Ex Parte ABREU

Patent Trials and Appeals Board

Mar 27, 2019

13554349 - (D) (P.T.A.B. Mar. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/554,349 07/20/2012
78198 7590
Studebaker & Brackett PC
8255 Greensboro Drive
Suite 300
Tysons, VA 22102
03/29/2019
FIRST NAMED INVENTOR
Marcia Marc ABREU
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.
813315-678402 5428
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
03/29/2019 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):
info@sbpatentlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARCIO MARC ABREU
Appeal2018-000376
Application 13/554,349 1
Technology Center 1600
Before DONALD E. ADAMS, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for reducing muscle contraction of normal muscle around an eye,
which have been rejected as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
STATEMENT OF THE CASE
Botulinum toxin is known to treat a variety of neuromuscular
disorders including muscle hyperactivity and muscle over contraction by the
injection of the toxin directly into the hyperactive or hypertonic muscle or in
1 Appellant identifies Geelux Holdings, Ltd. as the assignee and the real
party in interest as Marcio Marc Abreu. (Br. 2.)
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Application 13/554,349
the surrounding area of that muscle. (Spec. 2-3.) "For the treatment of
blepharospasm and hemifacial spasm[,] injections ofbotulinum toxin are
done at multiple sites in the eyelid and facial musculature to decrease the
spastic state or hyperactive state of said muscles." (Id. at 4.)
Glaucoma is "characterized by decreased filtration of eye fluid and
increase of intraocular pressure to values which the eye cannot withstand."
(Spec. 1.) The eye is subject to factors outside the eye that also "cause
change in pressure inside the eye." (Id. at 2.)
The present invention is directed at "treating the external pressure
effects acting on the eye or around the eye by the administration of
compounds that reduce and/ or modulate said external pressure effects [by
modulating blinking and facial musculature and eye muscles] and achieve
long lasting reduction of: pressure fluctuation, pressure spikes and baseline
eye pressure while preserving normal eye muscle function. (Id. at 5---6.)
Claims 10-18 are on appeal. Claim 10 is representative and reads as
follows:
10. A method for reducing muscle contraction of normal
muscle around an eye, the eye having one of glaucoma and
diabetic retinopathy, said method comprising the steps of:
treating damaging external pressure effects acting on the
eye by obtaining a chemomodulating agent capable of reducing
muscle tension of the normal muscle around the eye, the normal
muscle being involved in eyelid function; and
injecting an effective amount of said chemomodulating
agent into or adjacent to said normal muscle to thereby reduce
the muscle tension of said normal muscle and to thereby reduce
pressure applied on the eye by the normal muscle around the
eye to reduce eye pressure in the eye while simultaneously
preserving normal eye function, the injecting of the
chemomodulating agent into or adjacent said normal muscle
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causing eyelid function to be lowered to a less than normal
strength,
wherein the normal muscle being injected is an
orbicularis muscle;
wherein the normal muscle being injected and involved
with eyelid function is also a muscle of Riolan.
(Supplemental Br., filed Feb. 16, 2017, Appendix of Appealed Claims at 1.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 10-15 under 35 U.S.C. § I03(a) as unpatentable over
Donovan,2 Fogel, 3 Scott, 4 Rosenbaum, 5 and Koch. 6
2 Donovan, US 6,306,403 Bl, issued Oct. 23, 2001.
3 Fogel, WO 00/28999, published May 25, 2000.
4 Alan B. Scott, MD, Botulinum Toxin Injection of Eye Muscles to
Correct Strabismus, LXXIX Tr. Am. Ophth. Soc., 734--70 (1981). The
Examiner refers to this reference as Alan Scot or Alan Scott (Final Action 4--
5), and erroneously as Ian Scot or Ian Scott (Final Action 12).
5 Rosenbaum et al., Botulinum Toxin Therapy in the Management of
Strabismus and Lid Disorders, W. J. Med., 456-57 (1986). The
Examiner refers to this reference as Scott, Rosendbaum. (Final Action 4,
12.) We refer to it, instead, as Rosenbaum.
