Ex Parte Naito

Board of Patent Appeals and Interferences

Mar 29, 2005

09967791 (B.P.A.I. Mar. 29, 2005)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ALBERT T. NAITO
__________
Appeal No. 2005-0126
Application No. 09/967,791
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, ELLIS, and MILLS, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. §134 from the examiner's final
rejection of claims 1-10 and 12-28, which are all of the claims pending in this
application.
Claim 1 is illustrative of the claims on appeal and reads as follows:
1. A method for increasing the effect of a chemical compound within the body of
a patient comprising administering said chemical compound to said patient, co-
administering with said chemical compound a hypertonic sugar composition by a route
other than by enteral administration or intravascular injection, and permitting said sugar
composition to increase said effect, wherein said increase in effect of said chemical
compound by said hypertonic sugar composition is by increasing the passage of said
compound through the patient’s blood-brain barrier.
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2
The prior art references cited by the examiner are:
Keep et al (Keep) 5,972,924 Oct. 26, 1999
Naito EP 0652012 A1 May 10, 1995
Grounds of Rejection
Claims 1-10 and 12-28 stand rejected under 35 U.S.C. §103(a), as obvious in
view of Naito and Keep.
We reverse this rejection.
DISCUSSION
Background
According to the background section of the specification describing the state of
the art, the “blood-brain barrier that exists in all vertebrate brains was discovered in the
latter part of the 19th century and the first half of the 20th century. Researchers
discovered that dyes injected intravenously into the bloodstream stained all internal
organs except the brain and that dyes injected into the cerebrospinal fluid stained cells
of the brain but did not enter the bloodstream to stain other internal organs. It was later
discovered that the blood-brain barrier was due to the structure of the capillary walls of
the brain.” Specification, page 1. “In organs other than the brain, fluid leaks out of the
capillaries and enters the tissue through pores formed at the junction of adjacent
endothelial cells. In the brain, however, endothelial cells of capillaries are intimately
fused by intracellular tight junctions. The tight junctions prevent the paracellular
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leakage of fluid from the capillaries, leaving transcellular flow from the capillary to the
brain as the only means for fluid and solutes to enter the brain from the bloodstream.”
Id.
“Among the means of transcellular fluid flow available to other organs of the
body, pinocytosis is virtually non-existent in brain capillaries. Consequently, solutes
may enter the brain in one of two ways. Facilitated transport, a specialized carrier or
receptor catalyst molecule transports a particular molecule through the endothelial cell
wall into the brain. In lipid-mediated transport, small lipid molecules dissolve in and
diffuse through the endothelial cell membrane. ” Specification, pages 1-2.
“While these mechanisms permit entry into the brain of essential nutrients, the
existence of the blood-brain barrier effectively prevents other substances, such as
hormones, proteins, certain ions, and drugs from entering the brain.” Specification,
page 2.
According to the specification, it has been discovered that a hypertonic sugar
composition is effective to promote the entry of a chemical substance, such as a
nutrient or diagnostic or therapeutic agent, across the blood-brain barrier when the
composition is administered to an animal by other than by gastrointestinal absorption or
intravascular injection. In particular, the described invention provides for the promotion
of the entry of a nutrient or a diagnostic or therapeutic agent across the blood-brain
barrier by co-administering the agent with a hypertonic sugar composition, which sugar
is administered by a route that permits absorption into the body through the nasal,
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ocular, oral, otic rectal, vaginal, or upper respiratory mucosa, or through the skin or
lungs. Specification pages 4-5.
35 U.S.C. §103(a)
Claims 1-10 and 12-28 stand rejected under 35 U.S.C. §103(a), as obvious in
view of Naito and Keep.
In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden
of presenting a prima facie case of obviousness. See In re Rijckaert, 9 F.3d 1531,
1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993). It is well-established that the
conclusion that the claimed subject matter is prima facie obvious must be supported by
evidence, as shown by some objective teaching in the prior art or by knowledge
generally available to one of ordinary skill in the art that would have led that individual to
combine the relevant teachings of the references to arrive at the claimed invention. See
In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
According to the examiner, “Naito teaches ingesting substances with a
combination of sugar and amino acid [hypertonic sugar composition] so that they
coexist in the blood stream and result in the facilitation of the use of the added material
by the body... The sugar/amino acid combination provides a vehicle and method for
transporting substances across the blood-brain barrier (column 2, lines 2-4).” Answer,
page 5. Naito exemplifies the administration of beta-carotene or xanthophylls with the
sugar composition and indicates this composition has the effect of increasing the growth
of hair and replacing grayness with original hair color. Id. Naito also teaches that any
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non-carcinogenic material having apparent utility in connection with the
treatment of the disorder being investigated may be combined with the hypertonic sugar
composition. Id.
According to the examiner, “Naito teaches oral administration of hypertonic sugar
compositions which is but one non-enteral or non-intravascular mode of administration.”
Answer, page 6.
Keep is relied on by the examiner for the disclosure of cyclosporins which cross
the blood-brain barrier with the aid of osmotic agents for example, mannitol and
arabinose and saccharose solutions, which are able to temporarily disrupt the blood-
brain barrier and allow therapeutic delivery of the drug to the brain. Answer, page 6;
Keep, column 5, lines 35-42. According to the examiner, suitable modes of
administration described in Keep are “oral, sublingual, buccal, nasal, inhalation,
parenteral, intraorgan, subcutaneous,” etc. Answer, page 6.
The examiner concludes (Answer, pages 6-7):
It would have been obvious to one of ordinary skill in the art at the time the
invention was made to co-administer or sequentially administer the
hypertonic sugar composition of Naito along with a chemical compound in
order to increase the effectiveness of said compound, to increase the
passage of the compound through or across the blood brain barrier, or to
increase the permeability of the blood-brain barrier by a route other than
enteral or intravascular injection since Keep teaches the use of hypertonic
sugar compositions for passing therapeutic agents across the blood-brain
barrier. The mode of administration is not seen to be a critical limitation
that would lend patentability of the instantly claimed process over the prior
art. The mode of administration is seen to be a choice of experimental
design as the art teaches suitable alternatives. One of ordinary skill in the
art would have been motivated to modify the teachings of Naito in order to
treat traumatic brain damage.
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The appellant responds, arguing Naito or Keep do not disclose any route of
administration of a sugar composition to open the blood-brain barrier than oral (Naito) or
intravascular (Keep). Brief, page 13.
With respect to Naito, appellant argues that “[t]he oral administration disclosed by
Naito ... is by ingestion, that is by swallowing followed by absorption in the small
intestines. Thus, the oral administration of Naito is an ‘enteral (i.e. intestinal)
administration.’” Reply Brief, page 2. Appellant further argues that the “present
specification, at each instance where it discloses 'oral', refers to absorption through the
oral mucosa, such as occurs when a subject sucks on a lozenge or gargles or chews
gum.” Reply Brief, page 2. Appellant argues claim 10 does not call for oral
administration, but for administration via one of 6 different mucosal surfaces, one of
which may be the oral mucosa. Id.
Appellant argues that, “Keep does not disclose any method of osmotic disruption
of the blood-brain barrier other than by administration of a hypertonic osmotic agent by
an intravascular route, either intra-arterial or intra-venous.” Id. Instead Keep describes
alternative modes of administration for only the formulary drug.
In addressing the appellant’s arguments, the examiner submits that “[o]ral
administration of the hypertonic composition [in Naito] meets the instant requirement of
administration by a route other than enteral administration or intravascular injection (see
claim 10).” Answer, page 8.
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1 The Merck Manual of Diagnosis and Therapy, Section 22, Chapter 298 (2004),
states that “For oral administration, the most common route, absorption refers to the
transport of drugs across membranes of the epithelial cells in the GI tract. .... The oral
mucosa has a thin epithelium and a rich vascularity that favors absorption, but contact is
usually too brief, even for drugs in solution, for appreciable absorption to occur. A drug
placed between the gums and cheek (buccal administration) or under the tongue
(sublingual administration) is retained longer so that absorption is more complete.”
