Ex Parte Lockwood et al

Board of Patent Appeals and Interferences

Mar 2, 2009

10793676 (B.P.A.I. Mar. 2, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SAMUEL LOCKWOOD, SEAN O’MALLEY,
DAVID WATUMULL, LAURA HIX,
HENRY JACKSON, and GEOFF NADOLSKI
__________

Appeal 2008-5693
Application 10/793,676
Technology Center 1600
__________

Decided:1 March 2, 2009
__________

Before DONALD E. ADAMS, ERIC GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, begins to run from the
decided date shown on this page of the decision. The time period
does not run from the Mail Date (paper delivery) or Notification
Date (electronic delivery).

Appeal 2008-5693
Application 10/793,676

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of reducing C-reactive protein. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse-in-part, vacate-in-part, and enter a new ground of rejection.
Statement of the Case
Background
“Cardiovascular disease (CVD), and specifically coronary artery
disease (CAD), remains the leading cause of death in the United States and
worldwide” (Spec. 1, ll. 27-28). According to the Specification,
“[t]hrombolytic therapy is unsuccessful in reperfusion of about 20% of
infarcted arteries” (Spec. 3, ll. 15-16). The Specification notes that “[o]f the
arteries that are successfully reperfused, approximately 15% abruptly reclose
(within 24 hours). Measures of systemic inflammation (e.g., serum levels of
C-reactive protein or CRP) correlate strongly with clinical reclosure in these
patients” (Spec. 3, ll. 16-19).
The Claims
Claims 2493, 2497-2507, 2509-2524, 2529, and 2532 are on appeal.
We will focus on claim 2493, which is representative and reads as follows:
2493. A method of reducing C-reactive protein (CRP)
levels in a subject comprising administering to a subject who
would benefit from such treatment, an effective amount of a
pharmaceutically acceptable formulation to reduce the level
of circulating CRP in the subject, said pharmaceutically
acceptable formulation comprising a non naturally occurring
carotenoid analog or derivative;
wherein the synthetic carotenoid analog or derivative
has the structure

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where each Y is independently O or H2;
where each X is independently

-aryl-NR13+, -alkyl-CO2-, -aryl-CO2-, -amino acid-NH3+,
-phosphorylated amino acid-NH3+, polyethylene glycol,
dextran, alkyl, -vitamin C, -phosphorylated vitamin C,
benzyl, aryl,

wherein each R1 is independently –alkyl-NR23+,-aryl-NR23+,
-alkyl-CO2-, -aryl-CO2-, -amino acid-NH3+,
-phosphorylated amino acid-NH3+, polyethylene glycol,
dextran, H, alkyl, aryl, or alkali salt; and
where each R2 is independently H, alkyl, or aryl; and
where each R3 is independently hydrogen or methyl; and
where each R5 is independently hydrogen, alkyl, benzyl,
or alkali salt.

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The prior art
The Examiner does not rely upon any prior art.

