DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges the reply filed on 1/20/2026 in which claims 1 and 7 have been amended. Claim 11, 15, 17 and 24-76 are cancelled. Currently claims 1-10, 12, 13, 16 and 18-23 are pending for examination in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al. (US 10,952,812 B1) in view of Ellen (US 7,479,103 B2).
Regarding claim 1, Saadat discloses: A mask for performing a medical procedure via a nasal cavity (figure 4-6), comprising:
a containment wall (60) comprising:
an inner surface configured to extend over a face of a wearer (inner surface of 60 facing the user), an outer surface opposite the inner surface (outer surface of 60), and a peripheral edge (periphery of 60) at an interface between the inner surface and the outer surface (see figure 5);
a gasket (63) at the peripheral edge of the containment wall (see figure 6), wherein the gasket is configured to conform to the face of a wearer (col. 12, lines 31-34), wherein the containment wall and the gasket define a chamber between the inner surface of the containment wall and the face of the wearer when the mask is worn by the wearer (see figures 5-6; col. 12, lines 34-37),
a nasal access (74) opening in the containment wall, wherein the nasal access opening is aligned with a nose of the wearer when the mask is worn by the wearer (see figure 5-6);
an inlet (78) at a superior end of the containment wall (see figure 4), wherein the inlet is configured to receive a gas into the chamber (see figure 4); and
an outlet (64) at an inferior end of the containment wall (see figure 4), wherein the outlet is configured to exhaust out of the chamber (i) the gas and (ii) at least one of droplets or aerosols exhaled by the wearer while wearing the mask (col. 12, lines 51-57).
Figures 4-6 of Saadat do not explicitly disclose a pump coupled to the inlet and to the outlet, wherein the pump is configured to: provide a positive flow of the gas at the inlet; and provide suction at the outlet.
However, Figure 3 of Saadat teaches it is known for an air mover (38) to be coupled to the inlet and to the outlet (see figure 3; the modification results in the inlet at 78 being attached to tubing as shown in figure 3), wherein the air mover (38) is configured to provide a positive flow of the gas at the inlet and provide suction at the outlet (see figure 3, col. 11, lines 36-40).
Saadat as modified does not explicitly state the air mover (38) is a pump.
However, Ellen teaches that it is known to use pumps to move air in isolation enclosures (col. 2, lines 51-56).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Saadat such that the air mover is a pump as this is a known air mover in the art and the results of this combination would have been predictable to one having ordinary skill in the art.
Regarding claim 2, Saadat discloses the claimed invention substantially as claimed as set forth for claim 1 above. While figures 4-6 do not explicitly state the containment wall is configured to provide a laminar flow of the gas between the inlet and the outlet, and wherein the laminar flow of the gas directs the at least one of the droplets or the aerosols toward the outlet.
Saadat teaches it is known to provide a laminar airflow pattern through the medical procedure field (col. 4, lines 35-37).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified figures 4-6 of Saadat to provide a laminal airflow pattern from inlet to outlet for the benefit of creating the desired airflow within the mask as discussed in col. 18, lines 27-30). This modification would result in a laminar flow of the gas between the inlet and the outlet, and wherein the laminar flow of the gas directs the at least one of the droplets or the aerosols toward the outlet. (col. 12, lines 51-57).
Regarding claim 3, Saadat discloses the claimed invention substantially as claimed
and further discloses wherein the inner surface of the containment wall has a rounded shape with an apex that is located between the inlet and the nasal access opening (see annotated figure below).
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Regarding claim 4, Saadat discloses the claimed invention substantially as claimed
and further discloses wherein the laminar flow of the gas flows across the nasal access opening to inhibit the at least one of the droplets or the aerosols from flowing out of the chamber at the nasal access opening. (col. 12, lines 51-57).
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). It is the examiner’s position that the prior art teaches all the structural limitations of the claim.
Regarding claim 5, Saadat discloses the claimed invention substantially as claimed
and further discloses wherein wherein the laminar flow of the gas is over at least a central longitudinal portion of the containment wall such that the gas flows over the nose and a mouth of the wearer when the wearer wears the mask (see figure 4, and for example 18a-b which shows laminar flow although in an opposite direction from figure 4. The modification for laminar flow (claim 2) results in the same flow (up to down) but in a laminar way as shown in figure 18a-b).
Regarding claim 6, Saadat discloses the claimed invention substantially as claimed as set forth for claim 1 above and further discloses a membrane (68) covering the nasal access opening (see figure 4-6), and wherein the membrane comprises a membrane opening (70) that provides access to the nasal access opening (col. 12, lines 39-41).
Regarding claim 21, Saadat discloses the claimed invention substantially as claimed as set forth for claim 1 above and further discloses wherein the containment wall (62) is made from a material that causes the containment wall to be at least partially translucent (col. 12, lines 31-34).
Regarding claim 22, Saadat discloses the claimed invention substantially as claimed as set forth for claim 1 above. While figures 4-6 do not explicitly state a gas filter at the inlet, wherein the gas filter is configured to remove one or more particles from the gas as the gas is received into the chamber, another embodiment of Saadat (figures 7,8) teach it is known to provide a gas filter at the inlet (108) (col. 13, lines 6-8) wherein the gas filter is configured to remove one or more particles from the gas as the gas is received into the chamber (as per col. 13, lines 6-8 the inlet includes a filter which has a function from removing particles from gas).
Therefore, it would have been obvious so one having ordinary skill in the art to have modified Saadat such that the inlet includes a gas filter as taught by Saadat for the benefit of providing filtered air to the patient.
Regarding claim 23, Saadat discloses the claimed invention substantially as claimed as set forth for claim 1 above and further discloses a strap extending from a first lateral side of the containment wall to a second lateral side of the containment wall, wherein the strap is configured to couple the mask to a head of the wearer (strap holders shown in figures 5 and 6; bands/straps described in col. 12, lines 34-37).
Alternative to claim 1 above:
Regarding claim 1, Saadat discloses: A mask for performing a medical procedure via a nasal cavity (figure 17a-17b), comprising:
a containment wall (400+406) comprising:
an inner surface configured to extend over a face of a wearer (inner surface of 400+406 facing the user), an outer surface opposite the inner surface (outer surface of 400+406), and a peripheral edge (periphery of 400) at an interface between the inner surface and the outer surface (see figure 17b);
a gasket (402) at the peripheral edge of the containment wall (see figure 17b), wherein the gasket is configured to conform to the face of a wearer (figure 17b), wherein the containment wall and the gasket define a chamber between the inner surface of the containment wall and the face of the wearer when the mask is worn by the wearer (see figure 17b),
a nasal access (404) opening in the containment wall, wherein the nasal access opening is aligned with a nose of the wearer when the mask is worn by the wearer (see figure 17a-17b).
This embodiment of Saadat does not explicitly disclose an inlet at a superior end of the containment wall, wherein the inlet is configured to receive a gas into the chamber; and
an outlet at an inferior end of the containment wall, wherein the outlet is configured to exhaust out of the chamber (i) the gas and (ii) at least one of droplets or aerosols exhaled by the wearer while wearing the mask. Although the examiner notes this embodiment does have an airflow as per col. 17, lines 38-48.
However, another embodiment (figure 4) of Saadat teaches an inlet (78) at a superior end of the containment wall (see figure 4), wherein the inlet is configured to receive a gas into the chamber (see figure 4); and
an outlet (64) at an inferior end of the containment wall (see figure 4), wherein the outlet is configured to exhaust out of the chamber (i) the gas and (ii) at least one of droplets or aerosols exhaled by the wearer while wearing the mask (col. 12, lines 51-57).
It would have been obvious to one having ordinary skill in the art to have modified Saadat to include an inlet at a superior end of the containment wall, wherein the inlet is configured to receive a gas into the chamber; and
an outlet at an inferior end of the containment wall, wherein the outlet is configured to exhaust out of the chamber (i) the gas and (ii) at least one of droplets or aerosols exhaled by the wearer while wearing the mask as taught by Saadat for the benefit of providing a desired airflow pattern and negative pressure field.
Figures 17a-17b of Saadat do not explicitly disclose a pump coupled to the inlet and to the outlet, wherein the pump is configured to: provide a positive flow of the gas at the inlet; and provide suction at the outlet.
However, Figure 3 of Saadat teaches it is known for an air mover (38) to be coupled to the inlet and to the outlet (see figure 3; the modification results in the inlet at 78 (figure 4) being attached to tubing as shown in figure 3), wherein the air mover (38) is configured to provide a positive flow of the gas at the inlet and provide suction at the outlet (see figure 3, col. 11, lines 36-40).
Saadat as modified does not explicitly state the air mover (38) is a pump.
However, Ellen teaches that it is known to use pumps to move air in isolation enclosures (col. 2, lines 51-56).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Saadat such that the air mover is a pump as this is a known air mover in the art and the results of this combination would have been predictable to one having ordinary skill in the art.
Regarding claim 20, Saadat discloses the claimed invention substantially as claimed for claim 1 (alternative rejection) above. Saadat further discloses wherein the containment wall comprises a first section (400 not including 406) and a second section (406), and wherein the first section and the second section are movable relative to each other to adjust a size of the nasal access opening (see figures 17a-17b).
Claim(s) 7-10, 12-14, 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Ellen, in further view of Widenhouse et al. (US 2010/0113882 A1), hereinafter Widenhouse.
