Ex Parte Sarstedt et al

Board of Patent Appeals and Interferences

Jun 11, 2009

10768386 (B.P.A.I. Jun. 11, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte WALTER SARSTEDT and HORST FARBER
__________

Appeal 2009-003461
Application 10/768,386
Technology Center 3700
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Decided:1 June 11, 2009
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, 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 1-5. We have jurisdiction under
35 U.S.C. § 6(b).

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 2009-003461
Application 10/768,386

STATEMENT OF THE CASE
The claims are directed to a blood collection device. Claims 1 and 2
are representative of the claims on appeal, and read as follows:
1. A blood collection device comprising:
a threaded holder having a rearwardly directed surface;
a hollow needle fixed in and extending through the holder and having
a sharp-edged front portion capable of venipuncture extending forward from
said holder and a coaxially rearwardly extending rear portion extending
rearward from the holder rear surface;
a guide sleeve having an open rear end into which a blood-collection
tube is insertable, an opposite front end threadedly receiving said holder
around the needle rear portion and formed with a forwardly directed front
surface juxtaposable with and confronting the holder rear surface when the
guide sleeve is threaded to the holder, whereby, when inserted into the
sleeve rear end, said collection tube can be filled with blood conducted
rearward by said needle into the device; and
an elastic tubular rubber sheath surrounding and hugging said rear
portion of the needle and having a closed rear end pierceable by the needle
rear portion and an open front end shape locked in said guide sleeve between
the rear surface of the holder and the front surface of the sleeve front end
when the guide sleeve and holder are threaded together.

2. The blood collection device defined in claim 1 wherein said guide
sleeve is formed unitarily with
an end wall at said front end of said sleeve,
a rearwardly projecting boss on said end wall and formed with the
front surface of the guide sleeve, and
a forwardly projecting and internally threaded collar on said end wall
aligned with said boss, said valve rubber sheath having at its open front end
a head formed with a surface juxtaposed with the front surface of the guide
sleeve, the holder having a threaded portion engaged in the threaded collar
and clamping the head of said sheath against said front surface of the guide
sleeve.

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The Examiner relies on the following evidence:

Lopez US 4,782,841 Nov. 8, 1988
Haber Re. 33,585 May. 7, 1991

Hollister EP 0 678 279 A1 Oct. 25, 1995

We affirm.

ISSUE (Indefiniteness)
The Examiner finds that claim 1 is indefinite on the grounds that it is
unclear what structure is referred to by the recited “forwardly directed front
surface.”
Appellants contend that the terms “rearward,” “front,” and “rear” are
used with consistency, with the ‘front’ being to the right in the drawings and
‘rear’ to the left.
The issue on appeal is thus: Have Appellants demonstrated that the
Examiner erred in rejecting claim 1, and the claims dependent thereon, i.e.,
claims 2-5, under 35 U.S.C. § 112, second paragraph, as being indefinite?

FINDINGS OF FACT
FF1 The Examiner rejects claims 1-5 under 35 U.S.C. § 112, second
paragraph, “as being indefinite for failing to particularly point out and
distinctly claim the subject matter which Appellant regards as the
invention.” (Ans. 3.)
FF2 The Examiner finds that “it is unclear exactly which structure is
referred to by the recited ‘forwardly directed front surface’” in claim 1. (Id.)
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FF3 According to the Examiner:
Although it is understood that said front surface resides within
the vicinity of the junction of the sheath, threaded holder, and
guide sleeve, which includes rearwardly projecting boss 17 as
claimed in Claim 2, the exact location of said forwardly
directed front surface is not clear. Therefore, in the following
rejection, it is assumed that said forwardly directed front
surface corresponds to a surface on said rearwardly projecting
boss 17, in which case, there is some confusion as to the use of
both the term “forwardly,” as recited in reference to “a
forwardly directed front surface” in Claim 1, as well as use of
the term “rearwardly,” as recited in reference to “a rearwardly
projecting boss” in Claim 2, to describe similar elements
because an element cannot be located both forwardly and
rearwardly at the same time from one reference point.
Therefore, it is unclear which portion constitutes the forwardly
directed front surface, and which portion constitutes the
rearwardly directed part.

(Id. at 3-4.)

PRINCIPLES OF LAW
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”
Miles Laboratories, Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir.
1993).

ANALYSIS
Appellants argue that the terms “rearward,” “front,” and “rear” “are
used with 100% consistency, with the ‘front’ being to the right in the
drawings and the ‘rear’ to the left.” (App. Br. 6.)
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Appellants, however, have not addressed the Examiner’s concerns as
set forth in FF3. We thus find that Appellants have not demonstrated error
in the Examiner’s rejection.

CONCLUSION OF LAW
We conclude that Appellants have not demonstrated that the Examiner
erred in rejecting claim 1, and the claims dependent thereon, i.e., claims 2-5,
under 35 U.S.C. § 112, second paragraph, as being indefinite.
We thus affirm the rejection of claims 1-5 under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which Appellants regard as the invention.

ISSUE (Obviousness)
The Examiner concludes that claims 1-5 are rendered obvious by the
combination of Lopez, Haber and Hollister.
Appellants contend that nothing in the art suggests clamping a sheath
edge between a pair of parts that are threaded together.
Thus, the issue on appeal is: Have Appellants demonstrated that the
Examiner erred in combining Lopez, Haber and Hollister, to arrive at the
blood collection device of claim 1 and meets the limitations of “a guide
sleeve having . . . a forwardly directed front surface juxtaposable with and
confronting the holder rear surface when the guide sleeve is threaded to the
holder,” and a “rubber sheath . . . front end shape locked in said guide sleeve
between the rear surface of the holder and the front surface of the sleeve
front end when the guide sleeve and holder are threaded together?”
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FINDINGS OF FACT
FF4 According the Specification, the “present invention relates to a blood
collection device of the type in which a guide sleeve, also commonly
referred to as a holder, is open at one end to receive a blood-collection tube
and at the other end receives the cannula and the cannula holder.” (Spec. 1.)
FF5 Figures 1 and 2 of the present Specification are reproduced below:

Figures 1 and 2 are axial cross-sections of two embodiments of the invention
(id. at 7).
FF The Specification teaches:
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In FIGS. 1 and 2, there are shown two embodiments of a
blood collection device which may be generally of the type
marketed under the trademark Vacutainer® and wherein a
guide sleeve 1 is formed with a closed front end formed by an
end wall la provided with an internally threaded and forwardly
projecting boss or collar 2 which receives the threaded portion 3
of a cannula holder 4a or 4b. The cannula holder 4a has a
venipuncture needle 9 extending outwardly and having a
sharpened front end or edge 6 adapted to pierce the vein. The
needle or cannula 9 is hollow and communicates with an inner
cannula or needle 8, extending rearward from the holder 4a into
the guide sleeve 1 and provide with a rear sharpened end 7
therein. The result is a so-called double cannula as designated
at 5.

(Id. (as amended December 26, 2006).)
FF6 As shown in Figure 1, the open end of the valve-rubber sheath 10 is
provided with a shoulder 13 that “is received in a chamber 13 at the end wall
1a of the guide sleeve 1 so that the surface 12a of the shoulder . . . directly
abuts a wall 13a of the compartment 13.” (Id. at 8.) As shown in Figure 1,
the end 12b of shoulder 12 “is engaged by an end 3a of the threaded portion
3 so that the head or shoulder 12 is held between the surfaces 3a and 13a in a
shape-locked and force-fitted engagement.” (Id.)
FF7 As shown in Figure 2, the “conically inwardly extending projection 17
on the end wall 1a has an internal conical surface 17a against which the
outer cone 14 of the head 18 of the valve-rubber sheath 11 can engage.”
(Id.) According to the Specification:
An inner conical surface 15 of the head 18 matches the conical
formation 16 at the junction of the inwardly extending needle 8
and the threaded portion 3. The conical surfaces are pressed
together by the end 3a of the threaded portion 3. Here, as well,
there is an axial clamping of the valve-rubber sheath between
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surfaces 17a and 3a in shape locking and force fitting the valve-
rubber sheath in place.

(Id. at 8-9.)
FF8 The Examiner rejects claims 1-5 under 35 U.S.C. § 103(a) as being
obvious over the combination of Lopez, Haber and Hollister (Ans. 4). As
Appellants do not argue the claims separately, we focus our analysis on
claim 1, and claims 2-5 stand or fall with that claim. 37 C.F.R. §
41.37(c)(1)(vii).
FF9 Lopez is drawn to a device for drawing a fluid, such as blood, from a
patient (Lopez, col. 1, ll. 12-14).
FF10 Figure 10 of Lopez is reproduced below:

