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 Amendment
This office action is responsive to the amendment filed on March 18, 2026. As directed by the amendment: claims 1, 12, and 16 have been amended, claims 3, 5-11, 13-15, 21, 22, and 24 have been canceled, and new claim 25 has been added. Thus, claims 1, 2, 4, 12, 16-20, 23, and 25 are presently pending in the application.
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 17, 19, and 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 pre-AIA the applicant regards as the invention.
Claim 17 recites the limitation "the sidebands" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitations "the sidebands" and “the forehead support” in line 2. There is insufficient antecedent basis for these limitations in the claim.
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 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 12 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Formica et al. (US 2011/0197341).
As to claim 12, Formica discloses a comfort pad (Fig. 14J), for use on a Continuous Positive Airway Pressure frame (rigidizer 1680, see for example, rigidizer 460 in Fig. 4 forming a frame for the mask 10, paragraphs [0106]-[0107]), which has a left part (on the left side of the patient’s face) and a right part (on the right side of the patient’s face) that is symmetric to the left part, wherein the comfort pad is configured to contact a face, and wherein each of the left part and the right part comprises:
an inside surface that is configured to contact the face, an outside surface opposite the inside surface (see annotated Fig. 14J below), and
an upper side and a lower side (see annotated Fig. 14J below),
wherein the comfort pad includes an outer layer formed by a first flexible material 1681 (single piece of fabric 1681) and an inner layer formed by a first foam material with a porous structure (foam 1682, paragraph [0174]), and
wherein a surface of the comfort pad that contacts the frame (rigidizer 1680) is formed by the first foam material 1682 (at the flat bottom surface of foam 1682), and a surface of the comfort pad that is configured to contact a patient (inside surface) is formed by the first flexible material 1681 (see Fig. 14J, paragraph [0174]).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Doherty et al. (US 2010/0258136).
As to claim 1, Doherty (‘136) discloses a comfort pad 21 (cheek pad 21, Fig. 83-84) for use on a Continuous Positive Airway Pressure frame with sidebands (rigidizers 80 of CPAP headgear 10, Fig. 1, paragraph [0256]), the comfort pad 21 comprising:
a left part 21 (for left rigidizer 80) and a right part 21 (for right rigidizer 80) that is symmetric to the left part (see Figs. 1-4), wherein the comfort pad 21 is configured to contact a face, and wherein each of the left part 21 and right part 21 comprises:
an inside surface that is configured to contact the face, an outside surface opposite the inside surface (see annotated Figs. 83-84 below), an upper side, and a lower side (see annotated Figs. 83-84 below); and
a material 21 having a chamber (see annotated Figs. 83-84 below),
wherein the chamber is empty (before retrofitting rigidizer 80 into it, see Fig. 83),
wherein the chamber has a first curved wall and a second straight wall (see annotated Fig. 83-84 below),
wherein an opening in the straight wall communicates with the chamber (see annotated Figs. 83-84 below), and
wherein a wall surface of the comfort pad 21 directly forms a fixed shape (see Fig. 83 where the pad 21 has a shape matching the shape of the rigidizer 80 with a chamber and male studs to receive it).
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Doherty (‘136) does not expressly disclose that the material of the cheek pad 21 in the embodiment of Figs. 83-84 comprises a foam material. However, Doherty (‘136) does teach a foam material in other embodiments of the pad (see foam pad 19 of Figs. 76-77, paragraph [0254]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the comfort pad 21 of Doherty’s Fig. 83 embodiment to comprise a foam material, as taught by Doherty’s Fig. 76 embodiment, in order to provide a suitable alternative material choice which is known to be moldable and comfortable against the patient’s skin.
As to claim 2, modified Doherty (‘136) discloses the comfort pad according to claim 1, wherein each of the left part 21 and right part 21 includes a left side and a right side opposite the left side, the left side and the right side do not extend beyond connection points of the sidebands 80 with other components, and the other components include the frame or a headband (see Figs. 78-80 showing the pads stop before the frame engaging end 81 (labeled in Fig. 67) of the rigidizer 80 where it connects to the patient interface).
As to claim 4, modified Doherty (‘136) discloses the comfort pad according to claim 1, wherein the contour of the inside surface, which is similar to the shape of the sidebands 80, includes one of the following shapes: straight line-shaped, curved line-shaped, Y-shaped, V-shaped, or T-shaped (the shape of the cheek pads 21 includes a straight line along the length of rigidizer 80, see Figs. 78-80 and 83).
Claims 16-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Formica et al. (US 2011/0197341), in view of Doherty et al. (US 8,800,563).
