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 .
Response to Arguments
This office action is responsive to Request for Reconsideration files on . As directed by the amendment: claims 1 – 3, 6 – 8 & 11 - 13 are pending, claims 4, 5, 9, 10, 14 & 15 were cancelled, no new claims have been added & claims 1, 3, 6, 8, 11 & 13 have been amended.
Applicant’s arguments, see Page 9, filed 09/04/2025, with respect to Specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments, see Page 9, filed 09/04/2025, with respect to 35 U.S.C 112 rejection have been fully considered and are persuasive. The 112 rejection of claims 3 – 5, 8 – 10 & 13 – 15 has been withdrawn.
Applicant’s arguments, see Page 9 - 10, filed 09/04/2025, with respect to the rejection(s) of claim(s) 1 – 15 under 35 U.S.C 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of different interpretation of the previous applied reference.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 3, 6 – 8 & 11 - 13 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Kooij et al. (WO 2017/124152 A1).
Regarding claim 1, A frame 3300 for use in an interface device 3000 having a sealing assembly 3100 for delivering a flow of treatment gas to the airway of a patient (Abstract), the frame 3300 comprising:
a generally hollow central hub 3600 (Note: as it allows air to flow it is obvious to consider it is generally hollow) having an inlet (see annotated Figure 7C) structured to be coupled to a conduit 4170 for receiving the flow of treatment gas (Paragraph 0133);
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Figure 7C: Annotated Figure from WO 2017/124152 A1
a first reduced portion 3370 integral with a first side (see annotated Figure 7C) of the central hub 3600, and a second reduced portion 3370 (see annotated Figure 7C) integral with a second side of the central hub 3600 opposite the first side. (Paragraph 0205 / Figure 7)
a generally hollow first arm (see annotated Figure 7C / Note: as it allows air to flow it is obvious to consider it is generally hollow) having proximal end (see annotated Figure 7C) that is slidingly disposed around the first reduced portion 3370 and extending from a first end (see annotated Figure 7C) of the central hub 3600 to a distal end (see annotated Figure 7C) structured to be coupled to the sealing assembly 3100 (Paragraph 0039 / 0118); and
a generally hollow second arm (see annotated Figure 7C / Note: as it allows air to flow it is obvious to consider it is generally hollow) having proximal end that is slidingly disposed around the second reduced portion 3370 and extending from a second end (see annotated Figure 7C) of the central hub 3600 to a second end (see annotated Figure 7C) structured to be coupled to the sealing assembly 3100 (Paragraph 0039 / 0118),
wherein the central hub 3600, the first reduced portion 3370, and the first arm (see annotated Figure 7C) define a first flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end (see annotated Figure 7C) of the first arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114)
wherein the central hub 3600, the second reduced portion 3370, and the second arm (see annotated Figure 7C) define a second flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end of the second arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114 / 0018), and
wherein the lengths of each of the first flow passage and the second flow passage are selectively adjustable (Paragraph 0205 - 0206 / Figure 7C) by moving the proximal end of the first arm over the first reduced portion or moving the proximal end of the second arm over the second reduced portion. (Paragraph 0206)
Regarding claim 2, Kooij discloses the frame as claimed in claim 1.
Kooij discloses wherein when positioned the head of a patient: the central hub is sized and configured to be positioned at or about the crown of the head of the patient, the first arm is sized and configured to extend along a first side of the head of the patient, and the second arm is sized and configured to extend along a second side of the head of the patient opposite the first side.
Kooij discloses wherein when positioned the head of a patient:
the central hub 3600 is sized and configured to be positioned at or about the crown of the head of the patient (Paragraph 0087),
the first arm (see annotated Figure 7C) is sized and configured to extend along a first side (see annotated Figure 7C) of the head of the patient (Paragraph 0137), and
the second arm (see annotated Figure 7C) is sized and configured to extend along a second side (see annotated Figure 7C) of the head of the patient opposite the first side (Figure 7C).
Regarding claim 3, Kooij discloses the frame as claimed in claim 1.
Kooij discloses wherein the length of each of the first flow passage (Paragraph 0133) and the second flow passage (Paragraph 0133) is selectively adjustable by applying opposing forces to the first and second arms that causes the proximal end of the first arm to slide over the first reduced portion 3370 or the proximal end of the second arm to slide over the second reduced portion 3370. (Paragraph 0209 discloses the tube sections to be moved relative to each other / Note: the examiner considers this to be applying opposite forces)
Regarding claim 6, An interface device 3000 for use in delivering a flow of treatment gas to the airway of a user of the device, (Abstract) the interface device 3000 comprising:
a sealing assembly 3100 having a compartment defined therein, a first opening 3200 having a perimeter structured to sealingly engage about at least one airway of the user of the device (Paragraph 0118), a second opening (see annotated Figure 7C), and a third opening (see annotated Figure 7C);
and a frame 3300 structured to couple the sealing assembly to the head of the user (Paragraph 0130), the frame 3300 comprising:
a generally hollow central hub 3600 having an inlet structured to be coupled to a conduit 4170 for receiving the flow of treatment gas (Paragraph 0133), a first reduced portion 3370 integral with a first side (see annotated Figure 7C) of the central hub 3600, and a second reduced portion 3370 (see annotated Figure 7C) integral with a second side of the central hub 3600 opposite the first side. (Paragraph 0205 / Figure 7);
a generally hollow first arm (see annotated Figure 7C) having proximal end (see annotated Figure 7C) that is slidingly disposed around the first reduced portion 3370 and extending from a first end (see annotated Figure 7C) of the central hub 3600 to a distal end (see annotated Figure 3B) selectively coupled to the second opening (see annotated Figure 3D) the sealing assembly 3100; and
a generally hollow second arm (see annotated Figure 7C) having proximal end that is slidingly disposed around the second reduced portion 3370 and extending from a second end (see annotated Figure 7C) of the central hub 3600 to a second end (see annotated Figure 7C) selectively coupled to the third opening (see annotated Figure 7C) of the sealing assembly 3100 (Figure 7C),
wherein the central hub 3600, the first reduced portion 3370, and the first arm (see annotated Figure 7C) define a first flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end (see annotated Figure 7C) of the first arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114)
wherein the central hub 3600, the second reduced portion 3370, and the second arm (see annotated Figure 7C) define a second flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end of the second arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114 / 0018), and
wherein the lengths of each of the first flow passage and the second flow passage are selectively adjustable (Paragraph 0205 - 0206 / Figure 7C) by moving the proximal end of the first arm over the first reduced portion or moving the proximal end of the second arm over the second reduced portion. (Paragraph 0206)
Regarding claim 7, Kooij discloses the interface device as claimed in claim 6.
Kooij discloses wherein when positioned the head of the user of the device:
the central hub 3600 is sized and configured to be positioned at or about the crown of the head of the patient (Paragraph 0087),
the first arm (see annotated Figure 7C) is sized and configured to extend along a first side of the head (Paragraph 0137), and
the second arm (see annotated Figure 7C) is sized and configured to extend along a second side (see annotated Figure 7C) of the head opposite the first side (Figure 7C).
Regarding claim 8, Kooij discloses the interface device as claimed in claim 6.
Kooij discloses wherein the length of each of the first flow passage (Paragraph 0133) and the second flow passage (Paragraph 0133) is selectively adjustable by applying opposing forces to the first and second arms that causes the proximal end of the first arm to slide over the first reduced portion 3370 or the proximal end of the second arm to slide over the second reduced portion 3370. (Paragraph 0209 discloses the tube sections to be moved relative to each other / Note: the examiner considers this to be applying opposite forces)
Regarding claim 11, A system for use in delivering a flow of a breathing gas to the airway of a user (Paragraph 0023 - 0024), the system (Paragraph 0023) comprising:
a pressure generating device 4140 structured to produce the flow of breathing gas (Paragraph 0341);
a conduit 4170 having a first end coupled to the pressure generating device 4140 and an opposite second end 3000 (Paragraph 0344), the conduit 4170 being structured to convey the flow of breathing gas from the first end 4140 to the second end 3000 (Paragraph 0345); and
an interface device 3000 comprising:
a sealing assembly 3100 having a compartment defined therein,
a first opening 3200 having a perimeter structured to sealingly engage about at least one airway of the user (Paragraph 0118), a second opening (see annotated Figure 3D), and a third opening (see annotated Figure 3D); and
a frame 3300 structured to couple the sealing assembly 3100 (Element 3150 is a part of the sealing assembly) to the head of the user (Paragraph 0173), the frame 3300 comprising:
a generally hollow central hub 3600 (Note: as it allows air to flow it is obvious to consider it is generally hollow) having an inlet (see annotated Figure 7C) selectively coupled to the second end (see annotated Figure 3B) of the conduit 4170 for receiving the flow of treatment gas (Paragraph 0133), a first reduced portion 3370 integral with a first side (see annotated Figure 7C) of the central hub 3600, and a second reduced portion 3370 (see annotated Figure 7C) integral with a second side of the central hub 3600 opposite the first side; (Paragraph 0205 / Figure 7)
a generally hollow first arm (see annotated Figure 7C / Note: as it allows air to flow it is obvious to consider it is generally hollow) having proximal end (see annotated Figure 7C) that is slidingly disposed around the first reduced portion 3370 and extending from a first end (see annotated Figure 7C) of the central hub 3600 to a distal end (see annotated Figure 7C) structured to be coupled to the sealing assembly 3100 (Paragraph 0039 / 0118); and
a generally hollow second arm (see annotated Figure 7C / Note: as it allows air to flow it is obvious to consider it is generally hollow) having proximal end that is slidingly disposed around the second reduced portion 3370 and extending from a second end (see annotated Figure 7C) of the central hub 3600 to a second end (see annotated Figure 7C) structured to be coupled to the sealing assembly 3100 (Paragraph 0039 / 0118),
wherein the central hub 3600, the first reduced portion 3370, and the first arm (see annotated Figure 7C) define a first flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end (see annotated Figure 7C) of the first arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114)
wherein the central hub 3600, the second reduced portion 3370, and the second arm (see annotated Figure 7C) define a second flow passage (Paragraph 0133) extending from the inlet (see annotated Figure 7C) to the distal end of the second arm (see annotated Figure 7C) that is structured to convey the flow of treatment gas from the inlet (see annotated Figure 7C) to the sealing assembly 3100 (Paragraph 0114 / 0018), and
wherein the lengths of each of the first flow passage and the second flow passage are selectively adjustable (Paragraph 0205 - 0206 / Figure 7C) by moving the proximal end of the first arm over the first reduced portion or moving the proximal end of the second arm over the second reduced portion. (Paragraph 0206)
Regarding claim 12, Kooij discloses the system as claimed in claim 11.
Kooij discloses wherein when positioned the head of the user of the device:
the central hub 3600 is sized and configured to be positioned at or about the crown of the head of the patient (Paragraph 0087),
the first arm (see annotated Figure 7C) is sized and configured to extend along a first side of the head (Paragraph 0137), and
the second arm (see annotated Figure 7C) is sized and configured to extend along a second side (see annotated Figure 7C) of the head opposite the first side (Figure 7C).
Regarding claim 13, Kooij discloses the system as claimed in claim 11.
Kooij discloses wherein the length of each of the first flow passage (Paragraph 0133) and the second flow passage (Paragraph 0133) is selectively adjustable by applying opposing forces to the first and second arms that causes the proximal end of the first arm to slide over the first reduced portion 3370 or the proximal end of the second arm to slide over the second reduced portion 3370. (Paragraph 0209 discloses the tube sections to be moved relative to each other / Note: the examiner considers this to be applying opposite forces)
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 GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACIELA NATALIA LEBRON DE JESUS/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785