DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed 11/14/2025. As directed by the amendment, claims 2, 8 and 11 have been amended, and claim 23 has been added. As such, claims 2-12 and 14-23 are pending in the instant application.
Applicant has amended the claims to clarify the subject matter therein; the previous rejections under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 11/14/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding amended claim 2, Applicant argues on page 11 of Remarks that “the inhalation manifold 20 and the exhalation manifold 22 [of Bowe] are not first ends of the nasal prongs 14,16” (emphasis Applicant’s).
The Examiner respectfully notes that the claims have not be amended in a way that excludes the manifolds 20,22 of Bowe from corresponding to the claimed first/second tube ends. The manifolds 20,22 extend from the base of prongs 14,16 and are integral therewith, see Bowe Fig. 1 and col. 6, lines 62-64, and thus prong 14+manifold 20 and prong 16+manifold 22 comprehend nasal prongs as claimed because manifolds 20,22 extend from the base of prongs 14,16 to form unitary structures that provide flow paths directly to the nares of a user, i.e. nasal prongs. Therefore, Bowe continues to read on the contested limitations (previously recited in claim 11) as discussed in the updated rejection below. Moreover, it is noted that previously-cited Davenport et al. (US 2008/0051674 A1; Fig. 1), previously-cited Kooij et al. (US 2011/0067704 A1; Fig. 1), and Kirsch et al. (US 6,763,832 B1; Fig. 1) also teach nasal prongs that extend horizontally and then curve upward toward the nares.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-12 and 14-23 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 2 (and thus its dependent claims) has been amended to positively recite the face of a (human) user, one of two nares of the user and a crown of the user. Applicant could address this rejection by amending claim 2 to read “toward a/the midline of the harness” (two instances, a/the as appropriate) and “curving upward toward the gas outlet of the first/second nasal prong” (two instances, first/second as appropriate).
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.
Claims 2-12 and 14-23 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 2 (and thus its dependent claims) recites the limitation "the first portion" and “the second portion” in lines 29 and 39, respectively. There is insufficient antecedent basis for these limitations in the claim. As best understood, for purposes of examination, the claim will be considered to read “the first nasal prong intermediate portion” and “the second nasal prong intermediate portion”.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2, 6, 8-10, 12, 15, 18 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe et al. (US 5,335,656; hereinafter “Bowe”) in view of Palfy (US 5,711,818 B2; hereinafter “Palfy”), Palmer (US 7,231,921 B2; hereinafter “Palmer”), Kooij et al. (US 2010/0000534 A1; hereinafter “Kooij”) and Beevers (US 7,331,348 B1; hereinafter “Beevers”).
Regarding claims 2, 15 and 18, Bowe discloses a nasal cannula arrangement (Fig. 1) comprising:
a first nasal prong (comprising nasal prong 14 and inhalation manifold 20) and a second nasal prong (comprising nasal prong 16 and exhalation manifold 22), each of the first nasal prong and the second nasal prong comprising:
a gas outlet (at the lower portion of the prongs in Fig. 1, wherein flexible tubing segment 27 is fully capable of being attached to a gas source such that air is output from nasal prong 16 because there is nothing that would preclude this intended use, such that the lower opening of prong 16 comprehends a gas outlet in the same way as that of prong 14) adapted to be inserted into a nare of a user (Fig. 6), and
a gas inlet (manifold portions corresponding to end portions 33, 35 in Fig. 1) (col. 7, lines 34-38; where the manifold portion corresponding to end portion 35 comprehends an inlet because tubing segment 27 is fully capable of supplying gas as discussed above and thus gas would be entering at this location) fluidly connected to the gas outlet (Fig. 1);
a harness (the middle portion of body 12 and/or of base member 29 between prongs 14, 16) coupling the first and second nasal prongs together (Fig. 1; col. 7, lines 24-33), the harness having a first side (left side) coupled to the first nasal prong and a second side (right side) coupled to the second nasal prong;
a first outrigger (the portion of the base member 29 to the left of prong 14) projecting outwardly from the first side of the harness (Fig. 1), the first outrigger having a first width at a first location (at the dashed line representing the end of tube 25 within manifold 20) proximate to the first nasal prong and a second width at a second location (the leftmost end of manifold 20 in Fig. 1) distal of the first nasal prong (Fig. 1);
