COVIDIEN LP

Patent Trials and Appeals Board

Jul 26, 2021

2020006689 (P.T.A.B. Jul. 26, 2021)

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.
15/596,050 05/16/2017 THOMAS E. DROCHNER 356699.USU2 (203-11091) 2048
90039 7590 07/26/2021
Covidien LP
Attn: IP Legal
5920 Longbow Drive
Mail Stop A36
Boulder, CO 80301-3299
EXAMINER
DELLA, JAYMI E
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
07/26/2021 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@carterdeluca.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS E. DROCHNER, JAMES D. ALLEN IV,
GARY M. COUTURE, DUANE E. KERR, WILLIAM H. NAU JR.,
ROBERT M. SHARP, and DAVID J. VAN TOL
Appeal 2020-006689
Application 15/596,050
Technology Center 3700
Before JENNIFER D. BAHR, DANIEL S. SONG, and
EDWARD A. BROWN, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 9–18.2 We have jurisdiction under
35 U.S.C. § 6(b). We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Covidien LP, the
“ultimate parent” of which is Medtronic, plc. Appeal Br. 1.
2 Claims 1–8 have been withdrawn from consideration. Final Act. 1; Appeal
Br. 11–13 (Claims App.).
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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to “surgical devices and, more
particularly, to cutting mechanisms for use with surgical end effector
assemblies, instruments, and systems.” Spec. ¶ 1. Claim 9, reproduced
below, is the only independent claim involved in this appeal and is
representative of the claimed subject matter.
9. An end effector assembly for a surgical instrument,
comprising:
first and second jaw members each including a jaw
housing, an electrically-conductive tissue-treatment plate, and a
longitudinally-extending channel, at least one of the first or
second jaw members movable relative to the other between
a spaced-apart position and an approximated position, the
longitudinally-extending channel of the second jaw member
defining a longitudinal axis; and
a cutting mechanism disposed within the second jaw
member, the cutting mechanism including:
at least one electromagnet disposed within the jaw
housing of the second jaw member;
at least one electrical wire coupled to the at least
one electromagnet and extending proximally from the
end effector assembly, the at least one electrical wire
adapted to connect to a source of energy for energizing
the at least one electromagnet to produce a magnetic
field; and
a knife at least partially disposed within the
longitudinally-extending channel of the second jaw
member, the knife including a magnetic portion or
having a magnetic base engaged thereto, wherein the
knife is repelled from or attracted to the at least one
electromagnet in response to magnetization of the at least
one electromagnet to thereby move the knife from a
retracted position to an extended position, wherein the
knife is movable in a first direction parallel to the
longitudinal axis, and in a second direction perpendicular
to the longitudinal axis.
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REJECTIONS
Claims 9–18 stand rejected under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
Claims 9–18 stand rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.
OPINION
Enablement
The enablement provision of 35 U.S.C. § 112(a) requires the
specification of a patent application to describe the invention, and the
manner and process of making and using it, “in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it pertains, or
with which it is most nearly connected, to make and use the same.” “The
enablement requirement ensures that the public knowledge is enriched by
the patent specification to a degree at least commensurate with the scope of
the claims.” Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
166 F.3d 1190, 1195-96 (Fed. Cir. 1999). Accordingly, the specification
must provide sufficient teaching such that one skilled in the art could make
and use the full scope of the invention without undue experimentation.
CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003);
Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997);
In re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988).
Factors to be considered in determining whether a disclosure would
require undue experimentation include (1) the quantity of experimentation
necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5)
the state of the prior art, (6) the relative skill of those in the art, (7) the
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predictability or unpredictability of the art, and (8) the breadth of the claims.
Wands, 858 F.2d at 737. These factors are illustrative; what is relevant to an
enablement determination depends upon the facts of the particular case. See
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1213 (Fed.
Cir. 1991).
The Examiner determines that the present application does not
provide sufficient disclosure to enable one of ordinary skill in the art to
make and/or use the claimed invention, particularly an end effector having a
knife that is moved from a retracted position to an extended position by
being repelled from or attracted to at least one electromagnet, “wherein the
knife is movable in a first direction parallel to the longitudinal axis, and in a
second direction perpendicular to the longitudinal axis,” as recited in claim
9, without undue experimentation. Final Act. 2. The Examiner addresses
the Wands factors on pages 2–4 of the Final Action.