The issues
A. The Examiner rejected claims 2493, 2497-2507, 2509-2524, 2529,
and 2532 under 35 U.S.C. § 112, first paragraph, written description (Ans.
3).
B. The Examiner rejected claims 2493, 2497-2507, 2509-2524, 2529,
and 2532 under 35 U.S.C. § 112, first paragraph, enablement (Ans. 4-6).
C. The Examiner rejected claims 2493, 2497-2507, 2509-2524, 2529,
and 2532 under 35 U.S.C. § 112, second paragraph (Ans. 7-8).
D. The Examiner rejected claims 2493, 2497-2507, 2509-2524, 2529,
and 2532 under 35 U.S.C. § 112, first paragraph, as containing new matter
(Ans. 3).
A. 35 U.S.C. § 112, first paragraph, Written Description
The Examiner finds that the “specification fails to disclose any
treatable diseases caused by increased C-reactive protein (CRP), and how
reducing CRP is the same as treating the diseases” (Ans. 4). The Examiner
finds that the “claims are attempts by applicant to claim treatment of any
disease arising from increased CRP. Therefore, they are reach-through
claims, and are no longer patentable under the US patent practice” (Ans. 4).
Appellants contend that the Specification teaches “that the serum level
of CRP is a measure for systemic inflammation. Page 8, lines 11-12, teaches
that inflammatory heart disease is measure [sic] and influenced by CRP”
(App. Br. 6). Appellants also contend that the Specification “teaches
‘reduction of circulating CRP levels, together with the reduction(s) in infarct
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size previously noted with CardaxTM in rodents, would form a powerful anti-
inflammatory therapeutic modality in the acute coronary syndrome setting’”
(App. Br. 7).
In view of these conflicting positions, we frame the written
description issue before us as follows:
Did the Examiner err in finding that the Specification did not convey
with reasonable clarity to the skilled artisan possession of a “method of
reducing C-reactive protein (CRP) levels in a subject comprising
administering . . . a non naturally carotenoid analog or derivative” as
required by claim 2493?
Findings of Fact (FF)
1. The Specification teaches that “[i]schemia is the lack of an
adequate oxygenated blood supply to a particular tissue. Ischemia underlies
many acute and chronic disease states” (Spec. 2, ll. 13-14). The
Specification associates ischemia with myocardial infarction, unstable
angina, stable angina pectoris, thrombotic stroke, and peripheral vascular
insufficiency, among other diseases (see Spec. 2, ll. 16-26).
2. The Specification teaches that “[c]ommon to each of these
[disease] settings is the phenomenon of reperfusion injury” (Spec. 2, ll. 30-
31).
3. The Specification teaches the association of C-reactive protein
with reperfusion injury, noting that “[m]easures of systemic inflammation
(e.g., serum levels of C-reactive protein or CRP) correlate strongly with
clinical reclosure in [reperfused] patients” (Spec. 3, ll. 17-19).
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4. The Specification teaches that the “administration of structural
analogs or derivatives of carotenoids by one skilled in the art . . . is expected
to inhibit and/or ameliorate . . . disease conditions” (Spec. 7, ll. 2-5). The
Specification teaches carotenoid analogs are intended to treat disease
conditions such as “inflammatory heart disease [as measured and influenced
by C-reactive protein (CRP) and myeloperoxidase (MPO)]” (Spec. 7, ll. 30-
31).
5. The Specification teaches specific structures of carotenoid
analogs, including some of the structures encompassed by claim 2493 (see
Spec. 50-52).
6. The Specification teaches that the “influence of parenteral
administration of the disodium disuccinate astaxanthin derivative (XVI)
[Cardax™] on induced infarct size and induced levels of circulating C-
reactive protein (CRP) in rabbits was investigated” (Spec. 148, ll. 12-14).
The Specification teaches the use of an “experimental myocardial ischemia-
reperfusion injury in the rabbit heart” (Spec. 148, ll.17-18).
7. The Specification teaches that “[i]t has been suggested that
CRP, commonly used as a marker for the acute inflammatory (‘acute-phase’)
response, may actually have a pro-inflammatory effect mediated through the
activation of the complement cascade” (Spec. 148, ll. 18-20).
8. The Specification teaches that “(1) the endogenous increase in
plasma CRP secondary to a remote inflammatory lesion was associated with
an increase in myocardial tissue injury secondary to regional ischemia and
reperfusion . . . and (3) CRP was an ‘effector’, and not merely an indirect
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measure of systemic inflammation, in this system” (Spec. 148, l. 23 to 149, l.
1).
9. The Specification teaches that “[r]eductions in infarct size of
approximately 55.4% percent were seen in CardaxTM - treated rabbits . . .
Similarly, the mean increase in circulating CRP levels in controls (+23.5%)
over baseline was completely abrogated in the CardaxTM - treated animals, to
mean levels below those observed at baseline (-15.7%)” (Spec. 150, ll. 14-
18).
10. The Specification teaches that “CRP is both an effector in the
acute coronary syndrome - resulting in an increased infarct size in the
presence of elevated levels of this acute phase reactant - and a strong
independent predictor of cardiovascular risk in primary and secondary
prevention cardiac patients” (Spec. 150, ll. 18-21).
11. The Specification teaches that “reductions in the levels of this
circulating protein forms a strong therapeutic modality” (Spec. 150, ll. 21-
22).
12. The Examiner presents no evidence regarding the description
issue (see Ans. 4).
Principles of Law
The first paragraph of 35 U.S.C. § 112 “requires a ‘written description
of the invention’ which is separate and distinct from the enablement
requirement.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
1991). An adequate written description of a chemical invention “requires a
precise definition, such as by structure, formula, chemical name, or physical
properties.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d
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916, 927 (Fed. Cir. 2004); Regents of the Univ. of Cal. v. Eli Lilly & Co.,
Inc., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164,
1171 (Fed. Cir. 1993).
“A description of what a material does, rather than of what it is,
usually does not suffice.” Rochester, 358 F.3d at 923; Eli Lilly, 119 F.3d at
1568. Instead, the “disclosure must allow one skilled in the art to visualize or
recognize the identity of the subject matter purportedly described.” Id.
In addition, possession of a genus “may be achieved by means of a
recitation of a representative number of [compounds] … falling within the
scope of the genus.” Eli Lilly, 119 F.3d at 1569. “Possession may not be
shown by merely describing how to obtain possession of members of the
claimed genus.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (BPAI 2007)
(citing Rochester, 358 F.3d at 927).
Analysis
The Specification provides direct descriptive support of an association
between many ischemic disease states and reperfusion injury (FF 1-2). The
Specification directly teaches that levels of C-reactive protein are associated
with reperfusion injury and that treatment of these conditions with
carotenoids “is expected to inhibit and/or ameliorate . . . disease conditions”
(Spec. 7, ll. 2-5; FF 3-4). The Specification also teaches possession of a
large number of specific carotenoids (FF 5).
The Specification provides a working example in which Cardax™
(which is the carotenoid disodium disuccinate astaxanthin) functions to
reduce CRP levels as well as infarct size in a rabbit experimental model of
myocardial ischemia-reperfusion injury (FF 6-9). The Specification teaches
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that CRP is an effector of inflammatory disease with reduction in CRP levels
functioning as a therapeutic modality (FF 10-11).
The Examiner has presented no evidence which demonstrates an
absence of descriptive support for the claimed invention (FF 12).
We are not persuaded by the Examiner’s argument that “the Examiner
found no conclusive evidence that reduction of circulating CRP is ‘a
powerful anti-inflammatory therapeutic modality’ and/or ‘a strong
therapeutic modality’” (Ans. 8). “The burden of showing that the claimed
invention is not described in the application rests on the PTO in the first
instance.” In re Edwards, 568 F.2d 1349, 1354 (CCPA 1978).
The Examiner has not met this burden of proof, and offers no
evidence or scientific reasoning why the claims do not satisfy the written
description requirement, other than a failure to provide “conclusive
evidence” (see Ans. 8). The Examiner’s requirement for “conclusive
evidence” is legally incorrect. Appellants must show that “as of the filing
date sought, [the inventor] was in possession of the invention.” Vas-Cath
Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). There is no
burden on Appellants to show “conclusive evidence” of possession.
The evidence of record more than amply demonstrates that Appellants
were in possession of the claimed invention (FF 1-11).
Conclusion of Law
The Examiner erred in finding that the Specification did not convey
with reasonable clarity to the skilled artisan possession of a “method of
reducing C-reactive protein (CRP) levels in a subject comprising
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administering . . . a non naturally carotenoid analog or derivative” as
required by claim 2493.
B. 35 U.S.C. § 112, first paragraph, Enablement
The Examiner finds that “the specification does not reasonably
provide enablement for using the . . . instant compounds for any diseases
arising from increased C-reactive protein” (Ans. 4). The Examiner finds that
“not all diseases arising from increased CRP are known today, and the
specification fails to cite any one” (Ans. 6).
Appellants contend that “the role of CRP in disease etiology is known
to the ordinary practitioner of the art” (App. Br. 8). Appellants cite Barrett2
and Pepys3 and Danenberg4 to show that CRP is associated with disease (see
App. Br. 8-10).
In view of these conflicting positions, we frame the enablement issue
before us as follows:
Did the Examiner err in finding that it would require undue
experimentation to administer the claimed carotenoid analogs to reduce the
levels of C-reactive protein in “a subject who would benefit from such
treatment”?

