Ex Parte Adib

Board of Patent Appeals and Interferences

Sep 7, 2012

10942622 (B.P.A.I. Sep. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRAY ADIB
__________

Appeal 2011-010531
Application 10/942,622
Technology Center 3700
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to method of
electrical muscle stimulation. The Examiner rejected the claims as failing to
comply with the written description requirement by incorporating new
matter. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
“The stimulation of muscles in the human body by way of electrical
stimuli to provide involuntary muscular response has become a useful
remedial, diagnostic, and clinical technique” (Spec. 1, ll. 14-16). The
Specification teaches that the “present invention generally relates to
electrical muscle stimulators designed to stimulate the masticatory and facial
muscles, and in addition, various muscles of the shoulder and back” (Spec.
1, ll. 10-12).
The Claims
Claims 19 and 21-23 are on appeal.
1
Claim 19 is representative and
reads as follows:
19. A method of electrical stimulation of a subject,
comprising:
placing at least one active electrode on the back of the
neck of a subject at a midline suboccipital area;
placing a first set of left and right passive electrodes
bilaterally below the neck over the left and right shoulder
muscles, respectively, of the subject;
placing a second set of left and right passive electrodes
on the subject near the left and right ears, respectively, of the
subject over a coronoid notch; and
substantially simultaneously providing current pulses
from the at least one active electrode to the first and second sets
of left and right passive electrodes to stimulate the subject.

1
Claims 1-6 and 10-18 stand allowed (see App. Br. 3).
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The issues
2

A. The Examiner objected to the Specification under 35 U.S.C. § 132(a)
as incorporating new matter (Ans. 3-4).
B. The Examiner rejected claims 19 and 21-23 under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement
(Ans. 4).
A. 35 U.S.C. § 132(a)
The Examiner finds that to
incorporate by reference an Applicant can only copy words
directly from the provisional that they incorporated into the
spec. Therefore in the amendment the page 6 insertions –
“for example”, “comprise” instead of “consist”, “as another
example”, “in this example” are not in the original
specification and are not copied as a whole into the amended
specification

(Ans. 3).
Appellant contends that the “present application also explicitly
incorporates by reference the entire text of the „397 provisional application”
(App. Br. 7). Appellant contends that “the March 19, 2009, Amendment did
not introduce new matter into the present application, and that the amended
specification is wholly supported by the disclosure as filed” (id. at 9).

2
With regard to Appellant‟s third ground for review, the refusal to
enter an After-Final Amendment, a refusal to enter an amendment
is a petitionable matter under 37 C.F.R. § 1.181 and not within the
jurisdiction of the Board. 37 C.F.R. § 1.127 (2011); In re Berger,
279 F.3d 975, 984 (Fed. Cir. 2002) (citing In re Hengehold, 440
F.2d 1395, 1403-1404 (CCPA 1971).)
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that the March 19, 2009 amendment to
page 6 of the Specification introduces new matter?
Findings of Fact
1. The text of page 2 of US 60/503,397 is reproduced below:
1) Configuration 1 as described in the J5 User‟s Guide
A total of 6 electrodes are used. Three (3) for each
bank of 2 channels. The three (3) electrodes consist of one
Common (Active) electrode placed on the neck below the
hairline and two (2) (Left and Right) passive electrodes. The
current is directed from the Active electrode to the other 2
electrodes.
The 2 Active electrode leads are shorted together
internally. Two (2) Active electrodes are placed adjacent to
each other (one below the other) to distribute the current
among the 2 electrodes, providing reduced current density
that results in enhanced patient comfort.
All 6 electrodes used in this configuration can be
made of standard electrodes, including Myotronics‟
Myotrode II wet gel electrodes.

2) Configuration 2
A total of 5 electrodes are used. The unique feature in
this configuration is the use of one (1) Active electrode from
which current flows to four (4) sites.
The active electrode is larger than the other 4
electrodes. The active electrode is 1.6 inches by 1.6 inches
in size and it uses Myotronics solid gel material that has a
superior uniformity of current distribution. In this
configurations [sic] only one Active lead is used.
As will be appreciated by those of ordinary skill in the
art, the present invention is not limited to electrodes of any
particular size or shape. Although this illustrative example
utilizes electrodes having a size of 1.6 inches by 1.6 inches,
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the systems and methods described herein can use electrodes
having a large or smaller size.