As to claim 16, Formica discloses a comfort pad (Fig. 14J), for use on a Continuous Positive Airway Pressure frame (rigidizer 1680, see for example, rigidizer 460 in Fig. 4 forming a frame for the mask 10, paragraphs [0106]-[0107]), wherein the comfort pad is configured to contact a face, and comprises a left part (on the left side of the patient’s face) and a right part (on the right side of the patient’s face) that is symmetric to the left part, wherein each of the left part and the right part comprises:
an inside surface that is configured to contact the face, an outside surface opposite the inside surface (see annotated Fig. 14J below), and
an upper side and a lower side (see annotated Fig. 14J below),
wherein the comfort pad is configured to be connectable to the frame 1680 and comprises a first flexible material 1681 (single piece of fabric 1681) and a second foam material with a porous structure (foam 1682, paragraph [0174]),
wherein the first flexible material 1681 has a chamber (formed by the loop of fabric material, see Fig. 14J),
wherein the second foam material 1682 is in the chamber (see Fig. 14J), and
wherein a surface of the comfort pad that contacts the frame (rigidizer 1680 is formed by the first foam material 1682 (at the flat bottom surface of foam 1682), and a surface of the comfort pad that is configured to contact a patient (inside surface) is formed by the first flexible material 1681 (see Fig. 14J, paragraph [0174]).
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Formica does not disclose that the comfort pad is configured to be detachably connectable to the frame, wherein the edges of the first flexible material have mating fasteners.
However, Doherty (‘563) teaches a comfort pad (sleeve or cover 917) for detachably connecting to a CPAP frame/rigidizer 80 (see Fig. 30-31), wherein edges of the comfort pad 917 have mating fasteners (zipper 925, Figs. 30-31, paragraph [0226]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the comfort pad of Formica so that the comfort pad is detachably connected to the frame/rigidizer via mating fasteners (a zipper) instead of being attached via an adhesive, as taught by Doherty (‘563), in order to allow the pad to be removed from the mask and headgear separately, for convenience of cleaning or replacing.
As to claim 17, modified Formica discloses the comfort pad according to claim 16, wherein each of the left part and right part has a left side and a right side opposite the left side, the left side and the right side do not extend beyond connection points of the sidebands with other components, and the other components include the frame or a headband (Formica’s foam 1682 and fabric 1685 only cover the rigidizer 1680, see Fig. 14J, Fig. 15).
As to claim 18, modified Formica discloses the comfort pad according to claim 16, wherein the first flexible material includes a fabric material (fabric 1481, see Formica, Fig. 14J, paragraph [0174]).
As to claim 19, modified Formica discloses the comfort pad according to claim 16, wherein the contour of the inner surface, which is similar to the shape of the sidebands, includes one of the following shapes: straight line-shaped, curved line-shaped, Y-shaped, V-shaped, or T-shaped (see Fig. 4 of Formica, showing the rigidizer 460, and thus its pad, having a curved shape around the cheeks and ears as well as a straight line shape between the cheek and ear regions).
As to claim 20, modified Formica discloses the comfort pad according to claim 16, wherein a part of the frame connectable to the comfort pad includes the sidebands or the forehead support (upper strap portions 462 of rigidizer 460, Fig. 4 of Formica, paragraphs [0106]-[0109], see also Figs. 30-31 of Doherty (‘563), paragraph [0226]).
As to claim 23, modified Formica discloses comfort pad according to claim 16, wherein the mating fasteners is a zipper 925 (see Figs. 30-31 of Doherty (‘563), paragraph [0226]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Formica et al. (US 2011/0197341), in view of Guney et al. (US 2009/0044808).
As to claim 25, Formica discloses a comfort pad (Fig. 14J), for use on a Continuous Positive Airway Pressure frame (rigidizer 1680, see for example, rigidizer 460 in Fig. 4 forming a frame for the mask 10, paragraphs [0106]-[0107]), wherein the comfort pad is configured to contact a face, and comprises a left part (on the left side of the patient’s face) and a right part (on the right side of the patient’s face) that is symmetric to the left part, wherein each of the left part and the right part comprises:
an inside surface that is configured to contact the face, an outside surface opposite the inside surface (see annotated Fig. 14J below), and
an upper side and a lower side (see annotated Fig. 14J below),
wherein the comfort pad is configured to be connectable to the frame 1680 and comprises a first flexible material 1681 (single piece of fabric 1681) and a second foam material with a porous structure (foam 1682, paragraph [0174]),
wherein the first flexible material 1681 has a chamber (formed by the loop of fabric material, see Fig. 14J),
wherein the second foam material 1682 is in the chamber (see Fig. 14J), and
wherein a surface of the comfort pad that contacts the frame (rigidizer 1680 is formed by the first foam material 1682 (at the flat bottom surface of foam 1682), and a surface of the comfort pad that is configured to contact a patient (inside surface) is formed by the first flexible material 1681 (see Fig. 14J, paragraph [0174]), and
wherein a wall surface of the comfort pad directly forms a fixed shape (the surface of foam 1682 forms a semicircular shape, see Fig. 14J).
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Formica does not disclose that the comfort pad is configured to be detachably connectable to the frame.
However, Guney et al. (US 2009/0044808) teaches a comfort pad (sock 3392, Fig. 12-14-1 to 12-14-3) that is configured to be detachably connectable to a CPAP frame/yok 3355, Fig. 12-14-1, paragraph [0635]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the comfort pad of Formica so that the comfort pad is detachably connectable to the frame/rigidizer 80, as taught by Guney, in order to allow the pad to be removed from the mask and headgear separately, for convenience of cleaning or replacing.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
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 VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 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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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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