Regarding claim 7, Saadat discloses the claimed invention substantially as claimed for claim 6 above. Saadat discloses wherein the membrane has an outer surface (outer surface of 68) and an inner surface (inner surface of 68) as well as the membrane opening 70. Saadat does not explicitly disclose wherein the membrane comprises a plurality of layers in a stacked arrangement between the outer surface and the inner surface of the membrane, wherein each layer comprises a respective aperture, wherein the respective apertures of the plurality of layers overlap with each other to define a membrane opening extending through the membrane between the outer surface of the membrane and the inner surface of the membrane.
However Widenhouse teaches a surgical access membrane (24, figure 4 or 44 in figure 7) wherein the membrane comprises a plurality of layers (figure 4; [0022]-[0023] or [0024]) in a stacked arrangement between the outer surface and the inner surface of the membrane (see figure 4 or figure 7), wherein each layer comprises a respective aperture (slits 28 or slits 48), wherein the respective apertures of the plurality of layers overlap with each other to define a membrane opening extending through the membrane between the outer surface of the membrane and the inner surface of the membrane [0023] or [0024].
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Saafan’s membrane 68 to include a plurality of layers in a stacked arrangement between the outer surface and the inner surface of the membrane, wherein each layer comprises a respective aperture, wherein the respective apertures of the plurality of layers overlap with each other to define a membrane opening extending through the membrane between the outer surface of the membrane and the inner surface of the membrane as taught by Widenhouse for the benefit of allowing objects to be inserted and removed in multiple locations of the membrane [0023].
Regarding claim 8, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse further discloses wherein each aperture defines a slit (Widenhouse: 28 or 48), wherein the slits of adjacent layers in the stacked arrangement are elongated in respective directions that are transverse to each other (Widenhouse: see figure 4 or figure 7).
Regarding claim 9, Saadat discloses the claimed invention substantially as claimed for claim 8 above. Saadat as modified by Widenhouse further discloses wherein the respective directions in which the slits of the adjacent layers are elongated are arranged at an angle of approximately 90 degree relative to each other (Widenhouse: see figure 4).
Regarding claim 10, Saadat discloses the claimed invention substantially as claimed for claim 8 above. Saadat as modified by Widenhouse further discloses wherein the respective directions in which the slits (Widenhouse: 48) of the adjacent layers are elongated are arranged at an angle between approximately 45 degrees and approximately 60 degrees relative to each other (Widenhouse: [0024] figure 7).
Regarding claim 12, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse further discloses wherein the plurality of layers comprise an elastic material such that the membrane opening is configured to (i) deform from a closed state to an enlarged state responsive to an instrument being inserted through the membrane opening and applying a force to the membrane, and (ii) return from the enlarged state to the closed state responsive to the instrument being withdrawn from the membrane opening (Widenhouse: [0022]-[0023]).
Regarding claim 13, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse further discloses wherein the membrane comprises an anti-viral material (Widenhouse: polyethylene glycol [0023]), and wherein the membrane is configured to transfer at least a portion of the anti-viralmaterial to the instrument responsive to the instrument applying the force to the membrane in the membrane opening (Widenhouse explains this is to reduce friction and thus it is the examiner’s position that at least a portion of the polyethylene glycol would transfer to the instrument being inserted [0023]).
Regarding claim 14, Saadat discloses the claimed invention substantially as claimed for claim 13 above. Saadat as modified by Widenhouse further discloses wherein the anti-viral material is disposed between adjacent layers in the stacked arrangement (Widenhouse: [0023]).
Regarding claim 16, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse as currently modified further disclose the membrane being removably coupled to the containment wall at the nasal access opening (Sadaat: col. 12, lines 51-54) but do not explicitly disclose wherein this is done by a friction fit coupling.
However, another embodiment of Saadat (figures 17a-b) teach that it is known to couple a membrane (406) to the containment wall via a friction fit coupling (col. 17, lines 1-2). The examiner notes that only the attachment to the containment wall is being altered (snap fit as opposed to the gel disclosed col. 12, lines 40-41).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have substituted the attachment to the containment wall to be a snap fit as opposed to gel and the results of this substitution would be predictable. The courts have held that a prima facia case of obvious when the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)
Regarding claim 18, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse as currently modified do not explicitly disclose wherein the membrane is made from a material that causes the membrane to be at least translucent.
However, in a different embodiment of Saadat (figure 15) the membrane (292) is transparent (col. 15, lines 63-65).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Saadat such that the membrane is made from a material that causes the membrane to be at least translucent as taught by Saadat (figure 15) for the benefit of allowing the clinician to see more clearly where they are inserting the instrument.
Regarding claim 19, Saadat discloses the claimed invention substantially as claimed for claim 7 above. Saadat as modified by Widenhouse further discloses wherein the plurality of layers comprises a quantity of layers between two layers and five layers (less than 9 as per [0022] of Widenhouse).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claims were amended to include limitations drawn to a pump. The newly added limitations are now rejected using figure 3 of Saadat and the prior art of Ellen.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785