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
This office action is responsive to the amendment filed on 10/31/2025. As directed by the amendment: claims 1, 10-11, 14, and 20 have been amended, claims 8-9, 13, and 17 have been canceled, and claims 21-24 have been added. Thus, claims 1-7, 10-12, 14-16, and 18-24 are presently pending in the application.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The following claim language should be disclosed in the specification:
The limitation “at least one strap secured to the outer perimeter of the covering material” as set forth in line 2 of claim 10.
The limitation “wherein the mask is configured to engage the face of the wearer to permit air to pass between the face and the outer perimeter of the mask” as set forth in lines 1-2 of claim 21
The limitation “wherein the outer perimeter of the covering material is rectangular ” as set forth in lines 1-2 of claim 22.
The limitation “wherein the outer perimeter of the covering material has a first side edge and a second side edge, wherein the covering material comprises a plurality of folds between the first side edge and the second side edge” as set forth in lines 1-3 of claim 23.
The limitation “wherein the elongate conduit projects outwardly from the at least one transparent membrane to enable a medical professional to pliably manipulate the at least one transparent membrane to position the hole relative to the head of the wearer” as set forth in lines 12-15 of claim 24.
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.
Claims 1-3, 18-19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Pierro (US 20120285466 A1) in view of Zilberstein (US 20160317848 A1).
Regarding claim 1, Pierro discloses a mask (FIG. 4 Patient Interface 119 set forth in 0065]) comprising: a covering material (FIG, 4 Frame 125, facial skin interface 130, and noes bridge seal 135 as set forth in [0054]-[0055] with respect to FIG. 1, but applies to the embodiment of FIG. 4) that is sufficiently sized to extend over a mouth and a nose on a head of a wearer (Shown in FIG. 4 covering patient’s 101 mouth and nose), wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer (FIG. 4 a facial skin interface 130 as set forth in [0054]-[0055]), wherein the covering material has an outer surface and an inner surface (FIG. 4 The portion of covering material, frame 125, facial skin interface 130, and noes bridge seal 135, has an outer surface exposed to the environment and an inner surface on the side of the mask closest to the user), wherein the covering material defines an opening therethrough (FIG. 4 Portion of the mask receiving interchangeable patient interface insert 120B as shown in the annotated figure below);
at least one transparent membrane (FIG. 4 Interchangeable patient interface insert 120B; The removable insert may be coated in the inside surface with an anti-fogging layer which assists in maintaining a transparent surface as set forth in [0156]) coupled to the covering material and covering the opening in the covering material (FIG. 4 Interchangeable patient interface insert 120B is coupled to frame 125, facial skin interface 130, and nose bridge seal 135), wherein the at least one transparent membrane defines a hole therethrough (FIG. 4 Access port 401 set forth in [0064]-[0065]);
a membrane reinforcement structure (FIG. 4 The ring surrounding access port 401 shown in the annotated figure below) surrounding the hole through the at least one transparent membrane (FIG. 4 Access port 401 set forth in [0064] as well as the ring surrounding access port 401 are through the interchangeable patient interface insert 120B);
and at least one securing element for securing the mask to the head of the wearer (FIG. 4 Head strap system 111 as set forth in [0051] with respect to FIG. 1, but applies to the embodiment of FIG. 4).
Pierro fails to explicitly disclose, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough.
However, Zilberstein teaches, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]).
Pierro and Zilberstein are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the covering material of Pierro to incorporate the teaching of Zilberstein and include wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]). Doing so would aid in the filtration of microbes or other airborne contaminants (Zilberstein: As set forth in [0089]).
Pierro fails to explicitly disclose, wherein the reinforcement structure is configured to reinforce portions of the transparent membrane.
However, the ring is included on the interchangeable patient interface insert 120B and surrounds the self-sealing access port 401 comprising one or more slits 402, the ring defining the change from the insert 120B and the port 401. The ability to enable the tube 403 be left in place within self-sealing access port 401 as set forth in [0065], provides sufficient reasoning to indicate that the ring supports the position of the access port 401 within the patient interface inset 120B, and therefore reinforces portions of the transparent membrane.
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Regarding claim 2, Pierro discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pierro further discloses the mask, further comprising a valve (FIG. 4 The access port 401 containing the one or more slits 402 as shown in the annotated figure below) that is configured to inhibit flow through the hole through the at least one transparent membrane (Intended use; The portion of access port 401 containing the one or more slits 402 would inhibit the flow through the access port 401).
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Regarding claim 3, Pierro discloses the claimed invention substantially as claimed as set forth for claim 2 above.
