DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, as originally filed on May 8, 2023.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 14, 17, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 1, Line 5 recites the limitation “the nose covered region”; yet, it appears this limitation lacks antecedent basis in the claims. Primary Examiner is unsure if this term “the nose covered region” is meant to be the same or different from the former recitation of the “nose covering region” as recited in Claim 1, Line 2. Additionally Primary Examiner notes the remaining limitations within the claim listing as shown in Claims 2 and 11 recite the term “nose covering region” which is consistent with the initial recitation of “nose covering region” as seen in Line 2 of Claim 1. Dependent claims, Claims 1-11, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 1, Line 8 recites “from the facemask” and Claim 1, Lines 9 and 10 recites “aperture in the facemask”, respectively; however, this recitation appears unclear. Primary Examiner is unsure if this limitation should read “from the pliable facemask cup” and “aperture in the pliable facemask cup”, respectively. The “facemask” of the preamble has the components of the “pliable facemask cup” and the “inlet tube”, thus the inlet tube is extending away from a component of the facemask – the “pliable facemask cup” - and not necessarily away from the entire invention that is the “facemask” of the preamble as referenced in Line 8, and the nose aperture is oriented the component of the facemask – the “pliable facemask cup”. Dependent claims, Claims 1-11, incorporate the indefinite subject matter from which they depend. For purposes of this rejection, Primary Examiner will presume Applicant’s recitations of “facemask” are intentional. Appropriate clarification is required.
Specifically, Claim 4, Line 1, Claim 14, Line 1, and Claim 20, Line 1 recite the limitation “the nose aperture”; however, this limitation appears to lack antecedent basis in the claims. With respect to Claim 4, as depending from Claim 1, it appears perhaps this limitation should refer back to the former recitation in Claim 1, Line 9 which recites “a proximal nose aperture”. Consequently, Claim 4 should be corrected to read “the proximal nose aperture”. However, with respect to the remaining claims, Claims 14 and 20, which depend from Claims 12 and 18, respectively, there is no former recitation of “the nose aperture”. Thus, in the absence of a former recitation, Primary Examiner cannot presume or ascertain the breadth and scope of this claim limitation. Appropriate correction and clarification is required.
Specifically, Claim 9, Line 1 and Claim 17, Line 1 recite “the inlet tube and the facemask”; however, this recitation is unclear. Primary Examiner is unsure if this limitation should read “the inlet tube and the pliable facemask cup”. The “facemask” of the preamble has the components of the “pliable facemask cup” and the “inlet tube”, thus the inlet tube is connected to pliable facemask cup, and each of the inlet tube and the pliable facemask cup make up the facemask as a whole. For purposes of this rejection, Primary Examiner will presume Applicant’s recitations of “facemask” is in error and should read “the pliable facemask cup”. Appropriate clarification is required.
Specifically, Claims 8, 9, and 17 recite components of the facemask are “a unitary polymer structure”; however, the breadth and scope of the term “unitary” is unclear. Primary Examiner is unsure if the concept of “unitary” is limited to a device that is molded in a single piece, or encompasses two pieces which can be permanently attached together by glue/epoxy/heat fusing, encompasses two pieces which can be removably attached together by frictional/interference fitment, or some other means or method of connection of component parts together. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 8, 9, 11-14, and 16-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Matsubara et al. (10,058,672).
As to Claim 1, Matsubara discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a pliable facemask cup (6, “As shown in FIGS. 2 and 5, an oxygen mask apparatus 1 as a gas supply mask apparatus includes a mask main body 6 capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3 of a mask wearer 2 such as a patient. Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45) that is essentially defined by a nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c, Column 5, Lines 15-45), a mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d, Column 5, Lines 15-45), two cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b, Column 5, Lines 15-45), and a perimeter (11, “At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5). Note that an upper side portion 11c of the outer peripheral portion 11 has a curved shape which slightly projects forward (in other words, outward), so as to substantially fit the shape of the nose 4 of the mask wearer 2. A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2. However, the lower side portion 11d may also have a curved shape which slightly projects forward (in other words, outward), so as to substantially fit a portion (and the vicinity) below the chin 12 of the mask wearer 2.” Column 5, Lines 15-45), the perimeter (11) essentially defined by a nose bridge rim (11c, “Note that an upper side portion 11c of the outer peripheral portion 11 has a curved