DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 May 2026 has been entered.
Claims 30-45 and 47-53 are pending in the application with claim 46 cancelled. Claims 30, 45 and 47-48 are currently amended. Applicant’s amendment to the Claims have overcome each and every objection and 35 U.S.C. 112 rejection previously set forth in the Final Office Action mailed 25 Feb 2026.
Response to Arguments
Applicant’s arguments, see Pg. 7-8, filed 26 May 2026, with respect to claim 30 have been considered but are not persuasive.
Applicant asserts that amended claim 30 patentably distinguishes over Hobson et al. (U.S. Pub. 2010/0192957) (Pg. 7-8). Specifically, applicant asserts that Hobson fails to teach the newly amended requirement of a distally increasing contact surface of the first elongate wing portion.
Several notes are made regarding the breadth of the new claim language. It is firstly noted that the claim has no concern for what the “contact surface” is to be contacting. The cited first elongate wing portion can be contacted by a person or object along any of its three-dimensional surfaces. Thus, for example, the forward-facing surface of side strap 31 in Fig. 6 is readable as the claimed contact surface and the forward projection along side strap 31 intended for strap connection presents an increased surface area at a distal location from where side strap 31 meets the cited base portion. In this regard it is further noted that the increased contact surface needs only occur at one location distally of the base portion. Similarly, the top view in Fig. 9 shows the forward projection along side strap 31 intended for strap connection presents an increased top surface area at a distal location from where side strap 31 meets the cited base portion.
As a second consideration it is noted that the breadth of the claim language does not preclude a reading on the claim of a cumulative surface area which increases as it moves distally along the first elongate wing portion. For example, consider the rear-facing surface of side strap 31 in Figs. 7-8 as the entire claimed contact surface. Where side strap 31 meets the cited base portion begin moving distally outward a small distance. After that small distance the “contact surface” will have a first area measured back to where the contact surface began. Continuing that process moving incrementally distally until the distal end of side strap 31 is reached will incrementally add more area to the contact surface as second, third, etc. areas until the entire contact surface has been reached. Thus, moving distally from the base portion leads to an increasing amount of contact surface. It is noted in this regard that the claim does not recite the contact surface as widening as it moves distally, as appears to be applicant’s intent.
In the interests of compact prosecution several prior art references are noted for applicant’s consideration which teach a distally widening wing portion along a face contacting surface. Firstly, note is made of the annotated Fig. 85a of Kooij et al. (U.S. Pub. 2011/0067704) presented in the below 35 U.S.C. 103 of claim 36. Secondly, further prior of note include: Palmer (U.S. Pub. 2006/0081256; Figs. 1-3), O’Connor (WO Pub. 2012/053910 A1; Figs. 7-8 & 26A-26D) and McAuley et al. (U.S. Pub. 2012/0318270; Figs. 4, 8A & 27).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 45 and 47-48 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 45 recites the limitation "forming the at least one substantially horizontal side entry of the face mount part on either side of the bridge." in Ln. 3-4 which deems the claim indefinite. The language “on either side of the bridge” appears to require two side entries. However, the language of the limitation only recites “the at least one substantially horizontal side entry.” There thus appears to be a conflict between the language “at least one,” which only requires a minimum of one, and the language “on either side,” which appears to require two. It is suggested to specify in the claim the “at least one” side entry as comprising two side entries for the present claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 30-35, 45 and 47-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobson et al. (U.S. Pub. 2010/0192957).
