Ex Parte SEWARD

Patent Trials and Appeals Board

Jun 10, 2019

13770659 - (D) (P.T.A.B. Jun. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/770,659 02/19/2013
21971 7590 06/12/2019
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
FIRST NAMED INVENTOR
Kirk Patrick SEW ARD
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
34634-725.401 1064
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/12/2019 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):
patentdocket@wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIRKPATRICK SEW ARD
(APPLICANT: MERCATORMEDSYSTEMS, INC.)
Appeal2018-006474
Application 13/770,659 1
Technology Center 1600
Before DONALD E. ADAMS, ROBERT A. POLLOCK, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-11 and 13-
18 (Br. 2 3). Examiner entered rejections under the written description
provision of 35 U.S.C. § 112, first paragraph, 35 U.S.C. § 102(b), and
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies "Mercator Medsystems, Inc." as the real party in
interest (Br. 3).
2 Appellant's December 21, 2017 Appeal Brief.
Appeal2018-006474
Application 13/770,659
STATEMENT OF THE CASE
Appellant's disclosure "relates generally to medical devices, systems,
and methods to treat disease. More particularly, the present invention relates
to methods to treat hypertension by delivering guanethidine to reduce
hyperactive sympathetic nerve activity in the adventitia of arteries and/or
veins that lead to the kidneys" (Spec. 3 ,r 2). Claims 1, 3, 13, and 14 are
representative and reproduced below:
1. A system for treating hypertension, said system
compnsmg:
a catheter adapted to be introduced into a patient's
vasculature;
a needle adapted to be deployed from the catheter
through a blood vessel wall into the adventitia surrounding the
blood vessel; and
a source of guanethidine, wherein the system is
configured to deliver a dosage of the guanethidine through the
needle into the adventitia in an amount effective to lower the
systemic blood pressure of the patient by a therapeutically
beneficial amount,
wherein the needle has a length such that the needle is
positioned into tissue bound on the inside by the external elastic
lamina and bound on the outside by the outer extent of the
adventitial and perivascular connective tissue that surrounds the
blood vessel when deployed from the catheter.
(Br. 16.)
(Id.)
3. A system as in claim 1, wherein the source contains from 10
µg to 200 mg of guanethidine.
3 Appellant's February 19, 2013 Specification.
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Application 13/770,659
13. A system as in claim 1, wherein the length of the needle is
in a range from 200 µm to 3 mm.
(Jd.at17.)
(Id.)
14. A system as in claim 13, wherein the length of the needle is
in a range from 500 µm to 1 mm.
Grounds of rejection before this Panel for review:
Claims 1-11 and 13-18 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 1, 2, 8-11, and 13 stand rejected under 35 U.S.C. § I02(b) as
anticipated by Yun. 4
Claims 3-7 and 14--18 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Yun.
Written Description:
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's Specification explains that "[ t ]he adventitia is a layer of
fatty tissue surrounding the arteries of the human and other vertebrate
cardiovascular systems," which is separated "from muscular tissue that
forms the media of the arterial wall" by the "external elastic lamina (EEL)"
(Spec. ,r 27).
4 Yun et al., US 2008/0004596 Al, published Jan. 3, 2008.
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Application 13/770,659
FF 2. Appellant's Specification defines the "perivascular region ... as the
region beyond the external elastic lamina of an artery or beyond the tunica
media of a vein" (id. ,r 26).
FF 3. Appellant discloses that
[t]he renal arteries or veins that are subject of [Appellant's]
invention usually have an internal (lumen) diameter of between
1 mm and 10 mm, more often between 3 and 6 mm, ... [ t ]he
thickness of the intima and media, which separate the lumen
from the EEL, are usually in the range from 200 µm to 3 mm,
more often in the range from 500 µm to I mm[,] [and] [t]he
adventitial tissue surrounding the EEL may be several
millimeters thick.
(Id. ,I 27.)
FF 4. Appellant discloses that "[n]eedles of [Appellant's] ... invention
pass through the muscular tissue of the blood vessel and the EEL in order to
reach the adventitia and perivascular space into which the drug is injected"
(id.; see also id. ,r 33 ("The aperture of the microneedle will be positioned so
that it lies beyond the external elastic lamina (EEL) of the blood vessel wall
and into the perivascular region surrounding the wall")).
ANALYSIS
Examiner asserts that Appellant's Specification fails to provide
written descriptive support for "a needle 'having a length such that the
needle is positioned into tissue bound on the inside by the external elastic
lamina on the outside by the outer extent of the adventitial and perivascular
connective tissue that surrounds the blood vessel when deployed from [a]
catheter"' (Ans. 5). We are not persuaded.
As Appellant explains, "the limitation at issue is described by ... [,
inter alia,] ,r,r 0033 and 0027 [of Appellant's Specification] as originally
filed" (Br. 6; see FF 1--4). In this regard, Appellant describes and identifies
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Application 13/770,659
the relative location of the adventitia, perivascular region, and EEL (see FF
1-2). Appellant provides diameter or thickness ranges for blood vessels, the
intima and media which separates the blood vessel lumen from the EEL, the
adventitia, and EEL (see FF 3; see also Br. 6 ("Typical ranges for the
dimensions and depth of various layers of blood vessel walls are well known
by those of ordinary skill in the art")). In addition, Appellant discloses that
needles within the scope of Appellant's claimed "invention pass through the
muscular tissue of the blood vessel and the EEL in order to reach the
adventitia and perivascular space into which the drug is injected" (FF 4).
CONCLUSION
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 1-11
and 13-18 under the written description provision of 35 U.S.C. § 112, first
paragraph is reversed.
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Yun teaches Appellant's claimed invention?
FACTUAL FINDINGS (FF)
FF 5. Yun "relates to methods and systems for delivering agents adjacent
to or within the encircling or encapsulating smooth muscle or connective
tissue component of a conduit, vessel, or cavitary organ for the prophylaxis
or treatment of disease" (Yun ,r 3; see Ans. 6; cf FF 1--4).
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FF 6. Yun defines "[t]he term 'vessel' ... [as] a structural element
containing a hollow lumen that is intended to transport liquid materials from
one site in the body to another" (Yun ,r 35; id. ,r 37 (Yun discloses that
"[r]epresentative conduits, vessels, and cavitary organs include, but are not
limited to ... vasculature (venous and arterial systems)"); see Ans. 6).
FF 7. Yun discloses that "[as] used [in Yun's disclosure] ... the terms
'agent' and 'drug' are used interchangeably and refer to any substance used
for purposes of treatment" (Yun ,r 40).
FF 8. Yun discloses that guanethidine is a useful agent within the scope of
Yun (Yun ,r,r 45--46).
FF 9. Yun discloses that "[t]he agent or agents may be used to treat a
condition including, but not limited to, cardiovascular diseases, such as ...
hypertension, ... malignant hypertension, secondary hypertension, primary
pulmonary hypertension, secondary pulmonary hypertension" (Yun ,r 51 ).
FF 10. Yun's Figure 3 is reproduced below:
Yun's "FIG. 3 is a schematic, perspective view of [Yun's]
intraluminal/intraconduit catheter ... injecting therapeutic agent into an
adventitial, extraluminal, or periluminal space surrounding a body lumen in
accordance with [Yun's] methods," wherein Yun's catheter 20 is inserted
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into a lumen 32, with microneedle 14 puncturing vascular wall 32a to arrive
at target region 34 (Yun ,r 19); see also id. ,r,r 67----69; see also id. ,r 71 (Yun's
"microneedle ... travels with such force that it can enter sub-epithelial or
peri-luminal tissue 32b as well as mucosal, or luminal tissue."); Ans. 7; cf
Appellant's FIG. 3 (Appellant's FIG. 3 is identical to Yun's FIG. 3)).
FF 11. Yun's Figure 8 is reproduced below:
. . . . ~::I~~~~,::~~){~1
/
HG. 8
Yun's FIG. 8 illustrates Yun's
needle injection catheter 310 ... comprises a catheter body 312
having a distal end 314 and a proximal 316. . . . A two-port hub
320 ... attached to the proximal end 316 of the catheter body
312 and includes ... port 326 for delivering the pharmaceutical
agent, e.g., using a syringe 328.
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(Yun ,r 82; see also id. ,r 24 (Yun's "FIG. 8 is a perspective view of a needle
injection catheter useful in [Yun's] methods and systems"); Ans. 7; cf
Appellant's FIG. 6 (Appellant's FIG. 6 is identical to Yun's FIG. 8).)
FF 12. Yun discloses:
By way of example, the microneedle may have an overall
length of between about 200 and 3,000 microns (µm). The
interior cross-sectional dimension of the shaft ... and supply
tube ... may be on the order of 20 to 250 µm, while the tube's
and shaft's exterior cross-sectional dimension may be between
about 100 and 500 µm. The overall length of the actuator body
may be between about 3 and 50 millimeters (mm), while the
exterior and interior cross-sectional dimensions of the actuator
body can be between about 0.4 and 4 mm, and 0.5 and 5 mm,
respectively. The gap or slit through which the central section
of the actuator unfurls may have a length of about 4-40 mm,
and a cross-sectional dimension of about 100-500 µm. The
diameter of the delivery tube for the activating fluid may be
about 100 µm. The catheter size may be between 1.5 and 15
French (Fr).
(Yun ,r 74; cf Spec. ,r 87 (Appellant provides substantially the same
disclosure as in Yun's ,r 74).)
FF 13. Seward declares that Yun:
describes a drug delivery catheter system that is not adapted for
such specific drug delivery. As [sic] the time of invention of
the systems disclosed in the Yun reference, Anthony Yun, the
other co-inventor, and I did not contemplate specifically
adapting the disclosed system to be suitable for therapeutic
sympathectomy to treat hypertension. We also did not
contemplate more specifically doing so by delivering
guanethidine or similar agents to tissue bound on the inside by
the external elastic lamina and bound on the outside by the
outer extent of the adventitial and perivascular connective tissue
that surround the blood vessel as claimed in the instant
application. Only after the filing of the Yun reference patent
application did I begin even contemplating using and adapting
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our company's local drug delivery device for therapeutic
sympathectomy.
(Seward Declaration5 ,r 6.)
ANALYSIS
Examiner finds that Yun anticipates the system for treating
hypertension set forth in Appellant's claim 1 (see Ans. 6-9; FF 1-12).
Appellant contends, however, that Yun fails to disclose a catheter and
needle system that is "adapted to meet very specific dimensional
requirements to be suitable for drug delivery at specific dosages into the
specific anatomical locations to treat hypertension" (Br. 10 ( citing Seward
Declaration ,r,r 5---6; see FF 13)). We are not persuaded. Notwithstanding
Appellant's contentions and Seward's statements to the contrary, Yun
discloses a catheter and needle system that falls within the scope of
Appellant's claimed system for the administration of guanethidine to treat,
inter alia, hypertension (see FF 5-12).
As Examiner explains, Appellant failed to establish a "structural
difference between [Appellant's claimed] system" and the system disclosed
by Yun (Ans. 15; see also id. at 16 (Examiner explains, inter alia, that
Appellant failed to establish a difference between the length of Appellant's
needle and the length ofYun's needle); FF 12; cf Br. 10 ("Yun fails to teach
the elements of the needle with a length for such precise anatomical
placement to target the claimed tissue layer")).
For the same reasons, we are not persuaded by Appellant's intimation
that Yun is not "configured to deliver a dosage of ... guanethidine through
the needle into the adventitia in an amount effective to lower the systemic
5 Declaration of Kirk Seward, signed April 28, 2016.
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blood pressure of [a] patient by a therapeutically beneficial amount," as set
forth in Appellant's claim 1 (see Br. 16; id. at 11 (Appellant contends that
"Yun does not disclose the local delivery of guanethidine to treat systemic
hypertension nor the therapeutically beneficial amount of guanethidine to do
so" (see also id. at 10). As Examiner explains Yun's system "satisfies all
the structural requirements of [Appellant's] claim 1" and Appellant failed to
establish an evidentiary basis on this record to support a finding that Yun's
system is not configured as set forth in Appellant's claim 1 (see Ans. 17
(Examiner finds that "[i]n the absence of evidence to the contrary, the
burden is on ... [Appellant] to prove that the medical device claimed is
different from the medical device taught by Yun")). See In re King, 801
F.2d 1324, 1327 (Fed. Cir. 1986) ("[A] prima facie case of anticipation [may
be] based on inherency .... "). Once a prima facie case of anticipation has
been established, the burden shifts to the Appellant to prove that the prior art
product does not necessarily or inherently possess the characteristics of the
claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where, as
here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes,
the PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product");
see also In re Spada, 911 F.2d 705, 708---09 (Fed. Cir. 1990).
CONCLUSION
The preponderance of evidence on this record supports Examiner's
finding that Yun teaches Appellant's claimed invention. The rejection of
Appellant's claim 1 under 35 U.S.C. § 102(b) as anticipated by Yun is
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affirmed. Appellant's claims 2, 8-11, and 13 are not separately argued and
fall with Appellant's claim 1.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Claim 3:
Appellant's claim 3 depends from and further limits the system of
Appellant's claim 1 to require that "the source [ of guanethidine] contains
from 10 µg to 200 mg of guanethidine" (Br. 16).
Examiner finds that Yun teaches Appellant's claimed invention,
"except for the amount of guanethidine present in the medical device" (Ans.
10). Examiner reasons, however, that
the amount of a drug present in a medical device will depend,
among other factors: of the disease being treated, the specific
formulation of the drug, the conditions of the patient, etc., as
such it will be within the capability of the ordinary artisan to
determine these amounts for a particular patient, disease, etc.,
and adjust dosage amounts based on the observed clinical
effectiveness.
(Id.) In support of this rationale, Examiner directed attention to Ellinwood 6
to establish that at the time of Appellant's claimed invention those of
ordinary skill in this art recognized that "[g]uanethidine is well known in the
art to be effective in treating hypertension" (Ans. 20; see also id. at 22 and
23; see Ellinwood 6:33-36 (Ellinwood discloses: "Currently the drug most
6 Ellinwood, Jr., US 4,003,379, issued Jan. 18, 1977.
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often used in the treatment of severe hypertension is guanethidine, which is a
long-acting drug that tends to accumulate in tissues and is excreted
slowly")). Thus, Examiner reasons that "the determination of known
effective amounts of known active agents (i.e. guanethidine) to be
administered to treat the same disease (i.e. hypertension) is considered well
in the competence level of an ordinary skilled artisan in pharmaceutical
science, involving merely routine skill in the art" (Ans. 10; see FF 5-12).
See In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.").
Therefore, based on Yun, Examiner concludes that, at the time Appellant's
invention was made, it would have been prima facie obvious to determine
the appropriate amount of guanethidine to treat hypertension in a particular
individual and provide that amount of guanethidine in the guanethidine
source of Yun's system (see Ans. 10; see id. (Examiner concludes that "it
would ... have been obvious to have chosen a dosage from among those
known to be effective in methods of treating [h]ypertension"); FF 9 (Yun
discloses that "[ t ]he agent or agents may be used to treat a condition
including, but not limited to, cardiovascular diseases, such as ...
hypertension")).
As discussed above, Yun discloses a system comprising, inter alia, a
catheter, needle, and reservoir, i.e., syringe 328, containing a therapeutic
agent, such as guanethidine, for use in treating, inter alia, hypertension (see
FF 5-12). Further, as Examiner explains, Appellant's claimed invention is
drawn to "a system not a method of treating hypertension" ( Ans. 19).
Therefore, we are not persuaded by Appellant's contention that "Yun does
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not provide any description for guanethidine for localized denervation to
treat hypertension" (Br. 12; see id. 11-12 (Yun fails to disclose a method of
treating hypertension with guanethidine) ).
For the foregoing reasons, we are not persuaded by Appellant's
contention that Examiner "improperly relied upon obvious to try rationale
and hindsight reconstruction" (Br. 12 ( emphasis omitted)).
Claim 14:
Appellant's claim 14 depends from and further limits the system of
Appellant's claim 13 to require that "the length of the needle is in a range
from 500 µm to 1 mm" (Br. 17).
Yun discloses a system, wherein the length of the needle is in a range
"of between about 200 and 3,000 microns (µm)" (FF 12). Thus, Appellant's
claimed range fall within the range of needle lengths disclosed by Yun (id.;
Ans. 11 ("Yun teaches that the length of the needle is from about 200
microns to about 3 mm ... , which completely overlaps [Appellant's claimed
needle length range]"); cf Br. 17). Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) ("[W]here there is a range
disclosed in the prior art, and the claimed invention falls within that range,
there is a presumption of obviousness.").
For the foregoing reasons, we are not persuaded by Appellant's
contention that "Yun does not teach a needle with a length for such precise
anatomical placement to target the claimed tissue layer as recited in the
underlying independent claim 1" (Br. 14).
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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of Appellant's claims 3 and 14
under 35 U.S.C. § 103(a) as unpatentable over Yun is affirmed. Appellant's
claims 4--7 and 15-18 are not separately argued and fall with Appellant's
claim 3.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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