a second outrigger (the portion of the base member 29 to the left of prong 16) projecting outwardly from the second side of the harness (Fig. 1), the second outrigger having a third width at a third location (at the dashed line representing the end of tube 25 within manifold 22) proximate to the second nasal prong and a fourth width at a fourth location (the rightmost end of manifold 20 in Fig. 1) distal of the second nasal prong (Fig. 1), each of the first outrigger and the second outrigger comprising a front surface (facing up in Fig. 1), wherein the gas inlet of the first nasal prong is provided on the front surface of the first outrigger and the gas inlet of the second nasal prong is provided on the front surface of the second outrigger (Fig. 1);
a first medical breathing tube (tubing segment 25) extending along the first outrigger from the second location of the first outrigger to the first location of the first outrigger, the first outrigger extending above and below the first medical breathing tube at the second location of the first outrigger, the first medical breathing tube being fluidly connected the gas inlet of the first nasal prong (Fig. 1; col. 7, lines 3-23), the first nasal prong comprising a first tube end (comprising manifold 20 proximate tubing end 33) (Fig. 1, see modified below) connecting to the first medical breathing tube (Fig. 1; col. 7, lines 3-23), the first tube end extending horizontally (along manifold 20) toward a midline of a face of the user/the harness/middle of base member 29 (Fig. 1 in view of Fig. 6), the first nasal prong further comprising an intermediate portion (at the base of the prong 14) of the first nasal prong extending from the first tube end toward a first user end (see Fig. 1 modified below), as best understood, the first [nasal prong intermediate] portion curving upward toward one of two nares of the user towards a crown of the user (Fig. 1 in view of Fig. 6);
PNG
media_image1.png
438
672
media_image1.png
Greyscale
a second medical breathing tube (tubing segment 27) extending along the second outrigger from the fourth location of the second outrigger to the third location of the second outrigger, the second outrigger extending above and below the second medical breathing tube at the fourth location of the second outrigger, the second medical breathing tube being fluidly connected to the gas inlet of the second nasal prong (Fig. 1; col. 7, lines 3-23), the second nasal prong comprising a second tube end (comprising manifold 22 proximate tubing end 35) (Fig. 1, see modified above) connecting to the second medical breathing tube (Fig. 1; col. 7, lines 3-23), the second tube end extending horizontally (along manifold 20) toward the midline of a face of the user/the harness/middle of base member 29 (Fig. 1 in view of Fig. 6), the second nasal prong further comprising an intermediate portion (at the base of the prong 16) of the second nasal prong extending from the second tube end toward a second user end (see Fig. 1 modified above), as best understood, the second [nasal prong intermediate] portion curving upward toward one of the two nares of the user towards a crown of the user (Fig. 1 in view of Fig. 6), the first medical breathing tube configured to supply breathing gases to the first nasal prong (col. 7, lines 3-8) and the second medical breathing tube configured to supply the breathing gases to the second nasal prong (col. 7, lines 3-8; wherein tubing segment 27 is fully capable of being connected to a breathing gas source and delivering said gas in the same manner as tubing segment 25, such that tubing segment 27 is configured as claimed).
Bowe is silent regarding the second and fourth widths being greater than the first and third widths, respectively. However, a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Palfy demonstrates that it was well known in the nasal cannula harness/support art at the time of invention for the backplate of a nasal prong arrangement to either be rectangular as disclosed by Bowe (Palfy Fig. 3) or to have first/third widths at first/third locations proximate to the nasal prongs and second/fourth widths at second/fourth locations distal of the nasal prongs, the second/fourth widths being greater than the first/third widths (Palfy Figs. 4 and 4B). Therefore, it would have been obvious to an artisan at the time of invention to modify Bowe to include the second/fourth widths being greater than the first/third widths as taught by Palfy (i.e. for the backplate of Bowe to be a dog-bone/bow-tie shape rather than a rectangle), in order to provide the predictable result of a harness/outriggers/backplate that is shaped to fit the narrow region of a user’s upper lip under the nose and then flare out toward the cheeks for a wider contact area, in order to better distribute forces and/or increase connection with the face, e.g. to provide additional surface area for strap-free attachment to the cheeks, as discussed below.
While Bowe further suggests accommodating curvature/matching a facial contour of the user because base member 29 is disclosed as being flexible (Fig. 1 and col. 7, lines 24-28 in view of col. 6, lines 3-5), and Palfy (Figs. 4/4C and col. 4, lines 65-67 in view of col. 1, lines 64-66) teaches that it was known in the nasal cannula art at the time of invention for a flat base member to be flexible so as to conform to facial contours of the patient, i.e. to curve because human faces are convex/curved, modified Bowe does not explicitly disclose/teach the first and second outriggers being pre-shaped to be curved to match a facial contour of the user. However, Palmer teaches that it was known in the nasal cannula art at the time of invention for a nasal cannula arrangement to include the first and second outriggers (first and second facial interfaces 2, 4) (Fig. 1) of a dog-bone/bow-tie shaped cannula arrangement being pre-shaped to be curved (along line 18) to match a facial contour of the user (Figs. 1 and 2; facial interface 2, 4…custom molded to the patient’s face 29 and then activated to take a permanent set, col. 5, lines 4-14; first 2 and second 4 facial interface are mirror images…not described separately, col. 5, lines 34-37; facial interface 2 may be…substantially contoured to follow the contours of a patient’s face, col. 5, lines col. 5, lines 45-47; ideally, the facial interface 2 should mechanically clasp…contouring of the facial interface 2 to the patient’s face…provides the mechanical clasping…to achieve this mechanical clasping…facial interface 2 is rotated…around the line 18, col. 5, line 54-col. 6, line 24). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include the first and second outriggers pre-shaped to be curved to match a facial contour of the user as taught by Palmer, in order to provide the predictable results of an interface that provides mechanical clamping as well as attachment via dermal patch as discussed below, thus enhancing resistance to movement of the interface (Palmer col. 6, lines 20-24), as well as provides a more comfortable, tailored/fitted interface for an improved patient experience.
Modified Bowe is silent regarding a securement comprising:
a dermal patch having a user side and an interface side, the user side of the dermal patch being configured to attach or adhere to a skin of the user and wherein the interface side of the dermal patch is provided with a first part of a two-part releasable attachment system, wherein the first part of the two-part releasable attachment system includes a substrate portion secured to the dermal patch; and
a user interface patch releasably attachable to the dermal patch, wherein each one of the first and second outriggers comprises a rear surface that receives or retains the interface patch such that, in use, attachment of the user interface patch with the dermal patch secures one of the first and second outriggers upon a face of the user, wherein a surface area of the dermal patch is larger than a surface area of the one of the first outrigger or the second outrigger. However, Kooij teaches that it was known in the nasal respiratory therapy interface art at the time of invention to utilize a securement system for first and second nasal prongs (on interface structure 2000) (Figs. 48-49; para [0177]) comprising:
a dermal patch (adhesive strip 2136) having a user side (facing into the page in Fig. 48 and down/towards the user in Fig. 49) and an interface side (facing the viewer in Fig. 48 and upwards in Fig. 49), the user side of the dermal patch being configured to attach or adhere to a skin of the user (para [0177]) and wherein the interface side of the dermal patch is provided with a first part (hook or loop fastener material 2138) of a two-part releasable attachment system (para [0177]), wherein the first part of the two-part releasable attachment system includes a substrate portion (the hooks or loops) secured to the dermal patch (Fig. 48; para [0177]); and
a user interface patch (material 2142) releasably attachable to the dermal patch (para [0177]), wherein the user interface patch has a patient facing side (down/towards the user in Fig. 49), the patient facing side being provided with a complementary second part (corresponding loop and hook fastener material 2142) of the two-part releasable attachment system (para [0177]), wherein one of first and second outriggers (either of the two extensions coming from support 2140) comprises a rear surface that receives or retains the interface patch (support 2140 comprises corresponding loop and hook fastener material 2142 configured to engage the hook and loop fastener material 2138 of the adhesive strip 2136, para [0177]; wherein, given the structure depicted in Figs. 48-49, the material 2142 is understood to be on the rear/user-facing surface of the extensions of the support 2140) such that, in use, attachment of the user interface patch with the dermal patch secures one of the first and second outriggers upon a face of the user (Fig. 49; para [0177]), wherein a surface area of the dermal patch (e.g. the entire surface area of the dermal patch) is larger than a surface area of the one of the first outrigger or the second outrigger (e.g. the surface area occupied by the material 2142 on a given outrigger), and