shape which slightly projects forward (in other words, outward), so as to substantially fit the shape of the nose 4 of the mask wearer 2.” Column 5, Lines 15-45), two cheek rims (11a and 11b, “At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5). … A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2.” Column 5, Lines 15-45), and a chin rim (11d, “A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2.” Column 5, Lines 15-45), the nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c) shaped to closely conform to the human nose (4), the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d) configured to be in front of the human mouth (5), the cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b) configured to at least partially contact corresponding sides of a human cheek (the lateral peripheries of the “face 3” remote form the midsagittal region); an inlet tube (31/32 via 33, “As shown in, e.g., FIGS. 1 and 5, in a portion slightly below a substantially central portion of the mask main body 6, a connector attaching portion 33 for attaching first and second connectors 31 and 32 is formed.” Column 6, Lines 50 thru Column 7, Line 20; also see: “As shown in, e.g., FIGS. 1 and 5, the oxygen mask apparatus 1 includes the first connector 31, the second connector 32, a third connector 43, a gas supply tube 44, and a fourth connector (not shown).” Column 7, Line 20 thru Column 8, Line 10) outwardly extending from the facemask (Figures 1 and 2), the inlet tube (31/32 via 33) generally defined by a passageway (defined by the lumens of 31/32) that leads through a distal aperture (via 44 as connected to 43, 32, and 31, “a gas supply tube 44” Column 7, Line 20 thru Column 8, Line 10) and a proximal nose aperture (via 51 of 31, “Also, a substantially circular opening 51 for introducing oxygen (in other words, for introducing a gas to the inside of the mask main body 6) is formed in a substantially central portion of the substantially pyramidal upper-end surface portion 46.” Column 7, Line 20 thru Column 8, Line 10; also see: “Also, in the embodiment shown in the drawings, the gas introduction opening 51 of the first connector 31 has a diameter of approximately 3 mm, and an opening area of approximately 7 mm.sup.2, which indicates the size of the opening 51. Column 8, Lines 10-25) in the facemask (Figures 1 and 2), the facemask (Figures 1 and 2) is arranged to be worn on a human face that when the human face is in neutral position the inlet tube (31/32 via 33) extends in a downward direction from the facemask (Figures 1 and 2) at an angle (angle θ2, “Note that in order to achieve the object of the present invention, each of the angles θ1 and θ2 generally preferably falls within the range of 30° to 60°, more preferably, the range of 35° to 55°, and most preferably, the range of 40° to 50°, from the viewpoint of practicality.” Column 10, Lines 5-25) between 30 and 60 degrees from horizontal.
As to Claims 3 and 13, Matsubara discloses the angle (angle θ2) is between 42 and 50 degrees (“most preferably, the range of 40° to 50°” Column 10, Lines 5-25). Although Matsubara discloses a slightly larger range by the disclosure of 40 and 41 degrees, the disclosure of Matsubara clearly considers the claimed range of between 42 and 50 degrees as a well-known and considered angle.
As to Claims 4, 14, and 20, Matsubara discloses the nose aperture (via 51 of 31) is configured to direct airflow into a human’s nostrils at approximately at the angle which is approximately a nostril angle of the nostril. As shown in Figure 1 of Matsubara, C1 represents the central axis of the nose aperture (via 51 of 31) which appears to intersect the philtrum of the nose (4) of the patient. By conventional anatomy, the philtrum is the entrance to the nostrils and thus it appears C1 meets the claimed orientation in which the gas from the nose aperture (via 51 of 31) is directed at an angle which is the entrance of the nostrils of the patient.
As to Claim 8, Matsubara discloses the facemask (Figures 1 and 2) is a unitary polymer structure (“Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45).
As to Claims 9 and 17, Matsubara discloses the inlet tube (31/32 via 33) and the pliable facemask cup (6) is a unitary polymer structure (“Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45; also see: “Note that each of the first to fourth connectors can integrally be molded from a substantially transparent (in other words, light-transmitting) hard synthetic resin such as hard vinyl chloride.” Column 7, Line 20 thru Column 8, Line 10). Despite the components of the inlet tube (31/32 via 33) and the pliable facemask cup (6) being made of different material properties, the components are attached together (“When attaching the first connector 31 to the mask main body 6, the cylindrical portion 45 of the first connector 31 is inserted into the opening 34 from inside the mask main body 6” Column 7, Line 20 thru Column 8, Line 10) as a unitary polymer structure form the facemask (Figures 1 and 2).
As to Claim 11, Matsubara discloses the inlet tube (31/32 via 33) is approximately in line with the nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c) along a facemask midline (best seen Figure 2) that is defined as extending along a center of the facemask (Figures 1 and 2) bisecting the nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c) and the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d).
As to Claim 12, Matsubara discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a pliable facemask cup (6, “As shown in FIGS. 2 and 5, an oxygen mask apparatus 1 as a gas supply mask apparatus includes a mask main body 6 capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3 of a mask wearer 2 such as a patient. Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45) configured to cover a mouth (5, “capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3” Column 5, Lines 15-45) and nostrils (via 4, “capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3” Column 5, Lines 15-45) of the wearer, the pliable facemask cup (6) having an outer surface (defined by the exterior of 6 exposed to the ambient environment) and an inner surface (defined by the interior of 6 proximate to the nose and mouth of the patient) that is configured to confront the mouth (5) and nose (4) when worn; an inlet tube (31/32 via 33, “As shown in, e.g., FIGS. 1 and 5, in a portion slightly below a substantially central portion of the mask main body 6, a connector attaching portion 33 for attaching first and second connectors 31 and 32 is formed.” Column 6, Lines 50 thru Column 7, Line 20; also see: “As shown in, e.g., FIGS. 1 and 5, the oxygen mask apparatus 1 includes the first connector 31, the second connector 32, a third connector 43, a gas supply tube 44, and a fourth connector (not shown).” Column 7, Line 20 thru Column 8, Line 10) extending from the facemask outer surface (defined by the exterior of 6 exposed to the ambient environment), the inlet tube (31/32 via 33) comprising a distal aperture (via 44 as connected to 43, 32, and 31, “a gas supply tube 44” Column 7, Line 20 thru Column 8, Line 10) and a proximal aperture (via 51 of 31, “Also, a substantially circular opening 51 for introducing oxygen (in other words, for introducing a gas to the inside of the mask main body 6) is formed in a substantially central portion of the substantially pyramidal upper-end surface portion 46.” Column 7, Line 20 thru Column 8, Line 10; also see: “Also, in the embodiment shown in the drawings, the gas introduction opening 51 of the first connector 31 has a diameter of approximately 3 mm, and an opening area of approximately 7 mm.sup.2, which indicates the size of the opening 51. Column 8, Lines 10-25) in the facemask (Figures 1 and 2), wherein the distal aperture (via 44 as connected to 43, 32, and 31) is in communication with the inner surface (defined by the interior of 6 proximate to the nose and mouth of the patient) of the facemask (Figures 1 and 2) via the proximal aperture (via 51 of 31, the inlet tube (31/32 via 33) extending in a downward direction from the facemask (Figures 1 and 2) at an angle (angle θ2, “Note that in order to achieve the object of the present invention, each of the angles θ1 and θ2 generally preferably falls within the range of 30° to 60°, more preferably, the range of 35° to 55°, and most preferably, the range of 40° to 50°, from the viewpoint of practicality.” Column 10, Lines 5-25) between 30 and 60 degrees from horizontal when the facemask (Figures 1 and 2) is in a neutral position, the neutral position defined when the facemask (Figures 1 and 2) is configured to be worn on a human face (3) that is in a neutral vertical position.
As to Claim 16, Matsubara discloses when the facemask (Figures 1 and 2) is configured to be in a neutral vertical position when the crown of the wearer is along a vertical axis and the eyes (69, “the possibility that the gas will flow to an eye 69 of the mask wearer 2 and give the mask wearer 2 discomfort is not so high.” Column 10, Lines 25-50) of the wearer are neutrally looking forward in a horizontal direction.
As to Claim 18, Matsubara discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a facemask cup (6, “As shown in FIGS. 2 and 5, an oxygen mask apparatus 1 as a gas supply mask apparatus includes a mask main body 6 capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3 of a mask wearer 2 such as a patient. Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45) defining a convex shaped outer surface (defined by the exterior of 6 exposed to the ambient environment), the facemask cup (6) configured to cover a mouth (5, “capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3” Column 5, Lines 15-45) and nostrils (via 4, “capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3” Column 5, Lines 15-45) of the wearer; an inlet tube (31/32 via 33, “As shown in, e.g., FIGS. 1 and 5, in a portion slightly below a substantially central portion of the mask main body 6, a connector attaching portion 33 for attaching first and second connectors 31 and 32 is formed.” Column 6, Lines 50 thru Column 7, Line 20; also see: “As shown in, e.g., FIGS. 1 and 5, the oxygen mask apparatus 1 includes the first connector 31, the second connector 32, a third connector 43, a gas supply tube 44, and a fourth connector (not shown).” Column 7, Line 20 thru Column 8, Line 10), that is linear, extending from the facemask outer surface (defined by the exterior of 6 exposed to the ambient environment) to a distal tube aperture (via 44 as connected to 43, 32, and 31, “a gas supply tube 44” Column 7, Line 20 thru Column 8, Line 10) a proximal aperture (via 51 of 31, “Also, a substantially circular opening 51 for introducing oxygen (in other words, for introducing a gas to the inside of the mask main body 6) is formed in a substantially central portion of the substantially pyramidal upper-end surface portion 46.” Column 7, Line 20 thru Column 8, Line 10; also see: “Also, in the embodiment shown in the drawings, the gas introduction opening 51 of the first connector 31 has a diameter of approximately 3 mm, and an opening area of approximately 7 mm.sup.2, which indicates the size of the opening 51. Column 8, Lines 10-25) in the facemask (Figures 1 and 2) in communication with the distal tube aperture (via 44 as connected to 43, 32, and 31) via the inlet tube (31/32 via 33), the inlet tube (31/32 via 33) extending in a downward direction from the facemask (Figures 1 and 2) at an angle (angle θ2, “Note that in order to achieve the object of the present invention, each of the angles θ1 and θ2 generally preferably falls within the range of 30° to 60°, more preferably, the range of 35° to 55°, and most preferably, the range of 40° to 50°, from the viewpoint of practicality.” Column 10, Lines 5-25) configured to point towards the nostrils (via 4) at approximately a nostril angle of the nostrils (via 4). As shown in Figure 1 of Matsubara, C1 represents the central axis of the nose aperture (via 51 of 31) which appears to intersect the philtrum of the nose (4) of the patient. By conventional anatomy, the philtrum is the entrance to the nostrils and thus it appears C1 meets the claimed orientation in which the gas from the nose aperture (via 51 of 31) is directed at an angle which is the entrance of the nostrils of the patient.
As to Claim 19, Matsubara discloses the angle (angle θ2) is between 42 and 50 degrees (“most preferably, the range of 40° to 50°” Column 10, Lines 5-25). Although Matsubara discloses a slightly larger range by the disclosure of 40 and 41 degrees, the disclosure of Matsubara clearly considers the claimed range of between 42 and 50 degrees as a well-known and considered angle. Additionally, Matsubara discloses when the facemask (Figures 1 and 2) is configured to be in a neutral vertical position when the crown of the wearer is along a vertical axis and the eyes (69, “the possibility that the gas will flow to an eye 69 of the mask wearer 2 and give the mask wearer 2 discomfort is not so high.” Column 10, Lines 25-50) of the wearer are neutrally looking forward in a horizontal direction.
Claims 18 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Matheson (2,858,828).
As to Claim 18, Matheson discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a facemask cup (1, “Referring more particularly to the drawing, numeral 1 denotes a respirator mask of molded rubber or similar elastic material having detachably secured thereto, by snap fasteners, straps 2 (shown broken away). Straps 2 are adapted to encircle the head of the wearer for holding the inturned mouth portion 1a of the mask in air-tight, sealing engagement about the nose, cheeks and chin of the wearer.” Column 2, Lines 5-25) defining a convex shaped outer surface (defined by the exterior of 1 exposed to the ambient environment), the facemask cup (1) configured to cover a mouth and nostrils of the wearer (“air-tight, sealing engagement about the nose, cheeks and chin of the wearer.” Column 2, Lines 5-25); an inlet tube (3, “Integrally formed on the front portion of the respirator mask is an inlet snout 3, also of rubber or the like, which extends downwardly at an angle away from the wearer's face. A ring 4 of metal or plastic material is slip-fitted in the end portion of the snout so that one end of a flexible breathing tube (not shown), such as one of accordion design, may be slip-fitted to the ring, like the end portion of the snout. The other end of the breathing tube is attached to any suitable source of air supply, such as a compressed air tank or a chemical cartridge worn by the wearer which filters incoming air from the atmosphere.” Column 2, Lines 20-50), that is linear, extending from the facemask outer surface (defined by the exterior of 1 exposed to the ambient environment) to a distal tube aperture (“attached to any suitable source of air supply” via 4, “A ring 4 of metal or plastic material is slip-fitted in the end portion of the snout so that one end of a flexible breathing tube (not shown), such as one of accordion design, may be slip-fitted to the ring, like the end portion of the snout. The other end of the breathing tube is attached to any suitable source of air supply, such as a compressed air tank or a chemical cartridge worn by the wearer which filters incoming air from the atmosphere.” Column 2, Lines 20-50), a proximal aperture (defined by the space about 1c, “At the junction of snout 3 and mask 1 there is provided an integral, vertically downwardly extending baffle 1c for the purpose of deflecting downwardly, directly into the exhalation valve 5, air exhaled by the wearer and thus preventing such air from being deflected against the face or upwardly of the nostrils of the wearer which would cause increased breathing resistance and annoyance. Also it prevents exhaled air and moisture from entering the snout 3 and air inlet tube.” Column 2, Lines 40-60) in the facemask (Figures 1 and 2) is in communication with the distal tube aperture (“attached to any suitable source of air supply” via 4) via the inlet tube (3), the inlet tube (3) extending in a downward direction (“extends downwardly at an angle away from the wearer's face”) from the facemask (Figures 1 and 2) at an angle configured to point towards the nostrils at approximately a nostril angle of the nostrils.
Regarding the angle limitation, the inherent nature of the facemask (Figures 1 and 2) having the facemask cup (1) that provides “air-tight, sealing engagement about the nose, cheeks and chin of the wearer” by the administration of supply air along the inlet tube (3) results in the angular relationship of the air supplied to be at an angle suitable to sustain respiratory support to the nose and mouth of the user. In this manner, at least one flow path of air within the passageway of the inlet tube (3) will meet the claimed orientation of the “approximately a nostril angle of the nostrils”, even if said flow path encompasses a deflection around the proximal aperture (defined by the space about 1c). Thus, Matheson appears to meet the limitations of the claims.
As to Claim 20, Matheson discloses the proximal aperture (defined by the space about 1c) which directs the flow of gas towards the nose of the patient is configured to direct airflow into the nostrils of the patient at an angle of one of the nostrils.
Regarding the angle limitation, the inherent nature of the facemask (Figures 1 and 2) having the facemask cup (1) that provides “air-tight, sealing engagement about the nose, cheeks and chin of the wearer” by the administration of supply air along the inlet tube (3) results in the angular relationship of the air supplied to be at an angle suitable to sustain respiratory support to the nose and mouth of the user. In this manner, at least one flow path of air within the passageway of the inlet tube (3) will meet the claimed orientation of the “approximately a nostril angle of the nostrils”, even if said flow path encompasses a deflection around the proximal aperture (defined by the space about 1c). Thus, Matheson appears to meet the limitations of the claims.
Claims 18 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Thornton (2005/0016544).
As to Claim 18, Thornton discloses a nasal directed flow facemask (Figures 4 and 5), comprising: a facemask cup (12, “In another embodiment, as illustrated in FIG. 4, mask 12 covers at least a portion of the user's nose surrounding the user's nostrils (which may or may not be limited to the soft cartilaginous portions of the user's nose and portions of the user's face to the sides of and below the soft cartilaginous portions of the user's nose) and additionally covers the user's mouth to prevent leakage from the user's mouth.” Para 0015; also see: “In another embodiment, as illustrated in FIG. 5, mask 12 covers at least a portion of the user's nose surrounding the user's nostrils (which may or may not be limited to the soft cartilaginous portions of the user's nose and portions of the user's face to the sides of and below the soft cartilaginous portions of the user's nose), covers the user's mouth, and additionally covers at least a portion of the user's face below the user's chin to better secure mask 12 to the user's face.” Para 0016) defining a convex shaped outer surface (defined by the exterior of 12 exposed to the ambient environment), the facemask cup (12) configured to cover a mouth and nostrils of the wearer; an inlet tube (one of 18, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12. Fittings 18 may be used to couple mask 12 to an external system 20, such as a continuous positive air pressure (CPAP) system, for supplying air or another gas to the user's nose at positive pressure to help open the user's breathing passage and thereby improve the user's breathing. For example, system 10 may include tubes 22 that snap onto, are force fitted onto, or otherwise couple to fittings 18.” Para 0013), that is linear, extending from the facemask outer surface (defined by the exterior of 12 exposed to the ambient environment) to a distal tube aperture (via one of 22, “tubes 22 that snap onto, are force fitted onto, or otherwise couple to fittings 18.” Para 0013), a proximal aperture (one of 16, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12. Fittings 18 may be used to couple mask 12 to an external system 20…” Para 0013) in the facemask (Figures 4 and 5) is in communication with the distal tube aperture (via one of 22) via the inlet tube (one of 18), the inlet tube (one of 18) extending in a downward direction from the facemask (Figures 4 and 5) at an angle configured to point towards the nostrils at approximately a nostril angle of the nostrils.
Regarding the angle limitation, the inherent nature of the facemask (Figures 4 and 5) having the facemask cup (12) that covers the nose and mouth of the user, whereby there is separate inlet tube for each nostril of the patient, results in the claimed angular relationship of the air supplied to be at an angle suitable to sustain respiratory support to the nose and mouth of the user. Thus, Thornton appears to meet the limitations of the claims.
As to Claim 20, Thornton discloses the proximal aperture (one of 16) configured for insertion about each nostril of the patient – thus forming a nose aperture that is configured to direct airflow into the nostrils at approximately the angle that of a nostril angle of one of the nostrils.
Regarding the angle limitation, the inherent nature of the facemask (Figures 4 and 5) having the facemask cup (12) that covers the nose and mouth of the user, whereby there is separate inlet tube for each nostril of the patient, results in the claimed angular relationship of the air supplied to be at an angle suitable to sustain respiratory support to the nose and mouth of the user. Thus, Thornton appears to meet the limitations of the claims.
Claim Rejections - 35 USC § 103
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (10,058,672).
As to Claim 10, Matsubara discloses two cheek rims (11a and 11b) at the two cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b, Column 5, Lines 15-45) extending away from the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d, Column 5, Lines 15-45) in an elongated flared lateral touch region (via U shape at the rim (11) best seen Figure 1; also see: Figure 5, wherein “. At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5).” Column 5, Lines 15-50) to a cheek rim (11a and 11b) at a right angle (via U shape) from a vertical reference line by a 90 degree reference angle that passes through a facemask nose bridge rim apex (via U shape at 11c) along the Y-axis and the chin rim apex (via U shape at 11a and 11b) along the X axis.
Yet, Matsubara does not explicitly disclose the explicit distance of the “elongated flared lateral touch region … is at least one inch in length”.
In light of the relationship of cheek rims (11a and 11b) to provide sealing engagement along the human cheek (the lateral peripheries of the “face 3” remote form the midsagittal region) of the patient, it would have been obvious to one having ordinary skill in the art to select the specific length of the claimed elongated flared lateral touch region to be consistent with the known anatomical features of the general demographics of the human patient.
By the consideration of the “upward” shape as shown in Figure 5, Matsubara appears to consider that the general demographics of the human patient includes the features of cheeks which extend anterior to the position of the mouth whilst in line with the philtrum of the nose of the patient to conform to a human patient by enabling a seal between the facemask and the face of the patient.
Consequently, the specific length as claimed to be “at least one inch” would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the “elongated flared lateral touch region” to form a seal between the facemask and the face of the patient. Hence, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Matsubara as the length of the “elongated flared lateral touch region” would yield the predictable results of forming a seal between the facemask and the face of the patient.
Moreover, Applicant has not asserted the specific “at least one inch in length” dimension of the “elongated flared lateral touch region” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of providing a sealing surface upon which the facemask may be sealed to the face of the patient; thus, the specific dimensions of “at least one inch in length” appears to lack criticality in its design.
Therefore, it would have been obvious to one having ordinary skill in the art to modify cheek rims of Matsubara to be the explicit length of the “elongated flared lateral touch region” to be “at least one inch in length” as claimed, a known result effective variable, in order to permit the sealing engagement of the facemask to the face of the patient.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (10,058,672) alone, OR ALTERNATIVELY, Matsubara et al. (10,058,672) in view of Chang (2016/0030695).
As to Claim 7, Matsubara discloses perforations (25, “Note that the plurality of petals includes a plurality of (in the embodiment shown in the drawings, three) first petals 25 formed by through holes, and a plurality of (in the embodiment shown in the drawings, three) second petals 26 formed by recesses which face the outside between the first petals 25. The plurality of petals 25 and 26 (in other words, the plurality of first petals 25 and the plurality of second petals 26) are sequentially arranged at substantially equal angles along the outer periphery of the flower stem 24. As shown in, e.g., FIGS. 1 and 5, the plurality of (in the embodiment shown in the drawings, three) first petals 25 are arranged on the inner circumferential surface of the mask main body 6 at substantially equal angles (in the embodiment shown in the drawings, an interval of 60°).” Column 6, Lines 25-55; also see: “Also, an extra gas existing between the mask wearer 2 and mask main body 6 can be released, as needed, outside the mask main body 6 by a natural flow through the three first petals (in other words, the holes) 25. Therefore, the possibility that the gas will flow to an eye 69 of the mask wearer 2 and give the mask wearer 2 discomfort is not so high.” Column 10, Lines 25-50) on the pliable facemask cup (6) for the purpose of permitting the exhaustion from the facemask (Figures 1 and 2) away from the eyes of the user. As shown in Figures 1 and 2, the perforations (25) appear interspersed between the nose (4) at the nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c, Column 5, Lines 15-45) and the mouth at the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d, Column 5, Lines 15-45).
Yet, Matsubara does not explicitly disclose “the perforations through the mouth covering region”.
In light of the desired of the perforations to permit the exhaust of gases from the facemask directed away from the eyes of the patient, it would have been obvious to one having ordinary skill in the art to modify the location of the perforations to be in a lower position along the facemask to include the “mouth covering region” as claimed, since it has been held where the general conditions of a claim are disclosed in the prior art discovering the optimum or workable ranges involves only routine skill in the art.
As Applicant has not asserted the specific orientation of the perforations in the mouth covering region provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of permitting the exhaust of gases from the facemask, the use of the specific orientation of the perforations in the mouth covering region appears to lack criticality in its design.
Moreover, the specific orientation of the perforations to be in the mouth covering region would have been obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the gas to be exhaust from the facemask and directed away from the eyes of the patient. In this fact, the decision to move the perforations of Matsubara more remote from the nose covering region and closer to the mouth covering region would be a result effective variable that would yield the ability of the gases to be exhausted from the facemask in a location that is remote from the eyes of the patient.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Matsubara, as the location of the perforations in the mouth covering region would yield the predictable results of providing an exhaust port from the facemask that is remote from the eyes of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the perforations within the pliable facemask cup to be located in the mouth covering region, a known result effective variable, in order to exhaust gases from the facemask away from the eyes of the patient.
Should Applicant respectfully disagree with the former rejection rationale of obvious to try, Primary Examiner presents an alternative rejection incorporating Chang (2016/0030695), wherein Chang teaches a similar nasal directed flow facemask (Figure 2) to Matsubara having a pliable facemask cup (210, “FIG. 2 illustrates an embodiment where the oxygen mask 200 includes a mask body 210, an oxygen port 220, vent ports 230, a nose clip 240, and strap attachments 250.” Para 0076) configured to cover the mouth and nose of the patient (“The mask body 210 defines a cavity adapted to fit over the mouth and the nose of the patient.” Para 0078) and an inlet tube (220, “an oxygen port 220” Para 0076) to direct the flow of gas into the pliable facemask cup (210), wherein the pliable facemask cup (210) has a nose covering region (proximate 240, “a nose clip 240” Para 0076) and a mouth covering region (distal and opposite from 240, “a nose clip 240” Para 0076).
Regarding the remaining limitations of the claims, Chang teaches a series of perforations (230, “vent ports 230” Para 0076) located within the mouth covering region (distal and opposite from 240, “a nose clip 240” Para 0076) as defined to be “the bottom half of the mask body 210” (Para 0082) to allow the venting of gas to be exhausted from the facemask (“One or more vent ports 230 are disposed on the bottom half of the mask body 210, allowing gases to be discharged from the oxygen mask. In various embodiments, the vent port(s) 230 are located between one and four inches from the bottom of the mask body 210, around three inches from the bottom of the mask body 210, or around two inches from the bottom of the mask body 210. In a particular embodiment, the oxygen mask 200 includes two vent ports 230. The vent ports 230 are disposed on opposite sides of the mask body 210. The vent ports are located on the mask body 210 such that they are below the patient's mouth when the oxygen mask 200 is worn.” Para 0082).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the perforations of the facemask of Matsubara to be located in the mouth covering region, as taught by Chang to enable the exhaustion of gas from the facemask.
In conclusion, whether rejected by Matsubara alone or Matsubara in combination with Chang, the claimed orientation of the perforations to be located at the mouth covering region is an obvious design consideration for the purpose of permitting the exhaust of gases from the facemask.
Claims 5, 6, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (10,058,672) in view of Biggs (2,104,016).
As to Claims 5, 6, and 15, Matsubara discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a pliable facemask cup (6) and inlet tube (31/32 via 33); yet, Matsubara does not explicitly disclose the use of a “diffuser that disrupts laminar flow of airflow” (Claims 5 and 15), wherein “the diffuser is selected from a group consisting of obstructing slots, obstructing grids, and a plurality of perforations”.
Biggs teaches an alternative nasal directed flow facemask (Figure 1) having a pliable facemask cup (7, “body portion” Page 1, Column 1, Line 45 thru Page 1 Column 2, Line 20) and an inlet tube (via 29, “a tube” Page 2, Line 10-25) for the administration of gases to the facemask (Figure 1) which covers the nose and mouth of the user (“covers merely the nose, mouth, and chin of the wearer” Page 1, Column 1, Lines 45-55) and further extends to the cheeks of the user (via 11, “forming roll 11… passes under the chin on a line transverse to that portion of the roll lying against the cheek, it prevents the distortion of the body member 7 from being absorbed merely as an increased roll and compels a relatively wide zone adjacent the edge to move bodily inwardly as through it were being swung on a hinge whereof the axis of rotation lies along the base of the roll 11, the angle between the portion passing under the chin and that lying against the cheek acting as a point of support…” Page 2, Column 1, Lines 20-70).
Regarding the remaining limitations , Biggs teaches a diffuser (23, best seen Figures 1 and 6, “filter canister” Page 2, Column 1, Lines 10-25) that disrupts laminar flow of airflow as a function its ability to “eliminate any noxious material carried thereby” (Page 2, Column 1, Lines 10-25). The act of filtering gases as introduced results in a disruption of laminar flow as the “noxious material” is filtered out and removed from the flow profile. Additionally, the nature of a filter includes the claimed “plurality of perforations” which effectively provide a treacherous pathway through its micron size to trap particles larger than the micron size of the filter material and permit the passage of particles smaller than the micron size of the filter.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the inlet tube of Matsubara to include the use of a diffuser in the form of a filter, as taught by Biggs to prevent the administration of noxious gas to the patient thereby assuring the operation of the facemask to sustain the life of the patient during use through the administration of fresh and clean gas to the patient.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Matsubara et al. (10,058,672) in view of Gradon et al. (2002/0005201).
As to Claim 2, Matsubara discloses a nasal directed flow facemask (Figures 1 and 2), comprising: a pliable facemask cup (6), an inlet tube (31/32 via 33), and the positioning of the facemask on the face of the user such that the facemask (Figures 1 and 2) is arranged to be worn on a human face that when the human face is in neutral position the inlet tube (31/32 via 33) extends in a downward direction from the facemask (Figures 1 and 2) at an angle (angle θ2, “Note that in order to achieve the object of the present invention, each of the angles θ1 and θ2 generally preferably falls within the range of 30° to 60°, more preferably, the range of 35° to 55°, and most preferably, the range of 40° to 50°, from the viewpoint of practicality.” Column 10, Lines 5-25) between 30 and 60 degrees from horizontal.
As best seen in Figure 2, the facemask is secured on the face of the user by straps (14/17, “The left and right end portions of a flat elastic string 14 as a flexible longitudinal attaching member are inserted into and attached to the insertion holes 15. Also, similar insertion holes 16 are arranged along a substantially longitudinal direction of each of the pair of left and right side portions 11a and 11b, and the number of insertion holes 16 is, e.g., three. Furthermore, each of the two ends of a second elastic string 17 which can be formed like the elastic string 14 may be inserted into and attached to one of the three insertion holes 16, in place of or in addition to the elastic string 14. … Note that the two end portions of an elastic bandage as a flexible longitudinal attaching member can be inserted into and attached to a pair of left and right insertion slits of the insertion slits 21, instead of the flat elastic string 14. Also, each of the elastic strings 14 and 17 and elastic bandage is extended over a head (in other words, a head including the face of a person) 18 of the mask wearer 2, so as to pass through the left cheek, the back of the head, and the right cheek of the mask wearer 2.” Column 5, Line 45 thru Column 6, Line 15) which are inserted into strap anchors (15/16, “The left and right end portions of a flat elastic string 14 as a flexible longitudinal attaching member are inserted into and attached to the insertion holes 15. Also, similar insertion holes 16 are arranged along a substantially longitudinal direction of each of the pair of left and right side portions 11a and 11b, and the number of insertion holes 16 is, e.g., three.” Column 5, Line 45 thru Column 6, Line 15) to secure the pliable facemask cup (6) of the facemask (Figures 1 and 2) to the face (3) of the user (2).
Yet, Matsubara does not explicitly disclose “at least one strap anchor between the inlet tube and the mouth covering region configured to retain a head retention strap, the at least one strap anchor is within 1.25 inches from a facemask midline, the facemask midline is defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region.”
Gradon teaches an alternative closely conforming facemask (best seen Figures 5-7) having a pliable facemask cup (102, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. … The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance.” Para 0039; and “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) a distal tube port (3, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) in communication with a nasal aperture (via 103, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033); and a facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7, wherein 120 – “This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 200 – “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance. As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Paras 0039 and 0040) disposed on the face covering cap (102) proximate the nasal tube (103).
Regarding the concept of the “between the nasal tube and the mouth center point”, the mask of Gradon is explicitly described for nasal only applications as best seen in Figure 4. Consequently, the orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) are located between the nasal tube (103) and the mouth center point, as the mouth center point is beyond and below the pliable facemask cup (102) of Gradon.
Regardless of Gradon’s nasal only facemask cup application, the teachings of Gradon with respect to the placement and orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) remain a feature which would be obvious to modify the facemask of Matsubara, for the purpose of achieving variable pressure points for sealing engagement of the facemask to conform to the face of the user – in order to “allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” (Para 0037) and “to allow pressure from different angles for different face shapes.” (Para 0040).
In light of the teaching of Gradon, the decision to modify the facemask of Matsubara to include the facemask retention strap between the nasal tube and along the centerline of the facemask proximate the mouth, would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to vary the sealing pressures applied to Matsubara as modified by Gradon to better conform to the anatomical features of the patient wearing the facemask.
Applicant has not asserted this specific orientation “between the nasal tube and the mouth center point” provides a particular advantage, solves a stated problem, or serves a particular purpose different from the ability to effectively seal the facemask to the face of the user; thus, the use of the specific orientation of “between the nasal tube and the mouth center point” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Matsubara, as the construction of the facemask retention straps “between the nasal tube and the mouth center point” would yield the predictable results of providing variable pressure points suitable to conform the facemask to seal to the anatomical features of the patient wearing the facemask.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the facemask retention strap of Matsubara to extend between the nasal tube and the mouth center point, a known result effective variable and as taught by Gradon to be a known orientation suitable for imparting variable pressure points for sealing engagement of the facemask to conform to the face of the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Blount (3,182,659) discloses an additional facemask (Figures 1 and 3) having a pliable facemask cup (1) suitable for covering the nose, mouth, and cheeks of the patient along a rim (2), and an inlet tube (17) having a distal aperture (via 25) and a proximal aperture (via 18 with 15). Although Blount does not expressly disclose the explicit angle of the inlet tube, based upon the drawings it appears the angle is approximately 45 degrees
Schwarz (2,931,356) discloses an additional facemask (Figures 1 and 2) having a pliable facemask cup (12) suitable for covering the nose, mouth, and cheeks of the patient along a rim (36), and an inlet tube (via 24). Although Schwarz does not expressly disclose the explicit angle of the inlet tube, Schwarz does teach a diffuser (26) in line with the inlet tube (via 24) for filtering gases.
Salvino et al. (2023/0256186 – also known as 18/137,955) shares at least one common assignee and/or inventor with the instant application; however, at this time there does not appear to be a double patenting rejection as the subject matter has variations.
For example: Claim 1 of the instant application requires “A nasal directed flow facemask”, “a proximal nose aperture in the facemask”, and “the facemask is arranged to be worn on a human face that when the human face is in a neutral position the inlet tube extends in a downward direction from the facemask at an angle between 30 and 60 degrees from horizontal.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 11, and 17, by the recitation of “a nasal tube that outwardly extends to a distal tube port” (Claim 1), and “a nasal tube extending from the outer surface” (Claims 11 and 17), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For example: Claim 12 of the instant application requires “A nasal directed flow facemask”, and “ the inlet tube extending in a downward direction from the facemask at an angle between 30 and 60 degrees from horizontal when the facemask is in a neutral position, the neutral position defined when the facemask is configured to be worn on a human face that is in a neutral vertical position.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 11, and 17, by the recitation of “a nasal tube that outwardly extends to a distal tube port” (Claim 1), and “a nasal tube extending from the outer surface” (Claims 11 and 17), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For Example: Claim 18 of the instant claims requires “A nasal directed flow facemask”, “an inlet tube, that is linear”, and “the inlet tube extending in a downward direction from the facemask at an angle configured to point towards the nostrils at approximately a nostril angle of the nostrils.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 11, and 17, by the recitation of “a nasal tube that outwardly extends to a distal tube port” (Claim 1), and “a nasal tube extending from the outer surface” (Claims 11 and 17), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
Salvino et al. (2023/0277792 – also known as 18/144,750) shares at least one common assignee and/or inventor with the instant application; however, at this time there does not appear to be a double patenting rejection as the subject matter has variations.
For example: Claim 1 of the instant application requires “A nasal directed flow facemask”, “a proximal nose aperture in the facemask”, and “the facemask is arranged to be worn on a human face that when the human face is in a neutral position the inlet tube extends in a downward direction from the facemask at an angle between 30 and 60 degrees from horizontal.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 10, and 18, by the recitation of “an inlet tube outwardly extending” (Claims 1 and 18), and “an inlet tube extending from the facemask” (Claim 10), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For example: Claim 12 of the instant application requires “A nasal directed flow facemask”, and “ the inlet tube extending in a downward direction from the facemask at an angle between 30 and 60 degrees from horizontal when the facemask is in a neutral position, the neutral position defined when the facemask is configured to be worn on a human face that is in a neutral vertical position.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 10, and 18, by the recitation of “an inlet tube outwardly extending” (Claims 1 and 18), and “an inlet tube extending from the facemask” (Claim 10), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For Example: Claim 18 of the instant claims requires “A nasal directed flow facemask”, “an inlet tube, that is linear”, and “the inlet tube extending in a downward direction from the facemask at an angle configured to point towards the nostrils at approximately a nostril angle of the nostrils.” Although the concept of the “inlet tube” is recited in copending claims, Claims 1, 10, and 18, by the recitation of “an inlet tube outwardly extending” (Claims 1 and 18), and “an inlet tube extending from the facemask” (Claim 10), each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785