2 Barrett et al., C-Reactive-Protein-Associated Increase in
Myocardial Infarct Size After Ischemia/Reperfusion, 303 J.
PHARMACOLOGY EXPERIMENTAL THERAPEUTICS 1007-1013 (2002).
3 Mark B. Pepys and Gideon M. Hirschfield, C-reactive protein: a
critical update, 111 J. CLINICAL INVESTIGATION 1805-1812 (June
2003).
4 Danenberg et al., Increased thrombosis after arterial injury in
human C-reactive protein-transgenic mice, 108 CIRCULATION 512-
515 (July 2003).
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Findings of Fact
Breadth of Claims
13. Claim 2493 encompasses a “method of reducing C-reactive
protein (CRP) levels in a subject comprising administering to a subject who
would benefit from such treatment . . . the synthetic carotenoid analog or
derivative [which] has the structure” described (Claim 2493).
Presence of Working Examples
14. The Specification teaches treatment of myocardial infarction in
rabbits using a carotenoid analog (see FF 6-11).
Amount of Direction or Guidance Presented
15. The Specification teaches the association of C-reactive protein
levels with a variety of ischemia-based diseases (FF 1-5).
16. The Specification teaches that “[i]t has been suggested that
CRP, commonly used as a marker for the acute inflammatory (‘acute-phase’)
response, may actually have a pro-inflammatory effect mediated through the
activation of the complement cascade” (Spec. 148, ll. 18-20).
State of the Prior Art and Unpredictability of the Art
17. The Examiner discusses Miao5, who teaches that “recent
studies have demonstrated that CRP can be used to help predict the risk of

