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 following section is in reference to the Applicant’s Amendments, filed June 12, 2026:
The Applicant’s amendments to Claim 1 to overcome the 35 U.S.C. 102(a)(1) rejection has been fully considered. See updated rejection below
The applicant’s amendments to Claims 5-7 to resolve informalities have been fully considered and are persuasive.
The applicant’s addition of Claims 8-13 has been acknowledged.
Claim Objections
Claim 4 is objected to because of the following informalities: “and nasal interface further comprises” should read “and the nasal interface further comprises” Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe et al. (US 20140094669 A1, hereinafter “Jaffe”) in view of Scheiner et al. (US 20200246572 A1, hereinafter “Scheiner”)
Regarding Claim 1, Jaffe discloses: A nasal respiratory assembly (Abstract, A patient interface for communicating fluids to and/or from a patient's nasal cavity and/or oral cavity is disclosed.), comprising:
a nasal interface comprising at least one opening for fluid communication with the nares of a patient (Paragraph 0100, Nostril interfaces 18 and 21 are configured to be inserted into an associated nostril of a patient and have respective internal orifices in communication with associated fluid paths 14 and 15, respectively);
an air chamber assembly (Paragraph 0095, As shown, patient interface 10 includes a body portion 12 configured to communicate with at least one fluid path. In the illustrated embodiment, a first fluid path 14 and a second fluid path 15 are provided by tubing 11 and 16, respectively) comprising
an air chamber (Paragraph 0101, As shown in FIG. 2, communication between nostril interface 18 and the orifice of connecting portion 17 is provided by an internal conduit 23 within body portion 12. Similarly, an internal conduit 25 communicates nostril interface 21 with connecting portion 19, as known in the art),
a gas supply port (Paragraph 101, nostril interface 18, connecting portion 17, and fluid path 14 may be configured to supply a fluid that includes oxygen (O2) to the patient from a suitable fluid supply and nostril interface 21),
an end tidal sample port (Paragraph 0101, connecting portion 19 and fluid path 15 may be configured to receive a fluid that includes carbon dioxide (CO2) expired from the patient. In such an embodiment, fluid path 15 communicates the carbon dioxide to a suitable device, such as a gas analyzer, so that the concentration of the carbon dioxide in the expired fluid and/or rate of flow of the expired fluid may be monitored over time)
and at least one opening in fluid communication with the nasal interface (Paragraph 0100, Nostril interfaces 18 and 21 are configured to be inserted into an associated nostril of a patient and have respective internal orifices in communication with associated fluid paths 14 and 15, respectively),
wherein the nasal interface comprises a pliable material (Paragraph 0110, interface 10 is manufactured from a soft (low durometer) material for a more comfortable fit for the patient. For example, the material of the interface may have a Shore A hardness of about 10 to about 40, and may be manufactured, for example, from a polyurethane or a silicone. In one embodiment, body portion 12, stabilizers 22, nostril interfaces 18, 21, and oral sampler 20 are molded from the same material) shaped to abut a patient's nasal base (Paragraph 0104, nostril interface 18 and/or 21 may be shaped or angled relative to body portion 12 so as to substantially conform with the nostril, which may make interface 10 more comfortable for the patient to wear)
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 0101, nostril interface 18, connecting portion 17, and fluid path 14 may be configured to supply a fluid that includes oxygen (O2) to the patient from a suitable fluid supply, and nostril interface 21, connecting portion 19, and fluid path 15 may be configured to receive a fluid that includes carbon dioxide (CO2) expired from the patient. In such an embodiment, fluid path 15 communicates the carbon dioxide to a suitable device, such as a gas analyzer, so that the concentration of the carbon dioxide in the expired fluid and/or rate of flow of the expired fluid may be monitored over time),
Jaffe discloses a nasal interface that conforms to a user’s nostrils as described above, but does not explicitly disclose a seal to contain airflow between the nares and the air chamber. In alternative embodiments, Jaffe describes the incorporation of sealing elements (Figure 8, Paragraph 127), however, they serve to that block fluid communication to the nostril interfaces.
