DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20, line 3, remove “and”.
Appropriate correction is required.
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.
Claim 17 is 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.
Claim 17 recites the limitation “wherein the interface comprises a sealing feature isolating an interior of the mask interface from an exterior environment of the mask interface and the internal passageway”, which is indefinite. Examiner believes that the “an interior of the mask interface” that claim 17 refers to is the same as “the internal passageway” since claim 1 recites “an internal passageway coupled to the first connector” which in light of the specifications and drawing would both be the airway region 8 seen in Fig. 6B. This is also supported by claim 7 and claim 20. Examiner believes that Applicant intends for “the internal passageway” in claim 17 to be referring to the internal passageway 11 in [0042] of Applicant’s specifications. Examiner suggests amending claim 11 “an internal passageway” and/or claim 17 “the internal passageway” to be consistent with the specifications and/or drawings, unless the current wording is as intended. Examiner is rejecting the claim as written.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 and 11 recite "wherein the interface is in contact with a subject’s face". This limitation should be amended to functionally recite "wherein the interface is configured to be in contact with a subject’s face".
Claim 20 recites "the interface in contact with a subject’s face". This limitation should be amended to functionally recite "wherein the interface is configured to be in contact with a subject’s face".
Claims 2-10 and 12-19 are rejected based on their dependency on rejected 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(s) 1-5, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nashed (US 20070295335 A1) and Eves et al. (US 20180272095 A1).
Regarding claim 1, Nashed discloses a mask interface (face mask assembly 120; figure 1-16) comprising:
a body comprising (shell member 122; figure 1, 3-7, and 12-16):
a nasal portion ([0049] top wall portion 130; figure 3-5) comprising an opening ([0049] first cylindrical hollow inlet member or port 126), wherein the nasal portion is dimensioned to cover a nose region (see figure 1-2, top wall portion 130 near port 126), and wherein the opening (126) is couplable with a positive pressure respiratory device ([0051] a conventional two-branch breathing circuit 144 such that anesthesia gas or gases are adapted to pass from a source (not shown) through one branch of the breathing circuit 144 through passageway 138 into the interior cavity 136 of shell member 122 (and mask 120) as indicated by arrow 146; figure 12); and
a mouth portion (portion of shell member 122 comprising continuous sidewall portion 134 and flange 158; figure 3-7) comprising an open channel ([0056] channel at inflation tube 176; see figure 6), wherein the mouth portion is dimensioned to cover a mouth region (see figure 1-2, sidewall portion 134 and flange 158 cover a mouth region), and wherein the open channel is couplable with tubing ([0056] inflation tube 176; figure 6); and
an interface coupled to the body ([0054] cushion 124; figure 1-16), wherein the interface is in contact with a subject's face (figure 1-2), and wherein the interface comprises a flexible material conformable to the subject's face ([0054] the pneumatic sealing cushion 124 which essentially comprises an inflatable donut-shaped hollow annular member made of pliable flexible material; figure 1-2).
Nashed is silent as to wherein the body comprises a rigid material. Nashed teaches [0048] Shell member 122 preferably is of one-piece or unitary construction fabricated in a known manner from a synthetic polymeric resin such as polyvinyl chloride.
However, Eves teaches a mask shell 6005 manufactured from polycarbonate, see [0299]. Applicant’s specifications [0038], teaches polycarbonate is a rigid material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask shell of Nashed to be made from polycarbonate, as taught by Eves, as it would have been obvious substitution of one known element for another, using the polycarbonate taught by Eves in place of the synthetic polymeric resin of Nashed, and would provide predictable results, providing a suitable material for a shell for a mask interface (see Eves [0299]).
Regarding claim 2, Nashed teaches wherein the flexible material is a porous medium or a viscoelastic solid ([0056] cushion 124 which essentially comprises an inflatable donut-shaped hollow annular member made of pliable flexible material, preferably synthetic polymeric resin such as polyvinyl chloride) with one or more holes ([0056] opening 178 in pad 162 of cushion member 124; figure 7).
Regarding claim 3, modified Nashed teaches the mask interface of claim 1, but is silent as to wherein the flexible material comprises one or more of silicone and open cell foam.
However, Eves teaches a cushion assembly 6000 made of silicone material (see [0299] and figure 24A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cushion of Nashed to be made from silicone, as taught by Eves, as it would have been obvious substitution of one known element for another, using the silicone taught by Eves in place of the synthetic polymeric resin of Nashed, and would provide predictable results, providing a suitable material for a cushion of a mask interface that is soft, flexible, and resilient (see Eves [0243] and [0299]).
Regarding claim 4, Eves teaches wherein the rigid material comprises polycarbonate ([0299] the shell 6005 may be made of a polycarbonate material).
Regarding claim 5, Nashed teaches wherein the interface is coupled to the body with a bond joint ([0056] As shown in FIG. 6A, cushion member 124 preferably is formed with a somewhat thickened top wall portion defining a mounting foot or pad 170 which advantageously may be adhered securely to the mounting surface 160 of flange member 158 suitably by means of a compatible adhesive (indicated by stippling 174 in FIG. 14) or the like applied all along the top surface of pad 170, the mounting surface 160, or both).
Regarding claim 7, Nashed teaches wherein the interface comprises a sealing feature ([0054] pneumatic sealing cushion 124; figure 6) isolating an interior of the body (interior cavity 136; figure 6) from an exterior environment of the mask interface (see figure 1-2) and an internal passageway of the body (interior cavity 136 is isolated from the channel formed at inflation tube 176 via the cushion 124; see figure 6).
Regarding claim 9, Nashed teaches wherein the body comprises a facial adapter ([0053] outwardly extending flange member 158 which defines on the bottom thereof a pneumatic sealing cushion mounting surface 160; figure 3-7 and 13-14) and a housing (shell member 122 comprising top wall portion130 and sidewall portion 134; figure 3-7 and 13-14).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nashed (US 20070295335 A1) and Eves et al. (US 20180272095 A1) as applied to claim 1 above, and further in view of Gee (GB 2336547 A).
Regarding claim 6, modified Nashed teaches the mask interface of claim 1, Nashed teaches wherein the body comprises one or more internal passageways ([0051] passageway 138 opening into interior cavity 136; figure 2-3, and 6-7), and wherein at least one of the one or more internal passageways is coupled to the opening (port 126 opens into passageway 138 and interior cavity 136; figure 6). Nashed does not disclose a double-walled body.
However, Gee teaches a mask interface (figure 1-3) comprising a double-walled body (label C and D; figure 1). Specifically, Gee teaches in Fig 1, labels C and D indicate the internal and external skins of the mask respectively. In Fig 1, label E indicates the void between the internal and external skins, C and D. This void is continuous with the suction outlet, label B, but not the ventilation inlet, label A. In Fig 1, label F indicates the flexible soft rubber padding; pg. 1 line 26-29. The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 6-9.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Nashed to implement a double walled body with a void connected to a suction outlet in order to enable the face mask to form an airtight seal via applying suction through the space between the double walled body as taught by Gee pg. 1 line 6-9 and 26-29. As modified, an additional internal passageway is formed by the double-walled body.
Regarding claim 10, modified Nashed discloses the mask interface of claim 1, but is silent as to wherein the tubing is coupled to a suction generator, and wherein applying suction via the suction generator isolates an interior of the mask interface from an exterior of the mask interface.
However, Gee teaches a mask interface (figure 1-3) comprising an open channel couplable with tubing (In Fig 1, label B indicates the suction outlet; pg. 1 line 22) wherein the tubing is coupled to a suction generator (a suction outlet B communicating with the void E and for connection to a suction device; abstract. Claim 9: The face mask has an optional plastic connector which is designed to connect the mask suction outlet aperture mentioned in claim 3, and the resident suction device tubing). Additionally, Gee teaches wherein applying suction via the suction generator isolates an interior of the mask interface from an exterior of the mask interface (in Fig 1, labels C and D indicate the internal and external skins of the mask respectively. In Fig 1, label E indicates the void between the internal and external skins, C and D. This void is continuous with the suction outlet, label B, but not the ventilation inlet, label A. In Fig 1, label F indicates the flexible soft rubber padding; pg. 1 line 26-29. The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Nashed to include applying suction to the open channel via a suction device, as taught by Gee, as it would have been obvious substitution of one known element for another, using the suction outlet and suction device communicating with the void of the body and interface taught by Gee in place of the inflation tube of Nashed, and would provide predictable results, enabling the face mask to form an airtight seal via applying suction (see Gee pg. 1 line 6-9 and 26-29).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nashed (US 20070295335 A1) and Eves et al. (US 20180272095 A1) as applied to claim 1 above, and further in view of Derringer et al. (US 20110209701 A1).
Regarding claim 8, modified Nashed teaches the mask interface of claim 1, but is silent as to wherein the interface comprises grooves on an exterior edge of the mask interface.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein the cushion interface comprises grooves on an exterior edge of the mask interface ([0012] The cushion can include an outer surface including pores, micro grooves, pits, or other textured surface means for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cushion of Nashed to implement grooves on an exterior edge of the mask interface in order to provide a textured surface for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface, as taught by Derringer [0012].
Claim(s) 11-15, 16-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nashed (US 20070295335 A1), Gee (GB 2336547 A) and Eves et al. (US 20180272095 A1).
Regarding claim 11, Nashed discloses a mask interface (face mask assembly 120; figure 1-16) comprising:
a housing (shell member 122; figure 1, 3-7, and 12-16) comprising:
a first connector ([0049] first cylindrical hollow inlet member or port 126), wherein the first connector is couplable with a positive pressure respiratory device ([0051] a conventional two-branch breathing circuit 144 such that anesthesia gas or gases are adapted to pass from a source (not shown) through one branch of the breathing circuit 144 through passageway 138 into the interior cavity 136 of shell member 122 (and mask 120) as indicated by arrow 146; figure 12);
an internal passageway coupled to the first connector ([0051] passageway 138 opening into interior cavity 136; figure 2-3, and 6-7); and
a second connector ([0056] inflation tube 176; see figure 6);
a facial adapter coupled to the housing ([0053] outwardly extending flange member 158 which defines on the bottom thereof a pneumatic sealing cushion mounting surface 160; figure 3-7 and 13-14) and an interface ([0054] cushion 124; figure 1-16); and
the interface, wherein the interface is in contact with a subject's face (figure 1-2), and wherein the interface comprises a flexible material conformable to the subject's face ([0054] the pneumatic sealing cushion 124 which essentially comprises an inflatable donut-shaped hollow annular member made of pliable flexible material; figure 1-2).
Nashed does not disclose wherein the second connector is couplable with tubing from a suction generator; and wherein the housing comprises a rigid material.
However, Gee teaches a mask interface (figure 1-3) comprising connector couplable with tubing (In Fig 1, label B indicates the suction outlet; pg. 1 line 22) from a suction generator (a suction outlet B communicating with the void E and for connection to a suction device; abstract. Claim 9: The face mask has an optional plastic connector which is designed to connect the mask suction outlet aperture mentioned in claim 3, and the resident suction device tubing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inflation tube of Nashed to be couplable with tubing from a suction device in order to facilitate selective inflation, taught by Nashed, and selective suction of the pneumatic cushion, taught by Gee pg. 1 line 6-9.
Nashed teaches [0048] Shell member 122 preferably is of one-piece or unitary construction fabricated in a known manner from a synthetic polymeric resin such as polyvinyl chloride.
However, Eves teaches a mask shell 6005 manufactured from polycarbonate, see [0299]. Applicant’s specifications [0038], teaches polycarbonate is a rigid material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask shell of Nashed to be made from polycarbonate, as taught by Eves, as it would have been obvious substitution of one known element for another, using the polycarbonate taught by Eves in place of the synthetic polymeric resin of Nashed, and would provide predictable results, providing a suitable material for a shell for a mask interface (see Eves [0299]).
Regarding claim 12, Nashed teaches wherein the flexible material is a porous medium or a viscoelastic solid ([0056] cushion 124 which essentially comprises an inflatable donut-shaped hollow annular member made of pliable flexible material, preferably synthetic polymeric resin such as polyvinyl chloride) with one or more holes ([0056] opening 178 in pad 162 of cushion member 124; figure 7).
Regarding claim 13, modified Nashed teaches the mask interface of claim 11, but is silent as to wherein the flexible material comprises one or more of silicone and open cell foam.
However, Eves teaches a cushion assembly 6000 made of silicone material (see [0299] and figure 24A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cushion of Nashed to be made from silicone, as taught by Eves, as it would have been obvious substitution of one known element for another, using the silicone taught by Eves in place of the synthetic polymeric resin of Nashed, and would provide predictable results, providing a suitable material for a cushion of a mask interface that is soft, flexible, and resilient (see Eves [0243] and [0299]).
Regarding claim 14, Eves teaches wherein the rigid material comprises polycarbonate ([0299] the shell 6005 may be made of a polycarbonate material).
Regarding claim 15, Nashed teaches wherein the interface is coupled to the interface with a bond joint ([0056] As shown in FIG. 6A, cushion member 124 preferably is formed with a somewhat thickened top wall portion defining a mounting foot or pad 170 which advantageously may be adhered securely to the mounting surface 160 of flange member 158 suitably by means of a compatible adhesive (indicated by stippling 174 in FIG. 14) or the like applied all along the top surface of pad 170, the mounting surface 160, or both).
Regarding claim 16, modified Nashed teaches the mask interface of claim 11, but is silent as to wherein the internal passageway comprises a double-walled body.
However, Gee teaches a mask interface (figure 1-3) comprising a double-walled body (label C and D; figure 1). Specifically, Gee teaches in Fig 1, labels C and D indicate the internal and external skins of the mask respectively. In Fig 1, label E indicates the void between the internal and external skins, C and D. This void is continuous with the suction outlet, label B, but not the ventilation inlet, label A. In Fig 1, label F indicates the flexible soft rubber padding; pg. 1 line 26-29. The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 6-9.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Nashed to implement a double walled body with a void connected to a suction outlet in order to enable the face mask to form an airtight seal via applying suction through the space between the double walled body as taught by Gee pg. 1 line 6-9 and 26-29.
Regarding claim 17, Nashed teaches wherein the interface comprises a sealing feature ([0054] pneumatic sealing cushion 124; figure 6) isolating an interior of the mask interface (interior of cushion 124; figure 6, 9-11, and 13-14) from an exterior environment of the mask interface (interior of cushion 124 is isolated from the external environment via the outer structure of cushion 124) and the internal passageway (interior of cushion 124 is isolated from the passageway 138 opening into interior cavity 136 via the outer structure of cushion 124).
Regarding claim 19, modified Nashed teaches the mask interface of claim 11, but is silent as to wherein applying suction via the suction generator isolates an interior of the mask interface from an exterior of the mask interface.
However, Gee teaches wherein applying suction via the suction generator isolates an interior of the mask interface from an exterior of the mask interface (in Fig 1, labels C and D indicate the internal and external skins of the mask respectively. In Fig 1, label E indicates the void between the internal and external skins, C and D. This void is continuous with the suction outlet, label B, but not the ventilation inlet, label A. In Fig 1, label F indicates the flexible soft rubber padding; pg. 1 line 26-29. The face mask works on the principle of the mask adhering to the contours of the face and creating an air tight seal via suction during the simultaneous delivery of ventilation therapy from the mechanical ventilator. The suction is generated from the suction units already available at the hospital bed sides; pg. 1 line 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Nashed to include applying suction to the open channel via a suction device, as taught by Gee, as it would have been obvious substitution of one known element for another, using the suction outlet and suction device communicating with the void of the body and interface taught by Eves in place of the inflation tube of Nashed, and would provide predictable results, enabling the face mask to form an airtight seal via applying suction (see Gee pg. 1 line 6-9 and 26-29).
Regarding claim 20, Nashed discloses a mask interface (face mask assembly 120; figure 1-16) comprising:
a housing (shell member 122; figure 1, 3-7, and 12-16) comprising:
a first connector ([0049] first cylindrical hollow inlet member or port 126), and wherein the first connector is couplable with a positive pressure respiratory device ([0051] a conventional two-branch breathing circuit 144 such that anesthesia gas or gases are adapted to pass from a source (not shown) through one branch of the breathing circuit 144 through passageway 138 into the interior cavity 136 of shell member 122 (and mask 120) as indicated by arrow 146; figure 12); and
a second connector ([0056] inflation tube 176; see figure 6);
a facial adapter coupled to the housing ([0053] outwardly extending flange member 158 which defines on the bottom thereof a pneumatic sealing cushion mounting surface 160; figure 3-7 and 13-14) and an interface ([0054] cushion 124; figure 1-16); and
the interface in contact with a subject's face (figure 1-2), and wherein the interface comprises a flexible material conformable to the subject's face to create a seal ([0054] the pneumatic sealing cushion 124 which essentially comprises an inflatable donut-shaped hollow annular member made of pliable flexible material; figure 1-2).
Nashed does not disclose wherein the second connector is couplable with tubing from a suction generator; and wherein the housing comprises a rigid material.
However, Gee teaches a mask interface (figure 1-3) comprising connector couplable with tubing (In Fig 1, label B indicates the suction outlet; pg. 1 line 22) from a suction generator (a suction outlet B communicating with the void E and for connection to a suction device; abstract. Claim 9: The face mask has an optional plastic connector which is designed to connect the mask suction outlet aperture mentioned in claim 3, and the resident suction device tubing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inflation tube of Nashed to be couplable with tubing from a suction device in order to facilitate selective inflation, taught by Nashed, and selective suction of the pneumatic cushion, taught by Gee pg. 1 line 6-9.
Nashed teaches [0048] Shell member 122 preferably is of one-piece or unitary construction fabricated in a known manner from a synthetic polymeric resin such as polyvinyl chloride.
However, Eves teaches a mask shell 6005 manufactured from polycarbonate, see [0299]. Applicant’s specifications [0038], teaches polycarbonate is a rigid material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask shell of Nashed to be made from polycarbonate, as taught by Eves, as it would have been obvious substitution of one known element for another, using the polycarbonate taught by Eves in place of the synthetic polymeric resin of Nashed, and would provide predictable results, providing a suitable material for a shell for a mask interface (see Eves [0299]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nashed (US 20070295335 A1) and Eves et al. (US 20180272095 A1) as applied to claim 1 above, and further in view of Derringer et al. (US 20110209701 A1).
Regarding claim 18, modified Nashed teaches the mask interface of claim 11, but is silent as to wherein the interface comprises grooves on an exterior edge of the mask interface.
However, Derringer teaches a nose pad cushion for attachment to a mask [0012] wherein the cushion interface comprises grooves on an exterior edge of the mask interface ([0012] The cushion can include an outer surface including pores, micro grooves, pits, or other textured surface means for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cushion of Nashed to implement grooves on an exterior edge of the mask interface in order to provide a textured surface for holding a liquid, paste, powder, gel, salve, or other form of a medical product impregnated thereon between the user's skin and the cushion surface, as taught by Derringer [0012].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra 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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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785