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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 21, 2023, October 31, 2023, November 26, 2024 have been received and considered by the Examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: line 6, “a patient’s nasal base interface with the membrane” should read “a patient’s nasal base interfaces with the membrane”
Claim 5 is objected to because of the following informalities: line 4, “provides an interference fit cause the open end to be fluidically sealed” should read “provides an interference fit causes the open end to be fluidically sealed”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allum et al. (US 20150314098 A1, hereinafter “Allum”).
Regarding Claim 1, Allum discloses: A nasal respiratory assembly (Abstract, Systems and methods may include a gas source, a gas delivery circuit, and a nasal interface allowing breathing ambient air through the nasal interface), comprising:
a nasal interface comprising at least one opening for fluid communication with the nares of a patient (Paragraph 0143, Nasal cushions 2817 may be located at gas flow path distal ends 2821);
an air chamber assembly (Paragraph 0140, FIG. 28A is a schematic cross-sectional view of a nasal interface 2801) comprising
an air chamber (Paragraph 0143, Positive pressure which is created inside of a gas delivery cone of flow 2823 is created in the substantially constant cross-sectional area throat section 2825, before the gas flow path begins to curve 2827 superiorly toward the gas flow path distal ends 2821),
a gas supply port (Paragraph 0141, Positive pressure is created inside and distal to the cone of flow 2823 emitted from the gas delivery nozzles 2807, and negative pressure is created outside and proximal to this cone of flow 2823)
an end tidal sample port (Paragraph 0143, One or more gas sampling ports 2815 may be located in the nasal interface 2801, such as for ETCO2 or FIO2 sampling)
and at least one opening in fluid communication with the nasal interface (Paragraph 0143, Nasal cushions 2817 may be located at gas flow path distal ends 2821. The gas flow path distal ends 2821 may or may not be connected by a channel 2819. Positive pressure which is created inside of a gas delivery cone of flow 2823 is created in the substantially constant cross-sectional area throat section 2825, before the gas flow path begins to curve 2827 superiorly toward the gas flow path distal ends 2821),
wherein the nasal interface comprises a pliable material shaped to abut and seal a patient's nasal base (Paragraph 0131, FIGS. 16-23 describe an alternate embodiment in which a nasal mask 1601 includes a manifold 1603 that is optimized for minimal size, minimal obtrusiveness, ergonomics, maximum comfort in form and fit, and maximal function. The nasal mask 1601 may include gas delivery tubing 1605, entrainment apertures 1607, and/or nasal cushions 1609. FIG. 16 shows a front view of the nasal mask 1601 being worn by a person), (Paragraph 0133, The nasal cushions 1609 can be attached to the manifold 1603 with a flex joint or comprise a flex point or corrugation to allow the nasal cushions 1609 to flex, bend, or angulate under slight pressure so that they self-align with the nostril openings. The nasal cushions 1609 can also compress inward toward the manifold 1603 so that the contact force at the contact points between the nasal cushions 1609 and the nostril are dampened and absorbed. The nasal cushions 1609 can have a distal round or oval opening that is off-center from the proximal base. For example, the distal end opening can be biased to the inward edge and posterior edge of the nasal cushions 1609. These features may make the nasal cushions 1609 a flexible seal or flexible quasi-seal with the nares and may make the assembly more forgiving to mate with different facial structures and inadvertent movement of the nasal mask 1601 while being worn. The nasal cushions 1609 are typically a compliant material such as silicone or elastomeric or thermoplastic material of Shore 10-60A, but other materials may be used) such that respiratory gasses pass via the patient's nostrils, the at least one opening, the air chamber, the gas supply port, and the end tidal sample port (Paragraph 0142, FIG. 28B describes the nasal interface 2801 of FIG. 28A when the gas delivery is off, typically during the patient's spontaneous expiratory phase. Gas exhaled by the patient 2851 can exit 2853 through the entrainment aperture 2813 and/or exit 2855 through the exhaled gas exhaust path 2811), (Paragraph 0141, FIG. 28A describes the system during ventilation gas delivery, typically during the patient's spontaneous inspiratory phase and optionally during expiratory phase. Gas delivered by the ventilator through the gas delivery nozzles 2807 is depicted by arrows, ambient air entrained is depicted by 2829, gas being delivered to the patient is depicted by 2827, and surplus gas depicted by 2831 is directed out of the nasal interface 2801 through the exhaled gas exhaust port to prevent the surplus gas 2831 from colliding with gas being delivered by the nozzles 2807 and gas being entrained by the delivered gas 2829).