(Attached)
7
We disagree. When the claims are viewed in accordance with the specification
and the prosecution history they encompass absorption through the oral mucosa and
specifically exclude enteral and intravascular administrations. We agree with appellant
that Naito does not describe administration of the sugar composition by a method other
than enteral or intravascular. In our view, Naito’s oral administration by ingestion
reasonably appears to be enteral administration.1 The examiner provides no evidence
that administration by ingestion as described by Naito would not have been considered
enteral administration by one of ordinary skill in the art. Moreover, we do not find that
Keep overcomes the deficiencies of Naito, as Keep only describes intravascular
administration of the sugar composition.
To establish prima facie obviousness of a claimed invention, all the claim
limitations must be taught or suggested by the prior art. In re Royka, 490 F.2d 981, 180
USPQ 580 (CCPA 1974). "All words in a claim must be considered in judging the
patentability of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165
USPQ 494, 496 (CCPA 1970). See also, MPEP § 2143.03. We do not find the
examiner has presented evidence of knowledge in the art of administration of the
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claimed sugar composition, through a method of administration other than enteral or
intravascular, i.e. through the oral or other mucosa.
The examiner cannot rely on lack of criticality or experimental design as a basis
for rejection of a positive claim limitation. Patent examiners, in relying on what they
assert to be general knowledge to negate patentability on the ground of obviousness,
must articulate that knowledge and place it of record, since examiners are presumed to
act from the viewpoint of a person of ordinary skill in the art in finding relevant facts,
assessing the significance of prior art, and making the ultimate determination of the
obviousness issue. Failure to do so is not consistent with either effective administrative
procedure or effective judicial review. Examiners cannot rely on conclusory statements
when dealing with particular combinations of prior art and specific claims, but must set
forth the rationale on which they rely. See In re Lee, 277 F.3d 1338, 1343-1344, 61
USPQ2d 1430, 1433-1434 (Fed. Cir. 2002). Thus, it is improper to rely on the “common
knowledge and common sense” of a person of ordinary skill in art to find an invention
obvious over a combination of prior art references, since the factual question of
motivation to select and combine references is material to patentability, and cannot be
resolved on subjective belief and unknown authority. In re Lee, 277 F.3d 1338, 1343-
1344, 61 USPQ2d 1430, 1433-1434 (Fed. Cir. 2002).
As with every case before the board, this board functions as a board of review,
not a de novo examination tribunal. 35 U.S.C. § 6(b) ("The [board] shall . . . review
adverse decisions of examiners upon applications for patents . . .."). Each appeal
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comes to the board with a unique record. On this record, we are constrained to find that
the examiner has not provided sufficient evidence to support a prima facie case of lack
of obviousness.
The dissent would appear to acknowledge the deficiencies of the record before
us, noting that, to the extent that further explanation of the strengths of the prior art (and
any de novo review by the board to establish a prima facie case of obviousness)
“diverges from the examiner's reasons, that the support for the examiner's position,
could, at the very least, have been denominated as a new ground of rejection.”
We respectfully disagree. First, this board serves statutorily as a board of
review, not a de novo examination tribunal. This administrative scheme necessarily
preserves an appellant's right to cross-examine any arguments and prior art cited by the
examiner and limit the appeal record in a manner appropriate for appellate review.
While the majority acknowledges the board has regulatory authority to enter a new
ground of rejection when warranted, we do not agree with the dissent that this is an
appropriate case for the exercise of such authority.
What is clear from the record is that the blood-brain barrier exists and is due to a
unique capillary structure in the brain. According to the specification and the prior art,
the existence of the blood-brain barrier effectively prevents substances such as
hormones, proteins, certain ions, and drugs from entering the brain without facilitated
transport or lipid mediated transport. Keep acknowledges that, to some extent, what
crosses the blood brain barrier is also dependent upon the nature of the compound.
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Keep states that highly lipid soluble drugs cross the blood brain barrier easily. Column
4, lines 49-50. Keep acknowledges that “mechanisms for opening the blood brain
barrier are known and include administration of hypertonic solutions intra-arterially &
intravenously...” Column 4, lines 50-52. Naito also acknowledges these known
methods for opening the blood brain barrier, and in addition finds that ingestion (enteral
administration) of pure sugars in combination with amino acids can open the blood brain
barrier. Thus, while drugs to be delivered to other parts of the body may be
administered by a variety of known routes of administration, the brain may be unique in
this respect, due to the relative impenetrability of the blood brain barrier.