2. The text of the first three paragraphs of page 13 (numbered as
page 7) of US 60/503,397 is reproduced below:
The Model J-5 Myo-monitor is a low frequency
neuromuscular stimulator. It emits an electrical impulse at a
fixed rate of once every 1.5 seconds, and at an amplitude
high enough to elicit muscle contractions. This rhythmic
pumping action of the muscles increases blood flow. Muscle
spasm is relieved since fresh blood and oxygen are pumped
in while accumulated toxins are flushed out.
The Model J-5 has two cables that are connected to
the back of the instrument, each cable containing leads
related to two stimulating channels. Output to each cable is
controlled by its own Amplitude and Balance controls. The
controls are labeled Set “A” (for TMJ/Occlusal stimulation)
and Set “B” (for cervical and thoracic stimulation).
The practitioner has the choice of using.either cable
Set “A” or Set “B” by itself, or both Sets “A” and “B”
simultaneously. If using only one cable at a time, it is best to
simply disconnect the unused cable.

3. The text added to page 6 of the Specification by the March 19,
2009 amendment is reproduced below:
For example, in a first configuration described in
applicant‟s J5 User‟s Guide as set forth in U.S. Provisional
Application No. 60/503,397 and expressly incorporated by
reference herein, a total of 6 electrodes are used, namely, a
set of three (3) electrodes for each bank of two (2) channels.
The three electrodes in each set comprise one common
(active) electrode placed on the neck below the hairline, and
two (left and right) passive electrodes. The current is
directed from the active electrode to the other two
electrodes.
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The two active electrode leads are shorted together
internally. The two active electrodes are placed adjacent to
each other (one below the other) to distribute the current
among the two electrodes, providing reduced current density
that results in enhanced patient comfort.
All six electrodes used in this configuration can be
made of standard electrodes, including Mytotronics‟
Myotrode II wet gel electrodes.
As another example in a second configuration, a total
of 5 electrodes are used. The unique feature in this
configuration is the use of one (1) active electrode from
which current flows to four (4) sites.
The active electrode is larger than the other four
electrodes. The active electrode in this example is 1.6 inches
by 1.6 inches in size and uses Myotronics solid gel material
that has a superior uniformity of current distribution. In this
configuration, only one active lead is used.
As will be appreciated by those of ordinary skill in the
art, the present invention is not limited to electrodes of any
particular size or shape. Although this illustrative example
utilizes electrodes having a size of 1.6 inches by 1.6 inches,
the systems and method described herein can use electrodes
that have a larger or smaller size.
The Model J-5 Myo-monitor is a low frequency
neuromuscular stimulator. It emits an electrical impulse at a
fixed rate of once every 1.5 seconds and at an amplitude
high enough to elicit muscle contractions. This rhythmic
pumping action of the muscles increases blood flow. Muscle
spasm is relieved since fresh blood and oxygen are pumped
in while accumulated toxins are flushed out.
The Model J-5 has two cables that are connected to
the back of the instrument, each cable containing leads
related to two stimulating channels. Output to each cable is
controlled by its own amplitude and balance controls. The
controls are labeled Set “A” (for TMJ/Occlusal stimulation)
and Set “B” (for cervical and thoracic stimulation).
The practitioner has the choice of using either cable
Set “A” or Set “B” by itself, or both Sets “A” and “B”
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simultaneously. If using only one cable at a time, it is best to
simply disconnect the unused cable.

Principles of Law
“The question … is not whether „carrying‟ was a word used in the
specification as filed but whether there is support in the specification for
employment of the term in a claim; is the concept of carrying present in the
original disclosure?” In re Anderson, 471 F.2d 1237, 1244 (CCPA 1973).
“Mere rephrasing of a passage does not constitute new matter.
Accordingly, a rewording of a passage where the same meaning remains
intact is permissible.” MPEP § 2163.07.
Analysis
In this case, the text being incorporated by Appellant from US
60/503,397 into the instant Specification is essentially identical to the text
found in the provisional application (FF 1-3). The only changes are very
minor rephrasing of the language into paragraph form for consistency with
the Specification. We therefore agree with Appellant that this is a proper
incorporation by reference from the provisional application and that no new
matter is incorporated.
Conclusion of Law
The evidence of record does not support the Examiner‟s conclusion
that the March 19, 2009 amendment to page 6 of the Specification
introduces new matter.
B. 35 U.S.C. § 112, first paragraph
The Examiner finds that “[c]laim 19 and its dependents are new
matter for the reason that the back electrode to provide current FROM the
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back electrode to the other 4 electrodes is considered new matter as it in
combination with the other elements of the claim can not be found in the
written description” (Ans. 4). The Examiner finds that it “is unclear where
the „method steps‟ are disclosed in the provisional to provide these since the
application only states that the back electrode is current receiving” (id.).
The Examiner finds that “combining the provisional with the present
application is a mixing of embodiments. Nowhere was it disclosed how the
incorporation by reference of the provisional proved a device or method for
mixing the provisional with the current specification for the current claimed
invention” (id.).
Appellant contends that “subject matter included by amendment in the
specification is found at least on page 2 of the „397 provisional application
as filed and on page 13 (in the section titled „Step-By-Step Operation‟) of
the „397 provisional application” (App. Br. 9).
3
Appellant contends that “the
teachings of the „397 provisional application as set forth in the present
specification provide explicit support for the subject matter that is claimed in
Claims 19 and 21-23” (id. at 12). Appellant contends that the teaching of
“[u]sing both Sets „A‟ and „B‟ simultaneously results in a configuration with
at least one active electrode and four receiving electrodes, as claimed in
Claim 19” (id. at 13).

3
Appellant refers to the Amendment after Final on May 14, 2010,
which was denied entry by the Examiner in the Advisory action
mailed May 21, 2010. As reproduced in the Claims Appendix,
claim 19 is properly the claim presented on Nov. 5, 2009, without
the non-entered amendments.
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that claim 19 lacks descriptive support in
the Specification?
Findings of Fact
4. The Specification teaches
placing four output electrodes and at least one common
electrode in the vicinity of the head of a subject. In
particular, two output electrodes are placed adjacent to the
ears of the subject and two output electrodes are placed
along the upper back of the subject. At least one common
electrode is placed on the back of the neck of the subject

(Spec. 3, ll. 4-7).
5. The Specification teaches “electrodes 98 and 100 positioned on
either side of the electrodes 94 and 96 on the subject‟s shoulder or back are
current producing electrodes, whereas the electrodes 94 and 96 on the
subject‟s neck are current receiving electrodes” (Spec. 5, ll. 19-21).
6. The Specification teaches that “non current producing
electrodes are placed over the suboccipital area (S504). The suboccipital
area is generally directly below the hairline of the subject. These electrodes
placed below the hairline and on the back neck of the subject are not current
producing electrodes” (Spec. 6, ll. 3-6).
7. The Specification teaches that “the electrodes placed over the
suboccipital area of the subject do not receive current. These are conducting
electrodes that are placed on the suboccipital area” (Spec. 6, ll. 15-17).
8. The Specification of US 60/503,397 teaches a “configuration 1”
in which:
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A total of 6 electrodes are used. Three (3) for each bank of 2
channels. The three (3) electrodes consist of one Common
(Active) electrode placed on the neck below the hairline and
two (2) (Left and Right) passive electrodes. The current is
directed from the Active electrode to the other 2 electrodes.
The 2 Active electrode leads are shorted together internally.
Two (2) Active electrodes are placed adjacent to each other
(one below the other) to distribute the current among the
2 electrodes, providing reduced current density that results
in enhanced patient comfort.

All 6 electrodes used in this configuration can be made of
standard electrodes, including Myotronics' Myotrode II wet
gel electrodes.

(Spec. US 60/503,397 2.)
9. The Specification of US 60/503,397 teaches a “configuration 2”
in which:
A total of 5 electrodes are used. The unique feature in this
configuration is the use of one (1) Active electrode from
which current flows to four (4) sites.

The active electrode is larger than the other 4 electrodes.
The active electrode is 1.6 inches by 1.6 inches in size and it
uses Myotronics solid gel material that has a superior
uniformity of current distribution. In this configurations [sic]
only one Active lead is used.

As will be appreciated by those of ordinary skill in the art,
the present invention is not limited to electrodes of any
particular size or shape. Although this illustrative example
utilizes electrodes having a size of 1.6 inches by 1.6 inches,
the systems and methods described herein can use electrodes
having a large or smaller size.

(Spec. US 60/503,397 2.)
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10. The Specification of US 60/503,397 states that “[w]hen
stimulating the occlusal/TMD and cervical areas simultaneously (using
all four channels) it is necessary to use two rear Myo-trodes, one above
the other, immediately below the hairline” (US provisional 60/503,397,
page 15, numbered as page 9).
Principles of Law
[T]he hallmark of written description is disclosure ... the test
requires an objective inquiry into the four corners of the
specification from the perspective of a person of ordinary
skill in the art. Based on that inquiry, the specification must
describe an invention understandable to that skilled artisan
and show that the inventor actually invented the invention
claimed.

Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010).
“[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement” id. at 1352. “[I]t is the specification itself
that must demonstrate possession. And while the description requirement
does not demand any particular form of disclosure, … or that the
specification recite the claimed invention in haec verba, a description that
merely renders the invention obvious does not satisfy the requirement” id.
Analysis
There is no dispute that the Specification teaches a method in which
the passive electrodes are placed on the patient‟s back neck and active
electrodes are placed on the shoulders and adjacent the ears of the patient as
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required by claim 1 (FF 4-7). There is also no dispute that the Specification,
prior to the incorporation by reference from US provisional 60/503,397,
does not describe the placement of active electrodes on the patient‟s back
neck and passive electrodes on the shoulders and adjacent the ears of the
patient as required by claim 19 (see, e.g., App. Br. 11).
Appellant therefore relies upon the information incorporated from US
provisional 60/503,397 to teach the placement of the electrodes to provide
descriptive support for claim 19. While page 2 of US provisional
60/503,397 teaches two configurations for the electrodes with configuration
1 discussing an active electrode placed at the patient‟s back neck and
configuration 2 discussing a larger active electrode, there is no teaching of
the placement of the remaining electrodes at page 2 of US provisional
60/503,397. That is, page 2 of the provisional does not teach where on the
patient the remaining electrodes should be attached (FF 8-9).
Page 13 of US provisional 60/503,397, also incorporated by reference
and included in the March 19, 2009 amendment, teaches the use of two cable
sets for the patient, but does not discuss the location of the active electrode
(FF 3).
None of these teachings as incorporated into the Specification
demonstrate possession of the use of an active electrode placed on the back
of the neck with two passive electrodes on the left and right shoulders, two
electrodes on the left and right ears, and simultaneously stimulating the
active electrodes to both sets of electrodes as required by claim 19. While
the combination of the placement of the active electrode in configuration 1
on page 2 of US provisional 60/503,397 with the placement of passive
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electrodes on the shoulders and ears may be understood as obvious based
upon the disclosure of the provisional Specification, “a description that
merely renders the invention obvious does not satisfy the [written
description] requirement.” Ariad, 598 F.3d at 1352.
In addition, even when reviewing portions of the provisional not
included in the amendment, such as the pages 13 and 14 (numbered 7 and 8),
these pages do not provide clear descriptive support for the claim as written.
Claim 19 recites placement of “at least one active electrode” on the back of
the neck, but US provisional 60/503,397 states that “[w]hen stimulating the
occlusal/TMD and cervical areas simultaneously (using all four
channels) it is necessary to use two rear Myo-trodes, one above the
other, immediately below the hairline” (US provisional 60/503,397, page
15, numbered as page 9; FF 10). Thus, while claim 19 is clearly open to one
or multiple active electrodes, US provisional 60/503,397 makes it clear that
one active electrode will not function in the context of claim 19, and that two
active electrodes are required, failing to provide descriptive support for the
full scope of claim 19.
We have considered the Houck Declaration,
4
which finds that “the
application teaches and describes a configuration in which a single current
producing electrode is provided on the back of the neck of the subject.”
(Houck Dec. 2 ¶ 5.) We are not persuaded, however, because the cited
portions of US provision 60/503,397 do not describe the placement of all of
the electrodes, nor do the cited portions explain how configuration 2 can
properly operate with a single active electrode on both regions

4
Declaration of Kevin Houck, filed Nov. 9, 2009.
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simultaneously when the provisional specifically teaches that two electrodes
are required (FF 10). Mr. Houck‟s opinion is contrary to this express
teaching of the provisional, and as we balance the weight given to the
express teaching of the provisional and the Houck Declaration, we give
more weight to the express teachings in the provisional.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that claim
19 lacks descriptive support in the Specification.

SUMMARY
In summary, we reverse the objection to the Specification under 35
U.S.C. § 132(a) as incorporating new matter.
We affirm the rejection of claims 19 and 21-23 under 35 U.S.C. §
112, first paragraph as failing to comply with the written description
requirement.

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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