DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/30/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 9/30/2025. As directed by the amendment, claims 1, 43, 61, 62 and 66 have been amended, and claim 33 has been cancelled. As such, claims 1, 5-9, 11, 12, 14, 27-29, 31, 32, 43, 44, 61, 62 and 65-74 are pending in the instant application.
Applicant has amended claim 43 to address a minor informality; the previous objection to the claims is withdrawn.
Applicant has amended claim 66 to address the previous rejection under 35 USC 112(b)/second paragraph, which is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 9/30/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding claims 1 and 61, Applicant argues on pages 10 and 13 of Remarks that, “The Office Action provides no articulated rationale as to why a person would discard Assi’s integral flexible tubing in favor of an elbow.”
The Examiner disagrees that the Office Action was lacking in this regard. Page 8 of the Office Action mailed 4/3/2025 clearly articulates that the rationale is “utilizing a known element(s) (i.e. flexible elbow(s)) for providing modularity (e.g. for customization and/or cleaning) to facilitate connection between components while maintaining flexibility for movement/adjustment and reducing drag (Barlow paras [0417-419]) and/or to provide a separate element (i.e. upstream elbow) for attachment to headgear in order to securely retain the cannula arrangement of Assi on the patient (Rollins Fig. 1)” (emphasis added).
Regarding claims 1 and 61, Applicant argues on pages 10 and 13 of Remarks that the elbow of Rollins is a rigid joint and that “use of a “flexible elbow portion” in place of Rollins’ rigid, fixed joint would destroy the alleged benefit of Rollins’ system…would not have looked to Rollins.”
First, the Examiner respectfully notes that the rejections were/are based on modification of Assi, not a modification of Rollins; the rejections do not suggest “use of a flexible elbow” in Rollins. Second, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Rollins was/is relied on to demonstrate the obviousness of locating an elbow upstream of a gases delivery side delivery member/between a collapsible portion and an inspiratory tube; it was/is Barlow that taught/teaches the use of a flexible elbow, and the rejections were based on a modification of Assi to have a flexible elbow as taught by Barlow, e.g. in a known elbow location as taught by Rollins, to provide the predictable results of a separate element (i.e. upstream elbow) for attachment to headgear as well as the modular benefits discussed above, where the elbow being flexible does not affect this functionality.
Regarding claim 61, Applicant argues on page 11 of Remarks that the prior art does not teach “a force-decoupling hierarchy as claimed in independent claim 61.”
The Examiner agrees that the prior art does not teach the newly added limitation of claim 61 in combination with the remainder of the claim; the rejections of claim 61 and its dependent claims under 35 USC 103 have been withdrawn.
Regarding claim 1, Applicant argues on page 12 of Remarks that the elbow of claim 1 is “specifically configured to yield at a lower bending moment than the gases delivery side member and/or collapsible portion…provide[s] the benefit of isolating the collapsible portion from external forces, and further can cause the elbow portion to deform first…force-decoupling hierarchy is not taught or suggested.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a force-decoupling hierarchy with a lower bending moment at the elbow or the elbow portion configured to deform first) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully notes that the language of claim 1 currently includes a comparison of the side member—which comprises the flexible elbow portion—to the flexible elbow portion. In as far as Barlow and Gradon teach an elbow with a flexible (middle) portion and (stiffer/thicker) end portions, the stiffer portion(s) can be considered the stiffer length of the side member and the flexible portion the less stiff length of elbow portion. It is noted that the Examiner has provided suggestions in the “Allowable Subject Matter” section below that would align the claim language with Applicant’s arguments.
Regarding claim 1, Applicant argues on page 13 of Remarks that the prior art does not teach “a force-decoupling hierarchy as claimed in independent claim 1.”
The Examiner disagrees, in as far as the current breadth of claim 1 allows for an interpretation in view of Barlow that meets the instant limitations as discussed in the updated rejection of claim 1 below.
Regarding claim 1, Applicant argues on page 14 of Remarks that the elbow of Gradon “is mechanically independent from any collapsible section.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is the combination of Assi, Barlow and Rollins that teaches an elbow in combination with a collapsible section; Gradon is not relied on for a teaching in this regard.
