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 .
Status of Claims
This Office Action is responsive to the amendment filed on December 22, 2025. As directed by the amendment: claims 1, 6, 11, and 17 have been amended; and claims 8 and 22 have been cancelled. Thus, claims 1, 3-7, 9-11, 13-18, and 20-21 are presently pending in this application.
Claims 8 and 22 were previously rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form. Applicant’s cancelling of claims 8 and 22 obviate the previous rejection under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph.
Claim(s) 1, 3-10, 17-18, and 20-22 were previously rejected under 35 U.S.C. 103 as being unpatentable over Eves et al. (U.S. Pub. No. 2018/0280649) in view of Barnett et al. (U.S. Pub. No. 2002/0043265). Claim(s) 11 and 13-16 were previously rejected under 35 U.S.C. 103 as being unpatentable over Eves et al. (U.S. Pub. No. 2018/0280649) in view of Eves et al. (U.S. Pub. No. 2021/0038848) in view of Barnett et al. (U.S. Pub. No. 2002/0043265).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Information Disclosure Statement
Acknowledgement is made to Applicant's lack of an Information Disclosure Statement submission.
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) 1, 3-7, 9-10, 17-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Eves et al. (U.S. Pub. No. 2018/0280649; hereinafter: “Eves’649”) in view of Barnett et al. (U.S. Pub. No. 2002/0043265; hereinafter: “Barnett”).
Regarding Claim 1, Eves’649 discloses a patient interface cushion, configured to deliver breathable pressurized gas to a patient to treat sleep breathing disorders (Abstract), the patient interface cushion comprising: a rigid section (3816; Fig. 21, 23B-23E) having an air intake opening (A, Fig. A annotated below) to receive breathable pressurized gas (¶ 0262), the rigid section being configured to connect to an elastic section (3810, 3812; Fig. 20-23E) at one end; the elastic section including a main body (3810; Fig. 21-23E) that is configured to at least partially contact and form a seal with a face of the patient during use (¶¶ 0286-0301), and a connecting portion (3812; Fig. 21-23E) that is configured to connect to the rigid section (Fig. 21); wherein the main body of the elastic section has at least three different wall thicknesses (3175A-3175F; Fig. 20; ¶¶ 0275-0284), the main body of the elastic section comprising at least an adjustment area (3175A; Fig. 20), with an opening (A, Fig. B annotated below) near the face of the patient and an edge portion (3175F; Fig. 20) near the opening and is gas-fillable [¶¶ 0262, 0263, 0267-0269, 0271-0273, 0275, 0288; Examiner notes: Eve’649 discloses the seal forming structure 3100, which 3175 is considered to be, as preventing blowout. Where blowout is caused by the seal forming structure is filled with gas, as claimed.], a support area (3175C, 3175B; Fig. 20), configured to connect to the connecting portion of the elastic section (Fig. 21; ¶ 0289), at least two different wall thicknesses (¶¶ 0275-0284; Fig. 20; Examiner notes: Eves’649 discloses the support area as region 3175B being a very thin region, for example, about 0.2 mm and as region 3175C being a semi-thin region, for example, about 1 mm. Thus, the support area has at least two different wall thickness), and a part near (Examiner notes: The term “near” is a relative term; thus BRI has been applied.) the connecting portion has a thicker wall thickness for support [¶¶ 0275-0284; Fig. 20-23E; Examiner notes: It is possible that “a part” is a portion of the connecting portion or the support area. Eves’649 depicts the connecting portion (3812; Fig. 21, 23A, 23B) as having a wall thickness mush less than the wall thickness of the support, thus any part of the support area “near” the connecting portion would have a thicker wall thickness. Further, Eves’649 discloses a part (3175E or 3175F; Fig. 20; ¶¶ 0280, 0281) that is “near” the connecting portion and has a “thicker” wall thickness for support]; and a stabilization area (3175D; Fig. 20), near and connected to the support area, having a wall thickness thicker than at least part of a wall thickness of the support area (¶¶ 0278-0281).
PNG
media_image1.png
661
495
media_image1.png
Greyscale
Figure A, Adapted from Figure 21 of Eves’649.
PNG
media_image2.png
577
464
media_image2.png
Greyscale
Figure B, Adapted from Figure 20 of Eves’649.
Eves’649 does not explicitly disclose the patient interface cushion wherein the elastic section is molded together with the rigid section; ; wherein the edge portion that surrounds the opening is configured to: fold inward to seal at the patient's face; and when a patient's face is larger, and wherein a width of the edge portion is 2 cm or less.
The claimed phrase “the elastic section is molded together with the rigid section” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Eves’649 is silent as to the process used to the elastic section and the rigid section, it appears that the product of Eves’649’s would be the same or similar as that claimed. (See MPEP 2113)
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the elastic section molded together with the rigid section, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (See MPEP 2144.04 V. (B)) and further, Applicant appears to have placed no criticality on the process by which the product is formed stating that molding is a merely exemplary (See Instant Specification: Pg. 15, ln 4-6).
Eves’649 in an alternate embodiment [Fig. 27; ¶¶ 0305-0311; hereinafter: Eves’649(2)] teaches a main body (6000; Fig. 27) of an elastic section (6005A-6005G) comprising at least an adjustment area (A, Fig. C annotated below and 6005D, 6005G; Fig. 27; ¶ 0311), with an opening (A, Fig. C annotated below) near the face of the patient and an edge portion (6005D, 6005G; Fig. 27) that surrounds the opening [¶ 0311; Examiner notes: Eves’649 depicts regions 6005D and 6005G as surround the opening (Fig. 27). Evens’649 discloses region 6005G as a sub-region of region 6005D, thus the edge portion surrounds the opening.] for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (¶ 0311).
PNG
media_image3.png
544
476
media_image3.png
Greyscale
Figure C, Adapted from Figure 27 of Eve’649(2).
Barnett teaches a patient interface (32; Fig. 1A-1E, 2A-2D; ¶ 0026) comprising an edge portion (52, 54; Fig. 1A, 1B, 2A) near an opening (formed by element 54 leading into cavity 42; Fig. 1A; ¶ 0030) configured to: fold inward to seal at the patient's face (¶ 0030), and be pressed down when a patient's face is larger [¶ 0030; Examiner notes: Barnett discloses the edge portion folding and being pressed down towards cavity 42 (¶ 0030) when the patient’s face is has a large enough face. See MPEP 2111.04] for the purpose of allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (¶ 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Eves’649 to include the edge portion that surrounds the opening as taught by Eves’649(2) and the edge portion being configured to: fold inward to seal at the patient's face, and be pressed down when a patient's face is larger, as taught by Barnett for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (See Eves’649(2): ¶ 0311) and allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (See Barnett: ¶ 0030), respectively.
The modified device of Eves’649 discloses the patient interface comprises a width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281).
The modified device of Eves’649 does not explicitly disclose the patient interface cushion wherein the width of the edge portion of the adjustment area is 2 cm or less.
The modified device of Eves’649 discloses the width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281). As such, the width of the edge portion of the adjustment area is disclosed to be a result effective variable in that changing the width of the edge portion of the adjustment area will alter the seal provided to various facial profiles and movement during sleep and impact the edge portion of the adjustment area from acting as the sealing membrane layer of the dual layer cushions. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Eves’649 device to have a width within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Finally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Eves’649 by making the width of the edge portion of the adjustment area is at most 2 cm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 3, the modified device of Eves’649 discloses the patient interface cushion wherein the adjustment area, during use, surrounds a nasal airway and an oral airway of the patient (See Eves’649: Fig. 30D; Abstract).
Regarding Claim 4, the modified device of Eves’649 discloses the patient interface cushion wherein the stabilization area is a least proportioned area in the main body of the elastic section of the patient interface cushion (See Eves’649: ¶¶ 0275-0284).
Regarding Claim 5, the modified device of Eves’649 discloses the patient interface cushion wherein each area of the main body of the elastic section is smoothly connected, without any obvious demarcation lines (See Eves’649: Fig. 20-23E).
Regarding Claim 6, Eves’649 discloses a patient interface cushion, configured to deliver breathable pressurized gas to a patient to treat sleep breathing disorders (Abstract), the patient interface cushion comprising: a rigid section (3816; Fig. 21, 23B-23E) having an air intake opening (A, Fig. A annotated above) to receive breathable pressurized gas (¶ 0262), the rigid section being configured to connect to an elastic section (3810, 3812; Fig. 20-23E) at one end; the elastic section with a single-layer wall (Fig. 21, 23A-23E), including a main body (3810; Fig. 21-23E) that is configured to at least partially contact and form a seal with a face of the patient during use (¶¶ 0286-0301), and a connecting portion (3812; Fig. 21-23E) to connect to the rigid section (Fig. 21); wherein the main body of the elastic section comprises: an adjustment area (3175A; Fig. 20), with an opening (A, Fig. B annotated above) near the face of the patient and an edge portion (3175F; Fig. 20) near the opening and is gas-fillable [¶¶ 0262, 0263, 0267-0269, 0271-0273, 0275, 0288; Examiner notes: Eve’649 discloses the seal forming structure 3100, which 3175 is considered to be, as preventing blowout. Where blowout is caused by the seal forming structure is filled with gas, as claimed.]; a support area (3175C, 3175B; Fig. 20), configured to connect to the connecting portion of the elastic section (Fig. 20, 21; ¶ 0289), at least two different wall thicknesses (¶¶ 0275-0284; Fig. 20; Examiner notes: Eves’649 discloses the support area as region 3175B being a very thin region, for example, about 0.2 mm and as region 3175C being a semi-thin region, for example, about 1 mm. Thus, the support area has at least two different wall thickness) including a wall thickness between 2 to 9 times a wall thickness of the adjustment area (¶¶ 0275-0284; Examiner notes: Eves’649 discloses a wall thickness of the support area as 1 mm which is 2 to 9 times that of a wall thickness of the adjustment area being 0.3 mm.), and a part near (Examiner notes: The term “near” is a relative term, thus BRI has been applied.) the connecting portion has a thicker wall thickness for support [¶¶ 0275-0284; Fig. 20-23E; Examiner notes: It is possible that “a part” is a portion of the connecting portion or the support area. Eves’649 depicts the connecting portion (3812; Fig. 21, 23A, 23B) as having a wall thickness mush less than the wall thickness of the support, thus any part of the support area “near” the connecting portion would have a thicker wall thickness. Further, Eves’649 discloses a part (3175E; Fig. 20; ¶¶ 0280, 0281) that is “near” the connecting portion and has a “thicker” wall thickness for support]; and a stabilization area (3175D; Fig. 20), near and connected to the support area (Fig. 20, 21), with a wall thickness between 3 to 10 times the wall thickness of the adjustment area (¶¶ 0275-0284; Examiner notes: Eves’649 discloses a wall thickness of the stabilization area as 1.5 mm which is 3 to 10 times that of a wall thickness of the adjustment area being 0.3 mm.).
Eves’649 does not explicitly disclose the patient interface cushion wherein the elastic section is molded together with the rigid section; wherein the adjustment area is disposed at a central portion of the elastic section to vertically divide the elastic selection into halves in a front view; wherein the edge portion that surrounds the opening is configured to: fold inward to seal at the patient's face; and when a patient's face is larger and wherein a width of the edge portion is 2 cm or less.
The claimed phrase “the elastic section is molded together with the rigid section” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Eves’649 is silent as to the process used to the elastic section and the rigid section, it appears that the product of Eves’649’s would be the same or similar as that claimed. (See MPEP 2113)
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the elastic section molded together with the rigid section, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (See MPEP 2144.04 V. (B)) and further, Applicant appears to have placed no criticality on the process by which the product is formed stating that molding is a merely exemplary (See Instant Specification: Pg. 15, ln 4-6).
Eves’649 in an alternate embodiment [Fig. 27; ¶¶ 0305-0311; hereinafter: Eves’649(2)] teaches a main body (6000; Fig. 27) of an elastic section (6005A-6005G) comprising at least an adjustment area (A, Fig. C annotated above and 6005D, 6005G; Fig. 27; ¶ 0311), with an opening (A, Fig. C annotated above) near the face of the patient and an edge portion (6005D, 6005G; Fig. 27) that surrounds the opening [¶ 0311; Examiner notes: Eves’649 depicts regions 6005D and 6005G as surround the opening (Fig. 27). Evens’649 discloses region 6005G as a sub-region of region 6005D, thus the edge portion surrounds the opening.], disposed at a central portion (B, Fig. C annotated above) of the elastic section to vertically divide the elastic selection into halves in a front view (Fig. 27; ¶¶ 0305-0311) for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (¶ 0311).
Barnett teaches a patient interface (32; Fig. 1A-1E, 2A-2D; ¶ 0026) comprising an edge portion (52, 54; Fig. 1A, 1B, 2A) near an opening (formed by element 54 leading into cavity 42; Fig. 1A; ¶ 0030) configured to: fold inward to seal at the patient's face (¶ 0030), and be pressed down when a patient's face is larger [¶ 0030; Examiner notes: Barnett discloses the edge portion folding and being pressed down towards cavity 42 (¶ 0030) when the patient’s face is has a large enough face. See MPEP 2111.04] for the purpose of allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (¶ 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Eves’649 to include the adjustment area, having the edge portion that surrounds the opening, being disposed at a central portion of the elastic section to vertically divide the elastic selection into halves in a front view as taught by Eves’649(2) and the edge portion near the opening being configured to: fold inward to seal at the patient's face, and be pressed down when a patient's face is larger, as taught by Barnett for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (See Eves’649(2): ¶ 0311) and allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (See Barnett: ¶ 0030), respectively.
The modified device of Eves’649 discloses the patient interface comprises a width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281).
The modified device of Eves’649 does not explicitly disclose the patient interface cushion wherein the width of the edge portion of the adjustment area is 2 cm or less.
The modified device of Eves’649 discloses the width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281). As such, the width of the edge portion of the adjustment area is disclosed to be a result effective variable in that changing the width of the edge portion of the adjustment area will alter the seal provided to various facial profiles and movement during sleep and impact the edge portion of the adjustment area from acting as the sealing membrane layer of the dual layer cushions. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Eves’649 device to have a width within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Finally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Eves’649 by making the width of the edge portion of the adjustment area is at most 2 cm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 7, the modified device of Eves’649 discloses the patient interface cushion wherein the wall thickness of the adjustment area is at least 0.3 mm (See Eves’649: ¶ 0276; Examiner notes: Eves’649 discloses the wall thickness of the adjustment area as about 0.3 mm, which is at least 0.3 mm.).
Regarding Claim 9, the modified device of Eves’649 discloses the patient interface cushion, shown above.
The modified device of Eves’649 does not explicitly discloses the patient interface wherein each area of the main body of the elastic section has a uniform wall thickness.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form each area of the main body of the elastic section as having a uniform wall thickness in the modified device of Eves’649 because Applicant has not disclosed that form each area of the main body of the elastic section as having a uniform wall thickness provides an advantage, is used for a particular purpose, or solves a stated problem (Instant Spec: Pg. 16, ln 26-30). One of ordinary skill in the art, furthermore, would have expected the modified device of Eves’649’s, and Applicant’s elastic section, to perform equally well because both mechanisms perform the same function of providing a facial seal.
Therefore, it would have been prima facie obvious to modify the modified device of Eves’649 to obtain the invention as specified in claim 9 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired facial seal and thus fails to patentably distinguish over the modified device of Eves’649.
Regarding Claim 10, the modified device of Eves’649 discloses the patient interface cushion, shown above.
The modified device of Eves’649 does not explicitly discloses the patient interface wherein the main body of the elastic section has abrupt changes in wall thicknesses between its areas, with distinct demarcation lines between each area.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the main body of the elastic section having abrupt changes in wall thicknesses between its areas, with distinct demarcation lines between each area in the modified device of Eves’649 because Applicant has not disclosed that the main body of the elastic section having abrupt changes in wall thicknesses between its areas, with distinct demarcation lines between each area provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the modified device of Eves’649’s and Applicant’s main body, to perform equally well because both mechanisms perform the same function of providing a facial seal.
Therefore, it would have been prima facie obvious to modify the modified device of Eves’649 to obtain the invention as specified in claim 10 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired facial seal and thus fails to patentably distinguish over the modified device of Eves’649.
Regarding Claim 17, Eves’649 discloses a patient interface cushion, configured to deliver breathable pressurized gas to a patient to treat sleep breathing disorders (Abstract), the patient interface cushion comprising: a rigid section (3816; Fig. 21, 23B-23E) having an air intake opening (A, Fig. A annotated above) to receive breathable pressurized gas (¶ 0262), the rigid section being configured to connect to an elastic section (3810, 3812; Fig. 20-23E) at one end; the elastic section with a single-layer wall (Fig. 21, 23A-23E; ¶ 0248), including a main body (3810; Fig. 21-23E) that is configured to at least partially contact and form a seal with a face of the patient during use (¶¶ 0286-0301), and a connecting portion (3812; Fig. 21-23E) that is configured to connect to the rigid section (Fig. 21); wherein the main body of the elastic section comprises: an adjustment area (3175A; Fig. 20), with an opening (A, Fig. B annotated above) near the face of the patient and an edge portion (3175F; Fig. 20) near the opening and is gas-fillable [¶¶ 0262, 0263, 0267-0269, 0271-0273, 0275, 0288; Examiner notes: Eve’649 discloses the seal forming structure 3100, which 3175 is considered to be, as preventing blowout. Where blowout is caused by the seal forming structure is filled with gas, as claimed.]; and a nasal side adjustment part (3175C; Fig. 20) near the edge portion with a wall thickness between a wall thickness of the edge portion and a support area (3175B, 3175D; Fig. 20; ¶¶ 0275-0248), wherein the adjustment area has at least part of a wall thickness of at least 0.3 mm (¶ 0276; Examiner notes: Eves’649 discloses the wall thickness of the adjustment area as about 0.3 mm, which is at least 0.3 mm.); the support area, configured to connect to the connecting portion of the elastic section (Fig. 20, 21; ¶ 0289); at least two different wall thicknesses (¶¶ 0275-0284; Fig. 20; Examiner notes: Eves’649 discloses the support area as region 3175B being a very thin region, for example, about 0.2 mm and as region 3175D being a semi-thick region, for example, about 1.5 mm. Thus, the support area has at least two different wall thickness), and a part near (Examiner notes: The term “near” is a relative term; thus BRI has been applied.) the connecting portion has a thicker wall thickness for support [¶¶ 0275-0284; Fig. 20-23E; Examiner notes: It is possible that “a part” is a portion of the connecting portion or the support area. Eves’649 depicts the connecting portion (3812; Fig. 21, 23A, 23B) as having a gradually varying wall thickness, thus any segment of the connecting portion “near” the support area would meet the claimed limitation. Further, Eves’649 discloses a part (3175B, 3175C, and 3175D; Fig. 20, 23A; ¶¶ 0277-0279) that is “near” the connecting portion and has a gradually varying wall thickness for support]; and a stabilization area (3175E; Fig. 20), near and connected to the support area (Fig. 20; ¶¶ 0275-0284).
Eves’649 does not explicitly disclose the patient interface cushion wherein the elastic section is molded together with the rigid section; wherein the adjustment area is disposed at a central portion of the elastic section to vertically divide the elastic selection into halves in a front view; wherein the edge portion that surrounds the opening is configured to: fold inward to seal at the patient's face; and when a patient's face is smaller, receive a pressurized gas to expand, or when a patient's face is larger, be pressed down and wherein a width of the edge portion is 2 cm or less.
The claimed phrase “the elastic section is molded together with the rigid section” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Eves’649 is silent as to the process used to the elastic section and the rigid section, it appears that the product of Eves’649’s would be the same or similar as that claimed. (See MPEP 2113)
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the elastic section molded together with the rigid section, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (See MPEP 2144.04 V. (B)) and further, Applicant appears to have placed no criticality on the process by which the product is formed stating that molding is a merely exemplary (See Instant Specification: Pg. 15, ln 4-6).
Eves’649 in an alternate embodiment [Fig. 27; ¶¶ 0305-0311; hereinafter: Eves’649(2)] teaches a main body (6000; Fig. 27) of an elastic section (6005A-6005G) comprising at least an adjustment area (A, Fig. C annotated above and 6005D, 6005G; Fig. 27; ¶ 0311), with an opening (A, Fig. C annotated above) near the face of the patient and an edge portion (6005D, 6005G; Fig. 27) that surrounds the opening [¶ 0311; Examiner notes: Eves’649 depicts regions 6005D and 6005G as surround the opening (Fig. 27). Evens’649 discloses region 6005G as a sub-region of region 6005D, thus the edge portion surrounds the opening.], disposed at a central portion (B, Fig. C annotated above) of the elastic section to vertically divide the elastic selection into halves in a front view (Fig. 27; ¶¶ 0305-0311) for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (¶ 0311).
Barnett teaches a patient interface (32; Fig. 1A-1E, 2A-2D; ¶ 0026) comprising an edge portion (52, 54; Fig. 1A, 1B, 2A) near an opening (formed by element 54 leading into cavity 42; Fig. 1A; ¶ 0030) configured to: fold inward to seal at the patient's face (¶ 0030), and be pressed down when a patient's face is larger [¶ 0030; Examiner notes: Barnett discloses the edge portion folding and being pressed down towards cavity 42 (¶ 0030) when the patient’s face is has a large enough face. See MPEP 2111.04] for the purpose of allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (¶ 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Eves’649 to include the adjustment area, having the edge portion that surrounds the opening, being disposed at a central portion of the elastic section to vertically divide the elastic selection into halves as taught by Eves’649(2) and the edge portion near the opening being configured to: fold inward to seal at the patient's face, and be pressed down when a patient's face is larger, as taught by Barnett for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (See Eves’649(2): ¶ 0311) and allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (See Barnett: ¶ 0030), respectively.
The modified device of Eves’649 discloses the patient interface comprises a width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281).
The modified device of Eves’649 does not explicitly disclose the patient interface cushion wherein the width of the edge portion of the adjustment area is 2 cm or less.
The modified device of Eves’649 discloses the width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281). As such, the width of the edge portion of the adjustment area is disclosed to be a result effective variable in that changing the width of the edge portion of the adjustment area will alter the seal provided to various facial profiles and movement during sleep and impact the edge portion of the adjustment area from acting as the sealing membrane layer of the dual layer cushions. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Eves’649 device to have a width within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Finally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Eves’649 by making the width of the edge portion of the adjustment area is at most 2 cm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 18, the modified device of Eves’649 discloses the patient interface cushion wherein the stabilization area has a wall thickness thicker than at least part of a wall thickness of the adjustment area and the support area (See Eves’649: Fig. 20; ¶¶ 0275-0248).
Regarding Claim 20, the modified device of Eves’649 discloses the patient interface cushion wherein the elastic section has at least three different wall thicknesses (See Eves’649: 3175A-3175F; Fig. 20; ¶¶ 0275-0284).
Regarding Claim 21, the modified device of Eves’649 discloses the patient interface cushion wherein each area of the main body of the elastic section is smoothly connected, without any obvious demarcation lines (See Eves’649: Fig. 20-23E; ¶¶ 0275-0284).
Claim(s) 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Eves’649 (U.S. Pub. No. 2018/0280649) in view of Eves et al. (U.S. Pub. No. 2021/0038848; hereinafter: “Eves’848”) in view of Barnett (U.S. Pub. No. 2002/0043265) .
Regarding Claim 11, Eves’649 discloses a patient interface cushion, configured to deliver breathable pressurized gas to a patient to treat sleep breathing disorders (Abstract), the patient interface cushion comprising: a rigid section (3816; Fig. 21, 23B-23E) having an air intake opening (A, Fig. A annotated above) to receive breathable pressurized gas (¶ 0262), the rigid section being configured to connect to an elastic section (3810, 3812; Fig. 20-23E) at one end; the elastic section including a main body (3810; Fig. 21-23E) that is configured to at least partially contact and form a seal with a face of the patient during use (¶¶ 0286-0301), and a connecting portion (3812; Fig. 21-23E) to connect to the rigid section (Fig. 21); the main body of the elastic section having at least three different wall thicknesses (3175A-3175F; Fig. 20; ¶¶ 0275-0284), the main body of the elastic section at least comprising: an adjustment area (3175A; Fig. 20), with an opening (A, Fig. B annotated above) near the face of the patient and an edge portion (3175F; Fig. 20) near the opening and is gas-fillable [¶¶ 0262, 0263, 0267-0269, 0271-0273, 0275, 0288; Examiner notes: Eve’649 discloses the seal forming structure 3100, which 3175 is considered to be, as preventing blowout. Where blowout is caused by the seal forming structure is filled with gas, as claimed.], a support area (3175B, 3175C, 3175D; Fig. 20; ¶¶ 0275-0284), configured to connect to the connecting portion of the elastic section (Fig. 20, 21; ¶ 0289), having a gradually varying wall thickness that is thicker than a wall thickness of the adjustment area at a top near the adjustment area to prevent a nose of the patient from bottoming out during use [Fig. 20-23E; ¶¶ 0275-0301; Examiner notes: Eves’649 discloses the support area as region 3175B being a very thin region, for example, about 0.2 mm; as region 3175C being a semi-thin region, for example, about 1 mm; and as region 3175D being a semi-thick region, for example, about 1.5 mm where the wall thickness gradually varies to have a thickness greater than the wall thickness of the adjustment area (0.2mm; ¶ 0276).] and also has a thicker wall thickness near (Examiner notes: The term “near” is a relative term, thus BRI has been applied.) the connecting portion [Examiner notes: Eves’649 depicts the support area as having a thicker wall thickness “near” the connecting portion (Fig. 23A).]; and a stabilization area (3175E; Fig. 20), near and connected to the support area (Fig. 20-23E; ¶¶ 0275-0284), with a wall thickness thicker than the wall thickness of the adjustment area (Fig. 20; ¶¶ 0275-0284).
Eves’649 does not explicitly disclose the patient interface cushion wherein the elastic section is molded together with the rigid section, nor specifically disclose the main body of the elastic section having at least two surface treatments; wherein at least part of the edge portion has a surface treatment of polishing; that surrounds the opening is configured to: fold inward to seal at the patient's face; and when a patient's face is larger, and wherein a width of the edge portion is 2 cm or less.
The claimed phrase “the elastic section is molded together with the rigid section” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Eves’649 is silent as to the process used to the elastic section and the rigid section, it appears that the product of Eves’649’s would be the same or similar as that claimed. (See MPEP 2113)
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the elastic section molded together with the rigid section, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (See MPEP 2144.04 V. (B)) and further, Applicant appears to have placed no criticality on the process by which the product is formed stating that molding is a merely exemplary (See Instant Specification: Pg. 15, ln 4-6).
The modified device of Eves’649 does not specifically disclose the patient interface cushion wherein the main body of the elastic section having at least two surface treatments and wherein at least part of the edge portion has a surface treatment of polishing; and wherein the edge portion that surrounds the opening is configured to: fold inward to seal at the patient's face; and when a patient's face is larger, and wherein a width of the edge portion is 2 cm or less.
Eves’848 teaches a patient interface comprising a main body (3200; Fig. 47) of an elastic section (3230, 3260; Fig. 47) having at least two surface treatments (¶¶ 0088, 0115, 0475) and wherein at least part of an edge portion (3136; Fig. 48) has a surface treatment of polishing (3103; Fig. 47; ¶ 0475) for the purpose of providing a smooth feel on the patient's face and a grippy contact on the patient's face (¶ 0475).
Eves’649 in an alternate embodiment [Fig. 27; ¶¶ 0305-0311; hereinafter: Eves’649(2)] teaches a main body (6000; Fig. 27) of an elastic section (6005A-6005G) comprising at least an adjustment area (A, Fig. C annotated above and 6005D, 6005G; Fig. 27; ¶ 0311), with an opening (A, Fig. C annotated above) near the face of the patient and an edge portion (6005D, 6005G; Fig. 27) that surrounds the opening [¶ 0311; Examiner notes: Eves’649 depicts regions 6005D and 6005G as surround the opening (Fig. 27). Evens’649 discloses region 6005G as a sub-region of region 6005D, thus the edge portion surrounds the opening.] for the purpose of providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (¶ 0311).
Barnett teaches a patient interface (32; Fig. 1A-1E, 2A-2D; ¶ 0026) comprising an edge portion (52, 54; Fig. 1A, 1B, 2A) near an opening (formed by element 54 leading into cavity 42; Fig. 1A; ¶ 0030) configured to: fold inward to seal at the patient's face (¶ 0030), and when a patient's face is smaller, receive a pressurized gas to expand, or when a patient's face is larger, be pressed down (¶ 0030; Examiner notes: As indicated in the interview on December 3, 2024, limitation “when a patient's face is smaller, receive a pressurized gas to expand, or when a patient's face is larger, be pressed down” is a conditional functional limitation. Such that, only one of the conditions must be met to fulfil the claim limitation. In this instance, Barnett discloses the edge portion folding and being pressed down towards cavity 42 (¶ 0030) when the patient’s face is has a large enough face. See MPEP 2111.04] for the purpose of allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (¶ 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Eves’649 to include the elastic section having at least two surface treatments and wherein at least part of the edge portion has the surface treatment of polishing as taught by Eves’848; to include the edge portion that surrounds the opening as taught by Eves’649(2) and to include the edge portion near the opening being configured to: fold inward to seal at the patient's face, and when a patient's face is larger, be pressed down as taught by Barnett for the purpose of a smooth feel on the patient's face and a grippy contact on the patient's face (See Eves’848: ¶ 0475); providing a relatively deeper nasal bridge area to better accommodate patients that have a relatively high nasal bridge and/or provide a more comfortable seal (See Eves’649(2): ¶ 0311); and allowing the edge portion to roll as the force by which the patient interface is pressed against the face increases, thereby reducing pressure points along the patient interface (See Barnett: ¶ 0030), respectively.
The modified device of Eves’649 discloses the patient interface comprises a width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281).
The modified device of Eves’649 does not explicitly disclose the patient interface cushion wherein the width of the edge portion of the adjustment area is 2 cm or less.
The modified device of Eves’649 discloses the width of the edge portion of the adjustment area (B, Fig. B annotated above) configured to contact on the sides of the patient's mouth may be about 0.5 mm and may act like the sealing membrane layer of the dual layer cushions, which maintain a seal with micro variations of the facial profile and movement during sleep (See Eves’649: ¶ 0281). As such, the width of the edge portion of the adjustment area is disclosed to be a result effective variable in that changing the width of the edge portion of the adjustment area will alter the seal provided to various facial profiles and movement during sleep and impact the edge portion of the adjustment area from acting as the sealing membrane layer of the dual layer cushions. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Eves’649 device to have a width within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Finally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Eves’649 by making the width of the edge portion of the adjustment area is at most 2 cm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, the modified device of Eves’649 discloses the patient interface cushion having a maximum width (A, Fig. D annotated below) at a top of the patient interface cushion to accommodate the nose.
PNG
media_image4.png
590
551
media_image4.png
Greyscale
Figure D, Adapted From Fig. 20 of Eves’649.
The modified device of Eves’649 does not explicitly discloses the patient interface cushion wherein the maximum width of the adjustment area at the top of the patient interface cushion to accommodate the nose does not exceed 5.5 cm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the maximum width of the adjustment area at the top of the patient interface cushion to accommodate the nose does not exceed 5.5 cm in the modified device of Eves’649 because Applicant has not disclosed that setting the maximum width of the adjustment area at the top of the patient interface cushion to accommodate the nose to not exceed 5.5 cm provides an advantage, is used for a particular purpose, or solves a stated problem (Instant Spec: Pg. 17, ln 9-12). One of ordinary skill in the art, furthermore, would have expected the modified device of Eves’649’s, and Applicant’s maximum width of the adjustment area at the top of the patient interface cushion, to perform equally well because both mechanisms perform the same function of accommodating the nose.
Therefore, it would have been prima facie obvious to modify the modified device of Eves’649 to obtain the invention as specified in claim 13 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired nasal accommodation and thus fails to patentably distinguish over the modified device of Eves’649.
Regarding claim 14, the modified device of Eves’649 discloses the patient interface cushion wherein part of the adjustment area that contacts the nose of the patient during use has an inward concave, configured to better accommodate the nose and form a seal (See Eves’649: Fig. 20-23E; ¶¶ 0275-0284).
Regarding claim 15, the modified device of Eves’649 discloses the patient interface cushion wherein the stabilization area is a least proportioned area in the main body of the elastic section of the patient interface cushion (See Eves’649: Fig. 20-23E; ¶¶ 0275-0284).
Regarding claim 16, the modified device of Eves’649 discloses the patient interface cushion wherein the adjustment area includes a nasal side adjustment (See Eves’649: 3175C, Fig. 20) part with a wall thickness between a wall thickness of the edge portion and the support area (See Eves’649: Fig. 20; ¶¶ 0275-0248).
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to an edge portion that surrounds the opening and is gas-fillable as recites in independent claims 1, 6, 11, and 17 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection, shown above.
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 ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
Prosecution Insights