Ex Parte De Simone

Board of Patent Appeals and Interferences

Feb 23, 2012

11576130 (B.P.A.I. Feb. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CLAUDIO DE SIMONE
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Appeal 2010-011262
Application 11/576,130
Technology Center 1600
____________

Before DONALD E ADAMS, DEMETRA J. MILLS, and
STEPHEN WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1 and 3-16, the
only claims pending in this application.1 We have jurisdiction under 35
U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to “[a] glove for detecting the presence of a
vaginal affection” (see Claim 1). Claims 3-16 depend directly or indirectly

1 Pending claims 17-40 and 43-71 stand withdrawn from consideration (Ans.
2).
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from claim 1. Appellant contends that “the present claims should be
considered in two groups: (1) claims 1 and 4-16 and (2) claim 3.” (App. Br.
4.) Claims 1 and 3 are representative and are reproduced in the “CLAIMS
APPENDIX” of Appellant’s Brief (id. at 19).
Claims 1 and 3-16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of De Simone,2 CAREPLAN®VPH,3
Caillouette,4 and Bonstein.5
Claims 1 and 3-16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Anapliotis,6 Caillouette, and Bonstein.
Claims 1 and 3-16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Caillouette, and Bonstein.
We affirm.
The three rejections of record are substantially cumulative.
Appellant’s contentions for each of the three rejections are essentially the
same. Accordingly, our analysis addresses the three rejections together.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?

2 De Simone, et al., WO 2004/035072 A2, published April 29, 2004.
3 CAREPLAN®VPH, GYNAECOLOGICAL EXAMINATION GLOVES,
Package Insert. Appellants do not dispute Examiner’s finding that this
reference was available as prior art in “1998” (Ans. 3).
4 Caillouette, US 2002/0058886 A1, published May 16, 2002. Caillouette
‘886 is a divisional of Caillouette ‘705, US 6,402,705 B1, issued June 11,
2002. Thus, these two references share the same Specification and are
cumulative on this record. Accordingly, we will only discuss Caillouette
‘886.
5 Bonstein et al., US 6,562,297 B1, issued May 13, 2003.
6 Anapliotis, US 6,123,676, issued September 26, 2000.
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FACTUAL FINDINGS (FF)
FF 1. De Simone suggests a
[P]robe, used to collect a sample of . . . vaginal fluid, may take
any convenient shape such as an applicator, cotton swab or
wand. A convenient, disposable single use probe such as a
rubber or plastic examination glove, optionally provided with
an indicator/reporter substance or substances thereon, may be
used, although the indicator/reporter substance may form part
of a separate device.
(De Simone 2: 5-10; Ans. 5.)
FF 2. De Simone suggests that the indicator/reporter substance is a pH
indicator (see generally De Simone 1: 29 - 2: 35; Ans. 5).
FF 3. De Simone suggests that “disposable gynecological examination
gloves bearing thereon a pH-sensitive test indicator are commercially
available, such as CarePlan VpH gynecological examination gloves” (De
Simone 2: 11-13; Ans. 5).
FF 4. CAREPLAN®VPH suggests a glove bearing a pH-sensitive test
indicator that “would appear to be located on the index finger,” e.g., the
finger intended to be used to collect a sample (Ans. 5).
FF 5. CAREPLAN®VPH suggests that the “pH information is then compared
to a color scale to indicate the presence of a vaginal infection,” wherein the
“pH is read on a scale from about 4-4.7, with a pH of 4.4 being regarded as
normal” (Ans. 5-6).
FF 6. Caillouette suggests a method of measuring pH of vaginal sample,
wherein a vaginal sample is collected, transferred to an indicator that lies
outside the body, “whereby the indicator then exhibits a characteristic color,
which is a function of pH of the . . . [sample]; and providing a color
comparison measurement means, and comparing the indicator characteristic
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color with [the] color comparison measurement means” (Caillouette,
Abstract and 2: ¶¶ [0040]-[0043]; see generally Ans. 6).
FF 7. Caillouette suggest that the sample collection device, e.g., “moisture
receiver” can be in the form of a collecting swab, flexible carrier sheet, or
flexible glove, wherein the receiver is “carried by [a] glove finger” (2: ¶
[0040] and 3: ¶[0051]; see generally Ans. 6).
FF 8. Bonstein suggests “an absorbent article comprising a pH sensor to
detect pH changes in the vaginal fluid,” wherein the pH indicator is “a
mixture of Methylorange and Bromocresol Green to show color changes as a
function of pH” (Ans. 7).
FF 9. Anapliotis suggests “a glove bearing a reporter substance . . .
indicating the presence of a vaginal infection,” wherein the collection means
and indicator means are located on the same area of the glove (Ans. 9;
Anapliotis, Abstract).
ANALYSIS
De Simone and Caillouette suggest the use of a variety of means for
collecting a vaginal sample, including a glove (FF 1 and 7). Each of
CAREPLAN®VPH and Anaploitis suggest the use of a glove for collecting a
vaginal sample (FF 4 and 9). Each of Examiner’s combinations of
references suggest that a pH indicator may be part of or separate from the
collection means (see FF 1, 3, 4, and 6 in combination; FF 6-9 in
combination; or FF 6 and 7). Each of Examiner’s combination of references
suggest the use of a pH indicator to detect the pH of a vaginal sample and
thereby detect the presence of a vaginal affection (see FF 2-6 and 8 in
combination; FF 6, 8, and 9 in combination; or FF 6 and 8 in combination).
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Caillouette specifically suggests that once collected the vaginal sample is
transferred to an indicator that lies outside the body (FF 6).
Based on the combination of (1) De Simone, CAREPLAN®VPH,
Caillouette, and Bonstein (FF 1-8); (2) Anapliotis, Caillouette, and Bonstein
(6-9); or (3) Caillouette and Bonstein (FF 6-8), we find no error in
Examiner’s prima facie case of obviousness. Specifically, we find that at the
time this invention was made, a person of ordinary skill in this art would
have found it prima facie obvious to utilize a glove comprising a collecting
means and a pH indicator located on separate regions of the glove, e.g., on
separate fingers, finger and thumb, finger and palm, etc.
Claim 1:
For the foregoing reasons we are not persuaded by Appellant’s
contention that “[t]here is no acceptable evidence or reasoning provided by
the Examiner . . . that one of ordinary skill in the art would have found it
obvious to separate the first and the second means on different positions of
the glove” (App. Br. 5 and 11; see also App. Br. 15; Cf. FF 6). Given
Caillouette’s suggestion to transfer a vaginal sample to an indicator that lies
outside the body, we are not persuaded by Appellant’s contention that the
alternative suggested by CAREPLAN®VPH “teaches away from Appellant’s
claimed invention” (App. Br. 7; Cf. FF 6). For the same reasons we are not
persuaded by Appellant’s contention that based on the combination of
references relied upon by Examiner “[o]ne of ordinary skill in the art would
not have had a reasonable expectation of success” in “(1) avoiding the
introduction of pH indicator substance into the vagina and (2) preventing the
alteration of the first means, which is provided with pH indicator substance,
by excess mucus and/or discharge” (App. Br. 7; see also App. Br. 11-12 and
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15; Cf. FF 6). Moreover, Appellants provide no evidence of vaginal
irritation by the pH indicator, or interference of test results by excess mucus
and/or discharge to support their no reasonable expectation of success
argument.
Lastly, we are not persuaded by Appellant’s contention that “[t]he
cited documents might possibly render obvious placing the collection and
the indicator means on two separate gloves,” but not “on separate positions
of the same glove” (App. Br. 8; see also App. Br. 12 and 16). “The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 416 (2007). Each of Examiner’s
combinations of references suggest separately locating the collection means
and indicator means. A person of ordinary skill in this art would realize that
the separate locations could be on separate devices or on different locations
of the same device. As a matter of convenience and economy, as well as
limiting the number of articles coming into contact with bodily materials, a
person of ordinary skill in this art, at the time of Appellant’s invention,
would have realized that the detection means and collection means may be
placed on separate areas of a single examination glove. It is proper to “take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. See also id. at 421 (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”).
Claim 3:
Claim 3 depends from and further limits claim 1 by requiring the
“means for detecting pH are placed on [the] thumb finger and said second
means are placed on the index finger or medium finger” (Claim 3).
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For the reasons set forth above, we are not persuaded by Appellant’s
contentions (App. Br. 9-10, 13-14, and 16-18).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness.
The rejection of claims 1 and 3 under 35 U.S.C. § 103(a) as
unpatentable over the combination of De Simone, CAREPLAN®VPH,
Caillouette, and Bonstein is affirmed. Because they are not separately
argued claims 4-16 fall together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
The rejection of claims 1 and 3 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Anapliotis, Caillouette, and Bonstein
is affirmed. Because they are not separately argued claims 4-16 fall together
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
The rejection of claims 1 and 3 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Caillouette, and Bonstein is affirmed.
Because they are not separately argued claims 4-16 fall together with claim
1. 37 C.F.R. § 41.37(c)(1)(vii).
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

cdc