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
The present office action is in response to the Remarks/Amendments filed 07/27/2026. As directed by the amendment, claims 52, 58, 65-66, 76-77, 79, and 84 has been amended. Thus, claims 52, 57-60, 63, 65-66, 71, 73-74, and 76-84 are presenting pending in this application.
Applicant has amended claims 52, 58, 65-66, 76-77, 79, and 84 to address minor informalities. Therefore, the previously held claim objection is hereby withdrawn.
Applicant has amended claim 76 to overcome the rejections under 35 U.S.C. §112. Therefore, the previously held claim rejection is hereby withdrawn.
Applicant has amended claims 77 and 79 to overcome the rejections under 35 U.S.C. §101. Therefore, the previously held claim rejections are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see Fifth Paragraph of Page 9, filed 07/27/2026, with respect to claim objection of claim 74 have been fully considered and are persuasive. Therefore, the previously held claim objection is hereby withdrawn.
Applicant’s arguments, see section “Rejection under 35 U.S.C. § 102(a)(1)” of Page 11, filed 07/27/2026, have been fully considered and are not persuasive.
Applicant acknowledges that where the prior art reference fails to expressly disclose a relevant feature, the Doctrine of Inherency can be used to establish the presence of a feature, result, or characteristic, with certain limitation. Per MPEP §211, to “establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present and the thing described in the reference, and that it would be recognized by persons of ordinary skill…The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Based on the acknowledgement, Applicant argues that the Office action fails to cite any language that identically discloses, “wherein the nasal interface is configured such that at least 60% of a total volumetric flow rate of gases flow into the gases inlet is delivered out of the nasal interface through the first prong” as it only recites certain paragraphs in Tatkov with implication of said limitation. However, the Office Action fails to establish that the claimed volumetric flow rate is necessarily present in Tatkov. Thus, Applicant submits that the standard for anticipation has not been met for independent claim 52 or any of dependent claims.
Examiner respectfully disagree with Applicant’s argument. As noted, Examiner cited the following paragraphs of ¶0013-0014,0019 of Tatkov (US 20160158476 A1). Tatkov discloses a nasal interface uses asymmetrical nasal delivery elements to delivery an asymmetrical flow (abstract). In various embodiments, the second cross-sectional area may be about 1.5 to about 50 mm.sup.2 and the first cross-sectional area may be about 20% to about 80% of the second cross-sectional area, preferably about 50% (¶0013) and the ratio of the first cross-sectional area to the second cross-sectional area may be at least about 1:1.2, 1:1.25, 1:1.3, 1:1.35, 1:1.4, 1:1.45, 115, 1:1.55, 1:1.6, 1:1.65, 1:1.7, 1:1.75, 1:1.8, 1:1.85, 1:1.9, 1:1.95, 1:2, 1:2.05, 1:2.1, 1:2:15, 1:2.2, 1:2.25, 1:2.3, 1:2.35, 1:2.4, 1:2.45, or 1:2.5, and useful ranges may be selected between any of these values (for example, about 1:1.2 to about 1:2.5). Preferably the ratio may be about 1:2 (¶0014) while the interface may be adapted so that fittings be attached to alter the shape or inner or outer diameter to clear dead space, reduce operational flow, and reduce noise (¶0019). Examiner acknowledges that Tatkov is silent on the volumetric flow for each prong having different cross-sectional area/diameter/shape.
However, Tatkov discloses that the first cross-sectional areas is preferably about 50% which translate to 1:2 ratio. One of ordinary skill in the art would recognize that, for flow paths subjected to the same driving pressure, the relative volumetric flow rates are affected by the relative flow-path cross-sectional area which can be interpreted as to --one-to-one relationship of relative area ratio equals the relative flow ratio--.
For the disclosed 1:2 ratio, the larger flow path would therefore mathematically receive 2/(1+2), or approximately 66.7% of the total flow. Likewise, for the above ratio of 1:2 (or 1:2.5, 1:2.1, etc.) as described in ¶0014, the larger flow path would receive more than 66.7%.
Further, looking at other consideration, claim 10 of Tatkov discloses, “wherein the gas is delivered to one nare of the subject at a first flow rate of about 5 L/min to about 60 L/min and to the other nare of the subject at a second flow rate that is about 20% to about 80% of the first flow rate, preferably about 50%”.
For these reasons, the previously held rejections of claim 52 and associated dependent claims will be maintained as established in the preceding Office action.
In view of claim 77, Applicant argues that Tatkov does not discloses, teach or suggest that “wherein the first prong is configured to form a first gap between an outer surface of the first prong and a surface of one of the patient's nare, and wherein the second prong is configured to form a second gap between an outer surface of the second prong and a surface of another of the patient's nare.”
Examiner respectfully disagree with Applicant’s argument. Tatkov discloses that the nasal delivery elements may be desired to seal or semi-seal at the nose, or may not be required to seal at the nose, to deliver the therapy and Nasal high flow typically is a non-sealing therapy (¶0115) and the prongs are sized to maintain a sufficient gap between the outer surface of the prongs and the patient's skin to avoid sealing the gas path between the cannula 100 and patient (¶0161). Thus, as noted in the preceding Office action, it would be matter of routine optimization to select different fit to the patient that results in the first gap between a surface of the first prong with the larger area and a surface of one of the nares and the second gap between a surface of the second prong with the lesser area and a surface of another of the nares in order to improve dead space clearance, preferably to reduce the volume of anatomical dead space within the volume of the airway of a subject, to reduce peak expiratory pressure, to reduce noise, and/or to reduce resistance to flow at the patient interface (¶0009).
For reasons above, the previously held rejections with respect to amended independent claims 77 and 84 and associated dependent claims are modified as necessitated by the amendments as discussed below.
Claim Rejections - 35 USC § 102
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 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.
Claims 52, 57-60, 63, 65-66, 71, 73, and 84 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tatkov (US 20160158476 A1).
Regarding claim 52, Tatkov discloses, a nasal interface (a nasal interface of Fig 2) comprising:
a first prong and a second prong that are asymmetrical to each other (¶0118, “an asymmetrical cannula interface can involve making an interface in which the nasal delivery elements are of different length, internal or external diameter, or a combination of these”; a first prong and a second prong of Figs 4a-4n; 9A-9I);
a gases manifold (120, Figs 24A-B; ¶0114, “a perspective view of a preferred form patient interface and headgear”) comprising a gases inlet (where the corrugated tube 300 connects to 120 as shown in Fig 24B; 122 of Fig 20);
wherein the first prong and the second prong are in fluid communication with the gases inlet (prongs 111, 112 are in fluid communication with the gas inlets as shown in Figs 20, and 24A-B; ¶0043, “a gases flow manifold part having a gases inlet for receiving a flow of gas from a gas source, and a gases outlet for delivering the flow of gas to the nasal delivery elements of the face mount part”; ¶0164, “The inlet 122 is preferably removably attachable to a conduit”),
wherein the first prong fully occludes at a patient's first naris and the second prong partially occludes at the patient's naris (¶0125, “where one nare may be sealed….one of the nares may be left unobstructed, providing a more comfortable therapy that has lower noise than conventional NHF therapies”);
wherein the nasal interface is configured to cause an asymmetrical flow of gases at the patient's nares (¶0066, “a nasal interface comprising asymmetrical nasal delivery elements to generate an asymmetrical flow or a partial unidirectional flow of gases at the nares”);
wherein the nasal interface is configured such that at least 60% of a total volumetric flow rate of gases flow into the gases inlet is delivered out of the nasal interface through the first prong (¶0013-0014,0019, “…the first cross-sectional area may be about 20% to about 80% of the second cross-sectional area, preferably about 50%...the ratio…1:2, 1:2.05, 1:2.1, 1:2:15, 1:2.2, 1:2.25, 1:2.3, 1:2.35, 1:2.4, 1:2.45, or 1:2.5”, implies that the volumetric flow rate of gases can be at least 60% through the first prong based on the ratio of the cross-sectional areas of the prongs; see response to the arguments above).
Regarding claim 57, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein the nasal interface comprises a cannula body (118, Fig 20) comprising the first prong and the second prong (prongs are attached to the base 118 as shown in Figs 22, and 24A-B; ¶0161-0163).
Regarding claim 58, Tatkov discloses the interface of claim 57 as discussed above.
Tatkov further discloses, wherein the gases manifold is separate from and couplable with the cannula body (120 is couplable to the cannula body 118 as shown in Figs 20-21 for attached, Fig 22-23 for separated from, and 24A-B).
Regarding claim 59, Tatkov discloses the interface of claim 58 as discussed above.
Tatkov further discloses, wherein the nasal interface comprises a face mount part (110, Figs 22, and 24A-B), and wherein the first prong and the second prong comprise a pair of asymmetrical tubular nasal prongs (¶0161, The nasal prongs 111 and 112 are substantially hollow and substantially tubular in shape…the nasal prongs 111 and 112 are modified to be asymmetric as shown in Figs 22, and 24A-B) integrally moulded to the face mount part (as shown in Figs 22, and 24A-B).
Regarding claim 60, Tatkov discloses the interface of claim 59 as discussed above.
Tatkov further discloses, wherein the face mount part comprises at least one substantially horizontal side entry passage to an interior of a base portion or cannula body of the face mount part for releasably receiving an outlet of the gases manifold therethrough (¶0163, “the face mount part 110 comprises an elongate base portion 118 from which the nasal prongs 111 and 112 extend, and two wing portions…two horizontal side entry passages 121a and 121b for insertion of the outlet 123 of the manifold 120 from either side 121a or 121b there-through”).
Regarding claim 63, Tatkov discloses the interface of claim 59 as discussed above.
Tatkov further discloses, wherein the gases manifold is formed from a relatively harder material (¶0046, “the gases flow manifold part may be formed from a relatively harder material than the face mount part”) and the face mount part provides a soft interfacing component to the patient (¶0048, a substantially soft plastics material, such as silicone”), wherein the gases manifold fluidly couples a conduit to the first prong and the second prong of the face mount part (¶0163-0164, “The face mount part 110 comprises an elongate base portion 118 from which the nasal prongs 111 and 112 extend…attachable to a conduit”; as shown in Fig 24A).
Regarding claim 65, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein the first prong and the second prong are configured to provide gases to the patient without interfering with the patient's spontaneous respiration (¶0117-0120, implies that provides gases to the patient without interfering with respiration as the exhalation/expiration peak pressure is reduced as one nare may be open to the atmosphere from the combination of smaller diameter and larger dimeter in prongs so that flow that may enter the nose via both nares and leave the nose from one or both nares).
Regarding claim 66, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein the first prong and the second prong are curved to extend into the patient's nares in use and to provide a smooth flow path for gases to flow through, and/or inner surfaces of the first prong and the second prong are contoured to reduce noise, and/or bases of the first prong and the second prong include curved surfaces to provide for smoother gases flow (¶0159, “nasal prongs…are curved to extend into the patient's nares in use and to provides smooth flow path for gases to flow through …inner surfaces of the prongs…may be contoured to reduce noise.. The bases of the prongs 111 and 112 may include curves surfaces to provide for smoother gases flow”), and/or the first prong and the second prong are substantially hollow and substantially tubular in shape (¶0161), and/or the first prong and the second prong are consistent in diameter along their lengths or alternatively are shaped to fit contours of nares of the patient (¶0161), and/or a face mount part is shaped to generally follow contours of the patient's face around an upper lip area (¶0162), and/or the face mount part is molded or pre-formed to be able to conform to and/or is pliable to adapt (¶0162), accommodate and/or correspond with contours of the patient's face in a region of the patient's face where the nasal interface is to be located (¶0162).
Regarding claim 71, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein a flow path of the first prong and a flow path of the second prong are unobstructed (the flow paths of the prongs are not obstructed as shown in Figs 4a-4n; 9A-9I).
Regarding claim 73, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein the gases inlet is in fluid communication with a breathable tube (¶0163-0164; as shown in Figs 24A-B).
Regarding claim 76, Tatkov discloses the interface of claim 52 as discussed above.
Tatkov further discloses, wherein the first prong and the second prong are asymmetrical to each other and differ in shape and configuration to each other (prongs as shown in Figs 4a-4n; 9A-9I; ).
Regarding claim 84, Tatkov discloses a nasal interface (a nasal interface of Fig 2) comprising:
a gases inlet (where the corrugated tube 300 connects to 120 as shown in Fig 24B; 122 of Fig 20);
a first prong and a second prong, wherein the first prong and the second prong are asymmetrical to each other (¶0118, “an asymmetrical cannula interface can involve making an interface in which the nasal delivery elements are of different length, internal or external diameter, or a combination of these”; a first prong and a second prong of Figs 4a-4n; 9A-9I);
a gases flow path fluidly connecting the gases inlet with the first prong and the second prong (prongs 111, 112 are in fluid communication with the gas inlets as shown in Figs 20, and 24A-B; ¶0043, “a gases flow manifold part having a gases inlet for receiving a flow of gas from a gas source, and a gases outlet for delivering the flow of gas to the nasal delivery elements of the face mount part”; ¶0164, “The inlet 122 is preferably removably attachable to a conduit”);
wherein an external cross-sectional area of the first prong is larger than an external cross-sectional area of the second prong (prongs 200, 300, Fig 9b; ¶0013-0014,0136);
wherein the nasal interface is configured to cause an asymmetrical flow of gases at a patient's nares (¶0066, “a nasal interface comprising asymmetrical nasal delivery elements to generate an asymmetrical flow or a partial unidirectional flow of gases at the nares”);
wherein the first prong has a lower leak rate with one of a patient's nares than the second prong with another of the patient's nares (¶0006, implies that the smaller diameter have higher leakage; ¶0117,0130,0133, implies that large diameter have reduced leakage); and
wherein the nasal interface is configured such that at least 60% of a total volumetric flow rate of gases flow into the gases inlet is delivered out of the nasal interface through the first prong (¶0013-0014,0019, “…the first cross-sectional area may be about 20% to about 80% of the second cross-sectional area, preferably about 50%...the ratio…1:2, 1:2.05, 1:2.1, 1:2:15, 1:2.2, 1:2.25, 1:2.3, 1:2.35, 1:2.4, 1:2.45, or 1:2.5”, implies that the volumetric flow rate of gases can be at least 60% through the first prong based on the ratio of the cross-sectional areas of the prongs; ¶0068-0069, “…one nare of the subject at a first flow rate of about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 L/min… other nare of the subject may be at a second flow rate that may be about 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 78, 79, or 80%”; claim 10, “ one nare of the subject at a first flow rate of about 5 L/min to about 60 L/min and to the other nare of the subject at a second flow rate that is about 20% to about 80% of the first flow rate, preferably about 50%”; see response to the arguments above).
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.
Claims 77-83 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20160158476 A1).
Regarding claim 77, Tatkov discloses, a nasal interface (a nasal interface of Fig 2) comprising:
a gases inlet (where the corrugated tube 300 connects to 120 as shown in Fig 24B; 122 of Fig 20);
a first prong and a second prong, wherein the first prong and the second prong are asymmetrical to each other (¶0118, “an asymmetrical cannula interface can involve making an interface in which the nasal delivery elements are of different length, internal or external diameter, or a combination of these”; a first prong and a second prong of Figs 4a-4n; 9A-9I);
a gases flow path fluidly connecting the gases inlet with the first prong and the second prong (prongs 111, 112 are in fluid communication with the gas inlets as shown in Figs 20, and 24A-B; ¶0043, “a gases flow manifold part having a gases inlet for receiving a flow of gas from a gas source, and a gases outlet for delivering the flow of gas to the nasal delivery elements of the face mount part”; ¶0164, “The inlet 122 is preferably removably attachable to a conduit”);
wherein an external cross-sectional area of the first prong is larger than an external cross-sectional area of the second prong (prongs 200, 300, Fig 9b; ¶0013-0014,0136);
wherein the nasal interface is configured to cause an asymmetrical flow of gases at a patient's nares (¶0066, “a nasal interface comprising asymmetrical nasal delivery elements to generate an asymmetrical flow or a partial unidirectional flow of gases at the nares”), and
wherein the nasal interface is configured such that at least 60% of a total volumetric flow rate of gases flow into the gases inlet is delivered out of the nasal interface through the first prong (¶0013-0014,0019, “…the first cross-sectional area may be about 20% to about 80% of the second cross-sectional area, preferably about 50%...the ratio…1:2, 1:2.05, 1:2.1, 1:2:15, 1:2.2, 1:2.25, 1:2.3, 1:2.35, 1:2.4, 1:2.45, or 1:2.5”, implies that the volumetric flow rate of gases can be at least 60% through the first prong based on the ratio of the cross-sectional areas of the prongs; ¶0068-0069, “…one nare of the subject at a first flow rate of about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 L/min… other nare of the subject may be at a second flow rate that may be about 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 78, 79, or 80%”; claim 10, “ one nare of the subject at a first flow rate of about 5 L/min to about 60 L/min and to the other nare of the subject at a second flow rate that is about 20% to about 80% of the first flow rate, preferably about 50%”; see response to the arguments above).
While Tatkov discloses that the nasal delivery elements may be desired to seal or semi-seal at the nose, or may not be required to seal at the nose, to deliver the therapy and Nasal high flow typically is a non-sealing therapy (¶0115) and the prongs are sized to maintain a sufficient gap between the outer surface of the prongs and the patient's skin to avoid sealing the gas path between the cannula 100 and patient (¶0161) and wherein the first prong (200 of 100, Fig 9b) having larger diameter and a fitting (¶0132, “by attaching the different fittings to the interface it may be possible to benefit from the combination of the inner and outer diameters, while still providing the patient with soft nasal delivery elements to be fitted into the nares, maintaining patient comfort”) at a patient’s first naris and the second prong (300 of 100, Fig 9b) having a smaller diameter at the patient's second naris, Tatkov is silent on wherein the first prong forms a first gap between an outer surface of the first prong and a surface of one of the patient's nares, and wherein the second prong forms a second gap between an outer surface of the second prong and a surface of another of the patient's nares; and wherein the first gap is smaller than the second gap.
Examiner notes that the human nasal anatomy may not be always symmetrical or same size/shape. If one to have different size/shape of the nares, then it would introduce different gaps when wearing same size/shape asymmetrical interface resulting in having the first gap smaller than the second gap.
However, Tatkov discloses that the nasal delivery elements may be desired to seal or semi-seal at the nose (¶0115), and the fitting may block a nasal delivery element, allowing NHF to be delivered through the unblocked nasal element (¶0135) as shown in Fig 5e which is similar to configuration of Fig 9b and further adding sleeve that had been individually fit to a patient reduce operation flow which many result in reduced noise, reduced supplemental oxygen use, improved patient comfort or like which can be specifically fit to the patient to vary pressure or dead clean clearance (¶0135; claim 7) while a smaller diameter may have a high leak and lower pressure to patient (¶0006) but it may produce a jet with a higher velocity that may more efficiently clear patient dead space (¶0130,0134) so that in combination would improve dead space clearance, preferably to reduce the volume of anatomical dead space within the volume of the airway of a subject, to reduce peak expiratory pressure, to reduce noise, and/or to reduce resistance to flow at the patient interface (¶0009). Thus, it would be matter of routine optimization to select different fit to the patient that results in the first gap between a surface of the first prong with the larger area and a surface of one of the nares and the second gap between a surface of the second prong with the lesser area and a surface of another of the nares.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interface of Tatkov to include wherein the first prong forms a first gap between an outer surface of the first prong and a surface of one of the patient's nares, and wherein the second prong forms a second gap between an outer surface of the second prong and a surface of another of the patient's nares; and wherein the first gap is smaller than the second gap 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." (see MPEP 2144.05(II)).
Regarding claim 78, Tatkov discloses the interface of claim 77 as discussed above.
While Tatkov discloses the asymmetrical cannula interface involve making different combination of different length, internal or external diameters, or a combination (¶0118) and various embodiments as shown in Figs 4a-4n and 9a-9i, the embodiment of Fig 9B of Tatkov does not specifically discloses, wherein the first prong is downstream in the gases flow path from the second prong.
However, Tatkov discloses the embodiment having the first prong is downstream in the gases flow path from the second prong (Figs 4i, 4k, 9f, and 9i) and teaches the motivation of having different length, or diameters, or a combination such as a longer nasal delivery element with a smaller internal diameter and higher resistance to gas flow and a shorter nasal delivery element with a large diameter has lower resistance to gas flow at the interface, so that a decreased resistance to flow allows the desired flow to be achieved using lower backpressure, or a lower motor speed of the gas generating device, or a combination of the two (¶0118-119). Thus, it would be matter of routine optimization to select different arrangement of the first prong and the second prong that results the first prong is downstream in the gases flow path from the second prong.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interface of Tatkov to include the arrangement wherein the first prong is downstream in the gases flow path from the second prong 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." (see MPEP 2144.05(II)).
Regarding claim 79, Tatkov discloses the interface of claim 77 as discussed above.
While Tatkov discloses the first cross-sectional area may be about 20% to about 80% of the second cross-sectional area (¶0013) and the ratio of the first cross-sectional area to the second cross-sectional area (¶0014) and modified Tatkov discloses the gaps as discussed in claim 77 above, Tatkov does not specifically discloses, wherein a ratio of a first prong external cross-sectional area to a respective naris cross-sectional area is configured to be greater than a ratio of a second prong external cross-sectional area to another respective naris cross-sectional area.
However, Tatkov teaches wherein a ratio of a first prong external cross-sectional area to a respective naris cross-sectional area is greater than a ratio of a second prong external cross-sectional area to another respective naris cross-sectional area in view of Fig 9B. Even though the drawing is silent to areas to respective naris cross-sectional areas, the one of the ordinary skills would have recognize the relationship of the prong area and naris area such that
a
r
a
t
i
o
o
f
t
h
e
f
i
r
s
t
p
r
o
n
g
(
200
o
f
9
B
)
=
L
a
r
g
e
r
P
r
o
n
g
A
r
e
a
A
r
e
s
p
e
c
t
i
v
e
n
a
r
i
s
a
r
e
a
would have higher ratio than
a
r
a
t
i
o
o
f
t
h
e
s
e
c
o
n
d
p
r
o
n
g
(
300
o
f
9
B
)
=
S
m
a
l
l
e
r
P
r
o
n
g
A
r
e
a
A
r
e
s
p
e
c
t
i
v
e
n
a
r
i
s
a
r
e
a
.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interface of Tatkov to include wherein a ratio of a first prong external cross-sectional area to a respective naris cross-sectional area is configured to be greater than a ratio of a second prong external cross-sectional area to another respective naris cross-sectional area without any unexpected result since it is reasonably taught by the drawings.
Regarding claim 80, Tatkov discloses the interface of claim 77 as discussed above.
Tatkov further discloses, wherein the nasal interface comprises a cannula body (118, Fig 20) comprising the first prong and the second prong (prongs are attached to the base 118 as shown in Figs 22, and 24A-B; ¶0161-0163).
Regarding claim 81, Tatkov discloses the interface of claim 77 as discussed above.
Tatkov further discloses, comprising a gases manifold (120, Figs 24A-B; ¶0114, “a perspective view of a preferred form patient interface and headgear”), wherein the gases manifold is separate from and couplable with the cannula body (120 is couplable to the cannula body 118 as shown in Figs 20-21 for attached, Fig 22-23 for separated from, and 24A-B).
Regarding claim 82, Tatkov discloses the interface of claim 77 as discussed above.
Tatkov further discloses, wherein the nasal interface comprises a face mount part (110, Figs 22, and 24A-B), and wherein the first prong and the second prong comprise a pair of asymmetrical tubular nasal prongs (¶0161, The nasal prongs 111 and 112 are substantially hollow and substantially tubular in shape…the nasal prongs 111 and 112 are modified to be asymmetric as shown in Figs 22, and 24A-B) integrally moulded to the face mount part (as shown in Figs 22, and 24A-B).
Regarding claim 83, Tatkov discloses the interface of claim 82 as discussed above.
Tatkov further discloses, wherein the face mount part comprises at least one substantially horizontal side entry passage to an interior of a base portion or cannula body of the face mount part for releasably receiving an outlet of the gases manifold therethrough (¶0163, “the face mount part 110 comprises an elongate base portion 118 from which the nasal prongs 111 and 112 extend, and two wing portions…two horizontal side entry passages 121a and 121b for insertion of the outlet 123 of the manifold 120 from either side 121a or 121b there-through”).
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20160158476 A1) as applied to claim 52 above, and further in view of Hobson et al. (US 20100192957 A1).
Regarding claim 74, Tatkov discloses the interface of claim 52 as discussed above.
While Tatkov discloses, providing humidified respiratory gases to the patient via patient interface (¶0002) and in order to achieve comfortable asymmetrical flow, a high level of humidity may be necessary to prevent drying of the nasal epithelium (¶0128), Tatkov does not specifically discloses, wherein water vapour can pass through a wall of the breathable tube, but liquid water and a bulk flow of gases cannot flow through the wall of the breathable tube.
However, Hobson et al. which is analogous art for the humidification system with a nasal cannula (¶0099), teaches a wall of the breathable tubing which is made of materials which are well known in the art for the mechanism of water vapour transmission through these breathable material for allowing water vapour to pass through the supply conduit and into ambient air while substantially preventing liquid water or breathing gases to pass out of the supply conduit (¶0129) in order to reduce buildup of condensation with the breathing tube by drying the humidified breathing gases during the flow (¶0129).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interface of Tatkov to include wherein water vapour can pass through a wall of the breathable tube, but liquid water and a bulk flow of gases cannot flow through the wall of the breathable tube as taught by Hobson et al. in order to reduce buildup of condensation with the breathing tube by drying the humidified breathing gases during the flow (¶0129).
Conclusion
THIS ACTION IS MADE FINAL. 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 JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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 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.
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.
/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights