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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 2018/0177965), hereinafter Patel in view of Barlow et al (US 2013/0213400), hereinafter Barlow.
Regarding claim 1, Patel teaches a patient interface (Fig. 1) comprising:
a plenum chamber (Chamber 2125) pressurizable to a therapeutic pressure of at least 5 cm H2O above ambient air pressure (Paragraph 155, typical treatment pressures of about 3 to about 25cm H2O), said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Fig. 4: 2114, paragraph 137 opening communicates with connector 2105 which provides the therapeutic air);
a first seal forming structure connected to an oral portion of the plenum chamber, the first seal forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s mouth such that the flow of air at said therapeutic pressure is delivered to the mouth (Paragraph 137, Fig. 5: oral region 2166, paragraph 146), the first seal forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in user (Paragraph 146, the seal surrounds the oral opening);
a second seal forming structure connected to a nasal portion of the plenum chamber (Paragraph 148, region 2168 surrounds nasal opening 2124), the second seal forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nose such that the flow of air at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use (paragraph 148, gently seals around the nasal nose); and
a vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to vent to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber is use (paragraph 132, bias holes 2110 exhaust air and flush CO2, may be provided on the mask shell, on the mask seal or any combination of connector, shell and seal);
wherein the second seal forming structure comprises a pair of lateral portions (Paragraph 151, Fig. 10: 2163) respectively disposed at lateral sides of the second seal forming structure, (Fig. 10)
wherein posterior surfaces of the lateral portions of the second seal forming structure slope in a superior-anterior direction from a boundary of the first and second seal forming structures, (Fig. 8, 11, 14).
Patel does not teach wherein a boundary between the first seal forming structure and the second seal forming structure comprises a ridge.
However, Barlow teaches a similar mask (Fig. 132)wherein a boundary between the first seal forming structure (Fig. 130, Fig. 31, Fig. 132: 249) and the second seal forming structure (Fig. 130: 247) comprises a ridge. (Fig. 130, transition area between the mouth portion 233 and the nose portion 246, Fig. 31, Fig. 132)
Barlow further teaches wherein posterior surface of the lateral portions of the second seal forming structure slope in a superior-anterior direction from boundary of the first and second seal forming structures. (Figs. 134, 136)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the patient interface of Patel so that the boundary between the first and second seal forming regions comprises a ridge as taught by Barlow to provide nasal and oral portions which are visually distinct which may assist the patient with aligning the mask. (paragraph 132)
Regarding claim 2, Patel in view of Barlow teaches the patient interface of claim 1, but does not disclose wherein the slope of each lateral portion forms an angle of between 20 degrees and 90 degrees with a mid-contact plane of the mask.
However, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to modify Patel in view of Barlow to have a slope of each lateral portion form an angle between 20 degrees and 90 degrees with a mid-contact plane of the mask since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst, Inc. In the instant case the patient interface of Patel in view of Barlow would not operate differently with the claimed range of angles since the mask would still seal to the nasal area. Further, Applicant places no criticality simply indicating that the angle is within the range. (specification, paragraph 140)
Regarding claim 3, Patel in view of Barlow teaches the patient interface of claim 1, but does not teach wherein no part of the patient interface is configured to contact the patient's alar crest point, in use.
However, Patel teaches a variety of geometries for the lateral nasal portions (Paragraph 128, adapted to seal around the opening of the nostril, may extend upwardly to seal along a portion of the left and right dorsal walls) With this finite number of identified predictable solutions it would be obvious to a person of ordinary skill in the art prior to the filing date of the invention to configure the patient interface device so that no part of the interface is configured to contact the patient’s alar crest point in use. This would have provided the predictable result of sealing the patient interface device.
Regarding claim 4, Patel in view of Barlow teaches the patient interface of claim 1, and Patel further teaches wherein at least a portion of the oral portion of the plenum chamber comprises a flexible shell. (Paragraph 134, 137, paragraph 133 fairly rigid so not completely rigid)
Regarding claim 7, Patel in view of Barlow teaches the patient interface of claim 4, and Patel further teaches wherein a rigidizing member is connected to the shell. (paragraph 130, a mask frame is attached to the shell)
Regarding claim 8, Patel in view of Barlow teaches the patient interface of claim 1,and Patel further teaches wherein the plenum chamber is at least partially formed by a shell (Fig. 4: 2102)and the vent structure is provided to the shell. (paragraph 132, may be provided in the shell)
Regarding claim 9, Patel in view of Barlow teaches the patient interface of claim 1, and Barlow further teaches wherein the ridge is configured to engage the patient's face at least proximate an entrance to the patient's nares, in use. (Figs. 130-134, ridge is located near center opening for the patient’s nares.)
Regarding claim 10, Patel in view of Barlow teaches the patient interface of claim 1, and Barlow further teaches wherein the ridge extends across an entire boundary between the first-seal forming structure and the second seal-forming structure. (See Figs. 132-134 where the structure extends completely between the seal forming structures.
Regarding claim 14, Patel in view of Barlow teaches the patient interface of claim 1, and Barlow further teaches wherein, in use, the second seal-forming structure extends directly from the ridge in a superior-anterior direction. (See Figs. 132-134)
Regarding claim 16, Patel in view of Barlow teaches the patient interface of claim 1, and Barlow further teaches wherein the ridge forms an angle between the first seal-forming structure and the second seal forming structure. (See Figs. 132-134)
Regarding claim 17, Patel in view of Barlow teaches the patient interface of claim 16, and Barlow further teaches wherein the angle formed by the first seal-forming structure and the second seal forming structure is in the range of 20 degrees to 90 degrees. (See Figs. 132-134, angle appears to be close to 90 degrees)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Barlow and further in view of Smith et al (US 2015/0128954), hereinafter Smith.
Regarding claim 5, Patel in view of Barlow teaches the patient interface of claim 4, but does not teach wherein the flexible shell is formed from a material having a Young's modulus of less than 0.4GPa.
However, Smith teaches a mask with a shell (Fig. 204) wherein the flexible shell is formed from a material having a Young’s modulus of less than 0.4GPa. (paragraph 137, the flexible shell should be less than 480 MPa.)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Patel in view of Barlow so that the shell is formed from a material with a Young’s modulus of less than 0.4GPa as taught by Smith in order to provide a shell which can conform the interface to a particular facial geometry. (paragraph 138)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Barlow and further in view of Moore et al (US 2003/0196656), hereinafter Moore.
Regarding claim 6, Patel in view of Barlow teaches the patient interface of claim 4, but does not teach wherein the material of the flexible shell is the same as a material that forms the first seal-forming structure and the second seal- forming structure.
However, Moore teaches a patient interface device (abstract) wherein the material of the flexible shell is the same as a material that forms the first seal-forming structure and the second seal-forming structure. (paragraph 196, the mask frame and cushion may be formed from the same material)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the patient interface of Patel in view of Barlow so that the flexible shell is the same material as a material that forms the first seal-forming structure and the second seal-forming structure so that the shell and seal forming structures may be formed in one piece. (Paragraph 196)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Barlow and further in view of Patel et al (US 2016/0184544), hereinafter Patel ‘544.
Regarding claim 18, Patel in view of Barlow teaches the patient interface of claim 1, and but does not teach wherein, in use, the ridge is configured to allow patient-contacting portions of the second seal forming structure to pivot or hinge about an area at or adjacent the ridge.
However, Patel ‘544 teaches a similar mask (Fig. 1) wherein a ridge is configured to allow patient-contacting portions of the second seal forming structure to pivot or hinge about an area at the ridge. (Fig. 1: 120, paragraph 66)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provide Patel with the ability to pivot or hinge as taught by Patel ‘544 to allow decoupling of the nasal and oral portions of the mask. (paragraph 86)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Barlow, and further in view of Barlow et al (US 2016/0082214), hereinafter Barlow ‘214.
Regarding claim 20, Patel in view of Barlow teaches the patient interface of claim 1, but does not teaches wherein the second seal forming structure includes a pair of nasal apertures configured to, in use, deliver the flow of air to the patient’s nose.
However, Barlow ‘214 teaches a similar patient interface (Fig. 18e) wherein the second seal forming structure (3116) includes a pair of nasal apertures (3105) configured to deliver the flow of air to the patient’s nose. (paragraph 323)
It would have been obvious to have substituted the single nasal aperture of Patel with the pair of nasal apertures of Barlow ‘214 since either option would give the predictable result of allowing a flow of air to the nares of the patient.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 2018/0177965), hereinafter Patel in view of Barlow.
Regarding claim 1, Barlow teaches a patient interface (Fig.1) comprising:
a plenum chamber (Chamber 2125) pressurizable to a therapeutic pressure of at least 5 cm H2O above ambient air pressure (Paragraph 155, typical treatment pressures of about 3 to about 25cm H2O), said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Fig. 4: 2114, paragraph 137 opening communicates with connector 2105 which provides the therapeutic air);
a first seal forming structure connected to an oral portion of the plenum chamber, the first seal forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s mouth such that the flow of air at said therapeutic pressure is delivered to the mouth (Paragraph 137, Fig. 5: oral region 2166, paragraph 146), the first seal forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in user (Paragraph 146, the seal surrounds the oral opening);
a second seal forming structure connected to a nasal portion of the plenum chamber (Paragraph 148, region 2168 surrounds nasal opening 2124), the second seal forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nose such that the flow of air at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use (paragraph 148, gently seals around the nasal nose); and
a vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to vent to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber is use (paragraph 132, bias holes 2110 exhaust air and flush CO2, may be provided on the mask shell, on the mask seal or any combination of connector, shell and seal);
wherein the second seal forming structure comprises a pair of lateral portions (Paragraph 151, Fig. 10: 2163) respectively disposed at lateral sides of the second seal forming structure, (Fig. 10)
wherein posterior surfaces of the lateral portions of the second seal forming structure slope in a superior-anterior direction from a boundary of the first and second seal forming structures, (Fig. 8, 11, 14).
Patel does not teach wherein a boundary between the first seal forming structure and the second seal forming structure comprises a ridge.
However, in another embodiment of Patel (Fig. 38) Patel teaches a boundary between the first seal forming structure and the second seal forming structure comprising a ridge. (Fig. 38: 2240)
It would have been obvious to a person of ordinary skill in the art to provide the ridge as taught by Patel to provide structure for a larger mask. (Paragraph 196)
Barlow teaches a similar mask (Fig. 132)wherein a posterior surface of the lateral portions of the second seal forming structure slope in a superior-anterior direction from boundary of the first and second seal forming structures. (Figs. 134, 136, second seal forming structure 24)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the patient interface of Patel to slope from a superior anterior direction as taught by Barlow for a comfortable fit of the mask.
Regarding claim 11, Patel in view of Barlow teaches the patient interface of claim 1, wherein, in use, the ridge is configured to engage the patient’s face proximate the entrances to the patient’s nares where each of the patient’s ala meets the face above the lip superior. (Fig. 38)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Barlow, and further in view of Barlow et al (US 2016/0082214), hereinafter Barlow ‘214.
Regarding claim 20, Patel in view of Barlow teaches the patient interface of claim 1, but does not teaches wherein the second seal forming structure includes a pair of nasal apertures configured to, in use, deliver the flow of air to the patient’s nose.
However, Barlow ‘214 teaches a similar patient interface (Fig. 18e) wherein the second seal forming structure (3116) includes a pair of nasal apertures (3105) configured to deliver the flow of air to the patient’s nose. (paragraph 323)
It would have been obvious to have substituted the single nasal aperture of Patel with the pair of nasal apertures of Barlow ‘214 since either option would give the predictable result of allowing a flow of air to the nares of the patient.
Allowable Subject Matter
Claims 12-13, 15, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 10/1/25 have been fully considered but they are not persuasive.
Applicant argues that the channel feature of Barlow is not a ridge and that the feature of Barlow does not teach as a means of minimizing creasing. However, minimizing creasing is never claimed. The Barlow reference teaches a feature which forms a ridge like structure which forms a boundary between the seal forming structures. Therefore, the rejection is maintained.
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 MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785