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 Objections
Claim 15 is objected to because of the following informalities: the preamble stating “The cord restraint of claim 10” should be replaced with -- The medical tubing restraint of claim 10 --. Appropriate correction is required.
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) 1-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paleschuck et al., US 2015/0089975 in view of Henning, US 2008/0097333.
Regarding claim 1, Paleschuck discloses a restraint [for an elongate flexible cord having a diameter], the restraint comprising: a body (10; soft or pliable) having a diameter (largest cross-sectional dimension of about 0.25 to 5 inches, [0024]; ball configuration), wherein the body (10) forms a channel (12) having a diameter that is substantially uniform in diameter (substantially constant largest cross-sectional dimension along its length, [0026]) [and that is adapted for circumferentially receiving the cord (18)], the channel (12) formed through the body (10); and wherein the body (10) has a longest dimension (of the sphere or ball configuration) and the channel (12) is co-extensive with the longest dimension of the body (channel 12 penetrates along a central axis, spanning the diameter of the spherical body); wherein the body (10) circumferentially engages the cord (18) in the channel (12) via surface friction (channel 12 sized to provide frictional contact with the cord, [0025]; no more than 1% to 20% larger than the cord, [0027]; gripping surfaces, [0028]) to restrict movement of the cord within the body (prohibiting substantial sliding of the object on the cord without user manipulation); and wherein the diameter of the body (10) is substantially greater than the diameter of the cord (18).
Paleschuck does not explicitly disclose a flexible foam body, or medical tubing received and circumferentially engaged in the channel.
Henning teaches a medical tubing restraint comprising a flexible foam body (polyethylene foam tube) in combination with medical tubing (including IV tubing, central lines, oxygen tubing, drains, epidural analgesia and more, [0001]) received within the flexible foam body (tubes placed in the circular spaces through the beveled slots, [0015]). Henning is relied upon only for the flexible foam material and the medical tubing; the frictional engagement restricting movement is disclosed by Paleschuck.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Palechuck’s body (10) to be a flexible foam body mounted on medical tubing, as taught by Henning, in order to identify and organize medical tubing at a patient’s bedside.
It is noted that the cord retaining structure of Paleschuck could also hold medical tubing because both are flexible elongated members requiring retention without permanent securement. Additionally, the foam material is known to grip cylindrical objects by elastic compression so applying such material for a cord holder would predictably improve retention and allow insertion through a slot.
Claim language set in brackets [] set forth above and below in this office action are considered by the examiner to be intended use that fails to further limit the structure of the claimed invention. Since the claimed invention is directed solely to that of the restraint, the prior art must only be capable of performing the functional recitations in order to be applicable, and in the instant case, the examiner maintains that the cord holder taught by the combination of Paleschuck and Henning, is indeed capable of the intended use statements. Note that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
Regarding claim 2, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. Paleschuck further discloses a slit (14) terminating in and communicating with the channel (12), wherein the channel (12) is ingressed and egressed through the slit (14) in the flexible foam body (10 when modified).
Regarding claim 3, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. Paleschuck further discloses wherein the channel (12) is formed through the center of the flexible foam body (10 when modified).
Regarding claim 4, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. The combination does not expressly teach wherein the flexible foam body is constructed of a material selected from the group consisting of ethylene-vinyl acetate (EVA) foam, polyethylene-vinyl acetate (PEVA), low-density polyethylene (LDPE) foam, first grade of polyethylene (PE), nitrile rubber (NBR) foam, the copolymers of acrylonitrile (ACN) and butadiene, polychloroprene foam or neoprene, polyimide foam, polypropylene (PP) foam, including expanded polypropylene (EPP) and polypropylene paper (PPP), polystyrene (PS) foam, including expanded polystyrene (EPS), extruded polystyrene foam (XPS) and sometimes polystyrene paper (PSP), styrofoam, including extruded polystyrene foam (XPS) and sometimes expanded polystyrene (EPS), polyurethane (PU) foam, viscoelastic polyurethane foam, or low-resilience polyurethane foam (LRPu), memory foam, sorbothane, polyvinyl chloride (PVC) foam, closed-cell PVC foamboard, microcellular foam, and combinations of the foregoing.
Henning further teaches wherein the flexible foam body is constructed of a material selected from the group consisting of … low-density polyethylene foam (LDPE), first grade of polyethylene (PE) … (cross-inked polyethylene foam, [0001]). Alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a foam material from the list as claimed, since it has been held to be within the general skill of a worker in the art to select a known (commercially available) material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 4. The combination does not expressly teach wherein the flexible foam body is constructed from polyurethane foam (PU). However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select polyurethane foam (PU) as the foam material, since it has been held to be within the general skill of a worker in the art to select a known (commercially available) material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 6, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. Paleschuck further discloses wherein the flexible foam body (10) is spherical (spheres and ball configurations, [0024]).
