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 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 (i.e., changing from AIA to pre-AIA ) 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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 38 and 42-54 are rejected under 35 U.S.C. 103 as being unpatentable over Clawson et al. 5,392,770 in view of Dwyer et al. 2018/0104433
Regarding claim 38, Clawson teaches a medical conduit configured to deliver breathable gases in a respiratory therapy system (The abstract states “Tubing circuits systems for delivering humidified respiratory gas to a human or an animal are disclosed”), the medical conduit (the expandable inspiratory conduit 62) comprising: a first conduit end connector configured to be connected to a user interface (Figure 1 depicts conduit 62 connected to patient manifold 66, which is connected to tracheal tube 38); a second conduit end connector (coupling 55) configured to be connected to a heated inspiratory conduit (coupling 55 has the ability to connect to an inspiratory conduit that is heated as it can connect to an inspiratory conduit as shown by its connection to tube 14, Column 8 line 9 states “single heating wire loop 34 is used in both tubes 14 and 16”, the inspiratory conduit being heated is irrelevant to the connection taking place); and wherein the medical conduit forms a component of an inspiratory conduit (Figure 2 depicts tube 62 being a component of tube 14 as they are in direct connection with each other, the combination of both forms an overall inspiratory conduit) and is configured to connect the user interface to the heated inspiratory conduit (Figure 5 depicts tube 62 connecting tracheal tube 68 to tube 14), wherein the medical conduit is configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator (Column 5 line 60 states “if a warmer or incubator is used, the expandable conduits 62 and 64 are preferably extended so that the assembled plug portion 50/cup portion 52 is away from the warmer or outside the incubator”, this indicates conduits 62 and 64 being placed within the incubator), and wherein the medical conduit is unheated (conduit 62 is not mentioned as being heated).
Clawson fails to teach wherein an entire length of the medical conduit comprises a breathable material configured to allow a transfer of water vapor from within the medical conduit to reduce liquid condensate forming within the medical conduit.
Dwyer teaches an analogous breathing circuit apparatus that does teach wherein an entire length of the medical conduit (breathing circuit tubing 11) comprises a breathable material (0042 states “the breathing circuit tubing 11 may include a permeable portion or membrane (as depicted in broken lines) along part or all of the inner tube 32”) configured to allow a transfer of water vapor from within the medical conduit to reduce liquid condensate forming within the medical conduit (0042 states “The permeable portion may be permeable to water vapor but impermeable to liquid water, such that the moisture transmission pathway (T) is provided by the permeable portion of the breathing circuit tubing 11.”). Furthermore, Dwyer teaches a solution which eliminates heated wire ((unheated medical conduit), [0005]). It would have been prima facie obvious for one of ordinary skill in the art to modify inspiratory conduit 62 oof Clawson with the teachings of Dwyer and include a breathable material as this would allow for the passage of water vapor (0042).
Regarding claim 42, modified Clawson teaches the medical conduit of claim 38, wherein the medical conduit is compressible, that is, a length of the medical conduit can be reduced, or wherein the medical conduit is extensible, that is, the length of the medical conduit can be increased (Column 5 line 51 states “The medical conduit of claim 38, wherein the medical conduit is compressible, that is, a length of the medical conduit can be reduced, or wherein the medical conduit is extensible, that is, the length of the medical conduit can be increased.”).
Regarding claim 43, modified Clawson teaches the medical conduit of claim 38, wherein the medical conduit is breathable in that at least part of the medical conduit is highly permeable to a moisture vapor, but is substantially impermeable to a liquid moisture (0042 of Dwyer states “the permeable portion may be permeable to water vapor but impermeable to liquid water”) and substantially impermeable to a bulk flow of gases (0041 discusses the use of the material being meant to remove moisture from the breathing gas itself, meaning that the breathable material is impermeable to the breathing gasses).
Regarding claim 44, modified Clawson teaches the medical conduit of claim 43, wherein the moisture vapor comprises a water vapor (0042 of Dwyer).
Regarding claim 45, modified Clawson teaches the medical conduit of claim 43, wherein the liquid moisture comprises a liquid water (0042 of Dwyer).
Regarding claim 46, modified Clawson teaches the medical conduit of claim 38, wherein a length of the medical conduit is less than a length of the heated inspiratory conduit with which the medical conduit is used (Figure 1 of Clawson depicts 62 being less than a length of 14).
Regarding claim 47, modified Clawson teaches a respiratory therapy kit for use in a respiratory therapy system, the respiratory therapy kit (Figure 1 of Clawson) comprising: a conduit according to claim 38 (Clawson in view of Dwyer); a user interface configured to be secured to a user's head to deliver breathable gases to a user (tracheal tube 68 is connected to the head of the user); and a heated inspiratory conduit configured (Inspiratory tube 14) to receive humidified breathable gases from a humidifier of the respiratory therapy system (humidifier 70 is connected to tube 14 as shown in figure 1 of Clawson).
Regarding claim 48, modified Clawson teaches the respiratory therapy kit of claim 47, wherein a connector on the user interface is substantially identical to the second conduit end connector of the medical conduit (Both 66 and 55 are substantially identical connections as both are a type of manifold assembly).
Regarding claim 49, modified Clawson teaches an incubator comprising the medical conduit of claim 38 wherein the medical conduit and the heated inspiratory conduit are configured such that the medical conduit is inside the incubator, and the heated inspiratory conduit is outside of the incubator (Column 5 line 60 of Clawson states “if a warmer or incubator is used, the expandable conduits 62 and 64 are preferably extended so that the assembled plug portion 50/cup portion 52 is away from the warmer or outside the incubator”).
Regarding claim 50, modified Clawson teaches the incubator of claim 49, wherein the incubator (Column 5 line 60) has an incubation enclosure configured to contain a user in use (the incubator is meant to enclose a patient), that does teach the medical conduit (62) as being located inside the enclosure (Column 5 line 60).
Modified Clawson does not explicitly disclose the length being sufficient to extend from a periphery of the incubation enclosure to the center of the incubation enclosure, however 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 is not patentably distinct from the prior art device. MPEP § 2144.04-IV-A. Therefore, the conduit of claim 38 could be modified to include the length being sufficient to extend from a periphery of the incubation enclosure to the center of the incubation enclosure.
Regarding claim 51, modified Clawson teaches a respiratory therapy system (Figure 1 of Clawson) comprising: a flow generator (ventilator 74); a humidifier (70); a heated inspiratory conduit (tubing 14); a user interface coupled to a gases conduit (tracheal tube 68) to deliver a gases flow to a user (figure 1); a sensor configured to determine pressure or flow of the gases flow; a controller configured to control the flow generator to generate the gases flow (Column 6 line 1 states “patient manifold 66 includes a pressure port 67 which is coupled to pressure line 69 to provide pressure signals to ventilator 74 for control and monitoring purposes); the respiratory therapy system further comprising the medical conduit of claim 38 (Conduit 62 in view of Dwyer).
Regarding claim 52, modified Clawson teaches the respiratory therapy system of claim 51, wherein the heated inspiratory conduit comprises a temperature sensor positioned outside of the incubator (Column 5 line 60 states that the temperature sensor would be placed outside the incubator), configured to measure a temperature of breathable gases in the heated inspiratory conduit (Column 3 line 62 states “a temperature sensor is provided which includes a sensing element positioned in or near the outlet of the inspiratory tube to sense the temperature of the gas exiting the first elongate hollow space.”).
Regarding claim 53, modified Clawson teaches the respiratory therapy system of claim 51, configured for use in an environment comprising both an ambient environment, subject to ambient environment conditions (Column 5 line 50 states “or example, if no patient warmer or incubator is involved in the application, the expandable conduits are preferably used in the compressed state. This allows temperature control of the humidified respiratory gas at a point relatively close to where the gas enters the patient 12”), and a controlled environment subject to at least one of controlled temperature or humidity (purpose of an incubator), wherein the gases conduit is configured to be located in the ambient environment, and the medical conduit is configured, when connected to the gases conduit, to be located in the controlled environment (Column 5 line 50 states “if a warmer or incubator is used, the expandable conduits 62 and 64 are preferably extended so that the assembled plug portion 50/cup portion 52 is away from the warmer or outside the incubator so that the gas temperature being sensed and controlled is not greatly influenced by the warmer or incubator.”).
Regarding claim 54, modified Clawson teaches the respiratory therapy system of claim 51, wherein the breathable material is configured to absorb liquid water into a conduit wall (0042 of Dwyer states “A first wicking layer may be provided as an inner layer of inner tube 32 and may be configured to contact the breathing gas flow (B) inside of the inner tube 32. The wicking layer may be made of one or more wicking materials that allow for adsorption and/or absorption of moisture and/or water in any phase (e.g., gas and/or liquid), for example, through capillary action.”).
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over modified Clawson in view of Smith et al. 2001/0054422
Regarding claim 39, modified Clawson teaches the medical conduit of claim 38, but fails to teach further comprising one or more thermally insulating portions formed by one or more air pockets or other insulating material. Smith discloses an analogous breathing circuit component that does teach one or more thermally insulating portions formed by one or more air pockets or other insulating material (0056 states “In addition a further sheath of breathable membrane 203 may be applied to the outside of the conduit, with the edges of adjacent urns 203 pressed onto and bonded to the outside of bead 201.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Clawson in view of Smith and include one or more thermally insulating portions formed by one or more air pockets or other insulating material as this provides thermal insulation while also allowing for dehumidification of the space between the inner and outer walls of the conduit (0056).
Regarding claim 40, modified Clawson teaches the medical conduit of claim 38, but fails to teach further comprising an elongate film spirally wrapped with an elongate reinforcing member to form a lumen, wherein the elongate film bonds with the elongate reinforcing member. Smith further discloses further comprising an elongate film spirally wrapped with an elongate reinforcing member to form a lumen (Paragraph 062 states that “a second layer of breathable membrane 210 is provided on the outside of second bead 209.” This is depicted in figure 10 where the elongate film (breathable member 210) is wrapped around the bead layer 209 in a helical manner.), wherein the elongate film bonds with the elongate reinforcing member (Paragraph 066 states the method of bonding the beads (reinforcing member) with the breathable member 210. Paragraph 0050 also contains additional detail on the bonding method).
It would have been prima facie obvious to one of ordinary skill in the art to modify modified Clawson with the teachings of Smith and include an elongate film spirally wrapped with an elongate reinforcing member to form a lumen, the elongate film bonding with the elongate reinforcing member as the use of a helical reinforcement shape allows for the formation of a flexible and resilient conduit (0050).
Regarding claim 41, modified Clawson in view of Smith teaches the medical conduit of claim 40. Smith further discloses wherein the at least one portion of the medical conduit comprises at least one portion of the elongate film (Paragraph 0049 states that “a spiral or helical internal (or external) reinforcing members, or a series of annular hoop reinforcing members, may be provided outside (or inside) the tubular membrane”. Figure 10 depicts the elongate film portion is located on the delivery conduit.).
Response to Arguments
Applicant’s arguments with respect to claim 38 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ROHAN DEEP PATEL whose telephone number is (571)270-5538. The examiner can normally be reached Mon - Fri 5:30 AM - 3:00 PM PST.
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, Brandy S Lee can be reached at (571) 2707410. 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.
/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights