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 .
Information Disclosure Statement
The IDS form(s) submitted on 2/22/2024 and 11/29/2022 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
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.
Claims 11-20 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 11 recites “a coupling mechanism for coupling the cannula plug with the head strap” on lines 13-14 and again on lines 18-19 of the same claim. This renders the claim indefinite as it is unclear within the claim if this is the same coupling mechanism first recited or a different coupling mechanism. In the interest of compact prosecution Examiner will consider the second recitation to be “a second coupling mechanism for coupling the cannula tube fitting with the head strap” in light of Applicants disclosure and figures.
Claim Rejections - 35 USC § 103
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 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 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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0175861 A1 to Holyoake et al. in view of US 2006/0107958 A1 to Sleeper.
In regard to claim 1:
Holyoake teaches an air flow cannula (Fig. 9B element 700), comprising: a body (Fig. 3 elements 701, 703, and 704), having a radius of curvature less than about 180 degrees (Fig. 13B “106°”), the body including two solid portions (Fig. 9B elements 703 and 704), two nasal posts (Fig. 9B elements 702), and two end portions (Fig. 9B ends of elements 703 and 704 that elements 708/707 insert into).
Holyoake does not appear to explicitly disclose the adjustable portion as claimed. Sleeper teaches a body including two solid portions (Fig. 1 elements 136), an adjustable portion (Fig. 1 element 132) between the two solid portions (Fig. 1 elements 136).
It would have been obvious to one having ordinary skill in the art, prior the effective date of filing, to modify the middle portion of the air flow cannula taught by Holyoake to be adjustable as taught by Sleeper. This would have been motivated by making the patient interface adjustable to each respective user and thus increasing patient comfort. This would have further been motivated by reducing the chance of kinking the tube and fitting multiple different users face size/shape as described by Holyoake para. 296 “In this case the cannula will lie on the face or may be slightly bent or deformed inwards to conform to the user's face as the head strap is tightened. Bending the cannula inward (i.e., around the user's face) is much less likely to kink the flexible cannula than bending the cannula outward (i.e., away from the user's face, such as when a smaller angle is used). A large angle is also particularly useful to fit patients who receive this therapy who are likely to be high BMI and thus have larger head circumferences”.
In regard to claim 2:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches wherein the radius of curvature is greater than about 90 degrees (Fig. 13B “106°”).
In regard to claim 3:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches wherein each of the two end portions (Fig. 9B elements 704 and 703) comprises a hole for receiving a cannula tube fitting (Fig. 9B Fitting’s elements 707 and 708, hole in the ends of elements 704/703 that elements 707/708 fit into).
In regard to claim 4:
The air flow cannula of claim 3, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches wherein each of the two end portions further comprises a window (Fig. 9B Fitting’s elements 707 and 708, window Para. 286 “In such an embodiment the plug 708 and conduit connector 707 may pneumatically block an opening through the female connector half that would otherwise communicate with a lumen of the side members. For example, the plug and conduit connector 708, 707 each comprises a projection 708A, 707A that fits into an inside of the female connector half 711. The projection 708A, 707A may be a projection that is received in a recess within the side arm to assist retaining the plug or connector 708, 707 within the side member against a pulling force to remove the plug or connector” (emphasis added). The window is the blocked passage through element 711, element 710 received in the other end of said window.)
In regard to claim 5:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches wherein the two end portions are configured to facilitate attaching tubing at either end of the air flow cannula (Fig. 9B elements 108 and 707 considered interchangeable due to using identical connection methods of projection 708A and 707B in combination with a recess, para. 286 “In such an embodiment the plug 708 and conduit connector 707 may pneumatically block an opening through the female connector half that would otherwise communicate with a lumen of the side members. For example, the plug and conduit connector 708, 707 each comprises a projection 708A, 707A that fits into an inside of the female connector half 711. The projection 708A, 707A may be a projection that is received in a recess within the side arm to assist retaining the plug or connector 708, 707 within the side member against a pulling force to remove the plug or connector.”
In regard to claim 6:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches further comprising: an adjustable frame (Para. 301 “In some embodiments the cannula 700, 800 may be configured to be used without collapsing, by providing a shield or support member (e.g., a frame) to fit over and/or cover a side member, or both side members and the manifold.”) attached to the body and configured to provide additional structural integrity to the air flow cannula (considered adjustable due to para. 310 “a side member, or both side members and the manifold” (emphasis added) as it can be adjusted to cover a single side or both side members).
In regard to claim 7:
The air flow cannula of claim 6, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches wherein the adjustable frame is inserted into the body, snap-fit to the body, pressed-fit to the body, or directly molded in the body (Para. 301 “The shield may comprise one or more (e.g., two) pairs of jaws 802 that are configured to grab around a portion of the cannula side arm or manifold or the plug or conduit connector to hold the shield to the cannula”).
In regard to claim 8:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teaches, wherein the adjustable portion is configured to collapse to a plurality of positions (Fig. 1 element 132).
In regard to claim 9:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teach wherein the adjustable portion is configured to collapse and expand as needed (Fig. 1 element 132).
In regard to claim 10:
The air flow cannula of claim 1, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teach wherein the adjustable portion is a bellows portion (Fig. 1 element 132. [0018] of Sleeper. Considered a bellows under broadest reasonable interpretation due to Merriam-Webster definition of bellows: the pleated expansible part in a camera also: a metallic or plastic flexible and expansible vessel).
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0175861 A1 to Holyoake et al. in view of US 2006/0107958 A1 to Sleeper, further in view of US 2005/0172969 A1 to Ging et al.
In regard to claim 11:
Holyoake teaches, A tube system (Fig. 9A) comprising: tubing (Fig. 9A element 112); a head strap (Fig. 9A element 713); an air flow system cannula (Fig. 9A elements 701, 703, 704, 705, 707, 708), comprising: a body (Fig. 9B elements 701, 704, and 705 element having a radius of curvature less than about 180 degrees (Fig. 13B “106°”), the body comprising two nasal posts (Fig. 9B elements 702), and two end portions (Fig. 9B ends of elements 703 and 704 that elements 708/707 insert into), each of the two end portions comprising a hole (Fig. 9B Fittings elements 707 and 708, hole in the ends of elements 704/703 that elements 707/708 fit into) and a window (Fig. 9B Fittings elements 707 and 708, window Para. 286 “In such an embodiment the plug 708 and conduit connector 707 may pneumatically block an opening through the female connector half that would otherwise communicate with a lumen of the side members. For example, the plug and conduit connector 708, 707 each comprises a projection 708A, 707A that fits into an inside of the female connector half 711. The projection 708A, 707A may be a projection that is received in a recess within the side arm to assist retaining the plug or connector 708, 707 within the side member against a pulling force to remove the plug or connector” (emphasis added). The window is the blocked passage through element 711, element 710 received in the other end of said window.); a cannula plug (Fig. 9B element 708) comprising a first cannula plug tab (Fig. 9B element 708A) configured to engage the window in one of the two end portions (Fig. 9B element 708A para. 286), and a coupling mechanism for coupling the cannula plug with the head strap (Fig. 9B element 710, couples head strap element 713 to cannula plug element 708 indirectly through element 711/704 as seen in Fig. 9A); and a cannula tube fitting (Fig. 9B element 707) comprising a first cannula tube fitting tab (Fig. 9B element 707A) at a first end of the cannula tube fitting configured to engage the window in the other of the two end portions (Fig. 9B element 707A, para. 289), a second coupling mechanism for coupling the cannula tube fitting with the head strap (Fig. 9B element 710, couples head strap element 713 to cannula tube fitting element 707 indirectly through element 711/703 as seen in Fig. 9A), and a second end of the cannula tube fitting configured to couple with the tubing (Fig. 9B element 112 couples to element 707 as seen in Fig. 9A).
Holyoake does not appear to explicitly disclose the adjustable portion as claimed. Sleeper teaches, the body comprising two solid portions (Fig. 1 elements 136) and an adjustable portion between the two solid portions (Fig. 1 element 132 between elements 136), two nasal posts (Fig. 1 elements 134), each of the two nasal posts protruding from a respective one of the two solid portions of the body (Fig. 1 elements 134 each on a respective element 136).
It would have been obvious to one having ordinary skill in the art, prior the effective date of filing, to modify the middle portion of the air flow cannula taught by Holyoake to be adjustable as taught by Sleeper. This would have been motivated by making the patient interface adjustable to each respective user and thus increasing patient comfort. This would have further been motivated by reducing the chance of kinking the tube and fitting multiple different users face size/shape as described by Holyoake para. 296 “In this case the cannula will lie on the face or may be slightly bent or deformed inwards to conform to the user's face as the head strap is tightened. Bending the cannula inward (i.e., around the user's face) is much less likely to kink the flexible cannula than bending the cannula outward (i.e., away from the user's face, such as when a smaller angle is used). A large angle is also particularly useful to fit patients who receive this therapy who are likely to be high BMI and thus have larger head circumferences”.
Holyoake does not appear to explicitly disclose the second tabs on claimed. Ging teaches, a second cannula plug tab configured to enable the cannula plug to be pushed into the window of the same end portion (Fig. 1 element 28 large tabs left and right of center. Para. 158 “The port cap includes one or more large grip tabs, which are easier to operate, particularly for clinicians. The large grip tabs allow for easy location.” Element 28 is a small size (relative to user hands) port cover for element 26 and is therefore considered analogous is function to cannula plug and cannula tube fittings taught by Holyoake), a second cannula tube fitting tab configured to enable the cannula tube fitting to be pushed into the window of the same end portion (Fig. 1 element 28 large tabs left and right of center. Para. 158 “The port cap includes one or more large grip tabs, which are easier to operate, particularly for clinicians. The large grip tabs allow for easy location.” Element 28 is a small size (relative to user hands) port cover for element 26 and is therefore considered analogous is function to cannula plug and cannula tube fittings taught by Holyoake).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the cannula plug and cannula tube fitting each taught by Holyoake to have second tab as taught by Ging. This would have been motivated by Ging para. 158 “The port cap includes one or more large grip tabs, which are easier to operate, particularly for clinicians. The large grip tabs allow for easy location. The grip tabs are visible, and show whether they are on or off, and their operation is obvious to inexperienced users, thereby avoiding the error of cap being left off” (emphasis added).
In regard to claim 12:
The system of claim 11, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, wherein the radius of curvature is greater than about 90 degrees (Fig. 13B “106°”)
In regard to claim 13:
The system of claim 11, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teach, wherein the adjustable portion is configured to collapse to a plurality of positions for additional flex and angular contouring (Fig. 1 element 132).
In regard to claim 14:
The system of claim 13, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teach, wherein each of the plurality of positions is a discrete position (Fig. 1 element 132).
In regard to claim 15:
The system of claim 13, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake in view Sleeper teach, wherein the adjustable portion is a bellows portion (Fig. 1 element 132. [0018] of Sleeper. Considered a bellows under broadest reasonable interpretation due to Merriam-Webster definition of bellows: the pleated expansible part in a camera also: a metallic or plastic flexible and expansible vessel).
In regard to claim 16:
The system of claim 11, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, further comprising an adjustable frame attached to the body and configured to provide additional structural integrity to the body (Para. 301 “In some embodiments the cannula 700, 800 may be configured to be used without collapsing, by providing a shield or support member (e.g., a frame) to fit over and/or cover a side member, or both side members and the manifold.”, considered adjustable due to para. 310 “a side member, or both side members and the manifold” (emphasis added) as it can be adjusted to cover a single side or both side members).
In regard to claim 17:
The system of claim 16, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, wherein the adjustable frame is attached to the two solid portions of the body (Fig. 15 elements 801 and 802. Para. 301 “The shield may comprise one or more (e.g., two) pairs of jaws 802 that are configured to grab around a portion of the cannula side arm or manifold or the plug or conduit connector to hold the shield to the cannula”).
In regard to claim 18:
The system of claim 16, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, wherein the adjustable frame is configured to be inserted into the body, snap-fit to the body, pressed-fit to the body, or directly molded in the body (Fig. 15 elements 801 and 802. Para. 301 “The shield may comprise one or more (e.g., two) pairs of jaws 802 that are configured to grab around a portion of the cannula side arm or manifold or the plug or conduit connector to hold the shield to the cannula”).
In regard to claim 19:
The system of claim 16, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, further comprising a coupling mechanism for coupling the adjustable frame to the body, wherein the comprising mechanism is one of a zip tie, hook and loop, quick disconnect, adjustable strap, or plastic clip (Fig. 15 elements 802 considered to be a quick disconnect due to para. 301 “The shield may comprise one or more (e.g. two) pairs of jaws 802 that are configured to grab around a portion of the cannula side arm or manifold or the plug or conduit connector to hold the shield to the cannula” as such a connection can be put on and taken off quickly by a user.).
In regard to claim 20:
The system of claim 19, taught by Holyoake in view of Sleeper as described in parent claim rejection above.
Holyoake teaches, wherein the coupling mechanism is configured to engage with the first cannula plug tab or the first cannula tube fitting tab (Fig. 15 elements 801 “In some embodiments the cannula 700, 800 may be configured to be used without collapsing, by providing a shield or support member (e.g., a frame) to fit over and/or cover a side member, or both side members and the manifold”. Considered to engage with the first cannula plug tab and/or first cannula tube fitting tab as it is stated to cover the either a side member or both side members providing support for said side members. Fig. 9B elements 707A and 708A engage through the end holes of element 704 and 715. Element 801 providing support (increased rigidity), para. 301 “The cannula may comprise a cannula body formed of a relatively flexible material, the cannula body comprising the manifold and at least one nasal prong or outlet, and a side member extending from each side of the manifold, as described earlier. The shield or frame is formed of a relatively rigid material (compared to the cannula body material). The shield attaches to the cannula body, to support the cannula body against collapse of the side arms.” to elements 704 and 703. Therefore element 801 is considered to engage the tabs through this increased rigidity of elements 704 and 703 as it would make it more difficult for elements 708/707 to accidentally pop out.).
Conclusion
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/M.A.I./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783