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Allum Annotated Figure 28
Regarding Claim 4, Allum discloses all of the limitations of Claim 1. Allum further discloses: wherein the air chamber assembly includes a nasal dam anchor extending from a surface of the air chamber assembly above the air chamber (Figure 18, Paragraph 0133, stems 1625 for attachment of the nasal cushions 1609. The stems 1625 can be positioned on the superior surface of the manifold 1603, or the superior-posterior surface),
and nasal interface further comprises an air chamber anchor channel complementary to the nasal dam anchor (Figures 19A-19C), whereby insertion of the nasal dam anchor into the air chamber anchor channel provides an interference fit to hold the nasal interface in abutment with the air chamber assembly (Paragraph 0133, stems 1625 for attachment of the nasal cushions 1609. The stems 1625 can be positioned on the superior surface of the manifold 1603, or the superior-posterior surface. The nasal cushions 1609 can be attached to the manifold 1603 with a flex joint or comprise a flex point or corrugation to allow the nasal cushions 1609 to flex, bend, or angulate under slight pressure so that they self-align with the nostril openings. The nasal cushions 1609 can also compress inward toward the manifold 1603 so that the contact force at the contact points between the nasal cushions 1609 and the nostril are dampened and absorbed).
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Allum Annotated Figure 19
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 20150314098 A1) in view of Tero (US 20150083123 A1)
Regarding Claim 2, Allum discloses all of the limitations of Claim 1. Allum further discloses: wherein the nasal interface comprises a solid material having a roughly round cross section (Paragraph 0133, The nasal cushions 1609 can have a distal round or oval opening that is off-center from the proximal base. For example, the distal end opening can be biased to the inward edge and posterior edge of the nasal cushions 1609) and Shore A 5-20 durometers (Paragraph 0133, The nasal cushions 1609 are typically a compliant material such as silicone or elastomeric or thermoplastic material of Shore 10-60A, but other materials may be used).
whereby the at least one opening extends from a surface of the nasal interface through the solid material to an opposite surface of the material and aligns with the at least one opening in fluid communication with the nasal interface (Paragraph 0133, The nasal cushions 1609 can be attached to the manifold 1603 with a flex joint or comprise a flex point or corrugation to allow the nasal cushions 1609 to flex, bend, or angulate under slight pressure so that they self-align with the nostril openings. The nasal cushions 1609 can also compress inward toward the manifold 1603 so that the contact force at the contact points between the nasal cushions 1609 and the nostril are dampened and absorbed).
Allum does not explicitly disclose wherein the nasal interface comprises a solid material having a roughly rectangular cross section. However, it is known in the art to modify the shape and hardness of the nasal interfaces through routine experimentation to better accommodate the anatomy and comfort of different users. For example, Allum discloses that “other materials may be used” for the interface (Paragraph 0133).
If the Applicant is not convinced, Tero more explicitly discloses wherein the nasal interface comprises a solid material having a roughly rectangular cross section (Paragraph 0057, Nasal cannula assembly 1400 includes generally rectangular inspiratory lumen 1402 and expiratory lumen 1404).
Tero teaches a wide variety of cross-sectional embodiments that can be utilized in a nasal respiratory assembly (Nasal cannula assembly 1100 includes generally "D-shaped" inspiratory lumen 1102 and expiratory lumen 1112, with a common flat surface 1120 that is formed to lay against the face of the patient. Nasal cannula assembly 1200 has a generally square cross-section with a triangle shaped inspiratory lumen 1202 and a triangle shaped expiratory lumen 1212. The generally flat faces on the outer perimeter of nasal cannula assembly 1200 provide two faces along inspiratory lumen 1202 that may lay against the face of the patient. Nasal cannula assembly 1300 includes a generally circular or oval-shaped inspiratory lumen 1302 and expiratory lumen 1304). Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the embodiments taught by Tero with the nasal assembly disclosed by Allum, so as to better accommodate different users.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 20150314098 A1) in view of Scheiner et al. (US 20200246572 A1, hereinafter “Scheiner”).
Regarding Claim 3, Allum discloses all of the limitations of Claim 1. Allum further discloses:
wherein the nasal interface comprises a cavity of material having Shore A 5-20 durometers (Paragraph 0133, The nasal cushions 1609 are typically a compliant material such as silicone or elastomeric or thermoplastic material of Shore 10-60A, but other materials may be used),
wherein the at least one opening extends through the membrane into the cavity,
the cavity further comprising a second opening in a floor of the cavity and in fluid communication with the air chamber via the at least one opening in fluid communication with the nasal interface,
whereby a patient's nasal base interface with the membrane for providing a seal (Paragraph 0133, the distal end opening can be biased to the inward edge and posterior edge of the nasal cushions 1609. These features may make the nasal cushions 1609 a flexible seal or flexible quasi-seal with the nares and may make the assembly more forgiving to mate with different facial structures and inadvertent movement of the nasal mask 1601 while being worn).
Allum does not explicitly disclose a membrane extending over the cavity, but the side walls of the nasal cushions 1609 could be understood to be membranes, based on their material structure (Figure 19C, Paragraph 0133, The nasal cushions 1609 are typically a compliant material such as silicone or elastomeric or thermoplastic material of Shore 10-60A, but other materials may be used).
However, if the Applicant is not convinced, Scheiner explicitly discloses: a membrane extending over the cavity (Paragraph 0383, The seal-forming structure 3100 may each include a support structure 3120 that provides support to a sealing portion 3130 (e.g., a textile membrane) that creates a seal with the patient's face. The sealing portion 3130 is configured to sealingly engage the patient's face (e.g., when pressurized air is supplied to the plenum chamber 3200)),
wherein the at least one opening extends through the membrane into the cavity (Paragraph 0378, At least one opening (e.g., a pair of nasal openings 3102) in the seal-forming structure may allow for fluid communication between the cavity 3101 and the patient's nares),
the cavity further comprising a second opening in a floor of the cavity and in fluid communication with the air chamber via the at least one opening in fluid communication with the nasal interface (Paragraph 0378, The seal-forming structure 3100 and the plenum chamber 3200 may at least partly form a cavity 3101 that is pressurized by the flow of air), (Paragraph 0378, At least one opening (e.g., a pair of nasal openings 3102) in the seal-forming structure may allow for fluid communication between the cavity 3101 and the patient's nares),
whereby a patient's nasal base interface with the membrane for providing a seal (Paragraph 0379, Alternatively, the seal-forming structure 3100 may be joined to the plenum chamber 3200 at the plenum chamber connection opening by a mechanical removably detachable connection)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Scheiner with Allum to provide an additional means of sealing and securing the nasal assembly to a user’s nares.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 20150314098 A1) in view of Jaffe et al. (hereinafter “Jaffe”).
Regarding Claim 5, Allum discloses all of the limitations of Claim 1. Allum further discloses:
wherein the air chamber or the air chamber assembly includes an open end (Figure 28, Paragraph 0143, Positive pressure which is created inside of a gas delivery cone of flow 2823 is created in the substantially constant cross-sectional area throat section 2825, before the gas flow path begins to curve 2827 superiorly toward the gas flow path distal ends 2821), (Paragraph 0142, Gas exhaled by the patient 2851 can exit 2853 through the entrainment aperture 2813 and/or exit 2855 through the exhaled gas exhaust path 2811),
and the nasal interface includes an air chamber insert complementary to the open end (Paragraph 0144, a heat moisture exchanger (HME) (not shown) may be coupled with exhaled gas exhaust path 2811 or entrainment aperture 2813)
Allum does not explicitly disclose an interference fit to fluidically seal the air chamber. However, Jaffe does disclose the nasal interface includes an air chamber insert complementary to the open end (Paragraph 0131, Oral sampler portion 67 has an orifice 68 that is configured to communicate with at least one of fluid paths 61, 63), (Paragraph 0205, Other arrangements of the moisture exchanger may be used with the nostril interface. The illustrated embodiment is not intended to be limiting in any way) such that insertion of the air chamber insert into the open end of the air chamber provides an interference fit (Paragraph 0131, patient interface 60 also includes an oral sampler portion 67 that is operatively joined to the body portion 62 and extends from body portion 62 in a direction away from nostril interfaces 64, 65. Oral sampler portion 67 has an orifice 68 that is configured to communicate with at least one of fluid paths 61, 63. Orifice 68 is configured to receive a fluid being exhaled from the oral cavity through the mouth of the patient or, in a different embodiment, to deliver a fluid, such as oxygen, for the patient to inhale) cause the open end to be fluidically sealed (Paragraph 0168, Oral sampler 211 includes a conduit 213 for communicating a fluid between the patient's mouth and the second fluid path 202. In the illustrated embodiment, oral sampler 211 is received by second nostril interface 192 in a frictional engagement. It is also contemplated that oral sampler 211 may be permanently connected to nostril interface 192 with a suitable adhesive or plastic weld)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the oral sampling device disclosed by Jaffe with the nasal assembly disclosed by Allum, so as to provide an adjustable means for testing and analyzing the fluids travelling to and from a user (Paragraph 0016, The oral sampler portion comprises an adjustable structure that enables an orientation of the orifice of the oral sampler portion to be changed and retained in different positions), (Paragraph 0106, oral sampler 20 includes an internal passageway or conduit 29 that connects opening 27 in oral sampler 20 with internal conduit 25 leading to connecting portion 19 so that fluid being exhaled by one nostril and the mouth may enter fluid path 15 and be transmitted to the gas analyzer. As illustrated in the embodiment of FIG. 3, internal conduit 23 only communicates fluid path 14 with one of nostril interfaces 18. Internal conduits 23, 25, and 29 should have smooth surfaces and should be sized and shaped so as to minimize gas mixing and maintain the fidelity of the gas waveform).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 20150314098 A1) in view of Scheiner (US 20200246572 A1), further in view of Moore et al. (US 20030196656 A1, hereinafter “Moore”).
Regarding Claim 6, Allum in view of Scheiner discloses all of the limitations of Claim 3. Scheiner further discloses: wherein a spring stiffness of an interface between the membrane and a patient's nasal base (Paragraph 0333, In some forms, the textile membrane 10135 can exhibit a low spring constant (i.e. high compliance) in both warp and weft. In such forms, unlike conventional designs where a fixed cushion may cause the skin of a patient's face 1300 to distort in order to form an effective seal, the textile material 10133 and/or the resulting textile membrane 10135 may have a material spring constant and spring length such that the textile membrane 10135 is more compliant than the patient's skin that engages the textile membrane 10135. This may advantageously improve the comfort of the mask, and reduce the formation of localized pressure “hot spots,” or locations likely to result in irritation because of contact with the seal-forming structure 3100, 6100, 9100) is defined by
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L = Nominal nasal dam membrane thickness ≈ 0.00025m (Paragraph 0320, In some examples, the thickness of the textile membrane 10135 is between approximately 0.25 mm and approximately 0.55 mm. In some examples, the thickness of the textile membrane 10135 is between approximately 0.30 mm and approximately 0.50 mm. In some examples, the thickness of the textile membrane 10135 is between approximately 0.35 mm and approximately 0.45 mm. In some examples, the thickness of the textile membrane 10135 is approximately 0.40 mm.)
R = membrane radius (Paragraph 0352, As can be seen, in some examples, at a transition portion 36, the support structure 3120 and the textile membrane 3130 may both have a radius of curvature (e.g., the same or similar radius of curvature) along the curve 35 in a direction from the anterior side of the seal-forming structure 3100 to the posterior side of the seal-forming structure (see FIGS. 16-18). The textile membrane 3130 may have a predefined curvature imparted thereto such that a portion of the textile membrane 3130 not directly supported by the support structure 3120 extends along the curve 35 (FIGS. 16-18)).
Moore more explicitly discloses:
L = Nominal nasal dam membrane thickness ≈ 0.002m (Paragraph 0175, The sealing element (e.g., membrane) is preferably elastomeric having a thickness in the range of 0.1 and 2.0 mm, preferably 0.35 mm, to allow the membrane to stretch readily over the lower portion of the nasal bridge. The stretch of the membrane may be varied in different regions by varying its thickness, adding stiffening structure such as ribs, or using composites)
R = membrane radius ≈ 0.01m (Paragraph 0188, FIGS. 25d-25i also show various other dimensions in one preferred embodiment, such as the radii of curvature, the angles at which the membrane extends, etc. For example, at the apex of the nasal bridge region, in FIG. 25d, the radius of curvature of the membrane is in the range of about 514 mm, preferably 9 mm, with an angle of about 70-90 degrees, preferably 80 degrees. As shown in FIG. 25e, the radius of curvature is within the range of about 4-10 mm, preferably 7 mm, with an angle of about 50-70 degrees, preferably 60 degrees)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to calculate a spring stiffness of an interface between a membrane and a patient's nasal base when provided the membrane thickness and radius.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 20150314098 A1) in view of Tero (US 20150083123 A1), further in view of Moore (US 20030196656 A1)
Regarding Claim 7, Allum in view of Tero discloses all of the limitations of Claim 2. Allum further discloses: wherein a spring stiffness of an interface between the nasal interface and a patient's nasal base (Paragraph 0131, FIGS. 16-23 describe an alternate embodiment in which a nasal mask 1601 includes a manifold 1603 that is optimized for minimal size, minimal obtrusiveness, ergonomics, maximum comfort in form and fit, and maximal function. The nasal mask 1601 may include gas delivery tubing 1605, entrainment apertures 1607, and/or nasal cushions 1609. FIG. 16 shows a front view of the nasal mask 1601 being worn by a person), (Paragraph 0133, The nasal cushions 1609 can be attached to the manifold 1603 with a flex joint or comprise a flex point or corrugation to allow the nasal cushions 1609 to flex, bend, or angulate under slight pressure so that they self-align with the nostril openings. The nasal cushions 1609 can also compress inward toward the manifold 1603 so that the contact force at the contact points between the nasal cushions 1609 and the nostril are dampened and absorbed. The nasal cushions 1609 can have a distal round or oval opening that is off-center from the proximal base. For example, the distal end opening can be biased to the inward edge and posterior edge of the nasal cushions 1609. These features may make the nasal cushions 1609 a flexible seal or flexible quasi-seal with the nares and may make the assembly more forgiving to mate with different facial structures and inadvertent movement of the nasal mask 1601 while being worn. The nasal cushions 1609 are typically a compliant material such as silicone or elastomeric or thermoplastic material of Shore 10-60A, but other materials may be used) is defined by
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Allum in view of Tero does not explicitly disclose a nominal nasal dam membrane thickness.
Moore explicitly discloses: L = Nominal nasal dam membrane thickness ≈ 0.004m (Paragraph 0191, In yet another embodiment of a cushion 40 that is wider and/or shallower in depth ("wide/shallow"), the membrane 205 of the cushion 40 has a width w in the range of 35-45 mm, preferably 41 mm, a height h in the range of 19-28 mm, preferably 22 mm, and the notch 255 has a depth d.sub.1 in the range of 12-20 mm, preferably 16 mm. It is to be understood that these dimensions refer to a particular embodiment of the invention, and a differently sized mask (for example, a "small" size versus a "large" size) while having the same shape would have different dimensions and nevertheless be within the scope of the invention. Further, while the "standard" size cushion, "deep" size cushion, and "wide/shallow" size cushion may be provided individually, these cushions may be provided together as a set of cushions. This set of three cushions provides a good fit in a wide range of patients without having an excessive inventory), (Paragraph 0175, The stretch of the membrane may be varied in different regions by varying its thickness, adding stiffening structure such as ribs, or using composites)
Both Moore and Allum disclose varying ranges and materials for improved user comfort and effectiveness within the nasal cannula assembly. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges since the general conditions of the claimed methods are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to calculate a spring stiffness of an interface between a nasal interface and a patient's nasal base when provided a membrane thickness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chandran et al. (US 20060124131 A1) discloses a modular, nasal interface, formed in various sizes and shapes
Pedro et al. (US 20170007795 A1) discloses a nasal ventilation mask with a plurality of attachment ports
Tatkov (US 20160158476 A1) discloses a nasal interface with varying, asymmetrical delivery elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL ZAHRA HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISHAL ZAHRA HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785