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Figure 10 is a cross-sectional view showing the needle assembly of Lopez
connected to the tube holder, with the tube being moved towards the
inwardly projecting tube end of the needle element (Lopez, col. 2, ll. 62-66).
FF11 The Examiner finds that Lopez teaches:
(1) “a threaded (60) holder, referred to as ‘needle assembly’ (16), having a
rearwardly directed surface” (Ans. 4 (citing Lopez, Figure 2));
(2) “a hollow needle . . . fixed in and extending through the holder and
having a sharp-edged front portion . . . and a coaxially rearwardly extending
rear portion extending rearward from the holder rear surface (26)” (Ans. 4
(citing Lopez, Figure 3));
(3) “a guide sleeve, referred to as [a] ‘tube holder’ (14), having an open rear
end into which a blood collection tube . . . is insertable and an opposite front
end threadedly (64) receiving said holder around the needle rear portion and
formed with a forwardly directed front surface” (Ans. 4 (citing Lopez, Fig.
10)); and
(4) “an elastic tubular valve rubber sheath, referred to as ‘rubber cap’ (44),
surrounding and hugging said rear portion of the needle (26) and having a
closed rear end pierceable by the needle rear portion and an open front end
in said guide sleeve between a rear surface of the holder and a front surface
of the sleeve front end.” (Ans. 4-5 (citing Lopez, Fig. 10).)
FF12 The Examiner notes that “Lopez does not disclose the forwardly
directed front surface of the guide sleeve juxtaposable and confronting the
holder rear surface when the guide sleeve is threaded to the holder.” (Id. at
5.)
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FF13 Haber is cited by the Examiner for teaching a blood collection needle
with a guide sleeve (inner cylinder 2, 92, 132, 162) “having a forwardly
directed front surface juxtaposable and confronting a rear surface of a
threaded holder when the guide sleeve is threaded to the holder, referred to
as ‘hub’ (20, 96, 136), along with sheath 26, . . . as an effective way to
secure a needle in the proper position within said guide sleeve and holder”
(Ans. 5 (citing Haber Figs. 1, 2, 10, 11, 14, 15, 19, and 20; col. 5, ll. 9-19)).
FF14 Haber is drawn to a disposable syringe for use in vacuum tube
phlebotomy (Haber, col. 1, ll. 56-58).
FF15 Figure 1 of Haber is reproduced below:

Figure 1 shows a cross-section of the syringe of Haber (Haber, col. 3, ll. 19-
23).
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FF16 According to Haber:
A hole is formed through the neck 16 to define a distal
bore which communicates with the interior of inner cylinder 2.
The distal bore is threaded to receive therewithin a
correspondingly threaded end 20 of a hub 24 which carries a
conventional double ended needle 22. The needle carrying hub
24 is removably secured to the distal bore within neck 16, so
that a first end of the needle 22 projects into the inner cylinder 2
and the opposite end thereof projects outwardly from the inner
cylinder. A soft rubber sheath 26 covers the end of the needle
22 which projects into the inner cylinder 2.

(Id. at col. 5, ll. 9-19.)
FF17 The Examiner concludes:
[I]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to modify the device of
Lopez such that the forwardly directed front surface of the
guide sleeve is juxtaposed and confronts the holder rear surface
when the guide sleeve is threaded to the holder along with the
sheath, as taught by Haber et al, as an effective manner of
securing said components together within the blood collection
device.

(Ans. 5.)
FF18 The Examiner notes that the combination of Lopez and Haber “do[es]
not disclose the valve rubber sheath with the open front end shape locked in
said guide sleeve.” (Ans. 5.)
FF19 The Examiner cites Hollister for disclosing “a sheath (12) shape
locked in guide sleeve or ‘tube holder’ (2) to optimally secure the sheath and
to provide a better fit between the sheath and guide sleeve” (id. (citing
Hollister Fig. 2A; col. 5, ll. 7-19)).
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FF20 Hollister is drawn to a blood collection device (Hollister, col. 1, ll. 3-
5).
FF21 Figure 2A of Hollister is reproduced below:

Figure 2A is a side view of an embodiment of the blood collection device of
Hollister (Hollister, col. 3, ll. 28-29).
FF22 Hollister teaches:
Further shown in Figure 2A is an elastic tubular sheath
12 . . . . Specifically, sheath 12 . . . is held in place by means of
a circumferential hanger 42 welded to the upper interior portion
of tube holder 2. The top portion of sheath 12 has a circular
hanging lip 44, which mates with the support fingers 42a of
holder 42. To further secure sheath 12 within tube holder 2,
and to further prevent the tip of cannula 13 from piercing the
upper sides of sheath 12, a plastic insert 46 is pressedly fixed to
the upper portion of sheath 12.

(Hollister, col. 5, ll. 7-19.)
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FF23 The Examiner concludes further:
[I]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to shape lock the valve
rubber sheath (44) of Lopez as modified by Haber et al in said
tube holder (14), as disclosed by Hollister, to create a superior
seal between the sheath and guide sleeve, thereby in
combination, Lopez in view of Haber et a1 and Hollister teach a
valve rubber sheath with an open front end shape locked in a
guide sleeve between the rear surface of the holder and the front
surface of the guide sleeve front end when the guide sleeve and
holder are threaded together.

(Ans. 5-6.)

PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court rejected a rigid application of a teaching-suggestion-
motivation test in the obviousness determination. The Court emphasized
that “the [obviousness] analysis need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. Thus, an “[e]xpress suggestion to
substitute one equivalent for another need not be present to render such
substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982).
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Further,

If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

Id. at 418. Moreover, it is proper to “take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418. See also id. at 421 (“A person of ordinary skill is also a person of
ordinary creativity, not an automaton.”).

ANALYSIS
Appellants argue that “[n]othing in the art suggests clamping a sheath
edge between a pair of parts that are threaded together,” as in Lopez the
screwthread connection is used only to secure the holder in the sleeve, and
the only teaching regarding clamping a sheath edge in a sleeve uses a
separate press-fitted insert (App. Br. 9).
Appellants argue, referencing Figure 10 of Lopez, that Lopez shows a
system in which a sheath 44 is force fitted over a frustoconically flared
surface 62 of a threaded holder, and that “[t]here is nothing resembling front
and rear surfaces that clamp the sheath 44 when the holder and sleeve are
threaded together.” (Id. at 6-7.) Thus, Appellants assert, Lopez “lacks
clearly defined structure of claim 1,” and thus cannot anticipate claim 1, and
as there is no suggestion to clamp the sheath end, it also cannot render claim
1 obvious (id. at 7).
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Application 10/768,386

Appellants argue further that “Hollister does not show a sheath
clamped between a sleeve adapted to hold a collection tube and a holder
carrying a needle.” (Id.) According to Appellants, there is no threaded
connection in Hollister, and Hollister uses a sleeve with an insert 42 that
serves to clamp the sheath 12 (id.). Thus, Appellants argue, even if one
were to combine Lopez and Hollister, at best the ordinary artisan would
“provide a press-fitted insert as in Hollister in the Lopez system,” and would
not clamp “a sheath edge between two threaded-together parts.” (Id.)
Appellants also argue that Hollister is not relevant to the instant invention, as
in Hollister the function of the sheath is to prevent needle sticks, not to cut
off blood flow as in the present invention (id.).
As to Haber, Appellants assert that it adds nothing to the combination,
as the sheath 26 “is apparently a simple cylindrical structure glued or force-
fitted inside a rearwardly projecting collar of the front end of the guide
sleeve 92.” (Id. at 9.) According to Appellants, “[t]here is absolutely
nothing in Haber to suggest a structure where the sheath has a front end
pinched between a rear surface of the holder 136 and the front surface of the
sleeve 92.” (Id.)
Appellants’ arguments are not convincing. Appellants are primarily
arguing individual deficiencies of the references, rather than presenting
arguments as to the combination presented by the Examiner. As found by
the Examiner, Lopez teaches all the elements of the blood collection device
of claim 1 except for “a guide sleeve having . . . a forwardly directed front
surface juxtaposable with and confronting the holder rear surface when the
guide sleeve is threaded to the holder,” and a “rubber sheath . . . front end
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shape locked in said guide sleeve between the rear surface of the holder and
the front surface of the sleeve front end when the guide sleeve and holder are
threaded together.”
The Examiner cites Haber for teaching “a guide sleeve having . . . a
forwardly directed front surface juxtaposable with and confronting the
holder rear surface when the guide sleeve is threaded to the holder.” Haber
provides evidence that the use of such a guide sleeve would be known to the
ordinary artisan in this art, and as noted by the Examiner, the guide sleeve
and sheath of Haber provide an effective way to secure a needle in the
proper position within said guide sleeve and holder.
The Examiner then relies on Hollister for teaching a “rubber sheath
. . . front end shape locked in said guide sleeve between the rear surface of
the holder and the front surface of the sleeve front end when the guide sleeve
and holder are threaded together” for securing the sheath and provide a
better fit between the sheath and guide sleeve.
Thus, the art relied upon by the Examiner demonstrates that all of the
elements of claim 1 are known and used in blood collection devices. The
Examiner notes that the combination would allow a way to secure a needle
to the device, and provide a better fit between the guide sleeve and holder.
Thus, it would have been obvious to the ordinary artisan to combine the
references as suggested by the Examiner to arrive at the claimed blood
collection device, which is a predictable variation of the collection devices
of Lopez, Haber, and Hollister, and as Appellants have not provided
evidence that it would have been beyond the level of the ordinary artisan to
combine the references as suggested by the Examiner.
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CONCLUSIONS OF LAW
We conclude that Appellants have not demonstrated that the Examiner
erred in combining Lopez, Haber and Hollister, to arrive at the blood
collection device of claim 1 and meets the limitations of “a guide sleeve
having . . . a forwardly directed front surface juxtaposable with and
confronting the holder rear surface when the guide sleeve is threaded to the
holder,” and a “rubber sheath . . . front end shape locked in said guide sleeve
between the rear surface of the holder and the front surface of the sleeve
front end when the guide sleeve and holder are threaded together.
We thus affirm the rejection of claims 1-5 under 35 U.S.C. § 103(a) as
being obvious over the combination of Lopez, Haber, and Hollister.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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