Regarding claim 1, Applicant argues on page 14 of Remarks that the flexibility taught by Gradon is “not to provide any kind of force-decoupling hierarchy” and that Gradon “teaches away from the present application…combining a rigid elbow with a collapsible tube would negate the very purpose of an elbow that is engineered to deform first and thereby protect the collapsible portion.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a force-decoupling hierarchy where the elbow portion is configured to deform first and thereby protect the collapsible portion) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). A difference in flexibility/stiffness is suggested by Barlow (the hinging middle portion of the elbow is suggested to be more flexible/less stiff than the non-hinging ends thereof) as well as between the variable-thickness portions of Gradon; therefore, Gradon educates modified Assi to include thinner flexible/less stiff portions (at the middle portion of the elbow and the collapsible portion) and thicker less-flexible/stiffer portions (at the end portion(s) of the elbow), which reads on claim 1 as currently written.
Applicant argues on page 15 of Remarks that “Barlow and Rollins do not teach that their wall is thicker than an adjacent section, nor thicker than a separately thinned collapsible portion.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a wall thicker than an adjacent section) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is Gradon that educates modified Assi to include an elbow with ends formed by a thicker wall with a thinner, flexible inner portion, and thinner down- and/or upstream collapsible portion.
Claim Objections
Claims 61 and 66 are objected to because of the following informalities:
Claim 61, the last line should read “gases” for clearer antecedent basis
Claim 66, lines 4-5 would be clearer if they read “about an inner surface of the collapsible portion comprising said upper portion and lower portion
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-9, 11, 12, 14, 27-29, 31, 32, 43 and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 (and thus its dependent claims), the amendment to claim 1 combines limitations from now-cancelled claim 33 and relates a length parameter of the side member [note: the side member includes the elbow portion] and/or the collapsible portion to “at least one of” a length parameter and a height parameter of the elbow portion. However, the original claims 33 and 34, as well as the specification as originally filed, see e.g. paras [0258-259], only support relating a length parameter to a length parameter and a height parameter to a height parameter, not mixing and matching as currently recited. To address this rejection, Applicant could amend claim 1 to read “along
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 61, 62 and 65-74 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.
Regarding claim 61 (and thus it dependent claims), the last line of claim 61 recites “the end,” wherein it is unclear to which end (the downstream end or the upstream end of lines 16-17) it is referring. As best understood from para [0268] of the specification as originally filed, it could be either or both ends, such that, for purposes of examination, claim 61 will be considered to read “applied at at least one of the ends of the gases delivery side member.”
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 (i.e., changing from AIA to pre-AIA ) 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, 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-9, 11, 12, 14, 27-29, 31-32, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Assi et al. (WO 2016/157105 A1; hereinafter “Assi”) in view of Barlow et al. (US 2012/0067349 A1; hereinafter “Barlow”), Rollins (US 3,799,164; hereinafter “Rollins”) and Gradon et al. (US 2003/0154978 A1; hereinafter “Gradon”).
Regarding claim 1, Assi teaches a patient interface (nasal interface 200) (Fig. 3 [page 67 lines 22-25]) comprising:
a nasal prong or an outlet of said patient interface to be received by a user's nare(s) (nasal delivery element 208 with flow manifold 206 [page 68 lines 4-10]);
a gases delivery side member extending from a side of the nasal prong or said outlet (first gas lumen 202; [page 71 lines 9-18; page 82 lines 1-8]; 202 extends from the right side of 208/206 in Fig. 3), wherein the gases delivery side member comprises a lumen (lumen 202; Fig. 3; page 68 lines 3-5) for a flow of gases from an inlet (to the left of 202 in Fig. 7) of the patient interface to the nasal prong or said outlet (208), the lumen comprising:
a collapsible portion (first portion 204 Figs. 4 and 7, [page 71 line 9 – 18]) configured to transition between a first configuration (first configuration, e.g. Fig. 9 left) and a second configuration (second configuration, e.g. Fig. 4 or Fig. 9 right) (page 2, lines 14-22; page 3, lines 4-10; page 69, lines 3-6; page 71, lines 9-23), wherein the first configuration allows the flow of gases to pass through the nasal prong or the outlet of the patient interface to the user's nare(s), and wherein the second configuration reduces and/or stops the flow of gases from passing through the nasal prong or the outlet of the patient interface to the user's nare(s) (Figs. 4-10; page 2, lines 14-22; page 3, lines 4-10; page 69, lines 3-6; page 71, lines 9-23); and
a bent flexible portion (region that angles downward at label 202 in Fig. 3 [page 71 lines 15-18]), located substantially at or towards an upstream end of said gases delivery side member, and a flexible portion (at 203 in Fig. 7) located substantially at or towards a downstream end of said gases delivery side member.
