Ex parte FARRIS

Board of Patent Appeals and Interferences

Dec 28, 2000

08818958 (B.P.A.I. Dec. 28, 2000)

1
The opinion in support of the decision being entered today was not written for
publication and is not precedent of the Board.
Paper No. 16
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte BARRY FARRIS
____________
Appeal No. 2000-0526
Application No. 08/818,958
____________
ON BRIEF
____________
Before COHEN, STAAB and BAHR, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 1-10 as amended subsequent to the final
Appeal No. 2000-0526
Application No. 08/818,958
The two amendments (Paper Nos. 6 and 9) to claim 3, line 1, actually1
requested by the appellant result in the term "bending" appearing twice in
succession. We note, however, that the second amendment (Paper No. 9) was
clerically entered so that the claim reads ". . . including bending closed a
gas passageway . . ." (i.e., the term "bending" appears only once), which
appears to have been the appellant's intent and which is consistent with the
copy of claim 3 in the appendix to the appellant's brief. In any event, we
shall interpret claim 3 as it appears in the appendix to the appellant's
brief.
2
rejection (see Paper Nos. 9 and 11). No other claims are1
pending in this application.
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Application No. 08/818,958
3
BACKGROUND
The appellant's invention relates to a plungerless
syringe (claims 1 and 4-8) and a method for sequestering gas
from therapeutic fluid and injecting therapeutic fluid using
the plungerless syringe (claims 2, 3, 9 and 10). An
understanding of the invention can be derived from a reading
of exemplary claims 1 and 2, which appear in the appendix to
the appellant's brief.
The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Farris (Farris I) 5,102,398 Apr. 7, 1992
Farris (Farris II) 5,370,626 Dec. 6,
1994
The following rejections are before us for review.
(1) Claims 2 and 10 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Farris I.
(2) Claims 3 and 9 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Farris I in view of Farris II.
(3) Claims 1 and 4-8 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Farris I.
(4) Claims 1 and 4-8 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Farris I.
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Application No. 08/818,958
4
(5) Claims 1, 2 and 4-8 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being
unpatentable over claims 1-14 of Farris I.
(6) Claims 3, 9 and 10 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being
unpatentable over claims 1-14 of Farris I in view of Farris
II.
Reference is made to the brief and reply brief (Paper
Nos. 12 and 14) and the final rejection and answer (Paper Nos.
7 and 13) for the respective positions of the appellant and
the examiner with regard to the merits of these rejections.
OPINION
In reaching our decision in this appeal, we have given
careful consideration to the appellant's specification and
claims, to the applied prior art references, and to the
respective positions articulated by the appellant and the
examiner. As a consequence of our review, we make the
determinations which follow.
At the outset, we note that, notwithstanding the
appellant's groupings as set forth on page 9 of the brief, the
appellant has not argued separately the patentability of claim
Appeal No. 2000-0526
Application No. 08/818,958
Merely pointing out differences in what the claims cover is not an2
argument as to why the claims are separately patentable. 37 CFR §
1.192(c)(7).
5
10 apart from claim 2 or claim 3. Therefore, claim 10 shall2
stand or fall with representative claim 2 in deciding the
appeal of rejection (1) and with representative claim 3 in
deciding the appeal of rejection (6) (see In re Young, 927
F.2d 588, 590, 18 USPQ2d 1089, 1091 (Fed. Cir. 1991); In re
Wood, 582 F.2d 638, 642, 199 USPQ 137, 140 (CCPA 1978)).
For the reasons discussed, infra, in the new ground of
rejection of method claims 2, 3, 9 and 10 under the second
paragraph of 35 U.S.C. § 112 pursuant to 37 CFR § 1.196(b), we
have determined that claims 2, 3, 9 and 10 are indefinite. We
recognize the inconsistency implicit in our holding that these
claims are rejectable under 35 U.S.C. § 112, second paragraph,
as failing to particularly point out and distinctly claim the
invention with our holding, infra, that these claims are
unpatentable under 35 U.S.C. § 102 or 103 or under the
judicially created doctrine of obviousness-type double
patenting. Normally, when substantial confusion exists as to
the interpretation of a claim and no reasonably definite
Appeal No. 2000-0526
Application No. 08/818,958
6
meaning can be ascribed to the terms in a claim, a
determination as to patentability under 35 U.S.C. § 102 or 103
or under the judicially created doctrine of obviousness-type
double patenting is not made. See In re Steele, 305 F.2d 859,
862, 134 USPQ 292, 295 (CCPA 1962) and In re Wilson, 424 F.2d
1382, 1385, 165 USPQ 494, 496 (CCPA 1970). However, in this
instance, we consider it to be desirable to avoid the
inefficiency of piecemeal appellate review. See
Ex parte Ionescu, 222 USPQ 537, 540 (Bd. App. 1984). For the
reasons outlined below, we interpret the appellant's method
claims 2, 3, 9 and 10 as being directed to a method for
sequestering gas from therapeutic fluid in a plungerless
syringe and injecting therapeutic fluid using the syringe. We
interpret claim 9 as further requiring that the body portion
of the plungerless syringe be provided with a wide central
portion tapering towards both the outlet and gas passageway.
Therefore, we have made a determination below as to the
patentability under 35 U.S.C. §§ 102 and 103 and the doctrine
of obviousness-type double patenting of method claims 2, 3, 9
and 10 in the interest of judicial economy.
Rejection (1)
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7
Anticipation is established only when a single prior art
reference discloses, expressly or under the principles of
inherency, each and every element of a claimed invention. RCA
Corp. v. Applied Digital Data Sys., Inc., 730 F.2d 1440, 1444,
221 USPQ 385, 388 (Fed. Cir. 1984). In other words, there
must be no difference between the claimed invention and the
reference disclosure, as viewed by a person of ordinary skill
in the field of the invention. Scripps Clinic & Research
Found. v. Genentech Inc., 927 F.2d 1565, 1576, 18 USPQ2d 1001,
1010 (Fed. Cir. 1991). It is not necessary that the reference
teach what the subject application teaches, but only that the
claim read on something disclosed in the reference, i.e., that
all of the limitations in the claim be found in or fully met
by the reference. Kalman v. Kimberly Clark Corp., 713 F.2d
760, 772, 218 USPQ 781, 789 (Fed. Cir. 1983), cert. denied,
465 U.S. 1026 (1984). Under principles of inherency, when a
reference is silent about an asserted inherent characteristic,
it must be clear that the missing descriptive matter is
necessarily present in the thing described in the reference,
and that it would be so recognized by persons of ordinary
Appeal No. 2000-0526
Application No. 08/818,958
8
skill. Continental Can Co. v. Monsanto Co., 948 F.2d 1264,
1268, 20 USPQ2d 1746, 1749 (Fed. Cir. 1991).
The examiner's position in rejecting claims 2 and 10 as
being anticipated by Farris I, as set forth in the final
rejection (pages 2-3) and repeated substantially verbatim in
the answer (pages 3-4), is as follows:
Farris '398 [Farris I] discloses the method
steps as claimed in column 4, lines 7-38. The only
step that is not explicitly taught is the urging of
any gas from the infusion device and the syringe
into the air trap. However, Farris discloses (4:21-
27) indicating that the needle is installed onto the
syringe and the device horizontally oriented causing
any air trapped in the syringe to move upwardly into
the air trap. This also is considered to inherently
expel air from the needle since the device will
undergo shaking while the syringe needle is
positioned to be inserted into the patient and will
inherently urge gas toward the gas chamber. At this
position, the air trap will be located at the
highest elevation of the syringe. The syringe
clearly includes a removable tab at 20, 20a and 20b.
The appellant's statement on page 11 of the brief that
the examiner's observation that there is no "urging" step
defeats anticipation is a mischaracterization of the
examiner's position. The examiner has determined that air
will inherently be expelled or urged from the needle (device)
and the syringe by the positioning of the device for insertion
Appeal No. 2000-0526
Application No. 08/818,958
9
into the patient in the manner disclosed by Farris I, thereby
meeting the "urging" step of claim 2.
In our opinion, the method of using a plungerless syringe
disclosed by Farris I in column 4, lines 7-38, fully
anticipates the subject matter of claim 2. Farris I discloses
docking a syringe, which has an air trap (chamber 22) located
remote from a fluid exit (outlet tip 18a), with a hypodermic
needle or cannula (column 4, lines 13-14); orienting the
syringe so that the air trap is at a highest elevation as
shown in Figure 3, this orientation also performing the
"urging" step by causing any air trapped in the syringe to
move upwardly into the air trap 22 (column 4, lines 24-27);
inserting the needle into the patient and injecting the
therapeutic liquid by pressing the wall 12a forwardly (column
4, lines 31-33). While Farris I does not explicitly state
that the disclosed "horizontal" orientation of the syringe
will cause air (gas) from the device (needle or cannula) to
move upwardly into the air trap, one of ordinary skill in the
art would understand that the interior of the needle or
cannula and the container 12 are in fluid communication and
that, as such, any gas trapped in liquid which has migrated
Appeal No. 2000-0526
Application No. 08/818,958
10
into the needle or cannula will also move upwardly into the
air trap.
We note that claim 2 does not require that the "urging"
step take place after the orienting step as the appellant's
argument on page 2 of the reply brief implies. From our
viewpoint, nothing in claim 2 precludes the urging taking
place simultaneously with the orienting step, for example.
Moreover, the examiner's position that the step of
maintaining the syringe in the horizontal orientation (after
having first placed it in such orientation) while inserting it
into the patient will inherently urge gas from the needle or
cannula and syringe upward into the air trap, since the needle
or cannula will undergo shaking, appears reasonable to us.
After the PTO establishes a prima facie case of anticipation
based on inherency, the burden shifts to the appellant to
prove that the prior art does not possess the characteristics
of the claimed invention. See In re Thorpe, 777 F.2d 695,
698, 227 USPQ 964, 966 (Fed. Cir. 1985). The appellant has
not even specifically argued, much less proven, that such
shaking and consequent gas movement will not inherently occur
during insertion.
Appeal No. 2000-0526
Application No. 08/818,958
For the record, we note that Farris I discloses (column 4, lines 7-14)3
a step of initially (i.e., prior to positioning a needle or cannula on the tip
18a) removing a tab at the fluid exit, as required by claim 10.
11
For the foregoing reasons, the appellant's arguments fail
to persuade us that the examiner has committed error by
determining that Farris I anticipates the method recited in
claim 2. Accordingly, we shall sustain the examiner's
rejection of claim 2, and of claim 10 which falls therewith,3
as being anticipated by Farris I.
Rejection (2)
Claim 3 depends from claim 10 and further recites a step
of "bending closed a gas passageway which extends between the
gas trap and a fluid containing body portion of the syringe
just prior to the injecting step." The examiner concedes that
this step is not disclosed by Farris I. However, the examiner
notes that Farris I discloses that the main objective of the
plungerless deformable syringe is to trap gas so that it will
be prevented from being injected into the patient and that
Farris II discloses closing the gas chamber of a plungerless
deformable syringe prior to injection so the trapped air has
no chance at all of being injected into the patient. The
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12
examiner then concludes that, in light of the combined
teachings of Farris I and Farris II, it would have been
obvious to one of ordinary skill in the art to close off the
gas chamber of Farris I as taught by Farris II "since it is
well desired that no gas/air be injected into the patient due
to the ill effects that may occur therefrom" (answer, page 5).
The appellant argues that there is no teaching in the
prior art applied by the examiner of bending the passageway
closed as required by claim 3 (brief, page 12). We disagree.
