Ethicon Endo-Surgery, LLC

Patent Trials and Appeals Board

Sep 14, 2020

14840758 - (D) (P.T.A.B. Sep. 14, 2020)

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.
14/840,758 08/31/2015 Frederick E. Shelton IV END7634USNP/171F01US 7429
123907 7590 09/14/2020
Mintz Levin/EES
One Financial Center
Boston, MA 02111
EXAMINER
LOPEZ, MICHELLE
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/14/2020 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):
ipdocketingbos@mintz.com
ipfileroombos@mintz.com
mintzdocketing@cpaglobal.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte FREDERICK E. SHELTON IV and
JASON L. HARRIS
__________

Appeal 2020-001178
Application 14/840,758
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

GREENHUT, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–3, 5–13, and 15–28. See Final Act. 1.
Claims 4 and 14 have been canceled. See Appeal Br. 5. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Ethicon LLC,
a Johnson & Johnson company. Appeal Br. 1.
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Application 14/840,758

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STATEMENT OF THE CASE
The claims are directed to surgical staples and adjuncts with
medicants affected by activators. Claim 1, reproduced below, is illustrative
of the claimed subject matter:
1. A staple cartridge assembly for use with a surgical
stapler, comprising:
a cartridge body having a plurality of staple cavities, each
staple cavity having a surgical staple disposed therein;
a biocompatible, bioabsorbable adjunct material
releasably coupled to the cartridge body and configured to be
delivered to tissue within a body of a patient by deployment of
the staples in the cartridge body; and
an effective amount of at least one medicant disposed
within and releasable from the adjunct material, the at least one
medicant including an activator material configured to be
activated within the body of the patient by an activator located
outside the body of the patient, the activation of the at least one
medicant allowing monitoring of the adjunct material after its
delivery to the tissue, the activator material being configured to
be activated by a magnetic field induced by the activator.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Schmid US 2013/0256373 A1 Oct. 3, 2013
Dormer US 8,740,872 B2 June 3, 2014
REJECTION
Claims 1–3, 5–13, and 15–28 are rejected under 35 U.S.C. § 103 as
being unpatentable over Schmid and Dormer. Final Act. 2.

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OPINION
In order to arrive at the claimed subject matter, the Examiner proposes
modifying Schmid’s staple cartridge assembly that has a cartridge body
(staple cartridge body 126), a surgical staple (staple driver 130), a
biocompatible, bioabsorbable adjunct material (tissue thickness compensator
200), and an effective amount of medicant, by adding Dormer’s activator
material that is configured to be activated within the body of a patient by an
activator located outside the body of the patient. Final Act. 2–3 (citing
Schmid ¶¶ 169, 170, 172, 173; Figs. 2–3; Dormer Abstr., 2:29–39, 9:52–55,
10:1–30). The Examiner reasons that it would have been obvious to a skilled
artisan to “have provided Schmid’s [staple cartridge assembly] with the
features as taught by Dormer in order to target deliver[y] of a medicament.”
Id. at 3.
Appellant contends that the Examiner’s proposed modification is
based on improper hindsight reconstruction because there is no reason for
the proposed modification of Schmid. See Appeal Br. 10. Appellant argues
that “Schmid already provides targeted delivery of its medicament, so
Dormer’s magnetic targeted delivery is wholly unnecessary.” Id. at 11.
In response, the Examiner modifies the rationale for the proposed
modification by stating that Schmid already has “an activator, such as a fluid
activator or an oxidizing agent, for a controlled release of the medicament as
shown in paragraph 173” and “Dormer is relied upon to show the mode of
activating a material, such as using a magnetic field.” Ans. 4. The Examiner
then reasons that it would have been obvious to “apply Dormer’s mode of
activation, i.e.[, a] magnetic field, to Schmid’s adjunct material in order [to]
control the release of the medicament.” Id.
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Appellant argues that “there is no objective reason for the Examiner’s
new basis of rejection” because, as the Examiner previously stated, Schmid
already “discloses an effective amount of at least one medicament disposed
within and releasable from an adjunct material.” Reply Br. 3 (citing Final
Act. 4).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR Int’l. v. Teleflex, 550 U.S. 398, 418 (2007). Further, our
reviewing court has frequently cautioned that it is not proper to base a
conclusion of obviousness upon facts gleaned only through hindsight. “To
draw on hindsight knowledge of the patented invention, when the prior art
does not contain or suggest that knowledge, is to use the invention as a
template for its own reconstruction—an illogical and inappropriate process
by which to determine patentability.” Sensonics Inc. v. Aerosonic Corp., 81
F.3d 1566, 1570 (Fed. Cir. 1996) (citing W.L. Gore & Assoc. v. Garlock,
Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983)). “The invention must be viewed
not after the blueprint has been drawn by the inventor, but as it would have
been perceived in the state of the art that existed at the time the invention
was made.” Id. (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132,
1138 (Fed. Cir. 1985)).
Dormer’s use of “magnetically-susceptible nanoparticles” is for
“targeted delivery” of medicants to “specific locations of the heart.” Dormer
Abstr. In other words, Dormer uses its magnetically-susceptible
nanoparticles to move medicants from a site of delivery to a site of
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treatment, in which the site of delivery is different from the site of treatment.
Schmid, on the other hand, has its medicants already at the site of delivery
and the site of treatment. Schmid ¶¶ 141, 149; Figs. 17, 18. Thus, in regards
to the Examiner’s first reason for modifying Schmid’s staple cartridge
assembly, i.e., “to target deliver[y] of a medicament” (Final Act. 3), we
agree with Appellant that there is no reason to do that because “Schmid
already provides targeted delivery of its medicament” (Appeal Br. 11).
Further, Dormer has a need to control the release of its medicant
because the site of delivery and the “target” site, i.e., the site of treatment,
are different. Dormer Abstr., 4:43–57, 5:28–35, 6:42–45, 7:14–23, 9:40–55,
10:4–15; Fig. 1. That is, once Dormer’s magnetically-susceptible
nanoparticles are drawn to the site of treatment in the heart, a magnetic force
is then applied to oscillate the nanoparticles causing release of a bioactive
agent from the nanoparticles’ coatings. Dormer 10:4–15. As the Examiner
acknowledges, Schmid already controls the release of its medicant at the
treatment site using, for example, an oxidizing agent. Ans. 4; Schmid ¶ 173.
Thus, there would appear to be no reason for modifying Schmid’s “mode of
activation” for that of Dormer’s because Schmid does not need to “target” its
medicant. If anything, it can be argued that Dormer’s magnetically-
susceptible nanoparticles and the equipment necessary to generate a
magnetic force to move or oscillate the nanoparticles (Schmid 10:1–29,
12:6–29) seem more complex than Schmid’s oxidizing agent. The Examiner
does not provide a reason why it would be obvious to substitute a simple
mode of activation for a more complex one. Thus, in regards to the
Examiner’s second reason for modifying Schmid’s staple cartridge
assembly, i.e., “in order [to] control the release of the medicament” or to
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substitute one “mode of activating a material” for another (Ans. 4), we agree
with Appellant that “there is no objective reason for the Examiner’s new
basis of rejection” (Reply Br. 2).
As such, because the Examiner has not articulated a persuasive reason
supported by rational underpinnings for combining the referenced teachings
in the manner proposed, we conclude that it is more likely than not that the
Examiner improperly resorted to hindsight in reaching a conclusion of
obviousness.
For the foregoing reasons, we do not sustain the Examiner’s rejection.
CONCLUSION
The Examiner’s rejection is reversed.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 5–13,
15–28
103 Schmid, Dormer 1–3, 5–13,
15–28

REVERSED