6 Paul S. Koch, MD, Efficacy of lidocaine 2% jelly as a topical agent
in cataract surgery, 25(5) J. Cataract & Refractive Surgery, 632-34
(1999)
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Application 13/554,349
Claims 16-18 under 35 U.S.C. § 103(a) as unpatentable over
Donovan, Fogel, Scott, Rosenbaum, Weber,7 Lev, 8 Koch, and DiSanto. 9
DISCUSSION
The Examiner finds that Donovan teaches that botulinum toxin has
been used to treat strabismus ( a neuromuscular disorder of the eye) by
intramuscular injection into extra ocular muscles and that the amount
injected can vary based upon the size of the muscle to be injected and the
extent of muscle paralysis desired. (Final Action 4 ). The Examiner also
finds that Donovan teaches botulinum toxin has been used to treat
blepharospasm 1 ° ( a neuromuscular disorder of the eye) by intramuscular
injection in to the orbicularis oculi muscle. (Id.) The Examiner also finds
that Donovan teaches local administration of a neurotoxin "at or to the
vicinity of a site on or within an animal body, at which site a biological
effect of the pharmaceutical is desired, (lines 44--50 in col. 15)." (Id.)
According to the Examiner, this reference "demonstrates that the direct
administration of a pharmaceutical could be made at or on the vicinity of a
7 Paul A. Weber, MD, Neovascular Glaucoma: Current
Management, 26(3) Surv. of Ophthalmology, 149--53 (1981). The
Examiner refers to this reference as Webber.
8 Lev et al., Prophylactic lidocaine use preintubation: A review,
12(4) J. EmERGENCY Med., 499-508 (1994). The Examiner relied on the
Abstract only.
9 DiSanto, US 6,117,912, issued Sept. 12, 2000.
10 The Examiner explains that blepharospasm "is a condition that involves
continually recurring involuntary eye closure or excessive forceful
blinking." (Id. at 7.)
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site, on or within an animal body, at which a biological effect of the
pharmaceutical is desired." (Id. at 5.)
The Examiner finds that Fogel discloses injection of botulinum toxin
into orbicularis oculi muscles adjacent to the eye "is [a] mainstay of
treatment [ for blepharospasm ]" and that the injections "weaken the muscles
responsible for eye closure, thereby mitigating the involuntary movements
of those muscles." (Id.)
The Examiner finds that Scott teaches injection ofbotulinum toxin
into eye muscle is an alternative treatment to surgical manipulation to treat
strabismus, and that the injection of the drugs into the eye muscle weakens
it. (Id.) The Examiner notes that Scott teaches that "botulinum type A
appears to have great muscle paralytic effect in humans." (Id. at 6.) The
Examiner further finds that Scott teaches that there is an "effect of the drug
on adjacent muscles" where the injected muscle itself receives a strongly
weakening effect. (Id. ( emphasis omitted).) The Examiner finds that
Rosenbaum, like Scott, teaches botulinum toxin injection in orbicularis
muscle to treat strabismus, and that the injection reduces muscle contraction.
(Id. at 6.)
The Examiner finds that, in light of the fact that intramuscular
injection of Botox (i.e., botulinum toxin) to muscles (a) near the eye, such as
in the orbicularis oculi, to treat blepharospasm is known to weaken the
muscles, or reduce muscle activation and thus reduce the blinking of the
eyelid and (b) into extra ocular muscles to treat strabismus is known to
reduce muscle tension and that adjacent muscles are affected when the
injected muscle receives a strongly weakening effect, it would be inherent
that this weakening of the muscle activity would also result in reducing
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intraocular pressure ("IOP"). (Id. at 7-8.) The Examiner concludes that the
foregoing inherent effect of reducing IOP would result even when the
muscle is normal and the patient has glaucoma or retinal diabetic
retinopathy. (Id. at 8.)
The Examiner concludes that it would have been obvious to inject
botulinum to orbicularis oculi muscle to reduce muscle contraction in that
muscle or Riolan, which is near it and is also a muscle that is outside the eye
in patients who had a preexisting condition such as glaucoma. (Id. at 9
("Therefore, it would have been obvious to one skilled in the art to prepare a
composition of botulinum A or B-G and apply to a muscle including muscle
near the eye to reduce the muscle contraction on an eye and reducing eye
pressure in patient of any preexisting eye condition i.e. having any one of
glaucoma, diabetic retinopathy, the muscle contraction caused by a muscle
orbicularis or Riolin which is outside the eye.").) 11 The Examiner contends
that reducing IOP would have been an inherent consequence of causing the
reduced muscle contraction. (Id.)
We agree with Appellant that in the rejection "the Examiner has
emphasized the results produced by the cited references instead of the steps
of the method of the invention." (Br. 9.) However, we conclude, as did the
Examiner, that the prior art renders the claims prima facie obvious.
11 The Examiner also asserts that one would have been motivated "to reduce
IOP in the eye by injecting Botulin." (Final Action 8; see also id. at 10-11.)
We do not rely on this statement because the claims are not directed to a
method for reducing IOP in the eye, but to reducing muscle contraction of
muscle around the eye which thereby results in reducing IOP, as will be
discussed herein.
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"[T]he examiner bears the initial burden ... of presenting a prima
facie case ofunpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant." In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellant in the Appeal Brief (no Reply Brief was submitted);
arguments not so presented in the Brief are waived. See 37 C.F.R.
§ 41.3 7 ( c )( 1 )(iv) (2015); see also Ex parte Borden, 93 USPQ2d 14 73, 14 7 4
(BP AI 2010) (informative) ("Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived.").
Appellant's invention requires two steps. The first is to obtain a
chemomodulating agent that is capable of reducing muscle tension in normal
muscle around the eye of a patient having glaucoma or diabetic retinopathy.
We note that the claim indicates that, in some way, obtaining this compound
"treat[ s] damaging external pressure effects." We understand that the
treating is more likely the result of injecting the agent, which is the recited
second step. The second step requires injecting the obtained
chemomodulating agent intramuscularly into a muscle of Riolan or near that
muscle of an eye that has glaucoma or diabetic retinopathy. The amount
injected is required to be an effective amount to reduce the muscle tension
and reduce pressure applied on the eye to reduce pressure in the eye. The
injection is also required to cause eyelid function to be lowered to a less than
normal strength. While the claim refers to reduction of eye pressure, we
agree with the Examiner that this is the natural result of the effective amount
to reduce the muscle tension. (See, e.g., Final Action 11.) As Appellant's
Specification explains, increased eye pressure occurs with the closure of the
eyelid during blinking and forceful closure of the eyelid. (Spec. 2.) Thus
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Application 13/554,349
reducing blepharospasm by weakening the tension of the eyelid (see Fogel
9) causes eyelid function to be reduced to less than normal strength, which
reduces blinking and in so doing will inherently result in reducing IOP.
Appellant's claim does not recite treating glaucoma or diabetic
retinopathy by reducing intraocular pressure in the patient's eye and
injecting an effective amount of a chemomodulating agent to effect that
result. Nor does Appellant's claim recite a "method of use of a muscle
tension reducing agent for the treatment of increased intraocular pressure" as
asserted by Appellant. (Br. 6.) The invention sought to be patented is "[a]
method for reducing muscle contraction" of muscle around the eye in a
patient that has glaucoma or diabetic retinopathy. The steps of the method
require injecting an effective amount of a chemomodulating agent into or
around the muscle to thereby reduce muscle tension in the eye. While the
effective amount is also required to be one that "thereby reduce[ s] pressure
applied on the eye ... to reduce eye pressure in the eye," the reduction in
muscle tension, as explained in the Specification, will inherently reduce
pressure applied on the eye and thereby reduce IOP. (See, Spec. 2 (noting
that "Increased eye pressure, eye pressure spikes and fluctuation of pressure
[is caused by] external pressure effects such as blinking, forceful closure of
the eyelid, and eyelid muscle tension."); see also Spec. 11.) We note that
the claim requires that the eye being treated has glaucoma or diabetic
retinopathy, but does not exclude the eye also having blepharospasm. We
conclude that the Examiner has made out a prima facie case of obviousness
of the claims on appeal.
Appellant does not contest that it was known in the art to inject
botulinum toxin into eye muscles to treat strabismus, which is a
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misalignment of the eyes. (Br. 7.) Appellant, however, contends that the
muscles involved in such treatment are (1) not normal muscle involved in
eyelid function and (2) were not normal muscle at all, but rather unhealthy
muscle that adversely affect the movement of the eyeball. (Id. at 7-8.)
Appellant argues that the Examiner's rejection is improper because "the
person of ordinary skill in the art would find no teaching whatsoever in the
prior art suggesting that injection into or adjacent to any normal muscle
involved in eyelid function could affect intraocular pressure by moderating
the effect ofblinking." (Id. at 8 (emphasis omitted).)
We do not find Appellant's arguments persuasive. As to the first
point regarding muscle normally involved in eyelid function, Appellant
ignores the fact mentioned in the Specification (Spec. at 4), and explained in
Donovan (Donovan 11 :24--28) and Fogel (Fogel at 9), that botulinum toxin
was known to be injected into the orbicularis oculi muscles of the upper and
lower lid, which are muscles normally involved in lid opening and closing,
to treat blepharospasm. As Fogel explains, "[t]hese injections weaken the
muscles responsible for eye closure." (Fogel 9.) Moreover, it was known in
the art that the Riolan muscles are an orbicularis oculi muscle. (See Ans.
23-25 (Figures 1--4 ). )
In addition, it was known that the injection ofbotulinum toxin into
extraocular muscles to treat strabismus, if it provided a strongly weakening
effect, affects adjacent muscles similarly. (Scott 766, see also id. at 767 ("It
is a practical problem to restrain effect to an individual vertical muscle
without effect on adjacent muscles.").) It is not disputed that the extraocular
muscles for treating strabismus are not the orbicularis oculi muscle but the
rectus muscles. (See, e.g., Rosenbaum 456.) However, we find no reason
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that one of ordinary skill in the art would not reasonably conclude that this
same weakening of adjacent muscles would apply when other muscles of the
eyelid are injected with botulinum toxin, such as when injecting orbicularis
oculi to treat blepharospasm. 12
Thus, we agree with the Examiner's position that the art teaches
injection into eyelid muscle normally involved in eyelid opening and
closing. Moreover, given that the orbicularis oculi muscle was injected to
treat blepharospasm, we find that it is likely injection was either directly into
Riolan muscles and resulted in their weakening or such muscles were
affected because other muscles of the eyelid were strongly weakened when
they were injected. 13
12 We do not agree, however, with the Examiner that Donovan supports
such a conclusion. (Final Action 6-7.) After reviewing clinical settings in
which botulinum toxin type A has been used including for treating
strabismus and blepharospasm (Donovan 11: 12-62), Donovan teaches
intracranial administration of botulinum toxin to treat movement disorder
where the intracranial administration permits the blood brain barrier to be
bypassed (see, e.g., id. at 17: 21--45, 18:18-59.) The activity of the
neurotoxin is said to be injected into specific target tissue where diffusion is
minimized, or is provided by way of implant to control the continuous
release of therapeutic amount of the toxin at the desired location over a
prolonged period. (See, e.g., id. at 22:3-14.) The injection is directed at
affecting cholinergic neurons, there is nothing to indicate that the
administration near a target site is directed at reducing muscle tension. (See,
e.g., id. 13:18-39.)
13 The Examiner also stated in the answer that
The muscle orbicularis oculi and muscle of Riolan are
close/adjacent to each other and are near the eye. When the
same drug is injected in muscle orbicularis oculi .... The
involvement and effect of adjacent riolan muscles is expected
because it is in the same area as shown in figures and since
there is no evidence indicating that the injected drug is
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As for Appellant's second point above regarding the absence of
teaching in the art regarding treatment of "normal muscle," we note that
Appellant argues that the muscles described as receiving botulinum A toxin
"were unhealthy, enlarged and restricted in motion so as to adversely affect
the movement of the eyeball in its socket." (Br. 8 (referring to inferior
rectus muscles being injected and affecting movement of the eyeball in its
socket).) Appellant's argument in this regard is focused on the prior art use
of botulinum toxin to treat strabismus, not blepharospasm. Moreover,
Appellant does not define the claim term "normal" in the Specification or
claims themselves. Appellant does not provide any evidence to substantiate
the argument that the eye muscles injected with botulinum toxin disclosed in
the cited prior art were not normal in either the treatment of strabismus,
much less blepharospasm. "Attorney's argument in a brief cannot take the
place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974); see
also Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989)
("Attorneys' argument is no substitute for evidence.").
Moreover, as the Examiner explained (Final Action 7), and Appellant
does not contest, blepharospasm is a problem directed at contraction of the
muscles of the eyelids. There is no evidence of record that these muscles are
necessarily "unhealthy." Furthermore, blepharospasm is not a condition that
completely confined within those muscle cells directly injected
with the drug and will not effect at all to adjacent muscles in
blinking the eyes to lower the eye pressure.
Ans. 25. We do not rely on this finding of apparent seepage of the drug to
other muscles after injecting into orbicularis oculi for our determination that
claim 10 would have been obvious from the teachings of the prior art as it is
not supported by reference to the prior art.
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concerns movement of the eyeball in its socket. Thus, for these reasons we
do not find Appellant's argument that the muscles injected with botulinum
toxin to treat blepharospasm were unhealthy.
Furthermore, we agree with the Examiner that injecting this toxin into
healthy tissue would have been expected to result in lowering IOP by
weakening the muscles that cause the eyelid to raise and lower. 14 That is the
blinking would be less and/or less forceful. As the Specification indicates, it
was known that increased eye pressure results from external effects such as
blinking and forceful closure of the eyelid. (Spec. 2.) Appellant provides no
argument or evidence contradicting that reducing IOP is an inherent result of
reducing blinking or causing it to be less forceful. Instead, Appellant argues
just that "the person of ordinary skill in the art would find no teaching
whatsoever in the prior art suggesting that injection into or adjacent to any
normal muscle involved in eyelid function could affect intraocular pressure
by moderating the effect of blinking." (Br. 8 ( emphasis omitted)). That the
art does not expressly recite this result does not change the fact that it is
inherent.
In sum, the evidence of record establishes that it would have been
prima facie obvious to treat blepharospasm with the method that falls within
the scope of Appellant's claim 10. The question, therefore, distills down to
whether the prior art treatment of an eye experiencing blepharospasm
14 The Examiner mentions in the Answer that the prior art teaches
botulinum toxins are useful to lower IOP in patients. (Ans. 27.) We do not
agree with the Examiner's finding. That the results might be inherent is not
the same thing as teaching that result. Thus, we do not rely on this finding
in our conclusion that the Examiner has made out a proper prima facie case
of obviousness.
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encompasses, within its genus, the treatment of eyes that may also have
glaucoma or diabetic retinopathy? We find that it does. In addition, we find
that Appellant has not provided persuasive evidence or argument to establish
an evidentiary basis on this record to support a contrary conclusion.
Arguments not made are waived. See 37 C.F.R. § 4I.37(c)(l)(iv).
Thus, a person of ordinary skill in the art, when treating
blepharospasm in a patient with glaucoma or diabetic retinopathy, would
have been motivated to inject botulinum toxin intramuscularly into the
orbicularis oculi, including into the Riolan muscle or near it, to reduce
blinking in that patient, just as it would have been in a patient that has
blepharospasm but not having glaucoma or diabetic retinopathy. Doing so
would not only reduce the muscle contraction of the orbicularis oculi
muscle, and thus, meet the requirement of claim 10 of "a method for
reducing muscle contraction of normal muscle around an eye, the eye having
one of glaucoma and diabetic retinopathy," but it would necessarily meet the
claim 10 requirement that the effective amount of the chemomodulating
agent injected "thereby reduce pressure applied on the eye by the normal
muscle around the eye to reduce eye pressure in the eye while
simultaneously preserving normal eye function." (See Spec. 2 (explaining
that it was known that increased eye pressure results from external effects
such as blinking and forceful closure of the eyelid).) In short, the claimed
process here is not directed to a new use; it is the same use, and it consists of
the same steps as described by the prior art, and simply identifies another
result that is unspecified in the prior art, but that is an inherent result. Such
newly discovered results of known processes are not patentable. Bristol-
Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir.
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2001). For the foregoing reasons, therefore, we do not find the Examiner
erred in rejecting claim 10 as obvious over Donovan, Fogel, and Scott.
We do not find it necessary to rely on the Examiner's findings with
respect to Rosenbaum or Koch. However, we note that, in affirming a
multiple reference rejection under 35 U.S.C. § 103, we may rely on fewer
than all of the references relied on by the Examiner in an obviousness
rationale and we may do so without designating it as a new ground of
rejection. In re Bush, 296 F.2d 491,496 (CCPA 1961).
In light of the foregoing, we affirm the Examiner's rejection of claim
10 for obviousness over Donovan, Fogel, Scott, Rosenbaum, and Koch.
Claims 11-15 have not been argued separately and therefore fall with
claim 10. 37 C.F.R. § 4I.37(c)(l)(iv).
Appellant also does not provide a different argument for why the
Examiner erred in rejecting claims 16-18. (See Br. 9 ("These claims are
dependent from independent claim 10. As such they should be allowable for
the same reasons as claim 10 is allowable.") For the reasons just discussed,
we are not persuaded by Appellant's argument that the rejection of claim 10
was improper.
SUMMARY
We affirm the rejection of claims 10-15 under 35 U.S.C. § 103(a) as
unpatentable over Donovan, Fogel, Scott, Rosenbaum, and Koch.
We affirm the rejection of claims 16-18 under 35 U.S.C. § 103(a) as
unpatentable over Donovan, Fogel, Scott, Rosenbaum, Weber, Lev, Koch,
and DiSanto.
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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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