DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 3-4 is/are objected to because of the following informalities:
Claim 3, Ln. 1 recites “a wall of the expiratory tube” which should read “the wall of the expiratory tube” following after claim 2
Appropriate correction is required.
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.
Claim(s) 2-8 and 10-14 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7 and 9-10 of U.S. Patent No. 12,053,586. Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 2 are found within the overall scope of patent claim 1, the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 3 vs. patent claim 2
Instant claim 4 vs. patent claim 3
Instant claim 5 vs. patent claim 4
Instant claim 6 vs. patent claim 5
Instant claim 7 vs. patent claim 7
Instant claim 8 vs. patent claim 1
Instant claim 10 vs. patent claim 9
Instant claim 11 vs. patent claim 9
Instant claim 12 vs. patent claim 9
Instant claim 13 vs. patent claim 10
Instant claim 14 vs. patent claim 1
Claim(s) 9 and 15-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 9 of U.S. Patent No. 12,053,586 in view of Stoks et al. (WO Pub. 2014/088430 A1). Patent claim 1 includes all limitations of instant claim 9 with the exception of the requirement that the inspiratory tube encloses a heating element within the inspiratory central bore. (Note is also made of the close relationship between instant claim 9 and patent claims 13 and 16.)
Stoks teaches a breathing circuit (Fig. 1) and teaches a heating element within an inspiratory central bore (¶0292 – heating filament bonded to bore surface of the lumen wall). Stoks teaches a heating element within an inspiratory central bore as an obvious design choice alternative for heating element placement within an inspiratory tube.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in patent claim 1 the inspiratory tube encloses a heating element within the inspiratory central bore based upon an obvious design choice selection of within an inspiratory tube bore as one commonly recognized locational placement for a heating element placement within an inspiratory tube in view of Stoks. Instant claim 15 and its dependent claims are further rendered obvious in view of Stoks as follows:
Instant claim 15 vs. Stoks (a respiratory apparatus (Fig. 1) comprising: a humidifier (Fig. 1 #107; ¶0123) configured to humidify an inspiratory gases flow to a patient, the humidifier comprising: a humidification chamber (Fig. 1 #129; ¶0126) configured to store a volume of liquid water and configured to be in fluid communication with the inspiratory gases flow, and a heater (Fig. 1 #131; ¶0126) configured to heat the volume of liquid water in the humidification chamber to create vapor, such that the inspiratory gases flow is humidified by the vapor; the breathing circuit of claim 2 (see claim 2 above) and wherein the respiratory apparatus further comprising a control system (Fig. 1 #125 and other electronic control elements; ¶¶0127, 0182, 0381) configured to deliver power to the heater of the humidifier.)
Instant claim 16 vs. Stoks (Fig. 1)
Instant claim 17 vs. patent claim 4
Instant claim 18 vs. patent claim 9
Instant claim 19 vs. patent claim 4 or 9 and further in view of Stoks (Figs. 2B-2C #215; ¶¶0182-0183; ¶0131 – composite tube 201 useable for both the inspiratory tube and the expiratory tube)
Instant claim 20 vs. patent claim 1
Claim(s) 2, 5-12 and 14-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,691,243 in view of Stoks et al. (WO Pub. 2014/088430 A1). Patent claim 11 includes all limitations of instant claim 2 with the exception of the requirement that the inspiratory tube is formed from a second elongate member spirally wound and joined between adjacent turns of a first elongate member.
Stoks teaches a breathing circuit (Fig. 1) including a first elongate member (Figs. 2A-2E #203; ¶0130) comprising a hollow body (e.g. Fig. 2C bubble of #203 between #211 and #219; ¶0133) spirally wound (¶0133) to form at least in part: an inspiratory tube (Figs. 2A-2E) having a longitudinal axis (horizontal in Fig. 2C); an inspiratory central bore (Fig. 2C below and touching #211; ¶0133) extending along the longitudinal axis; and a wall (Fig. 2C wall including #211) enclosing the inspiratory central bore; and the inspiratory limb also comprising a second elongate member (Figs. 2A-2E #205; ¶0130) spirally wound (¶0130) and joined between adjacent turns of the first elongate member (e.g. Fig. 2C; ¶0140), the second elongate member forming at least a portion of the inspiratory central bore of the inspiratory tube (e.g. Fig. 2C). Stoks teaches this form of composite inspiratory tube as providing the benefit of improving thermal insulation and flexibility of a respiratory tube (¶¶0143, 0147).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in patent claim 11 the inspiratory tube is formed from a second elongate member spirally wound and joined between adjacent turns of a first elongate member in order to provide the benefit of improving thermal insulation and flexibility of a respiratory tube in view of Stoks. A further mapping of dependent claims is as follows:
Instant claim 5 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 6 vs. Stoks (Fig. 2C between #211 and #219; ¶0133)
Instant claim 7 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 8 vs. limitations in patent claim 1
Instant claim 9 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 10 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 11 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 12 vs. Stoks (Figs. 2B-2C; ¶¶0182-0183)
Instant claim 14 vs. limitations in patent claim 1
Instant claim 15 vs. Stoks (a respiratory apparatus (Fig. 1) comprising: a humidifier (Fig. 1 #107; ¶0123) configured to humidify an inspiratory gases flow to a patient, the humidifier comprising: a humidification chamber (Fig. 1 #129; ¶0126) configured to store a volume of liquid water and configured to be in fluid communication with the inspiratory gases flow, and a heater (Fig. 1 #131; ¶0126) configured to heat the volume of liquid water in the humidification chamber to create vapor, such that the inspiratory gases flow is humidified by the vapor; the breathing circuit of claim 2 (see claim 2 above) and wherein the respiratory apparatus further comprising a control system (Fig. 1 #125 and other electronic control elements; ¶¶0127, 0182, 0381) configured to deliver power to the heater of the humidifier.)
Instant claim 16 vs. Stoks (Fig. 1)
Instant claim 17 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 18 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 19 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183, 0381)
Instant claim 20 vs. limitations in patent claim 1
Claim(s) 3-4 and 13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,691,243 in view of Stoks et al. (WO Pub. 2014/088430 A1) and further in view of Hurmez et al. (U.S. Pub. 2013/0098360). Patent claim 11 fails to specify the wall of the expiratory tube comprises a foamed polymer (instant claim 3) or the expiratory tube has an inner surface and the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned (instant claim 13).
Regarding instant claim 3, Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) formed of a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases (¶¶0063, 0066). Hurmez teaches an expiratory tube formed from a foamed polymer as providing the benefit of combining Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials (¶0066).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in patent claim 11 the wall of the expiratory tube comprises a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases in order to provide the benefit of selecting an expiratory tube known to combine Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials in view of Hurmez.
Instant claim 4 is then further obvious in view of Hurmez (¶¶0028, 0073-0075).
Regarding instant claim 13, Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) which may be formed as a breathable tube (Figs. 7A-7B #701; ¶0124) and which comprises a plurality of reinforcing ribs (Fig. 7B #703; ¶¶0124-0125) circumferentially arranged around the inner surface and generally longitudinally aligned. Hurmez teaches reinforcing ribs as providing the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube (¶¶0112-0114, 0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in instant claim 13 the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned between the inlet and the outlet in order to provide the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube in view of Hurmez.
Claim(s) 2, 5-12 and 15-20 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 19/019,279 in view of Stoks et al. (WO Pub. 2014/088430 A1). Reference claim 23 includes all limitations of instant claim 2 with the exception of the requirement that the inspiratory tube is formed from a second elongate member spirally wound and joined between adjacent turns of a first elongate member.