Regarding claim 7, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. Henning further teaches wherein: the flexible foam body has a color (any color); the medical tubing (including IV tubing, central lines, oxygen tubing, drains, epidural analgesia and more) supplies a source, function, substance or contents to be administered or removed (IV tubing, central lines, oxygen tubing, drains, epidural analgesia and more).
The combination does not expressly teach wherein the flexible foam body is coded by color to identify, restrain (via the foam body), separate (with different indicia), organize (by the ornamentation), categorize (by the ornamentation) or retrieve (via the body) the object(s) by source, function, substance or contents. Paleschuck further discloses wherein the flexible foam body (10) is coded by color (see paragraph [0005]) to identify (for identifying information), restrain (via the foam body), separate (with different indicia), organize (by the ornamentation), categorize (by the ornamentation) or retrieve (via the body) the object(s) by source, function, substance or contents. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to color-code the flexible foam body of the combination to identify, restrain, separate, organize, categorize or retrieve the medical tubing by source, function, substance or contents, in order to allow caregivers to distinguish the multiple lines serving a patient.
Regarding claim 8, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. Paleschuck further discloses wherein: the flexible foam body (10) has a shape (a geometric configuration, [0024]) and is coded by the shape (the three-dimensional configuration itself may serve as the identifying indicia, [0047]). Henning further teaches wherein the medical tubing supplies a source (IV, oxygen), function, substance or contents to be administered or removed ([0010]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to shape code the flexible foam body of the combination to identify, restrain, separate, organize, categorize or retrieve the medical tubing by source, function, substance or contents, in order to allow caregivers to distinguish the multiple lines serving a patient.
Regarding claim 9, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 1. The combination further teaches wherein the medical tubing restraint is a flotation device (buoyant cross-linked polyethylene foam body) for medical tubing (of Henning) [for waterproof devices].
Regarding claim 10, Paleschuck discloses a restraint [for an elongate flexible cord having a diameter], the restraint comprising: a body (10; soft or pliable) having a diameter (largest cross-sectional dimension of about 0.25 to 5 inches, [0024]; ball configuration), wherein the body (10) forms a channel (12) having a diameter that is substantially uniform in diameter (substantially constant largest cross-sectional dimension along its length, [0026]) [and that is adapted for circumferentially receiving the cord (18)]; wherein the body (10) has a longest dimension (diameter of the sphere or ball configuration) and the channel (12) is co-extensive with the longest dimension of the body (central axis) and restrains the cord (18) therein without looping the cord (cord passes straight through the channel, figures 1-3) to restrict movement of the cord within the body (prohibiting substantial sliding of the object on the cord, [0025], [0034]); and wherein the diameter of the body (10) is substantially greater than the diameter of the cord ([0024]).
Paleschuck does not explicitly disclose a flexible foam body, or medical tubing restrained in the channel. Henning teaches a flexible foam body (cross-linked polyethylene foam tube, [0001]) in combination with medical tubing ([0010]) received within the flexible foam body. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Paleschuck’s body (10) to be a flexible foam body mounted on medical tubing, as taught by Henning, in order to identify and organize medical tubing at a patient’s bedside while retaining the restraint’s position on the tubing through the frictional channel (bore 12) engagement (disclosed by Paleschuck).
It is noted that the cord retaining structure of Paleschuck could also hold medical tubing because both are flexible elongated members requiring retention without permanent securement. Additionally, the foam material is known to grip cylindrical objects by elastic compression so applying such material for a cord holder would predictably improve retention and allow insertion through a slot.
Regarding claim 11, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. Paleschuck further discloses a slit (14) terminating in and communicating with the channel (12), wherein the channel (12) is ingressed and egressed through the slit (14) in the flexible foam body (10 when modified).
Regarding claim 12, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. The combination does not expressly teach wherein the flexible foam body is constructed of a material selected from the group consisting of ethylene-vinyl acetate (EVA) foam, polyethylene-vinyl acetate (PEVA), low-density polyethylene (LDPE) foam, first grade of polyethylene (PE), nitrile rubber (NBR) foam, the copolymers of acrylonitrile (ACN) and butadiene, polychloroprene foam or neoprene, polyimide foam, polypropylene (PP) foam, including expanded polypropylene (EPP) and polypropylene paper (PPP), polystyrene (PS) foam, including expanded polystyrene (EPS), extruded polystyrene foam (XPS) and sometimes polystyrene paper (PSP), styrofoam, including extruded polystyrene foam (XPS) and sometimes expanded polystyrene (EPS), polyurethane (PU) foam, viscoelastic polyurethane foam, or low-resilience polyurethane foam (LRPu), memory foam, sorbothane, polyvinyl chloride (PVC) foam, closed-cell PVC foamboard, microcellular foam, and combinations of the foregoing.
Henning further teaches wherein the flexible foam body is constructed of a material selected from the group consisting of … low-density polyethylene foam (LDPE), first grade of polyethylene (PE) … (cross-inked polyethylene foam, [0001]). Alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a foam material from the list as claimed, since it has been held to be within the general skill of a worker in the art to select a known (commercially available) material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 13, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. Henning further teaches wherein: the flexible foam body has a color (any color); the medical tubing (including IV tubing, central lines, oxygen tubing, drains, epidural analgesia and more) supplies a source, function, substance or contents to be administered or removed (IV tubing, central lines, oxygen tubing, drains, epidural analgesia and more).
The combination does not expressly teach wherein the flexible foam body is coded by color to identify, restrain (via the foam body), separate (with different indicia), organize (by the ornamentation), categorize (by the ornamentation) or retrieve (via the body) the object(s) by source, function, substance or contents. Paleschuck further discloses wherein the flexible foam body (10) is coded by color (see paragraph [0005]) to identify (for identifying information), restrain (via the foam body), separate (with different indicia), organize (by the ornamentation), categorize (by the ornamentation) or retrieve (via the body) the object(s) by source, function, substance or contents. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to color-code the flexible foam body of the combination to identify, restrain, separate, organize, categorize or retrieve the medical tubing by source, function, substance or contents, in order to allow caregivers to distinguish the multiple lines serving a patient.
Regarding claim 14, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. Paleschuck further discloses wherein: the flexible foam body (10) has a shape (a geometric configuration, [0024]) and is coded by the shape (the three-dimensional configuration itself may serve as the identifying indicia, [0047]). Henning further teaches wherein the medical tubing supplies a source (IV, oxygen), function, substance or contents to be administered or removed ([0010]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to shape code the flexible foam body of the combination to identify, restrain, separate, organize, categorize or retrieve the medical tubing by source, function, substance or contents, in order to allow caregivers to distinguish the multiple lines serving a patient.
Regarding claim 15, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. The combination further teaches wherein the medical tubing restraint is a flotation device (buoyant cross-linked polyethylene foam body) for medical tubing (of Henning) [for waterproof devices].
Regarding claim 16, the combination of Paleschuck and Henning teaches the medical tubing restraint of claim 10. Paleschuck further discloses wherein the flexible foam body (10) is spherical (spheres and ball configurations, [0024]).
Concerning claims 17-34, given the structure of a tubing restraint and medical tubing, the structural elements of the combination of Paleschuck and Henning would render the claimed method steps obvious since such would be a logical manner of using the combination.
Regarding claim 17, Paleschuck discloses a method of restraining an elongated flexible member (18) having a diameter, the method comprising the steps of: providing a body (10) having a width and a longest dimension (sphere or ball configuration, [0024]), wherein the diameter of the body (10) is substantially greater than the diameter of the cord ([0024]); providing a channel (12) through the body (10) for circumferentially receiving the cord (18), wherein: the channel (12) has a diameter that is substantially uniform in diameter ([0026]); and the channel (12) is co-extensive with the longest dimension of the flexible foam body (10); and circumferentially engaging the cord (18) in the channel (12) via surface friction ([0025]-[0028]) to restrict the movement of the cord within the body (mounting the object so as to prevent undesired sliding or repositioning, [0034]). Paleschuck does not explicitly disclose a flexible foam body, or medical tubing circumferentially engaged in the channel. Henning teaches a flexible foam body (cross-linked polyethylene foam tube, [0001]) in combination with medical tubing ([0010]) received within the flexible foam body. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Paleschuck’s body (10) to be a flexible foam body mounted on medical tubing, as taught by Henning, in order to identify and organize medical tubing at a patient’s bedside while retaining the restraint’s position on the tubing through the frictional channel (bore 12) engagement (disclosed by Paleschuck).
Regarding claims 18, the combination of Paleschuck and Henning teaches the method of claim 17. Paleschuck further discloses the step of providing a slit (14) terminating in and communicating with the channel (12).
Regarding claims 19, the combination of Paleschuck and Henning teaches the method of claim 18. Paleschuck further discloses the step of ingressing and egressing the channel (12) through the slit (14) in the flexible foam body (10 when modified).
Regarding claims 20, the combination of Paleschuck and Henning teaches the method of claim 17. Paleschuck further discloses wherein the step of providing the channel (12) is formed through the center of the flexible foam body (central axis, [0029]).
Regarding claims 21, see the rejection of claim 4 above.
Regarding claims 22, the combination of Paleschuck and Henning teaches the method of claim 17. Paleschuck further discloses the step of securing the member in the body (secure positioning of objects on a cord), which in combination is the medical tubing secured in the flexible foam body.
Regarding claims 23, the combination of Paleschuck and Henning teaches a method of using the restraint of claim 10. The combination further teaches the step of using the flexible foam body (10 as modified) as a flotation device (when closed cell foam is selected as a material for the foam body) [in liquid (when placed in the liquid)].
Regarding claim 24, see the rejection of claim 7 above.
Regarding claim 25, see the rejection of claim 8 above.
Regarding claim 26, Paleschuck discloses a method of restraining an elongated flexible member (18) having a diameter, the method comprising the steps of: providing a body (10) having a diameter and a longest dimension ([0024], [0047]), wherein the diameter of the flexible body (10) is substantially greater than the diameter of the cord ([0024]); providing a channel (12) through the flexible body (10) for circumferentially receiving the cord (18), wherein: the channel (12) has a diameter that is substantially uniform in diameter ([0026]); and the channel (12) is co-extensive with the longest dimension of the flexible foam body (10); and circumferentially engaging the cord (18) in the channel (12) without looping the cord (figures 1-3) to restrict movement of the cord within the body ([0025], [0034]).
Paleschuck does not explicitly disclose a flexible foam body, or medical tubing circumferentially engaged in the channel.
Henning teaches a flexible foam body (cross-linked polyethylene foam tube, [0001]) in combination with medical tubing ([0010]) received within the flexible foam body. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Paleschuck’s body (10) to be a flexible foam body mounted on medical tubing, as taught by Henning, in order to identify and organize medical tubing at a patient’s bedside while retaining the restraint’s position on the tubing through the frictional channel (bore 12) engagement (disclosed by Paleschuck).
Regarding claims 27, the combination of Paleschuck and Henning teaches the method of claim 26. Paleschuck further discloses the step of providing a slit (14) terminating in and communicating with the channel (12).
Regarding claims 28, the combination of Paleschuck and Henning teaches the method of claim 27. Paleschuck further discloses the step of ingressing and egressing the channel (12) through the slit (14) in the flexible foam body (10 when modified).
Regarding claims 29, the combination of Paleschuck and Henning teaches the method of claim 26. Paleschuck further discloses wherein the step of providing the channel (12) is formed through the center of the flexible foam body (central axis, [0029]).
Regarding claims 30, see the rejection of claim 21 above.
Regarding claims 31, the combination of Paleschuck and Henning teaches the method of claim 26. Paleschuck further discloses the step of securing the member in the body (secure positioning of objects on a cord), which in combination is the medical tubing secured in the flexible foam body.
Regarding claims 32, the combination of Paleschuck and Henning teaches a method of using the restraint of claim 26. The combination further teaches the step of using the flexible foam body (10 as modified) as a flotation device (when closed cell foam is selected as a material for the foam body) [in liquid (when placed in the liquid)].
Regarding claim 33, see the rejection of claim 24 above.
Regarding claim 34, see the rejection of claim 25 above.
Response to Arguments
Applicant's arguments filed July 18, 2026 have been fully considered but they are not persuasive. Arguments directed to McMahon are moot, as McMahon is no longer relied upon in the current rejection. The remaining arguments are not persuasive for the reasons below.
With respect to the amended recitation that the flexible foam body circumferentially engages the medical tubing via surface friction “to restrict movement of the medical tubing within the flexible foam body,” Paleschuck discloses a through-bore sized to provide frictional contact with the received cord that prohibits substantial sliding of the object on the cord without user manipulation ([0025]), and that prevents undesired sliding or re-positioning ([0034]). This is a restriction of relative movement between the body and the elongated member received in its channel, as claimed.
With respect to the argument that Henning teaches away by permitting movement of the tubing, Henning is relied upon only for the flexible foam material and the medical tubing; the frictional restriction of movement is disclosed by Paleschuck. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With respect to the argument that Paleschuck is non-analogous, Paleschuck is directed to objects mounted on electrical and electronics cords, the same field as applicant’s disclosure, and addresses the same problem of retaining a body on an elongated flexible member without sliding.
With respect to the argument of hindsight, the motivation is drawn from the references themselves: Henning’s purpose of facilitating identification of medical lines and Paleschuck’s identifying and labeling of tubs and flexible tubing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.D./ Examiner, Art Unit 3677
/JASON W SAN/ SPE, Art Unit 3677