Scheiner does disclose:
wherein the nasal interface comprises a pliable material shaped to abut and seal a patient's nasal base (Paragraphs 0313-0314, A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone), (Paragraph 0324, Particularly, the textile material 10133 may be able to deform into crevices on the patient's face (e.g., the region between the nasal ala and the nasolabial sulcus) as a result of an applied force (e.g., via a positioning and stabilizing structure 3300), but will not crease and form locations where air could leak out. This may assist the patient in establishing a seal between their skin and the textile membrane 10135, without needing the textile membrane 10135 to contact the exact same location (e.g., which may make donning the seal-forming structure 3100 easier). This may also allow the seal-forming structure 3100, 6100, 9100 to move and/or shift while it is worn without creating a leak, because the spongy properties assist in maintaining the necessary contact against the patient's skin)
wherein the seal is a pressure seal between the pliable material and the patient's nasal base to contain airflow between the nares of the patient and the air chamber (Paragraphs 0081-0082, a seal-forming structure having: a textile membrane constructed and arranged to form a pressure-assisted seal with a region of the patient's face surrounding an entrance to the patient's airways inferior to a nasal bridge region of the patient's face, said textile membrane having a portion, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the cavity throughout the patient's respiratory cycle in use)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Scheiner with Jaffe to provide an additional means of sealing and securing the nasal assembly to a user’s nares. The seal forming structure also allows for more controlled administration of air flow therapy to a user.
Regarding Claim 3, Jaffe in view of Scheiner discloses all of the limitations of Claim 1. Jaffe further discloses: wherein the nasal interface comprises a cavity of material having Shore A 5-20 durometers (Paragraph 0110, interface 10 is manufactured from a soft (low durometer) material for a more comfortable fit for the patient. For example, the material of the interface may have a Shore A hardness of about 10 to about 40, and may be manufactured, for example, from a polyurethane or a silicone. In one embodiment, body portion 12, stabilizers 22, nostril interfaces 18, 21, and oral sampler 20 are molded from the same material), but does not explicitly disclose a membrane extending over the cavity.
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)
Regarding Claim 5, Jaffe in view of Scheiner discloses all of the limitations of Claim 1. Jaffe further discloses: wherein the air chamber or the air chamber assembly includes an open end and 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) that causes 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)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 20140094669 A1) in view of Scheiner (US 20200246572 A1), further in view of Tero (US 20150083123 A1)
Regarding Claim 2, Jaffe in view of Scheiner discloses all of the limitations of Claim 1. [NAME] further discloses: wherein the nasal interface comprises a solid material having a roughly round cross section (Figure 2, Paragraph 0104, nostril interface 18 and/or 21 may be shaped or angled relative to body portion 12 so as to substantially conform with the nostril, which may make interface 10 more comfortable for the patient to wear) and Shore A 5-20 durometers (Paragraph 0110, interface 10 is manufactured from a soft (low durometer) material for a more comfortable fit for the patient. For example, the material of the interface may have a Shore A hardness of about 10 to about 40, and may be manufactured, for example, from a polyurethane or a silicone. In one embodiment, body portion 12, stabilizers 22, nostril interfaces 18, 21, and oral sampler 20 are molded from the same material).
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 0105, As shown in FIG. 1, patient interface 10 in one embodiment may also include an oral sampler 20 that is on a side of body portion 12 opposite the nostril interfaces 18, 21 and projects from the body 12 in a direction opposite the nostril interfaces 18, 21. Oral sampler 20 is configured to receive a fluid from the mouth of the patient. Oral sampler 20 has an opening 27, or sampling inlet, that can be positioned near the patient's mouth).
Jaffe in view of Scheiner 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 (Jaffe, Figure 28, Paragraph 0187)
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 Jaffe, so as to better accommodate different users (Jaffe, Paragraph 130, the nostril interfaces may be longer and shaped to follow the natural curvature of the interior of the nostril, as shown and described in other embodiments herein. The illustrated embodiment is not intended to be limiting in any way).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 20140094669 A1) in view of Scheiner (US 20200246572 A1), further in view of Moore et al. (US 20030196656 A1, hereinafter “Moore”).
Regarding Claim 6, Jaffe 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 Jaffe (US 20140094669 A1) in view of Scheiner (US 20200246572 A1), in view of Tero (US 20150083123 A1), further in view of Moore (US 20030196656 A1).
Regarding Claim 7, Jaffe in view of Scheiner and Tero discloses all of the limitations of Claim 2. Scheiner further discloses: wherein a spring stiffness of an interface between the nasal interface 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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Jaffe in view of Scheiner and 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 Jaffe in view of Scheiner and Tero 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.
Response to Arguments
Applicant’s arguments, filed June 12, 2026, with respect to the rejections of Claim 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the amendments to the claim language. See updated rejection above.
Allowable Subject Matter
Claims 4 and 8 (and all subsequent dependent claims) are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record fails to teach, disclose, or render the following limitations obvious:
Claim 4: a nasal dam anchor extending from a surface of the air chamber assembly above the air chamber, and nasal interface further comprises an air chamber anchor channel complementary to the nasal dam anchor,
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.
Claim 8: the nasal interface comprises a nasal dam formed of the pliable material, the nasal dam having a lower surface, an upper surface, and one or more nares ports extending from the upper surface to the lower surface, and
a portion of the lower surface of the nasal dam abuts the upper portion of the air chamber assembly such that the one or more nares ports of the nasal dam align with an opening formed in the upper portion of the air chamber assembly to provide fluid communication between the one or more nares ports and the air chamber.
The closest prior art of record is the following references:
Goldstein (US 5752510 A) discloses a nasal interface further including a nasal dam in the form of a cup element (Figure 2, cup 21). Goldstein further describes the structure and fluid communication of the cup in relation to the other features of the nasal interface as follows:
Column 3, lines 32-47, “One end of each tube 11 and 12 is disposed within a connector fixture 18 carried on the end of an air supply or delivery hose 20 while the opposite end of each tube is terminated at the nostrils of the user and are sealed with respect to the nose by means of a pliable or soft cup 21. A pair of bellows 22 and 23 are disposed about respective tubes 11 and 12 and are compressed between the cup 21 and the end 16 of the support bracket 15. Therefore, it can be seen that pressurized breathable air is supplied from the source 13 via the hose 20 and connector 18 to the respective tubes 11 and 12. The breathable air continues through the tubes to the nose of the user, while the combination of cup 21 with the bellows 22 and 23 serves as a seal to insure delivery of the breathable air directly to the user's nose without leakage”
Goldstein is silent regarding a nasal dam anchor or an interference fit of the structure with the air chamber assembly.
Keifer (US 6769432 B1) discloses) a nasal interface further including a nasal dam in the form of an attachable nasal cushion (Figure 2, nostril piece 20). Keifer further describes the structure and intended attachment means for the cushion as follows:
Column 2, lines 51-67, “The nostril piece 20 (FIGS. 2,3) fits an apparatus such as that disclosed in U.S. Pat. No. 5,975,077. Block 24 on a bottom face of the nostril piece 20 includes openings 26 to frictionally override an outer periphery of an air delivery apparatus (not shown) in tight, sealing engagement. A relief 28 extends between the openings 26, serving to equalize airflow between the nares. A side 12 of the nostril piece 20 opposite the block 24 includes a pair of nares receiving stems 22, hollow and in fluid communication with the openings 26 and therefore the air delivery apparatus. A ledge 32 of the nostril piece 20 includes a peripheral wall 33 which ensures no air leakage at the connection site. The upper wall 33 of the ledge 32 includes extended ends 34 for removal of the nostril piece from the attached air delivery apparatus. The cushion layer 1 covers the upper surface of the ledge 32. FIGS. 4-6 show the nostril piece 20 with the cushion layer 1 in place”
Though Keifer does teach an interference fit and an attachable nasal dam structure, this structure is intended to attach to a specific nasal interface arrangement that is not represented in the cited prior art of record.
It would not have been obvious to one of ordinary skill in the art to incorporate the structure of Goldstein or Keifer with the combination of Jaffe in view of Scheiner. Modifying the nasal interface, cushion, or membrane to incorporate a nasal dam is not a common arrangement in the art of respiratory therapy systems. It would require undue experimentation and modification to the systems in order to meet the claim limitations using Goldstein or Keifer.
Conclusion
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, 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.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights