and 90/011,869
Patent 7,777,074 B2

32
FOR PATENT OWNER:

BOOTH UDALL FULLER, PLC
1255 W. RIO SALADO PKWY.
TEMPE, AZ 85281

FOR THIRD-PARTY REQUESTER:

GREGORY M. KRAKAU, ESQ.
LELAND PARACHINI STEINBERG MATZGER & MELNICK LLP
199 FREMONT STREET, 21ST FLOOR
SAN FRANCISCO, CA 94105