With respect to the state of the prior art and the level of ordinary skill,
the Examiner finds that, as evidenced by the Scheib publication
(US 2015/0083782 A1, published March 26, 2015) and the Shelton patent
(US 7,799,039 B2, issued September 21, 2010), the use of magnetic
propulsion to actuate cutting elements in end effectors was known, but “the
direction of actuation has been either longitudinal (from either the proximal
end of the end effector to the distal end, or vice versa[]) or vertical (from
inside of one jaw, through the gap between the jaws, and to/into the second
jaw).” Final Act. 3. The Examiner finds “no suggestion that a set of
electromagnets in an end effector can actuate a cutting member in both
directions to cut tissue due to the difference in the attracting and repelling
nature of each electromagnetic actuation mechanism.” Id. Appellant does
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not dispute the Examiner’s findings as to the state of the art or the level of
ordinary skill in the art, nor does Appellant proffer any evidence showing
that magnetic propulsion techniques or configurations were known for
moving cutting elements in end effectors in both the longitudinal direction
and the direction perpendicular to the longitudinal direction away from one
jaw toward the other jaw.
With respect to the level of predictability in the art, the Examiner
finds that many ways are known for actuating cutting elements in end
effectors, the most common of which include drive shafts to push the cutting
element through a channel between the jaws, hydraulic actuators, and the use
of memory shape material to push the cutting element. Final Act. 3. The
Examiner finds that “[e]lectromagnetic propulsion from electromagnets
inside the end effector has been used to propel cutting mechanism[s];
however, [this] is very rare due to its increased complexity.” Id. at 3–4.
Appellant does not dispute the Examiner’s findings in this regard.
With respect to the amount of direction provided and the existence of
working examples in the application, the Examiner finds that the application
explains “how a single electromagnet can cause actuation of a magnetic
cutting element in the vertical direction” (Spec. ¶¶ 70–71) and also explains
“an alternate series of electromagnets that can be actuated in sequence”
(Spec. ¶¶ 74–75). Final Act. 4. As the Examiner explains in the written
description rejection, Figures 10A–11B (described in paragraphs 68–71 of
the Specification) and Figures 12–14 (described in paragraphs 72–75 of the
Specification) of the present application are drawn to two different
embodiments of Appellant’s invention, and the Examiner finds no indication
in the Specification that the knife mechanisms of these two embodiments
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“were designed, intended, or contemplated as being usable together.” Id. at
4–5.
With respect to the quantity of experimentation needed to make and/or
use the invention based on the disclosure in the present application, the
Examiner finds that the application does not disclose how the single
electromagnet used to actuate the knife in the vertical direction
(perpendicular to the longitudinal direction) can also be used to actuate the
knife in the longitudinal direction and, likewise, fails to disclose how the
series of electromagnets used to actuate the knife in the longitudinal
direction can also be used to actuate the knife in the vertical direction. Final
Act. 4. Further, the Examiner finds that the application does not disclose or
suggest any manner in which the electromagnet for vertical actuation and the
electromagnets for longitudinal actuation “could be deposited, oriented, or
activated together to achieve both motions.” Id. In the absence of any such
disclosure, the Examiner determines that undue experimentation would be
required by one of ordinary skill in the art to determine how many
electromagnets would be needed, how they should be positioned and
oriented relative to one another and to the magnetic cutting element, “and in
what sequence they should be activated in order to allow for the magnetic
cutting element to move in a way that allows it to sever tissue effectively
given the close proximity of the different electromagnetic fields.” Id.
Appellant submits that “a skilled artisan, having the benefit of the
present application, would clearly be able to design an end effector assembly
where ‘the knife is movable in a first direction parallel to the
longitudinal axis, and in a second direction perpendicular to the longitudinal
axis,’ as recited in claim 9.” Appeal Br. 5–6. To support this position,
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Appellant begins by asserting that, in grouping Figures 10–14 together as
one species (Species III) in the election of species requirement set forth in
the Non-Final Action dated February 26, 2019, the Examiner determined
that Figures 10–14 do not “have mutually exclusive characteristics.” Id.
at 6. Thus, Appellant contends that the feature of the knife moving
perpendicular to the longitudinal axis in Figures 10A–11B and the feature of
the knife moving parallel to the longitudinal axis in Figures 12–14 “are not
mutually exclusive.” Id.
Appellant’s argument is unsound. As the Examiner explains, there are
two aspects of restriction ((A) a showing of independence or distinctness and
(B) a showing of why there would be a serious burden on the examiner if
restriction is not required) that must be satisfied for an examiner to insist
upon restriction between inventions. Ans. 3–4 (citing MPEP § 808).
According to the Examiner, the embodiment of Figures 10A–11B and the
embodiment of Figures 12–14 “were not deemed as separate species in the
restriction requirement since the second aspect (B), a serious search burden
on the examiner if restriction is not required, did not exist.” Id. at 4. The
Examiner correctly explains that “the mere inclusion of Figs. 10A-11B and
Figs. 12-14 together under Species III of the restriction requirement does not
support enablement of claims 9-18.” Id.
Paragraphs 34–40 of the Specification convey that Figures 10A–11B
are directed to one embodiment, and Figures 12–14 are directed to a
different embodiment. In particular, paragraph 34 states that Figure 10A is a
“view of another end effector assembly,” and paragraphs 35–37 state that
Figures 10B, 11A, and 11B are views “of the end effector assembly of
[Figure] 10A.” Paragraph 38 describes Figure 12 as a “view of another end
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effector assembly,” and paragraphs 39 and 40 describe Figures 13 and 14 as
views “of the end effector assembly of [Figure] 12.” Thus, Appellant’s
Specification supports the Examiner’s finding that Figures 10A–11B and
Figures 12–14 are directed to two different embodiments of Appellant’s
invention (see Final Act. 4).
Next, Appellant baldly asserts “that one of ordinary skill in the art
would clearly be able to combine the features of FIGS. 10A and 11A, with
the features of FIGS. 12-14 to make an end effector having a knife that is
movable both parallel to a longitudinal axis,” as illustrated in Figures 12–14
and described in paragraph 75 of the Specification, “and perpendicular to the
longitudinal axis,” as illustrated in Figures 10A–11B and described in
paragraph 71 of the Specification, “without undue experimentation.” Appeal
Br. 7. Appellant does not provide any evidence (such as known end
effectors having a knife movable in both of these directions by being
attracted or repelled by at least one electromagnet) or technical explanation
to support this assertion.
Providing an end effector as recited in claim 9, “wherein the knife is
movable in a first direction parallel to the longitudinal axis, and in a second
direction perpendicular to the longitudinal axis,” entails more than a simple
combination of the elements of Figures 10A and 11A and the elements of
Figures 12–14. It is not immediately apparent how the knife and the
electromagnets would need to be arranged relative to one another, and in
what sequences the electromagnets would need to be activated and de-
activated to yield an operational device in which movements in both
directions would be achievable in a predictable and desired manner to sever
tissue.
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As discussed above, the Examiner has explained that, in the absence
of disclosure in the application as to how to do so, undue experimentation
would be required by one of ordinary skill in the art to determine how many
electromagnets would be needed, how they should be positioned and
oriented relative to one another and to the magnetic cutting element, “and in
what sequence they should be activated in order to allow for the magnetic
cutting element to move in a way that allows it to sever tissue effectively
given the close proximity of the different electromagnetic fields.” Final
Act. 4. In raising these points, the Examiner has met the initial burden of
establishing a reasonable basis to question the enablement provided for the
claim limitation “wherein the knife is movable in a first direction parallel to
the longitudinal axis, and in a second direction perpendicular to the
longitudinal axis” in claim 9, thereby shifting the burden to Appellant to
come forth with suitable evidence and/or technical explanation indicating
that the disclosure in the application is indeed enabling. See In re Wright,
999 F.2d 1557, 1561–62 (Fed. Cir. 1993) (explaining that, 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 the claim is not
adequately enabled by the description provided in the specification, and,
“[i]f the PTO meets this burden, the burden then shifts to the applicant to
provide suitable proofs indicating that the specification is indeed enabling”).
Appellant’s bald assertion that one of ordinary skill in the art would be able
to combine the features of Figures 10A and 11A and the features of Figures
12–14, unaccompanied by any evidence or technical explanation supporting
this assertion or addressing the points raised by the Examiner questioning
enablement, does not satisfy Appellant’s burden.
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Accordingly, we sustain the rejection of claim 9, and of claims
10–18, which depend from claim 9, and for which Appellant relies on the
arguments presented for claim 9 (Appeal Br. 7), under 35 U.S.C. § 112(a) as
failing to comply with the enablement requirement.
Written Description
The written description requirement also found in 35 U.S.C. § 112(a)
is separate and distinct from the enablement requirement of that provision.
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed.
Cir. 1991)). The purpose of the written description requirement in 35 U.S.C.
§ 112, first paragraph, is to “‘clearly allow persons of ordinary skill in the art
to recognize that [the inventor] invented what is claimed.’” Id. “[T]he test
for sufficiency is whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Id. This test
“requires an objective inquiry into the four corners of the specification from
the perspective of a person of ordinary skill in the art.” Id. “Based on that
inquiry, the specification must describe an invention understandable to that
skilled artisan and show that the inventor actually invented the invention
claimed.” Id. This inquiry is a question of fact. Id. (citing Ralston Purina
Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)).
The Examiner finds that the present application fails to provide
written description support for the end effector recited in claim 9, “wherein
the knife is movable in a first direction parallel to the longitudinal axis, and
in a second direction perpendicular to the longitudinal axis.” Final Act. 4.
The Examiner explains that Figures 10A–11B and Figures 12–14 “are drawn
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to two different embodiments of [Appellant’s] invention” and that “the
Examiner has found no reference in [Appellant’s Specification] that the
knife mechanisms show[n] by the two sets of figures were designed,
intended, or contemplated as being usable together . . . at the time of filing”
of the present application. Id. at 4–5. As discussed above, paragraphs
34–40 of Appellant’s Specification support the Examiner’s finding that
Figures 10A–11B and Figures 12–14 are drawn to two different
embodiments of Appellant’s invention.
Appellant directs our attention to paragraph 71 of the Specification,
which states that “[k]nife 636 may define a length that extends a substantial
portion of the length of jaw member 620, e.g., between 50% and 90% of the
length thereof.” Appeal Br. 9. Appellant submits that, for a knife having a
length on the lower end of the disclosed range, such as half the length of jaw
member 620, “the ability to also move the knife 636 in a direction that is
parallel to the longitudinal axis would be helpful to ensure the full length of
tissue between the jaw members 610 and 620 is cut.” Id. Thus, Appellant
contends that, “while a single embodiment of a knife moving parallel and
perpendicular to the longitudinal axis may not be explicitly disclosed, such
features are clearly implicitly and/or inherently disclosed in accordance with
[the] written description requirement under 35 U.S.C. § 112(a).” Id.
Appellant’s argument is not persuasive. The Specification’s
disclosure of a range of 50–90% of the jaw member length for the length of
the knife in Figures 10A–11B is insufficient to reasonably convey to a
person having ordinary skill in the art that this knife, in addition to moving
in a direction perpendicular to the longitudinal axis, must also have the
ability to move in a direction parallel to the longitudinal axis. As the
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Examiner points out, Appellant’s Specification does not explain the
significance of a shorter knife length, and gives no indication that a knife
having a length on the lower end of this range would be unable to sever
tissue effectively with the movement shown in Figures 10A–11B. See
Ans. 6. A person having ordinary skill in the art could reasonably infer from
the disclosure in paragraph 71 of the Specification that a knife having a
length anywhere within the claimed range, which the Specification
characterizes as “extend[ing] a substantial portion of the length of jaw
member 620,” would be suitable for severing tissue with the movement
shown in Figures 10A–11B and described in paragraph 71 of the
Specification.
Moreover, even assuming that a person having ordinary skill in the art
would have appreciated, from Appellant’s Specification’s disclosure
regarding the length of the knife, that the ability to also move a knife,
particularly one having a length on the lower end of the disclosed range, in a
direction parallel to the longitudinal axis would be helpful, as Appellant
contends, this is insufficient to satisfy the written description requirement.
“[W]hile the description requirement does not demand any particular form
of disclosure, or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement. Ariad, 598 F.3d at 1352. “It is not sufficient for
purposes of the written description requirement of §112 that the disclosure,
when combined with the knowledge in the art, would lead one to speculate
as to modifications that the inventor might have envisioned, but failed to
disclose.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed.
Cir. 1997).
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In short, the portions of the Specification on which Appellant relies do
not amount to implicit and/or inherent disclosure of an end effector as
recited in claim 9 having a knife that is movable parallel and perpendicular
to the longitudinal axis in accordance with the written description
requirement of 35 U.S.C. § 112(a).
For the above reasons, Appellant fails to apprise us of error in the
Examiner’s finding that the limitation “wherein the knife is movable in a
first direction parallel to the longitudinal axis, and in a second direction
perpendicular to the longitudinal axis” in claim 9 lacks written description
support. Accordingly, we sustain the rejection of claim 9, and of claims
10–18, which depend from claim 9, and for which Appellant relies on the
arguments presented for claim 9 (Appeal Br. 9), under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement.
CONCLUSION
We AFFIRM both of the Examiner’s rejections (i.e., enablement and
written description) of claims 9–18 under 35 U.S.C. § 112(a).
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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
9–18 112(a) Enablement 9–18
9–18 112(a) Written
Description
9–18
Overall
Outcome
9–18

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED