DETAILED ACTION
This is a non-final rejection in response to application filed 1/12/24. Claims 16-30 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "substantially punctiform". It is unclear how the contact point can be substantially point-like. Furthermore, claim 16 recites the limitations "inner portion” and "middle section” but is not clear on a reference point. All subsequent dependent claims are further rejected.
Claim 22 recites the limitation "generally larger” and generally “smaller". These are relative terms and it is unclear what is implied.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (US 7810784) in view of D’Alessio et al. (US 5259587).
Regarding independent claim 16, Abe teaches an infusion set comprising: a tube T; and a roller clamp 10, the roller clamp configured to regulate a flow of fluid through the tube (col. 1, l. 44-62), the roller clamp comprising a housing (11,12,13 combined) and a wheel 20, the housing being U-shaped or C-shaped in cross-section and comprising side walls 12,13 and a crosspiece 11 that connects the side walls (see fig. 5), the tube resting on the crosspiece (col. 2, l.31-67), the side walls comprising running surfaces in or on the side walls, the running surfaces 14,15 facing the crosspiece, each running surface comprising a length and a width, the widths of the running surfaces extending in a transverse direction of the housing and the lengths of the running surfaces extending in a longitudinal direction of the housing, the wheel comprising a wheel axle 22 extending along an axis of rotation of the wheel, the wheel being supported on the running surfaces so as to be rotatable and displaceable in the longitudinal direction of the housing, the wheel and the tube arranged such that a movement of the wheel along the running surfaces alters a cross-section of the tube (col. 3, l.53-col.4, l.16).
Abe teaches the bottom part 11 being flat and has a slope, such that the distance between the grooves and bottom part changes (col. 3, l.1-42). However, Abe is silent to the running surfaces being inclined with respect to the axis of rotation of the wheel, the running surfaces and the wheel axle forming a support or contact point that is substantially punctiform, the support or contact point being positioned on an inner portion of the wheel axle, and the inner portion of the wheel axle facing a middle section of the wheel when viewed in a width direction.
D’Alessio teaches the running surfaces being inclined with respect to the axis of rotation of the wheel, the running surfaces and the wheel axle forming a support or contact point that is substantially punctiform, the support or contact point being positioned on an inner portion of the wheel axle, and the inner portion of the wheel axle facing a middle section of the wheel when viewed in a width direction (col. 1, l.15 - col. 2, l. 10).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Abe with the running surfaces of D’Alessio, D’Alessio teaches inclined running surfaces which would result in punctiform contact, as D’Alessio teaches using specific geometric shapes improves pressure distribution and eliminates voids (col. 2, l. 5-10).
Regarding dependent claim 17, Abe in view of D’Alessio teaches the invention as claimed and discussed above. D’Alessio further teaches wherein the wheel axle is formed conically and wherein the support or contact point is formed in an inner portion of the running surface (col. 2, l. 40-50).
Regarding dependent claim 18, Abe in view of D’Alessio teaches the invention as claimed and discussed above. D’Alessio further teaches wherein the wheel axle is hollow (col. 2, l. 33-39).
Regarding dependent claim 19, Abe in view of D’Alessio teaches the invention as claimed and discussed above. D’Alessio further teaches wherein the wheel comprises trunnions 24 extending to both sides of the wheel, wherein the wheel axle comprises a bore extending along the axis of rotation of the wheel, and wherein the bore is provided at least in one of the trunnions.
Regarding dependent claim 20, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the support or contact point is formed on a maximally innermost portion of the running surfaces, when viewed in the width direction (col. 3, l. 53-col.4, l.16).
Regarding dependent claim 21, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the crosspiece comprises a motion link, wherein the motion link becomes narrower and/or flatter in the longitudinal direction of the housing, wherein the wheel presses the tube into the motion link during longitudinal movement of the wheel, wherein pressing of the wheel onto the tube increases during longitudinal movement of the wheel and a cross-sectional area of the tube decreases (col. 2, l. 31-67).
Regarding dependent claim 22, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the motion link comprises a longitudinal section of a generally smaller tube 11a pressing and a longitudinal section of a generally larger tube pressing 11b, and wherein the longitudinal section of the generally larger tube pressing is longer than the longitudinal section of the generally smaller tube pressing (see fig. 1).
Regarding dependent claim 23, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein a width of the longitudinal section of the generally smaller tube pressing motion link of the smallest tube pressing is larger than a width of the section of the largest tube pressing (col. 3, l. 53-col.4, l.16).
Regarding dependent claim 24, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the crosspiece comprises an edge 18b,18c, wherein the housing comprises a through-opening 18, wherein the through-opening comprises an edge portion facing the crosspiece 11c, and wherein the tube abuts both on the edge portion of the through-opening and the edge of the crosspiece when the roller clamp is locked on the tube by means of the wheel.
Regarding dependent claim 25, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the edge is defined by a step formed in the crosspiece and wherein the step extends in the transverse direction of the housing (col. 2, l. 44-54).
Regarding dependent claim 26, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the diameter of the through-opening of the clamp housing corresponds substantially to the diameter of the tube (col. 3, l. 43-52).
Regarding dependent claim 27, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the wheel is displaceable in the longitudinal direction over a pre-defined displacement path and wherein the edge is positioned in a central portion of the displacement path (col. 3, l. 43-67).
Regarding dependent claim 28, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the clamp housing comprises an asymmetrical tube holder (col. 2, l. 31-43).
Regarding dependent claim 29, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the clamp housing comprises a rib 18b,18c inside the clamp housing configured to clamp a spike of the tube.
Regarding dependent claim 30, Abe in view of D’Alessio teaches the invention as claimed and discussed above. Abe further teaches wherein the side wall comprises a wheel lifting motion link, wherein the crosspiece forms a tube bearing surface on which the tube rests, and wherein the wheel lifting motion link enables the wheel to lift off the tube bearing surface (the geometry of a sharp declination 11c leading to a lower, wider 11b allows for lift off).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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