Ex Parte Kaesemeyer

Patent Trial and Appeal Board

Nov 23, 2015

13048736 (P.T.A.B. Nov. 23, 2015)

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.
13/048,736 03/15/2011 Wayne H. KAESEMEYER 126625.00711 9330
21269 7590 11/23/2015
PEPPER HAMILTON LLP
500 GRANT STREET
SUITE 5000
PITTSBURGH, PA 15219-2507
EXAMINER
ROGERS, JAMES WILLIAM
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
11/23/2015 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 APPEAL BOARD
____________

Ex parte WAYNE H. KAESEMEYER
____________

Appeal 2013-004537
Application 13/048,736
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 1–6, 8, and 10–
20 (Br. 4). Examiner entered rejections under 35 U.S.C. § 102(e) and 35
U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellant’s “invention relates to L-arginine [] formulated in a
controlled release or sustained release formulation” (Spec. 4). Independent
claims 1, 13, and 16 are representative and reproduced in the Claims
Appendix of Appellant’s Brief.

1 Appellant identifies the Real Party in Interest as “Palmetto
Pharmaceuticals, LLC” (Br. 2).
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Claims 1–4, 8, 10, 13, 16, 19, and 20 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Kuhrts.2
Claims 1–6, 8, 10, 13, 16, 19, and 20 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kuhrts.
Claims 1–6, 8, and 10–20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kuhrts and Mills.3
Claims 1–6, 8, and 10–20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kuhrts and Ullah.4
Claims 1–6, 8, and 10–20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Levere,5 Gills,6 and Mills.
Claims 1–6, 8, and 10–20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Levere and Ullah.
We vacate, and will not further discuss, the rejections over the
combination of Kuhrts and Ullah; the combination of Levere, Gills, and
Mills; and the combination of Levere and Ullah, which are cumulative to the
rejection of the same claims over the combination of Kuhrts and Mills.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Kuhrts teaches Appellant’s claimed invention?

2 Kuhrts, US 2002/0068365 A1, published Jun. 6, 2002.
3 Mills et al., US 5,686,104, issued Nov. 11, 1997.
4 Ullah et al., US 6,235,311 B1, issued May 22, 2001.
5 Levere et al., US 5,217,997, issued Jun. 8, 1993.
6 Gills et al., US 5,681,582, issued Oct. 28, 1997.
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FACTUAL FINDINGS (FF)
FF 1. Kuhrts “discloses controlled release pharmaceutical preparations of
L-arginine along with botanical extracts that enhance or modulate
production of nitric oxide from L-arginine” (Final Rej. 2; Kuhrts ¶ 1).
FF 2. Kuhrts discloses “hydroxypropyl methylcellulose” as useful carrier
in Kuhrts’ formulations (Kuhrts ¶ 37; Final Rej. 2; cf. Spec. 17 (“A preferred
HPMC [(hydroxypropylmethylcellulose)] is Methocel® K100M”)).
FF 3. Kuhrts’ L-arginine compositions “may be administered or
coadministered with conventional pharmaceutical binders, excipients and
additives,” such as “natural sugars such as raw sugar or lactose, [] guar gum,
[] silica gel (for example colloidal), [and] hydroxypropyl methyl cellulose”
(Kuhrts ¶ 42; Final Rej. 2; cf. Spec. 18 (“Preferred fillers include [] sugars,
for example [] lactose” and “[p]referred glidants include colloidal silica and
precipitated silica”)).
FF 4. Kuhrts discloses that
[t]he amount of L-arginine contained in each dose can be
adjusted, to meet the needs of the individual patient, and the
indication. One of skill in the art will readily recognize how to
adjust the level of L-arginine and the release rates in a
controlled release formulation, in order to optimize delivery of
L-arginine and its bioavailability. In a preferable embodiment,
the amount of L-arginine in a dose ranges from about 500 mg[]
to about 30 grams.
(Kuhrts ¶ 50; id. ¶ 53 (“[d]osages of the controlled release formulations []
may be optimized by one of skill, using conventional dosing trials”)).
FF 5. Kuhrts discloses a formulation, wherein free-flowing particles are
compressed into a tablet that comprises METHOCEL® K100, guar gum,
micronized silica, and “about 732 mg[] of L-arginine per tablet (Kuhrts
¶¶ 60– 61; see generally, Final Rej. 3).
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ANALYSIS
Examiner finds that Kuhrts anticipates Appellant’s claimed invention
(Final Rej. 2–3).

Claims 1–4, 8, and 10:
We recognize, but are not persuaded by Appellant’s contention that
“Kuhrts fails to expressly or impliedly teach the step of dry mixing L-
arginine and the sustained release matrix with a glidant and filler” (Br. 11–
13; cf. FF 1–5; Final Rej. 3). Appellant provides no persuasive argument or
evidence to support a finding that Kuhrts’ exemplification of blending free-
flowing particles comprising L-arginine, hydroxypropylmethylcellulose in
the form of METHOCEL® K100, a glidant in the form of micronized silica,
and a filler in the form of guar gum; and subsequent compression of the
particles to form tablets containing “about 732 mg[] of L-arginine” fails to
teach all elements of Appellant’s claimed method (see FF 5; see Ans. 3).

Claims 13 and 16:
We recognize, but are not persuaded by Appellant’s contention that
Kuhrts’ “formulation [] does not encompass hydroxypropylmethylcellulose”
(Br. 13–19; cf. FF 2 and 3; Ans. 4). Kuhrts exemplifies a composition
comprising “about 732 mg[] of L-arginine,” therefore, we are not persuaded
by Appellant’s contention that Kuhrts fails to teach a composition
comprising an amount of L-arginine from about 100mg to about 2000mg
(Br. 14 and 16–17; see Appellant’s claims 13 and 16; cf. FF 5; Ans. 2). In re
Petering, 301 F.2d 676, 682 (CCPA 1962) (“[i]t is [] an elementary principle
of patent law that when, as by a recitation of ranges or otherwise, a claim
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covers several compositions, the claim is ‘anticipated’ if one of them is in
the prior art”).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Kuhrts teaches Appellant’s claimed invention. The rejection of
claims 1, 13, and 16 under 35 U.S.C. § 102(e) as being anticipated by Kuhrts
is affirmed. Claims 2–4, 8, and 10 are not separately argued and fall with
claim 1. “Claims 19 and 20 depend from claim 16,” are not separately
argued, and fall with claim 16 (Br. 19).

Obviousness:
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 6. Examiner relies on Kuhrts as set for the above (FF 1–5; see Final
Rej. 4).
FF 7. Appellant discloses, as fact, that “L-arginine has a relatively fast
half[-]life in the bloodstream. Accordingly, a controlled release formulation
of 350 mg may have the overall therapeutic impact of [a] much larger
[immediate release] dos[age] [formulation]” (Spec. 24).
FF 8. Kuhrts discloses “that the bioavailability of L-arginine and its
biological equivalents can be enhanced through incorporation into a
controlled release oral dosage form. This incorporation provides higher
absorption of L-arginine, thus increasing L-arginine’s effect” (Khurts ¶ 13).
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FF 9. Kuhrts discloses that “[n]itric oxide (NO) plays an important role in
the regulation of many physiological functions such as [] atherosclerosis”
(Kuhrts ¶ 2).
FF 10. Mills “relates to stable oral pharmaceutical formulations of [HMG
CoA reductase inhibitor] useful in the treatment of hypercholesterolemia or
hyperlipidemia” (Mills 1–2).
FF 11. Mills discloses that “[h]yercholesterolemia and hyperlipidemia,
conditions of excessively high levels of blood cholesterol and lipids, are well
recognized risk factors in the onset of atherosclerosis” (Mills 1).
ANALYSIS
The rejection over Kuhrts:
Having found that Kuhrts anticipates Appellant’s claims 1–4, 8, 10,
13, 16, 19, and 20, we find that Kuhrts also makes obvious these claims.
Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)
(“anticipation is the epitome of obviousness”). Therefore, we will not
further discuss the obviousness rejection of claims 1–4, 8, 10, 13, 16, 19, and
20; but, instead direct attention to our discussion of the anticipation
rejection. This leaves the rejection of claims 5 and 6 under 35 U.S.C.
§ 103(a) as unpatentable over Kuhrts.
Claims 5 and 6 depend from and further limit claim 1 to require that
arginine is present in an amount sufficient to produce tablets with about 750
mg or 350 mg of L-arginine respectively. Based on Kuhrts, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious to optimize the amount of L-arginine in Kuhrts
formulation as disclosed by Kuhrts (Final Rej. 4; Ans. 4–6; cf. FF 4–5).
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“L-arginine has a relatively fast half[-]life in the bloodstream” (FF 7).
Further, Kuhrts discloses that incorporation of L-arginine into a controlled
release oral dosage form enhances the bioavailability of L-arginine, thus
increasing L-arginine’s effect (FF8). Therefore, notwithstanding
Appellant’s contention to the contrary, it was neither surprising nor
unexpected that a lower L-arginine dosage in a sustained release formulation
will have similar efficacy as a higher dose of L-arginine in an immediate
release formulation (see Br. 26).

The rejection over the combination of Kuhrts and Mills:
Having found that Kuhrts anticipates Appellant’s claims 1–4, 8, 10,
13, 16, 19, and 20, we find that Kuhrts also makes obvious the subject
matter of these claims. Connell v. Sears, Roebuck & Co., 722 F.2d 1542,
1548, 220 USPQ 193, 198 (Fed. Cir. 1983) (“anticipation is the epitome of
obviousness”). In addition, for the foregoing reasons, we find that Kuhrts
makes obvious the subject matter of Appellant’s claims 5 and 6. Therefore,
we will not further discuss the obviousness rejection of claims 1–6, 8, 10,
13, 16, 19, and 20. See In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976)
(the Board may rely upon less than all the references cited by the Examiner).
This leaves the rejection of claims 11, 12, 14, 15, 17, and 18 under 35
U.S.C. § 103(a) as unpatentable over Kuhrts. Claims 11 and 17 depend from
and further limit the method of claim 1 and tablet of claim 16, respectively,
to require the inclusion of an agent which enhances the biotransformation of
arginine into nitric oxide (see Appellant’s claims 11 and 17). Claim 14
depends from and further limits the composition of claim 13 to require the
addition of a nitrate. Claims 12, 15, and 18 depend from and further limit
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the method, composition, and tablet of claims 11, 13, and 17, respectively, to
require the inclusion of an HMG-CoA reductase inhibitor or an agent
selected from the group consisting of an HMG-CoA reductase inhibitor.

Claims 11, 14, and 17:
Appellant does not dispute that Kuhrts suggests a composition
comprising, inter alia, agents “that enhance or modulate production of nitric
oxide from L-arginine” (FF 1). Therefore, we find no error in Examiner’s
rejection of claim 11 over the combination of Kuhrts and Mills. Because
they are not separately argued claims 14 and 17 fall with claim 11.

Claim 15:
Based on the combination of Kuhrts and Mills, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to include the HMG-CoA inhibitor of Mills in Kuhrts’
formulation, because the compositions of both Mills and Kuhrts as useful in
the treatment of “cardiovascular disease,” e.g., they both have, inter alia, an
effect on atherosclerosis (see Ans. 6; FF 9 and 11; cf. Br. 30 (“The O[f]fice
provides no factual basis for wanting to combine a treatment for
hypertension with a treatment for high cholesterol or that such combinations
would be feasible to treat body conditions”)). In re Kerkhoven, 626 F.2d
846, 850 (CCPA 1980) (“it is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose”). We recognize, but are not persuaded by,
Appellant’s contention that the combination of Kuhrts and Mills does not
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suggest that “HMG-CoA reductase inhibitor salts [] stimulate NOS and
potentiate the effect of L-arginine,” which is not required by Appellant’s
claim 15 (Br. 33; cf. Appellant’s claim 15).

Claims 12 and 18:
Claims 12 and 18 depend from claims 11 and 17, respectively, and
require the HMG-CoA reductase inhibitor to enhance the bio-transformation
of L-arginine into nitric oxide (see Appellant’s claims 11, 12, 17, and 18).
For the reasons discussed above, we find no error in Examiner’s conclusion
that it would have been prima facie to a person of ordinary skill in this art to
include the HMG-CoA inhibitor of Mills in Kuhrts’ formulation, because the
compositions of both Mills and Kuhrts as useful in the treatment of
“cardiovascular disease” (Ans. 6; cf. Br. 33 (“Kuhrts, provides no indication
that the combination of L-arginine with HMG-CoA reductase inhibitor salts
would be a suitable approach for the treatment of high cholesterol or
vasodilator dysfunction. Mills in turn does not correct these deficiencies”)).
We recognize, but are not persuaded by, Appellant’s contention that
Mills does not teach that HMG-CoA reductase inhibitor will enhance the
bio-transformation of L-arginine into Nitric Oxide (see Br. 33). As
discussed above, the combination of Kuhrts and Mills supports a conclusion
that it would have been prima facie obvious to combine L-arginine and an
HMG-CoA inhibitor in a sustained release formulation. Appellant’s
recognition that, in the formulation suggested by the combination of Kuhrts
and Mills, HMG-CoA reductase inhibitor will enhance the biotransformation
of arginine into Nitric Oxide does not render nonobvious an otherwise
known invention. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
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Cir. 1991) (“Mere recognition of latent properties in the prior art does not
render nonobvious an otherwise known invention”).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to the rejection over Kuhrts. The
rejection of claims 1, 5, 6, 13, and 16 under 35 U.S.C. § 103(a) as
unpatentable over Kuhrts is affirmed. Claims 2–4, 8, and 10 are not
separately argued and fall with claim 1. “Claims 19 and 20 depend from
claim 16,” are not separately argued, and fall with claim 16 (Br. 30).
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to the rejection over the combination
of Kuhrts and Mills. The rejection of claims 1, 5, 6, 11–13, 15, and 16 under
35 U.S.C. § 103(a) as unpatentable over the combination of Kuhrts and Mills
is affirmed. Claims 2–4, 8, and 10 are not separately argued and fall with
claim 1. Claim 18 is not separately argued and falls with claim 12. Claims
19 and 20 are not separately argued and fall with claim 16. Claims 14 and
17 are not separately argued and fall with claim 15.
We vacate the rejection of claims 1–6, 8, and 10–20 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Kuhrts and Ullah as
cumulative to the rejection of the same claims over the combination of
Kuhrts and Mills.
We vacate the rejection of claims 1–6, 8, and 10–20 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Levere, Gills, and Mills as
cumulative to the rejection of the same claims over the combination of
Kuhrts and Mills.
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We vacate the rejection of claims 1–6, 8, and 10–20 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Levere and Ullah as
cumulative to the rejection of the same claims over the combination of
Kuhrts and Mills.
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).

AFFIRMED

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