While Assi does teach that the collapsible portion could be a separate section (e.g. page 82, lines 22-26), since the bent flexible portion and flexible portion of Assi discussed above are disclosed as parts of a flexible tube/a temporary bend rather than separate elements that retain a bend per the common usage of the term “elbow,” Assi is considered to be silent regarding at least one flexible elbow portion located substantially at or towards one or both of a downstream end of said gases delivery side member or an upstream end of said gases delivery side member. 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 Barlow demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to include a flexible elbow portion (comprising at least the middle of elbow 230) (Figs. 14-1 to 14-4; paras [0417-419]) located substantially at or towards a downstream end of a gases delivery side member (see e.g. elbow 542 and tube 486 in Fig. 102), and Rollins demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to include an elbow portion (elbow joint 28) (Figs. 1-3) located substantially at or towards an upstream end of a gases delivery side member (comprising connector 20, extension hose 24 and elbow joint 28)/between a collapsible portion (hose 24) and an inspiratory tube (hose 32). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Assi to include a flexible elbow portion (as taught by Barlow) located substantially at or towards an upstream end of said gases delivery side member (i.e. at the location of the bent flexible portion discussed above, as taught by Rollins), and/or substantially at or towards a downstream end of said gases delivery side member (i.e. at the location of the flexible portion discussed above, as taught by Barlow), in order to provide the predictable results of utilizing a known element(s) (i.e. elbow(s) with a flexible portion) for providing modularity (e.g. for customization and/or cleaning) to facilitate connection between components while maintaining flexibility for movement/adjustment and reducing drag (Barlow paras [0417-419]) and/or to provide a separate element (i.e. upstream elbow) for attachment to headgear in order to securely retain the cannula arrangement of Assi on the patient (Rollins Fig. 1).
Regarding wherein the at least one flexible elbow portion comprises a wall thickness that is greater than a wall thickness of the collapsible portion and wherein the gases delivery side member and/or the collapsible portion is relatively stiffer or less flexible or more resilient to a flex, along a length of the gases delivery side member and/or the collapsible portion than along at least one of (i) a length of the flexible elbow portion; and (ii) a height of the flexible elbow portion, Barlow further suggests a difference in flexibility/stiffness between the middle and ends of the elbow (the hinging middle portion of the elbows is suggested to be more flexible/less stiff than the non-hinging ends thereof, see Barlow Figs. 14-1-14-4), modified Assi further teaches that the lumen is configured to be more collapsible, deformable or otherwise adapted to fully close off the flow at the collapsible portion than at other portions of the lumen (Assi page 71, lines 21-23), i.e. including the bent flexible portion/elbow or flexible portion/elbow discussed above, and that providing a thinner wall than the other gas portions was a known means by which to provide such collapsibility (Assi Fig. 8; portion 204 comprises a wall 209 that is thinner than one or more walls 207 of the first gases lumen, page 81, lines 24-26), and Gradon teaches that it was known in the respiratory elbow art before the effective filing date of the claimed invention to provide at least one elbow portion that comprises a wall thickness that is greater [relatively stiffer or less flexible or more resilient to flex, along a length] than a wall thickness of a flexible portion (the elbow connector is manufactured to have a thin portion…in comparison to the remainder of the elbow connector which is considerably thicker…its flexibility is dependent on its thickness…the thin section…is relatively flexible and in the remainder is relatively rigid, para [0086]), which together would have suggested to an artisan before the effective filing date of the claimed invention that the collapsible portion and flexible elbow portion(s) of modified Assi be constructed such that the at least one flexible elbow portion comprises a wall thickness that is greater than a wall thickness of the collapsible portion and wherein the gases delivery side member is relatively stiffer or less flexible or more resilient to a flex, along a length of the gases delivery side member (i.e. at an end portion of the elbow(s), see Barlow Figs. 14-1-14-4) than along at least one of (i) a length of the flexible elbow portion; and (ii) a height of the flexible elbow portion (i.e. at the middle hinged portion of the elbow(s), see Barlow Figs. 14-1-14-4), in order to provide the predictable result of a collapsible portion that is configured to collapse before other components to prevent unintentional collapse at other regions (Assi page 83, lines 1-6) by virtue of the elbow(s) having a thicker wall(s) than the collapsible portion, particularly in the end portions thereof, which would also lend more rigidity to those regions required for connecting to other components to facilitate the connection, e.g. snap fit (Gradon para [0086]; Barlow para [0381]).
