Ex Parte 5562631 et al

Board of Patent Appeals and Interferences

Sep 28, 2010

90010350 (B.P.A.I. Sep. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/010,350 02/21/2009 5562631 MDXVA-37RX 5938
26875 7590 09/28/2010
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
EXAMINER
CLARK, JEANNE MARIE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
09/28/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SMITHS MEDICAL ASD, INC.,
Appellant & Patent Owner
____________

Appeal 2010-009101
Reexamination Control 90/010,350
Patent 5,562,631
Technology Center 3900
____________

Before SALLY C. MEDLEY, RICHARD M. LEBOVITZ, and
DANIEL S. SONG, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
shown on the PTOL-90A cover letter attached to this decision.
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Patent 5,562,631

This is a decision on the appeal by the Patent Owner of U.S. Patent
No. 5,562,631 from the Patent Examiner’s rejections of claims 1 and 14-22
in an ex parte reexamination proceeding. The Board’s jurisdiction in this
appeal is based under 35 U.S.C. §§ 6(b), 134, and 306. We affirm the
Examiner.
STATEMENT OF THE CASE
U.S. Patent No. 5,562,631 (hereinafter “the ‘631 patent”) issued
October 8, 1996. The named inventor is David L. Bogert. A Request for Ex
Parte Reexamination of claim 1 of the ‘631 patent was filed by the Patent
Owner on February 21, 2009, pursuant to 35 U.S.C. §§ 302-307 and 37
C.F.R. § 1.510 (“Req.”). Reexamination was sought on the basis of PCT
Patent Publication WO 94/13341 (Req. 2). The PCT publication is no
longer a basis of a rejection in this appeal.
Reexamination of claim 1 was granted by the Examiner.
Reexamination of patented claims 2-13 was not requested (Final Rej’n 3).
The proceeding before the Examiner culminated in a final rejection, dated
November 4, 2009. Claim 1, as amended during reexamination, and new
claims 14-22 were rejected (Final Rej’n 3). Three grounds of rejection are
on appeal:
1. Claim 1 under 35 U.S.C. § 102(b) as anticipated by Mastronardi2
(Ans. 4);
2. Claims 1 and 14-22 under 35 U.S.C. § 103(a) as obvious in view of
Martell3 (Ans. 5); and

2 WO 93/08865 published May 13, 1993.
3 U.S. Patent No. 4,897,083 issued January 30, 1990.
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3. Claims 1 and 14-22 under 35 U.S.C. § 103(a) as obvious in view of
Mastronardi, Chang,4 and Martell (Ans. 9).
Claim 1, as amended during reexamination, is representative and
reads as follows:
1. An arrangement for protecting a cannula of a catheter insertion
device, comprising:
(a) a housing for receiving a cannular needle, said cannular needle
extending from an end of said housing and being adapted to administer a
catheter to a patient, said cannular needle extending into the housing for only
a portion of the length of the housing;
(b) needle guarding means slidably mounted on said housing, said
cannular needle extending through said needle guarding means in the
operative position of said cannular needle, said needle guarding means
comprising:
(i) a back guarding member slidably mounted in said housing;
and
(ii) a forward guarding member slidably mounted in said back
guarding member, said forward guarding member being retracted into said
back guarding member and said back guarding member being retracted into
said housing in the operative condition of said cannular needle, and said
back guarding member and said forwarding guarding member being
telescopically extendable relative to each other and said housing so as to
form a protective containment for said cannular needle upon the withdrawal
thereof from the body of the patient.

