Ex Parte 8061359 et al

Patent Trial and Appeal Board

Oct 21, 2016

95002058 (P.T.A.B. Oct. 21, 2016)

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.
95/002,058 07/31/2012 8061359 729924-000104 1006
23628 7590 10/21/2016
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC AVENUE
BOSTON, MA 02210-2206
EXAMINER
WEHNER, CARY ELLEN
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
10/21/2016 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 PATENT TRIAL AND APPEAL BOARD
____________________

HOLOGIC, INC.
Requester, Respondent

v.

SMITH & NEPHEW, INC.1
Patent Owner, Appellant
____________________

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Technology Center 3900
____________________

Before DANIEL S. SONG, MICHAEL L. HOELTER, and
BRETT C. MARTIN, Administrative Patent Judges.

SONG, Administrative Patent Judge

DECISION ON APPEAL

1
Smith & Nephew, Inc. is the Patent Owner and the real party in interest
(Appeal Brief of Patent Owner (hereinafter “App. Br.”)). Covidien LP is
also said to be a real party in interest (Updated Mandatory Notices
Regarding Real Party-In-Interest, filed August 25, 2016).

2 Patent US 8,061,359 B2 (hereinafter “the ’359 patent”) issued November
22, 2011 to Emanuel.
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STATEMENT OF THE CASE
Claims 1–3 and 5–7 of the ’359 patent are subject to reexamination,
and stand rejected, while claims 4 and 8 have been canceled (Right of
Appeal Notice3 (hereinafter “RAN”) 4). The Patent Owner appeals under 35
U.S.C. §§ 134(b) and 315 from the Examiner’s rejections with respect to all
of the rejected claims (App. Br. 7). We have jurisdiction under 35 U.S.C.
§§ 134(b) and 315.
In addition to its Appeal Brief and Rebuttal Brief, the Patent Owner
relies on declarations of Messrs. Apley, Isaacson and Chinnock, and
evidence submitted therewith, in support of its appeal. In addition to its
Respondent Brief, the Requester relies on declarations of Messrs. Dominicis
and Walbrink, and evidence submitted therewith, in support of the
Examiner’s rejection.
The ’359 patent was involved in the legal action Smith & Nephew,
Inc. v. Interlace Medical, Inc. & Hologic, Inc., Civil Action No. 10-10951-
RWZ (D. Mass.), the court having issued a decision in Smith & Nephew, Inc.
v. Interlace Medical, Inc., 955 F.Supp. 2d 69, 71–72 (D. Mass. 2013), with
further proceedings relative to damages having been stayed pending
outcome of the present reexamination proceeding (App. Br. 6; Resp. Br. 18,
Appendix –– Related Proceedings; Order, dated May 14, 2015;
Memorandum of Decision, dated June 27, 2013).
An oral hearing with the representatives of the Patent Owner and the
Requester was held before the Patent Trial and Appeal Board on September

3 The Examiner’s Answer incorporates the RAN by reference. Hence we
cite to the RAN herein.
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22, 2016, and a transcript of the hearing will be entered into the record in
due course.
We REVERSE the Examiner’s rejection.

INVENTION
The ’359 patent is directed to a method for removing tissue from a
uterus (App. Br. 43, Claims App.). Representative independent claim 1
reads as follows (id., italics added):
1. A method for removal of tissue from a uterus,
comprising:
inserting a distal region of an endoscope into said uterus,
the endoscope including a valve and an elongated member
defining discrete first and second channels extending from a
proximal region of the elongated member to the distal region,
the second channel having a proximal end in communication
with the valve such that fluid from the valve is able to flow into
and through the second channel to the uterus, and the first
channel having a light guide permanently affixed therein and
being sealed from the second channel to prevent fluid from the
valve from entering the uterus through the first channel;
followed by:
inserting a motor driven cutter into the second channel
such that a distal cutting region of the cutter extends distally
beyond the endoscope in the uterus;
delivering fluid into the uterus through the valve and the
second channel to distend the uterus;
energizing an electric motor to drive the cutter to cut
tissue within the uterus; and
aspirating cut tissue and fluid from the uterus and the
endoscope through the cutter.

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The Examiner rejects claims 1–3 and 5–7 under 35 U.S.C. § 103(a) as
being unpatentable over Emanuel PCT4 in view of Bonnet.5

ISSUE
The dispositive issue raised in the present appeal is whether Emanuel
PCT provides written descriptive support for the claims of the ’359 patent,
so that the ’359 patent is entitled to claim priority to Emanuel PCT, and
Emanuel PCT is not prior art.

