Ex Parte Brauker et al

Patent Trial and Appeal Board

Feb 28, 2018

14619651 (P.T.A.B. Feb. 28, 2018)

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.
14/619,651 02/11/2015 James H. Brauker DEXCOM.006C4 5522
68851 7590 03/02/2018
KNOBBE, MARTENS, OLSON & BEAR, LLP
DEXCOM, INC.
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
WINAKUR, ERIC FRANK
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
03/02/2018 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):
jayna.cartee@knobbe.com
efiling @ knobbe. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES H. BRAUKER,
MARK C. SHULTS, and MARK A. TAPSAK
(APPLICANT: DexCom, Inc.)
Appeal 2017-002805
Application 14/619,6511
Technology Center 3700
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 11—19 (App. Br.
5). Examiner entered a rejection under the written description provision of
35 U.S.C. § 112, first paragraph. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant’s disclosure “relates to [] biointerface membranes, to
sensors and implantable devices including these membranes, and to methods
1 Applicant is the real party in interest (App. Br. 3).
Appeal 2017-002805
Application 14/619,651
for monitoring glucose levels in a biological fluid sample using an
implantable analyte detection device” (Spec. 12). Appellant’s claim 11 is
representative and reproduced below:
11. An implantable device for continuous measurement of a
glucose concentration, comprising:
a sensing region configured to continuously measure a
signal indicative of a glucose concentration in a host; and
a membrane system located over the sensing region,
wherein the membrane comprises a sensing membrane and a
biointerface membrane, wherein the sensing membrane
comprises an enzyme configured to catalyze a reaction with
glucose as a reactant, wherein the biointerface membrane is
configured to resist cellular attachment and is impermeable to
cells and cell processes.
(App. Br. 15.)
The claims stand rejected as follows:
Claims 11—19 stand rejected under the written description provision of
35 U.S.C. § 112, first paragraph.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Appellant discloses that prior art “bilayer membranes . . . that have
cell impermeable layers that are porous and adhesive to cells” allow “cells
. . . to reach pseudopodia into the interstices of the membrane to adhere to
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Application 14/619,651
and flatten on the membrane . . . thereby blocking transport of molecules
across the membrane-tissue interface” (Spec. 19).
FF 2. Appellant discloses that “[t]he term ‘cell processes’ and the like
refers to pseudopodia of a cell” (Spec. 132).
FF 3. Appellant discloses
in one aspect of the [] invention, a biointerface membrane for
use with an implantable device . . . [that] includes]; a first
domain distal to the implantable device wherein the first
domain supports tissue ingrowth and interferes with barrier-cell
layer formation and a second domain proximal to the
implantable device wherein the second domain is resistant to
cellular attachment and is impermeable to cells and cell
processes.
(Id. 115.)
FF 4. Appellant’s figure 2 is reproduced below:
fM £
Appellant’s “FIG. 2 is an illustration of a device having increased
neovascularization within the intermediary layer of [a] foreign body
response” (Spec. 146). More specifically, Appellant’s “FIG. 2 illustrates a
situation in which some blood vessels 45 are brought close to an implant
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Application 14/619,651
membrane 48, but the primary layer 40 of cells adherent to the cell-
impermeable membrane blocks glucose” (Spec. 1 8).
FF 5. Appellant discloses that “[a] disadvantage of cell-impermeable
membranes is that they often stimulate a local inflammatory response, called
the foreign body response (FBR) that has long been recognized as limiting
the function of implanted devices that require solute transport” (Spec. 1 6).
FF 6. Appellant discloses that
[t]he FBR ... is composed of three main layers .... The
innermost FBR layer 40, adjacent to the device [48], is
composed generally of macrophages and foreign body giant
cells 41 (herein referred to as the barrier cell layer). These cells
form a monolayer 40 of closely opposed cells over the entire
surface 48 [A] of a smooth or microporous . . . membrane 48.
The intermediate FBR layer 42 (herein referred to as the
fibrious zone), lying distal to the first layer with respect to the
device, is a wide zone . . . composed primarily of fibroblasts 43
and fibrous matrix 44. The outermost FBR layer 46 is loose
connective granular tissue containing new blood vessels 45
(herein referred to as the vascular zone 46).
(Spec. 1 6-7)
FF 7. Appellant discloses that “[bjecause the cell impenetrable layers [48,
illustrated in Appellant’s FIG. 2,] are porous, cells are able to reach
pseudopodia into the interstices of the membrane to adhere to and flatten on
the membrane . . . thereby blocking transport of molecules across the
membrane-tissue interface” (Spec. 19).
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Application 14/619,651
FF 8. Appellant’s figure 3 is reproduced below:
5®
FIG* S
Appellant’s “FIG. 3 is an illustration of membrane of [Appellant’s] . . .
invention including a barrier-cell disruptive domain composed of fibers and
a cell impermeable domain” (Spec. 147). More specifically, Appellant’s
“FIG. 3 illustrates how the non-woven fibers 49 serve to disrupt the
