SCHIEBER, Andrew T. et al.

Patent Trials and Appeals Board

Feb 7, 2020

15012544 - (D) (P.T.A.B. Feb. 7, 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.
15/012,544 02/01/2016 Andrew T. SCHIEBER 10502-700.502 6210
66854 7590 02/07/2020
SHAY GLENN LLP
2929 CAMPUS DRIVE
SUITE 225
SAN MATEO, CA 94403
EXAMINER
LOPEZ, LESLIE ANN
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
02/07/2020 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW T. SCHIEBER and CHARLES L. EUTENEUER
Appeal 2019-002184
Application 15/012,544
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
LISA M. GUIJT, Administrative Patent Judges.
GREENHUT, 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 1–7, 9–15, 17–25, 27, 28, 30, and 31.2
See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter NEW GROUNDS OF REJECTION.

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 Ivantis, Inc. Appeal
Br. 2.
2 Claims 20 and 23 are included in the listing of rejected claims in the Office
Action Summary. However, we do not find claims 20 and 23 specifically
addressed in the Examiner’s Action. Appellant does not take issue with this.
Appeal 2019-002184
Application 15/012,544
2
CLAIMED SUBJECT MATTER
The claims are directed to ocular implants for increasing aqueous
humor outflow. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. An ocular implant comprising:
a longitudinally extending body having an inlet portion
and a Schlemm’s canal portion distal to the inlet portion, the inlet
portion being configured to extend into and be in fluid
communication with an anterior chamber of a human eye and the
Schlemm’s canal portion being configured to be inserted into
Schlemm’s canal adjacent to collector channels of the eye;
a plurality of alternating spines and frames positioned
longitudinally along at least a portion of the Schlemm’s canal
portion wherein the plurality of alternating spines and frames
define a central channel extending therethrough, with the central
channel being in fluid communication with the inlet portion;
each of the spines having edges partially defining an
opening across from the central channel and in fluid
communication with the central channel; and
each of the frames including first and second struts, the
first and second struts each having an edge contiguous with the
edges of adjacent spines, the edges of the first and second struts
and of the spines defining the opening in fluid communication
with the central channel;
wherein the ocular implant is configured to provide at least
a 121% increase in average outflow facility of aqueous humor
from the anterior chamber through the collector channels of the
eye.
REFERENCES
Name Reference Date
Neuhann US 6,494,857 B1 Dec. 17, 2002
Bergheim US 2006/0074375 A1 Apr. 6, 2006
Schieber US 8,372,026 B2 Feb. 12, 2013
Wardle US 8,657,776 B2 Feb. 25, 2014
Schieber US 8,961,447 B2 Feb. 24, 2015
Schieber US 9,039,650 B2 May 26, 2015
Appeal 2019-002184
Application 15/012,544
3
Name Reference Date
Schieber US 9,155,655 B2 Oct. 13, 2015
Wardle US 9,211,213 B2 Dec. 15, 2015
Wardle US 9,358,156 B2 June 7, 2016
Schieber US 9,402,767 B2 Aug. 2, 2016
Schieber US 9,610,196 B2 Apr. 4, 2017
Wardle US 9,693,899 B2 July 4, 2017
REJECTIONS
Claim 30 is rejected under 35 U.S.C. § 112, second paragraph, as
being indefinite. Final Act. 17.
Claim 1, 9, and 31 are rejected under 35 U.S.C. § 102(b) as being
anticipated by Neuhann. Final Act. 17.
Claims 2–7, 10–15, 17, 18, and 30 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Neuhann. Final Act. 23.
Claims of the present 15/012,544 application indicated in each row of
the following table are rejected for obviousness–type double patenting based
on the application, patent, and claims indicated in that row:3
Claims in
15/012,544
Application Patent# Claims in Prior
Case
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28, 31
12/236,225 US 8,734,377 1, 21
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28,
30, 31
13/160,355 US 8,657,776 1, 2, 6–11, 13, 14

