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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 06/08/2023, 11/30/2023, 10/04/2024, 10/22/2025 and 02/23/2026 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 02/26/2024. As directed by the preliminary amendments, claims 1-18 have been cancelled and claims 19-38 have been added. As such, claims 19-38 are being examined in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the polymer injection port and gas inlet port must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 19-20 and 22-23 is/are objected to because of the following informalities:
Claim 19, line 3, recites “…locating the filter and the support frame in a mould…” but it is unclear if it is the first mould or second mould of claim 21. For clarity, claim 1 should recite “…locating the filter and the support frame in a first mould…”
Claim 19, line 5, recites “…providing a mould having…” it is unclear if it is the first mould or second mould of claim 21. For clarity, claim 1 should recite “…providing a second mould having…” Similarly, the mould referred to in lines 8, 9 and 13 of claim 1 should be amended to “second” mould for clarity.
Claim 20, line 3, recites “…and the sheet of filtering material…” but should recite “…and the filter…” for clarification.
Claim 22, line 1, recites “…into the mould with the support frame…” but should recite “…into the first mould with the support frame…” for clarity (as best understood from claim 21).
Claim 23, line 1, recites “…located in the mould…” but should recite “…located in the first mould…” for clarity (as best understood from claim 21).
Claim 29, lines 2-3, recites “… comprises an internal chamber at least partially bounded by a resiliently deformable closing wall” but should recite “…comprises the internal chamber at least partially bounded by the resiliently deformable closing wall” due to antecedent basis.
Claim 37, lines 2-3, recites “… comprises an internal chamber at least partially bounded by a resiliently deformable closing wall” but should recite “…comprises the internal chamber at least partially bounded by the resiliently deformable closing wall” due to antecedent basis.
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) 19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 16 and 18 of copending Application No 17/637,685 in view of Gebrewold (US 20120125341 A1).
Claim 19 of the instant application is/are rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1, 16 and 18 of copending Application No 17/637,685. Although the claims at issue are not identical, they are not patentably distinct from each other because Leary does not teach “a support frame and a filter.”
However, Gebrewold teaches a method of manufacturing a filter mask (shaped filtering face-piece respirator 10, see Figs. 1-2 and 5 and [0062]), the filter mask comprising a support frame (support structure 16, perimeter portion 20, frame member 36 and valve assembly 38, see Figs. 1 and [0006] and [0055]), a filter (filtering structure 18, see Figs. 3-4), and a sealing member (face seal 40, see Figs. 1-2). Gebrewold further securing the frame to the filter before overmolding the face seal as seen in Fig. 5 and [0062] and [0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Leary to include a support frame and filter as taught by Gebrewold to prevent containments from entering the wearers respiratory system by using filters (see [0001]-[0002] and [0058]) and for a structure that will hold up and protect the sealing cushion as part of a mask (as seen in Figs. 1-2).
This is a provisional nonstatutory double patenting rejection.
Claim(s) 27 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 16 and 18 of copending Application No 17/637,685.
Claim 27 of the instant application is/are rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1, 16 and 18 of copending Application No 17/637,685. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 31 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 16 and 18 of copending Application No 17/637,685.
Claim 31 of the instant application is/are rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1, 16 and 18 of copending Application No 17/637,685. Although the claims at issue are not identical, they are not patentably distinct from each other. The patient-contact surface of the enclosing wall is of claim 1 is equivalent to the external surface of the enclosing wall of claim 31 as the enclosing wall is both a patient-contact surface and external surface of the sealing member.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 31 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/021,968.
Claim 31 of the instant application is/are rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 1 of copending Application No 17/637,685. Although the claims at issue are not identical, they are not patentably distinct from each other. The patient-contact surface of the enclosing wall is of claim 1 is equivalent to the external surface of the enclosing wall of claim 31 as the enclosing wall is both a patient-contact surface and external surface of the sealing member.
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 (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 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.
Claim(s) 27-29 and 35-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gebrewold (US 20120125341 A1).
