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 .
Response to Arguments
This Office Action is in response to the Amendment filed 01/17/2025. As directed by the amendment, Claim 49 is amended, Claims 146, and 158-160 are cancelled. Claims 49, 136, 137, 139, 144, and 147-157 are pending in the application.
Regarding the Office Action filed 09/05/2024:
Objections to the claims have been resolved.
Applicant’s arguments filed 07/31/2025 have been fully considered but they are not persuasive. Examiner agrees that Kutnyak and Mallinson do not teach the amended limitation of claim 49. However, Examiner does not agree that Kaye, which was used to reject part of the amended limitation in a now cancelled claim, does not teach the amended limitation of claim 49. Figures 1-4 of Kaye clearly depicts the first and second cuff 3a, 3b overmolded and overlapping over an end tube body while being aligned with the helical rib. Even with the recess 10, the cuffs of Kaye still teach the limitations of the claim. Applicant also argues there would be an issue with amending Kutnyak and Kaye in claim 155, stating a liner would be penetrated with the modified wires being positioned at the flat wall. Without conceding this being an issue, Examiner notes that figures 2-3 of Kutnyak which are relied upon for the rejection have no such mention of the inner plastic liner so this could not possibly be an issue. The liner is only mentioned for the prior art embodiment and for figure 4. Additionally, [0090] of Kaye states “ Optionally at least one electrical wire 9 is integrated into the outer wall of the hose body 2, the electrical wire 9 preferably being located inside and being isolated by the reinforcing ribs 8” so even if the liner is being considered, Kaye explicitly discloses that the wires are located inside and isolated by the reinforcing ribs so they would not interact with the liner in order to penetrate it.
New ground of rejections are NECESSITATED by Applicant’s amendments in view of Kaye.
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) 49, 136, 137, 139, and 147-154 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kutnyak et al. (US 4304266 A), Mallinson et al. (WO 2016048172 A1), and Kaye et al. (US 20140053939 A1).
Regarding claim 49, Kutnyak discloses a medical tube for transporting gases (Statement of intended use or functional, see MPEP 2114. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” MPEP 2111.02), the medical tube (smooth bore flexible hose; figure 3; the invention of Kutnyak is disclosed as a flexible hose which may be used in a medical context as flexible hoses are used to transport gases from a source to the patient) comprising:
a tube body (smooth bore flexible hose; figure 3) comprising:
a bead (reinforcing element including a circular metal wire 15 covered with an outer plastic sheath 16; figures 2-3) comprising a substantially flat surface (flat side 17; figures 2-3), the bead positioned such that the substantially flat surface (flat side 17; figures 2-3) forms a first portion of a lumen wall of the medical tube (see figures 2-3);
a film (wall strip 19; figures 2-3), a first portion of the film laid over the bead (see figure 2-3; portion of wall strip 19 bonded to rounded side at reference numeral 18 of sheath 16) and a second portion of the film forming a second portion of the lumen wall (see figure 3; portion of wall strip 19 extending between adjacent windings of the sheath 16);
wherein the lumen wall, formed by the substantially flat surface of the bead and the second portion of the film (see figure 3), comprises a substantially smooth bore (As a consequence of the flat side 17 of the reinforcing element the interior surface or bore of the hose is substantially smooth; col. 2 line 52-54) such that the substantially flat surface of the bead and the second portion of the film are aligned when the medical tube is straight along a longitudinal axis of the medical tube (see figure 3).
Kutnyak is silent as to the bead further comprising two heating wires disposed within the bead; and
a connector overmolded onto a first end of the tube body, a first end of the connector overlapping the tube body and a portion of the first end of the connector being aligned with the bead about a circumferential portion of the tube body.
However, Mallinson teaches a medical tube (medical tube 200; figures 2-5) comprising a bead (elongate reinforcing member 220; figures 2-5D) and a film (elongate film 210; figures 2-5D) the bead further comprising two heating wires disposed within the bead ([0053] The elongate reinforcing member 220 can comprise at least one wire, which can provide a heating and/or sensing component to the medical tube 200).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheath of Kutnyak to implement two heating wires to provide heating when the hose is used in a medical device to deliver heated gases directly to the patient as taught by Mallinson ([0003]).
Additionally, Kaye teaches a medical tube ([0066] hose body 2; Fig. 1) comprising a connector overmolded onto a first end of the tube body ([0079] The hose of FIG. 1 has at its both ends a first and a second cuff 3a, 3b. [0016] The connection of the cuff to the hose does not necessarily need to be achieved by overmoulding, as long as the connection responds to the desired properties, such as the mechanical properties and/or an acceptable isolation of the inside of the hose from the outside environmnent of the hose. Any other suitable process for connecting the cuff to the hose may be used, such as for instance through spin welding, or by screwing. [0067] a cuff 3a mounted to a first extremity of the hose body 2 and comprising a moulded end fitting 5a having a bore 14 for connecting the hose 1 to another device, the end fitting 5a being bonded to the first extremity 16a of the hose body 2; Fig. 1-4), a first end of the connector overlapping the tube body (see Fig. 1 and 3-4, right end of cuff 3a and left end of cuff 3b overlapping the hose body 2) and a portion of the first end of the connector being aligned with a bead about a circumferential portion of the tube body (see Fig. 3 and 4, portion of right end of cuff 3a and left end of cuff 3b aligned with reinforcing ribs 8 about a circumferential portion of hose body 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kutnyak to implement cuffs overmolded onto each end of the tube, and a first end of the cuffs overlapping the tube body and a portion of the first end of the connectors being aligned with the bead about a circumferential portion of the tube body in order to facilitate connecting the tube to another device as taught by Kaye.
Regarding claim 136, modified Kutnyak discloses the medical tube of claim 49, wherein the second portion of the film (see figure 3; portion of wall strip 19 extending between adjacent windings of the sheath 16) comprises a substantially flat surface forming the second portion of the lumen wall (see figure 3).
Regarding claim 137, modified Kutnyak discloses the medical tube of claim 136, wherein the substantially flat surface of the bead (17) and the substantially flat surface of the second portion of the film (19) are substantially aligned (see figures 2-3).
Regarding claim 139, modified Kutnyak discloses the medical tube of claim 49, wherein a cross-section of the bead (sheath 16; figure 2-3) is substantially D-shaped (see figure 2-3).
Regarding claim 147, modified Kutnyak discloses the medical tube of claim 49, wherein at least one of: the bead comprises a thermoplastic elastomer (TPE); or the film comprises a thermoplastic elastomer (TPE) (Various thermoplastic materials have been used for the elements of such a hose. Ethylene vinyl acetate, polyethelene or polypropylene are commonly employed for the purpose; col. 2 line 35-41).
Regarding claim 148, modified Kutnyak discloses the medical tube of claim 49, wherein the film (19) comprises a plurality of layers (layers of 19 overlaid on each other at the rounded side at the rounded side of sheath 16; see figures 2-3).
Regarding claim 149, modified Kutnyak discloses the medical tube of claim 148, wherein each of the plurality of layers comprises a winding of the film (windings of 19 at each sheath 16; see figures 2-3).
Regarding claim 150, modified Kutnyak discloses the medical tube of any of claims 148, wherein a first layer of the plurality of layers overlaps a second layer of the plurality of layers over an outer surface of the bead to form an overlapping portion (See Examiner Annotations 1 of figure 3 below, specifically at the first winding).
PNG
media_image1.png
337
551
media_image1.png
Greyscale
Examiner Annotations 1
Regarding claim 151, modified Kutnyak discloses the medical tube of claim 150, but is silent as to wherein the overlapping portion overlays between 55% and 95% of the outer surface of the bead.
Though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Kutnyak clearly depicts the overlapping portion overlays the majority of the outer surface of the sheath; see figure 3 and Examiner Annotations 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the overlapping portion of Kutnyak to overlay between 55% and 95% of the outer surface of the bead since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kutnyak would not operate differently with the claimed overlapping portion overlaying between 55% and 95% of the outer surface of the bead. Further, it appears that applicant places no criticality on the overlapping portion claimed, indicating simply that the overlapping portion overlays more than half of the outer bead surface in some embodiments and between 55% and 95% of the outer bead surface in a further embodiment (specifications [0058]).
Regarding claim 152, modified Kutnyak discloses the medical tube of claim 148, wherein a first layer of the plurality of layers and a second layer of the plurality of layers overlap over an outer surface of a first winding of the bead, and the first layer and a third layer of the plurality of layers overlap over an outer surface of a second winding of the bead, the second winding adjacent to the first winding to form an overlapping portion (see Examiner Annotations 1 above).
Regarding claim 153, modified Kutnyak discloses the medical tube of claim 152, but is silent as to wherein the overlapping portion overlays at least half of the outer surface of each of the first winding of the bead and the second winding of the bead.
Though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Kutnyak clearly depicts the overlapping portion overlays the majority of the outer surface of the sheath; see figure 3 and Examiner Annotations 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the overlapping portion of Kutnyak to overlay at least half of the outer surface of each pf the first winding and the second winding of the bead since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kutnyak would not operate differently with the claimed overlapping portion overlaying at least half of the outer surface of each pf the first winding and the second winding of the bead. Further, it appears that applicant places no criticality on the overlapping portion claimed, indicating simply that the overlapping portion overlays more than half of the outer bead surface in some embodiments and between 55% and 95% of the outer bead surface in a further embodiment (specifications [0058]).
Regarding claim 154, modified Kutnyak discloses the medical tube of claim 152, but is silent as to wherein the overlapping portion overlays between 55% and 95% of each of the first winding of the bead and the second winding of the bead.
Though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Kutnyak clearly depicts the overlapping portion overlays the majority of the outer surface of the sheath; see figure 3 and Examiner Annotations 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the overlapping portion of Kutnyak to overlay between 55% and 95% of the outer surface of each of the first winding and second winding of the bead since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kutnyak would not operate differently with the claimed overlapping portion overlaying between 55% and 95% of the outer surface of each of the first winding and second winding of the bead. Further, it appears that applicant places no criticality on the overlapping portion claimed, indicating simply that the overlapping portion overlays more than half of the outer bead surface in some embodiments and between 55% and 95% of the outer bead surface in a further embodiment (specifications [0058]).
Claim(s) 144 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kutnyak et al. (US 4304266 A), Mallinson et al. (WO 2016048172 A1), and Kaye et al. (US 20140053939 A1) as applied to claim 49 above, and further in view of Maurer (US 20180296787 A1).
Regarding claim 144, modified Kutnyak discloses the medical tube of claim 49, but does not disclose wherein the bead comprises at least one sensor wire for conveying power and/or data between at least one sensor and a controller.
Mallinson teaches a medical tube (medical tube 200; figures 2-5) comprising a bead (elongate reinforcing member 220; figures 2-5D) and a film (elongate film 210; figures 2-5D) wherein the bead comprises a sensing wire ([0053] In some embodiments, the elongate reinforcing member 220 can comprise at least one wire, which can provide a heating and/or sensing component to the medical tube 200).
Additionally, Maurer teaches a medical tube (tube portion 6100) comprising a bead (auxiliary structures 6120 and 6130; Fig. 6C-6N) with at least one sensor wire ([0163] The first auxiliary structure 6120 comprises electrical wires 6151, 6152 and 6153; Fig. 6M) for conveying power and/or data between at least one sensor and a controller ([0089] The central controller 4230 may be configured to receive input signal(s) from one or more transducers, as a sensor located on the air conduit 6000. [0118] The air conduit 6000 may comprise a set of electrical conductors. An electrical conductor may be configured to carry, or transmit, an electrical signal and/or power. [0119] Examples of an electrical conductor include a copper wire and an aluminium wire, as well as a number of other known alternatives. An electrical conductor may extend throughout a length of the air conduit 6000, such as to provide heat to the length of the air conduit 6000. Additionally, or alternatively, an electrical conductor may transmit electrical signal(s) from a first end of the air conduit 6000 to a second end of the air conduit 6000, such as from a sensor located in an end to a humidifier electrically connected to the air conduit 6000)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the sheath of Kutnyak to implement a sensing wire when the hose is used in a medical device, as taught by Mallinson, to transmit electrical signals from a sensor to a controller as taught by Maurer in order to monitor the power of the device or the conditions of the gases in the tube and adjust parameters in response to the obtained signals to optimize patient therapy.
Claim(s) 155-157 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kutnyak et al. (US 4304266 A) and Mallinson et al. (WO 2016048172 A1).
Regarding claim 155, Kutnyak discloses a medical tube for transporting gases (Statement of intended use or functional, see MPEP 2114. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” MPEP 2111.02), the medical tube (smooth bore flexible hose; figure 3; the invention of Kutnyak is disclosed as a flexible hose which may be used in a medical context as flexible hoses are used to transport gases from a source to the patient) comprising:
a bead (reinforcing element including a circular metal wire 15 covered with an outer plastic sheath 16; figures 2-3) comprising a surface (flat side 17; figures 2-3) that forms a first portion of a lumen wall of the medical tube (see figures 2-3), the bead further comprising an apex spaced away from the surface (curved top opposite the flat side 17; figures 2-3);
a film (wall strip 19; figures 2-3) comprising a first portion (see figure 2-3; portion of wall strip 19 at the curved top of sheath 16) and a second portion (see figure 3; portion of wall strip 19 extending between adjacent windings of the sheath 16), the first portion of the film laid over the apex of the bead (see figure 2-3; portion of wall strip 19 bonded to rounded side at reference numeral 18 of sheath 16), the second portion of the film forming a second portion of the lumen wall (see figure 3; portion of wall strip 19 extending between adjacent windings of the sheath 16), and
wherein the lumen wall being formed by the surface of the bead and the second portion of the film (see figure 3).
Kutnyak is silent as to comprising one or more wires positioned within the bead, the one or more wires being positioned closer to the surface of the bead than to the apex of the bead.
However, Kaye teaches a medical tube ([0066] hose body 2; figure 1. Flexible plastic hose; title. [0091] The flexible plastic hose 1 described above, may be used advantageously as a medical hose) comprising a bead ([0066] at least one reinforcing rib 8 having predetermined properties for providing sufficient crush resistance to the hose body 1; figure 1 and 6), and one or more wires positioned within the bead ([0090] two electrical wires are integrated in the helical enforcing rib 8. The electrical wire 9 may be a heating resistance, a communication wire or both. [0092] In a particular use, the hose 1 is a medical hose comprising at least one electrical wire, integrated into the outer wall of the hose body 2, preferably being located inside and isolated by the reinforcing ribs 8, but possibly alternatively in the web or in the weld, and being used for instance for a purpose selected from (i) warming up a fluid (gas and/or liquid) inside the hose body 2; figure 6), the one or more wires being positioned closer to the surface of the bead than to the apex of the bead (see figure 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheath of Kutnyak to implement two heating electrical wires close to the surface of the sheath as taught by Kaye for the purpose of using the hose in medical applications, specifically warming up a gas or liquid inside the hose ([0091 – 0092]).
Regarding claim 156, modified Kutnyak discloses the medical tube of claim 155, wherein a cross-section of the bead (sheath 16; figure 2-3) is substantially D-shaped (see figure 2-3).
Regarding claim 157, modified Kutnyak discloses the medical tube of claim 156, wherein the one or more wires comprise two heating elements (Kaye teaches [0090] The electrical wire 9 may be a heating resistance. As per the modification above the one or more wires are two electrical wires with heating capabilities/heating resistance).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 49, 136, 137, and 147-152 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 7, 10, and 15 of U.S. Patent No. 11766536, hereinafter ‘536 in view of Kaye et al. (US 20140053939 A1).
Regarding claim 49, ‘536 discloses a medical tube for transporting gases (claim 1), the medical tube comprising:
a tube body (medical tube; claim 1) comprising:
a bead comprising a substantially flat surface (claim 1: a bead…a flat surface of the bead), the bead further comprising two heating wires disposed within the bead (claim 1: one or more wires is disposed within the bead, the one or more wires being a heating wire), the bead positioned such that the substantially flat surface forms a first portion of a lumen wall of the medical tube (claim 1: the lumen wall, formed by a flat surface of the bead);
a film, a first portion of the film laid over the bead and a second portion of the film forming a second portion of the lumen wall (claim 1);
wherein the lumen wall, formed by the substantially flat surface of the bead and the second portion of the film, comprises a substantially smooth bore such that the flat surface of the bead and the second portion of the film are aligned when the medical tube is straight along a longitudinal axis of the medical tube (claim 1).
