Ex Parte North

Patent Trial and Appeal Board

Aug 22, 2017

13640616 (P.T.A.B. Aug. 22, 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.
13/640,616 01/16/2013 Richard B. North 082916.00011/46901.211US0 6462
12243 7590 08/24/2017
Haynes and Boone, LLP (46901)
2323 Victory Avenue
Suite 700
Dallas, TX 75219
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/24/2017 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):
ipdocketing@haynesboone.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD B. NORTH
Appeal 2016-006487
Application 13/640,616
Technology Center 3700
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a system
for positioning a lead within a patient. The Examiner rejected the claims as
indefinite and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm, but designate our affirmance as a new ground of rejection.
Statement of the Case
Background
“Percutaneous electrodes were introduced in the 1970’s as a
minimally invasive technique to deliver spinal cord stimulation (SCS)”
(Spec. 1:8—9). “Percutaneous SCS electrodes are inserted into the epidural
space through a Tuohy type needle, bent at its tip to allow the electrode to
1 Appellant does not identify the Real Party in Interest.
Appeal 2016-006487
Application 13/640,616
emerge at an angle and then ascend cephalad, in or parallel to the midline”
(id. at 1:14—16).
percutaneous SCS electrode steerability is very
important, and none of the presently available products address
it adequately. Not only must the electrode be steerable, but the
steering must also be variable. . . . The electrode must negotiate
a bend; if it does not bend sufficiently, it may indent the dura
(or even the spinal cord). If it deviates to one side, it will still
tend to continue ventrally, into the “gutter” in the lateral
epidural space.
(Spec. 2:21 to 3:3).
The Claims
Claims 1 and 3—12 are on appeal. Claim 1 is representative and reads
as follows:
1. A system for positioning a lead within a patient,
comprising:
a lead comprising a shaft having a plurality of electrode
contacts disposed thereon and a flexible spacer portion between
each of said electrode contacts, and a stylet lumen extending
into said lead from a proximal end thereof towards a distal end
thereof; and
a stylet having a plurality of bends therein and relatively
straight portions extending between said bends, wherein said
bends are positioned a distance apart from one another so as to
simultaneously align with said flexible spacer portions of said
lead when said stylet is positioned within said stylet lumen;
wherein a first one of said flexible spacer portions has
greater flexibility than a second one of said flexible spacer
portions, such that one of said bends in said stylet engaging said
first one of said flexible spacer portions will cause said lead to
bend at a larger angle than said one of said bends in said stylet
engaging said second one of said flexible spacer portions.
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The issues
A. The Examiner rejected claims 1 and 3—12 under 35U.S.C. § 112,
second paragraph, as indefinite (Final Act. 2).
B. The Examiner rejected claims 1 and 3—12 under 35 U.S.C. § 103(a) as
obvious over Erickson,2 Bradley,3 and Bomzin4 (Final Act. 3—6).
A. 35 U.S.C. § 112, second paragraph, indefiniteness
The Examiner finds:
In claim 1, the claim is vague for having at the minimum two
electrodes—i.e. “a plurality of electrode contacts”— and one
spacer between the electrodes, at the minimum, but having a
plurality of bends to match up with the spacers. In addition, the
dependent claims use multiple spacers. It is suggested to state
“at least three electrodes” and this will therefore require at least
two spacers to match up with the bends.
(Final Act. 2).
Appellant contends:
The claim specifically recites a first said flexible spacer portion
and a second said flexible spacer portion, requiring at least two
flexible spacer portions. Moreover, each flexible spacer portion
must be positioned between a pair of electrode contacts.
Further, the claimed stylet incorporates bends that “are
positioned a distance apart from one another so as to
simultaneously align with said flexible spacer portions of said
lead when said stylet is positioned within said stylet lumen,”
such that the flexible spacer portions must likewise be
positioned a distance apart from one another. If there are at
2 Erickson et al., US 6,895,283 B2, issued May 17, 2005.
3 Bradley et al., US 2007/0213795 Al, published Sept. 13, 2007.
4 Bomzin, US 2010/0228330 Al, published Sept. 9, 2010.
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Application 13/640,616
least two flexible spacer portions that are spaced apart from one
another, and each flexible spacer portion must be positioned
between a pair of electrode contacts, there inherently must be at
least three electrode contacts.
(App. Br. 6).
On this issue, we find that Appellant has the better position. As
Appellant points out, the requirement for “first” and “second” flexible spacer
portions combined with the requirement that each flexible spacer portion is
located between “electrode contacts” necessarily results in a system with
three electrode contacts as desired by the Examiner. Moreover, we do not
find the language at issue indefinite, only broadly encompassing three or
more electrodes and two or more spacer portions.
B. 35 U.S.C. § 103(a) over Erickson, Bradley, andBornzin
The Examiner finds “Erickson discloses the use of a lead having
multiple electrodes (e.g. 20), with flexible spacers (e.g. 50) between the
electrodes. Erickson discloses that a bent stylet is inserted into the lead and
‘keyed’ to the multiple spacers to control the lead bending in multiple
directions/angles” (Final Act. 3). The Examiner finds Bradley teaches “the
use of the stylet bend at the flexible spacer location to easily control the
bending of the lead” and Bornzin teaches “the use of a stylet with multiple
bends” (id.).
The Examiner finds “Erickson in view of Bradley and Bornzin
disclose the claimed invention except for the first spacer having greater
flexibility than the second spacer to cause the lead to bend at a larger angle”
(Final Act. 4).
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The Examiner finds it obvious:
to have modified the system as taught by Erickson or Erickson
in view of Bradley and Bomzin, with the different flexibilities
and constructions of the spacers for the different bends, since it
would provide the predictable results of allowing the lead to be
flexible and less flexible along different portions of the lead to
correctly implant the lead at different locations in the body and
allow the lead to properly stimulate and sense at these different
locations.
(id.).
The Examiner also states, “Smits provided evidence and showed that
it is well known to use different flexibilities along the lead to allow the lead
to be easily inserted in the body and conform to the area where the lead is
implanted” (Final Act. 6). The Examiner further states: “In addition, three
other pieces of prior art are cited with this office action (Hine, Tockman, and
Smits) to show evidence of this well-known claim limitation.” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the prior art renders the claims
obvious?
Findings of Fact
1. Erickson teaches a “stimulation lead having a plurality of
electrodes, a plurality of terminals, and a plurality of conductors, wherein a
conductor of the plurality of conductors electrically couples one terminal of
the plurality of terminals with at least one electrode of the plurality of
electrodes” (Erickson 3:20—24).
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2. Figure 7B of Erickson is reproduced below:
Figure 7B depicts a “stimulation lead lOOe [that] includes two principal,
substantially planar surfaces, one of which carries the plurality of electrodes
20 . . . The stimulation lead lOOe includes necked portions 50 ... . This
structural configuration creates a stimulation lead having a varying cross-
sectional moment of inertia, which enables a predetermined flexibility”
(Erickson 8:39-67).
3. Erickson teaches:
when the contoured end of the stylet 54a is oriented
substantially parallel to the principal planar surfaces of the
stimulation lead lOOe, the stimulation lead lOOe deforms in a
direction consistent with a predetermined direction of the bent
end of the stylet 54a. Accordingly, through rotation of a bent
stylet 54a, a practitioner can purposely control and direct the
stimulation lead being implanted to a desired site.
(Erickson 9:20—27).
4. Erickson teaches: “Steering control could be accomplished
with multiple stylets, each stylet including a unique contour to address a
corresponding waisted region, or a single stylet ‘keyed’ to corresponding
waisted regions” (Erickson 10:32—35).
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5. Figure 5 of Bradley is reproduced below:
no
FIG. 5
“FIG. 5 shows a partial, longitudinal, cut-away view of the lead . . . with a
stylet 137 inserted into the lumen” (Bradley 136).
6. Bradley teaches: “In one embodiment of the lead, a plurality of
concave necks 150 may be employed, the concave necks 150 variously
placed on the distal end of the lead. For example, a concave neck may be
placed between two adjacent electrode contacts 120” (Bradley 131).
7. Bomzin teaches: “In one embodiment, the distal portion 7 of
the lead 5 has a first bend 16 and a second bend 18 in different planes.
Because of the shape of its distal portion 7, the lead 5 may be placed more
easily and with overall higher stability” (Bomzin 122).
8. Smits ’6015 teaches a “lead may be configured to have one
relatively stiff portion 2 adjoining a relatively flexible portion 4, or may
have a series of alternating relatively stiff portions 2 and relatively flexible
sections 4” (Smits ’601162).
5 Smits, US 2004/0162601 Al, published Aug. 19, 2004.
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9. Smits ’5446 teaches the “relative lengths of relatively flexible
portions 4 and relatively stiff portions 2 may be varied according to the radii
of the different venous curves which are anticipated to be encountered
during lead implantation” (Smits ’544 151).
10. Smits’544 teaches:
In order not to lose the desired bending stiffness properties of
the present invention to the extent that destabilization might
occur after implantation, materials for forming lead body 12 of
the present invention include silicone rubber and polyurethane.
Other implantable grade materials are, of course, contemplated
in the present invention, including but not limited to, PEBAX,
PTFE, and ETFE.
(Smits ’544 1 66).
11. Tockman7 teaches the “lead assembly provides several benefits
including a lead which has varying stiffness throughout the lead.
Furthermore, the conductors and/or portions of the lead formed of materials
having increased stiffness will assist in retaining and/or positioning the lead
assembly in a desired location of the heart or vein or artery” (Tockman 9:65
to 10:3).
12. Hine8 teaches:
the lead body has varying flex or stiffness characteristics along
its length between each of the electrodes. The relation of the
varying flex or stiffness characteristics along the lead body
length as well as the various linear placements of the electrodes
along the lead body length function to simultaneously bring the
first electrode into contact with a first desired portion of the
6 Smits, US 2002/0065544 Al, published May 30, 2002.
7 Tockman et al., US 7,239,923 Bl, issued July 3, 2007.
8 Hine et al., US 6,070,104, issued May 30, 2000.
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heart, such as the right atrial wall, and the second electrode into
contact with a second desired portion of the heart, such as a
portion of the coronary sinus wall.
(Hine 3:4—12).
13. Hine teaches:
the varying flexibility characteristics along the lead body may
be provided and adjusted in many of the numerous ways well
known in the art, including the use of differing materials as well
as the design of the various components, including the design of
the conductors, as well as the relative positions of the
conductors within the lead body.
(Hine 7:2-8).
14. Hine teaches:
It is to be understood that the present invention is not limited to
use only in pacing leads, and may be employed in the
construction of may of various type of therapeutic and
diagnostic devices, including defibrillation leads, intended to be
disposed within the coronary sinus. In fact, for the purposes of
this specification and claims, the term “lead” is used herein in
its broadest sense and includes any stimulation lead or sensing
lead, a combination thereof or any other elongated member,
such as a catheter, which may usefully be introduced into a
body.
(Hine 7:57-66).
Principles of Law
“Where a reference is relied on to support a rejection, whether or not
in a ‘minor capacity,’ there would appear to be no excuse for not positively
including the reference in the statement of the rejection.” In re Hoch, 428
F.2d 1341, 1342 n.3 (CCPA 1970).
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“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” KSRInt’l Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3—6; FF 1—14) and agree that
the claims are rendered obvious by the prior art. However, because the
Examiner relies upon four references not positively included in the statement
of rejection, we designate our affirmance a New Ground of Rejection in
order to afford Appellant’s fair opportunity to fully respond.
The new statement of rejection is: claims 1 and 3—12 are rejected
under 35 U.S.C. § 103(a) as obvious over Erickson, Bradley, Bomzin, Smits
’601, Smits ’544, Tockman, and Hine.
We address Appellant’s arguments below.
Appellant contends “this feature of multiple spacers between electrode
contacts in a lead having varied flexibility so as to allow varied angles to be
achieved by a single stylet is key to Applicant’s invention, overcomes
shortcomings in the prior art, is not disclosed or suggested by the prior art”
(App. Br. 7).
We do not find this argument persuasive because Tockman teaches
that benefits of “a lead which has varying stiffness” includes “positioning
the lead assembly in a desired location” (FF 11). Smits ’544 teaches an
example where “relative lengths of relatively flexible portions 4 and
relatively stiff portions 2 may be varied according to the radii of the different
venous curves” (FF 9).
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Moreover, Hine teaches a “lead body has varying flex or stiffness
characteristics along its length between each of the electrodes” (FF 12).
Hine broadly teaches the applicability of varying lead flexibility by stating
“term ‘lead’ is used herein in its broadest sense and includes any stimulation
lead or sensing lead, a combination thereof or any other elongated member,
such as a catheter, which may usefully be introduced into a body” (FF 14).
Therefore, the evidence of record suggests that the ordinary artisan
would have had reason to modify the stimulation lead system of Erickson
(FF 1—3) with varying flexibilities in order to allow positioning in desired
locations (FF 11), address curves in the anatomy (FF 9), and thereby
properly contact the target tissue (FF 12), and the prior art also recognized
that these properties may be used in a “lead” in the broadest sense of the
term (FF 14).
Appellant contends the:
difference in bends achieved by the lead also significantly
enhances the ability to steer the lead through the patient’s body
using a single stylet (i.e., without requiring that the surgeon pull
out and replace one stylet with a differently configured stylet),
thus minimizing the risk of losing proper alignment or
inadvertently causing the lead to move away from its intended
position as one lead is withdrawn and another is inserted.
(App. Br. 8-9).
We do not find this argument persuasive because “apparatus claims
cover what a device is, not what a device does.'” Hewlett-Packard Co. v.
Bausch &Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). Claims 1 and
3—12 are drawn to a system, not a method. That system does structurally
require a lead with flexible spacer portions with two different flexibilities,
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and a stylet with bends, but the asserted advantage regarding stylets
represents an intended use of the system. However, the Examiner finds that
Erickson teaches a lead with a plurality of electrode contacts and flexible
spacer portions between the contacts (FF 2) as well as “a single stylet
‘keyed’ to corresponding waisted regions” (FF 6) with multiple bends. The
Examiner reasonably relies upon Smits ’601, Smits ’544, Tockman, and
Hine to provide reasons for altered flexibilities for different spacer portions
to allow positioning in desired locations (FF 11), address curves in the
anatomy (FF 9), and properly contact the target tissue (FF 12). That the
prior art may not recognize the intended use does not impart patentability to
the system claim. A “mere statement of a new use for an otherwise old or
obvious composition cannot render a claim to the composition patentable.”
In reZierden, 411 F.2d 1325, 1328 (CCPA 1969).
Appellant contends the:
claimed construction meets a clearly identified shortcoming of
prior art devices, and constitutes far more than mere selection
of a known material or an obvious design choice, by providing
a specific configuration that allows an operator to modify the
various angles achieved by different portions of a lead using
only a single stylet.
(App. Br. 10).
We find this argument unpersuasive. While it does not address the
additional references of Smits ’601, Smits ’544, Tockman, and Hine cited by
the Examiner, but not included in the statement of rejection, more
fundamentally, this argument implies secondary considerations should
overcome the prima facie case of obviousness, but provides no evidence
supporting any particular secondary consideration. “[Attorney argument
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[is] not the kind of factual evidence that is required to rebut a prima facie
case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Appellant contends:
Lacking any appreciation in the prior art of a benefit to be
achieved by varying the flexibility of spacer portions positioned
between electrode contacts in a lead that align with bends in a
stylet (as required by Applicant’s claim 1), it is clear that the
reasoning asserted in the Final Office Action to reject
Applicant’s claims 1 is gleaned entirely from Applicant’s own
specification through precisely the type of impermissible
hindsight that courts have consistently warned against.
(App. Br. 11).
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly
stated that the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416.
In the instant case, we agree with the Examiner that Erickson
substantively differs from the claimed system only in lacking a teaching that
the flexible portions between electrode contacts may have different
flexibilities (see Final Act. 4). However, as already discussed, other prior art
provide reasons to include varying flexibilities in order to allow positioning
a lead in desired locations (FF 11), address curves in the lead anatomy (FF
9), and allowing leads to properly contact the target tissue (FF 12). In
addition, Hine expressly recognizes that the varying flexibility properties
may broadly be used in any “lead” (FF 14). Thus, the rejection does not rely
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solely upon hindsight, but, rather, relies upon specific benefits of varying
flexibility in leads that were disclosed in the prior art and recognized as
broadly applicable to different lead assembly systems (FF 8—14).
Appellant specifically responds to the newly cited art in the Reply
Brief, and contends:
specifically, such references fail to show a lead having spacer
portions of varying flexibility between electrode contacts.
While the references disclose leads having varying flexibilities
so that they will rest in certain positions in a patient’s body in a
configuration matching the patient’s anatomy, they do not
disclose variably flexible spacer portions between electrode
contacts, or aligning any variably flexible portions with
portions of an external device, such as a stylet having multiple
bends as required by Applicant’s claims.
(Reply Br. 4).
We find this argument unpersuasive because “[n]on-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.” In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). A reference “must be
read, not in isolation, but for what it fairly teaches in combination with the
prior art as a whole.” Id.
The Examiner’s rejection relies upon Erickson to suggest a lead
having flexible spacer portions between electrode contacts (FF 1—3) and
relies upon Smits ’601, Smits ’544, Tockman, and Hine to teach and provide
reasons why spacer portions may have varying flexibility (FF 8—14). It is
this combination of teachings that renders the claims obvious, not any single
teaching alone that anticipates the claims.
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Dependent claims
Appellant contends “claims 3—7 and 9—11 all recite specific
configurations of portions of the claimed lead that provide the lead with
varied flexibility at the spacer portions” (App. Br. 12). Appellant contends:
“Absent such clearly articulated reasoning as to how the prior art discloses
the foregoing specific features of claims 3—7 and 9-11, the Final Office
Action fails to establish a prima facie case of obviousness with respect to
those claims” (App. Br. 13—14).
The Examiner finds, in the Final Action, that:
for claims 3—7 and 9-11, it would have been obvious to one
having ordinary skill in the art at the time the invention was
made to have modified Erickson or Erickson in view of Bradly
and Bomzin, with the different flexibilities and constructions of
the spacers, and different electrode and spacer sizings and
dimensions, since it would provide the predictable results of
allowing the lead to be flexible and less flexible along different
portions of the lead to correctly implant the lead at different
locations in the body and allow the lead to properly stimulate
and sense at these different locations. In addition, it has been
held to be within the general skill of a worker in the art to select
a known material on the basis of its suitability for the intended
use as a matter of obvious design choice. In re Leshin, 125
USPQ 416. Also, a change in size is generally recognized as
being within the level of ordinary skill in the art. In re Rose,
105 USPQ 237 (CCPA 1955).
(Final Act. 5—6).
We find that the Examiner has the better position because the
Appellant does not identity any specific error in the Examiner’s findings that
the limitations of these claims would have been predictable, suitable, and
represent changes in size or design obvious to the ordinary artisan. “Such a
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conclusory argument by appellants is not sufficient to raise separate issues
on appeal with respect to the dependent claims.” In re Thrift, 298 F.3d
1357, 1360 (Fed. Cir. 2002). We also note: “A statement which merely
points out what a claim recites will not be considered an argument for
separate patentability of the claim.” 37 C.F.R. § 41.37(c)(iv). See In re
Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (the Board reasonably
interpreted 37 C.F.R. § 41.37(c)(l)(vii) as requiring “more substantive
arguments in an appeal brief than a mere recitation of the claim elements and
a naked assertion that the corresponding elements were not found in the
prior art”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
prior art renders the claims obvious.
SUMMARY
In summary, we reverse the rejection of claims 1 and 3—12 under
35 U.S.C. § 112, second paragraph, as indefinite.
We affirm the rejection of claims 1 and 3—12 are rejected under
35 U.S.C. § 103(a) as obvious over Erickson, Bradley, Bomzin, Smits ’601,
Smits ’544, Tockman, and Hine, but designate this affirmance as a New
Ground of Rejection.
Therefore, 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:
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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.
AFFIRMED: 37 C.F.R, $ 41.50(b)
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