Ex Parte Morgan

Board of Patent Appeals and Interferences

May 26, 2010

10364194 (B.P.A.I. May. 26, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ALLEN MORGAN
____________

Appeal 2009-013945
Application 10/364,194
Technology Center 1600
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Decided: May 26, 2010
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Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 6, 8, and 10-14,
the only claims pending in this application. We have jurisdiction under 35
U.S.C. § 6(b).

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STATEMENT OF THE CASE
The claims are directed to a method of sampling and analyzing a
semen sample without visiting a doctor’s office, utilizing a kit including an
insulated box containing an ice brick, a sample bottle, and a preservative
solution. Claim 1 is illustrative:
1. A method of sampling and analyzing a semen sample without
visiting a doctor's office, utilizing a kit including an insulated box containing
an ice brick, a sample bottle, and a preservative solution, comprising the
steps of:
a) ordering a kit by telephone or on the Internet;
b) receiving and placing the kit in a freezer until ready for use, and
removing the kit from the freezer prior to use;
c) thawing a preservative solution by placing said preservative
solution in warm water for 10 minutes to allow said preservative solution to
thaw and warm up to room temperature prior to adding said preservative
solution to the sample bottle;
d) producing a semen sample and placing [ ] the semen sample into
the sample bottle and adding said preservation solution to the sample bottle;
and producing the semen sample within 2 to 3 hours prior to a step of
shipping;
e) placing the semen sample into said sample bottle and adding said
preservation solution to said sample bottle includes the step of shaking the
semen sample and said preservation solution for 10 seconds to ensure
adequate mixing within the sample bottle;
f) placing the sample bottle into the kit next to the ice brick in the
insulated box;
g) shipping the kit and the sample bottle to a diagnostic laboratory for
analysis of the semen sample;
h) analyzing the semen sample on a semen analyzer at the diagnostic
laboratory; and
i) transmitting a confidential analysis report from the diagnostic
laboratory to the patient setting forth the analysis of the semen sample[.]

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The rejection presented by the Examiner follows:
Claims 1, 6, 8, and 10-14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Zavos1, Cryogenic Labs2, Wiesman3,
Brown4, and Welner5.
We affirm.

ISSUE

Does the evidence of record support the Examiner’s prima facie case
of obviousness?

ANALYSIS
Appellant provides separate arguments for each claim. Accordingly,
we take each in turn.

Claim 1:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejections for the reasons

1 PM Zavos, et al., Viability of human semen specimens cryostored and
transported at 5 C using the Bio-Tranz shipping system, 5(4) Prim Care
Update Ob Gyns, 170-171 (1998), Pub Med Id No.: 10838318.
2 Cryogenic Laboratories, http://cryolab.com/prio_male.html, accessed
October 24, 2001.
3 Wiesman US 5,983,661 Nov. 16, 1999
4 Brown US 5,770,363 Jun. 23, 1998
5 Welner et al. US 5,509,064 Apr. 16, 1996

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set forth in the Answer, which we incorporate herein by reference, and add
the following primarily for emphasis.
Step b) of the claimed method requires that the kit be received and
placed in a freezer until ready for use, and then removed from the freezer
prior to use.
The Examiner concedes that the combination of references relied
upon “do not teach placing the kit in a freezer until ready for use then
removing the kit from the freezer prior to use” (Ans. 6; see also App. Br. 11
(the prior art relied upon by the Examiner does “not teach the specific step
of receiving and placing the semen sample kit into a freezer until ready for
use”) (emphasis removed)). However, the Examiner finds, essentially by
taking Official Notice, that this step “would have been obvious to one of
ordinary skill in the art . . . because it was common practice to store
biological kits and reagents in this manner” (Ans. 6; Fin. Rej. 8). To support
this finding and Official Notice, the Examiner relies on Tocci6, Strauss7, and
Gelfand8 to teach the storage of a variety of reagents and kits in a freezer
(Id.). Appellant does not dispute the evidence relied upon by the Examiner.
Accordingly, we are compelled to agree with the Examiner’s conclusion that
it would have been prima facie obvious to a person of ordinary skill in this
art to store the kit in a freezer upon receipt and maintain it at this
temperature until it is used. It is proper to “take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
KSR, 550 U.S. at 418. See also id. at 421 (“A person of ordinary skill is also

6 Tocci US 3,715,295 Feb. 6, 1973
7 Strauss US 5,755,788 May 26, 1998
8 Gelfand US 5,418,149 May 23, 1995

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a person of ordinary creativity, not an automaton.”). The “suggestion test is
in actuality quite flexible and not only permits, but requires, consideration of
common knowledge and common sense.” DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006).
We recognize Appellant’s contention that since “the CRYOGENIC
reference specifically states ‘Do not subject the (semen) specimen to
extremes in temperature such as (in) a refrigerator or freezer.’ Cryogenic
would never employ STEP b) as claimed in the method of the present
invention” (App. Br. 11). However, as the Examiner explains,
[S]tep b of the claimed method is drawn to freezing the kit
prior to use. Thus, the kit does not contain the semen sample
when placed in the freezer according to the claimed invention
[(e.g., upon receipt)]. Cryogenic teaches avoiding freezing
temperatures relative to the collected semen sample, not the test
kit prior to use.

(Ans. 10.) We find no error in the Examiner’s reasoning.
Step c) of the claimed method requires the preservative solution to be
thawed in warm water for 10 minutes to allow it to thaw and warm up to
room temperature prior to adding it to the sample bottle. Appellant contends
that the combination of prior art relied upon by the Examiner does not “teach
the thawing of the preservative solution in warm water for 10 minutes”
(App. Br. 12 (emphasis removed)).
The Examiner finds, however, that Cryogenic Laboratories teaches
thawing the preservative solution to room temperature prior to use (id.). In
this regard, the Examiner concludes, essentially by taking Official Notice
that thawing a reagent in a water bath was known and commonly used by
those of ordinary skill in the art (Ans. 12; Fin. Rej. 7-8). To support this
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conclusion and Official Notice, the Examiner relies on Harms9 and Boyse10
to teach the use of warm water baths to thaw frozen solutions (id.; FF 17-
19). Appellant does not dispute the evidence relied upon by the Examiner.
Accordingly, we are compelled to agree with the Examiner’s conclusion that
it would have been prima facie obvious to a person of ordinary skill in this
art to thaw the preservative solution in warm water to allow the preservative
solution to thaw and warm up to room temperature prior to adding the
preservative solution to the sample bottle. It is proper to “take account of
the inferences and creative steps that a person of ordinary skill in the art
would employ.” KSR, 550 U.S. at 418 and 421; DyStar, 464 F.3d at 1367.
Harms teaches that a composition may take from one and one half
minutes to thirty minutes to thaw in a warm water bath depending on the
container used (Harms, col. 7, ll. 57-62). In addition, one of ordinary skill in
the art would realize that the temperature of the warm water bath will affect
the time it takes for a solution to thaw and warm up. Accordingly, we find
the recitation of a time period of 10 minutes, as it appears in claim 1, to be a
result effective variable that will depend on a number of factors including
the container used and the temperature of the water bath. As such, the
discovery of an optimum value (e.g., 10 minutes) for the amount of time the
preservation solution is warmed in a water bath would have been prima facie
obvious to a person of ordinary skill in this art at the time the invention was
made. In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (“[D]iscovery of an
optimum value of a result effective variable in a known process is ordinarily
within the skill of the art”).

9 Harms et al. US 5,364,385 Nov. 15, 1994
10 Boyse et al. US 5,004,681 Apr. 2, 1991
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Step e) of the claimed method requires that the sample bottle
containing the semen sample and preservation solution be shaken for 10
seconds to ensure adequate mixing within the sample bottle. Appellant
contends that “[t]he CRYOGENIC reference clearly states ‘DO NOT
SHAKE’ the semen sample and the transport media together” (App. Br. 13).
We are not persuaded.
The prior art and Appellant’s claimed invention require the mixing of
the preservation solution and the semen sample (Cf. Ans. 5 and 7, and Claim
1(e)). Step e) of Appellant’s claim requires the semen sample and
preservation solution to be shaken for 10 seconds. Appellant’s
Specification, however, informs a person of ordinary skill in the art that the
term “shaken” in this context means to ‘gently shake . . . to ensure adequate
mixing’ (Spec. 11: 11-14). While Cryogenic teaches one not to shake the
semen sample, it does teach one to “gently tip the bottle back and forth to
ensure complete mixing” (Ans. 12). Accordingly, we find no error in the
Examiner’s conclusion that Cryogenic’s mixing step reasonably suggests, if
not the same as, Appellant’s mixing step.
Step f) of the claimed method requires the sample bottle to be placed
into the kit next to the ice brick in the insulated box. Appellant contends
that “none of the five references specifically teaches the step of placing the
sample bottle with semen in a kit . . . next to an ice brick” (App. Br. 11). We
are not persuaded.
Appellant’s Specification discloses that the kit includes a
“rectangularly-shaped ice brick or pack . . . for keeping the semen sample . .
. within the semen sample collection bottle . . . at a cooled temperature in the
range of 40 ºF to 50 ºF when stored in the styrofoam box” (Spec. 8: 8-10).
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Zavos teaches that the specimen is cooled to 5 ºC (41 ºF) during transport
(Ans. 7 and 10). Weisman teaches that a refrigerant or cool pack can be
used to safely transport semen that has been mixed with a preservation
solution at a temperature of 5-10 ºC (Ans. 7 and 10).

Claim 6:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference. Appellant
has failed to provide persuasive evidence or argument to support a
conclusion that a diagnostic laboratory would not receive a sample within 18
hours if it is both received and processed within 24 hours.

Claim 8:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer.

Claim 10:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference.

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Claim 11:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference. We also
incorporate our discussion with regard to claim 1 herein by reference.

Claim 12:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference. We also
incorporate our discussion with regard to claims 1 and 6 herein by reference.

Claim 13:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference. We also
incorporate our discussion with regard to claim 1 herein by reference and
add the following primarily for emphasis. Appellant appears to contend that
Welner does not teach the receipt of a semen sample and that the mailing of
a sample “could take 2 to 3 days” before it reaches the diagnostic laboratory
(App. Br. 20). We are not persuaded. While Welner may refer to blood as
the biological sample, the Examiner relies on Welner to teach that the
transmission to a patient of a confidential report on a biological sample with
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associated counseling or referrals is known in the art (Ans. 11). With regard
to the timing, we find no time requirement in the method of claim 13.

Claim 14:
Upon consideration of the evidence on this record and each of
Appellant’s contentions, we find no error in the obviousness rejection on this
record. Accordingly, we sustain the Examiner’s rejection for the reasons set
forth in the Answer, which we incorporate herein by reference. We also
incorporate our discussion with regard to claims 1 and 13 herein by
reference.

CONCLUSION OF LAW
The evidence of record supports the Examiner’s prima facie case of
obviousness. The rejection of claims 1, 6, 8, and 10-14 under 35 U.S.C. §
103(a) as unpatentable over the combination of Zavos, Cryogenic Labs,
Wiesman, Brown, and Welner is affirmed.

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

alw

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