Ex Parte Post et al

Board of Patent Appeals and Interferences

Sep 22, 2010

10846488 (B.P.A.I. Sep. 22, 2010)

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.
10/846,488 05/13/2004 Sarah S. Post FLE01-001-US 8781
43320 7590 09/23/2010
EVAN LAW GROUP LLC
600 WEST JACKSON BLVD., SUITE 625
CHICAGO, IL 60661
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
09/23/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SARAH S. POST, MICHAEL L. CASWELL, and
CHARLES H. COX
____________

Appeal 2010-004326
Application 10/846,488
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
DEMETRA J. MILLS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1-8, 10-13, 20-23,
and 31-34, the only claims pending in this application. We have jurisdiction
under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
The claims are directed to an enema. Claim 1 is representative and is
reproduced in the “CLAIMS APPENDIX” of Appellants’ Brief (App. Br.
13).
The rejections presented by the Examiner follow:
1. Claims 1-8, 10-13, 20-23, and 31-34 stand rejected under 35 U.S.C
§ 103(a) as unpatentable over the combination of Hussey2, the Federal
Register3, and MoonDragon4.
2. Claims 1-8, 10-13, 20-23, and 31-34 stand rejected under 35 U.S.C
§ 103(a) as unpatentable over the combination of Hussey, Remington’s5, and
the Federal Register.
We affirm.
Given the similarity between the two rejections presented for our
review we address both rejections together.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness and, if so, does Appellants’ evidence of
unexpected results rebut the prima facie case of obviousness?

2 Hussey, US 4,619,645, issued October 28, 1986.
3 Laxative Drug Products for Over-the-Counter Human Use; Tentative Final
Monograph, 50(10) Federal Register 2151-2158 (1985).
4 MoonDragon’s Health Therapy: Enemas - Phosphosoda Enema,
http://web.archive.org/web/20030130063720/http://www.moondragon.org/h
ealth/therapy/p..., accessed January 14, 2009.
5 Enemas in Remington’s (17th ed., Alfonso R. Gennaro, ed., Mack
Publishing Co., PA) (1985).
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FINDINGS OF FACT
FF 1. Hussy teaches a bottle with a lubricated rectal tip filled with sterile
enema fluid (Ans. 4; see also Ans. 8).
FF 2. Hussey does not teach the amount, volume, or components of the
enema solution (Ans. 5; see also Ans. 8).
FF 3. The Federal Register teaches the use of 6.84-7.56 grams of dibasic
sodium phosphate and 18.24-20.16 grams of monobasic sodium phosphate
for a rectal enema dosage for adults and children 12 years of age and over
(Ans. 4; see also Ans. 8).
FF 4. MoonDragon teaches that a “cleansing enema . . . is used to flush out
the colon” (MoonDragon 1: 6-7).
FF 5. The Examiner finds that MoonDragon “teaches a phosphosoda
enema solution including monobasic sodium phosphate and dibasic sodium
phosphate made by adding 2 quarts, which is about 1892 ml, of warm water
and 1.5 fluid ounces (45 ml) of Phosphosoda” (Ans. 5).
FF 6. The Examiner finds that MoonDragon “establishes the concept that
dilution of phosphate salts up to 1892 ml of volume create enemas that
work” (Ans. 5; see also App. Br. 8 (“The Examiner rightly asserts that
Moondragon teaches the preparation of an enema solution comprising 1892
ml of water”)).
FF 7. Remington’s teaches that “enemas are usually given in [a] 1 to 2 pt
volume” (Ans. 8).
FF 8. Remington’s teaches that dibasic and monobasic sodium phosphate
“are used in enemas and can be used alone or in combination with each other
or in combination with soap” (Ans. 8-9).
FF 9. Remington’s teaches “a soap enema of 1000 mL volume” (Ans. 9).
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FF 10. The Examiner finds that “[t]he volume . . . of the single dose [taught
by Federal Register] is merely a matter of routine optimization by one of
ordinary skill in the art because the art has shown dilution up to 1892 ml”
(Ans. 6).
FF 11. A “typical enema” has a volume of 133 ml (Spec. 4).
FF 12. Appellants disclose that an enema composition “containing 19 g of
monobasic sodium phosphate . . . and 7 g of dibasic sodium phosphate . . .
dissolved in 230.88 ml of water” packaged in “the bottles” (Spec. 5: 6-8)
“proved superior to the typical volume enema for a variety of commercially
significant criteria” (Spec 5: 1-2), specifically “overall performance”,
“relieves constipation”, “cleanses well”, and “easy to squeeze” (Fig. 7; see
also App. 10; Spec. 6-11).
ANALYSIS
Appellants present arguments for claims 1 and 20. Accordingly, we
consider Appellants’ arguments in relation to representative claims 1 and 20.
37 C.F.R. § 41.37(c)(1)(vii).
Based on the combined teachings of Hussey, the Federal Register, and
MoonDragon the Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the claimed invention was made to use the guidelines
of the Federal Register respect to the amounts of sodium
phosphate and sodium diphosphate and Moon[D]ragon with
respect to the volume in the enema bottle of Hussey and
produce the instant invention.

(Ans. 6.) We agree.
The Federal Register identifies the amount of dibasic and monobasic
phosphate that can be provided to an adult in a single daily dose (FF 3).
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MoonDragon teaches an effective volume for the delivery of dibasic and
monobasic sodium phosphate (FF 4-6). Hussey provides an enema bottle
(FF 1).
We also agree with the Examiner’s conclusion that Appellants’
claimed invention would have been prima facie obvious to a person of
ordinary skill in the art in view of the combined teachings of Hussey,
Remington’s and Federal Register (Ans. 11). Specifically, the Examiner
reasons that a person of ordinary skill in the art would have found it obvious
“to follow the roadmap set forth by Remington’s [(FF 7-9)] . . . add[ing]
sodium monohydrogen phosphate (dibasic) and sodium dihydrogen
phosphate (monobasic) in the amounts taught by the Federal Register [(FF
2)] to 1000 ml of soap solution [(FF 9)] and place that solution in an enema
delivery device as taught by Hussey [(FF 1)] and [thereby] produce the
instant invention” (Ans. 10).
Appellants contend that claim 1 indirectly specifies the concentration
of dibasic and monobasic sodium phosphate (App. Br. 6). We are not
persuaded. Claim 1 places no upper limit on the volume into which the
dibasic and monobasic sodium phosphate is added. Therefore, while claim 1
places an upper limit on the concentration (e.g., 5-8 grams of dibasic sodium
phosphate and 15-21 grams of monobasic sodium phosphate in a 150 ml
volume), claim 1 is open to include diluted solutions containing 5-8 grams of
dibasic sodium phosphate and 15-21 grams of monobasic sodium phosphate
in any volume above at least 150 ml. Therefore, while Appellants are
correct in that “[n]one of the references [individually] teach or suggest using
the concentrations of salts in an enema as claimed by Applicants” (App. Br.
8); the concentration taught by the combination of the Federal Register and
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Application 10/846,488

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MoonDragon meet the indirect concentration requirement of claim 1.
Appellants’ contentions with regard to the rejection of Hussey, Remington’s
and the Federal Register as it applies to claim 1 (App. Br. 10) are not
persuasive for the same reasons.
Appellants contend that claim 20 “directly specifies concentration”
(App. Br. 6). While this is true, the Examiner finds that “[t]he volume . . . of
the single dose [taught by the Federal Register] is merely a matter of routine
optimization by one of ordinary skill in the art because the art has shown
dilution up to 1892 ml” (FF 10). We agree. 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.”). Appellants’ contentions with regard to the
rejection of Hussey, Remington’s and the Federal Register as it applies to
claim 20 (App. Br. 10) are not persuasive for the same reasons.
For the foregoing reasons we find no error in the Examiner’s prima
facie case of obviousness as it applied to the combination of Hussey, the
Federal Register, and either MoonDragon or Remington’s.
Appellants contend, however, that
[s]urprisingly and unexpectedly, the enema of the present
invention had substantially improved results over a typical
enema, on the following attributes: “overall performance”
(64%), “relieves constipation” (63%), “cleanses well” (57%),
and “easy to squeeze” (50%) as evidence by data provided by
the Applicants on pages 6 through 11 of the [S]pecification.

(App. Br. 10-11; see also FF 12.) We are not persuaded.
Initially we note that Appellants have failed to establish that the easy
to squeeze attribute is related to volume or the concentration of sodium
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Application 10/846,488

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phosphate in the enema. Absent evidence to the contrary, we find that the
easy to squeeze attribute is a property of the bottle itself. Appellants’ claims
1 and 20 place no limitation on the bottle other than a rectal administration
tip is attached thereto. Accordingly, scope of the bottle in Appellants’
claims 1 and 20 encompasses Hussey’s enema bottle.
With regard to the overall performance, relieves constipation, and
cleanses well attributes, we note that the comparative data relates to a
“typical volume enema” (FF 12). The prior art relied upon by the Examiner
does not relate to a typical volume enema, which has a volume of 133 ml
(FF 11). To the contrary, MoonDragon and Remington’s both teach enema
volumes in excess of 133 ml. Accordingly, with respect to the volume of the
enema the closest prior art of record is MoonDragon and Remington’s.
Appellants have not established unexpected results with respect to the
closest prior art of record. Accordingly, we are not persuaded by
Appellants’ evidence of unexpected results or Appellants’ contention that
“the experimental data demonstrates the unobviousness of the claimed
invention” (App. Br. 12).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness and Appellants’ evidence of unexpected results fails to rebut
the prima facie case of obviousness.
The rejection of claims 1 and 20 under 35 U.S.C § 103(a) as
unpatentable over the combination of Hussey, the Federal Register, and
MoonDragon is affirmed.
Appeal 2010-004326
Application 10/846,488

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The rejection of claims 1 and 20 under 35 U.S.C § 103(a) as
unpatentable over the combination of Hussey, Remington’s, and the Federal
Register is affirmed.
Claims 2-8, 10-13, and 31-34 fall together with claim 1. Claims 21-
23 fall together with claim 20.

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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