Stoks teaches a breathing circuit (Fig. 1) including a first elongate member (Figs. 2A-2E #203; ¶0130) comprising a hollow body (e.g. Fig. 2C bubble of #203 between #211 and #219; ¶0133) spirally wound (¶0133) to form at least in part: an inspiratory tube (Figs. 2A-2E) having a longitudinal axis (horizontal in Fig. 2C); an inspiratory central bore (Fig. 2C below and touching #211; ¶0133) extending along the longitudinal axis; and a wall (Fig. 2C wall including #211) enclosing the inspiratory central bore; and the inspiratory limb also comprising a second elongate member (Figs. 2A-2E #205; ¶0130) spirally wound (¶0130) and joined between adjacent turns of the first elongate member (e.g. Fig. 2C; ¶0140), the second elongate member forming at least a portion of the inspiratory central bore of the inspiratory tube (e.g. Fig. 2C). Stoks teaches this form of composite inspiratory tube as providing the benefit of improving thermal insulation and flexibility of a respiratory tube (¶¶0143, 0147).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in reference claim 23 the inspiratory tube is formed from a second elongate member spirally wound and joined between adjacent turns of a first elongate member in order to provide the benefit of improving thermal insulation and flexibility of a respiratory tube in view of Stoks. A further mapping of dependent claims is as follows:
Instant claim 5 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 6 vs. Stoks (Fig. 2C between #211 and #219; ¶0133)
Instant claim 7 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 8 vs. limitations in reference claim 2
Instant claim 9 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 10 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 11 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 12 vs. Stoks (Figs. 2B-2C; ¶¶0182-0183)
Instant claim 15 vs. Stoks (a respiratory apparatus (Fig. 1) comprising: a humidifier (Fig. 1 #107; ¶0123) configured to humidify an inspiratory gases flow to a patient, the humidifier comprising: a humidification chamber (Fig. 1 #129; ¶0126) configured to store a volume of liquid water and configured to be in fluid communication with the inspiratory gases flow, and a heater (Fig. 1 #131; ¶0126) configured to heat the volume of liquid water in the humidification chamber to create vapor, such that the inspiratory gases flow is humidified by the vapor; the breathing circuit of claim 2 (see claim 2 above) and wherein the respiratory apparatus further comprising a control system (Fig. 1 #125 and other electronic control elements; ¶¶0127, 0182, 0381) configured to deliver power to the heater of the humidifier.)
Instant claim 16 vs. Stoks (Fig. 1)
Instant claim 17 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183)
Instant claim 18 vs. Stoks (¶0292 – heating filament bonded to bore surface of the lumen wall)
Instant claim 19 vs. Stoks (Figs. 2B-2C #215; ¶¶0182-0183, 0381)
Instant claim 20 vs. limitations in reference claim 2
This is a provisional nonstatutory double patenting rejection.
Claim(s) 3-4 and 13-14 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 19/019,279 in view of Stoks et al. (WO Pub. 2014/088430 A1) and further in view of Hurmez et al. (U.S. Pub. 2013/0098360). Reference claim 23 fails to specify the wall of the expiratory tube comprises a foamed polymer (instant claim 3), the expiratory tube has an inner surface and the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned (instant claim 13) or the inspiratory central bore is smooth (instant claim 14).
Regarding instant claim 3, Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) formed of a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases (¶¶0063, 0066). Hurmez teaches an expiratory tube formed from a foamed polymer as providing the benefit of combining Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials (¶0066).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 23 the wall of the expiratory tube comprises a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases in order to provide the benefit of selecting an expiratory tube known to combine Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials in view of Hurmez.
Instant claim 4 is then further obvious in view of Hurmez (¶¶0028, 0073-0075).
Regarding instant claim 13, Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) which may be formed as a breathable tube (Figs. 7A-7B #701; ¶0124) and which comprises a plurality of reinforcing ribs (Fig. 7B #703; ¶¶0124-0125) circumferentially arranged around the inner surface and generally longitudinally aligned. Hurmez teaches reinforcing ribs as providing the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube (¶¶0112-0114, 0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 23 the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned between the inlet and the outlet in order to provide the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube in view of Hurmez.
Regarding instant claim 14, Hurmez teaches an inspiratory tube (Figs. 2A-2E; ¶0133) with a smooth inspiratory bore (Fig. 2C; ¶0180). Hurmez teaches a smooth inspiratory bore as providing the benefit of supplying a smooth flow path which reduces noise (¶¶0133, 0153).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in reference claim 23 the inspiratory central bore is smooth in order to provide the benefit of supplying a smooth flow path which reduces noise in view of Hurmez.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 2, 5-7, 9-12 and 14-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoks et al. (WO Pub. 2014/088430 A1).
Regarding claim 2, Stoks discloses a breathing circuit (Fig. 1) comprising: an inspiratory limb (Fig. 1 #103; ¶¶0123, 0131) for carrying inspiratory gases to a patient, the inspiratory limb comprising: a first elongate member (Figs. 2A-2E #203; ¶0130) comprising a hollow body (e.g. Fig. 2C bubble of #203 between #211 and #219; ¶0133) spirally wound (¶0133) to form at least in part: an inspiratory tube (Figs. 2A-2E) having a longitudinal axis (horizontal in Fig. 2C); an inspiratory central bore (Fig. 2C below and touching #211; ¶0133) extending along the longitudinal axis; and a wall (Fig. 2C wall including #211) enclosing the inspiratory central bore; and the inspiratory limb also comprising a second elongate member (Figs. 2A-2E #205; ¶0130) spirally wound (¶0130) and joined between adjacent turns of the first elongate member (e.g. Fig. 2C; ¶0140), the second elongate member forming at least a portion of the inspiratory central bore of the inspiratory tube (e.g. Fig. 2C); and the breathing circuit comprising an expiratory limb (Fig. 1 #117; ¶0124) for carrying expiratory gases from the patient, the expiratory limb comprising an expiratory tube comprising an inlet (Fig. 1 inlet into #117 from patient) and an outlet (Fig. 1 outlet of #117 into #105), and a wall (Figs. 2A-2E inner wall of #201; ¶0131 – composite tube 201 useable for both the inspiratory tube and the expiratory tube) enclosing an expiratory central bore (Fig. 2C below and touching #211; ¶0133), wherein the wall of the expiratory tube is configured to contain the expiratory gases and is permeable to water vapor (¶0245) and substantially impermeable to liquid water and bulk flow of the expiratory gases (¶0245).
Regarding claim 5, Stoks discloses the second elongate member of the inspiratory limb encloses at least one heating element (Figs. 2B-2C #215; ¶¶0182-0183).
Regarding claim 6, Stoks discloses the first elongate member of the inspiratory limb forms in longitudinal cross-section a plurality of bubbles (Fig. 2C between #211 and #219; ¶0133) each with a flattened surface (Fig. 2C #211; ¶0133) forming at least part of the wall enclosing the inspiratory central bore.
Regarding claim 7, Stoks discloses the second elongate member of the inspiratory limb encloses at least one inspiratory heating element (Figs. 2B-2C #215; ¶¶0182-0183), and wherein the at least one inspiratory heating element is between a bubble of the plurality of bubbles and the inspiratory central bore of the inspiratory limb (Fig. 2C).
Regarding claim 9, Stoks discloses the inspiratory tube encloses a heating element within the inspiratory central bore (¶0292 – heating filament bonded to bore surface of the lumen wall).
Regarding claim 10, Stoks discloses the expiratory tube encloses a heating element within the expiratory central bore (¶0292 – heating filament bonded to bore surface of the lumen wall).
Regarding claim 11, Stoks discloses the expiratory tube comprises a heating element attached to the wall of the expiratory tube (¶0292 – heating filament bonded to bore surface of the lumen wall).
Regarding claim 12, Stoks discloses the expiratory tube comprises a heating element embedded in the wall of the expiratory tube (Figs. 2B-2C; ¶¶0182-0183).
Regarding claim 14, Stoks discloses the inspiratory central bore is smooth (Fig. 2C; ¶0180).
Regarding claim 15, Stoks discloses a respiratory apparatus (Fig. 1) comprising: a humidifier (Fig. 1 #107; ¶0123) configured to humidify an inspiratory gases flow to a patient, the humidifier comprising: a humidification chamber (Fig. 1 #129; ¶0126) configured to store a volume of liquid water and configured to be in fluid communication with the inspiratory gases flow, and a heater (Fig. 1 #131; ¶0126) configured to heat the volume of liquid water in the humidification chamber to create vapor, such that the inspiratory gases flow is humidified by the vapor; the breathing circuit of claim 2 (see claim 2 above) and wherein the respiratory apparatus further comprising a control system (Fig. 1 #125 and other electronic control elements; ¶¶0127, 0182, 0381) configured to deliver power to the heater of the humidifier.
Regarding claim 16, Stoks discloses a patient interface assembly (Fig. 1 #115; ¶0123) between the inspiratory tube and the expiratory tube.
Regarding claim 17, Stoks discloses the second elongate member comprises at least one inspiratory heating element embedded within the second elongate member (Figs. 2B-2C #215; ¶¶0182-0183).
Regarding claim 18, Stoks discloses at least one expiratory heating element is provided within the expiratory central bore (¶0292 – heating filament bonded to bore surface of the lumen wall).
Regarding claim 19, Stoks discloses the second elongate member comprises at least one inspiratory heating element embedded within the second elongate member (Figs. 2B-2C #215; ¶¶0182-0183), the expiratory central bore has at least one expiratory heating element (Figs. 2B-2C #215; ¶¶0182-0183), and the control system is configured to deliver power to the at least one inspiratory heating element and the at least one expiratory heating element (¶¶0182, 0381).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-4, 8, 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stoks et al. (WO Pub. 2014/088430 A1) in view of Hurmez et al. (U.S. Pub. 2013/0098360).
Regarding claim 3, Stoks fails to disclose the wall of the expiratory tube comprises a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases.
It is initially noted that Stoks teaches that the expiratory tube can either be made in the form of its disclosed composite tube or as a medical tube previously known in the art (¶0129). Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) formed of a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases (¶¶0063, 0066). Hurmez teaches an expiratory tube formed from a foamed polymer as providing the benefit of combining Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials (¶0066).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in Stoks the wall of the expiratory tube comprises a foamed polymer that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of the expiratory gases in order to provide the benefit of selecting an expiratory tube known to combine Young's modulus (stiffness) and permeability (breathability) properties that are significantly improved over previously known breathable materials in view of Hurmez.
Regarding claim 4, Stoks teaches the invention as modified above and Hurmez as incorporated therein further teaches the foamed polymer comprises a solid thermoplastic elastomer material having cell voids distributed throughout (¶¶0028, 0073-0075).
Regarding claim 8, Stoks fails to disclose the expiratory central bore is corrugated.
It is initially noted that Stoks teaches that the expiratory tube can either be made in the form of its disclosed composite tube or as a medical tube previously known in the art (¶0129). Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) which may be formed as a breathable tube (Figs. 7A-7B #701; ¶0124) formed with a central bore which is corrugated (Figs. 7A-7B; ¶0125). Hurmez teaches a corrugated breathable, expiratory tube as providing the benefit of being an easily extruded tube which is flexible and suitable for having interior reinforcing ribs (¶¶0013, 0112-0114, 0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in Stoks the expiratory central bore is corrugated in order to provide the benefit of selecting an expiratory tube which can be easily extruded and which is flexible and suitable for having interior reinforcing ribs in view of Hurmez.
Regarding claim 13, Stoks discloses the expiratory tube has an inner surface (Fig. 2C below and touching #211; ¶0133).
Stoks fails to disclose the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned between the inlet and the outlet.
It is initially noted that Stoks teaches that the expiratory tube can either be made in the form of its disclosed composite tube or as a medical tube previously known in the art (¶0129). Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) which may be formed as a breathable tube (Figs. 7A-7B #701; ¶0124) and which comprises a plurality of reinforcing ribs (Fig. 7B #703; ¶¶0124-0125) circumferentially arranged around the inner surface and generally longitudinally aligned. Hurmez teaches reinforcing ribs as providing the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube (¶¶0112-0114, 0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in Stoks the expiratory limb further comprises a plurality of reinforcing ribs circumferentially arranged around the inner surface and generally longitudinally aligned between the inlet and the outlet in order to provide the benefit of supplying a reinforcing functionality to an extruded, flexible expiratory tube in view of Hurmez.
Regarding claim 20, Stoks fails to disclose the expiratory central bore is corrugated.
It is initially noted that Stoks teaches that the expiratory tube can either be made in the form of its disclosed composite tube or as a medical tube previously known in the art (¶0129). Hurmez teaches an expiratory tube (Fig. 1 #117; ¶0058) which may be formed as a breathable tube (Figs. 7A-7B #701; ¶0124) formed with a central bore which is corrugated (Figs. 7A-7B; ¶0125). Hurmez teaches a corrugated breathable, expiratory tube as providing the benefit of being an easily extruded tube which is flexible and suitable for having interior reinforcing ribs (¶¶0013, 0112-0114, 0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in Stoks the expiratory central bore is corrugated in order to provide the benefit of selecting an expiratory tube which can be easily extruded and which is flexible and suitable for having interior reinforcing ribs in view of Hurmez.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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