5 Wujian Miao and Allen J. Bard, Electrogenerated
chemiluminescence. 72. Determination of Immobilized DNA and
C-Reactive Protein on Au(111) Electrodes Using Tris(2,2’-
bipyridyl)ruthenium(II) Labels, 75 ANALYTICAL CHEMISTRY 5825-
5834 (2003). We note that the Miao reference was not cited in the
“evidence relied upon” section of the Examiner’s Answer, but was
previously relied upon by the Examiner in the Final Office Action.

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acute events in patients with atherosclerosis. CRP has also been shown to
predict risk of future events in patients with acute coronary syndromes and
in patients with stable angina and coronary artery stents” (Miao 5827, col.
1).
18. The Examiner states, without any supporting evidence, that
“CRP is a symptom and therefore a secondary reaction in the above diseases.
Increased CRP is not the cause of the diseases” (see Ans. 6).
19. Barrett teaches the “possibility that CRP is a mediator and
amplifier of injury secondary to ischemia/reperfusion. Pharmacological
modulation of the plasma CRP concentration . . . may be appropriate
therapeutic targets for the management of patients with unstable acute
coronary syndromes” (Barrett 1012, col. 2).
20. Pepys teaches that the “excellent correlation of circulating CRP
concentrations with the severity, extent, and progression of many different
pathologies, and the prognostic significance of these associations, are
consistent with CRP not just being a marker of disease but also contributing
to pathogenesis” (Pepys 1811, col. 1).
21. Danenberg teaches that “[e]merging in vitro evidence suggests
that CRP may have direct proinflammatory and prothrombotic effects on
monocytes and endothelial cells” (Danenberg 512, abstract). Danenberg
teaches that “CRP is a risk factor and possible causal agent, rather than
merely a risk marker, for increased rate of arterial thrombosis in vivo and
worsened outcome after controlled vascular injury” (Danenberg 514, col. 2).
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Quantity of Experimentation
22. The Examiner finds that “to use the invention as claimed, one
of ordinary skill in the art would have to perform experimentation in every
instance to determine if a patient has abnormally high CRP prior to
intervention” (Ans. 6).
23. Miao teaches that “CRP concentrations of unknown specimens,
for example, human plasma/serum, can be measured by the standard
addition method based on the ECL technique” (Miao 5834, col. 1).
Skill in the Art
24. The Examiner makes no findings regarding the skill in the art.
Principles of Law
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth
a reasonable explanation as to why it believes that the scope
of protection provided by that claim is not adequately
enabled by the description of the invention provided in the
specification of the application.

In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993). “[T]he question of
undue experimentation is a matter of degree. The fact that some
experimentation is necessary does not preclude enablement; what is required
is that the amount of experimentation ‘must not be unduly extensive.”’ PPG
Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996).
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Factors to be considered in determining whether a disclosure
would require undue experimentation … include (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).
Analysis
The Examiner bears the burden of providing an explanation as to why
the claims are not adequately enabled by the Specification. In re Wright, 999
F.2d at 1561-1562. In this case, the Examiner's position appears to be that
the Specification is not enabling because “not all diseases arising from
increased CRP are known today, and the specification fails to cite any one”
(Ans. 6).
In analyzing the Wands factors, based upon the evidence presented by
the Examiner, all of the factors other than breadth of the claims are clearly
either neutral or support the enablement position of Appellants. The
Specification has a working example (FF 9-11, 14) and the Specification
provides guidance on the association of CRP levels and therapeutic effects
of carotenoids (FF 1-6, 15-16). Barrett, Pepys, and Danenberg provide
evidence that the skilled artisan reasonably considered CRP as a potential
therapeutic target (FF 19-21), with only the Examiner’s unsupported
statement to show unpredictability (FF 18).
The Examiner reasons that there might be mutations in the C-reactive
protein gene which might lead to increased production (see Ans. 6). While
the Examiner does not complete this idea, presumably the Examiner
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concludes that treatment with the carotenoids of claim 2493 would not be
able to reduce the level of a protein that is constitutively expressed rather
than induced by cardiac injury. However, the fact that a claimed method
might encompass inoperative embodiments does not necessarily mean that
the claim is nonenabled. See Atlas Powder Co. v. E.I. du Pont De Nemours
& Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984) (“Even if some of the claimed
combinations were inoperative, the claims are not necessarily invalid”.) In
such cases, the issue of enablement turns on whether “the number of
inoperative combinations becomes significant, and in effect forces one of
ordinary skill in the art to experiment unduly in order to practice the claimed
invention,” id. at 1576, which the Examiner has not shown to be the case
here.
While the Examiner finds a need to test for CRP in order to determine
whether the proposed therapy is appropriate (FF 22), Miao demonstrates that
CRP concentrations “can be measured by the standard addition method
based on the ECL technique” (Miao 5834, col. 1; FF 23).
The Examiner has not provided the required evidence or scientific
reasoning to show that one of ordinary skill in the art would find that
reduction of CRP levels in a patient would have required “undue
experimentation”. The Examiner's mere assertions to that effect are not
sufficient for establishing a prima facie case of lack of enablement.
Balancing the factors in the Wands analysis, upon which the rejection is
based, demonstrates that there is no prima facie case of lack of enablement.
Conclusion of Law
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The Examiner erred in finding that it would require undue
experimentation to administer the claimed carotenoid analogs to reduce the
levels of C-reactive protein in “a subject who would benefit from such
treatment”.
C. 35 U.S.C. § 112, second paragraph
The Examiner finds that “[f]or reason [sic] set forth above under 35
USC 112, first paragraph6, the claims are indefinite” (Ans. 7).
Appellants contend that “the claims have been amended for
clarification” (App. Br. 10).
In view of these conflicting positions, we frame the indefiniteness
issue before us as follows:
Did the Examiner err in finding that the claims are indefinite?
Principles of Law
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations
omitted).
In Miyazaki, the Board stated that
rather than requiring that the claims are insolubly
ambiguous, we hold that if a claim is amenable to two or
more plausible claim constructions, the USPTO is justified
in requiring the applicant to more precisely define the metes
and bounds of the claimed invention by holding the claim

6 We are uncertain whether the Examiner refers to one or all of the
35 U.S.C. § 112, first paragraph rejections under written
description, enablement, and new matter here.
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unpatentable under 35 U.S.C. § 112, second paragraph, as
indefinite.

Ex Parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008).
Analysis
The Examiner has not identified any specific element of any claim
which is indefinite, simply referring to an asserted failure of written
description and/or enablement (see Ans. 7). Even under Miyazaki, the
Examiner has not provided a reason or argument why the claims are
amenable to two or more plausible claim constructions.
Conclusion of Law
The Examiner erred in finding that the claims are indefinite.
D. 35 U.S.C. § 112, first paragraph, New Matter
The Examiner’s Answer mailed January 11, 2008 included a new
matter rejection stating that the “definition of X as amended is new matter”
(Ans. 4). The Examiner did not present the new matter rejection to
Appellants in the previous office action, a non-final office action mailed
April 5, 2007.
According to the Manual of Patent Examining Procedure (MPEP),
Any new ground of rejection made by an examiner in an
answer must be: (A) approved by a Technology Center (TC)
Director or designee; and (B) prominently identified in the
“Grounds of Rejection to be Reviewed on Appeal” section
and the "Grounds of Rejection" section of the answer (see
MPEP § 1207.02). The examiner may use form paragraph
12.154.04. The examiner's answer must provide appellant a
two-month time period for reply.