continuity of cells, such that they are not able to form a classical foreign
body response. . . . [Because,] they are unable to form an ordered closely
opposed cellular monolayer parallel to the surface of the device as in a
typical foreign body response to a smooth surface” {id. 1 69).
FF 9. Appellant’s
biointerface membrane is constructed of two or more domains
. . ., preferably, the membrane includes a cell impermeable
domain 50 proximal to an implantable device, also referred to
as the second domain; and a cell disruptive domain, which in
the embodiment illustrated[, in Appellant’s FIG. 3,] includes
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Application 14/619,651
non-woven fibers 49 distal to an implantable device, also
referred to as the first domain.
(Spec. 1 63; see also id. ]Hf 64—77 (providing a description of the first and
second domains of Appellant’s biointerface membrane); id. 173
(Appellant’s cell impermeable domain “is permeable to oxygen and may or
may not be permeable to glucose and is constructed of biodurable materials .
. . that are impermeable by host cells (e.g., macrophages) such as, for
example, polymer blends of polycarbonate based polyurethane and PVP”);
id. 175 (Appellant’s cell impermeable domain “is resistant to cellular
attachment and is impermeable to cells and preferably composted of a
biostable material”); id. 177 (Appellant’s cell impermeable domain
“prevents cell entry or contact with device elements underlying the
membrane, and prevents the adherence of cells, and thereby prevents the
formation of a barrier cell layer”).)
ANALYSIS
Examiner finds that Appellant’s disclosure fails to establish “that
Appellant was in possession, at the time of filing, of a device including a
second layer [the “biointerface membrane” of claim 11 ] that is impermeable
to cells ‘and cell processes’” (Ans. 2—3). In support of this finding,
Examiner directs attention to paragraphs 75—77 of Appellant’s Specification,
finding that these paragraphs are
[t]he most relevant portion of the specification [and] . . . focuses
almost exclusively on cell ingrowth, thus there is no teaching or
inherent disclosure that a cell process (which is understood to
be one or several orders of magnitude smaller in scale than a
cell) would have been inhibited from growth relative to the
disclosed layer composed of the listed materials.
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Application 14/619,651
(Id. at 3). Examiner recognizes, however, that Appellant discloses a “second
domain [that] is resistant to cellular attachment and cell processes” (id. at 6).
Nevertheless, Examiner finds that this disclosure “is not sufficiently detailed
to constitute a teaching to one of skill in the art of the actual structure of
such a membrane” and “[t]hus, the sentence cannot serve to establish that
Appellant was in possession of the structure of the claimed invention,
without additional teachings elsewhere in the specification” (id.). In this
regard, Examiner finds that Appellant’s Specification provides “no
recognition or assertion that impermeability to cell processes has occurred in
the tested arrangement nor is there analysis presented to indicate that
impermeability to cell processes has influenced the observed results” (id.).
Examiner, therefore, finds that “[ajbsent a teaching of impermeability to
‘cell processes’, there is no evidence/basis for one of skill in the art to
reasonably conclude that Appellant was in possession of the claimed subject
matter at the time of filing” (id. at 5; see also id. at 7).
We are not persuaded.
As Examiner recognizes, Appellant discloses a device that comprises
a “biointerface member” as claimed, which comprises a “second domain
[that] is resistant to cellular attachment and cell processes” (see Ans. 6; FF
3). In addition, Appellant’s Specification provides details regarding this
domain’s composition (see FF 9; see generally FF 1—8). See generally App.
Br. 11—13; Reply Br. 5—6. Therefore, we find that Appellant satisfied the
requirements of the written description provision of 35 U.S.C. § 112, first
paragraph.
It may be that Examiner is concerned that Appellant’s Specification
fails to provide an enabling description of the subject matter set forth in
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Application 14/619,651
Appellant’s claims. The enablement provision of 35 U.S.C. § 112, first
paragraph, however, is not the same as the written description provision of
this Section. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (CAFC
1991) (“With respect to the first paragraph of §112 the severability of its
‘written description’ provision from its enablement (‘make and use’)
provision was recognized by this court’s predecessor, the Court of Customs
and Patent Appeals, as early as In re Ruschig, 379 F.2d 990, 154 USPQ 118
(CCPA 1967)”). The factual analysis required to address enablement is set
forth in, inter alia, In re Wands, 858 F.2d 731, 735, 736-37 (Fed. Cir. 1988).
We find no fact-based reasoned analysis of this record in the context of an
enablement rejection. Therefore, we decline to consider whether
Appellant’s Specification provides an enabling disclosure of Appellant’s
claimed invention.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention. The rejection of claims 11—19
under the written description provision of 35 U.S.C. § 112, first paragraph is
reversed.
REVERSED
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