In column 5, lines 45-57, Farris II teaches sealing the
passage 40 (and hence the chamber 22) from the container 12 by
applying compressive forces to the walls of the passage to
bring the inside wall surfaces 41, which either have adhesive
applied thereto or are provided with tongue and groove
structures as illustrated in Figures 2A and 2B, into contact
to form a seal 43. From our perspective, the application of
compressive forces to the passage walls bends the walls and
thus is a step of bending the passageway closed, as recited in
claim 3. Further, it is our opinion that the teachings of
Farris II (column 3, lines 3-8; column 7, lines 20-22) are
sufficient to have motivated one of ordinary skill in the art
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13
at the time of the appellant's invention to compress the
tubular connection 22a forming the passage 24 in the syringe
of Farris I to seal the chamber 22 from the container 12,
after urging any trapped air into the chamber, to remove any
risk that air will be injected therefrom.
For the foregoing reasons, we shall sustain the
examiner's rejection of claim 3 as being unpatentable over
Farris I in view of Farris II.
Claim 9 depends from claim 3 and further recites, as
interpreted, supra, the body portion having a wide central
portion tapering both towards the outlet and gas passageway.
As clearly illustrated in Figures 2 and 3, the body (container
12) of Farris I is formed with a wide central portion which
tapers towards the outlet (tip 18a) and towards the gas
passageway (passage 22a) (note column 3, lines 25-29 and 39).
Accordingly, we shall also sustain the examiner's rejection of
claim 9 as being unpatentable over Farris I in view of Farris
II.
Rejections (3) and (4)
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14
Claim 1 on appeal requires, inter alia, "a gas trap
disposed on said back wall at an opposite end of said body
from said fluid outlet." The gas trap in the syringe of
Farris I, as illustrated in Figures 1-4, is disposed on a side
(peripheral) wall 12d rather than the back (rear) wall 12a.
The examiner's position that Farris I anticipates the subject
matter of claim 1 is that
Farris, however, discloses (4:39-46) that it will be
recognized that the air trap can be positioned in
various locations and can have various shapes. It
is considered inherent that this includes the back
wall of the device [answer, page 5].
As pointed out above, under principles of inherency, when
a reference is silent about an asserted inherent
characteristic (in this case, positioning of the gas trap on
the rear wall 12a), it must be clear that the missing
descriptive matter is necessarily present in the thing
described in the reference, and that it would be so recognized
by persons of ordinary skill (Continental Can Co., 948 F.2d at
1268, 20 USPQ2d at 1749). As the court stated in In re
Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326 (CCPA 1981)
(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 40 USPQ 665,
667 (CCPA 1939)):
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15
Inherency, however, may not be established by
probabilities or possibilities. The mere fact that
a certain thing may result from a given set of
circumstances is not sufficient.
We see nothing in the teachings of Farris I that the air
trap can be positioned in "various" locations which would
necessarily result in placement of the gas chamber on the rear
wall of the syringe and thus conclude that the examiner has
failed to meet the initial burden of establishing a prima
facie case of anticipation based upon the theory of inherency.
See In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788
(Fed. Cir. 1984). Accordingly, we shall not sustain the
examiner's rejection of claim 1, or claims 4-8 which depend
therefrom, as being anticipated by Farris I.
Turning next to the examiner's alternative rejection of
claims 1 and 4-8 as being unpatentable over Farris I, the
examiner contends that it would have been an obvious design
alternative to one of ordinary skill in the art to move the
air trap to the rear wall based on the statement that the air
trap can be positioned in various locations and have various
shapes since this position will not compromise the intent of
the syringe at all and since the syringe will be needed to be
Appeal No. 2000-0526
Application No. 08/818,958
16
inserted into the patient straight up and down at times
(answer, page 5).
Rejections based on 35 U.S.C. § 103 must rest on a
factual basis. In making such a rejection, the examiner has
the initial duty of supplying the requisite factual basis and
may not, because of doubts that the invention is patentable,
resort to speculation, unfounded assumptions or hindsight
reconstruction to supply deficiencies in the factual basis.
In re Warner, 379 F.2d 1011, 1017, 154 USPQ 173, 177-78 (CCPA
1967).
As recognized by the examiner, Farris I does not teach
placing the gas trap chamber on the rear wall of the syringe.
In fact, Farris teaches that the air trap chamber is
positioned on one side of the container in a location that is
generally perpendicular to the direction that the container is
squeezed to collapse it (column 2, lines 41-44). This
teaching would appear to suggest that the rear wall might not
be a suitable location for the gas trap chamber and that the
"various locations" referred to in column 4, line 40, may, in
fact, be limited to locations on the side (peripheral) wall
12d, for example. We also note that the examiner has not
Appeal No. 2000-0526
Application No. 08/818,958
17
supplied any evidence that it was known in the art at the time
of the appellant's invention to place the gas trap chamber of
a plungerless syringe on the rear wall, opposite the liquid
outlet. Having reviewed the teachings of Farris I as a whole,
we fail to perceive any teaching, suggestion or incentive
therein which would have motivated an artisan to modify the
Farris I syringe in such a fashion as to meet the terms of
claim 1. From our perspective, the only suggestion for
modifying the Farris I syringe to place the gas trap chamber
on the rear wall in the manner proposed by the examiner is
found in the luxury of hindsight accorded one who first viewed
the appellant's disclosure. This, of course, is not a proper
basis for a rejection. See In re Fritch, 972 F.2d 1260, 1266,
23 USPQ2d 1780, 1784 (Fed. Cir. 1992).
In light of the foregoing, we shall also not sustain the
examiner's rejection of claim 1, and claims 4-8 which depend
therefrom, as being unpatentable over Farris I.
Rejections (5) and (6)
The double patenting rejections are based on a judicially
created doctrine of double patenting grounded in public policy
so as to prevent the unjustified or improper timewise
Appeal No. 2000-0526
Application No. 08/818,958
A terminal disclaimer in compliance with 37 CFR 1.321(c) may be used4
to overcome an obviousness-type double patenting rejection provided the
conflicting patent is shown to be commonly owned with an application. See 37
CFR § 1.130(b).
18
extension of the "right to exclude" granted by a patent by
prohibiting the issuance of the claims in a second patent not
patentably distinct from the claims of the first patent. See
In re Longi, 759 F.2d 887, 892, 225 USPQ 645, 648 (Fed. Cir.
1985).4
Turning first to claims 1 and 4-8, the examiner concedes
that none of the claims of Farris I recites that the gas trap
is disposed "on said back wall at an opposite end of said body
from said fluid outlet" as required by claims 1 and 4-8 on
appeal. However, the examiner asserts that, in light of the
disclosure in column 4, lines 39-40, of the Farris I patent
that the air trap can be positioned in various locations, "the
broad recitation in the patented claim would therefore cover
all locations for the gas trap or would have directed one of
ordinary skill in the art to moving the air trap to any
location that would still perform the desired result" (answer,
page 7).
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Application No. 08/818,958
19
As discussed above, we find nothing in the disclosure of
Farris I, including the teaching that the gas trap chamber may
be positioned in various locations, which teaches, either
explicitly or under the theory of inherency, or would have
suggested to one of ordinary skill in the art placing the gas
trap chamber on the back or rear wall of the syringe, at an
opposite end of the body from the fluid outlet, as recited in
claims 1 and 4-8 on appeal. For the foregoing reasons,
we shall not sustain the examiner's rejection of claims 1 and
4-8 under the doctrine of obviousness-type double patenting as
being directed to an invention which is not patentably
distinct from the subject matter of claims 1-14 of the Farris
I patent.
Turning next to the examiner's rejection of method claim
2 under the doctrine of obviousness-type double patenting as
being directed to an invention which is not patentably
distinct from the claims of the Farris I patent, we note that
patent claims 13 and 14, the only claims of the Farris I
patent directed to the method of injecting liquid with a
plungerless syringe, do not recite a step of docking the
syringe with a device at the fluid exit, as required by claim
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2 on appeal. As the examiner has not provided any evidence
that the addition of such a step in the method of claim 13 or
14 of the Farris I patent would have been obvious to one of
ordinary skill in the art at the time of the appellant's
invention, we are constrained to reverse the examiner's
rejection of claim 2 under the doctrine of obviousness-type
double patenting.
For the reasons which follow, however, we shall sustain
the examiner's rejection of claims 3, 9 and 10 under the
doctrine of obviousness-type double patenting as being
directed to an invention which is not patentably distinct from
the subject matter of the claims of the Farris I patent in
view of Farris II.
We note, at the outset, that none of claims 3, 9 and 10
requires that the air trap be located on the back wall. In
this regard, claim 2, from which claims 3, 9 and 10 depend,
recites merely that the syringe has an air trap "remote from a
fluid exit." Neither of claims 13 and 14 of the Farris I
patent expressly recites that the gas trap chamber is remote
from the liquid outlet. However, while the patent disclosure
may not be used as prior art in considering whether a claim in
Appeal No. 2000-0526
Application No. 08/818,958
As explained in Vogel, such use of the patent disclosure is permitted,5
and frequently required, because it is difficult, if not meaningless, to try
to say what is or is not an obvious variation of a claim, which is merely a
group of words defining only the boundary of the patent monopoly. The patent
claim may not describe any physical thing and indeed may encompass physical
things not yet dreamed of. See id.
Webster's New World Dictionary, Third College Edition (Simon &6
Schuster, Inc. 1988).
21
an application defines merely an obvious variation of an
invention disclosed and claimed in a patent under the doctrine
of obviousness-type double patenting, it is permissible to use
a tangible embodiment set forth in the disclosure which falls
within the scope of a patent claim to determine whether a
claim in the application defines merely an obvious variant of
the subject matter of the patent claim. See In re Vogel, 422
F.2d 438, 441, 164 USPQ 619, 622 (CCPA 1970). In this5
instance, as clearly illustrated in Figures 1-4 of the Farris
I patent, in the tangible embodiment of the method of claims
13 and 14, the gas trap chamber (22) is remote (distant in
space, far off, far away) from the liquid outlet (18a). 6
Thus, the location of the air trap remote from the fluid
outlet, as recited in the claims on appeal, does not
distinguish over the method of patent claims 13 and 14.
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Application No. 08/818,958
22
Each of claims 13 and 14 of the Farris I patent recites a
step of orienting the syringe so that the air (gas) trap
extends generally upwardly so that any gas in said chamber
will be displaced into said chamber. As illustrated in the
tangible embodiment of the method (Figures 3 and 4), the air
trap is at a highest elevation of the syringe in this
orientation of the syringe. It is this position of the air
trap which causes any gas in the container of the syringe to
be displaced into the chamber as set forth in the "orienting"
step of patent claims 13 and 14. Accordingly, the step of
orienting the syringe as recited in claim 2, from which claims
3, 9 and 10 on appeal depend, is met by the method of claims
13 and 14 of the Farris I patent. As for the step of urging
recited in claim 2, this step is also achieved by orienting
the syringe in the manner set forth in claims 13 and 14 of the
Farris I patent, for the reasons discussed above in our
discussion of rejection (1), supra.
In light of the preamble language "injecting liquid from
a plungerless syringe" set forth in claim 13 of the Farris I
patent, one of ordinary skill in the art would have understood
the step of "collapsing said container in a manner such that
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Application No. 08/818,958
23
liquid is ejected out of said container" recited in patent
claim 13 to be a step of injecting the liquid, as required by
claim 3.
Claims 13 and 14 of the Farris I patent differ from the
method recited in claim 3 on appeal, in that (1) the patent
claims are directed to injection of "liquid" rather than
"therapeutic fluid," (2) the patent claims omit a step of
docking the syringe with a device at the fluid exit and (3)
the patent claims do not recite a step of "bending closed a
gas passageway . . . just prior to the injecting step."
Farris II, however, discloses the use of plungerless
syringes as medical devices for the injection of fluids to
patients (column 1, lines 11-14), teaches connecting a needle
34 or cannula 26 to the outlet portion of the syringe in a
manner allowing liquids in the container of the syringe to be
ejected through the needle or cannula (column 5, lines 65-68)
and, as discussed above, teaches compressing (i.e., bending)
the walls of a passage between a gas chamber and the container
of the syringe to form a seal to prevent gas which has passed
into the gas chamber from being injected into the patient.
Appeal No. 2000-0526
Application No. 08/818,958
24
Farris II would have suggested to one of ordinary skill
in the art filling the container of the plungerless syringe of
the method of claims 13 and 14 of Farris I with a therapeutic
fluid and docking the plungerless syringe with a device, such
as a needle or cannula, in order to adapt the method of the
patent claims for injecting a therapeutic fluid into a
patient. Further, it would have been obvious to one of
ordinary skill in the art at the time of the appellant's
invention to provide a sealing device, such as an adhesive or
tongue and groove arrangement, on the inside surfaces of the
walls of the passage communicating the gas trap chamber and
container in the method of claims 13 and 14 of the Farris I
patent and to compress (i.e., bend closed) the passage walls
to form a seal to remove any risk that air trapped in the air
trap chamber will be injected into the patient, as taught by
Farris II.
Claim 9 on appeal depends from claim 3 and, as
interpreted, supra, further requires that the body portion of
the plungerless syringe be provided with a wide central
portion tapering both towards the outlet and gas passageway.
We note that the body (container 12) of the tangible
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Application No. 08/818,958
25
embodiment of the subject matter of claims 13 and 14 of the
Farris I patent is formed with a wide central portion which
tapers towards the outlet (tip 18a) and towards the gas
passageway (passage 22a) (note column 3, lines 25-29 and 39).
Moreover, such tapering of the container or body portion of a
plungerless syringe was conventional in the art at the time of
the appellant's invention, as evidenced by Farris II.
Accordingly, such tapering is not a patentable distinction
over the method of claims 13 and 14 of Farris I.
For the foregoing reasons, we find ourselves in agreement
with the examiner that the subject matter of claims 3 and 9 on
appeal is not patentably distinct from the subject matter of
claims 13 and 14 of the Farris I patent. Accordingly, we
shall sustain the examiner's obviousness-type double patenting
rejection of claims 3 and 9, as well as claim 10 which falls
with claim 3 in light of the appellant's failure to separately
argue the patentability of claim 10 apart from claim 3.
Appeal No. 2000-0526
Application No. 08/818,958
26
NEW GROUNDS OF REJECTION
Pursuant to our authority under 37 CFR § 1.196(b), we
enter the following new grounds of rejection.
Claims 2, 3, 9 and 10 are rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter
which the appellant regards as the invention.
The legal standard for definiteness is whether a claim
reasonably apprises those of skill in the art of its scope.
See In re Warmerdam, 33 F.3d 1354, 1361, 31 USPQ2d 1754, 1759
(Fed. Cir. 1994).
The preamble of claim 2 is not commensurate in scope with
the body of the claim, thereby rendering the scope of the
claim confusing. The preamble of claim 2 recites a method for
sequestering gas from therapeutic fluid in a plungerless
syringe. The body of the claim, on the other hand, recites
steps of docking, orienting and urging, which appear to
comprise the method for sequestering gas from therapeutic
fluid, and an additional step of injecting the therapeutic
fluid, which, as we see it, is not part of the method for
sequestering gas from therapeutic fluid. In light of this
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Application No. 08/818,958
27
inconsistency between the preamble and body of claim 2, one of
ordinary skill in the art cannot determine with any certainty
whether the claim is directed to a method of sequestering gas
from therapeutic fluid or to a method of sequestering gas from
therapeutic fluid and injecting the therapeutic fluid. Claims
3, 9 and 10 depend, either directly or indirectly, from claim
2 and are likewise indefinite.
Claim 9 recites an additional step of "forming the body
portion . . ." which is directed to a process for forming a
syringe, rather than a method for sequestering gas from
therapeutic fluid in a plungerless syringe, as recited in the
preamble. This inconsistency between the preamble and body of
the claim further confuses the scope of the claim, in that it
is not clear whether the claim is directed to a method of
forming a plungerless syringe or sequestering gas from
therapeutic fluid in a syringe (and injecting the fluid).
Claim 2 is rejected under the judicially created doctrine
of obviousness-type double patenting as being unpatentable
over claims 13 and 14 of the Farris I patent in view of Farris
II.
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Application No. 08/818,958
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The reasoning set forth above in determining that the
subject matter of claims 3, 9 and 10 is not patentably
distinct from the subject matter of claims 13 and 14 of the
Farris I patent in view of Farris II, which is incorporated
herein, also mandates a conclusion that the subject matter of
claim 2, from which claims 3, 9 and 10 depend, is likewise not
patentably distinct from claims 13 and 14 of the Farris I
patent in view of Farris II.
CONCLUSION
To summarize, the examiner's decision to reject claims 2
and 10 under 35 U.S.C. § 102(b) as being anticipated by Farris
I, claims 3 and 9 under 35 U.S.C. § 103 as being unpatentable
over Farris I in view of Farris II and claims 3, 9 and 10
under the judicially created doctrine of obviousness-type
double patenting as being unpatentable over the claims of
Farris I in view of Farris II is affirmed. The examiner's
rejections of claims 1 and 4-8 under 35 U.S.C. § 102(b)/103 as
being anticipated by or unpatentable over Farris I and claims
1, 2 and 4-8 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over
the claims of Farris I are reversed. New rejections of claims
Appeal No. 2000-0526
Application No. 08/818,958
29
2, 3, 9 and 10 under 35 U.S.C. § 112, second paragraph, and of
claim 2 under the judicially created doctrine of obviousness-
type double patenting are added pursuant to 37 CFR § 1.196(b).
In addition to affirming the examiner's rejections of one
or more claims, this decision contains new grounds of
rejection pursuant to 37 CFR § 1.196(b)(amended effective Dec.
1, 1997, by final rule notice, 62 Fed. Reg. 53131, 53197 (Oct.
10, 1997), 1203 Off. Gaz. Pat. Office 63, 122 (Oct. 21,
1997)). 37 CFR § 1.196(b) provides, "A new ground of
rejection shall not be considered final for purposes of
judicial review."
Regarding any affirmed rejection, 37 CFR § 1.197(b)
provides:
(b) Appellant may file a single request for
rehearing within two months from the date of the
original decision . . . .
37 CFR § 1.196(b) also provides that the appellant,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new
Appeal No. 2000-0526
Application No. 08/818,958
30
grounds of rejection to avoid termination of proceedings (37
CFR § 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the
claims so rejected or a showing of facts relating to
the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
application will be remanded to the examiner. . . .
(2) Request that the application be reheard
under § 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record. . . .
Should the appellant elect to prosecute further before
the Primary Examiner pursuant to 37 CFR § 1.196(b)(1), in
order to preserve the right to seek review under 35 U.S.C. §§
141 or 145 with respect to the affirmed rejections, the
effective date of the affirmance is deferred until conclusion
of the prosecution before the examiner unless, as a mere
incident to the limited prosecution, the affirmed rejections
are overcome.
If the appellant elects prosecution before the examiner
and this does not result in allowance of the application,
abandonment or a second appeal, this case should be returned
to the Board of Patent Appeals and Interferences for final
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Application No. 08/818,958
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action on the affirmed rejections, including any timely
request for rehearing thereof.
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED-IN-PART; 37 CFR § 1.196(b)
IRWIN CHARLES COHEN )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
LAWRENCE J. STAAB ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JENNIFER D. BAHR )
Administrative Patent Judge )
Appeal No. 2000-0526
Application No. 08/818,958
32
BERNHARD KRETEN
77 CADILLAC DRIVE
SUITE 245
SACRAMENTO, CA 95825