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 Amendment
The Amendments filed 09/18/2025 responsive to the Office Action filed 06/18/2025 has been entered. Claims 1 and 9 have been amended. Claims 2-8 and 13 have been canceled. Claims 1, 9-12 and 14-20 remain pending in this application.
Response to Arguments
Applicant’s arguments, see Amendment, filed 09/18/2025 in pages 6-9, with respect to the rejection of claim 1 under 103 have been fully considered and the rejection has been withdrawn due to the amendments. However, upon further consideration, a new ground(s) of rejection under 103 is made in view of Brain (WO 94/17848- of record) further in view of Broadbent (“Getting Into LSR: Part II- Choosing an Injection Machine”, Plastics Technology, 12/10/2010- of record), Leary et al. (US 2022/0280739), and Herzog (“Machine shut-off nozzle for elastomeric plastics; type E”, 07/02/2015-of record).
Applicant argues that “Brain is silent regarding any injection nozzle and a heat source connected to the mold. Broadbent discloses a shutoff nozzle having a diving tip that "penetrates the sprue bushing" (see "Injection Units" page 4). Herzog meanwhile discloses a nozzle having a tip that "lies against the cold channel" (see "Conical tip for cold channel" page 3). Thus, none of the cited references disclose or suggest the step of positioning the injection nozzle relative to the sprue bush such that a portion of the injection nozzle is in proximity to a portion of the sprue bush, as recited in amended independent claim 1.” (pages 7-8)
These arguments are found to be unpersuasive because:
Claim requires that a portion of the injection nozzle is in proximity to a portion of the sprue bush. Thus, even though Broadbent discloses a shutoff nozzle having a diving tip that "penetrates the sprue bushing", still other portion of the injection nozzle is in proximity to the sprue bush, thus the combination meets the claimed limitation.
Applicant further argues that “Herzog discloses a shut-off nozzle but it does not include an injection channel having a decreasing tapered diameter extending from the proximal end to the distal end. Rather, the injection channel of Herzog only has a distal tapered portion, as shown in the figures on pages 2 and 3. Also, as shown in the figure on page 1 of Herzog, the shut-off nozzle does not have a cooling channel having a fluid inlet and a fluid outlet disposed along the side of the injection nozzle at a location distal to the proximal end of the injection nozzle. Furthermore, figure 1 of Herzog also fails to show a portion of the cooling channel surrounds a portion of the injection channel.” (page 8)
These arguments are found to be unpersuasive because:
For the better view of Herzog’s Figures, the colored version of Herzog has been provided. As shown in the colored version of Herzog’s Figure below, Herzog teaches claimed injection nozzle.
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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.
Claims 1, 9-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brain (WO 94/17848- of record) in view of Broadbent (“Getting Into LSR: Part II- Choosing an Injection Machine”, Plastics Technology, 12/10/2010- of record), Leary et al. (US 2022/0280739), and Herzog (“Machine shut-off nozzle for elastomeric plastics; type E”, 07/02/2015-of record).
With respect to claim 1, Brain teaches a method of manufacturing a medical airway device (“A manufacturing process to produce a laryngeal mask (10)”) having a cuff (“the inflatable annular ring (13)”) (Abstract), the method comprising:
providing an injection mold (“the mould”, pg 7 li 27) comprising a mold cavity (“the cavity”, pg 9 li 26) and a sprue passage (“sprue-passage designation 39”, pg 9 li 29-30) in fluid communication with the mold cavity;
shaping the cuff by injecting the thermosetting elastomeric material through the sprue passage and into the mold cavity (“Various mould designers will have preferences for sprue accommodation, but in Fig. 4, the phantom sprue-passage designation 39 will be understood to suggest an advantage in having the flange-forming cavity 31' serve as an excellent manifold for efficient distribution of the silicon-rubber or the like material that is injected under pressure in the moulding process.”, pg 9 li 28-34);
forming the cuff by curing the thermosetting elastomeric material within the mold cavity (“the moulded intermediate product of Fig. 2 is cured sufficiently”, pg 9 li 34-35); and
attaching the formed cuff to an airway tube (“The mask of Fig. 1 is then completed by assembling the separately moulded plate component 12 (Fig. 2A) thereto.”, pg 10 li 27-28; “The plate 12 of Fig. 2A will then offer its cylindrical counterbore 40 for assembling connection to the airway tube 11”, pg 11 li 6-8).
Brain teaches that various mould designers will have preferences for sprue accommodation, but in Fig. 4, the phantom sprue-passage designation 39 will be understood to suggest an advantage in having the flange-forming cavity 31' serve as an excellent manifold for efficient distribution of the silicon-rubber or the like material that is injected under pressure in the moulding process (pg 9 li 28-34), but does not explicitly teach providing an injection molding apparatus loaded with a thermosetting elastomeric material, the injection molding apparatus comprising an injection nozzle; an injection mold comprising a sprue bush; positioning the injection nozzle relative to the sprue bush such that a portion of the injection nozzle is in proximity to a portion of the sprue bush; heating the injection mold with a mold heater to a temperature in a range of 160°C to 220°C, the mold heater being connected to the injection mold; forming the cuff by curing at the same time preventing premature curing of residual thermosetting elastomeric material within the injection nozzle by applying heat to the thermosetting elastomeric material within the mold cavity while cooling the injection nozzle with a cooling fluid at a temperature in a range of 5°C to 50°C.
In the same field of endeavor, liquid silicone rubber injection molding, Broadbent teaches that because LSR is a thermoset that cures when heated, the injection unit has a water-cooled barrel to maintain consistent temperature of the material during metering and injection and to retard reaction of the material prior to molding (pg 3, “Injection Units”), and the end of the barrel must be equipped with a shutoff nozzle, the tip penetrates the sprue bushing and can be retracted slightly to decompress the cold-runner system, this small amount of decompression helps avoid leakage in the mold nozzles when using an open-nozzle system, and the tip can be water-cooled (pg 4, “Injection Units”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Brain with the teachings of Broadbent and provide an injection molding apparatus loaded with the silicon-rubber material, the injection molding apparatus comprising a shutoff nozzle; an injection mold comprising a sprue bush; positioning the nozzle relative to the sprue bush such that the tip penetrates the sprue bushing and can be retracted slightly to decompress the cold-runner system, provide a water-cooled barrel with the nozzle tip in order to maintain consistent temperature of the material during metering and injection and to retard reaction of the material prior to molding. Furthermore, Broadbent teaches that thermoset cures when heated (pg 3, “Injection Units”), thus one would have found it obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a heat source with the injection mold in order to cure the silicone rubber material.
In the same field of endeavor, a method of manufacturing a sealing member for a respiratory interface device, Leary teaches that for liquid silicone rubber, a liquid injection moulding (LIM) process is typically used (Pa [0160]), and the mould is heated, eg at temperatures from 180 to 200° C., in order to initiate curing, and once the polymer has cured, the respiratory interface device may be removed from the mould (Pa [0162]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Brain in view of Broadbent with the teachings of Leary and perform heating the injection mold at temperatures from 180 to 200° C. in order to initiate curing.
Broadbent teaches that the fluid inlet being in fluid communication with a fluid supply source (“the end of the barrel must be equipped with a shutoff nozzle”, pg 4, “Injection Units”) and one of ordinary skill in the art would have considered that Broadbent teaches the injection nozzle inherently comprising a proximal end, a distal end, and an injection channel longitudinally extending from the proximal end to the distal end, the injection channel terminating at a nozzle outlet at the distal end, but does not explicitly teach the injection channel having a decreasing tapered diameter extending from the proximal end to the distal end; wherein the injection nozzle comprises a cooling channel in which the cooling fluid flows for preventing curing of the thermosetting elastomeric material within the injection channel, the cooling channel including a fluid inlet and a fluid outlet, and the fluid inlet and the fluid outlet being disposed along the side of the injection nozzle at a location distal to the proximal end of the injection nozzle; and wherein a first portion of the cooling channel flows along a first portion of the injection channel, and a second portion of the cooling channel surrounds a second portion of the injection channel.
In the same field of endeavor, machine shut-off nozzle for elastomeric plastics, Herzog teaches that the field of application for the E-Nozzle is primarily LSR (Liquid Silicone Rubber), and the E-nozzle shows a very compact design, a 2-way pneumatic cylinder controls the shut-off mechanism while the integrated cooling system, which goes up to the nozzle tip, ensures functional and reliable processing (pg 2 “Technical description”) for no vulcanization in the nozzle (pg 2, “For & Against”). Herzog further shows the injection channel having a decreasing tapered diameter extending from the proximal end to the distal end, and a cooling channel (“tempered circulation”) including a fluid inlet/outlet being disposed along the side of the injection nozzle at a location distal to the proximal end of the injection nozzle; and wherein a first portion of the cooling channel flows along a first portion of the injection channel, and a second portion of the cooling channel surrounds a second portion of the injection channel. (See the colored version of Fig. in pg 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Brain in view of Broadbent and Leary with the teachings of Herzog and provide the E-Nozzle comprising a 2-way pneumatic cylinder and integrated cooling system as the shutoff nozzle for the purpose of no vulcanization in the nozzle with controlled shut-off mechanism.
Even though the combination does not specifically teach a cooling temperature in a range of 5°C to 50°C, one would have found it obvious to select the optimum temperature range by routine experimentation in order to maintain consistent temperature of the material during metering and injection and to retard reaction of the material prior to molding. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
With respect to claim 9, Herzog as applied in the combination regarding claim 1 above further teaches that the proximal end of the injection nozzle is configured to threadedly engage a manifold of the injection molding apparatus (Figure in pg 5).
With respect to claim 10, Brain as applied to claim 1 above further teaches that the injection mold further comprises a mold core (“a rugged core element 20”, pg 7 li 30) defining a peripheral space within the mold cavity, the peripheral space corresponding to a shape of the cuff (“A peripherally continuous space 28 between core 20 and the cooperating outer mould parts 20, 21, 23, 24 will be seen to account for the moulded intermediate product of Fig, 2.”, pg 8 li 5-7).
With respect to claim 11, Brain as applied to claim 1 above further teaches that the formed cuff is inflatable (“a peripheral inflatable/deflatable element or ring 13”, pg 7 li 12).
With respect to claim 12, Broadbent as applied in the combination regarding claim 1 above teaches that the injection molding apparatus (“injection unit”) further comprises a manifold containing the thermosetting elastomeric material (“the screw and barrel assembly”, pg 3, “Injection Units”).
With respect to claim 14, Brain as applied to claim 1 above further teaches that the medical airway device is a tracheal tube (“This invention relates to an artificial airway device”, “an endotracheal tube, which is a flexible tube of rubber or plastics, usually with an inflatable cuff around the distal end”, pg 1 li 3, 12-14)
With respect to claim 15, Brain as applied to claim 1 above further teaches that the medical airway device is a laryngeal mask airway (pg 7 li 2-3).
With respect to claim 16, the combination as applied to claim 1 above further teaches comprising
shaping a backplate by injecting the thermosetting elastomeric material from the injection nozzle through the sprue passage and into the mold cavity (Brain: “the back-plate formation 50 is integrally moulded to and as part of the same process as that in which the skirt (Fig. 6) and its inflation/deflation connector 17 are formed”, pg 12 li 25-28; “The outer components of the mould are simplified to show establishment of a single cavity in outer-mould structure 55, supplied as by injection of liquid moulding material via one or more sprue passages, suggested at 56.”, pg 13 li 5-9);
forming the backplate by curing the thermosetting elastomeric material within the mold cavity (Brain: “cured sufficiently”, pg 9 li 35) and at the same time preventing premature curing of residual thermosetting elastomeric material within the injection nozzle by applying heat to the thermosetting elastomeric material within the mold cavity while cooling the injection nozzle with a cooling fluid (Broadbent: pg 3-4, “Injection Units”); and
attaching the formed backplate to the airway tube (Brain: “The completed laryngeal mask (Fig. 5) is functionally the equivalent of the mask of Fig. 1 and is shown connected in the same way to airway tube 11 and to the supply tubing 41 for inflation/deflation of the inflatable ring 51.”, pg 12 li 30-34).
With respect to claim 17, Brain as applied to claim 16 above further teaches that the injection mold further comprises a mold core (“a core 52”, pg 13 li 3; and “a mould-cavity defining plug 68”, pg 14 li 3-4) defining a space within the mold cavity corresponding to a shape of the backplate (“the core 52 rises with a convergent upper body portion which is profiled to establish internal features of the back-plate 50.”, pg 13 li 28-30 and Fig. 7).
With respect to claim 18, Brain as applied to claim 16 above further teaches that injection molding the cuff and the backplate are formed in a single step (“the mould of Fig. 7, which enables one-step moulding of the entire mask of Fig. 5”, pg 13 li 1-2).
With respect to claim 19, Brain as applied to claim 1 above further teaches that the thermosetting elastomeric material comprises liquid silicone rubber (“it may be moulded from the same silicone-rubber material as is the intermediate product of Fig. 2.”, pg 10 li 30-32).
With respect to claim 20, Broadbent as applied in the combination regarding claim 1 above teaches that the cooling fluid comprises water (“a water-cooled barrel”, “the tip can be water-cooled (pg 3-4, “Injection Units”).
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 YUNJU KIM whose telephone number is (571)270-1146. The examiner can normally be reached on 8:00-4:00 EST M-Th; Flexing Fri.
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/YUNJU KIM/Primary Examiner, Art Unit 1742