Regarding claim 30, Hobson discloses a nasal cannula (Figs. 6-9; ¶0132) comprising: a face mount part (Figs. 6-7 #32; ¶0133) comprising a base portion (see annotated Figs. 6 & 9 below) and a first elongate wing portion (Figs. 6-7 one of right or left side #31; see annotated Figs. 6 & 9 below) extending laterally from a first side of the base portion; a first nasal prong (Figs. 6-7 one of #33, 34; ¶0139) extending transversely from the base portion and capable of fitting in a nare of a user; the first elongate wing portion comprising an exterior surface (rear surface of #31 seen in Fig. 7) configured to contact a portion of a face of the user in use (e.g. Fig. 3), and an elongate ridge (see annotated Figs. 6 & 9 below; generally relating to #39 in ¶0140) extending transversely along the first elongate wing portion opposing the exterior surface to aid in stabilising the face mount part upon the face of the user in use; an edge of the elongate ridge forms an outermost edge of the first elongate wing portion (in annotated Fig. 9 below the elongate ridge is the farthest downward point of the wing portion), the nasal cannula further comprises a gases flow manifold part (Fig. 5 #35; ¶0133) having a gases inlet (Fig. 5 right side of #35) configured to receive a flow of gas from a gas source (Figs. 1-2), and the gases flow manifold part being adapted to be received by the base portion through at least one substantially horizontal side entry (Fig. 6 dual #38, see also Fig. 5 #38; ¶0140; see also Fig. 14) of the face mount part to fluidly connect an outlet (Fig. 5 #37; ¶0136) of the gases flow manifold part with the first nasal prong (Fig. 5) ; and wherein a contact surface of the first elongate wine portion increases in a distal direction away from the base portion (see following comments). It is firstly noted that the claim has no concern for what the “contact surface” is to be contacting. The cited first elongate wing portion can be contacted by a person or object along any of its three-dimensional surfaces. Thus, for example, the forward-facing surface of side strap 31 in Fig. 6 is readable as the claimed contact surface and the forward projection along side strap 31 intended for strap connection presents an increased surface area at a distal location from where side strap 31 meets the cited base portion. In this regard it is further noted that the increased contact surface needs only occur at one location distally of the base portion. Similarly, the top view in Fig. 9 shows the forward projection along side strap 31 intended for strap connection presents an increased top surface area at a distal location from where side strap 31 meets the cited base portion. As a second consideration it is noted that the breadth of the claim language does not preclude a reading on the claim of a cumulative surface area which increases as it moves distally along the first elongate wing portion. For example, consider the rear-facing surface of side strap 31 in Figs. 7-8 as the entire claimed contact surface. Where side strap 31 meets the cited base portion begin moving distally outward a small distance. After that small distance the “contact surface” will have a first area measured back to where the contact surface began. Continuing that process moving incrementally distally until the distal end of side strap 31 is reached will incrementally add more area to the contact surface as second, third, etc. areas until the entire contact surface has been reached. Thus, moving distally from the base portion leads to an increasing amount of contact surface. The term “portion” in the claim is not understood to define exact boundaries and thus can be variously defined. The recitation of the first elongate wing portion as aiding in stabilising the face mount part upon the face of the user in use represents an intended outcome and is given limited patentable weight (MPEP 2114). The discussion of the view of Fig. 5 on Pg. 14 of the instant specification as “from the outer side of the face mount part” indicates that “outer” is best understood as a side farthest from the user’s face. In Figs. 6 & 9 of Hobson a farthest (i.e. “outermost”) portion of each “wing” from the user’s face is defined by lip 39.
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Hobson – Annotated Fig. 6
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Hobson – Annotated Fig. 9
Hobson fails to explicitly disclose the elongate ridge forms a taper.
The front view of face mount part 32 in Fig. 6 and the top view of face mount part 32 in Fig. 9 have been annotated above to show an elongate ridge in Hobson which generally relates to lip 39. As lip 39 proceeds from a front of face mount part 32 toward a rear of face mount part 32 it is illustrated as curving outwardly until it ends by merging into side straps 31. That progression of curving and then merging is obviously readable as a tapering which is obviously suggested by the illustrations of Figs. 6 & 9 of Hobson.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Hobson the elongate ridge forms a taper based upon lip 39 is illustrated in at least Figs. 6 & 9 of Hobson as curving outwardly until it ends by merging into side straps 31, which one of ordinary skill in the art would have obviously considered as suggestive of a tapering configuration.
Regarding claim 31, Hobson further teaches the face mount part comprises a second elongate wing portion (see annotated Fig. 9 above) that extends laterally from a second side of the base portion.
Regarding claim 32, Hobson further teaches the face mount part comprises a second nasal prong (Figs. 6-7 other of #33, 34; ¶0139) that is capable of fitting into another nare of the user.
Regarding claim 33, Hobson further teaches the first nasal prong comprises a non-sealing prong configured such that, in use, a seal is not formed between the first nasal prong and the nare of the user (¶0171 – not intended to seal).
Regarding claim 34, Hobson further teaches the first nasal prong is sized to maintain a sufficient gap between an outer surface of the first nasal prong and skin of the user to avoid sealing a gas path between the nasal cannula and the user (¶0171 – no intended to seal).
Regarding claim 35, Hobson further teaches the elongate ridge of the first elongate wing portion extends along an upper region of the first elongate wing portion (see annotated Figs. 6 & 9 above).
Regarding claim 45, Hobson further teaches the nasal cannula further comprises a bridge (Fig. 6 #40; ¶0140) extending from the base portion of the face mount part to a lower region of the first elongate wing portion and forming the at least one substantially horizontal side entry of the face mount part (Fig. 6 dual #38, see also Fig. 5 #38; ¶0140) on either side of the bridge.
Regarding claim 47, Hobson further teaches the gases flow manifold part comprising a lip at a gases outlet (Fig. 5 raised C-shaped structure on each lateral side of outlet 37).
Hobson fails to explicitly teach the face mount part further comprises a recess formed in an interior of the base portion, the lip at the gases outlet configured to releasably engage the recess to fluidly connect the gases outlet with the first nasal prong of the face mount part.
However, one of ordinary skill in the art viewing Fig. 5 of Hobson would have noticed the conspicuous raised C-shaped structure on each lateral side of outlet 37. Hobson discusses outlet 37 as aligning with an underside of the face mount portion 32 (¶0140). One of ordinary skill in the art would have considered it prima facie obvious that the raised C-shaped structure on each lateral side of outlet 37 serve an aligning function when manifold part 35 is inserted into face mount part 32. It would then have been further prima facie obvious to have included a complimentary inner recess in face mount part 32 to the shaping of the raised C-shaped structure on each lateral side of outlet 37 in order to provide the predictable benefit of assisting alignment while also preventing over-insertion of manifold part 35.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Hobson the face mount part further comprises a recess formed in an interior of the base portion, the lip at the gases outlet configured to releasably engage the recess to fluidly connect the gases outlet with the first nasal prong of the face mount part in order to yield the predictable benefit of assisting alignment while also preventing over-insertion of manifold part 35 in view of the overall disclosure relating to Fig. 5 of Hobson.
Regarding claim 48, Hobson further teaches the face mount part is formed from a soft, flexible material relative (¶0142 – flexible polymer material, soft TPE) to the gases flow manifold part (¶0137 – hard plastic material).
Regarding claim 49, Hobson discloses a respiratory assistance system (Fig. 1) comprising: the nasal cannula of Claim 30 (see above) configured to deliver a flow of humidified gas to the user; and headgear (Fig. 2; ¶¶0123-0125) configured to retain the nasal cannula on the face of the user.
Regarding claim 50, Hobson discloses a flow source (Fig. 1 #15; ¶0118) configured to generate a flow of gases, and a humidifier (Fig. 1 #2; ¶0115) coupled to a gases outlet of the flow source to humidify the flow of gases.
Regarding claim 51, Hobson discloses an inspiratory conduit (Fig. 1 #3; ¶0114) configured to couple between the humidifier and the nasal cannula.
Regarding claim 52, Hobson discloses an extension tube (Fig. 2 #62; ¶0121) configured to couple between the inspiratory conduit and the nasal cannula.
Regarding claim 53, Hobson discloses a retention clip (Fig. 2 #55; ¶0125) configured to couple around the extension tube and to the headgear to tether the extension tube to the headgear and to relocate at least a portion of a pull force on the extension tube from the nasal cannula to the headgear.
Claim(s) 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobson et al. (U.S. Pub. 2010/0192957) in view of Kooij et al. (U.S. Pub. 2011/0067704).
Regarding claim 36, Hobson fails to explicitly disclose the first elongate wing portion comprises an accentuated terminal end extending in a direction substantially towards a cheek of the user in use. The term “accentuated” in interpreted in light of its use in the specification to describe distal or terminal end 113c/114c (e.g. Fig. 7; Pg. 20-21).
Kooij teaches a nasal cannula (Figs. 85a-85c; ¶0155) including an elongate wing portion (Fig. 85a rightward from #1011) comprising an accentuated terminal end (see annotated Fig. 85a below) extending in a direction substantially towards a cheek of the user in use (Fig. 85d). Kooij teaches an accentuated end of a wing as providing the benefit of supplying adequate space for different headgear straps, intended to be oriented in different directions, to be attached to the nasal cannula (¶¶0351-0353; Fig. 85d).
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Kooij – Annotated Fig. 85a
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Hobson the first elongate wing portion comprises an accentuated terminal end extending in a direction substantially towards a cheek of the user in use in order to yield the predictable benefit of supplying adequate space for different headgear straps, intended to be oriented in different directions, to be attached to the nasal cannula in view of Kooij.
Regarding claim 37, Hobson teaches the invention as modified above and further teaches the accentuated terminal end of the first elongate wing portion is angled obtusely relative to a longitudinal orientation of the base portion of the face mount part (Figs. 3 & 5). See also Fig. 85d of Kooij.
Regarding claim 38, Hobson teaches the invention as modified above and Kooij further teaches the accentuated terminal end of the first elongate wing portion has a greater contact surface area than a contact surface area of the first elongate wing portion that is adjacent the base portion (see annotated Fig. 85a above).
Regarding claim 39, Hobson teaches the invention as modified above and Kooij further teaches the accentuated terminal end of the first elongate wing portion tapers outwardly (see annotated Fig. 85a above).
Claim(s) 40-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobson et al. (U.S. Pub. 2010/0192957) in view of McAuley et al. (U.S. Pub. 2012/0204870).
Regarding claim 40, Hobson discloses the first elongate wing portion comprises a first formation (Figs. 6-7 strap connection location near lateral end of #31; ¶0141) configured to releasably couple with a first connector of headgear (¶0141 – may be clipped) associated with the nasal cannula.
Hobson fails to explicitly disclose the first formation at a distal end of the first elongate wing portion.
McAuley teaches a nasal interface (Fig. 77) including a wing portion (Fig. 78b #7623) including a formation (Figs. 78a-78b “loop” on #7623 receiving #7631; ¶1192) to releasably couple with a connector (Fig. 78a-78b #7631; ¶1192) of headgear (Fig. 77). One of ordinary skill in the art considering at least Figs. 78a-83 of McAuley and noticing how the “loops” which receive detachable elements 7630, 7631 are illustrated as nearly to the respective distal ends of connecting arms 7615, 7616 would have considered it prima obvious to have specified the location of the “loops” as sufficiently near to ends of connecting arms 7615, 7616 that their overall structure which encompass the distal ends of connecting arms 7615, 7616. McAuley teaches this form of headgear connection as an obvious design choice alternative for releasably securing headgear to a nasal interface.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Hobson the first formation at a distal end of the first elongate wing portion based upon an obvious design choice alternative of a different form of connection which allows releasable securing of headgear to a nasal interface via a push-fit type arrangement in view of McAuley. It is noted again the first connector is not read as positively recited and thus the first formation need only be capable of performing the recited coupling.
Regarding claim 41, Hobson teaches the invention as modified above and McAuley further teaches the first connector comprises a lateral projection (Fig. 78b barb end of #7633) at an end of an elongate body (Fig. 78b above barb end), the lateral projection configured to engage the first formation with a push-fit type arrangement (Figs. 78a-78b; ¶1192). It is noted that the first connector is not read as positively recited.
Regarding claim 42, Hobson teaches the invention as modified above and McAuley further teaches the first formation comprises a channel (Fig. 78b “loop”; ¶1192) with an entry aperture (Fig. 78b end of “loop” initially receiving #7631), an exit aperture (Fig. 78b end of “loop” secondly receiving #7631, see Fig. 78a), and an abutment surface (Fig. 78a where #7631 rests following insertion) located at the exit aperture, the first connector comprising the elongate body configured to be received and retained within the channel (Fig. 78a), and the lateral projection configured to engage the abutment surface at the exit aperture of the channel such that the first connector is retained therein (Fig. 78a).
Regarding claim 43, Hobson teaches the invention as modified above and together with McAuley further suggests as obvious the channel is configured to be elastically deformed (McAuley – ¶1213 – soft material; Hobson – ¶0142 – soft material) to receive the first connector.
McAuley further suggests as obvious the first connector can be rotated axially about 180° to enable ease of removal of the first connector from the channel. It is initially noted that the first connector is not positively recited. Thus, different shapes and forms of first connector could obviously be used with the channel cited from McAuley with some of those shapes and sizes obviously allowing full 360° rotation. The recitation in the claim of enabling ease of removal of the first connector represents an intended functionality and is given limited patentable weight (MPEP 2114). Applicant is encouraged to more particularly claim the structure creating the recited 180° rotation.
Regarding claim 44, Hobson teaches the invention as modified above and McAuley further suggests as obvious when the lateral projection of the first connector is rotated through about 180° within the channel, the lateral projection of the first connector disengages from the abutment surface of the exit aperture of the channel (Figs. 78a-78b; ¶1192). It is again noted that the first connector is not positively recited. McAuley suggests as obvious that various forces, including rotation, can be applied when desiring to detach detachable element 7631. There is nothing in the claim which would preclude disengaging from occurring in situations other than the recited 180° rotation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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