Ex Parte Odell et al

Patent Trial and Appeal Board

Feb 12, 2014

11525186 (P.T.A.B. Feb. 12, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte ROBERT B. ODELL, DONALD L. PORFANO,
JAMES C. KROPATSCH, JORGE J. CAMPOS,
MARIO DE AGUERO SERVIN, PATRICK G. CARRE, and
MARK A. GERMAN
____________________

Appeal 2014-001864
Application 11/525,186
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, STEFAN STAICOVICI, and
JAMES P. CALVE, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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Application 11/525,186

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STATEMENT OF THE CASE
The application at issue in this appeal is an application for reissue of
US Patent 6,792,743 B2, issued Sep. 21, 2004, owned by Becton, Dickinson
and Company. App. Br. 2. Robert B. Odell et al. (Appellants) appeal under
35 U.S.C. § 134 from the Examiner’s decision rejecting claims 12-19, 35,
38-40, 43-45, 48, and 49. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

The Claimed Subject Matter
Claim 12, reproduced below, is illustrative of the claimed subject
matter.
12. (Amended) A method of producing a filled syringe
comprising the steps of:
forming a plastic syringe barrel in an injection molding
machine, said syringe barrel having a cylindrical side wall, an
open proximal receiving end and a frustoconically shaped outlet
nozzle at its distal end;
transferring said syringe barrel[, without any additional
cleaning or sterilization,] into an environmentally controlled
area without exposing said syringe barrel to unfiltered air [to
maintain a predetermined cleanliness level];
directing a stream of filtered air toward said syringe
barrel in said environmentally controlled area to remove
particles from surfaces thereof to clean said syringe barrel;
delivering a tip cap to said environmentally controlled
area;
air washing said tip cap in said environmentally
controlled area;
assembling said tip cap to said outlet nozzle of said
syringe barrel to close said outlet nozzle; filling said syringe
barrel with a substance through its open proximal end;
delivering a stopper to said environmentally controlled
area;
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inserting said stopper into said open proximal end of said
barrel to form a prefilled syringe; and
removing said prefilled syringe from said
environmentally controlled area.

Evidence
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Schmitt
Smith

US 3,782,066
US 5,597,530

Jan. 1, 1974
Jan. 28, 1997

Rejections
Appellants request our review of the following rejections:
I. Claims 12-19, 35, 38-40, 43-45, 48, and 49 stand rejected under
35 U.S.C. § 112, first paragraph, as lacking enablement;
II. Claims 12-19, 35, 38-40, 43-45, 48, and 49 stand rejected under
35 U.S.C. § 112, second paragraph as being indefinite1; and
III. Claims 12-19, 35, 38-40, 43-45, 48, and 49 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Smith and Schmitt.

OPINION
Enablement
When rejecting a claim for lack of enablement, the PTO bears the
initial burden of setting forth a reasonable explanation as to why the scope of

1 Although this rejection was not specifically indicated as on appeal, we are
treating Appellants’ statement that “the claims on appeal are fully enabled
and in accord with 35 U.S.C. § 112” at page 5 of Appellant’s Brief as
appealing both the rejection under 35 U.S.C. § 112, first paragraph and the
rejection under 35 U.S.C. § 112, second paragraph.
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the claim is not adequately enabled by the description provided in the
specification. In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
Insofar as the enablement requirement is concerned, the dispositive
issue is whether the applicant’s disclosure, considering the level of ordinary
skill in the art as of the date of the appellant’s application, would have
enabled a person of such skill to make and use the applicant’s invention
without undue experimentation. In re Strahilevitz, 668 F.2d 1229, 1232
(CCPA 1982).
The Examiner’s basis for rejecting Appellants’ claims for lack of
enablement is that Appellants’ Specification fails to provide an enabling
disclosure of a method as called for in claim 12, comprising the step of
transferring the syringe barrel “without exposing said syringe barrel to
unfiltered air.” Ans. 3; Final Rej. 2. The Examiner’s position is that there is
no discussion of the scope of “unfiltered air” or level of filtration during the
transferring step. Ans. 3. The Examiner further takes the position that the
subsequent vacuum step “to remove particles” contradicts Appellants’
argument that the syringes are “clean.” Ans. 3-4. Appellants point to
column 8, lines 15-18 and column 9, lines 11-53 as providing adequate
support for the recitation “without exposing said syringe barrel to unfiltered
air.” App. Br. 5; Reply Br. 2. Appellants also point to the decision in
CFMT Inc. v. Yieldup International Corp., 349 F.3d 1333, 1338 (Fed. Cir.
2003) where the court stated:
Title 35 requires only that the inventor enable one of skill
in the art to make and use the full scope of the claimed
invention. Thus, when an invention claims a general system to
improve the cleaning process for semiconductor wafers, the
disclosure enables that invention by showing improvements in
the overall system. . . . . Of course, if a patent claimed a system
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that achieved cleanliness up to a specified numerical particle-
free range, then enablement would require disclosure of a
method that enables one of ordinary skill to achieve that range
without undue experimentation. Thus, the level of disclosure
necessary to satisfy section 112 of title 35 varies according to
the scope of the claimed invention. . . . .
The claims of the ′532 and ′123 patents state no standard
of cleaning. As the district court correctly found, “cleaning” in
the context of this invention means generally removing
contaminants from the wafer surface. Absent some standard for
cleanliness in the claims, this court proceeds to examine the
record for a showing that the disclosures of the CFMT patents
would enable a person of skill in the art to make and use a
system or apparatus to achieve any level of contaminant
removal without undue experimentation.

Reply Br. 2-3. Thus, Appellants’ argument is that the subject claims
indicate avoiding exposure to “unfiltered air” in general, not on a particular
level, and are therefore fully in accord with 35 U.S.C. § 112. Reply Br. 3.
The Examiner does not set forth the requisite findings and technical
reasoning to establish that the requirement for enablement has not been met.
In particular, the Examiner does not set forth the requisite findings and
analysis to show that a person of ordinary skill in the art would not have
been able to perform this method, by appropriate material selection and
dimensioning, without undue experimentation. See, e.g., In re Wands, 858
F.2d 731, 737 (Fed. Cir. 1988) (setting forth factors that may be considered
in determining whether a disclosure would require undue experimentation).
Although Appellants refer to column 8, lines 15-18 and column 9, lines 11-
53 as providing support for the claimed recitation, we find additional support
in column 9, line 8 to column 10, line 12 and Figure 7. These passages and
Figure 7 describe the modular housing components 112, 114, 116 and 118
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and, more specifically, how the components are connected together to
maintain a controlled environment. We agree with Appellants that the
decision in CFMT provides persuasive precedent for the situation in the
instant appeal. The Examiner’s position that the Specification must be
precise as to the level of filtration of air entering the housings 112, 114, 116
and 118 is unfounded. Furthermore, the Examiner’s position that the
subsequent vacuum step “to remove particles” contradicts the claim
recitation is similarly untenable. We note, as raised by the Examiner in the
Answer, that subsequent or redundant cleaning or sterilization steps are well
known in the art. Ans. 5.
We do not sustain the Examiner’s rejection of claims 12-19, 35, 38-
40, 43-45, 48 and 49 under 35 U.S.C. § 112, first paragraph, as lacking
enablement.

Indefiniteness
The Examiner’s basis for the indefiniteness rejection is that the metes
and bounds of the limitation “without exposing said syringe barrel to
unfiltered air” cannot be determined. Ans. 3; Final Rej. 3. This position
appears to be grounded on essentially the same reasoning forming the basis
of the rejection for lack of enablement and is similarly untenable for the
reasons discussed above. The Examiner’s implication that the claim must be
precise as to the level of filtration of air entering the controlled area is
unfounded. Merely that a claim is broad does not mean that it is indefinite.
See In re Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977). Thus, we do
not sustain the rejection of claims 12-19, 35, 38-40, 43-45, and 48-49 under
35 U.S.C. § 112, second paragraph.
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Obviousness
Appellants’ independent claims 12, 16, 35, 40, and 45 all require a
step of transferring a syringe barrel, drug or medical container, vial, or
ampoule to an environmentally controlled area “without exposing said
[syringe barrel, drug or medical container, vial, or ampoule] to unfiltered
air.”
The Examiner found that Smith lacks the step of transferring the
syringe from manufacture to filling without exposure to unfiltered air. Ans.
4-5; Final Rej. 3-4. The Examiner then found that Schmitt teaches
immediate transfer from a forming station to a filling station in order to
produce an aseptic package and determined that one of ordinary skill in the
art could easily employ a sterile transfer of containers in Smith as discussed
and taught by Schmitt, and reasoned that it would have been obvious to do
so “in order to maintain the cleanliness of the formed containers. Ans. 5;
Final Rej. 4.
For the reasons set forth on pages 10-11 of the Appeal Brief, Schmitt
does not cure the acknowledged deficiencies of Smith. In particular, Schmitt
does not disclose any method of creating and transferring a syringe to a
filling station without exposure to unfiltered air. The Examiner cited to
column 2, lines 29 et seq. of Schmitt as supporting the assertion that Schmitt
teaches immediate transfer to a filling station. Ans. 5. However, a review of
this passage reveals that it is devoid of any description of transfer without
exposure to unfiltered air during the process of forming a package. In fact,
like Appellants, we do not find in Schmitt any teaching “to form a package
and then ‘immediately transfer’ the package to a filling station,” as alleged
by the Examiner. See App. Br. 10; Ans. 5; Final Rej. 4. Schmitt refers
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repeatedly to “aseptic” contents or packaging and to sterilization. See, e.g.,
Abstract; col. 1, ll. 42-43; col. 6, l. 24; col. 7, l. 14; col. 7, l. 23 – col. 8, l. 1.
However, this disclosure does not establish that Schmitt employs “a sterile
transfer of containers” as asserted by the Examiner. See Ans. 5. In short,
Schmitt does not appear to teach what the Examiner relies on Schmitt to
teach. Accordingly, the Examiner fails to establish a prima facie case that
Smith and Schmitt render obvious a method as called for in Appellants’
claims including a step of transferring a syringe barrel or other container
without exposure to unfiltered air.
For the above reasons, we do not sustain the Examiner’s rejection of
claims 12-19, 35, 38-40, 43-45, 48, and 49 under 35 U.S.C. § 103(a).

DECISION
The Examiner’s decision rejecting claims 12-19, 35, 38-40, 43-45, 48,
and 49 is reversed.
REVERSED

JRG