Ex Parte Butler et al

Patent Trial and Appeal Board

Jul 28, 2016

12459112 (P.T.A.B. Jul. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/459,112 0612612009
26813 7590 07/29/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
FIRST NAMED INVENTOR
Terri L. Butler
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
365.00160101 5568
EXAMINER
MCINTOSH III, TRAVISS C
ART UNIT PAPER NUMBER
1673
MAILDATE DELIVERY MODE
07/29/2016 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 TERRIL. BUTLER, JOHN ST. CYR,
and CLARENCE A. JOHNSON
Appeal2014-006973
Application 12/459, 112
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for improving cardiovascular function. The Examiner rejected the claims on
the ground of nonstatutory obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Bioenergy, Inc., also
known as RiboCor, Inc. (See Br. 1.)
Appeal2014-006973
Application 12/459, 112
Statement of the Case
Background
Appellants' invention relates to "methods for supplementing the diet
of subjects ... who are in need of cardioprotection" (Spec. 5:8-10). "D-
Ribose (which may be subsequently referred to as 'ribose') is administered
to a patient at least once a day in unit dosages of from two to ten grams" (id.
at 5:15-16).
The Claims
Claims 18, 19, and 21-25 are on appeal. Independent claim 18 is
representative and reads as follows (emphasis added):
18. A method for improving the cardiovascular function of a
subject suffering from coronary artery disease or congestive
heart failure, the method consisting of the administration of two
to eight grams of D-ribose one to four times daily to the subject
for a period longer than three weeks.
The Issue
The Examiner rejected claims 18, 19, and 21-25 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1-3 of Butler2 (Ans. 2-5).
The Examiner determines that
[a] lthough the conflicting claims are not identical, they are not
patentably distinct from each other because both [the]
application[ and the patent] are drawn to improving the
cardiovascular function in subjects having reduced
cardiovascular function, such as those with congestive heart
failure (CHF) or coronary artery disease, with overlapping
dosages of the same drug, ribose. It is noted the instant
application is drawn to administration for a period of longer than
2 Butler et al., US 7,553,817 B2, issued June 30, 2009.
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Application 12/459, 112
three weeks and the '81 7 patent requires administration for 3
weeks.
(Ans. 3.)
(Id.)
The Examiner concludes that
[h ]owever, it would be prima facia [sic] obvious to modify the
"3 week" time period in the [patent] to arrive at the instant time
period of "to a period of longer than three weeks". Modifying
process conditions and dosing regimens is normal and routine in
the art, and going from 21 days to 22 days of administration, for
example, would be well within the purview of a skilled artisan
since dosing regimens are normally done based on the patient's
needs.
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that claims 1-3 of Butler render
the claims unpatentable for obviousness-type double patenting?
Findings of Fact
1. Claim 1 of Butler recites "[a] method for improving the
cardiovascular function of a subject having reduced cardiovascular function
consisting of the administration of two to eight grams of D-ribose one to
times daily to the subject for a period of three weeks" (Butler, claim 1; see
also Ans. 3).
2. Butler teaches
Over a relatively short term, treatment with oral D-ribose
significantly improved diastolic cardiac function in patients with
severe coronary artery disease and congestive heart failure.
Administration of ribose resulted in an enhanced quality of life.
Longer term studies with ribose supplementation and studies on
less severely ill patients are expected to show greater
improvement in diastolic and systolic function. In the absence
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Application 12/459, 112
of adverse effects, it is recommended that patients continue on a
maintenance method of at least one dose of ribose daily.
(Butler 9:58-67.)
3. The Specification teaches
Over a relatively short term, treatment with oral D-ribose
significantly improved diastolic cardiac function in patients with
severe coronary artery disease and congestive heart failure.
Administration of ribose resulted in an enhanced quality of life.
Longer term studies with ribose supplementation and studies on
less severely ill patients are expected to show greater
improvement in diastolic and systolic function. In the absence of
adverse effects, it is recommended that patients continue on a
maintenance method of at least one dose of ribose daily.
(Spec. 16:4--10; see also Ans. 4.)
Principles of Law
"Obviousness-type double patenting is a judicially created doctrine
intended to prevent improper timewise extension of the patent right by
prohibiting the issuance of claims in a second patent which are not
'patentably distinct' from the claims of a first patent." In re Braat, 937 F.2d
589, 592 (Fed. Cir. 1991) (citation omitted). "It is the claims, not the
specification, that define an invention . . . . And it is the claims that are
compared when assessing double patenting." Ortho Pharmaceutical Corp.
v. Smith, 959 F.2d 936, 943 (Fed. Cir. 1992) (internal citation omitted).
Analysis
Claims 18, 21, and 22
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior patent (Ans. 2-10; FF 1-3) and agree with the
Examiner's conclusion of obviousness-type double patenting. We address
Appellants' arguments below.
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Application 12/459, 112
Appellants contend that "the lack of articulated, credible reasoning by
the Examiner as to why the modified dosing regimen would have the same
properties, is clear error" (Br. 4).
We do not find this argument persuasive. As the Examiner explains,
"the examiner is not required to provide a reasoning showing the modified
regimen would have the same properties, but rather must establish that the
modified dosing would have been obvious to one of skill in the art at the
time of the invention" (Ans. 6). See In re Braat, 937 F.2d at 592.
Moreover, the Examiner explains that
the statement that "patients are expected to show greater
improvement in diastolic and systolic function" is not seen to
provide a showing of different properties. The improvement of
diastolic and systolic function were properties already present in
the first three weeks of administration as evidenced by the
language "greater improvement" - i.e. - greater improvement
after three weeks than in the first three weeks. Thus this
statement is only seen to further evidence that the instant
application \'l/ould be obvious, since it is the continued
improvement of the same cardiovascular functions upon
continued administration of the drug which is being achieved and
not a new and unexpected property which is achieved.
(Ans. 8-9; see also FF 3.)
Appellants contend that "the Examiner has failed to establish that the
selection of a subject suffering from coronary artery disease or congestive
heart failure as recited in present claim 18 would be obvious over the
selection of a subject having reduced cardiovascular function as recited in
Butler et al." (Br. 5.)
We are not persuaded. We agree with the Examiner that
when a skilled artisan would look at the '81 7 patent to determine
what was embraced by the patient population of those "having
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Application 12/459, 112
reduced cardiovascular function", they would see that the instant
patients would be embraced by, and obvious therefrom. See
column 9, lines 58---67 which states that "treatment with oral D-
ribose significantly improved diastolic cardiac function in
patients with severe coronary artery disease and congestive heart
failure". Thus a skilled artisan, when reviewing what was
embraced by those patients having "reduced cardiovascular
function", would find it prima facia [sic] obvious to practice the
invention on patients having coronary artery disease and
congestive heart failure with the '817 patent in front of them.
(Ans. 6; FF 2.)
Appellants argue that
the claims of Butler et al. (i.e., the underlying specification of
Butler et al. cannot be used to support the present rejection)
provide no motivation for one of skill in the art to modify the
claimed "period of three weeks" to a nonoverlapping "period
longer than three weeks" as recited in the present claims.
(Br. 6.)
We do not find this argument persuasive. Peterson "held that a prima
facie case of obviousness exists when the claimed range and the prior art
range do not overlap but are close enough such that one skilled in the art
would have expected them to have the same properties." In re Peterson, 315
F.3d 1325, 1329 (Fed. Cir. 2003). The Examiner finds that "going from 21
days to 22 days of administration, for example, would be well within the
purview of a skilled artisan" (Ans. 3), and Appellants provide no evidence
rebutting this finding or showing that extending D-ribose administration to
22 days would have been expected to have different results than
administration for 21 days.
Appellants argue that "administration of D-Ribose for a period longer
than three weeks can provide advantageous results" based on references
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cited by Appellants "all of which disclose administration of D-Ribose for a
period of eight weeks" (Br. 7).
We do not find this argument, which implies unexpected results,
persuasive, because Appellants do not identify a teaching in the cited papers
(see Br. 7), or in the Specification, that identifies administration for longer
than three weeks, when compared to administration for exactly three weeks,
as yielding unexpected results. The burden of demonstrating unexpected
results rests on the party asserting them. In re Klosak, 455 F .2d 1077, 1080
(CCPA 1972). See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ("'It is well
settled that unexpected results must be established by factual evidence. Mere
argument or conclusory statements ... [do] not suffice."')
We also agree with the Examiner that "the showing of unexpected
results must be reviewed to see if the results occur over the entire claimed
range" (Ans. 9; emphasis omitted; citing MPEP § 716.02(d), In re Clemens,
622 F.2d 1029, 1036 (CCPA 1980)). The Examiner explains that
In re Clemens makes [it] clear that arguing references
which teach of 8 weeks of administration is not sufficient to
overcome the rejection when the claims embrace a range of "a
period longer than 3 weeks" since "8 weeks" cannot be said to
be equivalent to the entire range claimed which is 3 weeks and 1
day to the end of a patient's life (possibly over 2,000 weeks).
Experiments limited to 8 weeks is not commensurate in scope
with the instant claims.
(Ans. 9-10.)
Accordingly, we agree with the Examiner that "a skilled artisan, when
reviewing what was embraced by those patients having 'reduced
cardiovascular function', would find it prima facie obvious to practice the
invention on patients having coronary artery disease and congestive heart
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Application 12/459, 112
failure" (Ans. 5), and that "one would be motivated to modify the prior
[patent's] claims which are drawn to treatment for 'three weeks' to arrive at
the instant claims which are drawn to 'a period longer than three weeks'
when reviewing that which supports the instant claims" (Ans. 4).
Claims 19 and 23-25
Appellants make similar arguments for claims 19 and 23-25 as for
claim 18 above (see Br. 9-16). We likewise are not persuaded for the same
reasons as discussed above.
Conclusion of Law
The evidence of the record supports the Examiner's conclusion that
claims 1-3 of Butler render claims 18, 19, and 21-25 unpatentable for
obviousness-type double patenting.
SUMMARY
In summary, we affirm the rejection of claims 18, 19, 23, and 24 on
the ground of nonstatutory obviousness-type double patenting over claims
1-3 of Butler. Pursuant to 37 C.F.R. § 41.37(c)(l), we also affirm the
rejection of claims 21, 22, and 25 as these claims were not argued
separately.
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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