PRINCIPLES OF LAW
It is elementary patent law that a patent application is entitled to
the benefit of the filing date of an earlier filed application only
if the disclosure of the earlier application provides support for
the claims of the later application, as required by 35 U.S.C.
§ 112.
PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299 (Fed. Cir. 2008)
(citation omitted).

4 PCT International Publication No. WO 99/11184, published March 11,
1999. The ’359 patent is a continuation of an application that issued as U.S.
Patent No. 7,249,602, which in turn, claims priority to Emanuel PCT. Some
of the declaration evidence of record refers to the ’602 patent rather than
Emanuel PCT, which serves as the basis of the Examiner’s rejection.
However, this distinction is substantively immaterial as the disclosures of
the ’602 patent is the same as Emanuel PCT from which it claims priority.
Correspondingly, for the purposes of this Decision, we refer to Emanuel
PCT, even with respect to specific statements in the declaration evidence
that refer to the ’602 patent.

5 U.S. Patent No. 4,606,330, issued August 19, 1986.
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The test for sufficiency of written description 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.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc).
[T]he test requires an objective inquiry into the four corners of
the specification from the perspective of a person of ordinary
skill in the art. 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.
Compliance with the written description requirement is a question of
fact, which must be resolved on a case-by-case basis. See Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). In that regard:
whether a patent complies with the written description
requirement will necessarily vary depending on the context.
Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed.Cir.2005).
Specifically, the level of detail required to satisfy the written
description requirement varies depending on the nature and
scope of the claims and on the complexity and predictability of
the relevant technology. Id. For generic claims, we have set
forth a number of factors for evaluating the adequacy of the
disclosure, including “the existing knowledge in the particular
field, the extent and content of the prior art, the maturity of the
science or technology, [and] the predictability of the aspect at
issue.” Id. at 1359.
Ariad Pharm., 598 F.3d at 1351.
Moreover,
it is the specification itself that must demonstrate possession.
And while the description requirement does not demand any
particular form of disclosure, or that the specification recite the
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claimed invention in haec verba, description that merely
renders the invention obvious does not satisfy the requirement.
Id. at 1352 (citations omitted).

ANALYSIS
The dispositive issue noted above is raised in the present appeal due to
the claim limitation reciting “the first channel having a light guide
permanently affixed therein.” The Specification of the ’359 patent claims
priority to Emanuel PCT, but the Specification of the ’359 patent differs
from that of Emanuel PCT in that the Specification of the ’359 patent was
amended to state:
A connection 8 for a light source is also present, for connection
to a light guide, such as a fibre optics bundle, which provides
for lighting at the end of lens 13.
(Col. 3, ll. 56–58, amended material bolded and underlined).
The Examiner finds that “[t]he limitation ‘a light guide permanently
affixed therein’ has two components that are not supported [under 35 U.S.C.
§ 112, 1st paragraph] by the priority documents, i) light guide and ii) the
light guide permanently affixed in the first channel.” (RAN 8; see also id. at
31). In this regard, the Examiner further finds that:
The priority documents do not even show an optical guide
means or even the fiber optic guide disclosed in the
specification. Furthermore, there is no indication in the priority
documents that the fiber optic guide is located in the first
channel.
(RAN 27).
Accordingly, the Examiner finds that:
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The ’359 patent is not entitled to the benefit of a priority date of
’602 patent, the PCT application and the Dutch patent. It has
been determined that the claims are not entitled to benefit of the
prior filed applications and are not entitled to claim priority
before July 20, 2007; therefore the Emanuel PCT publication,
which was published on March 11, 1999, is available prior art
to the ’359 patent claims.
(RAN 9).
In view of the priority determination, the Examiner rejects claims 1–3
and 5–7 of the ’359 patent, finding that Emanuel PCT discloses all of the
recited limitations “except the limitation that the light guide is permanently
affixed to the first channel,” and relying on Bonnet for disclosing an
endoscope having a “permanent optical guide means.” (RAN 10; see also
Bonnet, Claim 1). The Examiner concludes that “[i]t would have been
obvious to one of ordinary skill in the art at the time the invention was made
to permanently affix the light guide of the Emanuel PCT in the first channel
in view of the teachings of Bonnet, in order to protect the light guide.”
(RAN 10; see also RAN 29–30).
The Patent Owner argues that because Emanuel PCT provides written
description for the limitation at issue, the ’359 patent is entitled to claim
priority to Emanuel PCT, so that Emanuel PCT is not prior art, and the
Examiner’s rejection based thereon is erroneous. We generally agree with
the Patent Owner, and address the arguments of the parties infra. While we
have considered the entirety of the appeal record, we cite to specific portions
thereof infra in addressing the various issues raised.

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Written Description Requirement
The Patent Owner argues that in the proper written description
evaluation, “[t]he operative question is how a POSA [person of ordinary
skill in the art] would understand disclosures against the backdrop of the
experience and knowledge that the artisan would have possessed.” (App.
Br. 32). The Patent Owner argues that the Federal Circuit and the Board’s
jurisprudence establish that implicit disclosures may provide written
description support, and that this is “black-letter law.” (App. Br. 11–12; see
also App. Br. 5 and 29–33).
For example, the Patent Owner refers to Vas-Cath and asserts that the
court found figures of a priority design patent implicitly disclosed claim
limitations (pertaining to a range of a lumen’s diameter in relation to the
diameter of another cylindrical portion) of a subsequently filed utility
application such that the drawings showed inventor’s possession of the
claimed invention to a person of ordinary skill in the art (App. Br. 29–33,
citing Vas-Cath, 935 F.2d 1566; see also App. Br. 31, citing Pozen Inc. v.
Par Pharmaceutical, Inc., 696 F.3d 1151, 1166–68 (Fed. Cir. 2012) (claims
to a “therapeutic package” for dispensing a pharmaceutical had written
description support even though not explicitly disclosed in the
specification)). The Patent Owner also argues that descriptions of well-
known subject matter are to be omitted so that the patents are concise
statements of what is new (App. Br. 11, citing EnOcean GmbH v. Face Int’l
Corp., 742 F.3d 955, 962 (Fed. Cir. 2014)). The Patent Owner further relies
on the Patent Office’s Manual of Patent Examining Procedure (hereinafter
“MPEP”), which states in the context of new or amended claims, “newly
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added claim limitations must be supported in the specification through
express, implicit, or inherent disclosure.” MPEP § 2163(I)(B) (emphasis
added).
The Examiner disagrees with the Patent Owner’s argument that the
law establishes implicit disclosure, and instead, agrees with the Requester’s
position that the specification actually or inherently disclose the recited
claim element (RAN 27). In this regard, the Requester relies on numerous
Federal Circuit cases in support:
Thus, the Federal Circuit has held that the specification must
“actually or inherently disclose the claim element.”
PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306–
07 (Fed. Cir. 2008); see also TurboCare, 264 F.3d at 1118–20
(holding that written description must be express or “inherent”
in the original application) (quoting Schering Corp. v. Amgen
Inc., 222 F.3d 1347, 1352 (Fed. Cir. 2000) (“The fundamental
inquiry is whether the material added by amendment was
inherently contained in the original application.”)); Katz
Interactive Call Processing Patent Litig. v. Am. Airlines, Inc.,
639 F.3d 1303 (Fed. Cir. 2011) (“the patentee must show that
‘the application necessarily discloses that particular device.’”)
(quoting Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998)
(“it must be shown that a person of ordinary skill would have
understood, at the time the patent application was filed, that the
description requires that limitation.”)); Tronzo v. Biomet, Inc.,
156 F.3d 1154, 1159 (Fed. Cir. 1998) (“the missing descriptive
matter must necessarily be present in the [original]
application’s specification such that one skilled in the art would
recognize such a disclosure.”) (followed by PowerOasis).
(Resp. Br. 5).
As to the actual articulation of the law, we disagree with the Patent
Owner. We do not find, nor does the Patent Owner, direct us to binding
precedent, that utilizes the term “implicit disclosure” to satisfy the written
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disclosure requirement, or that such a standard is “black letter law.” Instead,
the Federal Circuit’s en banc decision makes clear that the test for
sufficiency of written description 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.”
Ariad, 598 F.3d at 1351. In addition, while the MPEP states that “implicit”
disclosure provides sufficient written description, the MPEP merely gives an
indication of “the presumptions under which the PTO operates,” and does
not have the force of law. Critikon, Inc. v. Becton Dickinson Vascular
Access, Inc., 120 F.3d 1253, 1257 (Fed. Cir. 1997). Furthermore, while
numerous Board decisions have been cited by the Patent Owner in support
of its assertion, none of these Board decisions is precedential so as to be
binding on this panel. Moreover, while the Requester’s cited cases from the
Federal Circuit as set forth above do state that the disclosure must be explicit
or inherent, we understand the articulation regarding sufficiency of written
description through “inherent” disclosure as having been clarified and/or
encompassed within Ariad’s articulation set forth above.
Nevertheless, based on the specific facts of this case, we do not agree
with the Examiner and the Requester, and while this present case is a close
call, the preponderance of the evidence indicates that the disclosure of
Emanuel PCT “reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Ariad, 598 F.3d at 1351.

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Permanently Affixed
The Patent Owner does not dispute that Emanuel PCT does not
explicitly disclose permanent affixation of the light guide. However, the
Patent Owner argues that a person of ordinary skill in the art would have
viewed the figures shown in Emanuel PCT as depicting a surgical
endoscopic cutting device with a conventional endoscope, which is a single
unitary instrument without removable components, and thus, the figures
would have conveyed to one of ordinary skill that the inventor was in
possession of a light guide that is “permanently affixed.” (App. Br. 20–22).
In this regard, the Patent Owner observes that Emanuel PCT discusses
various components of the invention as being removable, but never suggests
that the endoscope is anything other than unitary in construction (App. Br.
32).
The Patent Owner also relies on Declaration of Isaacson and
Declaration of Apley, both declarants testifying that Figures 2 and 3 of the
Emanuel PCT closely resemble drawings from various prior art references of
record that show endoscopes typically having fixed light guides, such as in
Bonnet and Kuboto, and that these endoscopes visually differ from
endoscopes having removable light guides referred to in the art as
“telescopes” such as in Grossi and Savage (App. Br. 22–28; Decl. Isaacson
¶¶ 19–20; Decl. Apley ¶¶ 6 and 8–11). The comparison of pertinent figures
of the prior art and Figure 2 of Emanuel PCT set forth in the declarations are
reproduced in summary in the Appeal Brief as follows:
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(App. Br. 27). The above reproduced illustration shows endoscopes of prior
art references Bonnet, Kuboto, Grossi, and Savage on the left side, and
Figure 2 of Emanuel PCT on the right side.
The Patent Owner also argues that the Specification of Emanuel PCT
supports the fact that a person of ordinary skill in the art would understand
the illustrated endoscope as being of unitary construction considering that it
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discusses removable components of the disclosed surgical cutting device,
but does not provide any such disclosure with respect to the disclosed
endoscope used therein (App. Br. 20–21).
The Patent Owner further argues that because the light guide and
permanent affixing in the first channel are not the focus of the method
claims, there is no need for disclosure of the details of a well-known,
conventional endoscope (App. Br. 5, 11–12, 33–34). Specifically, the Patent
Owner argues that:
The extent of description required depends on “the scientific
and technical knowledge already in existence” along with the
“nature of the claims and the complexity of the technology.”
Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269,
1285 (Fed. Cir. 2012) (citing the “well-known” nature of the
applicable technology and affirming summary judgment
dismissing defendant’s written description defense); Capon v.
Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) (vacating
Board’s decision rejecting claims for lack of written description
support). This approach “enables patents to remain concise
statements of what is new, not cumbersome repetitions of what
is already known and readily provided by reference.” EnOcean
GmbH v. Face Int’l Corp., 742 F.3d 955, 962 (Fed. Cir. 2014)
(vacating Board’s decision and holding that claims were
entitled to PCT application’s filing date).
(App. Br. 11).
In further support, the Patent Owner argues that Bonnet added
“permanent” to its claim limitation reciting “optical guide means” without
explicit disclosure in its drawings or Specification that its light guide is
permanently affixed without objection or comment from the Examiner that
examined Bonnet (App. Br. 25, fn. 10). The Patent Owner argues that,
similarly, the text of the reexamined ’359 patent was amended upon
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suggestion and approval by the original Examiner who stated that there
appears to be support for the amendment (App. Br. 14, citing Interview
Summary, dated January 5, 2011).
We are ultimately persuaded by the evidence of record and the Patent
Owner’s arguments that the Examiner erred in finding that Emanuel PCT
lacks written descriptive support for the claims at issue in the ’359 patent.
As noted supra, compliance with the written description requirement is a
question of fact, which must be resolved on a case-by-case basis. See Vas-
Cath, 935 F.2d at 1563. Moreover, drawings alone may provide adequate
written description. Id. at 1565. There is no material dispute between the
parties that a person of ordinary skill in the art is a “degreed engineer having
at least 5 years of experience designing and developing devices used in
minimally invasive surgery (endoscopes, resectoscopes, shavers, tissue
removal devices, etc.).” (App. Br. 19; Dominicis Decl. ¶ 21).
The preponderance of the above-noted prior art and declaration
evidence indicates that such a person of ordinary skill in the art would have
known of the visual and functional differences between endoscopes having
fixed light guides, and endoscopes having removable light guides. Indeed,
there does not appear to be a material factual dispute that endoscopes having
fixed light guides were well-known in the art (see, e.g., RAN 29). We also
find by preponderance of the evidence that a person of ordinary skill in the
art, in reviewing Emanuel PCT with its drawings, would have known that
the surgical endoscopic cutting device includes an endoscope having fixed
light guide, like that of Bonnet and Kuboto, instead of an endoscope having
a removable light guide, like that of Grossi and Savage, so that it would have
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been evident to one of ordinary skill in the art that the inventor of Emanuel
PCT was in possession of the claimed device wherein the light guide is
permanently affixed.
The Examiner relies on the Requester’s argument that Emanuel PCT
does not inherently disclose the limitation at issue because it does not
disclose that its endoscope necessarily has a permanently fixed light guide,
but rather, it could have a removable light guide (Resp. Br. 5–6; RAN 27).
In this regard, the Requester argues that the Patent Owner’s claim to priority
is based “only on the possibility of disclosure that is neither express nor
inherent.” (Resp. Br. 5). The Requester relies on its declarant’s testimony
that there are various ways that the endoscope disclosed in Emanuel PCT
could have included a removable light guide (id. at 5–6; 2nd Decl. Dominicis
¶ 11; Decl. Walbrink ¶¶ 11, 13, 18). The Requester also notes that a
description that merely renders the invention obvious does not satisfy the
written description requirement (Resp. Br. 5–6).
In our view, the Examiner and Requester misapplies the law, which
requires the inquiry to be focused upon what the disclosure reasonably
conveys to those skilled in the art as of the filing date. Ariad, 598 F.3d at
1351. Emanuel PCT should be viewed from the perspective of a person of
ordinary skill in the art. Id.; see also LizardTech, Inc. v. Earth Resource
Mapping, Inc., 424 F.3d 1336, 1345 (Fed.Cir.2005)
[T]he patent specification is written for a person of skill in the
art, and such a person comes to the patent with the knowledge
of what has come before . . . . Placed in that context, it is
unnecessary to spell out every detail of the invention in the
specification; only enough must be included to convince a
person of skill in the art that the inventor possessed the
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invention and to enable such a person to make and use the
invention without undue experimentation.

As the Patent Owner argues:
Requester’s witnesses are . . . silent as to how a POSA [person
of ordinary skill in the art] would have understood the
[Emanuel] PCT application in view of “the scientific and
technical knowledge already in existence.” Capon, 418 F.3d at
1357 (holding that Board “erred in refusing to consider the state
of the scientific knowledge”). They focus instead on whether
one could theoretically construct an endoscope that is consistent
with Dr. Emanuel’s disclosure while featuring a removable
light guide. (Second Dominicis Decl. ¶ 11; Walbrink Decl.
¶¶ 10–11). That is not the relevant inquiry under the law.
(App. Br. 28).
Specifically, neither the Requester and its declarants, nor the
Examiner, sufficiently address what the disclosure of Emanuel PCT
reasonably conveys to those in the art, but instead, focuses on the lack of
explicit disclosure (which is not in dispute), or that the light guide of
Emanuel PCT is not necessarily permanently affixed such that it could have
included a removable light guide. Neither the Requester and its declarants,
nor the Examiner, persuasively rebut the evidence and argument of the
Patent Owner that the illustrated endoscope of Emanuel PCT closely
resembles the endoscopes of Bonnet and Kuboto, that these endoscopes have
permanently affixed light guides, and that this fact would have been readily
apparent to those of ordinary skill in the art, so that such a person would
have understood Emanuel PCT has having a permanently affixed light guide.
For example, while seemingly asserted, the Requester fails to provide any
persuasive evidence that endoscopes constructed in the manner discussed
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and shown in Emanuel PCT, Bonnet, or Kuboto, but having a removable
light guide exist, or that their existence would have been known by those of
ordinary skill.
By focusing on possible ways that the endoscope of Emanuel PCT
could have included a removable light guide instead of focusing on how a
person of ordinary skill in the art would have understood the disclosure of
Emanuel PCT, the Requester is improperly requiring the Emanuel PCT to
necessarily exclude possible ways in which the disclosed endoscope may be
constructed to include a removable light guide. That is not the proper
inquiry. Vas-Cath, 935 F.2d at 1565–66 (rejecting the district court’s
reasoning that “[the claims] contain limitations that did not follow
ineluctably [i.e., inevitably] from the diagrams,” because the district court
essentially required the drawings of the parent design patent to “necessarily
exclude” all diameters other than those within the claimed range.). The
proper inquiry as to drawings is “whether the drawings conveyed with
reasonable clarity to those of ordinary skill that [the inventor] had in fact
invented [the claimed device],” and it is the “[c]onsideration of what the
drawings conveyed to persons of ordinary skill [that] is essential.” Vas-Cath,
935 F.2d at 1566.
The fact that the priority document in Vas-Cath was a design patent is
not lost in our consideration. In Vas-Cath, the lumens were shown in the
drawings of the priority document, whereas in the present appeal, Emanuel
PCT does not illustrate a light guide in its drawings. In this regard, as the
Examiner notes, even though Bonnet’s claim was amended to specifically
recite that its optical guide is “permanent,” Bonnet also specifically
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identifies the optical guide means in the specification and drawings (RAN
26–27). However, there is no dispute that the Specification of Emanuel PCT
discloses “a fibre optics bundle which provides for lighting at the end of lens
13.” (Emanuel PCT, pg. 4, ll. 35–36).6 Again, Emanuel PCT should be
viewed from the perspective of a person of ordinary skill in the art who has
knowledge of what has come before. LizardTech, 424 F.3d at 1345.
Accordingly, the omission of the fiber optics bundle in the drawings of
Emanuel PCT does not materially alter the analysis as to what the totality of
Emanuel PCT discloses to those of ordinary skill in the art.
The Examiner further notes that during the prosecution of the patent
application that ultimately issued as the ’359 patent, the Patent Owner
distinguished the prior art applied in the rejections based on permanently
affixed limitation so it cannot be reasonably argued that this feature is not
the focus of the claims (RAN 27–28; see also Resp. Br. 10). However, as
the Patent Owner argues (App. Br. 34–35), we find nothing improper about
overcoming a rejection by distinguishing the claimed invention over the
actual prior art applied by pointing to the deficiencies of the prior art.
The Requester also argues that if the endoscope of Figures 2 and 3 of
the ’359 patent was, in fact, conventional, then these figures should have
been indicated as “prior art.” (Resp. Br. 9). However, as the Patent Owner
persuasively argues (Reb. Br. 13), there is no requirement for such markings
for every subcomponent of a new device, and the disclosed invention is not
directed to an endoscope, but rather, “a method for removal of tissue from a

6 We address the issue of whether a disclosure of “a fibre optics bundle” is
sufficient to provide written descriptive support for the claimed “light guide”
infra.
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uterus,” which uses a surgical endoscopic cutting device (Title), and
includes an endoscope. In such a situation, like the Examiner during the
original prosecution who did not object to the drawings, we do not
understand the drawing requirements as necessitating designation of a sub-
component to be “prior art.”
The Requester further asserts that the Patent Owner’s own declarant
testified that a person of ordinary skill would not have had experience with
hysteroscopes with a permanently fixed light guide (Resp. Br. 9, quoting
Deposition of Isaacson on May 2, 2012 at pg. 179, ll. 2–8). However, the
relevance of this is not entirely clear because the testimony at issue pertains
to hysteroscopes which is apparently a special type of endoscope used in the
uterus (Reb. Br. 15). The testimony is not relevant as to what the entirety of
Emanuel PCT would have conveyed to those of ordinary skill in the art.
Moreover, as the Patent Owner explains, “[s]ince no one before Dr. Emanuel
had operated in the uterus using endoscopes with permanently fixed light
guides, Dr. Isaacson rightly testified that POSAs [persons of ordinary skill in
the art] lacked experience with ‘hysteroscopes’ (i.e., endoscopes used in
uterine treatment) having a permanently affixed light guide.” (Reb. Br. 15).
The Requester’s apparent argument that this testimony contradicts the
assertion that the Emanuel PCT would have conveyed to a person of
ordinary skill in the art that the inventor was in possession of an endoscope
having a permanently fixed light guide is unpersuasive.
In view of the above, we are persuaded that when a person of ordinary
skill in the art considers the ’359 patent in its entirety, its text and drawings
would have reasonably conveyed to those skilled in the art that the inventor
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had possession of an endoscopic cutting device including an endoscope
wherein the fiber optics bundle is permanent and not removable.

In the First Channel
As noted, the Examiner finds that because Emanuel PCT does not
show a fiber optic guide, it lacks written descriptive support for having the
fiber optic guide located in the first channel as recited by the claims (RAN
27; see also id. at 8, 31). The Examiner relies on the Requester’s argument
that Emanuel PCT does not inherently disclose the limitation at issue
because it does not disclose the fiber optic guide, much less the location of
the fiber optic guide (Resp. Br. 12–13; RAN 27). In this regard, the
Requester’s declarant testifies that a fiber optical guide could have been
located in the first channel or the second channel, or even outside the
channels, and is not necessarily in the first channel (Decl. Walbrink ¶¶ 11,
18, 19).
The Patent Owner disagrees and argues that the Requester’s evidence
and arguments as to where the light guide could be within the working
channel applies an improper legal standard, and that the pertinent limitation
is disclosed implicitly (App. Br. 37–38). The Patent Owner also argues that
the light guide is recited in the claims as being in a first channel, which need
not be the viewing channel as asserted by the Examiner, but merely must be
a channel that is sealed and separate from the second channel through which
the fluid may be delivered such as a working channel (App. Br. 35, citing
RAN 31). The Patent Owner further argues that a person of ordinary skill in
the art would have known that the light guide would be located in a channel
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different from the working channel, and permanently affixed and sealed due
to practical considerations and common sense (App. Br. 36). In this regard,
the Patent Owner argues that “the undisputed impracticality of placing the
light guide in the same channel as the cutting instrument confirms the
[Emanuel] PCT application’s implicit support for requiring that the light
guide be in a channel separate from the working channel.” (App. Br. 37).
Notwithstanding our disagreement with the Patent Owner with respect
to “implicit” disclosure for the reasons already discussed supra, we are
persuaded by the preponderance of the evidence that the disclosure of
Emanuel PCT “reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter” for reasons similar to
those discussed supra relative to permanently affixed light guide. In
particular, whereas the Patent Owner focuses on what Emanuel PCT
reasonably conveys to those in the art, the Requester’s arguments and
testimonial evidence relied upon by the Examiner focus on the potential
location of the light guide in Emanuel PCT, which again misapplies the law.
As discussed supra, the proper inquiry as to whether Emanuel PCT supports
the present limitation is not whether the endoscope described and illustrated
therein could have positioned the light guide in the working channel or
elsewhere, but rather, whether its disclosure reasonably conveys possession
of this limitation to those of ordinary skill.
Thus, under the facts of this case, the inquiry is whether a person of
ordinary skill would have understood that the endoscope disclosed in
Emanuel PCT had a light guide that is positioned within a channel, which
differs from the channel used for conveyance of fluid and for insertion of
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other components. The preponderance of the evidence indicates that
endoscopes of the type illustrated in Figures 2 and 3 of Emanuel PCT, such
as the endoscope of Bonnet, are provided with a light guide in a channel
(i.e., a first channel) that differs from a channel where other components of
the endoscope are inserted and removed (Bonnet, col. 2, ll. 32–40; Fig. 2).
Neither the Requester nor the Examiner persuasively rebuts the evidence and
argument of the Patent Owner that the endoscopes of the type illustrated in
Emanuel PCT have light guides in a channel separate from that used by
other components, or that this fact would not have been readily apparent to
those of ordinary skill in the art. In this regard, the manner in which the
device of Emanuel PCT is disclosed as being used makes it reasonably clear
to those of ordinary skill that the light guide would not be in the working
channel, but rather, in a different channel. Thus, ased on the preponderance
of the evidence, we find that Emanuel PCT reasonably conveys to those of
ordinary skill in the art, possession of a light guide located in a channel,
which is separate from a channel used by other components. In this regard,
we note that
the patent specification is written for a person of skill in the art,
and such a person comes to the patent with the knowledge of
what has come before.... Placed in that context, it is
unnecessary to spell out every detail of the invention in the
specification; only enough must be included to convince a
person of skill in the art that the inventor possessed the
invention and to enable such a person to make and use the
invention without undue experimentation.
LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345
(Fed.Cir.2005).

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Light Guide
As noted, the Examiner rejects the claims finding that Emanuel PCT
also does not support the limitation “light guide” because it merely discloses
a “fibre optics bundle.” (RAN 8). The Patent Owner argues that the
disclosure of the species “fibre optics bundle” supports the claimed genus of
“light guides” because a fibre optics bundle is an example of a light guide
(App. Br. 14; see also App. Br. 15–17, and 19). In this regard, the Patent
Owner argues that:
Given the predictability of the field and the fact that endoscopes
with light guides were well known to a POSA [person of
ordinary skill in the art] in 1998, Dr. Emanuel’s disclosure of a
“fibre optics bundle” species is more than sufficient to support
claims to the “light guide” genus. The original examiner
reached this conclusion when noting that the “drawings and the
specification appear to have support for the limitation ‘light
guide’” and subsequently approving a “minor amendment” to
the specification to recite “a light guide, such as a fibre optics
bundle.” (9/3/2010 Interview Summary; 1/5/2011 Office
Action).
(App. Br. 14).
The Examiner disagrees and finds that “the use of the term ‘fiber
optics bundle’ in the priority documents does not demonstrate that the
inventor had possession of an endoscope with any type of light guide.”
(RAN 28). The Requester agrees with the Examiner’s assessment (Resp. Br.
13–14). We are persuaded that the Examiner erred.
The Federal Circuit has explained that its case law recognizes that:
determining whether a patent complies with the written
description requirement will necessarily vary depending on the
context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir.
2005). Specifically, the level of detail required to satisfy the
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written description requirement varies depending on the nature
and scope of the claims and on the complexity and
predictability of the relevant technology. Id. For generic
claims, we have set forth a number of factors for evaluating the
adequacy of the disclosure, including “the existing knowledge
in the particular field, the extent and content of the prior art, the
maturity of the science or technology, [and] the predictability of
the aspect at issue.” Id. at 1359.
Ariad Pharm., 598 F.3d at 1351.
As pointed out by the Patent Owner, there is no dispute that “fibre
optic bundles” is a type of a light guide, or that various types of light guides
were also well-known in the art (App. Br. 15; Decl. Dominicis ¶ 12; see also
Decl. Walbrink ¶¶ 10(c) and 30). Moreover, the field of optical guides is not
an unpredictable field. Correspondingly, given the knowledge of those in
the art, and the predictability of the technology involved, the preponderance
of the evidence indicates that Emanuel PCT disclosure of a “fibre optics
bundle” reasonably conveys to those of ordinary skill in the art that the
inventor was in possession of the broader genus of a “light guide.”
While the Requester cites to various cases of the Federal Circuit in
support of the Examiner’s position (Resp. Br. 13–14), we again note that
compliance with the written description requirement is a question of fact,
which must be resolved on a case-by-case basis as indicated by the
numerous Federal Circuit cases cited by the Patent Owner in support of its
appeal (App. Br. 15–16). Vas-Cath 935 F.2d at 1563; see also Ariad
Pharm., 598 F.3d at 1352 (“whatever inconsistencies may appear to some to
exist in the application of the law, those inconsistencies rest not with the
legal standard but with the different facts and arguments presented to the
courts.”).
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Therefore, in view of the above, we reverse the Examiner’s finding
that Emanuel PCT fails to provide written description for the claims of the
’359 patent, and find that the ’359 patent is entitled to claim priority to
Emanuel PCT. Accordingly, we also find that Emanuel PCT is not prior art
against the ’359 patent and reverse the Examiner’s rejection based thereon.
Finally, the Patent Owner’s further arguments asserting that rejection
exceeds the Patent Office’s statutory authority because it contradicts the
original Examiner’s finding (App. Br. 38–40), and that the rejection is
unconstitutional in view of the related litigation’s jury verdict (App. Br. 40–
41), are not only beyond the jurisdiction of the Board to decide, but are also
moot in view of the above reversal of the Examiner’s rejection.

ORDER
The Examiner’s rejection is REVERSED.

Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. In the event neither party
files a request for rehearing within the time provided in 37 C.F.R. § 41.79,
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a
party seeking judicial review must timely serve notice on the Director of the
United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and
1.983.

REVERSED

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Patent Owner:
Wolf Greenfield & Sacks, P.C.
600 Atlantic Avenue
Boston, MA 02210-2206
Third Party Requester:
Arnold & Porter LLP
Attn: IP Docketing
601 Massachusetts Ave., NW
Washington, DC 20001-3743