Regarding claim 5, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi further teaches wherein the at least one flexible elbow portion comprises a first elbow (the elbow between nasal delivery element 208 and first portion 204, as taught by Barlow, OR the elbow at the location of the bend of Assi, as taught by Rollins, as discussed above), the first elbow is located at an end of the gases delivery side member (the elbow between nasal delivery element 208 and first portion 204 and the elbow at the location of the bend of Assi would each define (opposite) ends of the gases delivery side member in modified Assi), near or adjacent an inspiratory tube or an inspiratory tube connector (the elbow between nasal delivery element 208 and first portion 204 would be near/adjacent the tube/connector 206 that extends under/connects to the nasal prongs in Assi Fig. 3 OR the elbow at the location of the bend of Assi would be connected to tubing on the upstream side that connects to the respiratory therapy system 100 and thus is near the inspiratory tube and the inspiratory connector that joins said tubing to the system, see e.g. Assi Fig. 47).
Regarding claim 6, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 5 as shown above. Modified Assi further teaches an intermediate section (a section of tube between the elbow at the location of the bend of modified Assi and the gas source OR the recessed end of the elbow that fits into the supply tube as taught by Rollins Fig. 3) located between the first elbow and the inspiratory tube or the inspiratory tube connector (see claim 5 discussion above).
Regarding claim 7, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 6 as shown above. Modified Assi teaches wherein the intermediate section is located at an angle of about -25 degrees to about 45 degrees from a centreline of the patient interface (see Assi Fig. 3 in view of claim 6 above, where the intermediate section between the elbow at the location of the bend of modified Assi and the gas source is flexible tubing and therefore can be maneuvered to an angle which falls within -25 degrees to 45 degrees from the centreline, and/or it would have been obvious to an artisan before the effective filing date of the claimed invention for the elbow in the location taught by Rollins to be a fully flexible elbow as taught by Barlow 14-4 in order to predictably increase degrees of freedom for patient comfort, such the ends of the elbow are allowed to flex in all directions relative to one another as taught by Barlow Fig. 14-4, such that the intermediate section is located at an angle of about -25 degrees to about 45 degrees from a longitudinal centerline passing through 206 during portions of a full rotation).
Regarding claim 8, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 6 as shown above. Modified Assi teaches wherein the intermediate section is located at an angle of about 0 degrees to about 90 degrees from a front face, or a rear face, or a longitudinal axis of the collapsible portion and/or the gases delivery side member (the flexible intermediate section is capable of being maneuvered to be located at an angle which falls within 0 to 90 degrees from the longitudinal axis of the collapsible portion; see Assi Fig. 3 in view of claim 6 above; and Rollins Fig. 3 in view of Assi Fig. 3 teaches a 90 degree angle from the longitudinal axis of the collapsible portion, and/or it would have been obvious to an artisan before the effective filing date of the claimed invention for the elbow in the location taught by Rollins to be a fully flexible elbow as taught by Barlow 14-4 in order to predictably increase degrees of freedom for patient comfort, such the ends of the elbow are allowed to flex in all directions relative to one another as taught by Barlow Fig. 14-4, such that the intermediate section is located at an angle of about 0 degrees to about 90 degrees relative to a front face/rear face/longitudinal axis of the nasal cannula of the gases side delivery member during portions of a full rotation).
Regarding claim 9, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 6 as shown above. Modified Assi teaches wherein the intermediate section is located at an angle of about 0 degrees to about 30 degrees from a lower face, or an upper face, or a longitudinal axis of the gases delivery side member and/or the collapsible portion (the flexible intermediate section is capable of being maneuvered to be located at an angle which falls within 0 to 30 degrees from the longitudinal axis of the collapsible portion; see Assi Fig. 3 in view of claim 6 above and/or it would have been obvious to an artisan before the effective filing date of the claimed invention for the elbow in the location taught by Rollins to be a fully flexible elbow as taught by Barlow 14-4 in order to predictably increase degrees of freedom for patient comfort, such the ends of the elbow are allowed to flex in all directions relative to one another as taught by Barlow Fig. 14-4, such that the intermediate section is located at an angle of about 0 degrees to about 30 degrees relative to an upper face/lower face/longitudinal axis of the nasal cannula of the gases side delivery member during portions of a full rotation).
Regarding claim 11, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 5 as shown above. Modified Assi teaches wherein the first elbow provides for or comprises a pivot portion and/or a hinging portion, to allow for relative movement about at least one axis, either when the first elbow is a hinged elbow taught by Barlow Figs. 14-1/2 between nasal delivery element 208 and first portion 204 of Assi, such that the axis extends up and down when the gases side delivery member is positioned as in Assi Fig. 3, and/or because it would have been obvious to an artisan before the effective filing date of the claimed invention for the elbow in the location taught by Rollins to be a hinged flexible elbow as taught by Barlow 14-1/2, such the axis would be into the face of the patient when the gases side delivery member is positioned as in Assi Fig. 3, OR whether one or both of the elbows are the fully flexible elbows of Barlow Fig. 14-4, where hinging is allowed about infinite axes, in order to predictably increase the degrees of freedom for patient comfort.
Regarding claim 12, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 11 as shown above. Modified Assi teaches wherein said at least one axis comprises a first axis (as discussed above regarding claim 11), the first axis being oriented substantially parallel with, or along one or more of:
a height of the gases delivery side member and/or the collapsible portion (e.g. when the axis is the hinge on the elbow between nasal delivery element 208 and first portion 204 of Assi as taught by Barlow 14-1/2, and the gases side delivery member is positioned as in Assi Fig. 3, OR when the hinging portion allows relative movement along any axis per Barlow Fig. 14-4),
a patient's face in use (the patient’s face extends both up and down and front and back and along the front/rear face of the gases delivery side member and/or the collapsible portion, such that all of the axes discussed supra and in the discussion of claim 11 extend along the patient’s face),
a portion of the gases delivery side member and/or the collapsible portion configured to contact a user's face (see discussion above),
a front face and/or a rear face of the gases delivery side member and/or the collapsible portion (see discussion above), or
an axis bisecting the first elbow or the first flexible portion (see discussion above).
Regarding claim 14, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi teaches wherein the collapsible portion is a substantially straight section (the collapsible portion is straight; see Assi Fig. 3).
Regarding claim 27, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 5 as shown above. Modified Assi teaches wherein the at least one flexible elbow portion comprises a second elbow (when modified Assi comprises a flexible elbow at each of the locations taught Barlow and Rollins, as obvious in order to maximize the degrees of freedom with a modular system for patient comfort, the elbow between nasal delivery element 208 and first portion 204 of Assi corresponds the instantly claimed second elbow and the elbow at the location taught by Rollins corresponds to the first elbow), the second elbow located substantially in a region of the gases delivery side member proximate where said second elbow is attachable to a base portion supporting the nasal prong (the region between nasal delivery element 208 and first portion 204 of Assi is proximate to the portion 206 supporting the nasal prong, see Assi Fig. 3 and is where the second elbow would be attached as shown by Barlow Fig. 102).
Regarding claim 28, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 27 as shown above. Modified Assi teaches wherein the second elbow or the second flexible portion provides for, or comprises, a pivot portion and/or a hinging portion (hinge 287, flexible region 288 OR corrugated region 289), to allow for relative movement about at least one axis (Barlow Figs. 14-1 to 14-4; where the hinge axis/axes is/are taught to extend up and down OR in multiple directions when the gases side delivery member is positioned as in Assi Fig. 3, see claim 11 discussion above).
Regarding claim 29, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 28 as shown above. Modified Assi teaches wherein said at least one axis comprises a first axis, the first axis being oriented parallel with, or along one or more of:
a height of the gases delivery side member and/or the collapsible portion,
a patient's face in use,
a portion of the gases delivery side member and/or the collapsible portion configured to contact a user's face,
a front face and/or a rear face of the gases delivery side member and/or the collapsible portion,
an axis bisecting the second elbow (see claim 11 and 12 discussions above, as relevant to the hinged/fully flexible elbow in the location taught by Barlow).
Regarding claim 31, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi teaches wherein the gases delivery side member and/or the collapsible portion is located about 30 degrees to about 80 degrees from a centreline of the patient interface (the collapsible portion 204 is suggested to be about 30 to 80 degrees from a centerline extending through 206 of the patient interface 200, see Assi Fig. 3).
Regarding claim 32, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi teaches wherein the gases delivery side member and/or the collapsible portion is located about 10 degrees to about 60 degrees from a centreline of a base portion (the collapsible portion is suggested to be about 10 to 60 degrees from a centerline extending though 206 as the collapsible portion curves around the face; Assi Fig. 3).
Regarding claim 43, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi teaches wherein the at least one flexible elbow portion is configured to substantially deform before the collapsible portion when a force is applied to an end of the gases delivery side member (the hinged/corrugated portion(s) of the elbow(s) taught by Barlow will cause the elbow(s) to substantially deform before the collapsible portion substantially deforms when force is applied to either end of the gases delivery side member because the rigid reinforcing element 220 in the collapsible portion, see Assi Figs. 9-10, will provide some degree of stiffness in the longitudinal direction of the collapsible portion that will impede substantial deformation).
Regarding claim 44, Assi in view of Barlow, Rollins and Gradon teaches the limitations of claim 1 as shown above. Modified Assi teaches wherein the pre-formed elbow portion is configured to isolate or attenuate the collapsible portion from forces applied to the patient interface, due to the hinged/flexible/corrugated region of the flexible elbow taught between the collapsible portion and the nasal prongs and/or between the supply tubing and the collapsible portion as discussed above regarding claim 1, because the elbow(s) will attenuate drag forces applied by the attached supply hose and or nasal cannula, per the standard function of hinged/flexible/corrugated components in conjunction with respiratory tubing (e.g. Barlow para [0417]).
Allowable Subject Matter
Claims 61, 62 and 65-74 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 1, 5-9, 11, 12, 14, 27-29, 31, 32, 43 and 44 would be allowable if claim 1 were amended to read “wherein the gases delivery side member
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 1 (and thus its dependent claims), Assi is silent regarding a level of stiffness/resilience to flex along the length of the collapsible portion, such that there is no teaching or suggestion in modified Assi regarding the relative stiffness/resilience to flex along the length of the collapsible portion versus that of the flexible elbow taught by Barlow. Regarding claim 61 (and thus its dependent claims), Assi teaches that the collapsible portion is the most deformable portion (Fig. 3; page 71, lines 21-23: “lumen 202 is configured to be more…deformable…at the first portion 204 than at other portions”); therefore, Assi teaches away from the bent/elbow portion being configured to deform before the collapsible portion.
Conclusion
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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