DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, 10, 12, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tout et al. (US 2010/0030116).
With respect to Claims 1 and 12, Tout teaches a drainage system for draining bodily fluid from a body cavity (Figures 1-4B), the drainage system comprising:
a fluid-receiving body having a fluid-receiving chamber 126 located therein that receives a bodily fluid through an inlet 124; and
an actuation body (156/256 and 168/268; Figures 1-2) connected to the fluid-receiving body (Figure 1), the actuation body comprising an actuation member 156/256 that is accessible from outside the actuation body and is manually movable relative to the actuation body along a dimension of the actuation body (Figures 4A-4B; paragraph [0041]), the actuation member operatively connected to a suction inducing member (146/246; Figures 1-2);
wherein manual actuation of the actuation member relative to the actuation body moves the suction inducing member (153/253, 264; Figures 1-2) thereby increasing a volume of a suction chamber (the interior of chamber 246) and reducing a pressure within the suction chamber (Figures 4A-4B; paragraph [0041]), the reduced pressure communicated through the inlet 124 of the fluid-receiving body (paragraph [0041]).
With specific regard to the method of claim 12, Tout teaches the steps of forming the actuation body (156/256, 168/268) and fluid-receiving body 126 (Figures 1 and 2), and movably connecting the actuation member 156/256 and suction inducing member (153/253, 264; Figures 1-2) to the actuation body (as shown in Figures 4A-4B; paragraph [0041]), wherein manual actuation of the actuation member relative to the actuation body moves the suction inducing member thereby increasing a volume of the suction chamber 246 and reducing a pressure within the suction chamber, the reduction in pressure being communicated through the inlet of the fluid-receiving body for removing bodily fluid from the body cavity (paragraph [0041]).
With respect to Claims 7 and 18, Tout teaches that movement of the suction-inducing member (153/253, 264; Figures 1-2) expands the volume of the suction chamber (the interior of chamber 246) without allowing air from the surroundings into the suction chamber such that pressure is reduced within the suction chamber (Figures 4A-4B; paragraph [0041]).
With respect to Claims 10 and 21, Tout further teaches a fluid-receiving container 246 comprising a bellows 245 that defines the suction chamber (Figures 1-2; paragraph [0033]). The suction-inducing member (153/253, 264; Figures 1-2) connects the actuation member 156/256 to the fluid-receiving container 246 such that movement of the actuation member 156/256 expands the bellows without allowing air into the suction chamber such that pressure is reduced within the suction chamber (Figures 1, 2, and 4A-4B; paragraph [0041]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tout.
With respect to Claims 2 and 13, Tout teaches that the fluid-receiving body and actuation body are part of the same outer container (system 100; Figure 1; paragraph [0020]). The examiner notes that no structural specifics of the outer container have been claimed. Accordingly, the entirety of the system as shown in Figure 1 has been interpreted as an outer container, as it contains the entirety of the system.
In the alternative, it has been held that the mere integration of separate parts does not constitute a patentable improvement in the art when said integration does not result in a non-obvious change in functionality (MPEP 2144.04.V.B.). In this case, it is unclear why forming Tout’s fluid-receiving body 126 as integrally attached to the rest of housing 140 would result in a non-obvious change in functionality. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to form Tout’s fluid-receiving body and actuation body (156/256, 168/268; Figures 1-2) as part of the same outer container, because it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art.
Allowable Subject Matter
Claims 3-6, 8, 9, 11, 14-17, and 19, 20, and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to Claims 3-6 and 14-17, Tout does not teach an additional fluid receiving container of fixed volume that is located within the fluid-receiving chamber of the fluid-receiving body. It is unclear why one of ordinary skill in the art would have been motivated to provide an additional fluid-receiving container within the chamber of fluid-receiving body 126.
With respect to Claims 8, 9, 19, and 20, Tout does not teach or suggest that the suction chamber is part of a passageway through the actuation body along which the suction inducing member travels, the suction inducing member comprising a seal that seals against an outer wall of the passageway as the suction inducing member moves along the passageway. It is unclear why one of ordinary skill in the art would have modified Tout’s suction inducing member to comprise a seal that seals against outer walls of a passageway of the suction chamber.
With respect to Claims 11 and 22, Tout teaches that the suction chamber comprises a fluid-receiving container having a bellows (Figures 1, 2, and 4A-4B), but does not teach or suggest that this chamber is disposed within the fluid-receiving chamber 126. It is unclear how one of ordinary skill could have modified Tout’s system to have the claimed arrangement without destroying the functionality of the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hu (US 11,027,050), Hudspeth (US 8,414,519), Fleischmann (US 6,174,306), and Langdon (US 5,386,735) teach fluid collection containers comprising a rigid outer container and a flexible internal bellows.
The examiner also directs Applicant to the references cited in the attached PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781