Appeal No. 2001-1173 Page 2
Application No. 08/614,593
assaying the number of the organisms forming the biofilm at
the plural biofilm adherent sites.
The references relied upon by the examiner are:
Woodson 5,462,644 Oct. 31, 1995
Miyake, “Simple Method for Measuring the Antibiotic Concentration Required to
Kill Adherent Bacteria,” Microbiology, Vol. 38, pp. 286-290 (1992)
Darouiche, “Vancomycin Penetration Into Biofilm Covering Infected Prostheses
and Effect on Bacteria,” J. Infect. Dis., Vol. 170, pp. 720-723 (1994)
Gjaltema, “Heterogeneity of Biofilms in Rotating Annular Reactors: Occurrence,
Structure, and Consequences,” Biotech. Bioeng., Vol. 44, No. 2, pp. 194-204
(1994)
GROUNDS OF REJECTION
Claims 1-14 and 20-32 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and distinctly
claim the subject matter which applicant regards as the invention.
Claims 1-14 and 20-32 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Miyake or Gjaltema in view of Darouiche and Woodson.
We reverse.
DISCUSSION
THE REJECTION UNDER 35 U.S.C. § 112, SECOND PARAGRAPH:
As set forth in Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d
1200, 1217, 18 USPQ2d 1016, 1030 (Fed. Cir. 1991):
The statute requires that “[t]he specification shall conclude with one or
more claims particularly pointing out and distinctly claiming the subject matter
which the applicant regards as his invention.” A decision as to whether a claim is
invalid under this provision requires a determination whether those skilled in the
art would understand what is claimed. See Shatterproof Glass Corp. v. Libbey-
Owens Ford Co., 758 F.2d 613, 624, 225 USPQ 634, 641 (Fed. Cir. 1985)
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