The state of the art would thus appear to indicate that the ability of compounds to
cross the blood-brain barrier is dependent upon a number of variables, including the
nature of the chemical or compounds administered, and arguably, the prior art
recognizes only limited modes of administration of the hypertonic sugar composition.
While we believe it can be concluded from the prior art that administration of a
hypertonic sugar composition enterally, intra-arterially or intravenously is effective in
disruption of the blood brain barrier, we do not agree with either the examiner or our
colleague that the examiner has presented argument based on evidence of record
which would support the position that one of ordinary skill in the art would necessarily
conclude that all modes of administration of a hypertonic sugar composition which
eventually reach the blood stream, result in a sufficient opening of the blood brain
barrier for a sufficient amount of time to allow other therapeutic compounds to cross.
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While other modes of administration mentioned in Keep may be ready alternatives for
administration of drugs or treatment compounds (distinguished and distinct from the
hypertonic sugar solution) to other parts of the body, it would appear clear from the
record that the blood brain barrier is recognized by those of ordinary skill in the art as
being unique and distinct from other body tissues. Contrary to the dissent's
characterization of Keep, we do not find Keep states that the hypertonic sugar
composition may be administered by any mode of administration.
Furthermore, we note that unlike enteral absoprtion, contact is usually too brief
with the oral mucosa, even for drugs in solution, for appreciable absorption to occur.
Moreover, it is known from evidence of record that even with intravenous injection, the
blood brain barrier may be open from as little as 20 minutes to 2 hours. Keep, column
5, line 45. While the dissent views the statement from the Merck Manual as
demonstrating that persons having ordinary skill in the art understood that
administration of a pharmaceutical composition to the sublingual, buccal and nasal
mucosa was simply an alternative route of administering a composition to the blood
stream, we do not find that the statement provides acknowledgment that any
composition entering the blood stream by such routes would necessarily be of sufficient
chemical composition or nature or in sufficient amounts to open the blood-brain barrier
for a sufficient amount of time to allow entry of a therapeutic drug, administered by
another means. Therefore, we disagree with the dissent on this point and do not view
the evidence of record, without more, readily supports imposing a regulatory new
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ground of rejection by the board.
In view of the above, we do not find the examiner has established a prima facie
case of obviousness on the evidence before us. The rejection of claims 1-10 and 12-28
under 35 U.S.C. §103(a), as obvious in view of Naito and Keep is reversed.
CONCLUSION
The rejection of claims 1-10 and 12-28 under 35 U.S.C. §103(a), as obvious in
view of Naito and Keep is reversed.
No time period for taking any subsequent action in connection with this appeal
may be extended under 37 CFR § 1.136(a).
REVERSED
)
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
DEMETRA J. MILLS )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Appeal No. 2005-0126
Application No. 09/967,791
13
ELLIS, Administrative Patent Judge, dissenting.
Contrary to the majority, I find some merit in the examiner’s position. While the
examiner has not fully capitalized on the strengths of the applied prior art, I do not feel it
necessary to reverse the rejection. In my view, the examiner’s position, as is most often
the case given different perspectives and opinion, is in need of further explanation. To
the extent that such explanation diverges from the examiner’s reasons, the support for
the examiner’s position could, in the very least, have been denominated as a new
ground of rejection.
A determination of obviousness is based on several factual inquiries concerning
(i) the scope and content of the prior art, (ii) the level of ordinary skill in the art, (iii) the
differences between the claimed invention and the prior art, and
(iv) secondary considerations of nonobviousness, such as commercial success, failure
of others, unexpected results, etc. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966). It is well established, as pointed out by the majority, that the examiner sustains
the initial burden of establishing a prima facie case of obviousness. Pro-Mold &Tool Co.
v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573, 37 USPQ2d 1626, 1629 (Fed. Cir.
1996). In this regard, there must be some teaching in the art, or knowledge generally
available in the art, that would lead one having ordinary skill in the art to combine the
relevant teachings of the references. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d
1596,1598 (Fed. Cir. 1988). “The motivation, suggestion or teaching may come
explicitly from the statements in the prior art, the knowledge of one of ordinary skill in
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the art, or, in some cases the nature of the problem to be solved.” In re Kotzab, 217
F.3d 1365, 1369, 55 USPQ2d 1313,1317 (Fed. Cir. 2000); Pro-Mold &Tool Co. v. Great
Lakes Plastics, Inc., 75 F.3d at 1573, 37 USPQ2d at 1630. In this case, I find that the
suggestion to arrive at the claimed invention arises primarily from the latter two, i.e.,
from knowledge of those having ordinary skill in the art and the nature of the problem to
be solved.
Here, I find that all parties, the examiner, the appellant and the majority, are in
agreement that both Naito and Keep evince that the use of hypertonic sugar
compositions to increase the permeability of the blood-brain barrier for passage by other
compounds was known in the art at the time the application was filed. To that end, the
examiner points out that Naito discloses that a hypertonic sugar solution provides “a
vehicle and a method for transporting substances across the blood brain barrier.”
Answer, p. 5, pointing to Naito, col. 2, lines 2-4. The examiner further points out similar
teachings in Keep. Answer, p. 6 relying on Keep col. 5, lines 35-42 and
col. 6, lines 29-33. The applied prior art also discloses that the hypertonic sugar
composition can be administered “in combination, simultaneously or in sequence” with
the compound of interest (i.e., the compound/medication for which it is desired to treat
the nervous system). Keep, col. 6, lines 29-33; Naito, col. 3, lines 39-50. Thus, the only
difference between the claimed method and the methods taught by Naito and Keep is
the route of administration of the hypertonic sugar composition. In this regard,
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the examiner argues that the art teaches suitable alternatives for the mode of
administration of said sugar composition. Answer, p. 7. I agree.
Turning to the applied prior art, I find that Keep discloses that hypertonic agents
are typically “infused for 30 seconds through a major cerebral artery,” but that less
invasive and more convenient intravenous routes are also acceptable. Keep, col. 5,
lines 42-44 and lines 49-52. Keep further discloses (col. 6, lines 29-33) that the
invention includes
. . . all methods of administering treatment medications along with all methods of
opening, bypassing or disrupting the blood-brain barrier in combination,
simultaneously or in sequence to get the treatment medication in contact with
nervous tissues.
Keep still further discloses that numerous alternative routes of administering
pharmaceutical compositions into the blood stream were known in the art at the time the
application was filed. See, e.g., Keep, col. 5, line 64- col. 6, line 62. Keep still further
discloses that the preferred route depends on the condition of the patient. Id., col. 6,
lines 21-22. Keep still further discloses a formulation comprising a therapeutic drug
(desired compound for crossing the blood-brain barrier) and mannitol (a sugar
composition) which may be “isotonic, hypotonic or hypertonic with the blood of the
recipient.” Keep, e.g., col. 8, lines 59-66; see also, the Brief, p. 14, last para.
In addition to teaching that a hypertonic sugar composition increases the
permeability of the blood-brain barrier, Naito discloses that the mode of administration is
immaterial so long as the hypertonic sugar composition and compound of interest
Appeal No. 2005-0126
Application No. 09/967,791
2 Naito defines the base composition as “a combination of the hypertonic sugar
and amino acid which is effective to permit transportation of other materials into the glia
of the brain past the blood brain barrier.” Naito, col. 3, lines 18-21.
16
coexist in the blood stream. Naito, col. 3, lines 46-50. This is because the site of action
of the hypertonic sugar composition is in the bloodstream; said composition does not
cross the blood-brain barrier. Naito, col, 3, lines 38-39. In addition, Naito discloses that
the base material2 can enter the blood stream either by ingestion or by direct
introduction. Id., lines 35-38.
In my view, the aforementioned teachings of Keep and Naito would have
suggested to one of ordinary skill in the art that any art-recognized method of inserting
the hypertonic sugar solution into the blood stream (circulatory system) is acceptable for
increasing the permeability of the blood-brain barrier. That is, it would have been
obvious to one of ordinary skill in the art at the time of the present invention to employ
any convenient route of administering the hypertonic sugar composition to increase the
permeability of the blood brain barrier for passage by a therapeutic compound. In this
regard, Keep demonstrates that there were many alternative routes known in the art by
which pharmaceutical compositions could be introduced into the circulatory system,
other than enterally or by intravenous injection, and that the various routes of
pharmaceutical administration are interchangeable. See, e.g., Keep, col. 5, line 64-
col. 6, line 62. Keep describes the use of alternative routes of administration with
respect to the therapeutic drug as well as with the hypertonic sugar composition and a
formulation comprising a therapeutic drug and sugar composition. See, col. 6,
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3 As further evidence of the knowledge generally available in the art at the time of
the appellants’ invention, I direct attention to the Merck Manual relied upon by the
majority. The manual states that the “oral mucosa is known for its thin epithelium and a
rich vascularity that favors absorption.” See attached, p. 3, para. 2. Thus, the manual
demonstrates that persons having ordinary skill in the art understood that the
administration of a pharmaceutical composition to the sublingual, buccal and nasal
mucosa was simply an alternative routes of administering said composition to the blood
stream.
17
lines 29-33 and col. 8, lines 59-66. Thus, Keep demonstrates that one of ordinary skill
in the art would have understood at the time of the invention that (i) any pharmaceutical
composition could be administered by any one of numerous alternative routes; and
(ii) routes of administration through the sublingual, buccal or nasal mucosa, etc., are
simply art-recognized alternative routes of inserting a pharmaceutical agent into the
blood stream.3 In sum, since Naito teaches that the site of action of the hypertonic
sugar composition is the blood stream, one of ordinary skill in the art would have
understood that any art-recognized route of administering said composition into the
blood stream would be appropriate. Such persons select the route based on the
condition of the patient (Keep, col. 6, lines 21-22) and the timing necessary to ensure
that said composition and the therapeutic compound of interest are present in the blood
stream at the same time (Naito, col. 3, lines 46-50). Thus, contrary to the majority, I find
that the applied prior art demonstrates both the knowledge available in the art with
respect to the administration of pharmaceutical compositions and how persons with said
knowledge resolved the problems presented with different patients.
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4 Claim 10 lists several mucosa as routes of administration which include, inter
alia, the rectal mucosa. According to the definitions of enteral administration found by
the majority, rectal administration is a type of enteral administration which the claims are
said to exclude. See, independent claim 1 on which claim 10 depends.
5 Drugs which are administered orally, and which are absorbed by the
gastrointestinal tract as opposed to the oral mucosa, risk degradation by digestive
enzymes throughout the digestive tract prior to reaching the bloodstream. A hypertonic
sugar composition administered orally in solution form as taught by Naito (col. 5, lines
45-47) must survive the transit time from the mouth throughout the digestive tract as
well as encounters with low pH and potentially degrading enzymes. The Merck Manual,
p. 3. Thus, the time between administration and absorption into the bloodstream of a
hypertonic sugar composition which is administered orally is much greater than the time
for absorption when said composition is administered directly by intravenous injection.
18
Accordingly, in view of the teachings of Keep and Naito, I conclude that it would
have been obvious to persons having ordinary skill in the art to increase the
permeability of the blood-brain barrier by co-administering, or sequentially
administering, a hypertonic sugar composition using any art-recognized route of
administering a pharmaceutical composition to the bloodstream, which includes non-
enteral 4 and non-injection intravenous routes, such as administration via the sublingual,
buccal or oral mucosa, with a compound of interest. Moreover, in view of the teachings
of Naito that the hypertonic composition is effective when administered orally,5 one
having ordinary skill in the art would have a reasonable expectation that administration
of said composition via the sublingual, buccal, and nasal mucosa would be successful.
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19
Obviousness does not require absolute predictability, only a reasonable expectation of
success. In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).

JOAN ELLIS )
Administrative Patent Judge )
Appeal No. 2005-0126
Application No. 09/967,791
20
Howard Eisenberg, Esq.
2206 Applewood Court
Perkasi, PA 18944