However, ‘536 is silent as to a connector overmolded onto a first end of the tube body, a first end of the connector overlapping the tube body and a portion of the first end of the connector being aligned with the bead about a circumferential portion of the tube body.
However, Kaye teaches a medical tube ([0066] hose body 2; Fig. 1) comprising a connector overmolded onto a first end of the tube body ([0079] The hose of FIG. 1 has at its both ends a first and a second cuff 3a, 3b. [0016] The connection of the cuff to the hose does not necessarily need to be achieved by overmoulding, as long as the connection responds to the desired properties, such as the mechanical properties and/or an acceptable isolation of the inside of the hose from the outside environmnent of the hose. Any other suitable process for connecting the cuff to the hose may be used, such as for instance through spin welding, or by screwing. [0067] a cuff 3a mounted to a first extremity of the hose body 2 and comprising a moulded end fitting 5a having a bore 14 for connecting the hose 1 to another device, the end fitting 5a being bonded to the first extremity 16a of the hose body 2; Fig. 1-4), a first end of the connector overlapping the tube body (see Fig. 1 and 3-4, right end of cuff 3a and left end of cuff 3b overlapping the hose body 2) and a portion of the first end of the connector being aligned with a bead about a circumferential portion of the tube body (see Fig. 3 and 4, portion of right end of cuff 3a and left end of cuff 3b aligned with reinforcing ribs 8 about a circumferential portion of hose body 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify ‘536 to implement cuffs overmolded onto each end of the tube, and a first end of the cuffs overlapping the tube body and a portion of the first end of the connectors being aligned with the bead about a circumferential portion of the tube body in order to facilitate connecting the tube to another device as taught by Kaye.
Regarding claim 136, ‘536-Kaye discloses the medical tube of claim 49, wherein the second portion of the film comprises a substantially flat surface forming the second portion of the lumen wall (claim 4).
Regarding claim 137, ‘536-Kaye discloses the medical tube of claim 136, wherein the substantially flat surface of the bead and the substantially flat surface of the second portion of the film are substantially aligned (claim 1: such that the flat surface of the bead and the second portion of the film are aligned when the medical tube is straight along the longitudinal axis).
Regarding claim 147, ‘536-Kaye discloses the medical tube of claim 49, wherein at least one of: the bead comprises a thermoplastic elastomer (TPE); or the film comprises a thermoplastic elastomer (TPE) (claim 15).
Regarding claim 148, ‘536-Kaye discloses the medical tube of claim 49, wherein the film comprises a plurality of layers (claim 1: the film comprises a plurality of layers).
Regarding claim 149, ‘536-Kaye discloses the medical tube of claim 148, wherein each of the plurality of layers comprises a winding of the film (claim 10: the film comprises multiple windings that are fused together to form a single layer).
Regarding claim 150, ‘536-Kaye discloses the medical tube of claim 148, wherein a first layer of the plurality of layers overlaps a second layer of the plurality of layers over an outer surface of the bead to form an overlapping portion (claim 1: a first layer of the plurality of layers overlaps a second layer of the plurality of layers over an outer surface of the bead to form an overlapping portion).
Regarding claim 151, ‘536-Kaye discloses the medical tube of claim 150, wherein the overlapping portion overlays between 55% and 95% of the outer surface of the bead (claim 6: wherein the overlapping portion overlays: at least half of the outer surface of the bead, or between 55% and 95% of the outer surface of the bead).
Regarding claim 152, ‘536-Kaye discloses the medical tube of claim 148, wherein a first layer of the plurality of layers and a second layer of the plurality of layers overlap over an outer surface of a first winding of the bead, and the first layer and a third layer of the plurality of layers overlap over an outer surface of a second winding of the bead, the second winding adjacent to the first winding to form an overlapping portion (claim 7).
Claims 139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. '536 and Kaye et al. (US 20140053939 A1) in view of Kutnyak et al. (US 4304266 A).
Regarding claim 139, ‘536-Kaye discloses the medical tube of claim 49, but does not disclose wherein a cross-section of the bead is substantially D-shaped, triangular, square, trapezoidal, equilateral, or polygonal.
However, Kutnyak teaches a tube (smooth bore flexible tube; figure 3) comprising a bead (reinforcing element including a circular metal wire 15 covered with an outer plastic sheath 16; figures 2-3) wherein a cross-section (sheath 16; figure 2-3) of the bead is substantially D-shaped (see figures 2-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bead of ‘536 to be D-shaped to form a smooth bore as taught by Kutnyak.
Claims 153-154 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. '536 and Kaye et al. (US 20140053939 A1) in view of Kutnyak et al. (US 4304266 A).
Regarding claim 153, ‘536-Kaye discloses the medical tube of claim 152, but does not disclose wherein the overlapping portion overlays at least half of the outer surface of each of the first winding of the bead and the second winding of the bead.
Kutnyak teaches a tube (smooth bore flexible tube; figure 3) formed from overlapping films on beads (see figures 2-3).
Though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Kutnyak clearly depicts the overlapping portion overlays the majority of the outer surface of the sheath; see figure 3 and Examiner Annotations 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the overlapping portion of Kutnyak to overlay at least half of the outer surface of each pf the first winding and the second winding of the bead since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kutnyak would not operate differently with the claimed overlapping portion overlaying at least half of the outer surface of each pf the first winding and the second winding of the bead. Further, it appears that applicant places no criticality on the overlapping portion claimed, indicating simply that the overlapping portion overlays more than half of the outer bead surface in some embodiments and between 55% and 95% of the outer bead surface in a further embodiment (specifications [0058]).
Regarding claim 154, ‘536-Kaye discloses the medical tube of claim 152, but does not disclose wherein the overlapping portion overlays between 55% and 95% of each of the first winding of the bead and the second winding of the bead.
Kutnyak teaches a tube (smooth bore flexible tube; figure 3) formed from overlapping films on beads (see figures 2-3).
Though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Kutnyak clearly depicts the overlapping portion overlays the majority of the outer surface of the sheath; see figure 3 and Examiner Annotations 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the overlapping portion of Kutnyak to overlay between 55% and 95% of the outer surface of each of the first winding and second winding of the bead since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kutnyak would not operate differently with the claimed overlapping portion overlaying between 55% and 95% of the outer surface of each of the first winding and second winding of the bead. Further, it appears that applicant places no criticality on the overlapping portion claimed, indicating simply that the overlapping portion overlays more than half of the outer bead surface in some embodiments and between 55% and 95% of the outer bead surface in a further embodiment (specifications [0058]).
Claim 144 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. '536 and Kaye et al. (US 20140053939 A1). in view of Maurer (US 20180296787 A1).
Regarding claim 144, ‘536-Kaye discloses the medical tube of claim 49, but does not disclose wherein the bead comprises at least one sensor wire for conveying power and/or data between at least one sensor and a controller.
However, Maurer teaches a medical tube (tube portion 6100) comprising a bead (auxiliary structures 6120 and 6130; Fig. 6C-6N) with at least one sensor wire ([0163] The first auxiliary structure 6120 comprises electrical wires 6151, 6152 and 6153; Fig. 6M) for conveying power and/or data between at least one sensor and a controller ([0089] The central controller 4230 may be configured to receive input signal(s) from one or more transducers, as a sensor located on the air conduit 6000. [0118] The air conduit 6000 may comprise a set of electrical conductors. An electrical conductor may be configured to carry, or transmit, an electrical signal and/or power. [0119] Examples of an electrical conductor include a copper wire and an aluminium wire, as well as a number of other known alternatives. An electrical conductor may extend throughout a length of the air conduit 6000, such as to provide heat to the length of the air conduit 6000. Additionally, or alternatively, an electrical conductor may transmit electrical signal(s) from a first end of the air conduit 6000 to a second end of the air conduit 6000, such as from a sensor located in an end to a humidifier electrically connected to the air conduit 6000)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘536 to implement a sensing component to transmit electrical signals from a sensor to a controller as taught by Maurer in order to monitor the power of the device or the conditions of the gases in the tube and adjust parameters in response to the obtained signals to optimize patient therapy.
Claim 155-157 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. '536 in view of Kutnyak et al. (US 4304266 A) and Kaye et al. (US 20140053939 A1).
Regarding claim 155, ‘536 discloses a medical tube for transporting gases (claim 1), the medical tube comprising:
a bead comprising a surface that forms a first portion of a lumen wall of the medical tube (claim 1: the bead forming a first portion of a lumen wall of the medical tube…the lumen wall, formed by a flat surface of the bead); the bead further comprising two heating wires disposed within the bead (claim 1: one or more wires is disposed within the bead, the one or more wires being a heating wire), the bead positioned such that the substantially flat surface forms a first portion of a lumen wall of the medical tube (claim 1: the lumen wall, formed by a flat surface of the bead); and
a film, comprising a first portion and a second portion, the first portion of the film laid over the bead, and the second portion of the film forming a second portion of the lumen wall of the medical tube(claim 1);
one or more wires positioned within the bead (claim 1: one or more wires is disposed within the bead, the one or more wires being a heating wire); and
the lumen wall being formed by the surface of the bead and the second portion of the film(claim 1).
‘536 does not disclose the bead further comprising an apex spaced away from the surface; the first portion of the film laid over the apex of the bead, and the one or more wires being positioned closer to the surface of the bead than to the apex of the bead.
However, Kutnyak teaches a tube (smooth bore flexible tube; figure 3) comprising a bead (reinforcing element including a circular metal wire 15 covered with an outer plastic sheath 16; figures 2-3) comprising an apex spaced away from the surface (curved top opposite the flat side 17; figures 2-3), and a film (wall strip 19; figures 2-3) comprising a first portion of the film laid over the apex of the bead (see figure 2-3; portion of wall strip 19 bonded to rounded side at reference numeral 18 of sheath 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bead of ‘536 to implement an apex spaced away from the surface and the first portion of the film laid over the apex of the bead as taught by Kutnyak as doing so would provide sufficient structural support for the hose.
Additionally, Kaye teaches a medical tube ([0066] hose body 2; figure 1. Flexible plastic hose; title. [0091] The flexible plastic hose 1 described above, may be used advantageously as a medical hose) comprising a bead ([0066] at least one reinforcing rib 8 having predetermined properties for providing sufficient crush resistance to the hose body 1; figure 1 and 6), and one or more wires positioned within the bead ([0090] two electrical wires are integrated in the helical enforcing rib 8. The electrical wire 9 may be a heating resistance, a communication wire or both. [0092] In a particular use, the hose 1 is a medical hose comprising at least one electrical wire, integrated into the outer wall of the hose body 2, preferably being located inside and isolated by the reinforcing ribs 8, but possibly alternatively in the web or in the weld, and being used for instance for a purpose selected from (i) warming up a fluid (gas and/or liquid) inside the hose body 2; figure 6), the one or more wires being positioned closer to the surface of the bead than to the apex of the bead (see figure 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the bead of ‘536 to implement two heating electrical wires close to the surface of the sheath as taught by Kaye for the purpose of using the hose in medical applications, specifically warming up a gas or liquid inside the hose ([0091 – 0092]).
Regarding claim 156, modified ‘536 discloses the medical tube of claim 155, but does not disclose wherein a cross-section of the bead is substantially D-shaped, triangular, square, trapezoidal, equilateral, or polygonal.
However, Kutnyak teaches a tube (smooth bore flexible tube; figure 3) comprising a bead (reinforcing element including a circular metal wire 15 covered with an outer plastic sheath 16; figures 2-3) wherein a cross-section (sheath 16; figure 2-3) of the bead is substantially D-shaped (see figures 2-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bead of ‘536 to be D-shaped to form a smooth bore as taught by Kutnyak.
Regarding claim 157, modified ‘536 discloses the medical tube of claim 156, wherein the one or more wires comprise two heating elements (claim 1: the one or more wires being a heating wire).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.I.A./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights