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
This Office Action is in response to the preliminary amendment filed 5/23/2025. Claims 1-67 have been canceled. New claims 68-82 have been added. Therefore, claims 68-82 are presently pending in the application.
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.
Claim(s) 68-74 and 76-79 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et al. (US 20040261797 A1), hereafter White.
Regarding claim 68, White discloses a nasal cannula system (nasal cannula 20; Fig. 1-3), comprising: a patient interface (face mount part 21; Fig. 2-3) comprising an opening (front of the face mount part 21 has an opening; Fig. 2-3) and a first nasal prong (prong 22; Fig. 2-3) and a second nasal prong (prong 23; Fig. 2-3), wherein the first nasal prong and the second nasal prong provides an unsealed gas flow to a pair of nares of a patient (prongs 22 and 23 deliver a flow of gases to the patient’s nares, par. 0050; White does not specifically disclose that the prongs 22 and 23 are sealed and Fig. 2-3 show that the prongs do not have any sealing features, thus it can be understood that the prongs are unsealed); a connector (manifold 24; Fig. 2-3) configured to fluidly connect a supply tube (tubing 3; Fig. 1-3) to the patient interface (manifold 24 connects tubing 3 to the face mount part 21; Fig. 2-3, par. 0046, 0049-0050); the supply tube coupled to the connector (tubing 3 is coupled to manifold 24; Fig. 2-3, par. 0046, 0049) and in fluid communication with the first nasal prong and the second nasal prong (tubing 3 provides gas flow to the prongs 22 and 23; par. 0050), wherein the supply tube is configured to connect to a supply of gas from a gas source (tubing 3 connects to a blower 15 to supply gases; Fig. 1, par. 0040) to deliver a flow of gas to the first nasal prong and the second nasal prong (gases flow through tubing 3 to nasal cannula 20 comprising prongs 22 and 23; Fig. 1-3, par. 0040, 0050); wherein the supply tube is configured to move between a first position and a second position (manifold 24 can be switched or flipped such that the tubing 3 extends from either the left or right side of the patient's nares; par. 0051, 0054).
Regarding claim 69, White discloses the nasal cannula system of Claim 68 (shown above), wherein the supply tube can be rotated relative to the patient interface by at least 180 degrees to provide an effective change of a supply tube exit side (manifold 24 can be switched or flipped relative to the face mount part 21 such that the tubing 3 extends from either the left or right side of the patient's nares; par. 0051, 0054).
Regarding claim 70, White discloses the nasal cannula system of Claim 68 (shown above), wherein the supply tube is a highly flexible tube to allow the supply tube to be moved to either side of a face of the patient and away from a mouth of the patient (Fig. 1 shows patient end of tubing 3 moved to a side of the patient’s face and away from the mouth).
Regarding claim 71, White discloses the nasal cannula system of Claim 68 (shown above), wherein the connector is positioned at a first end of the supply tube (manifold 24 is positioned at a first end of tubing 3; Fig. 2-3, par. 0046, 0049) and a second connector is positioned at a second end of the supply tube (a second end of tubing 3 is connected to outlet 4; Fig. 1, par. 0040), wherein the second connector is configured to connect with a gas supply (outlet 4 is supplied with gas from blower 15; Fig. 1, par. 0040-0041).
Regarding claim 72, White discloses the nasal cannula system of Claim 68 (shown above), wherein the connector (manifold 24) and the patient interface (face mount part 21) comprise interference structures that are configured to limit a rotation of the supply tube (manifold 24 and face mount part 21 have an elongated oval outlet 29 and elongated recess 26, respectively, which engage to prevent rotation and must disengaged by force in order to rotate the supply tube to the other side; Fig. 2-3, par. 0050-0051).
Regarding claim 73, White discloses the nasal cannula system of Claim 68 (shown above), further comprising a clip for securing the supply tube to a side of a face of the patient (tubing 3 is secured to a strap at the patient’s cheek area by a clip, as seen in Fig. 1 and 12).
Regarding claim 74, White discloses the nasal cannula system of Claim 68 (shown above), wherein the patient interface comprises a prong portion and a connection portion that are separable from one another (prongs 22 and 23 can be removably attached to the face mount part 21; Fig. 2-3, par. 0046).
Regarding claim 76, White discloses the nasal cannula system of Claim 68 (shown above), wherein the patient interface is constructed as a single piece (prongs 22 and 23 can be integrally molded with the face mount part 21; Fig. 2-3, par. 0046).
Regarding claim 77, White discloses the nasal cannula system of Claim 68 (shown above), wherein the connector is removable from the patient interface (manifold 24 is removable from face mount part 21; Fig. 2-3, par. 0050).
Regarding claim 78, White discloses the nasal cannula system of Claim 68 (shown above), further comprising a retention assembly for securing the connector and the patient interface to a patient (Figs. 1 and 12 show a strap assembly for securing the nasal cannula to a patient).
Regarding claim 79, White discloses a nasal cannula system (nasal cannula 20; Fig. 1-3), comprising: a patient interface comprising a central body portion (face mount part 21; Fig. 2-3), a first nasal prong (prong 22; Fig. 2-3) and a second nasal prong (prong 23; Fig. 2-3) extending from the central body portion, the central body portion defining a cavity and a forward-facing inlet to the cavity (recesses 26, 27, 28 form a cavity with a forward facing inlet; Fig. 2-3), wherein the first nasal prong and the second nasal prong are fluidly connected with the cavity (gases flow from recesses 27 and 28 to prongs 22 and 23; Fig. 2-3, par. 0050) and each of the first nasal prong and the second nasal prong is configured to form an unsealed interface with a nare of a patient (White does not specifically disclose that the prongs 22 and 23 are sealed and Fig. 2-3 show that the prongs do not have any sealing features, thus it can be understood that the prongs are unsealed); a connector (manifold 24; Fig. 2-3) that receives a supply of gas from a gas source (manifold 24 connects to a blower 15 via tubing 3 to supply gases; Fig. 1-3, par. 0040, 0046, 0049), the connector comprising a gas inlet (circular inlet where tubing 3 connects to manifold 24; Fig. 2-3, par. 0049) and a gas outlet (outlet 29; Fig. 3, par. 0049), wherein the connector is connectable with the patient interface such that the gas outlet is aligned with the forward-facing inlet of the patient interface (manifold 24 connects to face mount part 21 by outlet 29 fitting into recess 26 in a friction or snap fit; Fig. 2-3, par. 0050); and a supply tube connected to the gas inlet of the connector (tubing 3 is received in inlet of manifold 24; Fig. 2-3, par. 0049) and positioned forward of the forward-facing inlet of the patient interface (tubing 3 is positioned forward of recess 26 of face mount part 21; Fig. 2-3).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over White in view of an alternate embodiment of White.
Regarding claim 75, White discloses the nasal cannula system of Claim 74 (shown above).
The embodiment of White that discloses claim 74, hereafter embodiment A (Fig. 2-3), does not disclose wherein the prong portion is selectable from a selection of at least two different sizes of prong portions comprising at least two different sizes of prongs, which can be coupled to the connection portion for use.
An alternate embodiment of White, hereafter embodiment B (Fig. 8-11), teaches the prong portion is selectable from a selection of at least two different sizes of prong portions comprising at least two different sizes of prongs (prongs 41 and 42 are different sizes; Fig. 10-11, par. 0067), which can be coupled to the connection portion for use (prongs 41 and 42 can be attached to the manifold 40; Fig. 8-10, par. 0067) for the purpose of allowing a range of different shaped and spaced prongs to be available to the patient (par. 0067).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the prong portion of embodiment A to be selectable from different sizes of prong portions as taught by embodiment B for the purpose of allowing a range of different shaped and spaced prongs to be available to the patient (par. 0067).
Claim(s) 80-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over White in view of Drew et al. (US 20040112385 A1), hereafter Drew.
Regarding claim 80, White discloses the nasal cannula system according to claim 79 (shown above), wherein the connector can be positioned in a first orientation with the gas inlet and a second orientation with the gas inlet (manifold 24 can be positioned with the gas inlet and tubing 3 extending from the left or right side of the patient’s nares; Fig. 2-3, par. 0051).
White does not disclose that the connector is a swivel type connector.
Drew teaches a nasal mask assembly (Fig. 1, par. 0186) wherein the connector is a swivel type connector (swivel elbow assembly 20 includes swivel elbow 160 rotationally connected to frame 10 which supplies air from an air tube 168 to the nasal cushion 30; Fig. 1-4, par. 0186, 0196) for the purpose of allowing the patient to position the supply tube in a wider variety of orientations based on preference (par. 0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector of White to be a swivel type connector as taught by Drew for the purpose of allowing the patient to position the supply tube in a wider variety of orientations based on preference (Drew par. 0009).
Regarding claim 81, White discloses a nasal cannula assembly (nasal cannula 20; Fig. 1-3), comprising: a patient interface defining a cavity (face mount part 21 defines recesses 26, 27, 28; Fig. 2-3), a pair of nasal prongs extending from the patient interface (prongs 22 and 23 extending from face mount part 21; Fig. 2-3), and an opening positioned at a front side of the patient interface (face mount part 21 has an opening positioned at a front side leading to recesses 26, 27, 28; Fig. 2-3), wherein the pair of nasal prongs are in fluid communication with the cavity (gases flow from recesses 27 and 28 to prongs 22 and 23; Fig. 2-3, par. 0050) and form an unsealed contact with a pair of nares of a patient (White does not specifically disclose that the prongs 22 and 23 are sealed and Fig. 2-3 show that the prongs do not have any sealing features, thus it can be understood that the prongs are unsealed), wherein the opening is positioned at a front side of the patient interface (face mount part 21 has an opening positioned at a front side leading to recesses 26, 27, 28; Fig. 2-3) and is in communication with the cavity (opening is in communication with recesses 26, 27, 28; Fig. 2-3), and wherein the opening comprises an axis (opening at the front side of face mount part 21 has an axis in a fore-aft direction; Fig. 3); a connector (manifold 24; Fig. 2-3); a tube coupled to the connector (tubing 3 is coupled to manifold 24; Fig. 2-3, par. 0046, 0049) and configured to supply gas to the connector (tubing 3 connects to a blower 15 to supply gases; Fig. 1, par. 0040); and wherein the connector includes a connector opening (outlet 29; Fig. 3, par. 0049) aligned with the opening (outlet 29 aligns with front opening of face mount part 21; Fig. 2-3) and in communication with the cavity (gases flow through outlet 29 and into recesses 26, 27, 28; Fig. 2-3, par. 0050).
White does not disclose the connector is movably coupled to the patient interface and configured to move about the axis of the opening.
Drew teaches a nasal mask assembly (Fig. 1, par. 0186) wherein the connector is movably coupled to the patient interface (swivel elbow assembly 20 includes swivel elbow 160 rotationally connected to frame 10; Fig. 1-4, par. 0186, 0196) and configured to move about the axis of the opening (swivel elbow 160 rotationally connected to frame 10 rotates about an fore-aft axis of the opening in the frame 10; Fig. 1-4, par. 0186, 0196) for the purpose of allowing the patient to position the supply tube in a wider variety of orientations based on preference (par. 0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector of White to be movably coupled to the patient interface and configured to move about the axis of the opening as taught by Drew for the purpose of allowing the patient to position the supply tube in a wider variety of orientations based on preference (Drew par. 0009).
Regarding claim 82, the modified White discloses the nasal cannula assembly of Claim 81 (shown above), wherein the axis of the opening is an axis that extends in a generally fore-aft direction (swivel elbow 160 rotationally connected to frame 10 rotates about an fore-aft axis of the opening in the frame 10, Drew Fig. 1-4, par. 0186, 0196) or a generally horizontal axis that lies in a sagittal plane of a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lubke et al. (US 20060283461 A1) discloses a nasal mask with swivel elbow assembly.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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