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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because:
Regarding Claim 1, the claim recites the judicial exception of an abstract idea, specifically a mathematical concept and mental process in the limitation “determining the infusion rate by measuring a time elapsed unit the fluid reaches the reference mark in the housing”. The additional elements in the claim are the “providing”, “receiving”, and “rotating” steps. These elements are extra-solution activity merely present to collect data for use in the mathematical concept and mental process. Furthermore, as a whole, the elements are not an improvement on the technology as they pertain to the generic use of a drip chamber and no limitation is recited which utilizes the result of the determination. The additional elements do not provide significantly more, as a whole or in combination, as they are well-understood, routine, and conventional. See at least GB 858731.
Regarding Claim 10, the claim recites the judicial exception of an abstract idea, specifically a mathematical concept and mental process in the limitation “determining the infusion rate by measuring a time elapsed until the fluid fills the flow collector”. The additional elements in the claim are the “providing” and “receiving” steps. These elements are extra-solution activity merely present to collect data for use in the mathematical concept and mental process. Furthermore, as a whole, the elements are not an improvement on the technology as they pertain to the generic use of a drip chamber and no limitation is recited which utilizes the result of the determination. The additional elements do not provide significantly more, as a whole or in combination, as they are well-understood, routine, and conventional. See at least GB 858731.
Claims 2 – 5, 7 – 9, 11 – 13, and 15 – 20 all recite additional elements which are not an improvement on the technology as they pertain to the generic use of a drip chamber and do not provide significantly more, as a whole or in combination, as they are well-understood, routine, and conventional. See at least GB 858731.
Claims 6 and 14 further limit the mathematical concept and mental process.
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.
Claim(s) 1 - 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leonard (GB 858731).
Regarding Claim 1, Leonard discloses a method for calculating an infusion rate in a drip chamber, the method comprising: providing a housing (20) receiving a fluid (Figure 1) (Page 2, lines 72 – 75), the housing configured to receive the fluid at a distal end (via 22) and expel the fluid at a proximal end (via 26), the housing comprising a reference mark (28) (Page 2, lines 63 – 71); receiving, at the proximal end of the housing, a flow controller (53) rotatably coupled to the housing (Figure 1), the flow controller comprising an aperture extending therethrough (aperture in which 29 lies) (Figure 1); rotating the flow controller relative to the housing such that the aperture prevents the fluid from traveling therethrough (53 inherently rotates with respect to the housing to close e.g. when legs of the clamp come closer together) (Page 2, lines 113 – 115) (Figure 1); and determining the infusion rate by measuring a time elapsed until the fluid reaches the reference mark in the housing (Page 4, lines 112 – 125).
Regarding Claim 2, Leonard discloses the flow controller (Leonard teaches the flow controller being a plug valve) (Page 2, lines 113 – 122) comprises an inner member (the body inherently present in the plug valve) and an outer member (the plug inherently present in a plug valve), the inner member being fixed relative to the housing (the body inherently being fixed via 29) and the outer member being rotatable relative to the inner member (inherently how a plug valve opens and closes).
Regarding Claim 3, Leonard discloses the outer member and the inner member each comprise an aperture extending therethrough (inherently in a plug valve to provide a flow path when opened).
Regarding Claim 4, Leonard discloses rotating the outer member relative to the inner member such that the apertures do not align prevents the fluid from traveling through the flow controller (inherently how a plug valve functions).
Regarding Claim 5, Leonard discloses a volume of the housing at the reference mark is known (Page 2, lines 63 – 71).
Regarding Claim 6, Leonard discloses determining the infusion rate comprises: dividing the volume by the time elapsed until the fluid reaches the reference mark (Page 4, lines 112 – 125).
Regarding Claim 7, Leonard discloses the housing comprises more than one reference mark (Figure 1).
Regarding Claim 8, Leonard discloses receiving, at a proximal end of the flow controller, a tubing (29) configured to receive the fluid (Figure 1).
Regarding Claim 9, Leonard discloses the flow controller comprises more than one aperture (at least at the top and bottom) (Figure 1).
Regarding Claim 10, Leonard discloses a method for calculating an infusion rate in a drip chamber, the method comprising: providing a housing (20) receiving a fluid (Figure 1) (Page 2, lines 72 – 75), the housing configured to receive the fluid at a distal end (via 22) and expel the fluid at a proximal end (via 35) (Page 3, lines 113 – 121); receiving, in the housing, a flow collector (Figure 6); and determining the infusion rate by measuring a time elapsed until the fluid fills the flow collector (Page 4, lines 112 – 125).
Regarding Claim 11, Leonard discloses the flow collector comprises a septum at a proximal end thereof (38, 43).
Regarding Claim 12, Leonard discloses a radial force acting upon the flow collector opens the septum thereby establishing a fluid pathway therethrough (Page 5, lines 13 – 25).
Regarding Claim 13, Leonard discloses volume of the flow collector is known (Page 4, lines 50 – 55).
Regarding Claim 14, Leonard discloses determining the infusion rate comprises: dividing the volume by the time elapsed until the fluid fills the flow collector (Page 4, lines 112 – 125).
Regarding Claim 15, Leonard discloses the flow collector has a diameter smaller than a diameter of the housing (as the flow collector is in the housing, its diameter is inherently smaller than that of the housing) (Page 4, lines 47 – 50).
Regarding Claim 16, Leonard discloses receiving, at a proximal end of the housing, a tubing configured to receive the fluid (inherently present as the fluid is intended to continue flowing) (Page 1, lines 58 – 63).
Regarding Claim 17, Leonard discloses the flow collector is coupled to the housing by at least one arm (40).
Regarding Claim 18, Leonard discloses the flow collector is received at a center of the housing (Figure 4).
Regarding Claim 19, Leonard discloses the flow collector is fixed relative to the housing (inherent for the device to function) (Figure 4).
Regarding Claim 20, Leonard discloses the flow collector allows for continuous use of the drip chamber when filled with the fluid (Page 4, line 112 - Page 5, line 5).
Conclusion
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ALEXANDER A. MERCADO
Primary Examiner
Art Unit 2855
/ALEXANDER A MERCADO/ Primary Examiner, Art Unit 2855