Pierro further discloses the mask, wherein the valve comprises a flexible membrane and a slit through the flexible membrane (FIG. 4 One or more slits 402 of the access port 401 through which a tube, such as tube 403 may be sealably inserted as set forth in [0064]-[0065]; this would indicate that the valve, portion of access port 401 containing the one or more slits 402, is flexible).
Pierro is silent as to whether the flexible valve membrane is a polymer material.
However, Pierro teaches the use of a Thermo Plastic Elastomer (TPE), two-layer or multi-layer plastic, a material of variable wall thickness, a combination of elastic and plastic materials, or other flexible materials that are known in the art, for the facial skin interface (Set forth in [0057]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pierro to use one of the disclosed flexible materials like a thermos plastic elastomer (TPE), a polymer, for use in the flexible membrane of the valve comprising the slits. Doing so would provide a well-known flexible material in the art, as well as simplify the manufacturing process given that the facial skin interface and membrane of the valve were composed of the same material.
Regarding claim 18, Pierro discloses a method of using a mask (FIG. 4 Patient Interface 119 set forth in 0065]) [The mask being the same mask from the rejection of claim 1, therefore, the rejection above reads on the limitations regarding the mask of claim 18] for a medical procedure (FIG. 4 Self-sealing access port 401 provides an opening through which a medical professional can perform procedures such as a bronchoscopy), the method comprising: positioning the mask on a patient (FIG. 4 shows the mask being positioned on the patient as set forth in [0065]); and inserting a medical instrument through the membrane reinforcement structure (FIG. 4 Self-sealing access port 401 comprises one or more slits 402 providing an opening through which a medical professional can perform procedures such as a bronchoscopy, as it gives access for a bronchoscope or other tubing or medical devices/instruments which may be inserted into the oral or nasal cavities of the patient as set forth in [0065]).
Regarding claim 19, Pierro discloses the claimed invention substantially as claimed as set forth for claim 18 above.
Pierro further discloses the method, wherein the medical procedure is an endoscopy procedure, and wherein the medical instrument is an endoscope (FIG. 4 Self-sealing access port 401 comprises one or more slits 402 providing an opening through which a medical professional can perform procedures such as a bronchoscopy, as it gives access for a bronchoscope or other tubing or medical devices/instruments which may be inserted into the oral or nasal cavities of the patient as set forth in [0065]; A bronchoscopy is a type of endoscopy specifically referring to insertion of an endoscope, a “bronchoscope” in this scenario, to examine the lungs).
Regarding claim 24, Pierro discloses a mask (FIG. 4 Patient Interface 119 set forth in 0065]) comprising: a covering material (FIG, 4 Frame 125, facial skin interface 130, and noes bridge seal 135 as set forth in [0054]-[0055] with respect to FIG. 1, but applies to the embodiment of FIG. 4) that is sufficiently sized to extend over a mouth and a nose on a head of a wearer (Shown in FIG. 4 covering patient’s 101 mouth and nose), wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer (FIG. 4 a facial skin interface 130 as set forth in [0054]-[0055]), wherein the covering material has an outer surface and an inner surface (FIG. 4 The portion of covering material, frame 125, facial skin interface 130, and noes bridge seal 135, has an outer surface exposed to the environment and an inner surface on the side of the mask closest to the user), wherein the covering material defines an opening therethrough (FIG. 4 Portion of the mask receiving interchangeable patient interface insert 120B as shown in the annotated figure below); at least one transparent membrane (FIG. 4 Interchangeable patient interface insert 120B; The removable insert may be coated in the inside surface with an anti-fogging layer which assists in maintaining a transparent surface as set forth in [0156]) coupled to the covering material and covering the opening in the covering material (FIG. 4 Interchangeable patient interface insert 120B is coupled to frame 125, facial skin interface 130, and nose bridge seal 135), wherein the at least one transparent membrane defines a hole therethrough (FIG. 4 Access port 401 set forth in [0064]-[0065]); an elongate conduit (FIG. 4 Tube 403 as set forth in [0065]) defining an interior passage having a central axis (It would be understood by one of ordinary skill in the art that a tube comprises an interior passage and central axis), wherein the elongate conduit has a proximal end portion coupled to the at least one transparent membrane so that the central axis of the interior passage is aligned with the hole (FIG. 4 Tube 403 which may be sealably inserted through the slits 402 of the interchangeable patient interface insert 120B as set forth in [0065]; the proximal end portion being the portion of the tube 403 that engages with the slits 402 when the end of the tube is inserted), wherein the elongate conduit projects outwardly from the at least one transparent membrane (FIG. 4 The end of the tube 403 not inserted into slits 402 would project outwardly from the membrane) to enable a medical professional to pliably manipulate the at least one transparent membrane to position the hole relative to the head of the wearer (FIG. 4 One or more slits 402 of the access port 401 through which a tube, such as tube 403 may be sealably inserted as set forth in [0064]-[0065]; this would indicate that the valve, portion of access port 401 containing the one or more slits 402, is flexible. Given that the access port with slits 402 is flexible, a medical professional would be able to pliably manipulate the at access port 401 to position the hole formed by the slits 402 relative to the head of the wearer); and at least one securing element for securing the mask to the head of the wearer (FIG. 4 Head strap system 111 as set forth in [0051] with respect to FIG. 1, but applies to the embodiment of FIG. 4).
Pierro fails to explicitly disclose, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough.
However, Zilberstein teaches, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the covering material of Pierro to incorporate the teaching of Zilberstein and include wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]). Doing so would aid in the filtration of microbes or other airborne contaminants (Zilberstein: As set forth in [0089]).
Claims 1, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080127984 A1) in view of Tirotta (US 5431158 A) and Zilberstein (US 20160317848 A1).
Regarding claim 1, Thornton discloses a mask (FIG. 1A,B and 2 Medical mask 10 set forth in [0017] and [0023]) comprising: a covering material (FIG. 1A,B and 2 Body 11 which includes shell 12 and sealing portion 13 as set forth in [0019]) that is sufficiently sized to extend over a mouth and a nose on a head of a wearer (Shown in FIG. 1A,B covering the user’s mouth and nose), wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer (FIG. 1A,B and 2 Sealing portion 13 as set forth in [0019]), wherein the covering material has an outer surface and an inner surface (FIG. 1A,B and 2 Body 11 which includes shell 12 and sealing portion 13, has an outer surface exposed to the environment and an inner surface on the side of the mask closest to the user), wherein the covering material defines an opening therethrough (FIG. 2 Opening 18 set forth in [0023]);
at least one membrane (FIG. 1A,B and 2 Deformable material 15 set forth in [0023]) coupled to the covering material and covering the opening in the covering material (FIG. 1A,B Shows deformable material 15 covering opening 18 from FIG. 2), wherein the at least one membrane defines a hole therethrough (FIG. 2 Hole of deformable material 15 as shown in the annotated figure below);
a membrane reinforcement structure configured to reinforce portions of the membrane (FIGS. 5A-5C illustrate example locking mechanisms 30 for use with orientation structure 14 of FIG. 1A,B and 2 as set forth in [0038]; FIG. 5B Locking mechanism 30 as set forth in [0039] which would surround the hole of the deformable material 15 as shown in FIG. 1A,B; the use flange 38 may provide additional structural support or stability for locking mechanism 30 and may provide improved coupling between locking mechanism 30 and deformable material 15, in other words, reinforce the portion of the mask at the edge of the deformable material) surrounding the hole through the at least one membrane.
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Thornton fails to explicitly disclose that the membrane covering the opening is transparent and that the at least one securing element for securing the mask to the head of the wearer.
However, Tirotta teaches that a portion of the mask is transparent (Tirotta: Column 5 Lines 23-27) and at least one securing element for securing the mask to the head of the wearer (Tirotta: FIG. 1-2 Strap 12 as set forth in Column 5 Lines 35-39).
Thornton and Tirotta are both considered to be analogous to the claimed invention because they are in the same field of medical masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of Tirotta and make the membrane covering the opening transparent (Tirotta: Column 5 Lines 23-27) and add at least one securing element for securing the mask to the head of the wearer (Tirotta: FIG. 1-2 Strap 12 as set forth in Column 5 Lines 35-39). Doing so would allow for visual observation of the patient’s nasal and oral regions by use of a transparent membrane (Tirotta: Column 5 Lines 23-27) and provide a method of adjustably securing the mask to the face of a patient using the strap (Tirotta: Column 5 Lines 35-39).
Thornton as modified fails to explicitly disclose, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough.
However, Zilberstein teaches, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]).
Thorton and Zilberstein are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the covering material of Thorton to incorporate the teaching of Zilberstein and include wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]). Doing so would aid in the filtration of microbes or other airborne contaminants (Zilberstein: As set forth in [0089]).
Regarding claim 4, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Thornton as modified further discloses the mask, wherein the membrane reinforcement structure comprises an elongate conduit (FIG. 1B,4, and 5B Locking mechanism 30 includes an opening 24 configured to receive and secure post 26, opening 34 being an elongate conduit) defining an interior passage having a central axis (FIG. 5B Opening 34 being an elongate conduit forms an interior passage having an central axis indicated by the dotted line in FIG. 2), wherein the elongate conduit is coupled to the at least one transparent membrane so that the central axis of the interior passage is aligned with the hole (FIG. 2 Locking mechanism 30, including opening 34 from FIG. 5B, is coupled to the deformable material 15,the central axis aligned with the hole; Tirotta: Transparent membrane [Column 5 Lines 23-27]), wherein the elongate conduit defines a radially extending flange having an inner flange surface and an outer flange surface (FIG. 5B Flange 38 of locking mechanism 30 as set forth in [0039]; the inner flange surface being the portion contacting the deformable material 15 and the outer flange surface being the portion exposed to the environment).
Regarding claim 10, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Thornton as modified by Tirotta further discloses the mask, wherein the at least one securing element comprises at least one strap secured to the outer perimeter of the covering material (Tirotta: FIG. 1-2 Strap 12 as set forth in Column 5 Lines 35-39; FIGS. 1 and 2 illustrate slots 14, 16 and 18, 20 provided in end portions of the portion of mask 10 covering the patients nose and mouth to threadably receive end portions of strap 12 for adjustably securing the mask to an associated face of a patient as set forth in column 5 lines 35-39).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080127984 A1) in view of Tirotta (US 5431158 A) and Zilberstein (US 20160317848 A1) as applied to claim 4, in further view of Koehler (US 20120103339 A1).
Regarding claim 5, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Thornton discloses the mask, wherein a radially extending flange having an inner flange surface and an outer flange surface (FIG. 5B Flange 38 of locking mechanism 30 as set forth in [0039]; the inner flange surface being the portion contacting the deformable material 15 and the outer flange surface being the portion exposed to the environment).
Thornton as modified fails to explicitly disclose, wherein the at least one transparent membrane comprises an inner layer and an outer layer, wherein the inner layer couples to the inner flange surface, and wherein the outer layer couples to the outer flange surface.
However, Koehler teaches wherein a portion of the mask comprises an inner layer and an outer layer (Koehler: FIG. 10 Inner and outer layer of mask body 30 formed by the recess 32b as shown in the annotated figure below), wherein the inner layer couples to the inner flange surface (Koehler: FIG. 10 Inner Edge portion of Valves 19,20 as shown in the annotated figure below; the flange being the edge portion of the valves), and wherein the outer layer couples to the outer flange surface of a valve (Koehler: FIG. 10 Outer Edge portion of Valves 19,20 as shown in the annotated figure below).
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Thornton and Koehler are both considered to be analogous to the claimed invention because they are in the same field of medical masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of Koehler and embed the flange within layers of the transparent membrane, specifically wherein a portion of the mask comprises an inner layer and an outer layer (Koehler: FIG. 10 Inner and outer layer of mask body 30 formed by the recess 32b as shown in the annotated figure), wherein the inner layer couples to the inner flange surface (Koehler: FIG. 10 Inner Edge portion of Valves 19,20 as shown in the annotated figure below; the flange being the edge portion of the valves), and wherein the outer layer couples to the outer flange surface (Koehler: FIG. 10 Outer Edge portion of Valves 19,20 as shown in the annotated figure). Doing so would enable the secure attachment of an element within another element of the device (Koehler: Set forth in [0087]), the concept of embedding an element within the device being a well-known method of securement in the art of the claimed invention.
Regarding claim 6, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Thornton as modified fails to explicitly disclose the mask, wherein the outer layer couples to the outer surface of the covering material, and wherein the inner layer couples to the inner surface of the covering material.
However, Koehler teaches wherein an outer layer couples to an outer surface of a covering material, and wherein an inner layer couples to the inner surface of the covering material (Koehler: FIG. 10 Inner and outer surface of mask body 30 formed by the recess 32b is coupled to an inner and outer layer of the valves as shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of Koehler and embed the transparent membrane within the inner and outer surfaces of the covering material, specifically wherein an outer layer couples to an outer surface of a covering material, and wherein an inner layer couples to the inner surface of the covering material (Koehler: FIG. 10 Inner and outer surface of mask body 30 formed by the recess 32b is coupled to an inner and outer layer of the valves as shown in the annotated figure). Doing so would enable the secure attachment of an element within another element of the device (Koehler: Set forth in [0087]), the concept of embedding an element within the device being a well-known method of securement in the art of the claimed invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080127984 A1) in view of Tirotta (US 5431158 A) and Zilberstein (US 20160317848 A1) as applied to claim 4, in further view of Vazales (WO 2011126812 A1).
Regarding claim 7, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Thornton as modified fails to explicitly disclose the mask, wherein the elongate conduit comprises a pair of notches that extend longitudinally from a distal end of the elongate conduit and are positioned on opposing transverse sides of the elongate conduit.
However, Vazales teaches wherein an elongate conduit (Vazales: FIG. 11A The cylindrical distal end 201 of scope retention member 125 set forth in [0155] and [0157]) comprises a pair of notches (Vazales: FIG. 11A,B Spaces between the fingers 209 as set forth in [0157]) that extend longitudinally from a distal end of the elongate conduit and are positioned on opposing transverse sides of the elongate conduit (Vazales: As shown in the annotated figure below).
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Thornton and Vazales are both considered to be analogous to the claimed invention because they are in the same field of medical devices comprising receiving members in the form of a conduit. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of Vazales and include wherein the elongate conduit (Vazales: FIG. 11A The cylindrical distal end 201 of scope retention member 125 set forth in [0155] and [0157]) comprises a pair of notches (Vazales: FIG. 11A,B Spaces between the fingers 209 as set forth in [0157]) that extend longitudinally from a distal end of the elongate conduit and are positioned on opposing transverse sides of the elongate conduit (Vazales: As shown in the annotated figure). Doing so would enable the insertion of a medical device or instrument through the conduit in a way that ensures it can be sufficiently held in place when the instrument has been correctly positioned (Vazales: Set forth in [0157]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080127984 A1) in view of Tirotta (US 5431158 A) and Zilberstein (US 20160317848 A1) as applied to claim 10, in further view of Duveen (US 20170119991 A1).
Regarding claim 11, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Thornton as modified fails to explicitly disclose the mask, wherein the at least one strap comprises a first strap that is configured to go around a first ear of the wearer and a second strap that is configured to go around a second ear of the wearer.
However, Duveen teaches wherein a first strap is configured to go around a first ear of the wearer and a second strap is configured to go around a second ear of the wearer (Duveen: FIG. 1 The mask 1 is to be held in place by straps 6 that preferably hook around the ears of the user as set forth in [0031]).
Thornton and Duveen are both considered to be analogous to the claimed invention because they are in the same field of medical masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the securement method of Thornton as modified to incorporate the teaching of Duveen and include a first strap is configured to go around a first ear of the wearer and a second strap is configured to go around a second ear of the wearer (Duveen: FIG. 1 The mask 1 is to be held in place by straps 6 that preferably hook around the ears of the user as set forth in [0031]). Doing so provides an improved and well-known securement method to hold the mask in place on the face of the wearer (Duveen: As set forth in [0031]).
Claims 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080127984 A1) in view of Tirotta (US 5431158 A) and Zilberstein (US 20160317848 A1) as applied to claim 4, in further view of McCracken (WO 2017013515 A1).
Regarding claim 12, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Thornton as modified fails to explicitly disclose the mask, wherein the elongate conduit comprises a nasal airway tool.
However, McCracken teaches a mask wherein the elongate conduit (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) comprises a nasal airway tool (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]).
Thornton and McCracken are both considered to be analogous to the claimed invention because they are in the same field of medical masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of McCracken and modify the elongate conduit of Thorton to include the nasal airway tool of McCracken wherein the elongate conduit (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) comprises a nasal airway tool (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]). While the conduit of Thorton is present for the purpose of orienting the mask to an oral appliance (Set forth in [0002]), it may be removable from the appliance (as set forth in [0037]). With the presence of a strap from the modification of Tirotta (Tirotta: FIG. 1-2 Strap 12 as set forth in Column 5 Lines 35-39), the need for the post coupled to the oral appliance for improved fit or performance is eliminated. With the attachment between the conduit/post and oral appliance gone, the conduit simply leads into the mask and enables the option of utilizing the mask for use in other medical or clinical applications (Set forth in [0002]). McCracken teaches a medical application of a user interface for use in aiding in an endoscopy. The teaching of McCracken would make it so that a bronchoscopy scope, a type of endoscope, would be provided with assisted guidance control within the interior of the mask, during insertion into the nasal cavity and associated airway of the patient in performance of a bronchoscopy procedure (McCracken: Set forth in [0036]).
Regarding claim 14, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Thornton as modified discloses wherein the hole through at least one transparent membrane is positioned so that a proximal end of the elongate conduit can be positioned at the mouth of the wearer (Shown in FIG. 1), but not the nose of the wearer.
However, McCracken teaches a mask wherein the elongate conduit (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) comprises a nasal airway tool (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]) and wherein the elongate conduit can be positioned at either nasal vestibule of the nose of the wearer (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thornton to incorporate the teaching of McCracken and modify the elongate conduit of Thorton to include the nasal airway tool of McCracken wherein the elongate conduit (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) comprises a nasal airway tool (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]) and wherein the elongate conduit can be positioned at either nasal vestibule of the nose of the wearer (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54 as set forth in [0033] and [0036]). While the conduit of Thorton is present for the purpose of orienting the mask to an oral appliance (Set forth in [0002]), it may be removable from the appliance (as set forth in [0037]). With the presence of a strap from the modification of Tirotta (Tirotta: FIG. 1-2 Strap 12 as set forth in Column 5 Lines 35-39), the need for the post coupled to the oral appliance for improved fit or performance is eliminated. With the attachment between the conduit/post and oral appliance gone, the conduit simply leads into the mask and enables the option of utilizing the mask for use in other medical or clinical applications (Set forth in [0002]). McCracken teaches a medical application of a user interface for use in aiding in an endoscopy. The teaching of McCracken would make it so that a bronchoscopy scope, a type of endoscope, would be provided with assisted guidance control within the interior of the mask, during insertion into the nasal cavity and associated airway of the patient in performance of a bronchoscopy procedure (McCracken: Set forth in [0036]) and the curved nature of the nasal air tool of the conduit of McCracken (McCracken: FIG. 4 shows the conduit in line with the mouth of the user, but curves up toward the nasal vestibule of the user) would indicate that the hole through at least one transparent membrane of Thorton would be positioned in a way that the proximal end of the elongate conduit could be positioned at either nasal vestibule of the nose of the wearer.
Regarding claim 15, Thornton as modified discloses the claimed invention substantially as claimed as set forth for claim 14 above.
Thornton as modified further discloses, wherein the hole through at least one transparent membrane is generally centered on the covering material relative to a length dimension and a width dimension (FIG. 2 Shows the hole of deformable material 15 generally centered on the body 11 of medical mask 10, lining up generally with the use’s mouth region).
Alternatively, It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the hole through at least one transparent membrane should be located on the covering material in a way that ensures a clear view of the nasal and oral pathways, which would obviously indicate that the hole be located in a generally centered region of the covering material.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pierro (US 20120285466 A1) in view of Zilberstein (US 20160317848 A1) as applied to claim 1, in further view of Sforza (“Age- and Sex-Related Changes in the Normal Human Ear.” Age and Sex-Related Changes in the Normal Human Ear, vol. 187, no. 1-3, 30 May 2009, pp. 110.e1–110.e7, https://doi.org/10.1016/j.forsciint.2009.02.019, Accessed 8/5/2025).
Regarding claim 16, Pierro discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pierro fails to explicitly disclose the mask, wherein the opening through the covering material has dimensions of at least three centimeters by at least five centimeters.
However, even though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Pierro clearly depicts the mask containing the opening (FIG. 4 Portion of the mask receiving interchangeable patient interface insert 120B) on the face of a user, wherein the user’s ear is shown (FIG. 4). The average dimensions of a human male ear are 37.54 mm wide and 61.93 mm tall (Sforza teaches the average ear dimensions in Table 2). The opening through the cover material of Pierro is shown to be around the dimensions of a human ear, thus any size of the opening would be at least three centimeters by at least five centimeters.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pierro (US 20120285466 A1) in view of Zilberstein (US 20160317848 A1) as applied to claim 19, in further view of McCracken (WO 2017013515 A1).
Regarding claim 20, Pierro discloses the claimed invention substantially as claimed as set forth for claim 19 above.
Pierro fails to explicitly disclose the method, wherein the membrane reinforcement structure comprises an elongate conduit defining an interior passage having a central axis, the method further comprising using the elongate conduit to orient the endoscope prior to insertion of the endoscope into the patient.
However, McCracken teaches a mask comprising an elongate conduit defining an interior passage having a central axis (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) the method further comprising using the elongate conduit to orient the endoscope prior to insertion of the endoscope into the patient (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54, the bronchoscopy scope guide 30 advantageously provides for assisted guidance control of the bronchoscopy scope as set forth in [0033] and [0036]).
Pierro and McCracken are both considered to be analogous to the claimed invention because they are in the same field of medical masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pierro to incorporate the teaching of McCracken and include an elongate conduit defining an interior passage having a central axis (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an entrance guide portion 38 set forth in [0034]) the method further comprising using the elongate conduit to orient the endoscope prior to insertion of the endoscope into the patient (McCracken: FIG. 4 Patient interface 10 comprises a semi-rigid scope guide tube with an exit guide portion 40, a distal end 46 of the exit guide portion 40 of the scope guide tube 32 is proximate to one of a nasal cavity 54, the bronchoscopy scope guide 30 advantageously provides for assisted guidance control of the bronchoscopy scope as set forth in [0033] and [0036]). Doing so would make it so that a bronchoscopy scope, a type of endoscope, would be provided with assisted guidance control within the interior of the mask, during insertion into the nasal cavity and associated airway of the patient in performance of a bronchoscopy procedure (McCracken: Set forth in [0036]).
Claims 1 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20120060258 A1) in view of Zilberstein (US 20160317848 A1), Reese (US 20180007982 A1), and Pierro (US 20120285466 A1).
Regarding claim 1, Stewart discloses a mask (FIG. 1-2 Face mask 10 as set forth in [0039]) comprising: a covering material (FIG. 2 Body 12 as set forth in [0039]) that is sufficiently sized to extend over a mouth and a nose on a head of a wearer (As shown in FIG. 13 as set forth in [0104]), wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer (FIG. 1-2 Perimeter 22), wherein the covering material has an outer surface and an inner surface (FIG. 1-2 Material 16 of body 12 having a front surface 18 and an opposing back surface 20 as set forth in [0039]), and at least one securing element for securing the mask to the head of the wearer (FIG. 1-2 One or more than one extension 14 joined to the body 12 for securing the facial mask 10 to the head of the wearer as set forth in [0039]).
Stewart fails to explicitly disclose, in reference to the embodiment according to FIGS. 1-2 and 13, that the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough.
However, Zilberstein teaches, wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]).
Stewart and Zilberstein are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the covering material of Stweart to incorporate the teaching of Zilberstein and include wherein the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough (Zilberstein: As set forth in [0089]). Doing so would aid in the filtration of microbes or other airborne contaminants (Zilberstein: As set forth in [0089]).
Stewart as modified fails to explicitly disclose, wherein the covering material defines an opening there through; at least one transparent membrane coupled to the covering material and covering the opening in the covering material.
However, Reese teaches wherein the covering material defines an opening there through (Reese: FIG. 3 Void 15 as set forth in [0049]); at least one transparent membrane coupled to the covering material and covering the opening in the covering material (Reese: FIG. 3 Transparent film 16 is fixed at its periphery to the surrounding air-permeable filtering media, the transparent film 16 covering the void 15 as set forth in [0049]).
Stewart and Reese are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the covering material of Stewart to incorporate the teaching of Reese and include wherein the covering material defines an opening there through (Reese: FIG. 3 Void 15 as set forth in [0049]); at least one transparent membrane coupled to the covering material and covering the opening in the covering material (Reese: FIG. 3 Transparent film 16 is fixed at its periphery to the surrounding air-permeable filtering media, the transparent film 16 covering the void 15 as set forth in [0049]). Doing so would provide visibility of the user’s mouth (Reese: As set forth in [0049]).
Stewart as modified fails to explicitly disclose wherein the at least one transparent membrane defines a hole there through; a membrane reinforcement structure configured to reinforce portions of the transparent membrane surrounding the hole through the at least one transparent membrane.
However, Pierro teaches wherein the at least one transparent membrane (Pierro: FIG. 4 Interchangeable patient interface insert 120B; The removable insert may be coated in the inside surface with an anti-fogging layer which assists in maintaining a transparent surface as set forth in [0156]) defines a hole there through (Pierro: FIG. 4 Access port 401 set forth in [0064]-[0065]); and a membrane reinforcement structure (Pierro: FIG. 4 The ring surrounding access port 401 shown in the annotated figure below) configured to reinforce portions of the transparent membrane (Pierro: The ring is included on the interchangeable patient interface insert 120B and surrounds the self-sealing access port 401 comprising one or more slits 402, the ring defining the change from the insert 120B and the port 401. The ability to enable the tube 403 be left in place within self-sealing access port 401 as set forth in [0065], provides sufficient reasoning to indicate that the ring supports the position of the access port 401 within the patient interface inset 120B, and therefore reinforces portions of the transparent membrane) surrounding the hole through the at least one transparent membrane (Pierro: FIG. 4 Access port 401 set forth in [0064] as well as the ring surrounding access port 401 are through the interchangeable patient interface insert 120B).
Stewart and Pierro are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transparent of Stewart as modified to incorporate the teaching of Pierro and include wherein the at least one transparent membrane (Pierro: FIG. 4 Interchangeable patient interface insert 120B; The removable insert may be coated in the inside surface with an anti-fogging layer which assists in maintaining a transparent surface as set forth in [0156]) defines a hole there through (Pierro: FIG. 4 Access port 401 set forth in [0064]-[0065]); and a membrane reinforcement structure (Pierro: FIG. 4 The ring surrounding access port 401 shown in the annotated figure below) configured to reinforce portions of the transparent membrane (Pierro: The ring is included on the interchangeable patient interface insert 120B and surrounds the self-sealing access port 401 comprising one or more slits 402, the ring defining the change from the insert 120B and the port 401. The ability to enable the tube 403 be left in place within self-sealing access port 401 as set forth in [0065], provides sufficient reasoning to indicate that the ring supports the position of the access port 401 within the patient interface inset 120B, and therefore reinforces portions of the transparent membrane) surrounding the hole through the at least one transparent membrane (Pierro: FIG. 4 Access port 401 set forth in [0064] as well as the ring surrounding access port 401 are through the interchangeable patient interface insert 120B). Doing so provides an opening through which a medical professional can perform procedures such as a bronchoscopy, as it gives access for a bronchoscope or other tubing or medical devices/instruments which may be inserted into the oral or nasal cavities of the patient (Pierro: As set forth in [0065]).
Regarding claim 21, Stewart as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Stewart further discloses, wherein the mask is configured to engage the face of the wearer to permit air to pass between the face and the outer perimeter of the mask (FIG. 13 Shows facemask 10 allowing an egress and ingress of airborne particles around the nose 302 of the wearer 300 as set forth in [0104]).
Regarding claim 22, Stewart as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Stewart further discloses, wherein the outer perimeter of the covering material is rectangular (As shown in FIG. 1-2 and 13).
Regarding claim 23, Stewart as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Stewart further discloses, wherein the outer perimeter of the covering material has a first side edge and a second side edge, wherein the covering material comprises a plurality of folds between the first side edge and the second side edge (FIG. 1-2 The body 12 further comprises a plurality of pleats 32, each pleat extending from one lateral edge 28 to the other lateral edge 30, the pleats 32 as set forth in [0039]).
Response to Arguments
In response to Applicant’s amendments to claims 14-15 and 20, the 35 USC § 112(b) rejections have been withdrawn.
In response to Applicant’s amendments to claims 1, the 35 USC § 102(a)(1) rejections have been withdrawn.
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
New grounds of rejection have been made above to address all the amendments to claims 1, 2, 4-8, 10, and 14.
Additionally, Examiner would like to note that while the Applicant argues that Pierro fails to disclose the that “the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough, wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer”, new grounds of rejection are made to address “the nonwoven material that is configured to filter microbes from air passing therethrough” as taught by Zilberstein. In the amended claim language, the limitation “comprises” is being interpreted to mean being made up of or to include, in this context, a nonwoven material. This would mean that only a part of the covering material needs to comprise a nonwoven material that is configured to filter microbes from air passing therethrough, and that despite the perimeter of the covering material of Pierro involving a means to seal with the face of the wearer, the covering material still has an outer perimeter that is configured to contact a face of the head of the wearer as stated in amended claim 1. The modification as stated would have no effect on the operation of Pierro. The Motivation provided for modifying Pierro with Hansen, in the now canceled claim 9, would still apply given the presence of the sealing portion of Pierro. The same is true for Zilberstein in the rejection above. New grounds of rejection have been made above to address all the amendments to claim 1.
Applicant argues that, similarly, Thorton fails to disclose the limitation of amended claim 1, wherein “the covering material comprises a nonwoven material that is configured to filter microbes from air passing therethrough, wherein the covering material has an outer perimeter that is configured to contact a face of the head of the wearer”. As previously stated above, the modification of a portion of the covering material to comprises a nonwoven fabric does not render the presence of a sealing element useless.
Applicant also argues that it would not have been obvious to modify Thorton to include wherein the membrane covering is transparent, given that Thorton is a sleep apnea mask. However, it would be obvious to one of ordinary skill in the art that sleep apnea masks are commonly used in clinical settings where a medical professional would benefit from being provided a means of visual observation of the patients nasal and oral regions.
New grounds of rejection have been made above to address the new claims 21-24 as well.
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 KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785