Ex Parte Yang

Patent Trial and Appeal Board

Jun 6, 2017

12977655 (P.T.A.B. Jun. 6, 2017)

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.
12/977,655 12/23/2010 Zhongping C. Yang P0029860.00(134.04650101) 9748
10723 7590 06/08/2017
Medtronic Inc. (CRDM/MRG)
710 Medtronic Parkway NE
MS LC-340
Minneapolis, MN 55432-5604
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/08/2017 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):
ptodocketing @ mrgs .com
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZHONGPING C. YANG
Appeal 2015-007410
Application 12/977,655
Technology Center 3700
Before NATHAN A. ENGELS, ERIC C. JESCHKE, and
GORDON D. KINDER, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Zhongping C. Yang (“Appellant”) seeks review under 35 U.S.C.
§ 134(a) of the Examiner’s decision, as set forth in the Final Office Action
dated July 31, 2014 (“Final Act.”), and as further explained in the Advisory
Action dated November 6, 2014 (“Adv. Act.”), rejecting claims 2-4, 7, 9—
12, and 20—31.1 Claims 32—34 have been cancelled. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal 2015-007410
Application 12/977,655
BACKGROUND
The disclosed subject matter relates to implantable electrical leads.
Claims 7, 9, and 10 are independent. Claim 7 is reproduced below:
7. An implantable electrical lead comprising an
external blood contacting surface comprising an
external coating comprising a monolayer of at least
one biological agent that promotes
endothelialization covalently attached to a
polymeric lead surface, the biological agent
comprising a polypeptide, the polypeptide
comprising collagen.
REJECTIONS
1. Claims 2-4, 7, 9, and 20-28 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Ng (US 2010/0174351 Al, published July 8,
2010) and Helland (US 7,353,067 Bl, issued Apr. 1, 2008).
2. Claims 10-12 and 29-31 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Ng, Helland, and Kutryk (US 7,037,332 B2,
issued May 2, 2006).
DISCUSSION
Rejection 1 — Claims 2—4, 7, 9, and 20—28
Each of independent claims 7 and 9 recites “[a]n implantable
electrical lead” including, among other aspects, “a monolayer of at least one
biological agent that promotes endothelialization.” Appeal Br., Claims App.
1. In the rejection of claims 7 and 9, the Examiner stated that Ng “sets forth
a variety of devices and target locations in the body (e.g. [[paragraph] 17]),
but an implantable medical lead is not specifically indicated.” Final Act. 3.
The Examiner stated, however, that “coating an implantable lead with a
2
Appeal 2015-007410
Application 12/977,655
endothelialization promoting layer is common in the art of implantable
medical devices” and that, “/i]n the same field of endeavor, Helland reveals
the need for an implantable lead to attach a biological agent (e.g. Fig. 7,
#730; Col 10, lines 7-42), in order to promote endothelialization or cell
growth to aide in fixation of the lead.” Id. (emphasis added).
Appellant argues that the Examiner “misinterprets the teachings of
Helland.” Appeal Br. 10. According to Appellant, Ng and the Specification
at issue teach “endothelialization” whereas the relied-upon “tissue growth in
Helland ... is not endothelialization.” Id. at 11. Appellant contends that
“[gjrowth of cells within the network of a mesh [as in Helland] is not the
same as the growth of a layer of viable endothelial cells.” Id. (citing Spec. 7,
11. 4—6, which provides “The coated medical electrical leads described
herein, when placed in contact with the circulatory system, become
endothelialized, that is, become covered, in whole or in part, with a layer of
viable endothelial cells.” (emphasis added)). Appellant argues, “[a]t the
time of the invention, a skilled artisan would have recognized
endothelialization and growth of cells in a mesh are completely different
processes, potentially with completely different results, in different fields of
endeavor.” Id.
“Two separate tests define the scope of analogous prior art: (1)
whether the art is from the same field of endeavor, regardless of the problem
addressed and, (2) if the reference is not within the field of the inventor’s
endeavor, whether the reference still is reasonably pertinent to the particular
problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320,
1325 (Fed. Cir. 2004). Here, the Examiner maintains the position that Ng
and Helland are in the same field of endeavor and does not set forth an
3
Appeal 2015-007410
Application 12/977,655
alternative position under the second test. For the reasons discussed below,
the record does not support either of the two alternative bases for the
Examiner’s finding that Ng and Helland are in the same field of endeavor.
First, the Examiner states that both Ng and Helland “are aimed at
preventing inflammatory reaction as are almost all intravascular implantable
devices, to avoid rejection from the body and clotting or thrombosis.” Ans.
4. The Examiner, however, does not identify any disclosure in Helland to
support this finding. Id. As argued by Appellant, the relied-upon aspects of
Helland “provides no such teachings” but rather relate to “methods for
securing an electrode to tissue.” Reply Br. 4; see also Final Act. 3 (citing
Helland, col. 10,11. 7—42). Thus, the record does not support the Examiner’s
first basis for finding that Ng and Helland are in the same field of endeavor.
Second, the Examiner states that “Ng exemplifies the close
relationship and almost interchangeable use of the term ‘celF and ‘tissue’ in
intravascular applications when using both in the discussion of appropriate
interaction of biocompatible materials.” Ans. 4 (citing Ng 111). The
Examiner also states that “Ng further discusses using both ‘vascular
endothelial growth factor’ along with ‘connective tissue growth factor’ as
preferred therapeutic agents, showing another close relationship between the
use of the terms endothelial growth and tissue growth.” Id. (citing Ng 1 83).
Having considered paragraphs 11 and 83 from Ng, as well as the passage
from paragraph 107 quoted by the Examiner (see Ans. 4), we determine that
these disclosures do not support the Examiner’s finding that Ng and Helland
are in the same field of endeavor. See Ans. 4—5 (stating that the Examiner
“maintains that the purpose of the cell growth on the mesh of Helland is
clearly in the same field of endeavor as the endothelialization discussed by
4
Appeal 2015-007410
Application 12/977,655
Ng”); see also Adv. Act. 2 (stating that “cell growth on a structure within the
human body is the connection between the two pieces of prior art and is
considered to be within the same field of endeavor”).
Paragraph 11 of Ng provides that “truly biocompatible materials
should facilitate beneficial cell and tissue interactions appropriate to the
specific application,” but we do not agree that this demonstrates a “close
relationship and almost interchangeable use of the term ‘cell’ and ‘tissue’”
(Ans. 4) such that Ng’s discussion of endothelial cells (see, e.g., 139) and
Helland’s discussion of tissue growth (see, e.g., col. 10,11. 33—37) show that
these references are in the same field of endeavor.
Further, although paragraph 83 lists “vascular endothelial growth
factor” along with “connective tissue growth factors” in a list of “Growth
Factors,” the Examiner has not shown why this demonstrates a “close
relationship between the use of the terms endothelial growth and tissue
growth” (Ans. 4) such that Ng’s discussion of endothelial cells and
Helland’s discussion of tissue growth support a finding that these references
are in the same field of endeavor.
Finally, the relied-upon passage from paragraph 107 provides: “For
vascular applications and implants that interface with cells or tissue, the
luminal side of the laminate or exterior portion of the implant is preferable
covered with the protoelastin.” Although this passage uses the terms “cells”
and “tissue” in proximity, the Examiner has not demonstrated why this
supports a finding that Ng and Helland are in the same field of endeavor.
Thus, the record does not support the Examiner’s second basis.
5
Appeal 2015-007410
Application 12/977,655
For these reasons, we do not sustain the rejection of independent
claims 7 and 9, and also do not sustain the rejection of claims 2—\ and 20-25
(which depend from claim 7) or claims 26—28 (which depend from claim 9).
Rejection 2 — Claims 10—12 and 29—31
Like independent claims 7 and 9, independent claim 10 recites “[a]n
implantable electrical lead” including, among other aspects, “a monolayer of
at least one biological agent that promotes endothelialization.” Appeal Br.,
Claims App. 2. In the rejection of claim 10 (and claims 11, 12, and 29—31
depending therefrom), the Examiner implicitly relied on the same finding at
issue above (i.e., that Ng and Helland are in the same field of endeavor). See
Final Act. 4 (implicitly relying on the statement of the rejection for claims 7
and 9 for all but the “biological agent” limitation of claim 10). Moreover,
the Examiner’s reliance on Kutryk does not remedy the deficiencies in the
combined teachings of Ng and Helland, discussed above. Thus, for the same
reasons discussed above, we also do not sustain the rejection of claims 10-
12 and 29-31.
DECISION
We REVERSE the decision to reject claims 2-4, 7, 9-12, and 20-31
under 35 U.S.C. § 103(a).
REVERSED
6