DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, as originally filed on March 7, 2023.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, 11, 15, 16, and 18 of U.S. Patent No. 11,638,798 in view of Stenzler et al. (2003/0200970).
Although the conflicting claims are not identical, they are not patentably distinct from the each other as there appears to be substantial congruency between the subject matter of the instant claims and the patent claims. The difference between the instant claims and the patent claims appears to be a simple duplication of parts, wherein the instant claims positively recite the features of “first and second nasal pillows” and “first and second prongs”, whilst the patent claim recite a singular “nasal pillow” and a singular “prong”. Nevertheless the modification of the patent claims with the teaching of Stenzler clearly disclose the usage of a plurality of nasal pillows – in the formation of one for each nostril of the patient, the usage of a plurality of prongs – in the formation of one of each nostril of the patient was well-known routine, and conventional practice to prescribe the delivery of gas to each nostril of the patient for breathing assistance (Title, Summary, and Figures 1 and 2).
Instant Claim - 1:
Patent Claim - 1:
A nasal interface comprising:
a nasal pillow set comprising a pillow body and first and second nasal pillows, each of the first and second nasal pillows extending in a direction away from the pillow body and having a proximal portion coupled to the pillow body, a distal portion having a pillow aperture, and an inner surface forming a pillow cavity,
wherein the inner surface of the nasal pillow set comprises a channel forming a first branch of a pressure monitoring passage having an opening at the proximal portion of the first nasal pillow and is fluidly coupled to the cavity of the first nasal pillow, and a second branch of a pressure monitoring passage having an opening at the proximal portion of the second nasal pillow and is fluidly coupled to the cavity of the second nasal pillow; and
a nasal cannula comprising a cannula body and first and second prongs, each of the first and second prongs extending in a direction away from the cannula body and having a proximal portion coupled to the cannula body and a distal portion forming a distal end thereof;
wherein the nasal cannula is coupled to the nasal pillow set such that each of the first and second prongs extends into each of the first and second nasal pillows, respectively, and the distal end of each of the first and second prongs is positioned between the opening of the pressure monitoring passage and the pillow aperture.
A nasal interface comprising:
a pillow body comprising a nasal pillow having a pillow opening and a pillow cavity that extends from the pillow opening into the nasal pillow,
wherein the nasal pillow is configured to engage a nose to fluidly couple the pillow cavity with a nostril of the nose, and a pressure channel extending into an inner surface of the pillow body;
a cannula body comprising a prong having a distal end that extends into and is fluidly coupled to the pillow cavity; a pressure monitoring port comprising a pressure passage,
wherein the pressure passage is formed by engagement of an outer surface of the cannula body against the inner surface of the nasal pillow along the pressure channel to enclose the pressure passage therebetween, and the pressure passage extends into and is in fluid communication with the pillow cavity with a distal end of the pressure passage positioned proximal to the distal end of the prong; and a pressure relief port coupled to the pillow cavity.
Regarding Claim 1, despite the minor differences in the claim language of the instant claims to recite “pillow aperture” and the patent claims to recite “pillow opening”, the general structure remains the same whereby the prong from the cannula body is inserted within the nasal pillow of the pillow body to form a pathway by which the cannula body is concentrically located within the pillow body to permit the pillow body to provide a pressure monitoring.
Yet, the patent claim ‘798 does not expressly disclose the configuration of “first and second nasal pillows” and “first and second prongs” as claimed in the instant application.
Stenzler teaches the usage of a plurality of nasal pillows – in the formation of one for each nostril of the patient, the usage of a plurality of prongs – in the formation of one of each nostril of the patient was well-known routine, and conventional practice to prescribe the delivery of gas to each nostril of the patient for breathing assistance (Title, Summary, and Figures 1 and 2).
As best seen in Figures 1 and 2, the nasal pillow set (24, “Referring now to FIGS. 2, 3, 5 and 6, a nose-piece member 24 is illustrated having an apparatus end 26 and a patient nose end 28.” Para 0027) includes a pillow body (28, “a patient nose end 28” Para 0027) including first and second nasal pillows (44/44, “The nose-piece member 24 includes a pair of outwardly extending nostril engaging stems 44 each having an axially extending aperture 36 extending therethrough.” Para 0027) with pillow apertures (36/36, “an axially extending aperture 36” Para 0027) in fluid communication with a pressure monitoring passage (58, “The pressure sensor portal 58 is designed in a manner as to fluidly communicate with the passageways 22, and thus with the proximal end 14 of the apparatus body 12.” Para 0033) and the nasal cannula (12, “The apparatus body 12 has a proximal end 14 (disposed toward patient's nostrils 16) and a distal end 18 (disposed toward the breathing hose 20).” Para 0026) having a cannula body (14, “a proximal end 14 (disposed toward patient's nostrils 16)” Para 0026) including first and second prongs (34/34, “More particularly, the proximal end 14 includes a well 32 having two spaced outwardly extending passageway portals 34. Each of the two passageway portals 34 are in flow communication with a respective one of the passageways 22 extending within the apparatus body 12.” Para 0027) wherein cannula body (12) is concentrically located within (“As such, the nose apertures/channels 36 fluidly communicate with the passageways 22 via the passageway portals 34.” Para 0027) the pillow body (28) to permit the pillow body (28) to provide a pressure monitoring (via 58).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the singular nasal pillow and prong structures of the combined pillow body and cannula body of the modified ‘798 to include the duplication of nasal pillows and prongs for each nostril as taught by Stenzler to be a known construction suitable for imparting breathing gas assistance and pressure monitoring to each nostril of the patient.
Instant Claims – 2 and 12:
Patent Claim - 1:
The nasal interface of Claim 1, wherein each of the first and second nasal pillows comprises an intermediate portion between the proximal and distal portions of the first and second nasal pillows, respectively, and the intermediate portion comprises a pressure relief port.
The nasal interface of Claim 11, wherein each of the first and second nasal pillows comprises an intermediate portion between the proximal and distal portions of the first and second nasal pillows, respectively, and the intermediate portion comprises a pressure relief port.
… a pillow cavity that extends from the pillow opening into the nasal pillow, wherein the nasal pillow is configured to engage a nose to fluidly couple the pillow cavity with a nostril of the nose, … and a pressure relief port coupled to the pillow cavity.
Regarding Claims 2 and 12, the modified ‘798 effectively teaches the orientation of the pressure relief port oriented within the pillow cavity whereby the pillow cavity is defined by the region which extends from the pillow opening into the nasal pillow. With respect to instant claims’ recitation of “an intermediate portion between the proximal and distal portions of the first and second nasal pillows”. By virtue of the pressure relief port of the modified ‘798 being located within the pillow cavity that is an orientation which is intermediate the ends (proximal and distal portions) of the nasal prong. Thus the modified ‘798 effectively meets the limitations of the claims.
Instant Claims – 3 and 13:
Patent Claim - 18:
The nasal interface of Claim 2, wherein the distal portion of each the first and second nasal pillows tapers such that a cross-sectional width of the first and second nasal pillows decreases in a direction away from the intermediate portion.
The nasal interface of Claim 12, wherein the distal portion of each the first and second nasal pillows tapers such that a cross-sectional width of the first and second nasal pillows decreases in a direction away from the intermediate portion.
The nasal interface of claim 1, wherein the pillow cavity comprises a cross-sectional width that decreases from an intermediate portion of the nasal pillow to a distal end of the nasal pillow comprising the pillow opening.
Regarding Claims 3 and 13, the modified ‘798 effectively teaches the cross-sectional width that decreases with respect to the nasal pillow. With respect to the instant claims’ recitation of “taper”, the modified ‘798, specifically Stenzler shows the construction by which the nasal pillow (44/44, as best seen in Figures 2, 5, and 6) have a tapered construction which provides for the insertion into the nostrils of the patient (“Because the peripheral walls 46 of these stems 44 each define an annular top portion 47 which transitions into a generally D-shaped base portion 49, such stems 44 comfortably conform to the interior anatomical features (i.e., septum) of the patient's nostrils 16.” Para 0039).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the modified ‘798 to include a tapered cross section as taught by Stenzler to permit the introduction of the nasal pillow to conform to the nostrils of the patient.
Instant Claims – 4 and 14:
Patent Claim - 7:
The nasal interface of Claim 1, wherein the nasal cannula comprises a first gas port fluidly coupled to the first prong, and a second gas port fluidly coupled to the second prong.
The nasal interface of Claim 11, wherein the nasal cannula comprises a first gas port fluidly coupled to the first prong, and a second gas port fluidly coupled to the second prong.
6. The nasal interface of claim 1, wherein the cannula body comprises another prong.
7. The nasal interface of claim 6, wherein the cannula body comprises a first gas port fluidly coupled to the prong, and a second gas port fluidly coupled to the another prong.
Instant Claims – 5/15:
Patent Claim - 8:
The nasal interface of Claim 4, wherein each of the first and second gas ports extend through opposing portions of the cannula body.
The nasal interface of Claim 14, wherein each of the first and second gas ports extend through opposing portions of the nasal cannula.
8. The nasal interface of claim 7, wherein each of the first and second gas ports extend through opposing portions of the cannula body.
Instant Claims – 6/16:
Patent Claim - 6:
The nasal interface of Claim 1, wherein the nasal cannula comprises a septum configured to separate an inner passage of the nasal cannula between the first and second prongs.
The nasal interface of Claim 11, wherein the nasal cannula comprises a septum configured to separate an inner passage of the nasal cannula between the first and second prongs.
The nasal interface of claim 1, wherein the cannula body comprises another prong.
Regarding Claims 6 and 16, the modified ‘798 effectively discloses the usage of first and second prongs as claimed; yet, does not positively recite the concept of a septum. The modified ‘798, specifically Stenzler teaches the configuration whereby the cannula body (12) includes a first and second prong (34/34), whereby each prong would be oriented to the direction of each nostril of the patient. In this configuration the cannula body (12) effectively bridges the anatomical septum of the patient’s nose so that each nostril of the patient is served by a nasal prong (34/34). Therefore, it would have been obvious to one having ordinary skill in the art to orient the cannula of the modified ‘798 to bridge the septum as taught by Stenzler to be a known anatomical configuration of the patient to service each nostril of the patient.
Instant Claims – 7/17:
Patent Claim - 11:
The nasal interface of Claim 1, wherein the pillow body comprises a cannula body channel configured to receive the cannula body therein.
The nasal interface of Claim 11, wherein the nasal pillow set comprises a cannula body channel configured to receive the nasal cannula therein.
The nasal interface of claim 1, wherein the pillow body comprises a cannula body channel configured to receive the cannula body therein.
Instant Claims – 8/18:
Patent Claim - 16:
The nasal interface of Claim 1, wherein the pillow body comprises a locating slot, and wherein the cannula body comprises a locating tab that is configured to be received into the locating slot of the pillow body.
The nasal interface of Claim 11, wherein the nasal pillow set comprises a locating slot, and wherein the nasal cannula comprises a locating tab that is configured to be received into the locating slot of the nasal pillow set.
15. The nasal interface of claim 1, wherein the cannula body comprises a locating tab that extends from an outer surface of the cannula body.
16. The nasal interface of claim 15, wherein the pillow body comprises a locating slot configured to receive the locating tab.
Instant Claims – 9/19:
Patent Claim - 6:
The nasal interface of Claim 1, wherein a plane formed by the distal end of the first and second nasal prongs is transverse relative to a longitudinal axis of each of the first and second nasal prongs.
The nasal interface of Claim 11, wherein a plane formed by the distal end of the first and second nasal prongs is transverse relative to a longitudinal axis of each of the first and second nasal prongs.
The nasal interface of claim 1, wherein the cannula body comprises another prong.
Regarding Claims 9 and 19, the modified ‘798 effectively discloses the usage of first and second prongs as claimed; yet, does not positively recite the concept of “the distal end of the first and second prongs is transverse relative to the longitudinal axis of each of the first and second prongs.” The modified ‘798, specifically Stenzler teaches the configuration whereby the cannula body (12) includes a first and second prong (34/34), whereby each prong would be oriented to the direction of each nostril of the patient. In this configuration the cannula body (12) effectively includes a plane at the distal end (proximal 14) which is transverse relative to the longitudinal axis (lateral extension – left and right) of the first and second prongs (34/34); thereby effectively bridges the anatomical septum of the patient’s nose so that each nostril of the patient is served by a nasal prong (34/34). Therefore, it would have been obvious to one having ordinary skill in the art to orient the cannula of the modified ‘798 to include a plane form from the distal end which is transverse relative to the longitudinal axis of each nasal prong as taught by Stenzler to be a known anatomical configuration of the patient to service each nostril of the patient.
Instant Claims – 10/20:
Patent Claim - 1:
The nasal interface of Claim 1, wherein the first and second branches of the pressure monitoring passage extend from a single pressure monitoring port.
The nasal interface of Claim 11, wherein first and second branches of a pressure monitoring passage extend from a single pressure monitoring port to the pressure monitoring passage openings in the first and second nasal pillows, respectively.
…a pressure monitoring port comprising a pressure passage, wherein the pressure passage is formed by engagement of an outer surface of the cannula body against the inner surface of the nasal pillow along the pressure channel to enclose the pressure passage therebetween, and the pressure passage extends into and is in fluid communication with the pillow cavity with a distal end of the pressure passage positioned proximal to the distal end of the prong;…
Regarding Claims 10 and 20, the modified ‘798 effectively discloses the configuration of a pressure monitoring port associated with the pressure passage; yet, does not expressly recite each branch from each nasal pillow extending to a singular pressure monitoring port. The modified ‘798, specifically Stenzler teaches a singular pressure monitoring port (via 58, “The pressure sensor portal 58 is designed in a manner as to fluidly communicate with the passageways 22, and thus with the proximal end 14 of the apparatus body 12.” Para 0033) to serve the nasal interface (Figures 1 and 2) to facilitate the delivery of breathing assistance to the patient. Consequently the decision to consolidate a dual pressure passage from each nasal pillow to a singular pressure monitoring port would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be to determine the average pressure of gases supplied/removed form the patient and/or compare the pressures from each nostril to ascertain the general optimization of gas delivery to/from the patient. Therefore, it would have been obvious to one having ordinary skill in the art to modify the pressure passage to communicate with a singular pressure monitoring port as taught by Stenzler to enable the averaging and/or comparing of the general pressures delivered to/from the patient during the treatment plan.
Instant Claim - 11:
Patent Claim - 1:
A nasal interface comprising:
a nasal pillow set and a nasal cannula removably coupled to the nasal pillow set with a first prong of the nasal cannula extending into a first nasal pillow of the nasal pillow set, and a second prong of the nasal cannula extending into a second nasal pillow of the nasal pillow set, wherein the first nasal pillow, and a distal end of the first nasal prong is positioned between a pressure monitoring passage opening at the proximal portion of the first nasal pillow and a pillow aperture at a distal end of the first nasal pillow, and wherein proximal portion of the second nasal prong extends through a proximal portion of the second nasal pillow, and a distal end of the second nasal prong is positioned between a pressure monitoring passage opening at the proximal portion of the second nasal pillow and a pillow aperture at a distal end of the second nasal pillow.
A nasal interface comprising:
a pillow body comprising a nasal pillow having a pillow opening and a pillow cavity that extends from the pillow opening into the nasal pillow, wherein the nasal pillow is configured to engage a nose to fluidly couple the pillow cavity with a nostril of the nose, and a pressure channel extending into an inner surface of the pillow body; a cannula body comprising a prong having a distal end that extends into and is fluidly coupled to the pillow cavity; a pressure monitoring port comprising a pressure passage,
wherein the pressure passage is formed by engagement of an outer surface of the cannula body against the inner surface of the nasal pillow along the pressure channel to enclose the pressure passage therebetween, and the pressure passage extends into and is in fluid communication with the pillow cavity with a distal end of the pressure passage positioned proximal to the distal end of the prong; and a pressure relief port coupled to the pillow cavity.
Regarding Claim 11, despite the minor differences in the claim language of the instant claims to recite “pillow aperture” and the patent claims to recite “pillow opening”, the general structure remains the same whereby the prong from the cannula body is inserted within the nasal pillow of the pillow body to form a pathway by which the cannula body is concentrically located within the pillow body to permit the pillow body to provide a pressure monitoring.
Yet, the patent claim ‘798 does not expressly disclose the configuration of “first and second nasal pillows” and “first and second prongs” as claimed in the instant application.
Stenzler teaches the usage of a plurality of nasal pillows – in the formation of one for each nostril of the patient, the usage of a plurality of prongs – in the formation of one of each nostril of the patient was well-known routine, and conventional practice to prescribe the delivery of gas to each nostril of the patient for breathing assistance (Title, Summary, and Figures 1 and 2).
As best seen in Figures 1 and 2, the nasal pillow set (24, “Referring now to FIGS. 2, 3, 5 and 6, a nose-piece member 24 is illustrated having an apparatus end 26 and a patient nose end 28.” Para 0027) includes a pillow body (28, “a patient nose end 28” Para 0027) including first and second nasal pillows (44/44, “The nose-piece member 24 includes a pair of outwardly extending nostril engaging stems 44 each having an axially extending aperture 36 extending therethrough.” Para 0027) with pillow apertures (36/36, “an axially extending aperture 36” Para 0027) in fluid communication with a pressure monitoring passage (58, “The pressure sensor portal 58 is designed in a manner as to fluidly communicate with the passageways 22, and thus with the proximal end 14 of the apparatus body 12.” Para 0033) and the nasal cannula (12, “The apparatus body 12 has a proximal end 14 (disposed toward patient's nostrils 16) and a distal end 18 (disposed toward the breathing hose 20).” Para 0026) having a cannula body (14, “a proximal end 14 (disposed toward patient's nostrils 16)” Para 0026) including first and second prongs (34/34, “More particularly, the proximal end 14 includes a well 32 having two spaced outwardly extending passageway portals 34. Each of the two passageway portals 34 are in flow communication with a respective one of the passageways 22 extending within the apparatus body 12.” Para 0027) wherein cannula body (12) is concentrically located within (“As such, the nose apertures/channels 36 fluidly communicate with the passageways 22 via the passageway portals 34.” Para 0027) the pillow body (28) to permit the pillow body (28) to provide a pressure monitoring (via 58).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the singular nasal pillow and prong structures of the combined pillow body and cannula body of the modified ‘798 to include the duplication of nasal pillows and prongs for each nostril as taught by Stenzler to be a known construction suitable for imparting breathing gas assistance and pressure monitoring to each nostril of the patient.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Upon the filing and acceptance of a terminal disclaimer in the instant application to conflicting U.S. Patent No. 11,638,798, the instant claims will be deemed allowable as the prior art made of record does not appear to disclose, teach, or fairly suggest the construction of a pair of nasal pillows oriented concentrically within a pair of prongs for the formation of a nasal interface, wherein the nasal interface is defined by the coupling of a nasal pillow set having the pair of nasal pillows and a nasal cannula having the pair of prongs, such that each nasal pillow includes a pressure monitoring passage opening at a proximal portion of the nasal pillow and a pillow aperture located at the distal portion of the nasal pillow, and the distal end of each of the prongs is positioned between the opening of the pressure monitoring passage and the pillow aperture. Thus, Claims 1-20 are deemed allowable over the prior art made of record.
Conclusion
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785