Regarding claim 27, Gebrewold teaches a filter mask (shaped filtering face-piece respirator 10, see Figs. 1-2 and 5 and [0062]) comprising a sealing member (face seal 40, see Figs. 1-2), at least a portion of the sealing member comprising an internal chamber at least partially bounded by a resiliently deformable enclosing wall (Gebrewold teaches an internal chamber at least partially bounded by a resiliently deformable enclosing wall formed of the polymer as seen in Fig. 2 where face seal element 40 defines an internal chamber as it is joined to the perimeter member 25 as seen in [0056] (similar to applicant’s Figs. 11-12 and page 47, lines 6-12). Furthermore, Gebrewold teaches the face seal element can be made from thermoplastic elastomers as seen in [0057], and therefore is a resiliently deformable enclosing wall), the enclosing wall including a face-contacting surface, the face-contacting surface having a form that provides an anatomical fit with a user (face seal element 40 includes a face-contacting surface that provides an anatomical fit with a user as it provides an “air-tight seal” to the wearer’s face and is to provide a snug fit as seen in [0056]).
Regarding claim 28, Gebrewold teaches the method of claim 27, and further teaches wherein the face-contacting surface of the sealing member is formed with a pre-determined anatomical shape (Gebrewold teaches the face seal element 40 may take on various shapes and sizes depending on the end user and the respiratory envisioned as seen in [0056], and therefore, face seal element 40 is formed with a pre-determined anatomical shape).
Regarding claim 29, Gebrewold teaches the method of claim 27, and further teaches only the nasal portion of the sealing member comprises a internal chamber at least partially bounded by a resiliently deformable enclosing wall (Gebrewold teaches only the nasal portion of sealing element 40 comprises an internal chamber (Gebreworld teaches face seal element 40 with flange portion 44 with a molded three-dimensional shape to accommodate a wearer’s nose as seen in [0056] and further teaches a nose clip 86 that can be deformed into a desired shape to provide a proper fit over the bridge of a wearer’s nose as seen in [0065]-[0066]) at least partially bounded by a resiliently deformable enclosing wall (sealing element 40 is made out of thermoplastic elastomers as seen in [0057])).
Regarding claim 36, Gebrewold teaches a sealing member (face seal 40, see Figs. 1-2) for a respiratory mask (shaped filtering face-piece respirator 10, see Figs. 1-2 and 5 and [0062]), a nasal region of the sealing member comprising an internal chamber at least partially bounded by a resiliently deformable enclosing wall, (Gebrewold teaches an internal chamber at least partially bounded by a resiliently deformable enclosing wall formed of the polymer as seen in Fig. 2 where a nasal region of face seal element 40 defines an internal chamber as it is joined to the perimeter member 25 as seen in [0056] (similar to applicant’s Figs. 11-12 and page 47, lines 6-12). Furthermore, Gebrewold teaches the face seal element can be made from thermoplastic elastomers as seen in [0057], and therefore is a resiliently deformable enclosing wall), the enclosing wall including a face-contacting surface, the face-contacting surface having a form that provides an anatomical fit with a user (face seal element 40 includes a face-contacting surface that provides an anatomical fit with a user as it provides an “air-tight seal” to the wearer’s face and is to provide a snug fit as seen in [0056]).
Regarding claim 37, Gebrewold teaches the sealing member of claim 36, and further teaches wherein only the nasal portion of the sealing member comprises an internal chamber at least partially bounded by a resiliently deformable enclosing wall (Gebrewold teaches only the nasal portion of sealing element 40 comprises an internal chamber (Gebreworld teaches face seal element 40 with flange portion 44 with a molded three-dimensional shape to accommodate a wearer’s nose as seen in [0056] and further teaches a nose clip 86 that can be deformed into a desired shape to provide a proper fit over the bridge of a wearer’s nose as seen in [0065]-[0066]) at least partially bounded by a resiliently deformable enclosing wall (sealing element 40 is made out of thermoplastic elastomers as seen in [0057]).
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claim(s) 19-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A), Chang (US 6408853 B1) and Gebrewold (US 20120125341 A1).
Regarding claim 19, Hicks teaches a method of manufacturing a mask (Hicks teaches a method of manufacturing an anatomical mask as seen in Figs. 1-5 and page 2, lines 5-10) the mask comprising a support frame (shell 13, see Fig. 1) and a sealing member (cushion 15, see Figs. 1-5), wherein the method comprises:
locating the support frame in a mould (shell 13 has already been moulded from a first, relatively hard polymeric material as seen in Fig. 2 and page 2, lines 5-10 and page 5, lines 8-9) and
forming the sealing member by:
providing a mould (mould 10, see Figs. 2-5) having a cavity (cavity 11, see Figs. 2-5) (mould 10 has upper and lower parts 5 and 4 with a cavity in between as seen in Figs. 2-5 and page 4, lines 25-30);
injecting a polymer into the cavity of the mould (second softer polymer is injected into outer region 9 of cavity 11 as seen in Fig. 2 and page 5, lines 4-9); and
introducing gas into the cavity of the mould, thereby forming a sealing member of the mask (Hicks teaches gas being introduced into cavity region 9 to form cushion 15 as seen in Figs. 2-5 and pages 5, lines 27-33), wherein at least part of the sealing member of the mask comprises an internal chamber at least partially bounded by a resiliently deformable enclosing wall formed of the polymer (Hicks teaches cushion 15 to be part of the internal chamber of finished mask 20 as seen in Fig. 1, wherein cushion 15 is made out of a second, soft polymer as seen on page 5, lines 4-17 (similar to applicant’s Figs. 11-12 and page 47, lines 6-12), the enclosing wall including a face-contacting surface (the bottom surface of cushion 15 in Fig. 1 would contact the patient’s face in use).
But is unclear on a polymer injection port and a gas inlet port and the face-contacting surface having a form that is determined by the cavity of the mould and provides an anatomical fit with a user and does not teach the mask comprising a filter.
However, Hendry teaches a method of manufacturing a molded article via injection molding, where the mold 15 is provided with a polymer injection port (bore 17 for receiving a plastic material as seen in Fig. 1 and Col. 4, lines 56-66) and a gas inlet port (bore 37 for receiving a pressurized gas as seen in Fig. 1 and Col. 5, lines 6-17).
Hicks lacks detailed description on how the second soft polymer and gas is being introduced into mould 10 when it is closed. 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 method taught by Hicks to include a polymer injection port and gas inlet port as taught by Hendry to facilitate the introduction of polymer and gas into the cavity while the mold is closed (see Col. 5, lines 41-52).
However, Chang teaches a method of molding air cushion 10 (taken as sealing member) wherein the mold cavity 23,24 determines the shape of the sealing member 10 wherein the material stretches to the walls of the mold to form a shape determined by the shape of the mold as seen in Fig. 3 and Col. 1, lines 39-45 and Col. 3, lines 8-35.
Hicks does not explicitly disclose that the patient-contacting surface has a form that is determined by the cavity of the mold but Hicks teaches the cushion expanding to its shape when the mould is opened. 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 method taught by Hicks in view of Hendry so that the sealing member is allowed to expand within a mold cavity having a shape corresponding to the desired shape of the sealing member as taught by Chang to have more control over the shape of the sealing member/cushion to better match a patient’s contour.
However, Gebrewold teaches a method of manufacturing a filter mask (shaped filtering face-piece respirator 10, see Figs. 1-2 and 5 and [0062]), the filter mask comprising a support frame (support structure 16, perimeter portion 20, frame member 36 and valve assembly 38, see Figs. 1 and [0006] and [0055]), a filter (filtering structure 18, see Figs. 3-4), and a sealing member (face seal 40, see Figs. 1-2). Gebrewold further securing the frame to the filter before overmolding the face seal as seen in Fig. 5 and [0062] and [0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Hicks to include a filter as taught by Gebrewold to prevent containments from entering the wearers respiratory system by using filters (see [0001]-[0002] and [0058]).
Regarding claim 20, modified Hicks teaches the method of claim 19, and further teaches wherein the sealing member is brought into engagement with the filter and the support frame, during injection moulding of the sealing member, in a manner that fixes the sealing member to the support frame and the sheet of filtering material (Modified Hicks teaches shell 13 (taught by Hicks) with filtering structure 18 (taught by Gebrewold) and further teaches injecting a second, softer polymer to be bonded to the periphery of shell 13 in a manner that fixes cushion 15 to shell 13 and filtering structure 18 as seen in Fig. 3 and page 5, lines 4-9 of Hicks).
Regarding claim 21, modified Hicks teaches the method of claim 20, and Hicks further teaches wherein the support frame is made in a preceding step of the method by injection moulding (Hicks teaches the shell to be typically made from injection moulding (see page 1, lines 16-17) wherein the shell 13 is already moulded as seen in Fig. 2 and page 5, lines 4-9), and the method further comprises a step of transferring the support frame from a first mould in which the support frame is injection moulded to a second mould in which the sealing member is injection moulded (Hicks teaches the central component/shell to be moulded in a first mould and then transferred to a second mould in which the cushion is to be moulded via injection moulding as seen on Figs. 2-5 and page 3, lines 1-5 and page 4, lines 25-30).
Regarding claim 22, modified Hicks teaches the method of claim 20, and further teaches wherein when the filter is located into the mould with the support frame, the support frame extends about the periphery of the filter (Gebrewold teaches the support structure joined to the filtering structure using injection molding (see [0063]) in which the perimeter portion 20 extends about the periphery of the filter as seen in Figs. 1-2. Therefore, modified Hicks teaches the filtering structure 18 (taught by Gebrewold) to be located in the mould with shell 13 (taught by Hicks), wherein the perimeter of shell 13 is to extend about the periphery of the filter).
Regarding claim 23, modified Hicks teaches the method of claim 20, and Gebreworld further teaches wherein the filter that is located in the mould in the method of manufacture comprises a filter substrate only (Gebreworld teaches filtering structure 18 to comprise only of filtration layers as seen in [0058]).
Regarding claim 24, modified Hicks teaches the method of claim 20, and further teaches wherein the support frame and the filter are not fixed or bonded together prior to injection moulding of the sealing member (Gebrewold teaches the filtering structure 18 to be adapted or fitted to the support structure as seen in [0058], however, they are not fixed or bonded together until face seal element 40 is overmolded onto the support structure and filtering structure 18 as seen in Fig. 3 and [0055] and [0081]. Therefore, modified Hicks teaches shell 13 and filtering structure 18 to not be fixed or bonded together before injection moulding of cushion 15).
Regarding claim 25, modified Hicks teaches the method of claim 19, and Hicks further teaches wherein a blowing agent may be injected with the polymer in the injecting step (Hicks teaches the second, soft polymer injected into the cavity region 9 contains a small proportion of a foaming agent which will release a gas when hot as seen on page 5, lines 11-14 and 27-33).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A), Chang (US 6408853 B1) and Gebrewold (US 20120125341 A1), as applied to claim 19 above, and further in view of Potnis (US 10314346 B2).
Regarding claim 26, modified Hicks teaches the method of claim 25, but does not teach wherein the blowing agent is a physical blowing agent.
However, Potnis teaches heat-activatable expandable inks that may include additives, known in the art as blowing agents, and can include chemicals which undergo physical or chemical changes on heating to form a gaseous product as seen in Col. 16, lines 4-30. Furthermore, the inks are to be used to form a face mask as seen in Col. 16, lines 23-30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Hicks to use a physical blowing agent instead of a chemical blowing agent as taught by Potnis as Potnis teaches either or can be used to form a face mask (see Col. 16, lines 23-30).
Claim(s) 30 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gebrewold (US 20120125341 A1) in view of Bowsher (US 20140053845 A1).
Regarding claim 30, Gebrewold in view of teaches the method of claim 29, but does not teach wherein cheek regions and a chin region of the sealing member comprise an outwardly and/or inwardly depending lip portion.
