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 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 83-85 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.
Claim 83 recites “a distal end portion”. It is unclear if applicant is introducing another distal end portion or if applicant is attempting to refer back to the distal end portion introduced in claim 1.
Claim 84 recites “a cross-sectional area”. It is unclear if applicant is introducing another cross-sectional area or if applicant is attempting to refer back to the cross-sectional area introduced in claim 1.
Claim 85 recites “a cross-sectional area”. It is unclear if applicant is introducing another cross-sectional area or if applicant is attempting to refer back to the cross-sectional area introduced in claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5, 15-17, 25-28, 32, 37-41 and 83-85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allum et al. (US 2010/0071693 A1)
Regarding claim 1, Allum discloses: A system for providing respiratory support to a subject (for example as shown in figure 3; [0062]), the system including:
a flow source (20) for providing a gas at a selected flow rate [0062];
an invasive respiratory device (60; [0062]) couplable with for delivery of gases to an airway of the subject [0062]; and
a connector (84) for coupling with the invasive respiratory device (60) (see figure 11), the connector (84) including a main body (body of 84) having:
a gases port (see annotated figure below) for receiving a flow of gas from the flow source (via 21), wherein the gases port includes an inlet and an outlet (see annotated figure below; outlet is at 66);
an outlet port (85) for outflow of gases from the main body ([0075]: 85 can be open); and
a device port (where 84 couples to 60) couplable with the invasive respiratory device (see figure 11);
wherein the connector is configured to receive the flow of gas from the flow source (20) via the inlet of the gases port (see figures 3 and 11), and to deliver a jet flow of gas through the outlet of the gases port (66 is a nozzle; [0075]),
wherein the system is configured to generate a pressure of at least about 2 cmH20 about the device port when in use [0069].
PNG
media_image1.png
380
690
media_image1.png
Greyscale
Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Further, Allum discloses the placement of the outlet of the gases port relative to the distal end portion of the invasive respiratory device as a results effective variable. [0076] discusses the placement results in increased or decreased entrainment and changes airway pressure. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Allum wherein a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Allum as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claim 2, Allum discloses: A system for providing respiratory support to a subject (for example as shown in figure 3; [0062]), the system including:
a flow source (20) for providing a gas at a selected flow rate [0062];
an invasive respiratory device (60; [0062]) couplable with for delivery of gases to an airway of the subject [0062]; and
a connector (84) for coupling with the invasive respiratory device (60) (see figure 11), the connector (84) including a main body (body of 84) having:
a gases port (see annotated figure below) for receiving a flow of gas from the flow source (via 21), wherein the gases port includes an inlet and an outlet (see annotated figure below; outlet is at 66);
an outlet port (85) for outflow of gases from the main body ([0075]: 85 can be open); and
a device port (where 84 couples to 60) couplable with the invasive respiratory device (see figure 11);
wherein the connector is configured to receive the flow of gas from the flow source (20) via the inlet of the gases port (see figures 3 and 11), and to deliver a jet flow of gas through the outlet of the gases port (66 is a nozzle; [0075]),
wherein a pressure loss between the device port and the outlet port of the connector is less than about 20 cmH2O when in use. "[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) The examiner notes that Allum discloses all the structural limitations of the claim.
Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Further, Allum discloses the placement of the outlet of the gases port relative to the distal end portion of the invasive respiratory device as a results effective variable. [0076] discusses the placement results in increased or decreased entrainment and changes airway pressure. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Allum wherein a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Allum as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claim 3, Allum discloses: A system for providing respiratory support to a subject (for example as shown in figure 3; [0062]), the system including:
a flow source (20) for providing a gas at a selected flow rate [0062];
an invasive respiratory device (60; [0062]) couplable with for delivery of gases to an airway of the subject [0062]; and
a connector (84) for coupling with the invasive respiratory device (60) (see figure 11), the connector (84) including a main body (body of 84) having:
a gases port (see annotated figure below) for receiving a flow of gas from the flow source (via 21), wherein the gases port includes an inlet and an outlet (see annotated figure below; outlet is at 66);
an outlet port (85) for outflow of gases from the main body ([0075]: 85 can be open); and
a device port (where 84 couples to 60) couplable with the invasive respiratory device (see figure 11);
wherein the connector is configured to receive the flow of gas from the flow source (20) via the inlet of the gases port (see figures 3 and 11), and to deliver a jet flow of gas through the outlet of the gases port (66 is a nozzle; [0075]),
wherein a pressure loss between the outlet of the gases port and the outlet port of the connector is less than about 20 cmH2O when in use. "[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) The examiner notes that Allum discloses all the structural limitations of the claim.
Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Further, Allum discloses the placement of the outlet of the gases port relative to the distal end portion of the invasive respiratory device as a results effective variable. [0076] discusses the placement results in increased or decreased entrainment and changes airway pressure. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Allum wherein a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Allum as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 60 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claim 5, Allum further discloses wherein the pressure about the device port is between about 2 cmH2O and about 20 cmH2O when in use. "[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) The examiner notes that Allum discloses all the structural limitations of the claim. The examiner notes that [0069] discusses pressure delivered to the patient.
Regarding claim 15, Allum further discloses wherein the selected flow rate is in a range of about 20 L/min to about 90 L/min [0073].
Regarding claim 16, Allum further discloses wherein wherein the selected flow rate is in a range of about 0.5 L/min to about 25 L/min [0073].
Regarding claim 17, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose a filter couplable with the outlet port of the connector for filtering the gases from the main body.
However, another embodiment of Allum teaches it is known to include a filter (102) couplable with the outlet port (85) of the connector for filtering the gases from the main body (see figure 19; [0082] 102 filters moisture).
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 Allum such that the system includes a filter couplable with the outlet port of the connector for filtering the gases from the main body for the benefit of trapping moisture from the gases from the main body and using the trapped moisture during inhalation [0082].
Regarding claim 25, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose further including a humidifier configured to condition the gas provided by the flow source to at least one of a selected temperature or a selected humidity.
However, another embodiment of Allum teaches it is known to have a humidifier configured to condition the gas provided by the flow source to at least one of a selected temperature or a selected humidity [0088].
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 Allum such that the system includes a humidifier configured to condition the gas provided by the flow source to at least one of a selected temperature or a selected humidity for the benefit of patient comfort.
Regarding claim 26, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the jet flow of gas delivered through the outlet of the gases port has a velocity in a range of about 5 m/s to about 60 m/s.
However Allum states that “Other contributors to the physically efficiency and clinical efficacy of the ventilation system include the exit velocity of gas exiting the ventilation catheter, the alignment of the velocity of the gas relative to the tip of the airway tube or the airway lumen, the gas volume surrounding and in the immediate vicinity of the ventilation catheter nozzle” (see [0069]), thus making the exit velocity (jet flow of gas delivered through the outlet of the gases port) a results effective variable in that changing the exit velocity will alter physical and clinical efficacy.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Allum wherein the jet flow of gas delivered through the outlet of the gases port has a velocity in a range of about 5 m/s to about 60 m/s as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claims 27-28, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a hydraulic diameter in a range of about 2 mm to about 10 mm, wherein the hydraulic diameter is in a range of about 5 mm to about 8 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a the outlet of the gases port has a hydraulic diameter in a range of about 2 mm to about 10 mm, wherein the hydraulic diameter is in a range of about 5 mm to about 8 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claims 32, Allum discloses the claimed invention substantially as claimed and further discloses wherein the connector further includes an expiratory flow path defined between the device port and the outlet port [0075] [0062] (85 allows passage of air). Allum does not explicitly disclose wherein the expiratory flow path has a minimum cross-sectional area of at least about 25 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the expiratory flow path has a minimum cross-sectional area of at least about 25 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claim 37, Allum further discloses wherein the gases port further includes a flow constriction (at 66) for providing the jet flow of gas through the outlet of the gases port (see figure 11).
Regarding claim 38, Allum further discloses wherein the flow constriction is disposed between the inlet of the gases port and the device port (see figure 11).
Regarding claim 39, Allum further discloses wherein the flow constriction includes a nozzle (66) having the outlet of the gases port through which the jet flow of gas is delivered (see figure 11).
Regarding claim 40, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the flow constriction includes the outlet of the gases port having a plurality of apertures through which the jet flow of gas is delivered.
However, another embodiment of Allum teaches it is known to have the outlet of the gases port (at 66) having a plurality of apertures (141, 144) through which the jet flow of gas is delivered [0088].
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Allum such that the flow constriction includes the outlet of the gases port having a plurality of apertures through which the jet flow of gas is delivered for the benefit of providing humidified gas to the patient [0088].
Regarding claim 41, Allum further discloses wherein the flow constriction (at 66) includes a tapered region for constricting the flow of gas prior to exiting the outlet (see figure 11).
Regarding claims 83, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: the distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 10 mm to about 30 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 10 mm to about 30 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Further, Allum discloses the placement of the outlet of the gases port relative to the distal end portion of the invasive respiratory device as a results effective variable. [0076] discusses the placement results in increased or decreased entrainment and changes airway pressure. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Allum wherein a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 10 mm to about 30 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claims 84, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: Allum as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 50 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the outlet of the gases port has a cross-sectional area in a range of about 10 mm2 to about 50 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Regarding claims 85, Allum discloses the claimed invention substantially as claimed but does not explicitly disclose wherein: Allum as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the outlet of the gases port has a cross-sectional area in a range of about 20 mm2 to about 50 mm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have the outlet of the gases port has a cross-sectional area in a range of about 20 mm2 to about 50 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.
Response to Arguments
Applicant's arguments filed 5/19/2026 have been fully considered but they are not persuasive.
The examiner agrees with applicant that the prior art of Allum no longer anticipates amended claims 1-3.
Applicant’s representative asserts that claims 1-3 are not rendered obvious by Allum. The examiner respectfully disagrees. As stated in the rejection set forth above: “It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Allum to have a distance from the outlet of the gases port to a distal end portion of the invasive respiratory device when coupled to the device port is in a range of about 0 mm to about 60 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Allum would not operate differently with the claimed dimensions. Further, applicant places no criticality on the range claimed.” Applicant then points to their specification for reasons why certain dimensions were chosen and states that the “disclosure directly contradicts the Office Action’s assertion that the claimed dimensional features would not affect operation.” The Office Action made no such assertion. The Office Action stated “the device of Allum would not operate differently with the claimed dimensions”. Applicant’s representative does not seem to refute this statement and further does not offer any evidence that proves otherwise.
Applicant points to [0294]-[0295] to assert criticality. While these paragraphs describe ratios between outlet cross-sectional area and distance from the outlet, it is the examiner’s position that these ratios do not result in unexpected results, nor does the cited disclosure support any unexpected results based on the dimensions claimed. As stated in MPEP 2144 III A, Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The prior art of Allum already contemplates that the placement of the outlet of the gases port relative to the distal end portion of the invasive respiratory device is a results effective variable. [0076] of Allum discusses the placement results in increased or decreased entrainment and changes airway pressure and therefore the placement can be optimized. The examiner notes that applicant has not provided evidence that there is anything unexpected or critical about the claimed distance range of about 0mm to about 60mm, nor has applicant provided evidence that the claimed cross-sectional area of the outlet is critical.
Further the examiner notes the disclosed ratios range from about 1:1 to 1:10, the claimed distances range from 0 to 60 mm and the claimed cross-sectional area ranges from about 10 to about 60 mm2. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)
Applicant’s representative states that a rejection based on “routine optimization” requires more than a conclusory assertion that a dimension could have been varied. The examiner has provided a citation in Allum that goes beyond that of a conclusory assertion. Allum specifically states in [0076] that varying placement of the outlet results in increased or decreased entrainment and changes airway pressure.
Applicant’s representative asserts that the prior art does not disclose the combination of dimensions claimed and does not recognize the balance between outlet cross-sectional area, generated patient pressure, resistance to flow and driving pressure. As set forth above, the examiner respectfully disagrees with applicant’s position and maintains that the prior art of Allum renders claims 1-3 obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Landis et al. (US 2009/0139530 A1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
Prosecution Insights