ANTICIPATION BY MASTRONARDI
Issue
Does Mastronardi’s external telescoping structure anticipate the
claimed arrangement for protecting a cannula of a catheter insertion device

4 U.S. Patent No. 5,688,249 issued November 18, 1997.
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comprising a housing, a back guarding member, and a forward guarding
member?
Legal Principles
The “Board gives claim language its broadest reasonable
interpretation consistent with the specification.” In re Buszard, 504 F.3d
1364, 1368 (Fed. Cir. 2007). During patent examination proceedings, claim
terms are given “the broadest reasonable meaning . . . in their ordinary usage
as they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant's
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). This
mode of claim construction applies even in reexaminations. In re Am. Acad.
of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Translogic
Tech., Inc., 504 F.3d 1249, 1256 (Fed. Cir. 2007).
“[W]hile it is true that claims are to be interpreted in light of the
specification and with a view to ascertaining the invention, it does not follow
that limitations from the specification may be read into the claims.” Sjolund
v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). “Absent an express
definition in their specification, the fact that appellants can point to
definitions or usages that conform to their interpretation does not make the
PTO's definition unreasonable when the PTO can point to other sources that
support its interpretation.” In re Morris, 127 F.3d at 1056.
“An essential purpose of patent examination is to fashion claims that
are precise, clear, correct, and unambiguous. Only in this way can
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uncertainties of claim scope be removed, as much as possible, during the
administrative process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).

Factual Findings (“FF”)
1. Mastronardi describes a needle catheter with a telescoping
extensible element comprising three tubular elements, 20 (innermost), 21,
and 22 (outermost), one inside the other, which, when extended, covers
needle 1 to eliminate risk of the being pricked (Mastronardi, p. 2, ll. 1-19; p.
3, ll. 3-7; p. 6, ll. 21-29; Fig. 10).
2. Figure 10 of Mastronardi is reproduced below:

Figure 10 shows tubular elements 20-22 in the non-extended
configuration, with element 20 inside element 21, and element 21 inside
element 22.

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3. Figure 13 of Mastronardi is reproduced below (annotations 20-22
were added and are not part of the original figure)):

Figure 13 shows a telescoping extensible element with tubular
element 20 in tubular element 21, and tubular element 21 in tubular element
22. When fully extended as shown in Figure 13, the needle is covered by
tubular elements 21 and 22.

Claim 1 of the ‘631 patent
4. Claim 1 is directed to “an arrangement for protecting a cannula”
comprising:
• “(a) a housing for receiving a cannular needle, said cannula needle
extending from an end of said housing”;
• (b)(i) “a back guarding member slidably mounted in said housing”;
and
• (b)(ii) “a forward guarding member slidably mounted in said back
guarding member.”
5. The claim recites the “forward guarding member being retracted
into said back guarding member” and “said back guarding member being
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retracted into said housing in the operative condition of said cannular
needle.”
6. The claim recites that “said back guarding member and said
forward guarding member being telescopically extendable relative to each
other and said housing so as to form a protective containment for said
cannular needle upon the withdrawal thereof from the body of the patient.”

‘631 patent
7. Figure 11e of the ‘631 patent is reproduced below (annotations 18,
24, and 20 were added and are not part of the original drawing):

Figure 11e shows a protecting arrangement for a used catheter needle
with forward guarding member 18, rear or back guarding member 24, and
housing 20.
8. According to the Summary of the Invention (col. 3, l. 50 to col. 4,
l. 8):
Accordingly, in order to provide an improved structure in the
provision of a protecting arrangement for a used cannula, and
especially a safety mechanism which will ensure a practically
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“fail-safe” operation, the present invention contemplates the
provision of telescopically sequentially movable guarding
members in the form of sleeves or housing whereby locking
devices provide for the locked extension of the cannula prior to
its use in guiding a catheter into the vein of a patient, and
thereafter, when it is desired to retract the cannula, while the
components remain in a locked condition, there is effected a
first extension step whereby an outer housing sleeve passes
beyond a detent in one of the guarding members, thereafter in a
second step permitting unlocking between the inner guarding
members, and enabling the 65 housing sleeve to be further
extended rearwardly while a second two-way lock is in an
unlocked position; and in a further step, while the initial locking
structure remains unlocked and the second remaining locking
structure is also in an unlocked condition, to facilitate further
complete extension between the sequenced interlocking
guarding members in which the forward guarding member in
which locked into the back guarding member, and the back
guarding member is locked into the sleeve-like housing so as to
fully encompass the cannula.