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MPEP § 1207.03 (I). The Examiner (and the members of the Appeals
Conference) did not follow any of the required procedures for entering a
new grounds of rejection, with no approval indicated by the TC Director, no
prominent identification of the rejection and no option to provide Appellants
with a two-month reply time period.
Accordingly, the 35 U.S.C. § 112, first paragraph, New Matter
rejection is not properly before us. In the interest of efficiency and in order
to minimize inconvenience to Appellants, we vacate the Examiner’s 35
U.S.C. § 112, first paragraph, New Matter rejection in favor of a New
Ground of Rejection under 37 C.F.R. § 41.50(b) in order to provide
Appellants the opportunity to respond.

New ground of rejection
Under the provisions of 37 C.F.R. § 41.50(b), we enter the
following new ground of rejection.
Claims 2493, 2497-2507, 2509-2524, 2529, and 2532 are rejected
under 35 U.S.C. 112, first paragraph, as failing to comply with the written
description requirement. The claim(s) contains subject matter, which was not
described in the Specification in such a way as to reasonably convey to one
skilled in the relevant art that the inventor(s), at the time the application was
filed, had possession of the claimed invention
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Findings of Fact
25. Independent claims 2493 and 2532 both recite that “R5 is
independently hydrogen, alkyl, benzyl, or alkali salt” (Claims 2493 and
2532).
26. The Specification does not teach an R5 substituent at pages 49-
73, where the structural disclosures of the carotenoid analogs are found (see
Spec. 49-73).
27. Independent claims 2493 and 2532 both recite that X may be

(Claims 2493 and 2532).

28. The Specification does not teach the structures shown in FF 27
with R5 substituents (see Spec. 54). Even where the Specification teaches a
similar structure, the structure is not the same. For example, the structure
below is similar to the first structure from claim 2493 shown in FF 27 with
hydrogens in the R5 positions. However, the structure in below has an
oxygen linked to the carbonyl group adjacent the mark for linkage,
while the first compound in claim 27 lacks such an oxygen.
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(see Spec. 54, Claim 2493).
Principles of Law
Adequate written description means that, in the Specification, the
applicant must “convey with reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she was in possession of the [claimed]
invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64
(Fed.Cir.1991).
“When no such description can be found in the specification, the only
thing the PTO can reasonably be expected to do is to point out its
nonexistence.” Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007). In
the context of the written description requirement, “an adequate prima facie
case must therefore sufficiently explain to the applicant what . . . is missing
from the written description.” Id.
Analysis
A specific recitation of R5 was not disclosed ipsis verbis in the
Specification (FF 25-26). Of course, ipsis verbis support is not required.
Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996).
However, the Specification does not reasonably appear to be in
possession of an R5 substructure as required by claims 2493 and 2532 (FF
25-26). Additionally, the Specification does not reasonably show possession
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of the structures shown in FF 27 since the structures do not reasonably
appear to be in the possession of Appellants in the Specification (FF 27-28).
Conclusion of Law
We find that claims 2493, 2497-2507, 2509-2524, 2529, 2532 fail to
comply with the written description requirement since the claims contain
subject matter, which was not described in the specification to demonstrate
possession of the claimed invention.
SUMMARY
In summary, we reverse the rejection of claims 2493, 2497-2507,
2509-2524, 2529, 2532 under 35 U.S.C. § 112, first paragraph, written
description. We reverse the rejection of claims 2493, 2497-2507, 2509-
2524, 2529, 2532 under 35 U.S.C. § 112, first paragraph, enablement. We
reverse the rejection of claims 2493, 2497-2507, 2509-2524, 2529, 2532
under 35 U.S.C. § 112, second paragraph. We vacate the rejection of claims
2493, 2497-2507, 2509-2524, 2529, and 2532 under 35 U.S.C. § 112, first
paragraph, new matter.
This decision also contains a new grounds of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides "[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of
rejection to avoid termination of the appeal as to the rejected claims:
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Appeal 2008-5693
Application 10/793,676

(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or
both, and have the matter reconsidered by the Examiner, in which event the
proceeding will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

REVERSED-IN-PART, VACATED-IN-PART, § 41.50(b)

dm

MEYERTONS, HOOD, KIVLIN,
KOWERT & GOETZEL., P.C
P.O. BOX 398
AUSTIN, TX 78767-0398

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