Beevers demonstrates that the use of similar hook and loop fastener configurations specifically in under-the-nose cannula arrangements such as those of Bowe (Beevers Figs. 1, 2, 3E and 4C; col. 2) was known at the time of invention, including wherein a surface area of the dermal patch (e.g. the entire surface area seal 10 in Fig. 1, which coextends on either side of the face with the cannula as well as being flared at the distal ends and sufficient to cover the bottom of the nose in the central region) is larger than a surface area of the one of the first outrigger or the second outrigger (i.e. the rear surface area of cannula 26 with loop material 54 thereon in Fig. 4C, in view of the extent of seal 10 depicted in Fig. 3D relative to the size of the cannula depicted in Fig. 4C). Also, changes in size and/or shape are generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A and B. Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include a securement system comprising: a dermal patch having a user side and an interface side, the user side of the dermal patch being configured to attach or adhere to a skin of the user and wherein the interface side of the dermal patch is provided with a first part of a two-part releasable attachment system, wherein the first part of the two-part releasable attachment system includes a substrate portion secured to the dermal patch; and a user interface patch releasably attachable to the dermal patch, wherein one of the first and second outriggers comprises a rear surface that receives or retains the interface patch such that, in use, attachment of the user interface patch with the dermal patch secures one of the first and second outriggers upon a face of the user, wherein a surface area of the dermal patch is larger than a surface area of the one of the first outrigger or the second outrigger as taught by Kooij and Beevers, in order to provide the predictable result of a strap-less, cheek-anchored fastening arrangement for the cannula that permits the positioning of the patient interface and/or fastening arrangement to be adjusted to provide a comfortable fit while providing efficient therapy (Kooij para [0176]), wherein use of a single dermal patch that is larger in surface area than either of the outriggers as taught by Kooij would have predictably provided a dermal patch that could be applied in a single step AND/OR utilizing a dermal patch that extends to cover the bottom of the nose as well as under the outriggers as taught by Beevers would have predictably provided additional anchoring area and/or protection from external irritation by the cannula AND/OR using a dermal patch that is larger in surface area than a respective outrigger (e.g. if using two dermal patches/interface patches as discussed below regarding claim 14) would have predictably provided a larger receiving area for allowing different positions/adjustments of an outrigger relative to the/a dermal patch without having to move the underlying dermal patch and/or would have predictably provided a buffer area around a given adhesion region to prevent the outriggers/associated interface patch(es) from extending beyond the dermal patch(es) and potentially irritating the wearer’s skin through rubbing contact therewith.
Regarding claim 6, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein the first nasal prong, second nasal prong, the harness, the first outrigger and the second outrigger are all provided together as an integrally formed component (Fig. 1; entire cannulae 10 is preferably molded from a flexible plastic material, col. 6, lines 62-64).
Regarding claim 8, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein:
the first medical breathing tube is configured to extend from a first side (left side) of a face of the user (Fig. 6); and
the second medical breathing tube is configured to extend from a second side (right side) of the face of the user (Fig. 6), the second side of the face of the user being opposite from the first side of the face of the user (Fig. 6).
Regarding claim 9, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein a shape of the first nasal prong and/or the second nasal prong allows the first nasal prong or the second nasal prong to follow an anatomical curvature of the nare of the user (Fig. 1; each of the nasal prongs may extend first laterally and then curve approximately in parallel so as to fit comfortably and well within the nasal passages, col. 5, lines 42-45).
Regarding claim 10, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein a shape of the first nasal prong and/or the second nasal prong allows the first nasal prong and/or the second nasal prong to avoid contact with a septum of the user at a base of a nose of the user (Figs. 1 and 6; where the prongs are shown to be spaced and sized so as to avoid contact with the septum, and see also col. 5, lines 22-33).
Regarding claim 12, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein one or each one of the first nasal prong and the second nasal prong comprises a cross-section that varies along a central trajectory (Fig. 1; col. 4, lines 37-38; where the prongs tapering towards the ends intended to be inserted into the nares means their cross-sectional area varies/gets smaller towards the ends to be inserted into the nares).
Regarding claim 20, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein the harness (i.e. when considered only as the middle portion of base member 29 between prongs 14, 16) is solid between the first nasal prong and the second nasal prong such that there is no fluid communication between the first nasal prong and the second nasal prong via the harness (Bowe Fig. 1), and see also the solid septum 18 in Bowe Fig. 1, which further teaches no fluid communication between the first nasal prong and the second nasal prong (Bowe Fig. 1; col. 6, lines 54-62).
Claims 3-5 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe in view of Palfy, Palmer, Kooij and Beevers as applied to claim 2, and further in view of Herron, Jr. (US 2009/0025724 A1; hereinafter “Herron”).
Regarding claims 3-5, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, but modified Bowe is silent regarding wherein each of the first and second medical breathing tubes comprises:
a tubular body that is a breathable tube/formed from one or more breathable materials that is one or more of a breathable thermoplastic urethane or a breathable polyamide defining a lumen;
an internal form enclosed within the lumen, the internal form being supportive of the tubular body; and
a coating encapsulating the internal form, the coating securing the internal form to the tubular body. However, Herron demonstrates that it was known in the respiratory tubing art at the time of invention for medical breathing tubes (e.g. Fig. 5) to comprise:
a tubular body (hose 10) that is a breathable tube/formed from a breathable thermoplastic urethane (abstract; para [0038]) defining a lumen (through the hose) (e.g. Fig. 5);
an internal form (helical wire) enclosed within the lumen (hose may have a helical wire…on an inside surface of the hose, para [0039]), the internal form being supportive of the tubular body (a helical wire present to provide the hose with additional strength, para [0039]); and
a coating (the wire may be coated and adhered to the surface by any suitable means such as an adhesive, para [0039]) encapsulating the internal form (as would have been reasonably inferred by an artisan at the time of invention given the term “coated” in para [0039], and obvious in order to provide a layer of protection on the wire, e.g. to protect the wire from potentially corrosive secretions within the tube), the coating securing the internal form to the tubular body (para [0039]). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include wherein each of the first and second medical breathing tubes comprises:
a tubular body that is a breathable tube/formed from a breathable thermoplastic urethane and defining a lumen; an internal form enclosed within the lumen, the internal form being supportive of the tubular body; and a coating encapsulating the internal form, the coating securing the internal form to the tubular body as taught by Herron, in order to provide the predictable result of reinforced, breathable tubes capable of removing any moisture or liquids that may build up within tubes and thus impede air flow therethrough (Herron paras [0005] and [0047]).
Regarding claim 7, Bowe in view of Palfy, Palmer, Kooij, Beevers and Herron teaches the nasal cannula arrangement of Claim 3, wherein modified Bowe further discloses/teaches wherein a terminal end (end portion 33) of the first medical breathing tube (25) is integrated with the gas inlet of the first nasal prong such that the lumen of the first medical breathing tube is fluidly connected with a lumen of the first nasal prong, and a terminal end (end portion 35) of the second medical breathing tube (27) is integrated with the gas inlet of the second nasal prong such that the lumen of the second medical breathing tube is fluidly connected with a lumen of the second nasal prong (Bowe Fig. 1; col. 7, lines 3-38; flexible tubing segments 25 and 27 may be…supplied as part of the cannulae…permanently fixed…in place by means similar to those for sealing securing septum 18, col. 7, lines 8-16; septum 18 being integrally molded, col. 6, line 64).
Claims 11 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe in view of Palfy, Palmer, Kooij and Beevers as applied to claim 2, and further in view of Thompson (US 2005/0033247 A1; hereinafter “Thompson”).
Regarding claims 11 and 23, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Bowe further discloses wherein each of the first and second nasal prongs has a trajectory (Fig. 1), and wherein the trajectory is configured to:
roll backwards into the head of the user following an anatomical curvature of the one of the two nares in a third portion (along the extension of the prongs 14, 16) (Fig. 1 in view of Fig. 6, see modified Fig. 1 above);
but modified Bowe is silent regarding wherein the trajectory is configured to tilt horizontally towards a center of the nasal cannula arrangement to align the gas outlet with an upper airway of the user in a fourth portion/wherein the first user end of the first nasal prong and the second user end of the second nasal prong converge toward each other in a mediolateral direction. However, Thompson demonstrates that it was well known in the nasal cannula prong art at the time of invention for nasal prongs to tilt horizontally towards a center of the nasal cannula arrangement to align the gas outlets with an upper airway of the user in a fourth portion/wherein the first user end of the first nasal prong and the second user end of the second nasal prong converge toward each other in a mediolateral direction (Figs. 2, 4 and 6B; para [0042]). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include wherein the trajectory of each prong tilts horizontally towards a center of the nasal cannula arrangement to align the gas outlet with an upper airway of the user in a fourth portion/wherein the first user end of the first nasal prong and the second user end of the second nasal prong converge toward each other in a mediolateral direction as taught by Thompson, in order to provide the predictable result of matching the natural contour of the nasal passages and increasing the distance between the open ends of the extensions and the nasal walls to direct gas flow into the open space of nasal cavity instead of against the nasal walls (Thompson para [0042]).
Claims 14, 16 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe in view of Palfy, Palmer, Kooij and Beevers as applied to claim 2 above, and further in view of Kalt et al. (US 4,838,867; hereinafter “Kalt”).
Regarding claim 14, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, wherein Kooij further educates modified Bowe to include a second interface patch (Kooji Fig. 49 teaches a patch of loop and hook fastening material 2142 on each of the extensions from support 2140), because it would have been obvious to an artisan at the time of invention that providing a loop/hook patch on either side of base member 29 of modified Bowe rather than across the entire length would reduce the amount of loop/hook material needed, thus reducing costs and/or lip irritation by virtue of less hook/loop material being present over the lip, while still providing adhesion on either side of the cannula, but modified Bowe is silent regarding a second dermal patch. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP 2144.04.V.C, and Kalt demonstrates that it was known in the art of two-part securement systems for facial breathing interfaces at the time of invention to include a first and a second dermal patch (left and right base portions 712 with hooks 714/715) (Fig. 32). Therefore, it would have been obvious to an artisan at the time of invention for modify Bowe to include a second dermal patch as taught by Kalt, in order to provide the predictable result of individually positionable dermal patches to interact with the spaced apart interface patches, thus providing more flexibility/options in the positioning of the fastening system on the face of the user.
Regarding claims 16 and 22, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 15, but modified Bowe is silent regarding wherein the substrate portion includes at least one crescent shaped slit, or at least one slot, the at least one slit or at least one slot separating areas of the substrate portion. However, Kalt teaches that it was known in the art of two-part securement systems for facial breathing interfaces at the time of invention to include wherein the substrate portion (e.g. the hook material forming strips 774 and 775 in Fig. 34) includes at least one slot (vacant area 772), the at least one slot separating areas (774, 775) of the substrate portion (Fig. 34). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include wherein the substrate portion includes at least one slot, the at least one slot separating areas of the substrate portion as taught by Kalt, in order to provide the predictable result of increasing versatility and holding force while decreasing the cost of hook material (Kalt col. 10, lines 51-60).
Claims 16, 17 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe in view of Palfy, Palmer, Kooij and Beevers as applied to claim 15 above, and further in view of Oertel (US 8,020,262 B2; hereinafter “Oertel”).
Regarding claims 16 and 17, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 15, but modified Bowe is silent regarding wherein the substrate portion includes at least one slit, or at least one slot, the at least one slit or at least one slot separating areas of the substrate portion, particularly wherein the substrate portion comprises a plurality of slits or slots arranged in the substrate portion such that a first set of the plurality of slits or slots extend into the substrate portion from a first edge of the substrate portion, and a second set of the plurality of slits or slots extend into the substrate portion from a second edge of the substrate portion, the second edge being opposite from the first edge, such that a path along the substrate portion from the first edge to the second edge without crossing the plurality of slits or slots follows a zig zag or serpentine path longer than a direct line between the first edge and the second edge. However, Oertel teaches that it was well known in the art of hook and loop fasteners at the time of invention/to solve the problem of stiff fasteners for a hook and loop substrate (patch 2 or male fastening means) to include at least one slit (incision 3) or slot (incisions 3’) (Figs. 1a-e and 3; page 7, line 14 and col. 6, lines 29-31; see also page 3, lines 11-14), the least one slit or at least one slot separating areas (the portions on either side of the slits/slots) of the substrate portion (patch 2), particularly wherein the substrate portion comprises a plurality of slits or slots arranged in the substrate portion such that a first set of the plurality of slits or slots (incisions 3 on the left in Figs. 1a-b/incisions 3’ on the top in Fig. 3) extend into the substrate portion from a first edge (edge line 21/top edge) of the substrate portion, and a second set of the plurality of slits or slots (incisions 3 on the right in Figs. 1a-b//incisions 3’ on the bottom in Fig. 3) extend into the substrate portion from a second edge (edge line 22/bottom edge) of the substrate portion, the second edge being opposite from the first edge, such that a path along the substrate portion from (the top/left of) the first edge to (the bottom/right of) the second edge without crossing the plurality of slits or slots follows a zig zag or serpentine path longer than a direct line between (the top/left of) the first edge and (the bottom/right of) the second edge (Figs. 1a-b/3). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include wherein the substrate portion includes at least one slit, or at least one slot, the at least one slit or at least one slot separating areas of the substrate portion, particularly wherein the substrate portion comprises a plurality of slits or slots arranged in the substrate portion such that a first set of the plurality of slits or slots extend into the substrate portion from a first edge of the substrate portion, and a second set of the plurality of slits or slots extend into the substrate portion from a second edge of the substrate portion, the second edge being opposite from the first edge, such that a path along the substrate portion from the first edge to the second edge without crossing the plurality of slits or slots follows a zig zag or serpentine path longer than a direct line between the first edge and the second edge as taught by Oertel, in order to ensure that the substrate is flexible enough to conform to movements of the wearer’s face and/or the general contours thereof to provide the predictable results of increasing the comfort of wearing the securement system (Oertel, page 1, lines 15-17 and page 10, line 31-page 11, line 2), as well as increased breathability to the substrate (by virtue of air/heat/moisture passing through the slit/slots) for increased wearer comfort.
Regarding claim 22, Bowe in view of Palfy, Palmer, Kooij, Beevers and Oertel teaches the nasal cannula arrangement of Claim 16, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Oertel further teaches that it was known in the art at the time of invention to utilize either straight/rectangular incisions (e.g. Figs. 1a-b) or curved incisions (col. 3, lines 33-37; see also col. 3, lines 60-67), such that it would have been obvious to an artisan before the effective filing date of the claimed invention obvious to an artisan at the time of invention for modified Bowe to include wherein the at least one slit is curved, i.e. crescent shaped, as further taught by Oertel, in order to provide the predictable result of suitably-shaped slit(s) for realizing the benefits discussed above, wherein a curved/crescent shape would reduce the number of corners and/or straight edges that might otherwise irritate a user’s face.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bowe in view of Palfy, Palmer, Kooij and Beevers as applied to claim 2, and further in view of Campbell (US 2004/0173210 A1; hereinafter “Campbell”).
Regarding claim 21, Bowe in view of Palfy, Palmer, Kooij and Beevers teaches the nasal cannula arrangement of Claim 2, but modified Bowe is silent regarding wherein the first medical breathing tube and the second medical breathing tube join at a common connector for attaching to a gases source. However, Campbell teaches that it was known in the bifurcated nasal cannula art (see Fig. 4) at the time of invention to include wherein the first medical breathing tube (tube A) and the second medical breathing tube (tube B) join at a common connector (switch 10) for attaching to a gases source (oxygen-containing housing 12) (Fig. 1). Therefore, it would have been obvious to an artisan at the time of invention for modified Bowe to include wherein the first medical breathing tube and the second medical breathing tube join at a common connector for attaching to a gases source as taught by Campbell, in order to provide the predictable result of avoiding patient discomfort by permitting switching of oxygen delivery back and forth between nostrils, while still permitting sampling (or pressure sensing, depending on the intended use of the bifurcated cannula) to occur (Campbell paras [0005-6]).
Allowable Subject Matter
Claim 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101 and 35 U.S.C. 112 112(b)/2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHRYN E DITMER/Primary Examiner, Art Unit 3785