Comparison between Mastronardi and the claimed invention
We adopt the following findings made by the Examiner:
9. Mastronardi’s tubular element 22 met the claimed “housing”
element (a).
10. Mastronardi’s tubular element 21 met the claimed “(b)(i) back
guarding member” because it was “slidably mounted in said housing”
(tubular element 22), as required by claim 1 (Ans. 4-5; FF3).
11. Mastronardi’s tubular element 20 met the claimed “(b)(ii) forward
guarding member” because it was “slidably mounted in said rear guarding
member” (tubular element 21) as required by claim 1 (Ans. 4-5; FF3).
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12. Figure 13 of Mastronardi shows “said back guarding member and
said forward guarding member being telescopically extendable relative to
each other and said housing so as to form a protective containment” (claim
1; FF6) because the combination of tubular elements 20, 21, and 22 forms a
compartment which contains the needle 1 (Ans. 13). We do not interpret the
latter claim limitation to require that each of the back guarding members,
forward guarding members, and housing be positioned over the needle when
extended – only that they form a “protective containment for said cannular
needle” as recited in the claim (FF6).

Analysis
There is no dispute that Mastronardi describes a catheter protection
device in which the outermost element 22 (FF3), when in the fully extended
configuration, is on the outside of the device, while the embodiment shown
in Figure 11e of the ‘631 patent shows the outermost element (FF7) on the
inside of the protection device. Thus, Mastronardi shows what the Examiner
refers to as an “external” telescoping structure and the ‘631 patent under
reexamination shows what is referred to as “internal” telescoping structure.
In sum, the orientation of the telescoping components in Mastronardi is
opposite to that shown Figure 11e – with respect to the direction of the
needle tip. The issue in this rejection comes down to whether claim 1 is
limited to the internal telescoping arrangement depicted in Figure 11e, or
whether the claim can be more broadly interpreted to cover the external
telescoping structure shown by Mastronardi.
In arguing that the Examiner improperly interpreted the claim,
Appellant contends that the terms “back”, “forward”, and “housing” have
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specific meanings that exclude them from reading on tubular elements 21,
20, and 22, respectively, of the Mastronardi device. “Back” and “forward,”
Appellant contends, are with respect to the needle tip and the patient, such
that the forward guarding member must be construed to be closer to the
needle tip and the back guarding member further from the needle tip. The
term “housing,” Appellant contends, has a “generally understood” meaning
that is not met by the external tubing element 22 of Mastronardi.
Appellant provided a declaration under 37 C.F.R. § 1.132 by Mr.
Dennis M. Bialecki, employed as a manager of Research and Development
for Smiths Medical, ASD, Inc., said to be the current assignee of the ‘631
patent (Bialecki I Decl. ¶ 4). Mr. Bialecki attests to having worked in the
medical industry since 1991 (id. at ¶ 3). Mr. Bialecki testified:
the term “housing” is generally understood to be a member to
which the needle is fixedly attached. The housing may have
several uses including providing a gripping point for a user to
insert the needle and catheter into a patient and/or withdraw the
needle from the catheter, or providing a flashback chamber for
blood, each of which is well understood in the medical arts. The
Bogert patent is in accordance with this clear understanding as
the cannula (12) is fixedly attached to a blood chamber (34)
which, in turn, is fixedly attached to the housing (20).
(Id. at ¶ 8.)
Mr. Bialecki contends that the housing described by Mastronardi does
not have the needle fixedly attached to it and therefore does not meet the
claimed limitation of a “housing for receiving a cannular needle.” (Bialecki I
Decl. ¶¶ 4 & 12).
Mr. Bialecki’s declaration does not have sufficient objective evidence
to persuade us that the Examiner erred.
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First, the plain language of claim 1 is broader than the definition of
“housing” relied upon by Mr. Bialecki to distinguish it from tubular element
20 of Mastronardi. Claim 1 recites that:
(a) a housing for receiving a cannular needle, said cannular
needle extending from an end of said housing . . . , said
cannular needle extending into the housing for only a portion of
the length of the housing . . . .
The claim therefore specifically recites the required relationship
between the housing and the needle: the needle “extending from an end”
and “for only a portion” of the housing length. We interpret “extending
from an end” of the housing to mean that the needle passes through an end
of the housing. There is no requirement in the claim that the needle be
attached to the housing. The explicit claim language reads on Mastronardi’s
tubular element 22 because its needle passes through one end of 22 (Fig. 13
reproduced in FF3) and is along only a portion of the element 22’s length
because there is a gap between the needle point and housing end 30 (Fig.
13). Thus, the claim language explicitly recites structural requirements for
the housing element which are broader than Appellant’s asserted definition
that the needle also be fixedly attached to the housing.
Second, we do not agree that the ‘631 patent compels us to interpret
housing as a structure to which the needle is fixedly attached and which
moves backward with respect to the needle tip. In the Summary of the
Invention, the “housing” is merely characterized as a guarding member and
as an “outer housing sleeve” (FF8), with no requirement that the needle be
attached to it.
Third, Appellant has not introduced sufficient evidence that the term
“housing” requires that the needle be “fixedly attached” to it. Mr. Bialecki
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expressed his opinion that he “believed the term ‘housing’ is generally
understood to be a member to which the needle is fixedly attached”
(Bialecki I Decl. ¶ 8), but did not provide any factual evidence to support
this opinion. Thus, while it is given some weight, the opinion testimony is
not sufficient to outweigh the plain claim language when read in light of the
Specification.
Mr. Bialecki also says that the “housing may have several uses”
including providing a “gripping point” and “flashback chambers” (Bialecki I
Decl. ¶ 9). These structures are absent from Mastronardi’s element 20.
However, Mr. Bialecki’s language is permissive, stating that the housing
“may” have such structures, without explicitly requiring that such structures
must be present to qualify as a housing.
Mr. Bialecki also testified in his declaration: “In addition, it is
recognized in the art and from the Bogert patent itself, that the end which is
closest to the patient is the front or distal end, and the opposite end is the
back or proximal end.” (Bialecki I Decl. ¶ 10.) Mr. Bialecki stated that the
Examiner’s interpretation of element 21, closest to the patient, as being the
“back guarding member,” and element 20, “closest to the proximal end of
the device” as being “the ‘front guarding member’ . . . is incorrect and an
awkward way to consider front and back in the context of such devices.”
(Id.) Appellant contends that the Examiner’s interpretation is unreasonable.
Appellant chose to use terms “forward” and “back” to characterize the
guarding members inside the claimed housing. With respect to the user of
the needle catheter, tubular element 20 is “forward” and tubular element 21
is “back.” Thus, identifying 20 as a forward element and 21 as a back
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element, is a reasonable description of the orientation of these elements. Mr.
Bialecki did not introduce any factual evidence that “forward” and “back”
have an art-recognized meaning contrary to the way terms were applied by
the Examiner.
It is also argued that the terms “forward” and “back” would be
understood to be with reference to the patient when read in light of the ‘631
patent. Appellant argued:
Additionally, the specification of the patent under
reexamination teaches that “the forward guarding member 18,
the back guarding member 24, and the housing 20 . . . are
telescoped in the extended position shown in FIGS. 2, 11e, and
12e.” Col. 7, lines 26- 28. FIG. 11e above taken from the
patent under reexamination, and the accompanying description,
reveal in unmistakable fashion what is meant in the patent
under reexamination by use of the terms forward and back.
Clearly, the forward guarding member 18 is closer to the patient
than the back guarding member 24 in this fully extended
position.
(App. Br. 12.)
It is undisputed that Figure 11e of the ‘631 patent depicts what it calls
the forward (18) and back (24) telescoping components in an orientation
with respect to a patient, which are opposite to components 22 and 21 of
Mastronardi. It is also undisputed that outermost forward component 18 is
on the inside of the telescope and Mastronardi’s outermost component 22 is
on the telescope’s outside. However, simply because the ‘631 patent
describes a configuration opposite to that described in Mastronardi does not
mean the Examiner’s interpretation that Mastronardi’s component 22
corresponds to the claimed forward guarding member was unreasonable.
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There is ever-present tension between interpreting claim terms in light
of the written description of a patent or patent application and reading
limitations from the written description into the claims. In this case, the
disputed terms are not expressly defined nor clearly circumscribed in the
‘631 patent in such a way that persons of ordinary skill in the art would have
understood them to have solely the meanings ascribed by Appellant. Simply
because a different interpretation is possible does not mandate against the
one adopted by the Examiner, as long as it is reasonable and supported by
evidence – as we have so found.
In this case, calling Mastronardi’s tubular element 22 a housing is not
unreasonable because it “houses” elements 21 and 20 when the device is in
the collapsed configuration – just as element 20 shown in Figure 11e (FF7)
“houses” elements 18 and 24. The terms “forward” and “back” are words to
describe the orientation of a structure with respect to something else. It was
not unreasonable to designate the forward location to be toward the person
who utilizes the cannular needle – rather than the patient or the needle tip –
and therefore to characterize element 21 as a “back guarding member” and
element 20 as a “forward guarding member.” Claim 1 does not contain any
additional words that would require “back” and “forward” to be with
reference to a certain location. Persuasive evidence was not presented that
“back” and “forward” are defined in light of the patent to mean with respect
to the needle tip.
Mr. Bialecki also attempted to distinguish the claimed structure from
Mastronardi’s because neither elements 20 and 21 “cover the tip of the
needle.” (Bialecki I Decl. ¶ 9).
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As discussed above, the claim refers to the back and forward guarding
members “extendable relative to each other and said housing so as to form a
protective containment” for the needle. We do not interpret this to require
that each component “cover” the needle tip (FF12).
For the reasons discussed above, we affirm the rejection of claim 1 as
anticipated by Mastronardi.

OBVIOUSNESS OVER MARTELL
Issue
Would it have been obvious to a person of ordinary skill in the art to
reverse the order of telescoping components in Martell’s external
telescoping needle guard to have made an internal telescoping structure as in
claim 1?

Factual Findings (“FF”)
13. Figure 5 of Martell is reproduced below:

Figure 5 shows a cannula with its protective sleeve extended (Martell,
col. 2, ll. 43-44). Needle guard 24 is formed of three telescoping sections
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comprising an inner section 30, an intermediate section 32, and an outer end
section 34.
14. “Commonly” a cannula cap 22 (shown in Figure 3) is provided
that has a closed and open end (id. at col. 3, ll. 30-34; Fig. 3). The open end
of the cap has an enlarged flange that is a hand tight friction fit on the lower
section 60 of the needle assembly hub (id. at col. 3, ll. 35-38).
15. There is a gap between the needle hub 18 and innermost section
30 which accommodates cannula cap 22 when friction fitted on the needle
hub 18 (id. at col. 2, ll. 55-60; see also Fig. 2).

Analysis
In this rejection, the Examiner interpreted the claims to read on an
internal telescoping structure with reference to the needle tip. The Examiner
found that the difference between Martell and the claimed invention is that
Martell describes an external telescoping needle guard, with the outermost
section radially located closest to the needle tip (FF13, element 34), while
the claims are drawn to an internal telescoping structure, with the innermost
section radially closest to the needle tip. The Examiner contends that it
would have been obvious to modify Martell to make an internal telescoping
needle guard because the ordinary skilled worker “would have recognized
the functional equivalence in covering the needle with external or internal
telescoping members” and that such internal telescoping “would predictably
result in the same protective function.” (Ans. 6 & 16.)
Appellant contends that the Examiner did not provide a valid
motivation to have made the proposed modification and that the proposed
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modification would undermine the functionality of Martell’s needle guard
(Reply Br. 5-6).
The Examiner’s reason for modifying Martell by utilizing an internal
telescoping needle guard rather than Martell’s external telescoping guard
was based on the finding that internal and external telescoping structures
were functionally equivalent in the stated purpose of covering the needle tip.
Because of their equivalence, the Examiner considered the internal
telescoping structure to be an obvious and predictable mechanical variation.
The Examiner’s reasoning is logical. An internal telescoping
structure, as claimed, functions in the same way as an external telescoping
structure, where the telescoping sections are constructed to slide past each
other in the desired direction. Both configurations – whether the innermost
element is extended over the needle tip, as in claim 1, or whether the
outermost element is extended over the tip as in Martell – accomplish the
same result in covering the needle using the same mechanical principle.
Appellant, in claiming the internal telescoping structure, is relying on the
same principle taught by Martell with the primary difference that the
claimed structure is inverted with respect to Martell’s needle guard. In fact,
the middle section 32 of Martell could be characterized as telescoping
externally with respect to the section 30, but telescoping internally with
respect to outer section 34.
As the claimed arrangement would be achieved by simply inverting
the structures, such arrangement appears to be a simple and predictable
variation, and we agree with the Examiner’s position that such change would
have been within the level of ordinary skill in the art. See KSR, 550 U.S. at
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417 ("When a work is available in one field of endeavor, design incentives
and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable
variation, §103 likely bars its patentability.").
Appellant contends that if “the needle guard were modified to be
internally telescoping . . . , the outer section 34 and the intermediate section
32 would block or interfere with the operation of the cannula cap 22.” (App.
Br. 17.) “In other words, this proposed modification would interfere with
exposing and inserting the tip 64 of the cannula 20 into a patient.” (Id.)
As shown in Figure 5, there is a space between the needle hub 18 and
innermost section 30, which accommodates cannula cap 22 that friction fits
on the needle hub 18 (FF13-15). Appellant contends that inverting the
telescoping guard would interfere with the capping and insertion function,
but does not explain nor provide evidence in support of this argument. As
Martell shows a gap to insert the cannula cap, it would be obvious to persons
of ordinary skill in the art to dimension the housing so that such gap would
be maintained were the telescoping inverted as proposed by the Examiner.
The rejection of claim 1 is affirmed. Claims 14-22 were not argued
separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS OVER MASTRONARDI, CHANG, & MARTELL
Issue
Did Appellant provide sufficient evidence to antedate the Chang
patent, eliminating it as prior art against the claimed invention?

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Legal Principles

37. C.F.R. § 1.131(a):
When any claim of an application or a patent under
reexamination is rejected, the inventor of the subject matter of
the rejected claim, the owner of the patent under reexamination,
or the party qualified under §§1.42, 1.43, or 1.47, may submit
an appropriate oath or declaration to establish invention of the
subject matter of the rejected claim prior to the effective date of
the reference or activity on which the rejection is based.

37. C.F.R. § 1.131(b):
The showing of facts shall be such, in character and weight, as
to establish reduction to practice prior to the effective date of
the reference, or conception of the invention prior to the
effective date of the reference coupled with due diligence from
prior to said date to a subsequent reduction to practice or to the
filing of the application. Original exhibits of drawings or
records, or photocopies thereof, must accompany and form part
of the affidavit or declaration or their absence must be
satisfactorily explained.
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We find ourselves in agreement with the board's decision to the
extent that it held the proofs submitted under Rule 131 “taken
as a whole” to be unconvincing. The original and supplemental
affidavits together with the accompanying comments do not
adequately explain what facts or data appellants are relying
upon to show a completion of their invention prior to April 13,
1961. The affidavits for the most part consist of vague and
general statements in the broadest terms as to what the exhibits
show along with the assertion that the exhibits describe a
reduction to practice. This amounts essentially to mere
pleading, unsupported by proof or showing of facts.

In re Borkowski, 505 F.2d 713, 718 (CCPA 1974); In re Harry, 333
F.2d 920 (1964).

Clearly, reasonable diligence can be shown if it is established
that the attorney worked reasonably hard on the particular
application in question during the continuous critical period.
With respect to the Bey application in this interference, it was
established only that the application was “to be typed” as of
May 31, 1977, and that the application was mailed to the PTO
from Strasbourg on July 5, 1977. Bey argued that the 40-45
page application had to be typed, revised, proofread and/or
finalized, mailed to the inventors in France for final review, and
the formal documents signed and mailed to the PTO. Bey
admitted, however, that Hattan’s records did not show the exact
days when activity specific to this application occurred. Thus,
we cannot say that the board clearly erred in finding that “the
documented activities with regard to [the present application]
are insufficient by themselves to prove diligence.”

. . .
Of course, it may not be possible for a patent attorney to begin
working on an application at the moment the inventor makes
the disclosure, because the attorney may already have a backlog
of other cases demanding his attention. Thus, the courts have
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recognized that reasonable diligence is all that is required of the
attorney.
Generally, the patent attorney must show that unrelated cases
are taken up in chronological order, thus, the attorney has the
burden of keeping good records of the dates when cases are
docketed as well as the dates when specific work is done on the
applications.

Bey v. Kollonitsch, 806 F2d 1024, 1027-28 (Fed. Cir. 1986) (footnotes
and citations omitted).

Analysis
As discussed above, both Mastronardi and Martell describe external
telescoping needle guards where the section closest to the needle tip is the
outermost telescope member. In the present obviousness rejection, the
Examiner construed the claims narrowly to be directed to an internal
telescoping structure in which the section next to the needle tip is the
innermost element of the telescoping structure. The Examiner relied on the
Chang patent for its description of an internal telescoping structure (Ans. 8),
concluding that it would have been obvious to reverse the external
“telescoping of the guard members” to have made the internal arrangement
recited in claim 1 (Ans. 8-9).
Appellant did not challenge the merits of the rejection, but rather
sought to rebut the rejection by establishing that Chang is not prior art to the
‘631 patent (App. Br. 18-19). Under 37 C.F.R. § 1.131(a), a publication can
be antedated and eliminated as prior art by establishing “invention of the
subject matter of the rejected claim prior to the effective date of the
reference or activity on which the rejection is based.” Appellant provided
two declarations under section 1.131 to show “conception of the invention
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prior to the effective date of the reference coupled with due diligence from
prior to said date to . . . to the filing of the application.”
The Examiner found the evidence insufficient to establish conception
of the invention since it did not show where each element of the claimed
invention could be found in the invention disclosure relied upon by Mr.
Bialecki in his declarations (Ans. 18). The Examiner also found the
evidence insufficient to establish diligence from a date prior to the Chang
patent to filing of the application upon which the ‘631 patent is based.

Conception
A first declaration under section 1.131 was executed by Mr. Dennis
M. Bialecki, manager of Research and Development for Smiths Medical,
ASD, Inc. (Bialecki II Decl. ¶¶ 4 & 5). Mr. Bialecki testified in the
declaration that the ‘631 patent originally issued to Johnson & Johnson,
where he, Mr. David L. Bogert (inventor of the ‘631 patent), and Dr. Joseph
Chang (inventor of the Chang patent) were all employed “during the
development of the subject matter disclosed in the Bogert and Chang
patents” (id. at ¶¶ 10-12). Mr. Bialecki testified that Exhibit A, a written
invention disclosure document upon which the Bogert patent was said to be
based, “bears a date (said date being masked) that is prior to the pertinent
time period,” prior to the filing date of the Chang patent (id. at ¶¶ 18 & 21).
In paragraph 20 of his first declaration under section 1.131 (Bialecki
II Decl.), Mr. Bialecki testified that Exhibit A “demonstrates an
arrangement” comprising a housing and cannular needle, and then went on
to identify certain features of the housing, the cannular needle with respect
to the housing, and forward and back guard members. However, Mr.
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Bialecki did not identify any of these features as elements of claim 1 nor did
Mr. Bialecki explain the correspondence between the drawings and the
recited elements of claim 1.
A second and supplemental declaration under section 1.131 by Mr.
Bialecki was also provided by Appellant (Bialecki III Decl.). In this
declaration, Mr. Bialecki described support for the limitation “said cannular
needle extending into the housing for only a portion of the length of the
housing” by identifying cross-section views in Exhibit 3 that illustrated the
claimed element (Bialecki III Decl. ¶ 5).
Under section 1.131(b), there must be a showing of facts of such
“weight and character” in order to establish conception of the claimed
invention. Exhibit A is a one-page description of a “mini-telescoping
protective catheter” with three pages of accompanying figures. Mr.
Bialecki’s general statements about what is shown in Exhibit A do not
establish that the inventors conceived of the specific structural elements
recited in claim 1 which are mounted and interact with each other in the
manner recited. As such, in essence, we are left to interpret Exhibit A, and
consider how the device described and illustrated in it corresponds to the
claimed invention. The description and drawings in Exhibit A may be
evidence of an invention, but without any explanation of how they relate to
the claimed invention, they are not of sufficient weight or character to show
conception of the subject matter of claim 1. As stated above and by the
Examiner, Mr. Bialecki did not explain the correspondence between the
description and drawings of Exhibit A and the recited elements of claim 1.
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Diligence
Mr. Bialecki testified, based on his personal experience, about the
process implemented by Johnson & Johnson for preparation and submission
of patent applications to the USPTO (Bialecki II Decl. ¶¶ 13 & 14).
According to Mr. Bialecki, if an invention disclosure document was
approved by the patent review board, it was forwarded to the in-house patent
counsel (id. at ¶ 14e). Mr. Bialecki stated in paragraph 14 of the Bialecki II
Declaration: “g. In the normal course of business, from time of approval, the
process of preparing and submitting a patent application with the USPTO
would typically be completed in a time period of about six months.” Mr.
Bialecki stated:
23. As evidenced by the document attached as Exhibit A, the
time period between the date on which Mr. Bogert and Mr.
Goral signed the document (said dates being masked) and the
filing date of the Bogert patent was also less than six months.

24. As evidenced by the document attached as Exhibit A, the
time period between the date on which the document was
submitted to the patent review board (said date being masked)
and the filing date of the Bogert patent was less than six
months.

(Bialecki II Decl. ¶¶ 23 7 24.)

Mr. Bialecki did not provide any testimony or evidence about how
diligently the attorney worked on the patent application prior to its
submission to the USPTO as a constructive reduction to practice of the
claimed invention. To establish “diligence” under section 1.131, there must
be evidence of what activities were undertaken by the attorney to prepare the
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application for submission; for example, on what days the attorney worked
on the application and whether it was worked on immediately or in the
chronological order in which it was received. Bey v. Kollonitsch, 806 F.2d
at 1027-28. All that is required is “reasonable diligence” on the part of a
patent attorney. Id. However, here the record is silent on what specific steps
the attorney took in preparing the application. Consequently, it cannot be
determined on this record whether the attorney acted with “due diligence” as
required under section 1.131(b).
Because Appellant did not antedate the Chang publication, we affirm
the rejection of claim 1 for the reasons set forth by the Examiner. Claims
14-22 fall with claim 1 because separate arguments for their patentability
were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

TIME FOR RESPONSE

Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

bim

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