Ex Parte Sanders et al

Patent Trial and Appeal Board

Feb 11, 2015

12165847 (P.T.A.B. Feb. 11, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/165,847 07/01/2008 Ira Sanders 21864-2 2621
28221 7590 02/12/2015
PATENT DOCKET ADMINISTRATOR
LOWENSTEIN SANDLER LLP
65 LIVINGSTON AVENUE
ROSELAND, NJ 07068
EXAMINER
FORD, VANESSA L
ART UNIT PAPER NUMBER
1646
MAIL DATE DELIVERY MODE
02/12/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
|UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte IRA SANDERS and
CHRISTOPHER SHAARI1
__________

Appeal 2012-008563
Application 12/165,847
Technology Center 1600
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and ULRIKE W.
JENKS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of preventing complications of an airway control device, such as ventilator-
associated pneumonia. The claims have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm but designate the affirmance a new ground of rejection.

1 According to Appellants, the Real Parties in Interest are the inventors (Br.
2).
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STATEMENT OF THE CASE
An endotracheal tube (ET) is inserted into the breathing passage of a
patient who needs a ventilator to breathe (Spec. 1, ¶ 3). Because the ET
keeps a conduit open to the lungs, fluids such as saliva can seep from the
mouth into the lungs (id. at 1, ¶ 5), causing ventilator-associated pneumonia
(id. at 2, ¶ 6).
The Specification discloses a method of preventing complications of
airway control devices by administering botulinum toxin (id. at 13, ¶ 28), for
example by injection (id. at 16, ¶ 47), to “[t]he secretory glands, includ[ing]
. . . salivary glands and respiratory secretory and mucus glands” (id. at 16,
¶ 48).
Claims 1–17 and 21 are on appeal. Claims 1 and 21 are the
independent claims and read as follows:
1. A method of preventing complications of airway control devices
comprising administering to a patient having an airway control device a
pharmaceutical composition comprising botulinum neurotoxin to one or
more of the upper or lower aerodigestive secretory glands, the
cricopharyngeus or the gastric or esophageal mucosal wall of the patient to
prevent complications of the airway control device.

21. A method of preventing ventilator associated pneumonia comprising
administering to a patient having an airway control device a pharmaceutical
composition comprising botulinum neurotoxin to one or more of the upper
or lower aerodigestive secretory glands, the cricopharyngeus or the gastric or
esophageal mucosal wall of the patient to prevent ventilator associated
pneumonia.

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DISCUSSION
Issue
The Examiner has rejected claims 1–13, 16, and 21 under 35 U.S.C.
§ 103(a) as obvious based on Davis,2 McGill,3 and Sanders4 (Answer 4).
The Examiner has rejected claims 14, 15, 17, and 21 under 35 U.S.C.
§ 103(a) as obvious based on Davis, McGill, Sanders, and Merello5 (Answer
4). Because Appellants have waived arguments directed to Merello (Br. 13–
14), the same issue is dispositive for both rejections.
The Examiner finds that Davis discloses that one mechanism for
development of ventilator-associated pneumonia (VAP) is microaspiration
of secretions from the oropharynx, which leak around the cuff of an
endotracheal tube (Answer 4–5). The Examiner finds that McGill teaches
administering botulinum toxin to treat excessive drooling, and that excessive
salivation can cause pneumonia if the patient aspirates the saliva (id. at 5).
The Examiner finds that Sanders teaches inhibiting saliva production by
administering botulinum toxin to the salivary glands (id.).
The Examiner concludes that it would have been obvious to
administer botulinum toxin to the secretory gland of a subject having an
endotracheal tube inserted in order to prevent saliva production and thereby
prevent the microaspiration of secretions taught by Davis to be one cause of

2 Kimberly A. Davis, Ventilator-Associated Pneumonia: A Review, 21
J. INTENSIVE CARE MEDICINE 211-25 (2006).
3 McGill University Hospital Centre, Botox injection saves infant’s life,
http://muhc.ca/newsroom/news/botox-injection-saves-infants-life, 2005
(accessed Jan. 3, 2010).
4 Sanders et al., US 5,766,605, June 16, 1998.
5 Merello et al., WO 2006/078998 A2, July 27, 2006.
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VAP, especially since McGill teaches that excessive salivation can cause
pneumonia (id. at 6–7).
Appellants contend that: (1) it would be counter-intuitive to
administer botulinum toxin to prevent VAP because of its known adverse
effects and because it is derived from a Gram-positive bacterium (Br. 10–
11); (2) that VAP is not due to excessive saliva production but failure of an
airway control device to maintain a proper seal (id. at 11–12); and (3) none
of Davis, McGill, or Sanders describe administering a pharmaceutical
composition to reduce fluid production in order to prevent complications of
an airway control device (id. at 12–13).
The issue presented is whether the cited references disclose or would
have made obvious a method meeting all of the limitations of claims 1 and
21.
Findings of Fact
1. McGill describes treatment of a patient with Charge Syndrome,
who suffered from multiple bouts of pneumonia caused by aspiration of his
saliva (McGill 1)
2. The patient described in McGill “had to be intubated, a tube was
inserted through his throat into his lungs” (id.).
3. McGill states that the patient was treated by “inject[ing] botulinum
toxin (Botox) to paralyze the saliva glands” (id.). See also id. at 2: “The
parents agreed to the Botox injection.”
4. McGill states that “within ten days the excess secretions dried up,
the intubation and ventilation were withdrawn, and eventually the little boy
went home” (id. at 2).
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5. McGill states that excessive salivation can cause pneumonia if the
saliva is aspirated (id. at 3).
Principles of Law
If . . . the body of the claim fully and intrinsically sets forth the
complete invention, including all of its limitations, and the
preamble offers no distinct definition of any of the claimed
invention’s limitations, but rather merely states, for example,
the purpose or intended use of the invention, then the preamble
is of no significance to claim construction because it cannot be
said to constitute or explain a claim limitation.
Pitney Bowes Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999).
“It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable.” In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
“It is well settled that ‘anticipation is the epitome of obviousness.’”
In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (quoting Connell v.
Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).
Analysis
Claim 1 is directed to a “method of preventing complications of
airway control devices.” Claim 21 is directed to a “method of preventing
ventilator associated pneumonia.” Both claims recite the same active step:
“administering to a patient having an airway control device a pharmaceutical
composition comprising botulinum neurotoxin to one or more of the upper
or lower aerodigestive secretory glands, the cricopharyngeus or the gastric or
esophageal mucosal wall of the patient” to prevent either complications of
airway control devices (claim 1) or ventilator-associated pneumonia (claim
21).
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McGill describes administering Botox (a pharmaceutical composition
comprising botulinum neurotoxin) to an intubated patient (i.e., a patient
having an airway control device) to paralyze the saliva glands (i.e., aero-
digestive secretory glands; see Spec. 13, ¶¶ 28, 33). Thus, McGill describes
treating the same patient in the same manner with the same composition as
recited in claims 1 and 21. The difference, if there is any, between the prior
art method and the claimed method therefore must reside in the claim
preambles.
We conclude, however, that the preambles of claims 1 and 21 do not
limit the claims, because they merely recite the purpose or intended use of
the claimed method. The bodies of claims 1 and 21 include all of the
limitations of the claimed method: they recite the patient being treated, the
composition used to treat the patient, and the manner of administering that
composition. The preambles of the claims do not result in any difference in
how the claimed processes are carried out, but merely recite the intended
results of practicing the claimed methods.
The relevant facts of this case are similar to those of Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001). In
Bristol-Myers, claim 1 of the ’803 patent was directed to a “method for
reducing hematologic toxicity in a cancer patient undergoing [t]axol
treatment comprising parenterally administering to said patient an
antineoplastically effective amount of about 135–175 mg/m2 taxol over a
period of about three hours.” Id. at 1371 (emphasis omitted).
The court concluded that the preamble phrase “for reducing
hematologic toxicity” was non-limiting and merely expressed a purpose of
the claimed method. Id. at 1375. The court noted that the steps of the
“method are performed the same way regardless whether or not the patient
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experiences a reduction in hematologic toxicity, and the language of the
claim itself strongly suggests the independence of the preamble from the
body of the claim.”
Similarly here, the single step of the methods of claim 1 and claim
21—specifically, administering a composition comprising botulinum
neurotoxin to, e.g., the salivary glands—is performed the same way whether
or not it results in preventing complications of an airway control device or
preventing ventilator-associated pneumonia. Like the preamble phrase “for
reducing hematologic toxicity” in Bristol-Myers, the preamble language of
claims 1 and 21 on appeal does no more than express a purpose of the
claimed methods, and is therefore non-limiting.
McGill describes treating a patient having an airway control device by
injecting a pharmaceutical composition comprising botulinum neurotoxin
into the salivary glands (FF 2, FF 3). Because McGill describes a method
that meets all the limitations of claims 1 and 21, it anticipates those claims,
even if it does not describe carrying out the method for the same purpose
recited in the claims. “It is well settled that ‘anticipation is the epitome of
obviousness.’” In re McDaniel, 293 F.3d at 1385.
Appellants argue that it would be counter-intuitive to administer
botulinum neurotoxin for the prevention of complications of airway control
devices or VAP (Br. 10–11). McGill, however, expressly describes
administering botulinum toxin to an intubated patient, and its intended
purpose in doing so is irrelevant to the issue of whether it anticipates claims
1 and 21.
Appellants also argue that “VAP is a distinct problem from excess
salivation, or drooling” (Br. 11) and that “complications of airway control
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devices, such as VAP, are not due to excessive saliva production, but rather
failure for the airway control device to maintain a proper seal” (id. at 12).
This argument is also unpersuasive because claims 1 and 21 are not
limited to patients with both an airway control device and normal saliva
production. Claims 1 and 21 merely recite “a patient having an airway
control device,” and therefore read on the patient described in McGill, who
was intubated because of pneumonia resulting from aspiration of saliva.
Finally, Appellants argue that none of Davis, McGill, or Sanders
describe administering a pharmaceutical composition that reduces fluid
production in order to prevent complications of airway control devices or
VAP (Br. 12–13). As discussed above, however, the preamble language of
claims 1 and 21 is not entitled to weight as a claim limitation because it
merely expresses the purpose of the claimed method and does not change the
way in which the active step is performed. As discussed above, McGill
describes a method meeting all of the actual limitations of claims 1 and 21
and therefore anticipates those claims.
Conclusion of Law
McGill discloses a method meeting all of the limitations of claims 1
and 21.
SUMMARY
We affirm the rejection of claims 1 and 21 under 35 U.S.C. § 103(a)
based on Davis, McGill, and Sanders. Claims 2–13 and 16 fall with claims 1
and 21 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) based on
Davis, McGill, Sanders, and Merello. Claims 14, 15, and 17 fall with claim
21 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
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Although we affirm the rejections on appeal, we rely on reasoning that
differs from that of the Examiner. In order to give Appellants a fair
opportunity to respond, therefore, we designate the affirmances as new
grounds of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37 CFR
§ 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12,
2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR
§ 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph
shall not be considered final for judicial review.”
37 CFR § 41.50(b) also provides that the appellants, 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 proceeding
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

37 C.F.R. § 41.50(b)

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