DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 11-17 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (Species B), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025. Claim 20, having been previously proposed to be generic in the requirement for restriction of 10/09/2025, has been, upon further consideration, recognized to correspond to nonelected species B, and is therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). The examiner apologizes for the confusion and any inconvenience.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jedweb (U.S. Pat. Pub. No. 2011/0098661 A1).
Regarding claim 1, Jedweb discloses a universal flow limiter assembly (Fig. 1-2) comprising: a body (assembly of side beams 11 and 12, joined together at hinge 13) configured to receive a portion of an intravenous (IV) tube (see Fig. 1-2, [0001-0008], and [0024], wherein the assembly is intended to receive and selectively compress a flexible tube 17 for controlling the transport liquids into a patient’s body), the body comprising: two opposing side beams (11, 12); a hinge portion (13) disposed at a first end of the body (see Fig. 1-2, [0025], and [0030]); a control portion (the expanded portions of the side beams 11 and 12 into which the grub screw 14 is driven) disposed at a second end of the body (see Fig. 1-2 and [0030]); a groove defined between the side beams and disposed between the hinge portion and the control portion (see Fig. 1-2, [0025-0026], and [0030-0032], wherein a gap of adjustable width extends between side beams 11 and 12 and between the hinge portion 13 and the control portion, into which the tube 17 is placed); and a control knob (assembly of the grub screw 14 and adjustment dial 15), wherein the universal flow limiter assembly is configured to regulate a flow rate of fluid flowing through the IV tube (see Fig. 1-2, [0009-0012] and [0030-0032]).
Regarding claim 4, Jedweb further discloses that the control portion comprises a C-shaped control portion defined by mirrored ends of the opposing side beams (see Fig. 2, wherein the mirrored ends of the side beams 11 and 12 at the second end of the body, i.e. the end opposite to the hinge end, are extended outward with respect to the remainder of the respective side beams to form a larger cavity for accommodating the control knob, each thereby forming half of an overall C-shaped control portion, wherein the “C” formed by these halves faces in the outward direction from the remainder of the body of the flow limiter assembly), and wherein a control receptacle (the cavity for accommodating the control knob) is disposed within the C-shaped control portion (see Fig. 2).
Regarding claim 8, Jedweb further discloses that the second end of the body comprises a tube opening disposed between two end portions of the C-shaped control portion, wherein the tube opening is configured to slidably receive a portion of the IV tube (see Fig. 2, wherein the mirrored ends of the side beams 11 and 12 at the second end of the body, i.e. the end opposite to the hinge end, are separated to thereby form a large cavity and opening between them for accommodating the control knob, and prior to installation of the control knob, receiving the IV/feed tube, which may be passed between the ends of the side beams 11 and 12 within the control portion and disposed in the gap between side beams 11 and 12, as shown in Fig. 2).
Claim(s) 1-3 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen (U.S. Pat. No. 4,620,690).
Regarding claim 1, Kamen discloses a universal flow limiter assembly (Fig. 1-6B) comprising: a body (fork 19) configured to receive a portion of an intravenous (IV) tube (21) (see Fig. 1-6B and Col. 1, ln 9-29, wherein the flow limiter is configured to control the rate of flow through a flexible tube, such as an IV tube, by clamping down on the exterior surface of the tube), the body comprising: two opposing side beams (arms 15 of the fork); a hinge portion (end at which arms 15 are joined) disposed at a first end of the body (see Fig. 5 and Col. 3, ln 1 – Col. 4, ln 7); a control portion (threaded portions of arms 15, which are threaded with a threading 18 for engaging with the adjusting nut 16) disposed at a second end of the body (see Fig. 5 and Col. 3, ln 1 – Col. 4, ln 7); a groove defined between the side beams and disposed between the hinge portion and the control portion (see Fig. 3A-6B, wherein a groove or gap extends along the center of the body from the hinge portion to the tips of the arms 15, thereby separating the arms); and a control knob (adjusting nut 16), wherein the universal flow limiter assembly is configured to regulate a flow rate of fluid flowing through the IV tube (see Fig. 1-6B, Col. 1, ln 58 – Col. 2, ln 10, and Col. 3, ln 27 – Col. 4, ln 7).
Regarding claim 2, Kamen further discloses that the hinge portion is a U- shaped joining of the opposing side beams (see Fig. 3A).
Regarding claim 3, Kamen further discloses that the hinge portion comprises a hinge axis defined by an opening (61) in the hinge portion (see Fig. 3A and Col. 3, ln 51-61), and wherein the hinge portion is configured to provide a biasing force on the opposing side beams towards each other (it is well understood that any hinge formed as an integral U-shape comprises a nominal or “at rest” angle of deflection, and such a hinge provides a biasing force opposing any deflection which expands or contracts the hinge away from its nominal angle of deflection, thus the hinge of Kamen is configured to (capable of) providing a biasing force which would act on the opposing side beams to bring them towards each other if the hinge portion were expanded beyond its nominal or “at rest” angel of deflection, such as may occur if a tube of large diameter where inserted into the groove between the side beam/arms 15).
Regarding claim 9, Kamen further discloses that the groove comprises a plurality of tubing clamp slots (61 and 62) (see Fig. 3-6B and Col. 3, ln 51 – Col. 4, ln 7; here, hole 62 is clearly intended to perform the function of a tubing clamp slot for holding the tube in place during clamping, and while hole 61 is not explicitly described or depicted as performing this function, it is clearly capable of doing so, since it is clear that a tube may also be received and retained within this hole during clamping, albeit perhaps one of smaller diameter that the tube accommodated within hole 62).
Regarding claim 10, Kamen further discloses that each of the plurality of tubing clamp slots defines a different groove width (see Fig. 3A-6B and Col. 3, ln 51 – Col. 4, ln 7, wherein it is clear that the hole 62 is larger in diameter than hole 61, thereby providing a different groove width that is experienced at hole 61), and wherein a first tubing clamp slot (hole 62) with a widest groove width is disposed adjacent the control portion (see Fig. 3A-6B, wherein the wider hole 62 is positioned adjacent to the beginning of the threaded portions of arms 15 – the control portion of the body) and a second tubing clamp slot (hole 61) with a narrowest groove width is disposed adjacent the hinge portion (see Fig. 3A-6B and Col. 3, ln 51 – Col. 4, ln 7, wherein the narrower hole 61 is directly adjacent to the hinge portion where the arms 15 are joined).
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.
Claim(s) 2-3 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jedweb in view of Greenspan (GB2079410A).
Regarding claim 2, Jedweb exhibits the universal flow limiter assembly of claim 1 (see in re claim 1). Jedweb fails to teach that the hinge portion is a U- shaped joining of the opposing side beams (rather, it is depicted as a sharp, angular bend – see Fig. 2). Yet, it is well known within the art that such a hinge may be formed as a U- shaped joining of the opposing side beams in order to accomplish the same tube-clamping effect.
For example, Greenspan exhibits a universal flow limiter assembly similar to that of Jedweb (see Fig. 2), comprising a body (clamp 10) to receive an IV tube (see Fig. 1-2 and pg. 2, ln 49-56), comprising a U-shaped hinge portion joining opposing side beams (“jaws” of the clamp), a control portion (the ends of the side beams, which are coupled to control bolt/nut 12/14), and a groove (gap) between the side beams and disposed between the hinge portion and control portion (see Fig. 1-2 and pg. 2, ln 49-56). Greenspan teaches that such a U-shaped hinge portion may operate in cooperation with a control means (bolt/nut 12/14) compress or expand an IV tube received within the groove in order to thereby regulate a flow rate of fluid flowing through an IV tube in the same manner as the hinge of Jedweb (see Fig. 2, pg. 1, ln 40-54, and pg. 2, ln 49-56).
Based on the teachings and example of Greenspan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hinge configuration of Jedweb to be formed as a U- shaped joining of the opposing side beams in the manner of Greenspan, rather than as a sharp angular bend, as a simple substitution of one known hinge configuration (that of Greenspan) for another (that of Jedweb) in order to obtain a predictable result (the same tube-clamping effect). See MPEP 2143(i)(B).
Regarding claim 3, Jedweb as modified by Greenspan further exhibits (by virtue of the above modification, in which the hinge configuration of Jedweb may be formed in the U-shaped manner of Greenspan) that the hinge portion comprises a hinge axis defined by an opening in the hinge portion (see Greenspan, Fig. 2, wherein the hinge axis is defined by a larger opening/gap between the joined ends of the side beams 11 and 12 at the hinge portion than exists within the remainder of the gap between the side beams 11 and 12, and the hinge axis is perpendicular to the extension direction of the side beams, and parallel to the extension direction of the tube), and wherein the hinge portion is configured to provide a biasing force on the opposing side beams towards each other (see above modification, wherein it is well understood that any hinge formed as an integral U-shape of the kind taught by Greenspan comprises a nominal or “at rest” angle of deflection, and such a hinge provides a biasing force opposing any deflection which expands or contracts the hinge away from its nominal angle of deflection, thus the hinge of Greenspan, and of Jedweb as modified by Greenspan, is configured to (capable of) providing a biasing force which would act on the opposing side beams to bring them towards each other if the hinge portion were expanded beyond its nominal or “at rest” angel of deflection, such as may be necessary when the control knob (assembly of grub screw 14 and adjustment dial 15) is installed between the side beams 11 and 12).
Regarding claim 18, Jedweb may be modified by Greenspan (according to claims 2-3), whereupon the proposed combination exhibits a universal flow limiter assembly coupled to a tube (see in re claim 1), the universal flow limiter assembly comprising: a body configured to receive a portion of an intravenous (IV) tube (see in re claim 1), the body comprising: two opposing side beams (see in re claim 1); a hinge portion disposed at a first end of the body, the hinge portion configured to provide a biasing force on the opposing side beams towards each other (see in re claim 1 and claim 3); a control portion disposed at a second end of the body (see in re claim 1); a groove defined between the side beams and disposed between the hinge portion and the control portion (see in re claim 1); and a control knob comprising: a control body configured to couple with the control portion (see in re claim 1, and see Fig. 2, [0026], and [0030], wherein assembly of the configuration of Fig. 2 requires that the grub screw 14 portion of the control knob must be threaded into the apertures within the side beams 11 and 12 such that the control knob is coupled to the side beams and within the control receptacle of the control portion of the universal flow limiter assembly); a manual interface (adjustment dial 15) disposed on a first portion (the center) of the control body, the manual interface configured to be manipulated by hand to rotate the control knob (see Fig. 1-2 and [0030-0032], wherein it is visually apparent from Fig. 1 that the “adjustment means 15” of Jedweb is embodied as a dial, and it is clear from the text that this dial is intended for being rotatable by the user for rotating the entire control knob, and thereby expanding or contracting the gap between the side beams 11 and 12); and a machine interface disposed on a second portion of the control body, the machine interface configured to be manipulated by a motor to rotate the control knob (see Fig. 2, wherein it is visually apparent that the grub screw 14 comprises a slot at its lower end for interfacing with a turning bit, such as a flathead bit, which may be driven by a motor in order to thereby rotate the entire control knob), wherein the universal flow limiter assembly is configured to regulate a flow rate of fluid flowing through the IV tube (see in re claim 1).
Jedweb does not teach explicitly teach that the tube is an IV tube, however, based upon the teachings of Jedweb in [0001-0008] and the example of Greenspan, which teaches a similar universal flow limiter configuration (see above discussion in re Greenspan) which may be useful for regulating flow through an IV tube (Greenspan, pg. 1, ln 40-54), it would have been obvious to one of ordinary skill in the art to use the universal flow limiter assembly of Jedweb for regulating flow through an IV tube. It follows then also that it would have been obvious to one of ordinary skill in the art to provide the universal flow limiter assembly of Jedweb as part of an intravenous (IV) set comprising: an IV tube; an infusion component coupled to the IV tube (a well known essential component of an IV set); and the universal flow limiter assembly.
Regarding claim 19, Jedweb discloses a method of operating a universal flow limiter assembly according to claim 1, the method comprising: sliding the IV tube into a tubing clamp slot (portion of the gap between side beams 11 and 12 which receives the tube, delimited from the remainder of the groove by guides 16 – see Fig. 2 and [0030], ln 12-13) of the groove having a smallest width that the IV tube fits into without compression of a fluid flow path within the IV tube (see Fig. 2, wherein in the state in which the side beams have not been deflected towards each other, the tube is initially placed at a location within the gap wherein the tube is in contact with both side beams 11 and 12, but is undeformed from its nominal circular cross-section, and see [0031], ln 1-2, wherein Jedweb describes that the flow limiter assembly is assembled around the tube, thus in order to arrive at the configuration of Fig. 2, wherein the tube is positioned within the tubing clamp slot portion of the groove, as described above, the tube must first be slid into the tubing clamp slot); coupling the control knob of the universal flow limiter assembly within a control receptacle of the control portion of the universal flow limiter assembly (see discussion in reclaim 5, and see Fig. 2, [0026], and [0030], wherein assembly of the configuration of Fig. 2 requires that the grub screw 14 portion of the control knob must be threaded into the apertures within the side beams 11 and 12 such that the control knob is coupled to the side beams and within the control receptacle of the control portion of the universal flow limiter assembly); rotating the control knob by manual rotation by hand ([0031]); and adjusting, by rotation of the knob, a deflection between the side beams due to a biasing force of the hinge portion to one of expand and compress the tube to set a fluid flow rate through the tube to a determined rate ([0009-00012] and [0031-0032]).
Jedweb does not teach explicitly teach that the tube is an IV tube, however, based upon the teachings of Jedweb in [0001-0008] and the example of Greenspan, which teaches a similar universal flow limiter configuration (see above discussion in re Greenspan) which may be useful for regulating flow through an IV tube (Greenspan, pg. 1, ln 40-54), it would have been obvious to one of ordinary skill in the art to use the universal flow limiter assembly of Jedweb for regulating flow through an IV tube. Further, while Jedweb does not explicitly teach the step of inserting a tube laterally into a tube opening in the control portion at the second end of the body of the universal flow limiter assembly, Jedweb teaches that the flow limiter assembly is assembled around the tube ([0031], ln 1-2). Such may only happen in one of two possible ways; either the tube may be inserted laterally into a tube opening in the control portion at the second end of the body of the universal flow limiter assembly prior to installation of the control knob, as discussed in re claim 8, or the tube must be threaded between the side beams 11 and 12 by inserting the tube through an opening (the gap between side beams 11 and 12) in the hinge portion of the universal flow limiter assembly, such likely being undertaken only after installation of the control knob. Because only two straightforward options exist for installing the tube within the universal flow limiter assembly, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to install the tube within the universal flow limiter assembly of Jedweb by inserting the tube laterally into a tube opening in the control portion at the second end of the body of the universal flow limiter assembly in the manner described above in re claim 8, as a matter of obvious design selection from among a finite number of straightforward and predictable solutions, with a reasonable expectation of success. See MPEP 2143(I)(E).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jedweb in view of Koland (U.S. Pat. No. 3,497,175).
Regarding claim 5, Jedweb further discloses that the control knob comprises: a control body (grub screw 14) configured to be disposed within the control receptacle (see Fig. 2, wherein at least a portion of the grub screw 14 extends throughout the length of the cavity for accommodating the control knob, and is thus disposed within the control receptacle); a manual interface (adjustment dial 15) disposed on the control body, the manual interface configured to be manipulated by hand to rotate the control knob (see Fig. 1-2 and [0030-0032], wherein it is visually apparent from Fig. 1 that the “adjustment means 15” of Jedweb is embodied as a dial, and it is clear from the text that this dial is intended for being rotatable by the user for rotating the entire control knob, and thereby expanding or contracting the gap between the side beams 11 and 12); and a machine interface disposed on a second end of the control body, the machine interface configured to be manipulated by a motor to rotate the control knob (see Fig. 2, wherein it is visually apparent that the grub screw 14 comprises a slot at its lower end for interfacing with a turning bit, such as a flathead bit, which may be driven by a motor in order to thereby rotate the entire control knob).
Jedweb fails to teach that the manual interface is disposed on a first end of the control body, however, it is well known within the art that such a dial may be positioned at an end of a screw, rather than in the middle thereof, in order to achieve the same effect of providing a means of turning the screw. For example, Koland exhibits a flow limiting device configured to regulate flow through a flexible tube in a similar manner to that of Jedweb – by use of a screw (57) which is turned by a dial (54), thereby imparting a force to contract or expand the gap between two plates (closure member 62 and wall 53) in order to compress or release a flexible tube disposed therein (see Fig. 7-8 and Col. 6, ln 9-34). Koland teaches that such a dial may be provided at the end of such a screw and externally to the gap between the plates, thereby allowing easy access to the user and also allowing for a scale of indications (56) to be provided on the outer surface of the plate into which the screw is provided, such as may assist the user in turning the screw to an appropriate setting (see Fig. 7-8 and Col. 6, ln 9-34). Based on such an example, and for the same reasons, it would have been obvious for one of ordinary skill in the art prior to the filing date of the claimed invention to modify the flow limiter assembly of Jedweb by providing a manual interface, such as the adjustment dial 15, on a first end of the control body.
Allowable Subject Matter
Claim(s) 6-7 is/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:
The prior art cited in this office action and any prior office actions represents the closest art to the claimed invention as found by the examiner. Regarding the above cited claims, none of these references teach or suggest the claimed invention as a whole, and it would not have been obvious to one of ordinary skill in the art at the time of filing to combine teachings from these references to obtain the claimed invention. In support of this finding, a comparison of the present claim limitations to the closest prior art is presented below.
Regarding claim 6, the entirety of the claim alongside intervening claims 1 and 4-5 renders the claim patentably distinct over the prior art. The combination of the structures of claim 1, the C-shaped control portion of claim 4, the control knob configuration of claim 5, and the stop member / stop surface configuration of claim 6 appears to be unanticipated within the art. While control knobs comprising a stop member and interacting with stop surfaces are known within the art, the manner in which the claimed control knob and first/second side beams are configured is not known within the prior art, and it would not have been obvious to modify any reference known to the examiner, including Jedweb, Greenspan, or Kamen, to exhibit such a configuration. Since these references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation(s), it is thus concluded that this limitation(s), in combination with the remainder of the claim and any intervening claims, is/are patentably distinct over prior art. Any claims that are dependent upon this claim are also considered to be patentably distinct over prior art by virtue at least of the subject matter of this claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3745
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783