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 filed on, 11/24/2025. As directed by the amendment: claims 58 & 62 – 85 are pending, claims 58, 78 – 80 & 84 have been amended and claims 86 & 87 have been added.
Applicant’s arguments, see Page 5, filed 11/24/2025, with respect to claim objections have been fully considered and are persuasive. The objection of the claim has been withdrawn.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues there is no reason provided as to why it would be obvious to have the connector extend over the opening. However, based on the modification already made to Allan with the opening, the location of the opening and the connection of the headgear would make it so the limitation is met. For this limitation, no modification is being made to include any type obviousness statement.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues Allan does not read on claim 65 & 66 as they are not substantially the same width. However, the examiner considers “substantially the same” to not be equally same, but to have difference to the width. Based on this, Allan does read on the limitation.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant discloses there is no rearrangement of parts in this claim, but the examiner modifies Allan by rearranging the lateral flange length with the medial flange in order to read on the limitation. Based on MPEP 2144.04-VI-C, rearranging parts only requires ordinary skill.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues there is critically for the specific lengths disclosed in claim 68. However, there is no specific criticality for the numbers disclosed in the claims. Because of this, the rejection still stands. In order to bring criticality, the choice of those specific numbers must be explained.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues there is critically for the specific lengths disclosed in claims 69 & 70. However, there is no specific criticality for the numbers disclosed in the claims. Because of this, the rejection still stands. In order to bring criticality, the choice of those specific numbers must be explained.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues in claim 71 the lateral flange does not extend beyond the lateral edge of the side arm. However, as disclosed in the office action “a gap between 717 and the lateral end created by the post” is what is considered to be the side arm. Based on the consideration of the examiner, Allan reads on the limitation.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues in claim 77 the recess is not found on the rear surface of a side arm. However, if a recess is already found in a part of the device it would be obvious for this limitation to be used on another area of the device if it provides a specific function that is favorable to the device. This obviousness statement was established.
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. The applicant argues claim 86 – 87 are allowable based on the independent claim 58. However, the rejection on claim 58 still stands and claim 86 – 87 have to be considered with the prior art.
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.
Claim(s) 58 – 87 are rejected under 35 U.S.C. 103 as being unpatentable over Allan (AU 2010241390 A1) in view of Barbara et al. (JP 6629726 B2).
Regarding claim 58, A mask frame (Figure 5A), comprising:
a mask frame inlet (Figure 5A / 13) and a mask frame outlet (Figure 5A);
at least one lateral frame portion 511 / 1117 comprising a front surface and a rear surface (Figure 7A);
a headgear connector 307 / 1118 extending from the front surface (Figure 3C);
Allan does not disclose an opening defined through the at least one lateral frame portion, from the front surface to the rear surface, and positioned between the headgear connector and the mask frame inlet.
Barbara discloses an opening 3302.4 (Barbara) defined through the at least one lateral frame portion 3302.3, from the front surface to the rear surface, and positioned between the headgear connector (Note: the examiner considers the headgear connector to be any mechanism that connects the mask inlet to the headgear, in the case of Barbara it would be the molded junction) and the mask frame inlet 3310. (Figure 260A)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an opening defined through the at least one lateral frame portion, from the front surface to the rear surface, and positioned between the headgear connector and the mask frame inlet as it may be formed as a result of an overmoulding process to remove unnecessary material and it would ensure that spreading apart the extending arms can increase the movement of inertia where it joins the frame. (Paragraph 0245)
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Figure 5A: Annotated figure from App. Allan (AU 2010241390 A1)
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Figure 7A: Annotated figure from App. Allan (AU 2010241390 A1)
Modified Allan discloses wherein the headgear connector 307:
comprises a post 513 (see annotated Figure 5A / 7A) positioned adjacent to the opening 3302.4 (Barbara) (Figure 5A);
a medial flange (see annotated Figure 5A) extending medially from the post 513 (see annotated Figure 5A / 7A).
wherein the media flange (see annotated Figure 5A) extends over the opening 3302.4 (Barbara) (Figure 5B – 5C / Note: this is incorporated in Modified Allan based on the position where the opening as modified above with Barbara wherein the opening is on the medial side of the post between the post and 509 of Allan (figure 5A) as shown in Barbara Figure 260A)
Regarding claim 62, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan further comprising a gap (see annotated Figure 7A) between the medial flange (see annotated Figure 5A) and the front surface of the at least one lateral frame portion 511 (Figure 7A).
Regarding claim 63, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan discloses further comprising a lateral flange (see annotated Figure 5A) extending laterally from the post 513 (see annotated Figure 5A / 7A). (Figure 5A)
Regarding claim 64, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan discloses wherein a width of the at least one lateral frame portion 511 is greater than a width of the post 513 (see annotated Figure 5A / 7A ). (see annotated Figure 6)
Regarding claim 65, Modified Allan discloses the mask frame as claimed in Claim 64.
Modified Allan discloses the width of the post 513 (see annotated Figure 5A / 7A) is substantially the same as a width of the medial flange (see annotated Figure 5A). (see annotated Figure 6)
Regarding claim 66, Modified Allan discloses the mask frame as claimed in Claim 63.
Modified Allan discloses a width of the post 513 (see annotated Figure 5A / 7A) is substantially the same as a width of the lateral flange (see annotated Figure 5A). (see annotated Figure 6)
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Figure 6: Annotated figure from App. Allan (AU 2010241390 A1)
Regarding claim 67, Modified Allan discloses the mask frame as claimed in Claim 63.
Modified Allan discloses the lateral flange (see annotated Figure 5A) and medial flange (see annotated Figure 5A).
Modified Allan does not expressly disclose wherein a length of the lateral flange is greater than a length of the medial flange.
Furthermore, the courts have held that rearrangement of parts requires only ordinary skill in the art and hence is considered a routine expedient. “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950): Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.” MPEP § 2144.04-VI-C. It would have been prima facie obvious to one of ordinary skill in the art before the filing date to rearrange the length of the flanges as it has been proven that different lengths work for headgear connections. (Figure 5)
Regarding claim 68, Modified Allan discloses the mask frame as claimed in Claim 67.
Modified Allan discloses a lateral flange. (see annotated Figure 5A)
Modified Allan discloses the claimed invention except for wherein the length is approximately 4.2mm and the length of the medial flange is approximately 0.5mm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a specific length for the lateral flange, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the length, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 69, Modified Allan discloses the mask frame as claimed in Claim 63.
Modified Allan discloses lateral flange (see annotated Figure 5A) and medial flange. (see annotated Figure 5A)
Modified Allan does not expressly disclose wherein a thickness of the lateral flange is greater than a thickness of the medial flange.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of thickness, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05. It has been proven by Allan that the flanges can be designed with the same
Regarding claim 70, Modified Allan discloses the mask frame as claimed in Claim 69.
Modified Allan discloses a lateral flange (see annotated Figure 5A).
Modified Allan discloses the claimed invention except for the thickness is approximately 1.5mm and the thickness of the medial flange is approximately 1mm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a specific thickness for the lateral flange, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the thickness, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 71, Modified Allan discloses the mask frame as claimed in Claim 63.
Modified Allan discloses a lateral flange (see annotated Figure 5A) extends beyond a lateral edge of a side arm. (Note: Figure 7A discloses a gap between 717 and the lateral end created by the post. Figure 7B further discloses a horseshoe piece between 717 and 513)
Modified Allan does not expressly disclose where in the horseshoe piece is relative to the post and the flange.
It would be within the skill of the art to position the arm between the post and the flange to further support the flange while creating enough gap and overlap to allow the fitting of the connector portion of the strap 321 between the tips 717 and the connector portion of the arm. Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of length, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 72, Modified Allan discloses the mask frame as claimed in Claim 63.
Modified Allan discloses wherein a front surface of the post 513 (see annotated Figure 5A / 7A) is continuous with a front surface of the medial flange (see annotated Figure 5A) and a front surface of the lateral flange (see annotated Figure 5A). (Figure 5A)
Regarding claim 73, Modified Allan discloses the mask frame as claimed in Claim 72.
Modified Allan discloses the lateral flange (see annotated Figure 5A).
Modified Allan does not disclose wherein the front surface has a curvature configured to follow the curvature of a user's face.
Barbara discloses wherein the front surface has a curvature 3323 following the curvature of a user's face (Figures 39 – 41).
It would have been prima facie obvious to one of ordinary sill in the art before the effective filing date to create a curvature in order to closely follow the contours of the patients face and this minimizes any vertical movement of the flanges relative to the patients face.
Regarding claim 74, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan discloses a post 513. (see annotated Figure 5A / 7A)
Modified Allan does not disclose a rectangular shape or cross-section.
Regarding the shape of the post, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), [t]he court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Regarding claim 75, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan discloses a post 513. (see annotated Figure 5A / 7A)
Modified Allan discloses the claimed invention except for a length of 6.5mm and a width of 3.9mm
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a specific length for the post, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the length, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 76, Modified Allan discloses the mask frame as claimed in Claim 58.
Modified Allan discloses an opening 3302.4 (Barbara), a mask frame inlet (Figure 13) and a recess 6352 (Figure 13).
Modified Allan does not expressly disclose the recess between the opening and mask frame inlet.
However, it would have been prima facie obvious to one of ordinary sill in the art before the effective filing date to add the recess in that specific location as it would provide a gripping feature on its surfaces. (Allan, Page 60, lines 21 – 22)
Regarding claim 77, Modified Allan discloses the mask frame as claimed in Claim 76.
Modified Allan discloses the recess 6352. (Page 60, lines 21 – 22)
Modified Allan does not expressly disclose wherein the recess is positioned on a rear surface of a side arm.
However, it would have been prima facie obvious to one of ordinary sill in the art before the effective filing date to add the recess in that specific location as it would provide a gripping feature on its surfaces. (Allan , Page 60, lines 21 – 22)
Regarding claim 78, Modified Allan discloses a headgear strap configured to mate with the headgear connector as claimed in Claim 58.
Modified Allan discloses wherein the headgear strap 323 has a headgear strap opening (see annotated Figure 3C) configured to secure to the headgear connector 307. (Figure 3C)
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Figure 3C: Annotated Figure of Allan
Regarding claim 79, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses wherein the headgear strap opening (see annotated Figure 3C) is located on a free end of the headgear strap 323. (Figure 3C)
Regarding claim 80, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses the headgear strap opening (see annotated Figure 3C) and the post 513 (see annotated Figure 5A / 7A).
Modified Allan does not disclose a rectangular shape.
Regarding the shape of the opening, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), [t]he court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Regarding claim 81, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses wherein, when assembled, a thickness of the headgear strap 323 fits within a gap (see annotated Figure 7A). (Figure 3B, shows the straps connected to the frame by fitting in the gap)
Regarding claim 82, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses wherein, when assembled, a medial flange (see annotated Figure 5A) and a lateral flange (see annotated Figure 5A) hang over the headgear strap 323. (Figure 3B)
Regarding claim 83, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses wherein Allan further discloses that the headgear strap 323 is formed of a flexible material. (Page 8 lines 33 – 35)
Regarding claim 84, Modified Allan discloses the headgear strap as claimed in Claim 78.
Modified Allan discloses the headgear strap opening 3302.4 (Barbara).
Modified Allan does not disclose formed through removal of material such as die-cutting and RF crease-cutting.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I. Although Allan is silent as to the method of how the opening is made it is well within the skill of the art to determine how to make the opening. Further, the modified Allan product is obvious over the claimed product as disclosed above.
Regarding claim 85, Modified Allan discloses the headgear strap as claimed in Claim 79.
Modified Allan discloses an opening 3302.4 (Barbara).
Modified Allan does not disclose formed through removal of material such as die-cutting and RF crease-cutting.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I. Although Allan is silent as to the method of how the opening is made it is well within the skill of the art to determine how to make the opening. Further, the modified Allan product is obvious over the claimed product as disclosed above.
Regarding claim 86, Modified Allan discloses the headgear strap as claimed in Claim 58.
Modified Allan discloses wherein a medial wall of the post 513 is next to the opening 3302.4 (Barbara) (Note: this is incorporated in Modified Allan based on the position where the opening as modified above with Barbara wherein the opening is on the medial side of the post between the post and 509 of Allan (annotated figure 5A) as shown in Barbara Figure 260A)
Modified Allan does not specifically disclose the medial wall of the post defines a lateral edge of the opening.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the medial wall of Allan to define a lateral edge of the opening based on the location in which the opening is found. The opening is found in close proximity and would be close enough for the medial wall of the post to define a lateral edge of the opening as it is considered to be next to the opening and would not destroy the function of the opening or the post. (Allan, Figure 7A / Barbara, Figure 260A)
Regarding claim 87, Modified Allan discloses the headgear strap as claimed in Claim 86.
Modified Allan discloses wherein the medial wall of the post 513 is connected with the front surface of the at least one lateral frame portion 717. (Figure 7A)
Modified Allan does not expressly disclose wherein the medial wall of the post defines an acute angle with the front surface of the at least one lateral frame portion.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify the median wall of the post of Allan to define an acute angle with the front surface of the at least one lateral frame portion as it would still provide the same function of connection the medial wall to the lateral frame portion. Having a specific angle would not change the function of the limitation.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the angle, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
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