However, Bowsher teaches wherein cheek regions and a chin region of the sealing member (sealing formation 20, see Fig. 3) comprise an outwardly and/or inwardly depending lip portion (lip portions 22 and 28, see Fig. 3) (Bowsher teaches sealing formation 20 to comprise of inwardly depending lip portion 22 (cheek region) and outwardly depending lip portion 28 (chin region) as seen in Fig. 3 and [0052]-[0053] and [0056]-[0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Gebrewold for the sealing member to comprise an outwardly and/or inwardly depending lip portion for the cheek and chin regions as taught by Bowsher for a seal that allows for a relatively larger range of facial profiles to be accommodated by a single mask design (see [0011]-[0012]).
Regarding claim 38, Gebrewold teaches the sealing member of claim 37, but does not teach wherein cheek regions and a chin region of the sealing member comprise an outwardly and/or inwardly depending lip portion.
However, Bowsher teaches wherein cheek regions and a chin region of the sealing member (sealing formation 20, see Fig. 3) comprise an outwardly and/or inwardly depending lip portion (lip portions 22 and 28, see Fig. 3) (Bowsher teaches sealing formation 20 to comprise of inwardly depending lip portion 22 (cheek region) and outwardly depending lip portion 28 (chin region) as seen in Fig. 3 and [0052]-[0053] and [0056]-[0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Gebrewold for the sealing member to comprise an outwardly and/or inwardly depending lip portion for the cheek and chin regions as taught by Bowsher for a seal that allows for a relatively larger range of facial profiles to be accommodated by a single mask design (see [0011]-[0012]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A) and Chang (US 6408853 B1).
Regarding claim 31, Hicks teaches a method of manufacturing a sealing member (cushion 15, see Figs. 1-5) for use in a respiratory mask (Hicks teaches a method of manufacturing cushion 15 for use in an mask for respiratory purposes as seen in Figs. 1-5 and page 1, lines 3-14 and page 2, lines 5-10), the method comprising the steps of:
providing a mould (mould 10, see Figs. 2-5) having a cavity (cavity 11, see Figs. 2-5) (mould 10 has upper and lower parts 5 and 4 with a cavity in between as seen in Figs. 2-5 and page 4, lines 25-30);
injecting a polymer into the cavity of the mould (second softer polymer is injected into outer region 9 of cavity 11 as seen in Fig. 2 and page 5, lines 4-9); and
introducing gas into the cavity of the mould, to form a sealing member (Hicks teaches gas being introduced into cavity region 9 to form cushion 15 as seen in Figs. 2-5 and pages 5, lines 27-33), wherein a nasal region of the sealing member comprises an internal chamber at least partially bounded by a resiliently deformable enclosing wall formed of the polymer (Hicks teaches a nasal region of cushion 15 (Hicks teaches a face mask designed to cover the nose and/or mouth of a user as seen in page 1, lines 3-5, and as such, the mask and cushion 15 is to cover a user’s nose) to be part of the internal chamber of finished mask 20 as seen in Fig. 1, wherein cushion 15 is made out of a second, soft polymer as seen on page 5, lines 4-17 (similar to applicant’s Figs. 11-12 and page 47, lines 6-12), the enclosing wall including an external surface (cushion 15 includes an external surface as seen in Fig. 1).
but is unclear on a polymer injection port and a gas inlet port;
the external surface having a form that is determined by the cavity of the mould
However, Hendry teaches a method of manufacturing a molded article via injection molding, where the mold 15 is provided with a polymer injection port (bore 17 for receiving a plastic material as seen in Fig. 1 and Col. 4, lines 56-66) and a gas inlet port (bore 37 for receiving a pressurized gas as seen in Fig. 1 and Col. 5, lines 6-17).
Hicks lacks detailed description on how the second soft polymer and gas is being introduced into mould 10 when it is closed. 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 method taught by Hicks to include a polymer injection port and gas inlet port as taught by Hendry to facilitate the introduction of polymer and gas into the cavity while the mold is closed (see Col. 5, lines 41-52).
However, Chang teaches a method of molding air cushion 10 (taken as sealing member) wherein the mold cavity 23,24 determines the shape of the sealing member 10 wherein the material stretches to the walls of the mold to form a shape determined by the shape of the mold as seen in Fig. 3 and Col. 1, lines 39-45 and Col. 3, lines 8-35.
Hicks does not explicitly disclose that the external surface has a form that is determined by the cavity of the mold but Hicks teaches the cushion expanding to its shape when the mould is opened. 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 method taught by Hicks in view of Hendry so that the sealing member is allowed to expand within a mold cavity having a shape corresponding to the desired shape of the sealing member as taught by Chang to have more control over the shape of the sealing member/cushion to better match a patient’s contour.
Regarding claim 34, modified Hicks teaches the method of claim 31, and Hicks further teaches wherein a blowing agent may be injected with the polymer in the injecting step (Hicks teaches the second, soft polymer injected into the cavity region 9 contains a small proportion of a foaming agent which will release a gas when hot as seen on page 5, lines 11-14 and 27-33).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A) and Chang (US 6408853 B1), as applied to claim 31 above, and further in view of Gebrewold (US 20120125341 A1)
Regarding claim 32, modified Hicks teaches the method of claim 31, but does not teach wherein only the nasal region of the sealing member comprises an internal chamber at least partially bounded by a resiliently deformable enclosing wall formed of the polymer.
However, Gebrewold teaches wherein only the nasal portion of the sealing member comprises an internal chamber at least partially bounded by a resiliently deformable enclosing wall (Gebrewold teaches only the nasal portion of sealing element 40 comprises an internal chamber (Gebreworld teaches face seal element 40 with flange portion 44 with a molded three-dimensional shape to accommodate a wearer’s nose as seen in [0056] and further teaches a nose clip 86 that can be deformed into a desired shape to provide a proper fit over the bridge of a wearer’s nose as seen in [0065]-[0066]) at least partially bounded by a resiliently deformable enclosing wall (sealing element 40 is made out of thermoplastic elastomers as seen in [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Hicks to include a nose clip 86 as taught by Gebrewold to deform the nasal section of the mask into a desired shape to provide a proper fit over the bridge of a wearer’s nose (see [0065]-[0066]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A) and Chang (US 6408853 B1), as applied to claim 31 above, and further in view of Bowsher (US 20140053845 A1).
Regarding claim 33, modified Hicks teaches the method of claim 31, but does not teach wherein cheek regions and a chin region of the sealing member comprise an outwardly and/or inwardly depending lip portion.
However, Bowsher teaches wherein cheek regions and a chin region of the sealing member (sealing formation 20, see Fig. 3) comprise an outwardly and/or inwardly depending lip portion (lip portions 22 and 28, see Fig. 3) (Bowsher teaches sealing formation 20 to comprise of inwardly depending lip portion 22 (cheek region) and outwardly depending lip portion 28 (chin region) as seen in Fig. 3 and [0052]-[0053] and [0056]-[0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Hicks for the sealing member to comprise an outwardly and/or inwardly depending lip portion for the cheek and chin regions as taught by Bowsher for a seal that allows for a relatively larger range of facial profiles to be accommodated by a single mask design (see [0011]-[0012]).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (WO 03016018 A1) in view of Hendry (US 4474717 A) and Chang (US 6408853 B1), as applied to claim 34 above, and further in view of Potnis (US 10314346 B2).
Regarding claim 35, modified Hicks teaches the method of claim 34, but does not teach wherein the blowing agent is a physical blowing agent.
However, Potnis teaches heat-activatable expandable inks that may include additives, known in the art as blowing agents, and can include chemicals which undergo physical or chemical changes on heating to form a gaseous product as seen in Col. 16, lines 4-30. Furthermore, the inks are to be used to form a face mask as seen in Col. 16, lines 23-30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Hicks to use a physical blowing agent instead of a chemical blowing agent as taught by Potnis as Potnis teaches either or can be used to form a face mask (see Col. 16, lines 23-30).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gooch (US 20110086078 A1) teaches blowing agents can be either physical or chemical.
Ho (US 20120318272 A1) teaches seal cushions for mask can be for nasal only, mouth only or for both the mouth and nose.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785