3 The Examiner withdrew the double-patenting rejections of (1) Claim 31
under US 8,961,447, (2) Claim 31 under US 9,402,767, (3) Claim 30 under
US 9,358,156, and (4) Claim 31 under US 9,610,196. Ans. 3.
Appeal 2019-002184
Application 15/012,544
4
Claims in
15/012,544
Application Patent# Claims in Prior
Case
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28,
30, 31
13/366,073 US 8,372,026 1, 2, 7, 11, 12, 17
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28, 30
13/763,394 US 9,402,767 1, 4–5, 8, 10, 13–
14, 16
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27–28, 30
13/776,592 US 8,961,447 1, 2, 9–12, 19–22,
29, 30
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28, 30
13/793,638 US 9,358,156 1–3
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28,
30, 31
13/865,770 US 9,211,213 1–4, 6–13, 15–20
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28,
30, 31
14/139,403 US 9,155,655 1, 2, 6–11, 13, 14
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28,
30, 31
14/246,363 US 9,039,650 1, 2, 10
1, 3, 4, 6, 7, 9,
11, 12, 14, 15,
17–19, 21, 22,
24, 25, 27, 28, 30
14/691,267 US 9,610,196 1–4, 8–10

Appeal 2019-002184
Application 15/012,544
5
OPINION
Indefiniteness of claim 30 under 25 U.S.C. § 112, second paragraph, based
on “the body extending in a curved volume having a large radius side and a
short radius side”
The Examiner determined “[i]t is unclear what radii are referred to”
(Final Act. 17) and “[n]ot knowing if the device is implanted or not alone
renders this language unclear as the term radius is also used to describe the
radius of the tube.” Ans. 4. Appellant points to the Specification’s
disclosure:
ocular implant 100 with a body 102 extending along a curved
longitudinal axis having a radius 150. A channel 126 has an
opening 124 on the side of body 102 having a radius larger than
radius 150, and a plurality of openings 138 are shown on the side
of body 102 having a radius smaller than radius 150.
Reply. Br. 2 (citing Spec. paras. 89–91]). The marked contrast between
claim 30 and the cited portion of the Specification is that in the cited excerpt
of the Specification it is clear that the longer and shorter radii are attributes
of the implant body, and in claim 30 they appear to be attributes of the
volume of Schlemm’s canal. Claim 30 is directed to an implant “adapted to
reside . . . in . . . Schlemm’s canal” and the recited body of the implant is
“configured to extend within Schlemm’s canal.” (Emphasis added). Hence,
it is not well-defined whether the “extending in a curved volume” limitation
is before or after implantation. Further, where the claim makes the
requirement for an “open side disposed on the large radius side” it becomes
unclear whether Appellant is attempting to claim (1) the implant in its
implanted state; (2) an implant having an open side “disposed on a large
radius side” of the implant body, as opposed to the large radius side of the
volume of Schlemm’s canal; or (3) an implant having an open side that is
Appeal 2019-002184
Application 15/012,544
6
configured to be “disposed on a large radius side [of the volume of
Schlemm’s canal].” The first interpretation requires no alteration to the
express wording of the claim, but would likely run afoul of the prohibition
against mixing statutory classes in such a way that it is unclear when
infringement actually occurs. See MPEP 2173.05(p)(II). The second and
third interpretation differ in whether there exists a requirement for curvature
of the implant body itself (second interpretation) or only the capability to be
curved once the implant is implanted in the curved volume (third
interpretation). The Examiner was reasonably justified in requiring
Appellant to resolve this ambiguity during prosecution while Appellant has
the opportunity to do so. See In re Packard, 751 F.3d 1307 (Fed. Cir. 2014).
Accordingly, we sustain the Examiner’s indefiniteness rejection of claim 30.

The recited term “adjacent,” in claims 9 and 31 as it relates to the
rejections under §§ 102(b) and 103(a), and the double-patenting rejections.
The Examiner, citing Merriam-Webster’s definition of the word
adjacent (Ans. 7), reasons:
the claimed language is that the opening “is adjacent a major
side”, so the claim does not require an opening to “face” a major
side as argued. Adjacent only requires a “nearby” location and
facing as argued by the Appellant.
“Nearby” may be a suitable synonym for “adjacent” in many contexts,
including this one. However, “adjacent” and “nearby” are both terms highly
dependent upon the context in which they are used. Here, the context in
which the positioning of the implant is described in claims 9 and 31 is “in
Schlemm’s canal.” When a structure is described as being adjacent one side
of a reference frame, here an “opening . . . adjacent a major side of
Appeal 2019-002184
Application 15/012,544
7
Schlemm’s canal,” considering that language to be satisfied when the
structure is on the polar opposite side of the reference frame, here the minor
side of Schelmm’s canal, effectively deprives the term “adjacent” of any
meaning within that reference frame. We therefore agree with Appellant
that, on the record presently before us, the Examiner has not adequately
demonstrated how the claim language “adjacent” in claims 9 and 31 is
satisfied by Neuhann. Thus, the Examiner’s anticipation rejection of claims
9 and 31 cannot be sustained on the record before us. As the Examiner has
not otherwise accounted for this deficiency in the obviousness rejection, the
Examiner’s obviousness rejection of dependent claims of 1–15, 17, and 18
also cannot be sustained.
The Examiner advances the same position regarding the term adjacent
with regard to the following double-patenting rejections:
Claims in
15/012,544
US Patent# Claims in Prior
Case
Answer page
9 8,734,377 1 13
1, 9 8,657,776 1 14
9 9,402,767 4 17
9 9,358,156 1 19
9 9,155,655 2 22
9 9,039,650 2, 3, 10, and 124 24
9 9,610,196 1, 8 26

It is unclear why the Examiner addresses the “adjacent” language with
regard to the rejection of claim 1 based on US 8,657,776 (Ans. 14) because
claim 1 of the present application does not include the “adjacent” language
in question. We regard this as a typographical error. Although we have

4 The Final Office Action cites only claims 1, 2, and 10 of US 9,039,650.
Final Act. 16.
Appeal 2019-002184
Application 15/012,544
8
determined the Examiner’s applied interpretation of “adjacent” was
unreasonably broad, this erroneous claim construction is not by itself fatal to
the double-patenting rejections of claim 9 in the table above premised on US
patents 8,734,377; 9,402,767; and 9,610,196. This is because the applied
claims in each of these patents contain language that, although not identical,
sufficiently satisfies the “adjacent a major side” language of claim 9 in
question. The pertinent language of the prior claims is indicated in the table
below:
US Patent# Claims in Prior
Case
Claim language in prior case
8,734,377 1 “an elongate opening disposed on an
outer side of the body”
9,402,767 4 “the opening defined by the edges of
the spines and struts being disposed
on the outside of the curve”
9,610,196 1 “having an open side disposed on the
large radius side”

It is additionally noted that claim 6 of US 9,039,650 contains the
limitation, “the elongate opening is disposed on a radially outward portion of
the cylindrical volume,” which would satisfy the language of claim 9 in
question. However, the Examiner did not apply claim 6 of US 9,039,650 in
the Examiner’s rejection. We are not apprised of anything in the remaining
applied patents, or of any reasoning articulated by the Examiner, for
explaining why, despite the differences between the subject matter of the
prior claims and present claim 9, the subject matter of claim 9 would
nevertheless have been obvious over the applied prior claims. Accordingly,
the obviousness-type double-patenting rejections against claim 9 premised
on 8,657,776; 9,358,156; 9,155,655; 9,039,650 cannot be sustained on the
basis set forth by the Examiner.
Appeal 2019-002184
Application 15/012,544
9

“the channel having an open side” according to claim 30 as it pertains to
the § 103(a) rejection
Claim 30 requires both a “plurality of openings” and an “open side.”
In the rejection the Examiner addresses the “open side” by referring, without
further explanation, to Figure 1(a) of Neuhann. Final Act. 26–27. The
Examiner addresses the “plurality of openings” limitation by indicating it
was “discussed supra.” Final Act. 27. “[S]upra,” as the term is used by the
Examiner, appears to refer to the Examiner’s citation to openings 2 and 3 in
Figure 1(a) of Neuhann. See Final Act. 18. The embodiment depicted in
Figure 1(a) of Neuhann clearly lacks both a “plurality of openings” and an
“open side.” The Examiner does not account for this difference between the
claimed subject matter and the prior art with any further evidence or
reasoning supported by rational underpinnings to address why, despite this
distinction, the claimed subject matter would nevertheless have been
obvious.
In the Examiner’s Answer, the Examiner indicates the rejection of
claim 30 was intended to be based on reasoning similar to that set forth by
the Examiner concerning claim 2. Ans. 10. However, “provid[ing] for
openings on both opposing sides of the tube” (Final Act. 23 (addressing
claim 2)) is different from proving an “open side.” Reply. Br. 7–8. There is
no legally recognizable essential gist or heart of the invention. W.L. Gore &
Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548 (Fed.Cir.1983), cert.
denied, 469 U.S. 851 (1984). The express language of the claim must be
considered in judging the obviousness of the claimed subject matter. See In
re Wilson, 424 F.2d 1382, 1385.
Appeal 2019-002184
Application 15/012,544
10
For the foregoing reasons, on the record presently before us, the
Examiner’s § 103(a) rejection of claim 30 cannot be sustained because the
Examiner has not established the obviousness of the precise subject matter
defined by claim 30.

The “inlet” as it pertains to the double-patenting rejections
The issue of whether Neuhann includes an “inlet portion” according to
claims 1 and 30 is moot with regard to the rejections predicated under
§§ 102(b) and 103(a) because we have reversed those rejections for
alternative reasons as discussed above. Insofar as the “inlet” limitation is
concerned with regard to the double-patenting rejections of claims 1, 19, and
30 (Appeal Br. 18–20, 22, 23, 25–29, 42–56), we agree with the Examiner
that, although the term “inlet” or “inlet portion” may not be expressly recited
in the applied prior claims, such a feature is necessarily present in any
structure that intakes a fluid at some location and conveys it from that
location to another. It is not disputed that the prior claims are directed to
such a fluid-conveying structure. Ans. 4–12. Once the examiner presents
evidence or reasoning tending to show inherency, the burden of production
shifts to the applicant. See MPEP § 2112(V). Appellant’s arguments do not
apprise us of any possible alternatives to demonstrate why inlets are not
necessarily required in the previously claimed subject matter.

The requirement for demonstrating that it would have been obvious to omit
claim elements from previous applications or patents to establish
obviousness-type double patenting
In numerous instances, Appellant argues that in order to establish
obviousness-type double patenting the Examiner must demonstrate that it
Appeal 2019-002184
Application 15/012,544
11
would have been obvious to omit features from the prior claims applied in
the rejection. Appeal Br. 18–21, 24, 25, 27, 30, 43, 45, 46, 48, 51, 52, 54,
57. As the Examiner points out, this is not required. Unless the claims of the
present application employ closed transitional phrases (see MPEP
§ 2111.03), which they do not, they are demonstrated unpatentable for
purposes of an obviousness-type double-patenting rejection in much the
same way as they are demonstrated unpatentable for covering obvious
subject matter under 35 U.S.C. § 103(a). MPEP § 804 (citing, inter alia, In
re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991)). “The fundamental reason
for the [obviousness-type double-patenting] rule is to prevent unjustified
timewise extension of the right to exclude granted by a patent no matter how
the extension is brought about.” In re Schneller, 397 F. 2d 350 (CCPA 1968)
(discussed in detail at MPEP § 804). Of course, an extension can effectively
be “brought about” by omitting elements from previous claims such that
later claims encompass subject matter for which an applicant was previously
conferred an exclusive right. Anyone undertaking to utilize the subject
matter of the patented claims on their expiration would remain precluded
from doing so notwithstanding the fact that the later claims omit elements of
the previously issued claims. This would undermine the very purpose of the
prohibition against obviousness-type double patenting. Accordingly, where,
as here, the claims recite an open-ended transitional phrase, the Examiner
need not demonstrate the obviousness of omitting additional elements of
prior claims applied in an obviousness-type double-patenting rejection.

Appeal 2019-002184
Application 15/012,544
12
The limitation “wherein the ocular implant is configured to provide at least
a 121% increase in average outflow facility of aqueous humor from the
anterior chamber through the collector channels of the eye”
A central issue in the rejections under §§ 102(b) and 103(a) and the
double-patenting rejection is the meaning of the recited phrase, “wherein the
ocular implant is configured to provide at least a 121% increase in average
outflow facility of aqueous humor from the anterior chamber through the
collector channels of the eye” in claim 1, and that of the similar limitations
in claims 9, 19, 30, and 31, which instead recite a “121%–222%” range.
Although we have reversed the §§ 102(b) and 103(a) on other grounds, a
discussion of the meaning of this phrase with regard to all rejections before
us is warranted.
First, it is easily observed that the claims in question are directed to
“ocular implant[s]” and are therefore machine or apparatus claims, as
opposed to method or process claims. “[A]pparatus claims cover what a
device is, not what a device does.” MPEP § 2114 (quoting Hewlett-Packard
Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990)). Thus,
the actual act of “provid[ing] at least a 121% increase in average outflow
facility of aqueous humor from the anterior chamber through the collector
channels of the eye” is not a requirement of the claims. The question then is:
what is the structural implication of reciting that the claimed “ocular
implant” is “configured to” perform this function? See K-2 Corp. v. Salomon
S.A., 191 F.3d 1356, 1363 (Fed. Cir. 1999) (“[T]he functional language tells
us something about the structural requirements. . .”). In certain contexts
“configured to” can simply mean, or be synonymous with, “capable of” in
that any structure that can actually perform the recited function satisfies the
claim limitation. On the other hand, in certain contexts “configured to” can
Appeal 2019-002184
Application 15/012,544
13
have a narrower meaning implicating the presence of some structure or
arrangement that demonstrates that the device was specifically designed,
made, or adapted to accomplish the particular recited function. The
Examiner repeatedly questions Appellant as to what structural meaning is
implicated by this phrase. See, e.g., Final Act. 13 (“With respect to the
functional language ‘the 121% increase in average outflow facility’, as the
structure is the same, so are the functions of the structure. The Examiner
notes that the Applicant must claim their invention in such a way that the
structural features define over the prior art.”); Ans. 6–7 (“Further, the
Appellant has failed to show what combination of structures are required to
produce the claimed outflow facility.”). Appellant simply argues Appellant
is under no obligation to provide that information. Reply. Br. 4 (“Section
102 has no such requirement.”).
Section 102 itself might not impose a requirement for an applicant to
precisely define the subject matter claimed. However, such a burden is
clearly and unequivocally imposed by 35 U.S.C. § 112, second paragraph. In
re Morris, 127 F. 3d 1048, 1056 (Fed. Cir. 1997) (“It is the applicants’
burden to precisely define the invention, not the PTO’s. See 35 U.S.C. § 112
¶ 2 . . . [T]his section puts the burden of precise claim drafting squarely on
the applicant.”). Furthermore, when functional language such as the
language at issue here, is considered under 35 U.S.C. §§ 102 or 103, courts
have sanctioned the PTO’s use of a burden-shifting framework to require an
applicant to come forward with evidence and/or explanation to demonstrate
why prior-art devices that appear to be similar or identical do not exhibit the
functional characteristic in question. MPEP § 2112.01; see In re Schreiber,
128 F. 3d 1473, 1478 (Fed. Cir. 1997) (citing In re Spada, 911 F.2d 705, 708
(Fed. Cir. 1990)); see also In re Swinehart, 439 F.2d 210, 213 (CCPA 1971).
Appeal 2019-002184
Application 15/012,544
14
This procedural tool is used because, as a practical matter, the PTO is not
equipped to obtain and test various devices and compare their functions,
characteristics, and properties. In re Best, 562 F.2d 1252, 1255 (CCPA
1977).
In the context of §§ 102(b) and 103(a) our reviewing court and its
predecessor have consistently summarized the underlying policy concern in
situations such as this is that “[m]ere recognition of latent properties in the
prior art does not render nonobvious an otherwise known invention. MPEP
§ 2145(II) (quoting In re Wiseman, 596 F.2d 1019 (CCPA 1979)) accord In
re Baxter Travenol Labs, 952 F. 2d 388, 392 (Fed. Cir. 1991). An applicant
should not be conferred an exclusive right to subject matter potentially in the
possession of the public because that applicant has discovered an inherent
but latent characteristic of that subject matter. See id. Under similar
reasoning, an applicant-patentee should not be permitted to extend a patent
monopoly by adding latent characteristics to the applicant-patentee’s
previously issued claims. That would be another way to “br[ing] about” an
“unjustified timewise extension of the right to exclude granted by a patent”
See In re Schneller, supra; MPEP § 804. Thus, the Examiner was not
unjustified in requiring Appellant to explain the structural implications of
“configured to provide at least a 121% increase in average outflow facility
of aqueous humor from the anterior chamber through the collector channels
of the eye” so that the Examiner may make a proper determination regarding
whether the present claims should be rejected over those previously issued
for obviousness-type double patenting.
Neither the Examiner nor Appellant make a very compelling case
regarding the precise meaning that should be attributed to the phrase
“configured to provide at least a 121% increase in average outflow facility
Appeal 2019-002184
Application 15/012,544
15
of aqueous humor from the anterior chamber through the collector channels
of the eye” in claim 1 or the similar phrases in the other independent claims.
According to the Examiner, these limitations should essentially be presumed
satisfied by the prior-art or by the previously claimed subject matter unless
Appellant can point to some concrete structural distinction that either
prevents it from occurring in the subject matter of the applied references or
causes it to occur in the present application. See, e.g., Final Act. 13 & Ans.
6–7, supra. Appellant, on the other hand, contends the Examiner’s rejection
is defeated simply because the Examiner has not demonstrated the actual act
occurs in the prior art or prior claims. Appeal Br. 9 (“the Examiner has not
shown that Neuhann's structure would necessarily provide at least a 121%
increase in average outflow facility of aqueous humor from the anterior
chamber through the collector channels of the eye.”); Appeal Br. 18 (the
Examiner [must] show[] that it would have been obvious to . . . modify the
configuration of the device recited . . . to provide a 121% increase in average
outflow facility.”).
As claims must be read in light of the Specification, we turn to
Appellant’s Specification for understanding. In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997) (“[T]he PTO applies to the verbiage of the proposed
claims the broadest reasonable meaning of the words 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 applicant’s
specification.”). Paragraph 234 of the Specification states:
The average C value for the 8 mm implant was 121% greater than
controls with a C value of 0.438 μl/min/mmHg and the 16 mm
implant was 46% greater than the 8 mm implant (222% greater
Appeal 2019-002184
Application 15/012,544
16
than controls) with a C value of 0.638 μl/min/mmHg (Table 3
above).
Where “[t]he total sum of the flow rates through the collector channels per
unit ΔP is defined as the outflow facility (C).” Spec. para. 232. The
referenced “Table 3” is provided on page 45 of the Specification and
indicates the “Simulated Outflow Facility” for a control and two specific
embodiments of the implant, an 8mm embodiment and a 16 mm
embodiment. As discussed in paragraphs 217–218 of the Specification, the
simulation results tabulated in Table 3 were derived from a mathematical
model:
A comprehensive mathematical model was developed in
this disclosure to evaluate changes in fluid dynamics of aqueous
humor outflow induced by combinations of trabecular mesh
bypass and/or Schlemm’s canal dilation, and to predict how the
changes would affect outflow facility. . . .

The mathematical model was developed to numerically
simulate aqueous humor outflow based on the assumptions and
physical principles that govern fluid flow.

The model relies on the following “Universal Parameters,” which essentially
represent assumptions about the anatomical characteristics of the patient
receiving the implant, as listed on page 42–43 of the Specification in Table
1:
Appeal 2019-002184
Application 15/012,544
17
Table 1: Universal Parameters
Parameter Description Value
h0 Intrinsic Height of SC[5] 20 μm
w Width of SC 230 μm
L Length of SC 36 mm
E Young's modulus of TM[6] 30 mmHg
ΔP IOP[7] - Pepi[8] 5 ≤ ΔP ≤ 30 mmHg
NCC Number of CCs[9] 30
RTM TM Resistance to Flow 9 cm
mmHg/(μl/min)
RCC Resistance to flow in CC 2.5*NCC
mmHg/(μl/min)
β Ratio of RCC in control SC vs.
SC with TM bypass
3
μ Viscosity of AH[10] 7.5x10-4 kg/(m sec)
or 0.75 cP

The model additionally relies on the following “Geometric parameters” for
the 8mm and 16mm implant embodiments as respectively indicated in
Tables 2A and 2B on pages 43–44 of the Specification:

5 Schlemm's Canal
6 Trabecular Meshwork
7 Intra-Ocular Pressure
8 Pressure in the Episcleral Vein
9 Collector Channels
10 Aqueous Humor
Appeal 2019-002184
Application 15/012,544
18
Table 2A: Geometric Parameters of 8mm implant
Parameter Description Value
Aw Area of window region 17553 μm2
As Area of spine region 22955 μm2
Ain Area of inlet region 29841 μm2
hw Height of window region 76.3 μm
hs Height of spine region 99.8 μm
hin Height of inlet region 129.7 μm
Lw Length of window region 1.1 mm
Nw Number of windows 3
Wd Width of device 230 μm
Lin Length of inlet spine region 1.1 mm
Ldev Length of device in SC 7.2 mm
Ls Length of spine region 0.9 mm

Table 2B: Geometric Parameters of 16mm implant
Parameter Description Value
Aw Area of window region 20994 μm2
As Area of spine region 32092 μm2
Ain Area of inlet region 29841 μm2
hw Height of window region 91.3 μm
hs Height of spine region 139.5 μm
hin Height of inlet region 129.7 μm
Lw Length of window region 1 mm
Nw Number of windows 5
Wd Width of device 230 μm
Lin Length of inlet spine region 1.1 mm
Ldev Length of device in SC 15 mm
Ls Length of spine region 1.5 mm

Thus, with regard to the “configured to provide at least a 121%
increase in average outflow facility of aqueous humor from the anterior
chamber through the collector channels of the eye,” the Specification
discloses that an implant is theoretically so configured where it (1) exhibits
the indicated values for each of the listed parameters indicated in Table 2A
Appeal 2019-002184
Application 15/012,544
19
and (2) is otherwise configured to be implanted in an eye exhibiting the
indicated values for each of the parameters listed in Table 1.11 For the recited
upper limit of a 222% increase (e.g., claims 9, 19, 30, 31) the implant must
(1) exhibit the indicated values for each of the listed parameters indicated in
Table 2B and (2) be otherwise configured to be implanted in an eye
exhibiting the indicated values for each of the parameters listed in Table 1.
These are very specific requirements to achieve the recited 121%, or 222%,
increase in average outflow facility of aqueous humor as recited in the
claims and none of the independent claims, each of which contain a
recitation pertaining to this result, recites any limitations pertaining to the
geometric requirements that appear to be necessary to bring these results
about according to the Specification. The Specification does not indicate any
specific or approximate ranges for these values that would operate to bring
about the recited results and it cannot be ascertained what influence
modification to one or more of these values will have on the outflow facility
of aqueous humor ultimately or theoretically provided. An ocular implant
may be “configured to provide” the recited outflow increase by designing it
with a geometry exhibiting all of the tabulated parameter values. However,
the question arises as to whether an implant is reasonably regarded as
similarly “configured” if it exhibits the outflow increase without exhibiting
all, or for that matter, any, of the tabulated parameter values. This
uncertainty, in our view, unduly burdens the potential infringer with too
much uncertainty when attempting to ascertain the metes and bounds of the
claimed subject matter. Stated differently, when read in light of the

11 It is noted that not all the independent claims indicate the implant is
configured to be implanted in a human eye based on which the assumed
“universal characteristics” appear to have been derived.
Appeal 2019-002184
Application 15/012,544
20
Specification, the limitation in claim 1 indicating that the claimed implant is
“configured to provide at least a 121% increase in average outflow facility
of aqueous humor from the anterior chamber through the collector channels
of the eye,” as well as the similar limitations in the other independent claims,
do not point out with sufficient particularity precisely what structural
arrangement is required of the claimed implant. This violates the
requirements of 35 U.S.C. § 112, second paragraph. We therefore reject all
the claims before us under 35 U.S.C. § 112, second paragraph, as being
indefinite.
An additional problem with the “configured to provide at least a 121%
[or 121%–222%] increase in average outflow facility of aqueous humor
from the anterior chamber through the collector channels of the eye”
limitation is that, as discussed above, Appellant’s disclosure includes only a
single (8 mm) embodiment theoretically exhibiting the “121% increase in
average outflow facility” and a single (16 mm) embodiment theoretically
exhibiting the “222% increase” These embodiments each rely on no less
than twelve very specific geometric parameters coupled with the assumption
of ten patient parameters to, respectively, arrive at the theoretical 121% and
222% results. The so called quid-pro-quo of the patent grant serves to ensure
that the right to exclude conferred by the patent is commensurate with the
patentee’s contribution to the art to which the patent pertains. Ariad
Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F. 3d 1336, 1349, 1353–4
(Fed. Cir. 2010). Both the written description and enablement requirements
of 35 U.S.C. § 112, first paragraph, which often rise and fall together, help
ensure that this is the case. Ariad, 598 F. 3d at 1350 (“[A] sufficient
[written] description of a genus . . . requires the disclosure of either a
representative number of species falling within the scope of the genus or
Appeal 2019-002184
Application 15/012,544
21
structural features common to the members of the genus so that one of skill
in the art can “visualize or recognize” the members of the genus.”)
(emphasis added); In re Moore, 439 F.2d 1232, 1236 (CCPA 1971) (“The
relevant inquiry may be summed up as being whether the scope of
enablement provided to one of ordinary skill in the art by the disclosure is
such as to be commensurate with the scope of protection sought by the
claims.”) accord also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp.,
315 F.3d 1335, 1339 (Fed. Cir. 2003). Thus, the disclosure of structures
theoretically exhibiting the characteristics of, two discrete endpoints of a
range (121–222%; claims 9, 19, 30, 31), or one endpoint and one value
within the range (at least 121%; claim 1), does not necessarily confer a right
to claim any and all structures exhibiting characteristics that fall within the
entire range.
Appellant chose to define this aspect of the claims using functional
language. There is no prohibition against doing that but, as our reviewing
court’s predecessor observed in In re Swinehart, 439 F. 2d 210, 213 (CCPA
1971):
“Functional” terminology may render a claim quite broad.
By its own literal terms a claim employing such language covers
any and all embodiments which perform the recited function.
Legitimate concern often properly exists, therefore, as to whether
the scope of protection defined thereby is warranted by the scope
of enablement indicated and provided by the description
contained in the specification. That is, the language may be so
broad that it causes the claim to have a potential scope of
protection beyond that which is justified by the specification
disclosure.
More recently, our reviewing court stated, “[t]he written description
requirement . . . ensures that when a patent claims a genus by its function or
result, the specification recites sufficient materials to accomplish that
Appeal 2019-002184
Application 15/012,544
22
function — a problem that is particularly acute in the biological arts.” Ariad,
598 F. 3d at 1352–53.
Based on Appellant’s Specification, we can see no reason why a
disclosure of two embodiments seemingly requiring very precise geometric
parameter values operating in a very specific biological environment in
order to yield a particular biological result is sufficient to support claims that
cover implants having any or none of those specific parameter values but
are, one way or another, by means known or unknown, somehow
“configured to” exhibit those same results. Broad generic claims of this
nature are examples of improper “attempt[s] to preempt the future before it
has arrived.” See Ariad, 598 F. 3d at 1353 (citation omitted). We see nothing
in the dependent claims that remedies this deficiency. Accordingly, we
additionally reject all the pending claims before us under 35 U.S.C. § 112,
first paragraph, because the Specification does not comply with the written
description and enablement requirements.

Disposition of remaining obviousness-type double-patenting rejections
Above, we have reached certain issues pertaining to the double-
patenting rejections in an effort to advance any further prosecution.
Ultimately, where we did not express other unrelated reasons for not
sustaining the Examiner’s double-patenting rejections, the double-patenting
rejections hinge on the meaning afforded to the “configured to provide at
least a 121% increase in average outflow facility of aqueous humor from the
anterior chamber through the collector channels of the eye” limitation in
claim 1 or the similar limitations of claims 9, 19, 30, and 31. Before a proper
obviousness or inherency analysis can be performed, the subject matter
encompassed by the claims on appeal must be reasonably understood
Appeal 2019-002184
Application 15/012,544
23
without resort to speculation. See In re Steele, 305 F.2d 859, 862 (CCPA
1962) (A prior art rejection cannot be sustained if the hypothetical person of
ordinary skill in the art would have to make speculative assumptions
concerning the meaning of claim language.). As we have determined that
these phrases render the claims indefinite when read in light of the
Specification, we do not make a final determination as to the merits of the
remaining obviousness-type double-patenting rejections at this time. We
reverse these rejections pro-forma without reaching their merits. See In re
Wilson, 424 F.2d 1382, 1385 (CCPA 1970) (“If no reasonably definite
meaning can be ascribed to certain terms in the claim, the subject matter
does not become obvious-the claim becomes indefinite.”)

CONCLUSION
The Examiner’s rejections are REVERSED.
Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter NEW
GROUNDS of rejection for claims 1–7, 9–15, 17–25, 27, 28, 30, and 31
under 35 U.S.C. § 112, first and second paragraphs, for the reasons
discussed above.
Appeal 2019-002184
Application 15/012,544
24
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed New
Ground
30 112(b) Indefiniteness 30
1, 9, 31 102(b) Neuhann 1, 9, 31
2–7, 10–
15, 17,
18, 30
103(a) Neuhann 2–7, 10–
15, 17,
18, 30

1, 3, 4, 6,
7, 9, 11,
12, 14,
15, 17–
19, 21,
22, 24,
25, 27,
28, 30,
31
Obviousness-type
double patenting
1, 3, 4, 6,
7, 9, 11,
12, 14,
15, 17–
19, 21,
22, 24,
25, 27,
28, 30,
31

1–7, 9–
15, 17–
25, 27,
28, 30,
31
112(b) Indefiniteness 1–7, 9–
15, 17–
25, 27,
28, 30,
31
1–7, 9–
15, 17–
25, 27,
28, 30,
31
112(a) Written
description,
enablement
1–7, 9–
15, 17–
25, 27,
28, 30,
31
Overall
Outcome
1–7, 9–
15, 17–
19, 21,
22, 24,
25, 27,
28, 30,
31
1–7, 9–
15, 17–
25, 27,
28, 30,
31

Appeal 2019-002184
Application 15/012,544
25
RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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).
REVERSED; 37 C.F.R. § 41.50(b)